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82 FR 81 pgs. 19796-20231 - Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Program Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Provider-Based Status of Indian Health Service and Tribal Facilities and...

Type: PRORULEVolume: 82Number: 81Pages: 19796 - 20231
Docket number: [CMS-1677-P]
FR document: [FR Doc. 2017-07800 Filed 4-14-17; 4:15 pm]
Agency: Health and Human Services Department
Sub Agency: Centers for Medicare & Medicaid Services
Official PDF Version:  PDF Version
Pages: 19796, 19797, 19798, 19799, 19800, 19801, 19802, 19803, 19804, 19805, 19806, 19807, 19808, 19809, 19810, 19811, 19812, 19813, 19814, 19815, 19816, 19817, 19818, 19819, 19820, 19821, 19822, 19823, 19824, 19825, 19826, 19827, 19828, 19829, 19830, 19831, 19832, 19833, 19834, 19835, 19836, 19837, 19838, 19839, 19840, 19841, 19842, 19843, 19844, 19845, 19846, 19847, 19848, 19849, 19850, 19851, 19852, 19853, 19854, 19855, 19856, 19857, 19858, 19859, 19860, 19861, 19862, 19863, 19864, 19865, 19866, 19867, 19868, 19869, 19870, 19871, 19872, 19873, 19874, 19875, 19876, 19877, 19878, 19879, 19880, 19881, 19882, 19883, 19884, 19885, 19886, 19887, 19888, 19889, 19890, 19891, 19892, 19893, 19894, 19895, 19896, 19897, 19898, 19899, 19900, 19901, 19902, 19903, 19904, 19905, 19906, 19907, 19908, 19909, 19910, 19911, 19912, 19913, 19914, 19915, 19916, 19917, 19918, 19919, 19920, 19921, 19922, 19923, 19924, 19925, 19926, 19927, 19928, 19929, 19930, 19931, 19932, 19933, 19934, 19935, 19936, 19937, 19938, 19939, 19940, 19941, 19942, 19943, 19944, 19945, 19946, 19947, 19948, 19949, 19950, 19951, 19952, 19953, 19954, 19955, 19956, 19957, 19958, 19959, 19960, 19961, 19962, 19963, 19964, 19965, 19966, 19967, 19968, 19969, 19970, 19971, 19972, 19973, 19974, 19975, 19976, 19977, 19978, 19979, 19980, 19981, 19982, 19983, 19984, 19985, 19986, 19987, 19988, 19989, 19990, 19991, 19992, 19993, 19994, 19995, 19996, 19997, 19998, 19999, 20000, 20001, 20002, 20003, 20004, 20005, 20006, 20007, 20008, 20009, 20010, 20011, 20012, 20013, 20014, 20015, 20016, 20017, 20018, 20019, 20020, 20021, 20022, 20023, 20024, 20025, 20026, 20027, 20028, 20029, 20030, 20031, 20032, 20033, 20034, 20035, 20036, 20037, 20038, 20039, 20040, 20041, 20042, 20043, 20044, 20046, 20047, 20048, 20049, 20050, 20051, 20052, 20053, 20054, 20055, 20056, 20057, 20058, 20059, 20060, 20061, 20062, 20063, 20064, 20065, 20066, 20067, 20068, 20069, 20070, 20071, 20072, 20073, 20074, 20075, 20076, 20077, 20078, 20079, 20080, 20081, 20082, 20083, 20084, 20085, 20086, 20087, 20088, 20089, 20090, 20091, 20092, 20093, 20094, 20095, 20096, 20097, 20098, 20099, 20100, 20101, 20102, 20103, 20104, 20105, 20106, 20107, 20108, 20109, 20110, 20111, 20112, 20113, 20114, 20115, 20116, 20117, 20118, 20119, 20120, 20121, 20122, 20123, 20124, 20125, 20126, 20127, 20128, 20129, 20130, 20131, 20132, 20133, 20134, 20135, 20136, 20137, 20138, 20139, 20140, 20141, 20142, 20143, 20144, 20145, 20146, 20147, 20148, 20149, 20150, 20151, 20152, 20153, 20154, 20155, 20156, 20157, 20158, 20159, 20160, 20161, 20162, 20163, 20164, 20165, 20166, 20167, 20168, 20169, 20170, 20171, 20172, 20173, 20174, 20175, 20176, 20177, 20178, 20179, 20180, 20181, 20182, 20183, 20184, 20185, 20186, 20187, 20188, 20189, 20190, 20191, 20192, 20193, 20194, 20195, 20196, 20197, 20198, 20200, 20201, 20202, 20203, 20204, 20206, 20207, 20208, 20209, 20210, 20211, 20212, 20213, 20214, 20215, 20216, 20217, 20218, 20219, 20220, 20221, 20222, 20223, 20224, 20225, 20226, 20227, 20228, 20229, 20230, 20231

[top] page 19796

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Centers for Medicare & Medicaid Services

42 CFR Parts 405, 412, 413, 414, 416, 486, 488, 489, and 495

[CMS-1677-P]

RIN 0938-AS98

Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Program Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Provider-Based Status of Indian Health Service and Tribal Facilities and Organizations; Costs Reporting and Provider Requirements; Agreement Termination Notices

AGENCY:

Centers for Medicare and Medicaid Services (CMS), HHS.

ACTION:

Proposed rule.

SUMMARY:

We are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2018. Some of these proposed changes would implement certain statutory provisions contained in the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013, the Improving Medicare Post-Acute Care Transformation Act of 2014, the Medicare Access and CHIP Reauthorization Act of 2015, the 21st Century Cures Act, and other legislation. We also are making proposals relating to the provider-based status of Indian Health Service (IHS) and Tribal facilities and organizations and to the low-volume hospital payment adjustment for hospitals operated by the IHS or a Tribe. In addition, we are providing the proposed estimated market basket update that would apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2018. We are proposing to update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2018.

In addition, we are proposing to establish new requirements or revise existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, LTCHs, and inpatient psychiatric facilities). We also are proposing to establish new requirements or revise existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. We are proposing to update policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program.

We also are proposing changes relating to transparency of accrediting organization survey reports and plans of correction of providers and suppliers; electronic signature and electronic submission of the Certification and Settlement Summary page of the Medicare cost reports; and clarification of provider disposal of assets.

DATES:

Comment Period: To be assured consideration, comments must be received at one of the addresses provided in the ADDRESSES section, no later than 5 p.m. EDT on June 13, 2017.

ADDRESSES:

In commenting, please refer to file code CMS-1677-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

You may submit comments in one of four ways (no duplicates, please):

1. Electronically. You may (and we encourage you to) submit electronic comments on this regulation to http://www.regulations.gov . Follow the instructions under the "submit a comment" tab.

2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1677-P, P.O. Box 8011, Baltimore, MD 21244-1850.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

3. By express or overnight mail. You may send written comments via express or overnight mail to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1677-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

4. By hand or courier. If you prefer, you may deliver (by hand or courier) your written comments before the close of the comment period to either of the following addresses:

a. For delivery in Washington, DC-Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.

(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)

b. For delivery in Baltimore, MD-Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.

If you intend to deliver your comments to the Baltimore address, please call the telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members.

Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

For information on viewing public comments, we refer readers to the beginning of the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:

Donald Thompson, (410) 786-4487, and Michele Hudson, (410) 786-4487, Operating Prospective Payment, MS-DRGs, Wage Index, New Medical Service and Technology Add-On Payments, Hospital Geographic Reclassifications, Graduate Medical Education, Capital Prospective Payment, Excluded Hospitals, Sole Community Hospitals, Medicare Disproportionate Share Hospital (DSH) Payment Adjustment, Medicare-Dependent Small Rural Hospital (MDH) Program, and Low-Volume Hospital Payment Adjustment Issues.

Michele Hudson, (410) 786-4487, Mark Luxton, (410) 786-4530, and Emily Lipkin, (410) 786-3633, Long-Term Care Hospital Prospective Payment System and MS-LTC-DRG Relative Weights Issues.

Mollie Knight, (410) 786-7948, and Bridget Dickensheets, (410) 786-8670, Rebasing and Revising the Hospital Market Basket Issues.


[top] Siddhartha Mazumdar, (410) 786-6673, Rural Community Hospital Demonstration Program Issues. page 19797

Jeris Smith, (410) 786-0110, Frontier Community Health Integration Project Demonstration Issues.

Lein Han, (617) 879-0129, Hospital Readmissions Reduction Program-Readmission Measures for Hospitals Issues.

Delia Houseal, (410) 786-2724, Hospital Readmissions Reduction Program-Administration Issues.

Elizabeth Bainger, (410) 786-0529, Hospital-Acquired Condition Reduction Program Issues.

Joseph Clift, (410) 786-4165, Hospital-Acquired Condition Reduction Program-Measures Issues.

Grace Im, (410) 786-0700 and James Poyer, (410) 786-2261, Hospital Inpatient Quality Reporting and Hospital Value-Based Purchasing-Program Administration, Validation, and Reconsideration Issues.

Reena Duseja, (410) 786-1999 and Cindy Tourison, (410) 786-1093, Hospital Inpatient Quality Reporting-Measures Issues Except Hospital Consumer Assessment of Healthcare Providers and Systems Issues; and Readmission Measures for Hospitals Issues.

Kim Spaulding Bush, (410) 786-3232, Hospital Value-Based Purchasing Efficiency Measures Issues.

Elizabeth Goldstein, (410) 786-6665, Hospital Inpatient Quality Reporting-Hospital Consumer Assessment of Healthcare Providers and Systems Measures Issues.

James Poyer, (410) 786-2261, PPS-Exempt Cancer Hospital Quality Reporting Issues.

Mary Pratt, (410) 786-6867, Long-Term Care Hospital Quality Data Reporting Issues.

Jeffrey Buck, (410) 786-0407 and Cindy Tourison (410) 786-1093, Inpatient Psychiatric Facilities Quality Data Reporting Issues.

Lisa Marie Gomez, (410) 786-1175, EHR Incentive Program Clinical Quality Measure Related Issues.

Kathleen Johnson, (410) 786-3295 and Steven Johnson (410) 786-3332, EHR Incentive Program Nonclinical Quality Measure Related Issues.

Caecilia Blondiaux, (410), 786-2190, and Ariadne Saklas, (410) 786-3322, Changes in Notice of Termination of Medicare Providers and Suppliers Issues.

Monda Shaver, (410) 786-3410, and Patricia Chmielewski, (410) 786-6899, Accrediting Organizations Survey Reporting Transparency Issues.

Kellie Shannon, (410) 786-0416, Medicare Cost Reporting and Valuation of Assets Issues.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.regulations.gov . Follow the search instructions on that Web site to view public comments.

Comments received timely will also be available for public inspection, generally beginning approximately 3 weeks after publication of the rule, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244, on Monday through Friday of each week from 8:30 a.m. to 4:00 p.m. EST. To schedule an appointment to view public comments, phone 1-800-743-3951.

Electronic Access

This Federal Register document is available from the Federal Register online database through Federal Digital System (FDsys), a service of the U.S. Government Printing Office. This database can be accessed via the Internet at: http://www.gpo.gov/fdsys .

Tables Available Only Through the Internet on the CMS Web Site

In the past, a majority of the tables referred to throughout this preamble and in the Addendum to the proposed rule and the final rule were published in the Federal Register as part of the annual proposed and final rules. However, beginning in FY 2012, some of the IPPS tables and LTCH PPS tables are no longer published in the Federal Register . Instead, these tables generally will be available only through the Internet. The IPPS tables for this proposed rule are available through the Internet on the CMS Web site at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html . Click on the link on the left side of the screen titled, "FY 2018 IPPS Proposed Rule Home Page" or "Acute Inpatient-Files for Download". The LTCH PPS tables for this FY 2018 proposed rule are available through the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/LongTermCareHospitalPPS/index.html under the list item for Regulation Number CMS-1677-P. For further details on the contents of the tables referenced in this proposed rule, we refer readers to section VI. of the Addendum to this proposed rule.

Readers who experience any problems accessing any of the tables that are posted on the CMS Web sites identified above should contact Michael Treitel at (410) 786-4552.

Acronyms

3M 3M Health Information System

AAMC Association of American Medical Colleges

ACGME Accreditation Council for Graduate Medical Education

ACoS American College of Surgeons

AHA American Hospital Association

AHIC American Health Information Community

AHIMA American Health Information Management Association

AHRQ Agency for Healthcare Research and Quality

AJCC American Joint Committee on Cancer

ALOS Average length of stay

ALTHA Acute Long-Term Hospital Association

AMA American Medical Association

AMGA American Medical Group Association

AMI Acute myocardial infarction

AO Accrediting Organizations

AOA American Osteopathic Association

APR DRG All Patient Refined Diagnosis Related Group System

APRN Advanced practice registered nurse

ARRA American Recovery and Reinvestment Act of 2009, Public Law 111-5

ASCA Administrative Simplification Compliance Act of 2002, Public Law 107-105

ASITN American Society of Interventional and Therapeutic Neuroradiology

ASPE Assistant Secretary for Planning and Evaluation (DHHS)

ATRA American Taxpayer Relief Act of 2012, Public Law 112-240

BBA Balanced Budget Act of 1997, Public Law 105-33

BBRA Medicare, Medicaid, and SCHIP [State Children's Health Insurance Program] Balanced Budget Refinement Act of 1999, Public Law 106-113

BIPA Medicare, Medicaid, and SCHIP [State Children's Health Insurance Program] Benefits Improvement and Protection Act of 2000, Public Law 106-554

BLS Bureau of Labor Statistics

CABG Coronary artery bypass graft [surgery]

CAH Critical access hospital

CARE [Medicare] Continuity Assessment Record & Evaluation [Instrument]

CART CMS Abstraction & Reporting Tool

CAUTI Catheter-associated urinary tract infection

CBSAs Core-based statistical areas

CC Complication or comorbidity

CCN CMS Certification Number

CCR Cost-to-charge ratio

CDAC [Medicare] Clinical Data Abstraction Center

CDAD Clostridium difficile -associated disease


[top] CDC Centers for Disease Control and Prevention page 19798

CERT Comprehensive error rate testing

CDI Clostridium difficile [C. difficile] infection

CFR Code of Federal Regulations

CLABSI Central line-associated bloodstream infection

CIPI Capital input price index

CMI Case-mix index

CMS Centers for Medicare & Medicaid Services

CMSA Consolidated Metropolitan Statistical Area

COBRA Consolidated Omnibus Reconciliation Act of 1985, Public Law 99-272

COLA Cost-of-living adjustment

CoP [Hospital] condition of participation

COPD Chronic obstructive pulmonary disease

CPI Consumer price index

CQL Clinical quality language

CQM Clinical quality measure

CY Calendar year

DACA Data Accuracy and Completeness Acknowledgement

DPP Disproportionate patient percentage

DRA Deficit Reduction Act of 2005, Public Law 109-171

DRG Diagnosis-related group

DSH Disproportionate share hospital

EBRT External beam radiotherapy

ECE Extraordinary circumstances exemption

ECI Employment cost index

eCQM Electronic clinical quality measure

EDB [Medicare] Enrollment Database

EHR Electronic health record

EMR Electronic medical record

EMTALA Emergency Medical Treatment and Labor Act of 1986, Public Law 99-272

EP Eligible professional

FAH Federation of American Hospitals

FDA Food and Drug Administration

FFY Federal fiscal year

FPL Federal poverty line

FQHC Federally qualified health center

FR Federal Register

FTE Full-time equivalent

FY Fiscal year

GAF Geographic Adjustment Factor

GME Graduate medical education

HAC Hospital-acquired condition

HAI Healthcare-associated infection

HCAHPS Hospital Consumer Assessment of Healthcare Providers and Systems

HCFA Health Care Financing Administration

HCO High-cost outlier

HCP Healthcare personnel

HCRIS Hospital Cost Report Information System

HF Heart failure

HHA Home health agency

HHS Department of Health and Human Services

HICAN Health Insurance Claims Account Number

HIPAA Health Insurance Portability and Accountability Act of 1996, Public Law 104-191

HIPC Health Information Policy Council

HIS Health information system

HIT Health information technology

HMO Health maintenance organization

HPMP Hospital Payment Monitoring Program

HSA Health savings account

HSCRC [Maryland] Health Services Cost Review Commission

HSRV Hospital-specific relative value

HSRVcc Hospital-specific relative value cost center

HQA Hospital Quality Alliance

HQI Hospital Quality Initiative

HwH Hospital-within-hospital

HWR Hospital-wide readmission

ICD-9-CM International Classification of Diseases, Ninth Revision, Clinical Modification

ICD-10-CM International Classification of Diseases, Tenth Revision, Clinical Modification

ICD-10-PCS International Classification of Diseases, Tenth Revision, Procedure Coding System

ICR Information collection requirement

ICU Intensive care unit

IGI IHS Global Insight, Inc.

IHS Indian Health Service

IME Indirect medical education

IMPACT Act Improving Medicare Post-Acute Care Transformation Act of 2014, Public Law 113-185

I-O Input-Output

IOM Institute of Medicine

IPF Inpatient psychiatric facility

IPFQR Inpatient Psychiatric Facility Quality Reporting [Program]

IPPS [Acute care hospital] inpatient prospective payment system

IRF Inpatient rehabilitation facility

IQR [Hospital] Inpatient Quality Reporting

LAMCs Large area metropolitan counties

LDS Limited Data Set

LOS Length of stay

LTC-DRG Long-term care diagnosis-related group

LTCH Long-term care hospital

LTCH QRP Long-Term Care Hospital Quality Reporting Program

MA Medicare Advantage

MAC Medicare Administrative Contractor

MACRA Medicare Access and CHIP Reauthorization Act of 2015, Public Law 114-10

MAP Measure Application Partnership

MCC Major complication or comorbidity

MCE Medicare Code Editor

MCO Managed care organization

MDC Major diagnostic category

MDH Medicare-dependent, small rural hospital

MedPAC Medicare Payment Advisory Commission

MedPAR Medicare Provider Analysis and Review File

MEI Medicare Economic Index

MGCRB Medicare Geographic Classification Review Board

MIEA-TRHCA Medicare Improvements and Extension Act, Division B of the Tax Relief and Health Care Act of 2006, Public Law 109-432

MIPPA Medicare Improvements for Patients and Providers Act of 2008, Public Law 110-275

MMA Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173

MMEA Medicare and Medicaid Extenders Act of 2010, Public Law 111-309

MMSEA Medicare, Medicaid, and SCHIP Extension Act of 2007, Public Law 110-173

MOON Medicare Outpatient Observation Notice

MRHFP Medicare Rural Hospital Flexibility Program

MRSA Methicillin-resistant Staphylococcus aureus

MSA Metropolitan Statistical Area

MS-DRG Medicare severity diagnosis-related group

MS-LTC-DRG Medicare severity long-term care diagnosis-related group

MU Meaningful Use [EHR Incentive Program]

MUC Measure under consideration

NAICS North American Industrial Classification System

NALTH National Association of Long Term Hospitals

NCD National coverage determination

NCHS National Center for Health Statistics

NCQA National Committee for Quality Assurance

NCVHS National Committee on Vital and Health Statistics

NECMA New England County Metropolitan Areas

NHSN National Healthcare Safety Network

NOP Notice of Participation

NOTICE Act Notice of Observation Treatment and Implication for Care Eligibility Act, Public Law 114-42

NQF National Quality Forum

NQS National Quality Strategy

NTIS National Technical Information Service

NTTAA National Technology Transfer and Advancement Act of 1991, Public Law 104-113

NUBC National Uniform Billing Code

NVHRI National Voluntary Hospital Reporting Initiative

OACT [CMS'] Office of the Actuary

OBRA 86 Omnibus Budget Reconciliation Act of 1986, Public Law 99-509

OES Occupational employment statistics

OIG Office of the Inspector General

OMB [Executive] Office of Management and Budget

ONC Office of the National Coordinator for Health Information Technology

OPM [U.S.] Office of Personnel Management

OQR [Hospital] Outpatient Quality Reporting

O.R. Operating room

OSCAR Online Survey Certification and Reporting [System]

PAC Post-acute care

PAMA Protecting Access to Medicare Act of 2014, Public Law 113-93

PCH PPS-exempt cancer hospital

PCHQR PPS-exempt cancer hospital quality reporting

PMSAs Primary metropolitan statistical areas

POA Present on admission

PPI Producer price index

PPR Potentially Preventable Readmissions

PPS Prospective payment system

PRA Paperwork Reduction Act

PRM Provider Reimbursement Manual

ProPAC Prospective Payment Assessment Commission

PRRB Provider Reimbursement Review Board


[top] PRTFs Psychiatric residential treatment facilities page 19799

PSF Provider-Specific File

PSI Patient safety indicator

PS&R Provider Statistical and Reimbursement [System]

PQRS Physician Quality Reporting System

PUF Public use file

QDM Quality data model

QIES ASAP Quality Improvement Evaluation System Assessment Submission and Processing

QIG Quality Improvement Group [CMS]

QIO Quality Improvement Organization

QM Quality measure

QPP Quality Payment Program

QRDA Quality Reporting Document Architecture

RFA Regulatory Flexibility Act, Public Law 96-354

RHC Rural health clinic

RHQDAPU Reporting hospital quality data for annual payment update

RIM Reference information model

RNHCI Religious nonmedical health care institution

RPL Rehabilitation psychiatric long-term care (hospital)

RRC Rural referral center

RSMR Risk-standard mortality rate

RSP Risk-standardized payment

RSSR Risk-standard readmission rate

RTI Research Triangle Institute, International

RUCAs Rural-urban commuting area codes

RY Rate year

SAF Standard Analytic File

SCH Sole community hospital

SCHIP State Child Health Insurance Program

SCIP Surgical Care Improvement Project

SFY State fiscal year

SGR Sustainable Growth Rate

SIC Standard Industrial Classification

SIR Standardized infection ratio

SNF Skilled nursing facility

SNF QRP Skilled Nursing Facility Quality Reporting Program

SNF VBP Skilled Nursing Facility Value-Based Purchasing

SOCs Standard occupational classifications

SOM State Operations Manual

SRR Standardized risk ratio

SSI Surgical site infection

SSI Supplemental Security Income

SSO Short-stay outlier

SUD Substance use disorder

TEFRA Tax Equity and Fiscal Responsibility Act of 1982, Public Law 97-248

TEP Technical expert panel

THA/TKA Total hip arthroplasty/total knee arthroplasty

TMA TMA [Transitional Medical Assistance], Abstinence Education, and QI [Qualifying Individuals] Programs Extension Act of 2007, Public Law 110-90

TPS Total Performance Score

UHDDS Uniform hospital discharge data set

UR Utilization review

VBP [Hospital] Value Based Purchasing [Program]

VTE Venous thromboembolism

Table of Contents

I. Executive Summary and Background

A. Executive Summary

1. Purpose and Legal Authority

2. Summary of the Major Provisions

3. Summary of Costs and Benefits

B. Summary

1. Acute Care Hospital Inpatient Prospective Payment System (IPPS)

2. Hospitals and Hospital Units Excluded From the IPPS

3. Long-Term Care Hospital Prospective Payment System (LTCH PPS)

4. Critical Access Hospitals (CAHs)

5. Payments for Graduate Medical Education (GME)

C. Summary of Provisions of Recent Legislation Proposed To Be Implemented in This Proposed Rule

1. The American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-240), the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015 (Pub. L. 114-10), and the 21st Century Cures Act (Pub. L. 114-255)

2. Pathway for SGR Reform Act of 2013 (Pub. L. 113-67)

3. Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) (Pub. L. 113-185)

4. The Medicare Access and CHIP Reauthorization Act (MACRA) of 2015 (Pub. L. 114-10)

5. The 21st Century Cures Act (Pub. L. 114-255)

D. Summary of the Provisions of This Proposed Rule

II. Proposed Changes to Medicare Severity Diagnosis-Related Group (MS-DRG) Classifications and Relative Weights

A. Background

B. MS-DRG Reclassifications

C. Adoption of the MS-DRGs in FY 2008

D. Proposed FY 2018 MS-DRG Documentation and Coding Adjustment

1. Background on the Prospective MS-DRG Documentation and Coding Adjustments for FY 2008 and FY 2009 Authorized by Public Law 110-90

2. Recoupment or Repayment Adjustment Authorized by Section 631 of the American Taxpayer Relief Act of 2012 (ATRA)

3. Proposed Adjustment for FY 2018 Required Under Section 414 of Public Law 114-10 (MACRA) and Section 15005 of Public Law 114-255

E. Refinement of the MS-DRG Relative Weight Calculation

1. Background

2. Discussion of Policy for FY 2018

F. Proposed Changes to Specific MS-DRG Classifications

1. Discussion of Changes to Coding System and Basis for Proposed FY 2018 MS-DRG Updates

a. Conversion of MS-DRGs to the International Classification of Diseases, 10th Revision (ICD-10)

b. Basis for FY 2018 Proposed MS-DRG Updates

2. MDC 1 (Diseases and Disorders of the Nervous System)

a. Functional Quadriplegia

b. Responsive Neurostimulator (RNS © ) System

c. Precerebral Occlusion or Transient Ischemic Attack With Thrombolytic

3. MDC 2 (Diseases and Disorders of the Eye: Swallowing Eye Drops (Tetrahydrozoline)

4. MDC 5 (Diseases and Disorders of the Circulatory System)

a. Percutaneous Cardiovascular Procedures and Insertion of a Radioactive Element

b. Proposed Modification of the Titles for MS-DRG 246 (Percutaneous Cardiovascular Procedures With Drug-eluting Stent With MCC or 4+ Vessels or Stents) and MS-DRG 248 (Percutaneous Cardiovascular Procedures With Non-Drug-Eluting Stent With MCC or 4+ Vessels or Stents)

c. Transcatheter Aortic Valve Replacement (TAVR) and Left Atrial Appendage Closure (LAAC)

d. Percutaneous Mitral Valve Replacement Procedures

e. Percutaneous Tricuspid Valve Repair

5. MDC 8 (Diseases and Disorders of the Musculoskeletal System and Connective Tissue)

a. Total Ankle Replacement (TAR) Procedures

b. Revision of Total Ankle Replacement (TAR) Procedures

c. Magnetic Controlled Growth Rods (MAGEC® System)

d. Combined Anterior/Posterior Spinal Fusion

6. MDC 14 (Pregnancy, Childbirth and the Puerperium)

a. Vaginal Delivery and Complicating Diagnoses

b. MS-DRG 998 (Principal Diagnosis Invalid as Discharge Diagnosis)

c. MS-DRG 782 (Other Antepartum Diagnoses Without Medical Complications)

d. Shock During or Following Labor and Delivery

7. MDC 15 (Newborns and Other Neonates With Conditions Originating in Perinatal Period): Observation and Evaluation of Newborn

8. MDC 21 (Injuries, Poisonings and Toxic Effects of Drugs): Complication Codes

9. MDC 23 (Factors Influencing Health Status and Other Contacts With Health Services): Updates to MS-DRGs 945 and 946 (Rehabilitation With CC/MCC and Without CC/MCC, Respectively)

10. Proposed Changes to the Medicare Code Editor (MCE)

a. Age Conflict Edit

b. Sex Conflict Edit

c. Non-Covered Procedure Edit

d. Unacceptable Principal Diagnosis Edit

e. Future Enhancement

11. Proposed Changes to Surgical Hierarchies

12. Proposed Changes to the MS-DRG Diagnosis Codes for FY 2018

a. Background of the CC List and the CC Exclusions List

b. Proposed Additions and Deletions to the Diagnosis Code Severity Levels for FY 2018

c. Principal Diagnosis Is Its Own CC or MCC

d. Proposed CC Exclusions List for FY 2018

13. Comprehensive Review of CC List for FY 2019


[top] 14. Review of Procedure Codes in MS DRGs 981 Through 983; 984 Through 986; and 987 Through 989 page 19800

a. Moving Procedure Codes From MS-DRGs 981 Through 983 or MS-DRGs 987 Through 989 Into MDCs

b. Reassignment of Procedures Among MS-DRGs 981 Through 983, 984 Through 986, and 987 Through 989

15. Proposed Changes to the ICD-10-CM and ICD-10-PCS Coding Systems

16. Proposed Replaced Devices Offered Without Cost or With a Credit

a. Background

b. Proposed Changes for FY 2018

17. Other Proposed Policy Changes: Other Operating Room (O.R.) and Non-O.R. Issues

a. O.R. Procedures to Non-O.R. Procedures

b. Revision of Neurostimulator Generator

c. External Repair of Hymen

d. Non-O.R. Procedures in MDC 17 (Myeloproliferative Diseases and Disorders Poorly Differentiated Neoplasms)

G. Recalibration of the Proposed FY 2018 MS-DRG Relative Weights

1. Data Sources for Developing the Relative Weights

2. Methodology for Calculation of the Relative Weights

3. Development of National Average CCRs

H. Proposed Add-On Payments for New Services and Technologies for FY 2018

1. Background

2. Public Input Before Publication of a Notice of Proposed Rulemaking on Add-On Payments

3. ICD-10-PCS Section "X" Codes for Certain New Medical Services and Technologies

4. Proposal To Revise Reference to an ICD-9-CM Code in §?412.87(b)(2) of the Regulations

5. Proposed FY 2018 Status of Technologies Approved for FY 2017 Add-On Payments

a. CardioMEMS TM HF (Heart Failure) Monitoring System

b. Defitelio® (Defibrotide)

c. GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE)

d. Idarucizumab

e. Lutonix® Drug Coated Balloon PTA Catheter and In.PACT TM Admiral TM Paclitaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

f. MAGEC® Spinal Bracing and Distraction System (MAGEC® Spine)

g. Vistogard TM (Uridine Triacetate)

h. Blinatumomab (BLINCYTO TM Trade Brand)

6. FY 2018 Applications for New Technology Add-On Payments

a. Bezlotoxumab (ZINPLAVA TM )

b. EDWARDS INTUITY Elite TM Valve System (INTUITY) and Liva Nova Perceval Valve (Perceval)

c. Ustekinumab (Stelara®)

d. KTE-C19 (Axicabtagene Ciloleucel)

e. VYXEOS TM (Cytarabine and Daunorubicin Liposome for Injection)

f. GammaTile TM

III. Proposed Changes to the Hospital Wage Index for Acute Care Hospitals

A. Background

1. Legislative Authority

2. Core-Based Statistical Areas (CBSAs) for the Proposed FY 2018 Hospital Wage Index

3. Codes for Constituent Counties in CBSAs

B. Worksheet S-3 Wage Data for the Proposed FY 2018 Wage Index

1. Included Categories of Costs

2. Excluded Categories of Costs

3. Use of Wage Index Data by Suppliers and Providers Other Than Acute Care Hospitals Under the IPPS

C. Verification of Worksheet S-3 Wage Data

D. Method for Computing the Proposed FY 2018 Unadjusted Wage Index

1. Proposed Methodology for FY 2018

2. Clarification of Other Wage Related Costs in the Wage Index

E. Proposed Occupational Mix Adjustment to the FY 2018 Wage Index

1. Use of 2013 Occupational Mix Survey for the FY 2018 Wage Index

2. Use of the 2016 Medicare Wage Index Occupational Mix Survey for the FY 2019 Wage Index

3. Calculation of the Proposed Occupational Mix Adjustment for FY 2018

F. Analysis and Implementation of the Proposed Occupational Mix Adjustment and the Proposed FY 2018 Occupational Mix Adjusted Wage Index

G. Proposed Application of the Rural, Imputed, and Frontier Floors

1. Proposed Rural Floor

2. Proposed Expiration of the Imputed Floor Policy

3. Proposed State Frontier Floor for FY 2018

H. Proposed FY 2018 Wage Index Tables

I. Revisions to the Wage Index Based on Hospital Redesignations and Reclassifications

1. General Policies and Effects of Reclassification and Redesignation

2. MGCRB Reclassification and Redesignation Issues for FY 2018

a. FY 2018 Reclassification Requirements and Approvals

b. Extension of PRA Information Collection Requirement Approval for MGCRB Applications

c. Proposed Deadline for Submittal of Documentation of Sole Community Hospital (SCH) and Rural Referral Center (RRC) Classification Status to the MGCRB

d. Clarification of Special Rules for SCHs and RRCs Reclassifying to Geographic Home Area

3. Redesignations Under Section 1886(d)(8)(B) of the Act

4. Proposed Changes to the 45-Day Notification Rules

J. Proposed Out-Migration Adjustment Based on Commuting Patterns of Hospital Employees

K. Reclassification From Urban to Rural Under Section 1886(d)(8)(E) of the Act Implemented at 42 CFR 412.103

L. Clarification of Application Deadline for Rural Referral Center (RRC) Classification

M. Proposed Process for Requests for Wage Index Data Corrections

1. Process for Hospitals To Accept Wage Index Data Corrections

2. Process for Wage Index Data Corrections by CMS After the January Public Use File (PUF)

N. Proposed Labor Market Share for the Proposed FY 2018 Wage Index

IV. Proposed Rebasing and Revising of the Hospital Market Baskets for Acute Care Hospitals

A. Background

B. Rebasing and Revising the IPPS Market Basket

1. Development of Cost Categories and Weights

a. Use of Medicare Cost Report Data

b. Final Major Cost Category Computation

c. Derivation of the Detailed Cost Weights

2. Selection of Proposed Price Proxies

3. Labor-Related Share

C. Market Basket for Certain Hospitals Presently Excluded From the IPPS

D. Rebasing and Revising the Capital Input Price Index (CIPI)

V. Other Decisions and Proposed Changes to the IPPS for Operating System

A. Proposed Changes to MS-DRGs Subject to Postacute Care Transfer and MS-DRG Special Payment Policies

B. Proposed Changes in the Inpatient Hospital Updates for FY 2018 (§?412.64(d))

1. Proposed FY 2018 Inpatient Hospital Update

2. Proposed FY 2018 Puerto Rico Hospital Update

C. Proposed Change to Volume Decrease Adjustment for Sole Community Hospitals (SCHs) and Medicare-Dependent, Small Rural Hospitals (MDHs) (§?412.92)

1. Background

2. Proposed Changes to the Volume Decrease Adjustment Calculation Methodology for SCHs

D. Rural Referral Centers (RRCs): Proposed Annual Updates to Case-Mix Index (CMI) and Discharge Criteria (§?412.96)

1. Case-Mix Index (CMI)

2. Discharges

E. Proposed Payment Adjustment for Low-Volume Hospitals (§?412.101)

1. Expiration of Temporary Changes to Low-Volume Hospital Payment Policy

2. Background

3. Proposed Payment Adjustment for FY 2018 and Subsequent Fiscal Years

4. Proposed Parallel Low-Volume Hospital Payment Adjustment Regarding Hospitals Operated by the Indian Health Service (IHS) or a Tribe

F. Indirect Medical Education (IME) Payment Adjustment (§?412.105)

G. Proposed Payment Adjustment for Medicare Disproportionate Share Hospitals (DSHs) for FY 2018 (§?412.106)

1. General Discussion

2. Eligibility for Empirically Justified Medicare DSH Payments and Uncompensated Care Payments

3. Empirically Justified Medicare DSH Payments

4. Uncompensated Care Payments

a. Proposed Calculation of Factor 1 for FY 2018

b. Proposed Calculation of Factor 2 for FY 2018


[top] (1) Background page 19801

(2) Proposed Methodology for Calculation of Factor 2 for FY 2018

c. Calculation of Proposed Factor 3 for FY 2018

(1) Background

(2) Proposed Data Source for FY 2018

(3) Proposed Time Period for Calculating Factor 3 for FY 2018, Including Methodology for Incorporating Worksheet S-10 Data

(4) Methodological Considerations for Calculating Factor 3

(5) Methodological Considerations for Incorporating Worksheet S-10 Data

H. Medicare-Dependent, Small Rural Hospital (MDH) Program (§?412.108)

1. Background for the MDH Program

a. Expiration of the MDH Program

I. Hospital Readmissions Reduction Program: Proposed Updates and Changes (§§?412.150 Through 412.154)

1. Statutory Basis for the Hospital Readmissions Reduction Program

2. Regulatory Background

3. Maintenance of Technical Specifications for Quality Measures

4. Proposed Policies for the Hospital Readmissions Reduction Program

5. Proposed Applicable Period for FY 2018

6. Proposed Calculation of Aggregate Payments for Excess Readmissions for FY 2018

7. Background and Current Payment Adjustment Methodology

a. Background

b. Current Payment Adjustment Methodology

8. Provisions for the Proposed Payment Adjustment Methodology for FY 2019: Proposed Methodology for Calculating the Proportion of Dual Eligible Patients

a. Background

b. Proposed Data Sources Used To Determine Dual Eligibility

c. Proposed Data Period Used To Define Dual Eligibility

9. Provision for the Proposed Payment Adjustment Methodology for FY 2019: Proposed Methodology for Assigning Hospitals to Peer Groups

10. Provisions for the Proposed Payment Adjustment Methodology for FY 2019: Proposed Payment Adjustment Formula Calculation Methodology

a. Background

b. Proposals

c. Analysis

11. Accounting for Social Risk Factors in the Hospital Readmissions Reduction Program

12. Extraordinary Circumstance Exception (ECE) Policy

13. Timeline for Public Reporting of Excess Readmission Ratios on Hospital Compare for the FY 2018 Payment Determination

J. Hospital Value-Based Purchasing (VBP) Program: Proposed Policy Changes

1. Background

a. Statutory Background and Overview of Past Program Years

b. FY 2018 Program Year Payment Details

2. Accounting for Social Risk Factors in the Hospital VBP Program

3. Retention and Removal of Quality Measures for the FY 2019 Program Year

a. Retention of Previously Adopted Hospital VBP Program Measures

b. Proposed Removal of the PSI 90 Measure

c. Summary of Previously Adopted Measures and Proposed Measure for Removal for the FY 2019 and FY 2020 Program Years

4. Proposed New Measures for the FY 2022 Program Year, FY 2023 Program Year, and Subsequent Years

a. Proposed New Measure for the FY 2022 Program Year and Subsequent Years: Hospital-Level, Risk-Standardized Payment Associated With a 30-Day Episode-of-Care for Pneumonia (PN Payment)

b. Proposed New Measure for the FY 2023 Program Year and Subsequent Years: Patient Safety and Adverse Events (Composite) (NQF #0531)

5. Previously Adopted and Proposed Baseline and Performance Periods

a. Background

b. Person and Community Engagement Domain

c. Efficiency and Cost Reduction Domain

d. Safety Domain

e. Clinical Care Domain

f. Summary of Previously Adopted and Proposed Baseline and Performance Periods for the FY 2019 Through FY 2023 Program Years

6. Proposed Performance Standards for the Hospital VBP Program

a. Background

b. Previously Adopted and Proposed Performance Standards for the FY 2020 Program Year

c. Previously Adopted Performance Standards for Certain Measures for the FY 2021 Program Year

d. Previously Adopted and Proposed Performance Standards for Certain Measures for the FY 2022 Program Year

e. Proposed Performance Standards for Certain Measures for the FY 2023 Program Year

7. Scoring Methodology and Data Requirements for the FY 2019 Program Year and Subsequent Years

a. Proposed Domain Weighting for the FY 2020 Program Year and Subsequent Years for Hospitals That Receive a Score on All Domains

b. Proposed Domain Weighting for the FY 2019 Program Year and Subsequent Years for Hospitals Receiving Scores on Fewer Than Four Domains

c. Minimum Numbers of Cases for Hospital VBP Program Measures for the FY 2019 Program Year and Subsequent Years

d. Weighting Measures Within the Efficiency and Cost Reduction Domain

K. Proposed Changes to the Hospital-Acquired Condition (HAC) Reduction Program

1. Background

2. Implementation of the HAC Reduction Program for FY 2018

3. Proposed Data Collection Time Periods for the FY 2020 HAC Reduction Program

4. Request for Comments on Additional Measures for Potential Future Adoption

5. Accounting for Social Risk Factors in the HAC Reduction Program

6. Request for Comments on Inclusion on Disability and Medical Complexity for CDC NHSN Measures

7. Maintenance of Technical Specifications for Quality Measures

8. Extraordinary Circumstances Exception (ECE) Policy for the HAC Reduction Program

L. Rural Community Hospital Demonstration Program

1. Introduction

2. Background

3. Provisions of the 21st Century Cures Act (Pub. L. 114-255) and Proposals for Implementation

a. Statutory Provisions

b. Proposed Terms of Continuation for Previously Participating Hospitals

c. Solicitation for Additional Participants

4. Budget Neutrality

a. Statutory Budget Neutrality Requirement

b. Methodology Used in Previous Final Rules

c. Proposed Budget Neutrality Methodology for Extension Period Authorized by the 21st Century Cures Act (Pub. L. 114-255)

d. Alternative Budget Neutrality Approach

e. Reconciling Actual and Estimated Costs of the Demonstration for Previous Years (2011, 2012, and 2013)

M. Payments for Services in Inpatient and Outpatient Settings

1. Adjustment to IPPS Rates Resulting From the 2-Midnight Policy for FY 2018

2. Eliminating Inappropriate Medicare Payment Differentials for Similar Services in the Inpatient and Outpatient Settings

N. Provider-Based Status of Indian Health Service and Tribal Facilities and Organizations

O. Request for Information Regarding Physician-Owned Hospitals

VI. Proposed Changes to the IPPS for Capital-Related Costs

A. Overview

B. Additional Provisions

1. Exception Payments

2. New Hospitals

3. Payments for Hospitals Located in Puerto Rico

C. Proposed Annual Update for FY 2018

VII. Proposed Changes for Hospitals Excluded From the IPPS

A. Proposed Rate-of-Increase in Payments To Excluded Hospitals for FY 2018

B. Proposed Revisions to Hospital-Within-Hospital Regulations

C. Critical Access Hospitals (CAHs)

1. Background

2. Frontier Community Health Integration Project (FCHIP) Demonstration

3. Physician Certification Requirement for Payment of Inpatient CAH Services Under Medicare Part A

a. Background

b. Notice Regarding Changes to Instructions for the Review of the CAH 96-Hour Certification Requirement

VIII. Proposed Changes to the Long-Term Care Hospital Prospective Payment System (LTCH PPS) for FY 2018

A. Background of the LTCH PPS

1. Legislative and Regulatory Authority


[top] 2. Criteria for Classification as an LTCH page 19802

a. Classification as an LTCH

b. Hospitals Excluded From the LTCH PPS

3. Limitation on Charges to Beneficiaries

4. Administrative Simplification Compliance Act (ASCA) and Health Insurance Portability and Accountability Act (HIPAA) Compliance

B. Proposed Medicare Severity Long-Term Care Diagnosis-Related Group (MS-LTC-DRG) Classifications and Relative Weights for FY 2018

1. Background

2. Patient Classifications Into MS-LTC-DRGs

a. Background

b. Proposed Changes to the MS-LTC-DRGs for FY 2018

3. Development of the Proposed FY 2018 MS-LTC-DRG Relative Weights

a. General Overview of the Development of the MS-LTC-DRG Relative Weights

b. Development of the Proposed MS-LTC-DRG Relative Weights for FY 2018

c. Data

d. Hospital-Specific Relative Value (HSRV) Methodology

e. Treatment of Severity Levels in Developing the MS-LTC-DRG Relative Weights

f. Proposed Low-Volume MS-LTC-DRGs

g. Steps for Determining the Proposed FY 2018 MS-LTC-DRG Relative Weights

C. Proposed Changes to the LTCH PPS Payment Rates and Other Proposed Changes to the LTCH PPS for FY 2018

1. Overview of Development of the LTCH PPS Standard Federal Payment Rates

2. Proposed FY 2018 LTCH PPS Standard Federal Payment Rate Annual Market Basket Update

a. Overview

b. Proposed Annual Update to the LTCH PPS Standard Federal Payment Rate for FY 2018

c. Proposed Adjustment to the LTCH PPS Standard Federal Payment Rate Under the Long-Term Care Hospital Quality Reporting Program (LTCH QRP)

d. Proposed Annual Update Under the LTCH PPS for FY 2018

D. Proposed Changes to the Short-Stay Outlier Adjustment Policy (§?412.529)

E. Temporary Exception to the Site Neutral Payment Rate for Certain Spinal Cord Specialty Hospitals

F. Temporary Exception to the Site Neutral Payment Rate for Certain Discharges With Severe Wounds Form Certain LTCHs

G. Moratorium and Proposed Regulatory Delay of the Full Implementation of the "25-Percent" Threshold Policy" Adjustment (§?412.538)

H. Revision to Moratorium on Increasing Beds in Existing LTCH or LTCH Satellite Locations Under the 21st Century Cures Act (Pub. L. 114-255) (§?412.23)

I. Proposed Changes to the Average Length of Stay Criterion Under the 21st Century Cures Act (Pub. L. 114-255)

J. Change in Medicare Classification for Certain Hospitals (§?412.23)

IX. Quality Data Reporting Requirements for Specific Providers and Suppliers

A. Hospital Inpatient Quality Reporting (IQR) Program

1. Background

a. History of the Hospital IQR Program

b. Maintenance of Technical Specifications for Quality Measures

c. Public Display of Quality Measures

d. Accounting for Social Risk Factors in the Hospital IQR Program

2. Retention of Previously Adopted Hospital IQR Program Measures for Subsequent Payment Determinations

3. Removal and Suspension of Previously Adopted Hospital IQR Program Measures

4. Previously Adopted Hospital IQR Program Measures for the FY 2019 Payment Determination and Subsequent Years

5. Considerations in Expanding and Updating of Quality Measures

6. Refinements to Existing Measures in the Hospital IQR Program for the FY 2020 Payment Determination and Subsequent Years

a. Refining Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey (NQF #0166) for the FY 2020 Payment Determination and Subsequent Years

b. Refinement of the Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate (RSMR) Following Acute Ischemic Stroke Hospitalization Measure for the FY 2023 Payment Determination and Subsequent Years

c. Summary of Previously Adopted Hospital IQR Program Measures for the FY 2020 Payment Determination and Subsequent Years

7. Proposed Voluntary Hybrid Hospital-Wide Readmission Measure With Claims and Electronic Health Record Data (NQF #2879)

a. Background

b. Proposal for Voluntary Reporting of Electronic Health Record Data for the Hybrid HWR Measure (NQF #2879)

c. Data Sources

d. Outcome

e. Cohort

f. Inclusion and Exclusion Criteria

g. Risk-Adjustment

h. Calculating the Risk-Standardized Readmission Rate (RSRR)

i. Data Submission and Reporting Requirements

j. Confidential Hospital-Specific Reports

8. Proposed Changes to Policies on Reporting of eCQMs

a. Background

b. Proposed Modifications to the eCQM Reporting Requirements for the Hospital IQR Program for the CY 2017 Reporting Period/FY 2019 Payment Determination

c. Proposed Modifications to the eCQM Reporting Requirements for the Hospital IQR Program for the CY 2018 Reporting Period/FY 2020 Payment Determination

9. Possible New Quality Measures and Measure Topics for Future Years

a. Potential Inclusion of the Quality of Informed Consent Documents for Hospital-Performed, Elective Procedures Measure

b. Potential Inclusion of Four End-of-Life (EOL) Measures for Cancer Patients

c. Potential Inclusion of Two Nurse Staffing Measures

d. Potential Inclusion of Additional Electronic Clinical Quality Measures (eCQMs) in the Hospital IQR and Medicare and Medicaid EHR Incentive Programs

10. Form, Manner, and Timing of Quality Data Submission

a. Background

b. Procedural Requirements for the FY 2020 Payment Determination and Subsequent Years

c. Data Submission Requirements for Chart-Abstracted Measures

d. Proposed Changes to the Reporting and Submission Requirements for eCQMs

e. Proposed Submission Form and Method for the Proposed Voluntary Hybrid Hospital-Wide Readmission Measure With Claims and Electronic Health Record Data (NQF #2879)

f. Sampling and Case Thresholds for the FY 2020 Payment Determination and Subsequent Years

g. HCAHPS Administration and Submission Requirements for the FY 2020 Payment Determination and Subsequent Years

h. Data Submission Requirements for Structural Measures for the FY 2020 Payment Determination and Subsequent Years

i. Data Submission and Reporting Requirements for HAI Measures Reported via NHSN

11. Proposed Modifications to the Validation of Hospital IQR Program Data

a. Background

b. Proposed Changes to the Existing Processes for Validation of Hospital IQR Program eCQM Data for the FY 2020 Payment Determination and Subsequent Years

c. Proposed Modifications to the Educational Review Process for Chart-Abstracted Measures Validation

12. Data Accuracy and Completeness Acknowledgement (DACA) Requirements for the FY 2020 Payment Determination and Subsequent Years

13. Public Display Requirements for the FY 2020 Payment Determination and Subsequent Years

a. Background

b. Potential Options for Confidential and Public Reporting of Hospital IQR Measures Stratified by Patient Dual Eligibility Status

14. Reconsideration and Appeal Procedures for the FY 2020 Payment Determination and Subsequent Years

15. Proposed Change to the Hospital IQR Program Extraordinary Circumstances Exceptions (ECE) Policy

a. Background

b. Proposals To Align the Hospital IQR Program ECE Policy With Other CMS Quality Programs

B. PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program

1. Background

2. Criteria for Removal and Retention of PCHQR Program Measures


[top] 3. Retention and Proposed Removal of Previously Finalized Quality Measures for PCHs Beginning With the FY 2020 Program Year page 19803

a. Background

b. Proposed Removal of Measures From the PCHQR Program Beginning With the FY 2020 Program Year

4. Proposed New Quality Measures Beginning With the FY 2020 Program Year

a. Considerations in the Selection of Quality Measures

b. Proposed New Quality Measures Beginning With the FY 2020 Program Year

c. Summary of Previously Finalized and Newly Proposed PCHQR Program Measures for the FY 2020 Program Year and Subsequent Years

5. Accounting for Social Risk Factors in the PCHQR Program

6. Possible New Quality Measure Topics for Future Years

a. Background

b. Localized Prostate Cancer: Vitality; Localized Prostate Cancer: Urinary Incontinence; Localized Prostate Cancer: Urinary Frequency; Obstruction, and/or Irritation; Localized Prostate Cancer: Sexual Function; and Localized Prostate Cancer: Bowel Function

c. 30-Day Unplanned Readmission for Cancer Patients

7. Maintenance of Technical Specifications for Quality Measures

8. Public Display Requirements

a. Background

b. Deferment of Public Display of Two Measures

9. Form, Manner, and Timing of Data Submission

a. Background

b. Proposed Reporting Requirements for the Proposed New Measures

10. Extraordinary Circumstances Exceptions (ECE) Policy Under the PCHQR Program

a. Background

b. Proposed Modification to the Exception Policy

C. Long-Term Care Hospital Quality Reporting Program (LTCH QRP)

1. Background and Statutory Authority

2. General Considerations Used for Selection of Quality Measures for the LTCH QRP

a. Background

b. Accounting for Social Risk Factors in the LTCH QRP

3. Proposed Collection of Standardized Patient Assessment Data Under the LTCH QRP

a. Proposed Definition of Standardized Patient Assessment Data

b. General Considerations Used for the Selection of Proposed Standardized Patient Assessment Data

4. Policy for Retaining LTCH QRP Measures and Proposal to Apply That Policy to Standardized Patient Assessment Data

5. Policy for Adopting Changes to LTCH QRP Measures and Proposal To Apply That Policy to Standardized Patient Assessment Data

6. Quality Measures Previously Finalized for the LTCH QRP

7. LTCH QRP Quality Measures Proposed Beginning With the FY 2020 LTCH QRP

a. Proposal To Replace the Current Pressure Ulcer Quality Measure, Entitled Percent of Residents or Patients With Pressure Ulcers That Are New or Worsened (Short Stay) (NQF #0678), With a Modified Pressure Ulcer Measure, Entitled Changes in Skin Integrity Post-Acute Care: Pressure Ulcer/Injury

b. Proposed Mechanical Ventilation Process Quality Measure: Compliance With Spontaneous Breathing Trial (SBT) by Day 2 of the LTCH Stay

c. Proposed Mechanical Ventilation Outcome Quality Measure: Ventilator Liberation Rate

8. Proposed Removal of the All-Cause Unplanned Readmission Measure for 30 Days Post-Discharge From LTCHs From the LTCH QRP

9. LTCH QRP Quality Measures Under Consideration for Future Years

a. LTCH QRP Quality Measures Under Consideration for Future Years

b. IMPACT Act Measure-Possible Future Update to Measure Specifications

c. IMPACT Act Implementation Update

10. Proposed Standardized Patient Assessment Data Reporting for the LTCH QRP

a. Proposed Standardized Patient Assessment Data Reporting for the FY 2019 LTCH QRP

b. Proposed Standardized Patient Assessment Data Reporting Beginning With the FY 2020 LTCH QRP

11. Proposals Relating to the Form, Manner, and Timing of Data Submission Under the LTCH QRP

a. Proposed Start Date for Standardized Patient Assessment Data Reporting by New LTCHs

b. Proposed Mechanism for Reporting Standardized Patient Assessment Data Beginning With the FY 2019 LTCH QRP

c. Proposed Schedule for Reporting Standardized Patient Assessment Data Beginning With the FY 2019 LTCH QRP

d. Proposed Schedule for Reporting the Proposed Quality Measures Beginning With the FY 2020 LTCH QRP

e. Proposed Removal of Interrupted Stay Items From the LTCH CARE Data Set

12. Proposed Changes to Previously Codified Participation Requirements Under the LTCH QRP

13. Proposed Changes to Previously Codified Data Submission Requirements Under the LTCH QRP

14. Proposed Changes to Previously Codified Exception and Extension Requirements Under the LTCH QRP

15. Proposed Changes to Previously Codified Reconsiderations Requirements Under the LTCH QRP

16. Proposal To Apply the LTCH QRP Data Completion Thresholds to the Submission of Standardized Patient Assessment Data Beginning With the FY 2019 LTCH QRP

17. Proposals and Policies Regarding Public Display of Measure Data for the LTCH QRP

18. Mechanism for Providing Feedback Reports to LTCHs

D. Inpatient Psychiatric Facility Quality Reporting (IPFQR) Program

1. Background

a. Statutory Authority

b. Covered Entities

c. Considerations in Selecting Quality Measures

2. Factors for Removal or Retention of IPFQR Program Measures

a. Background

b. Proposed Considerations in Removing or Retaining Measures

3. Proposed New Quality Measure for the FY 2020 Payment Determination and Subsequent Years-Medication Continuation Following Inpatient Psychiatric Discharge

a. Background

b. Appropriateness for the IPFQR Program

c. Measure Calculation

d. Data Sources

e. Public Comment

4. Summary of Proposed and Previously Finalized Measures for the FY 2020 Payment Determinations and Subsequent Years

5. Possible IPFQR Program Measures and Topics for Future Consideration

6. Public Display and Review Requirements

7. Form, Manner, and Timing of Quality Data Submission for the FY 2019 Payment Determination and Subsequent Years

a. Procedural Requirements for FY 2019 Payment Determination and Subsequent Years

b. Data Submission Requirements for the FY 2019 Payment Determination and Subsequent Years

c. Reporting Requirements for the FY 2019 Payment Determination and Subsequent Years

d. Population and Sampling

e. Data Accuracy and Completeness Acknowledgement (DACA) Requirements

8. Reconsideration and Appeals Procedures

9. Extraordinary Circumstances Exceptions (ECE) for the IPFQR Program

a. Background

b. Proposed ECE Policy Modifications

E. Clinical Quality Measurement for Eligible Hospitals and Critical Access Hospitals (CAHs) Participating in the EHR Incentive Programs

1. Background

2. Proposed Modifications to the CQM Reporting Requirements for the Medicare and Medicaid EHR Incentive Programs for CY 2017

a. Background

b. Proposed Changes to Policies Regarding Electronic Reporting of CQMs for CY 2017

3. CQM Reporting for the Medicare and Medicaid EHR Incentive Programs in 2018

a. Background

b. CQM Reporting Period for the Medicare and Medicaid EHR Incentive Programs in CY 2018

c. CQM Reporting Form and Method for the Medicare EHR Incentive Program in 2018


[top] F. Clinical Quality Measurement for Eligible Professionals (EPs) Participating in the Medicaid EHR Incentive Program in 2017 page 19804

1. Proposed Modifications to the CQM Reporting Period for EPs in 2017

2. Proposed Modifications to CQM Reporting Requirements for Medicaid EPs Under the Medicaid EHR Incentive Program

G. Changes to the Medicare and Medicaid EHR Incentive Programs

1. Proposed Revisions to the EHR Reporting Period in 2018

2. Significant Hardship Exception for Decertified Certified EHR Technology (CEHRT) for EPs, Eligible Hospitals, and CAHs Seeking To Avoid the Medicare Payment Adjustment

3. Ambulatory Surgical Center (ASC)-Based Eligible Professionals (EPs)

4. Certification Requirements for 2018 X. Proposed Revisions of Medicare Cost Reporting and Provider Requirements

A. Electronic Signature and Submission of the Certification and Settlement Summary Page of the Medicare Cost Report

1. Background

2. Proposed Changes Relating to Electronic Signature on the Certification and Settlement Summary Page of the Medicare Cost Report

3. Proposed Changes Relating to Electronic Submission of the Certification and Settlement Summary Page of the Medicare Cost Report

4. Clarifications Relating to the Items Required To Be Submitted by Providers With the Medicare Cost Report

a. Settlement Summary and Certification Statement

b. Removal of the Transition Period Language

5. Proposed Revisions to 42 CFR 413.24(f)(4)(iv)

B. Clarification of Limitations on the Valuation of Depreciable Assets Disposed of On or After December 1, 1997

XI. Proposed Changes Relating to Survey and Certification Requirements

A. Proposed Revisions to the Application and Re-Application Procedures for National Accrediting Organizations (AOs), Provider and Supplier Conditions, and Posting of Survey Reports and Acceptable Plans of Corrections (PoCs)

1. Background

2. Proposed Regulation Changes

B. Proposed Changes to Termination Public Notice Requirements for Certain Providers and Suppliers

1. Background

2. Basis for Proposed Changes

3. Proposed Changes to Regulations

XII. MedPAC Recommendations

XIII. Other Required Information

A. Publicly Available Data

1. CMS Wage Data Public Use File

2. CMS Occupational Mix Data Public Use File

3. Provider Occupational Mix Adjustment Factors for Each Occupational Category Public Use File

4. Other Wage Index Files

5. FY 2018 IPPS SSA/FIPS CBSA State and County Crosswalk

6. HCRIS Cost Report Data

7. Provider-Specific File

8. CMS Medicare Case-Mix Index File

9. MS-DRG Relative Weights (Also Table 5-MS-DRGs)

10. IPPS Payment Impact File

11. AOR/BOR Table

12. Prospective Payment System (PPS) Standardized File

13. Hospital Readmissions Reductions Program Supplemental File

14. Medicare Disproportionate Share Hospital (DSH) Supplemental File

B. Collection of Information Requirements

1. Statutory Requirement for Solicitation of Comments

2. ICRs for Add-On Payments for New Services and Technologies

3. ICRs for the Occupational Mix Adjustment to the Proposed FY 2018 Wage Index (Hospital Wage Index Occupational Mix Survey)

4. Hospital Applications for Geographic Reclassifications by the MGCRB

5. ICRs for Temporary Exception to the LTCH PPS Site Neutral Payment Rate for Certain Spinal Cord Specialty Hospitals

6. ICRs for the Hospital Inpatient Quality Reporting (IQR) Program

7. ICRs for PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program

8. ICRs for Hospital Value-Based Purchasing (VBP) Program

9. ICRs for the Long-Term Care Hospital Quality Reporting Program (LTCH QRP)

10. ICRs for the Inpatient Psychiatric Facility Quality Reporting (IPFQR) Program

11. ICRs for the Electronic Health Record (EHR) Incentive Programs and Meaningful Use

12. ICRs Relating to Proposed Electronic Signature and Electronic Submission of the Certification and Settlement Summary Page of Medicare Cost Reports

13. ICRs Relating to Survey and Certification Requirements

C. Request for Information on CMS Flexibilities and Efficiencies

D. Response to Public Comments

Regulation Text

Addendum-Proposed Schedule of Standardized Amounts, Update Factors, and Rate-of-Increase Percentages Effective With Cost Reporting Periods Beginning on or After October 1, 2017 and Payment Rates for LTCHs Effective With Discharges Occurring on or After October 1, 2017

I. Summary and Background

II. Proposed Changes to the Prospective Payment Rates for Hospital Inpatient Operating Costs for Acute Care Hospitals for FY 2018

A. Calculation of the Adjusted Standardized Amount

B. Adjustments for Area Wage Levels and Cost-of-Living

C. Calculation of the Prospective Payment Rates

III. Proposed Changes to Payment Rates for Acute Care Hospital Inpatient Capital-Related Costs for FY 2018

A. Determination of Federal Hospital Inpatient Capital-Related Prospective Payment Rate Update

B. Calculation of the Inpatient Capital-Related Prospective Payments for FY 2018

C. Capital Input Price Index

IV. Proposed Changes to Payment Rates for Excluded Hospitals: Proposed Rate-of-Increase Percentages for FY 2018

V. Proposed Changes to the Payment Rates for the LTCH PPS for FY 2018

A. Proposed LTCH PPS Standard Federal Payment Rate for FY 2018

B. Proposed Adjustment for Area Wage Levels Under the LTCH PPS for FY 2018

1. Background

2. Geographic Classifications (Labor Market Areas) for the LTCH PPS Standard Federal Payment Rate

3. Proposed Labor-Related Share for the LTCH PPS Standard Federal Payment Rate

4. Proposed Wage Index for FY 2018 for the LTCH PPS Standard Federal Payment Rate

5. Proposed Budget Neutrality Adjustment for Changes to the LTCH PPS Standard Federal Payment Rate Area Wage Level Adjustment

C. Proposed LTCH PPS Cost-of-Living Adjustment (COLA) for LTCHs Located in Alaska and Hawaii

D. Proposed Adjustment for LTCH PPS High-Cost Outlier (HCO) Cases

E. Update to the IPPS Comparable/Equivalent Amounts to Reflect the Statutory Changes to the IPPS DSH Payment Adjustment Methodology

F. Computing the Proposed Adjusted LTCH PPS Federal Prospective Payments for FY 2018

VI. Tables Referenced in This Proposed Rule and Available Only Through the Internet on the CMS Web Site

Appendix A-Economic Analyses

I. Regulatory Impact Analysis

A. Introduction

B. Need

C. Objectives of the IPPS

D. Limitations of Our Analysis

E. Hospitals Included in and Excluded From the IPPS

F. Effects on Hospitals and Hospital Units Excluded From the IPPS

G. Quantitative Effects of the Proposed Policy Changes Under the IPPS for Operating Costs

1. Basis and Methodology of Estimates

2. Analysis of Table I

3. Impact Analysis of Table II

H. Effects of Other Proposed Policy Changes

1. Effects of Proposed Policy Relating to New Medical Service and Technology Add-On Payments

2. Effects of Proposed Changes to MS-DRGs Subject to the Postacute Care Transfer Policy and the MS-DRG Special Payment Policy

3. Effects of the Proposed Changes to the Volume Decrease Adjustment for Sole Community Hospitals (SCHs)

4. Effects of Proposed Changes to Low-Volume Hospital Payment Adjustment Policy


[top] 5. Effects of the Proposed Changes to Medicare DSH and Uncompensated Care Payments for FY 2018 page 19805

6. Effects of Proposed Reduction Under the Hospital Readmissions Reduction Program

7. Effects of Proposed Changes Under the FY 2018 Hospital Value-Based Purchasing (VBP) Program

8. Effects of Proposed Changes to the HAC Reduction Program for FY 2018

9. Effects of Implementation of the Additional 5-Year Expansion of the Rural Community Hospital Demonstration Program

10. Effects of the Proposed Changes Relating to Provider-Based Status of Indian Health Service and Tribal Facilities and Organizations

11. Effects of the Proposed Changes Relating to Hospital-Within-Hospital Policy

12. Effects of Continued Implementation of the Frontier Community Health Integration Project (FCHIP) Demonstration

I. Effects of Proposed Changes in the Capital IPPS

1. General Considerations

2. Results

J. Effects of Proposed Payment Rate Changes and Policy Changes Under the LTCH PPS

1. Introduction and General Considerations

2. Impact on Rural Hospitals

3. Anticipated Effects of Proposed LTCH PPS Payment Rate Changes and Policy Changes

4. Effect on the Medicare Program

5. Effect on Medicare Beneficiaries

K. Effects of Proposed Requirements for Hospital Inpatient Quality Reporting (IQR) Program

L. Effects of Proposed Requirements for the PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program

M. Effects of Proposed Requirements for the Long-Term Care Hospital Quality Reporting Program (LTCH QRP)

N. Effects of Proposed Updates to the Inpatient Psychiatric Facility Quality Reporting (IPFQR) Program

O. Effects of Proposed Requirements Regarding the Electronic Health Record (EHR) Incentive Programs and Meaningful Use

P. Effects of Proposed Electronic Signature and Electronic Submission of the Certification and Settlement Summary Page of Medicare Cost Reports

Q. Effects of Proposed Changes Relating to Survey and Certification Requirements

R. Effects of Clarification of Limitations on the Valuation of Depreciable Assets Disposed of on or After December 1, 1997

S. Alternatives Considered

T. Reducing Regulation and Controlling Regulatory Costs

U. Overall Conclusion

1. Acute Care Hospitals

2. LTCHs

V. Regulatory Review Costs

II. Accounting Statements and Tables

A. Acute Care Hospitals

B. LTCHs

III. Regulatory Flexibility Act (RFA) Analysis

IV. Impact on Small Rural Hospitals

V. Unfunded Mandate Reform Act (UMRA) Analysis

VI. Executive Order 13175

VII. Executive Order 12866

Appendix B: Recommendation of Update Factors for Operating Cost Rates of Payment for Inpatient Hospital Services

I. Background

II. Inpatient Hospital Update for FY 2018

A. Proposed FY 2018 Inpatient Hospital Update

B. Proposed Update for SCHs for FY 2018

C. Proposed FY 2018 Puerto Rico Hospital Update

D. Proposed Update for Hospitals Excluded From the IPPS

E. Proposed Update for LTCHs for FY 2018

III. Secretary's Recommendation

IV. MedPAC Recommendation for Assessing Payment Adequacy and Updating Payments in Traditional Medicare

I. Executive Summary and Background

A. Executive Summary

1. Purpose and Legal Authority

This proposed rule would make payment and policy changes under the Medicare inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals as well as for certain hospitals and hospital units excluded from the IPPS. We also are making proposals relating to the provider-based status of Indian Health Service (IHS) and Tribal facilities and organizations and to the IPPS low-volume hospital payment adjustment for hospitals operated by the IHS or a Tribe. In addition, it would make payment and policy changes for inpatient hospital services provided by long-term care hospitals (LTCHs) under the long-term care hospital prospective payment system (LTCH PPS). It also would make policy changes to programs associated with Medicare IPPS hospitals, IPPS-excluded hospitals, and LTCHs.

We are proposing to establish new requirements or revising requirements for quality reporting by specific providers (acute care hospitals, PPS-exempt hospitals, LTCHs, and inpatient psychiatric facilities) that are participating in Medicare. We also are proposing to establish new requirements or revise existing requirements for eligible professionals (EPs), eligible hospitals, and CAHs participating in the Medicare and Medicaid EHR Incentive Programs. We are proposing to update policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are proposing changes related to the transparency of accrediting organization survey reports and plans of correction; to allow electronic signature and electronic submission of the Certification and Settlement Summary page of the Medicare cost reports; and to clarify provider reimbursement regulations relative to the sale or scrapping of depreciable assets on or after December 1, 1997.

Under various statutory authorities, we are proposing to make changes to the Medicare IPPS, to the LTCH PPS, and to other related payment methodologies and programs for FY 2018 and subsequent fiscal years. These statutory authorities include, but are not limited to, the following:

• Section 1886(d) of the Social Security Act (the Act), which sets forth a system of payment for the operating costs of acute care hospital inpatient stays under Medicare Part A (Hospital Insurance) based on prospectively set rates. Section 1886(g) of the Act requires that, instead of paying for capital-related costs of inpatient hospital services on a reasonable cost basis, the Secretary use a prospective payment system (PPS).

• Section 1886(d)(1)(B) of the Act, which specifies that certain hospitals and hospital units are excluded from the IPPS. These hospitals and units are: Rehabilitation hospitals and units; LTCHs; psychiatric hospitals and units; children's hospitals; cancer hospitals; long-term care neoplastic disease hospitals, and hospitals located outside the 50 States, the District of Columbia, and Puerto Rico (that is, hospitals located in the U.S. Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa). Religious nonmedical health care institutions (RNHCIs) are also excluded from the IPPS.

• Sections 123(a) and (c) of the BBRA (Pub. L. 106-113) and section 307(b)(1) of the BIPA (Pub. L. 106-554) (as codified under section 1886(m)(1) of the Act), which provide for the development and implementation of a prospective payment system for payment for inpatient hospital services of long-term care hospitals (LTCHs) described in section 1886(d)(1)(B)(iv) of the Act.

• Sections 1814(l), 1820, and 1834(g) of the Act, which specify that payments are made to critical access hospitals (CAHs) (that is, rural hospitals or facilities that meet certain statutory requirements) for inpatient and outpatient services and that these payments are generally based on 101 percent of reasonable cost.

• Section 1866(k) of the Act, as added by section 3005 of the Affordable Care Act, which establishes a quality reporting program for hospitals described in section 1886(d)(1)(B)(v) of the Act, referred to as "PPS-exempt cancer hospitals."


[top] • Section 1886(a)(4) of the Act, which specifies that costs of approved page 19806 educational activities are excluded from the operating costs of inpatient hospital services. Hospitals with approved graduate medical education (GME) programs are paid for the direct costs of GME in accordance with section 1886(h) of the Act.

• Section 1886(b)(3)(B)(viii) of the Act, which requires the Secretary to reduce the applicable percentage increase that would otherwise apply to the standardized amount applicable to a subsection (d) hospital for discharges occurring in a fiscal year if the hospital does not submit data on measures in a form and manner, and at a time, specified by the Secretary.

• Section 1886(o) of the Act, which requires the Secretary to establish a Hospital Value-Based Purchasing (VBP) Program under which value-based incentive payments are made in a fiscal year to hospitals meeting performance standards established for a performance period for such fiscal year.

• Section 1886(p) of the Act, as added by section 3008 of the Affordable Care Act, which establishes a Hospital-Acquired Condition (HAC) Reduction Program, under which payments to applicable hospitals are adjusted to provide an incentive to reduce hospital-acquired conditions.

• Section 1886(q) of the Act, as added by section 3025 of the Affordable Care Act and amended by section 10309 of the Affordable Care Act and section 15002 of the 21st Century Cures Act, which establishes the "Hospital Readmissions Reduction Program." Under the program, payments for discharges from an "applicable hospital" under section 1886(d) of the Act will be reduced to account for certain excess readmissions. Section 15002 of the 21st Century Cures Act requires the Secretary to compare cohorts of hospitals to each other in determining the extent of excess readmissions.

• Section 1886(r) of the Act, as added by section 3133 of the Affordable Care Act, which provides for a reduction to disproportionate share hospital (DSH) payments under section 1886(d)(5)(F) of the Act and for a new uncompensated care payment to eligible hospitals. Specifically, section 1886(r) of the Act requires that, for fiscal year 2014 and each subsequent fiscal year, subsection (d) hospitals that would otherwise receive a DSH payment made under section 1886(d)(5)(F) of the Act will receive two separate payments: (1) 25 percent of the amount they previously would have received under section 1886(d)(5)(F) of the Act for DSH ("the empirically justified amount"), and (2) an additional payment for the DSH hospital's proportion of uncompensated care, determined as the product of three factors. These three factors are: (1) 75 percent of the payments that would otherwise be made under section 1886(d)(5)(F) of the Act; (2) 1 minus the percent change in the percent of individuals who are uninsured (minus 0.2 percentage points for FY 2018 through FY 2019); and (3) a hospital's uncompensated care amount relative to the uncompensated care amount of all DSH hospitals expressed as a percentage.

• Section 1886(m)(6) of the Act, as added by section 1206(a)(1) of the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013 (Pub. L. 113-67), which provided for the establishment of site neutral payment rate criteria under the LTCH PPS with implementation beginning in FY 2016.

• Section 1886(m)(6) of the Act, as amended by section 15009 of the 21st Century Cures Act (Pub. L. 114-255), which provides for a temporary exception to the application of the site neutral payment rate under the LTCH PPS for certain spinal cord specialty hospitals for discharges in cost reporting periods beginning during FYs 2018 and 2019.

• Section 1886(m)(6) of the Act, as amended by section 15010 of the 21st Century Cures Act (Pub. L. 114-255), which provides for a temporary exception to the application of the site neutral payment rate under the LTCH PPS for certain LTCHs with certain discharges with severe wounds occurring in cost reporting periods beginning during FY 2018.

• Section 1886(m)(5)(D)(iv) of the Act, as added by section 1206 (c) of the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013 (Pub. L. 113-67), which provides for the establishment of a functional status quality measure under the LTCH QRP for change in mobility among inpatients requiring ventilator support.

• Section 1899B of the Act, as added by the Improving Medicare Post-Acute Care Transformation Act of 2014 (the IMPACT Act, Pub. L. 113-185), which imposes data reporting requirements for certain post-acute care providers, including LTCHs.

2. Summary of the Major Provisions

a. MS-DRG Documentation and Coding Adjustment

Section 631 of the American Taxpayer Relief Act (ATRA, Pub. L. 112-240) amended section 7(b)(1)(B) of Public Law 110-90 to require the Secretary to make a recoupment adjustment to the standardized amount of Medicare payments to acute care hospitals to account for changes in MS-DRG documentation and coding that do not reflect real changes in case-mix, totaling $11 billion over a 4-year period of FYs 2014, 2015, 2016, and 2017. The FY 2014 through FY 2017 adjustments represented the amount of the increase in aggregate payments as a result of not completing the prospective adjustment authorized under section 7(b)(1)(A) of Public Law 110-90 until FY 2013. Prior to the ATRA, this amount could not have been recovered under Public Law 110-90. Section 414 of the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015 (Pub. L. 114-10) replaced the single positive adjustment we intended to make in FY 2018 with a 0.5 percent positive adjustment to the standardized amount of Medicare payments to acute care hospitals for FYs 2018 through 2023. The FY 2018 adjustment was subsequently adjusted to 0.4588 percent by section 15005 of the 21st Century Cures Act.

For FY 2018, we are proposing to make the 0.4588 percent positive adjustment to the standardized amount as required by section 414 of Public Law 114-10, as amended by section 15005 of the 21st Century Cures Act.

b. Adjustment to IPPS Rates Resulting From 2-Midnight Policy

In FY 2017, we made a permanent adjustment to the standardized amount, the hospital-specific payment rates, and the national capital Federal rate to prospectively remove the 0.2 percent reduction to the rates put in place in FY 2014 to offset the estimated increase in IPPS expenditures as a result of the 2-midnight policy. In addition, we made a temporary one-time prospective increase to the FY 2017 standardized amount, the hospital-specific payment rates, and the national capital Federal rate of 0.6 percent by including a temporary one-time factor of 1.006 in the calculation of the standardized amount, the hospital-specific payment rates, and the national capital Federal rate to address the effects of the 0.2 percent reduction to the rate for the 2-midnight policy in effect for FYs 2014, 2015, and 2016.


[top] For FY 2018, we are including a factor of (1/1.006) in the calculation of the FY 2018 standardized amount, the hospital-specific payment rates, and the national capital Federal rate to remove the temporary one-time factor of 1.006, as established in the FY 2017 IPPS/LTCH PPS final rule. page 19807

c. Reduction of Hospital Payments for Excess Readmissions

We are proposing to make changes to policies for the Hospital Readmissions Reduction Program, which is established under section 1886(q) of the Act, as added by section 3025 of the Affordable Care Act, as amended by section 10309 of the Affordable Care Act. The Hospital Readmissions Reduction Program requires a reduction to a hospital's base operating DRG payment to account for excess readmissions of selected applicable conditions. For FY 2018 and subsequent years, the reduction is based on a hospital's risk-adjusted readmission rate during a 3-year period for acute myocardial infarction (AMI), heart failure (HF), pneumonia, chronic obstructive pulmonary disease (COPD), total hip arthroplasty/total knee arthroplasty (THA/TKA), and coronary artery bypass graft (CABG). In this proposed rule, we are proposing the following policies: (1) Specify applicable time period for FY 2018; (2) specify the calculation of aggregate payments for excess readmissions for FY 2018; (3) propose changes to the payment adjustment factor in accordance with the 21st Century Cures Act for FY 2019; and (4) update the Extraordinary Circumstances Exception policy.

d. Hospital Value-Based Purchasing (VBP) Program

Section 1886(o) of the Act requires the Secretary to establish a Hospital VBP Program under which value-based incentive payments are made in a fiscal year to hospitals based on their performance on measures established for a performance period for such fiscal year. In this proposed rule, we are proposing to remove one previously adopted measure, the PSI 90: Patient Safety for Selected Indicators measure, from the Hospital VBP Program beginning with the FY 2019 program year. We also are proposing to adopt one new measure, Hospital-Level, Risk-Standardized Payment Associated with a 30-Day Episode of Care for Pneumonia, beginning with the FY 2022 program year, and to adopt a modified version of a previously adopted measure, Patient Safety and Adverse Events Composite (NQF #0531), beginning with the FY 2023 program year. In addition, we are proposing two modifications to our domain scoring policies beginning with the FY 2019 program year, and further proposing a new weighting methodology for the Efficiency and Cost Reduction domain. We also are inviting public comment on the appropriateness of accounting for social risk factors in the Hospital VBP Program, including which social risk factors should be included; and how to account for these social risk factors in the Hospital VBP Program.

e. Hospital-Acquired Condition (HAC) Reduction Program

Section 1886(p) of the Act, as added under section 3008(a) of the Affordable Care Act, establishes an incentive to hospitals to reduce the incidence of hospital-acquired conditions by requiring the Secretary to make an adjustment to payments to applicable hospitals effective for discharges beginning on October 1, 2014. This 1-percent payment reduction applies to a hospital whose ranking is in the top quartile (25 percent) of all applicable hospitals, relative to the national average, of conditions acquired during the applicable period and on all of the hospital's discharges for the specified fiscal year. In this proposed rule, we are proposing the following policies: (1) Specifying the dates of the time period used to calculate hospital performance for the FY 2020 HAC Reduction Program; (2) requesting comments on additional measures for potential future adoption; (3) requesting comments on social risk factors; (4) requesting comments on accounting for disability and medical complexity in the CDC NHSN measures in Domain 2; and (5) updating the HAC Reduction Program's Extraordinary Circumstances Exception policy.

f. DSH Payment Adjustment and Additional Payment for Uncompensated Care

Section 3133 of the Affordable Care Act modified the Medicare disproportionate share hospital (DSH) payment methodology beginning in FY 2014. Under section 1886(r) of the Act, which was added by section 3133 of the Affordable Care Act, starting in FY 2014, DSHs receive 25 percent of the amount they previously would have received under the statutory formula for Medicare DSH payments in section 1886(d)(5)(F) of the Act. The remaining amount, equal to 75 percent of the amount that otherwise would have been paid as Medicare DSH payments, is paid as additional payments after the amount is reduced for changes in the percentage of individuals that are uninsured. Each Medicare DSH will receive an additional payment based on its share of the total amount of uncompensated care for all Medicare DSHs for a given time period.

In this proposed rule, we are proposing to update our estimates of the three factors used to determine uncompensated care payments for FY 2018. The statute permits the use of a data source other than the CBO estimates to determine the percent change in the rate of uninsurance as part of the calculation of Factor 2 beginning in FY 2018. We are proposing to use uninsured estimates produced by CMS' Office of the Actuary (OACT) as part of the development of the National Health Expenditure Accounts (NHEA) in the calculation of Factor 2. We also are proposing to begin incorporating data from Worksheet S-10 in the calculation of hospitals' share of uncompensated care by combining data on uncompensated care costs from the Worksheet S-10 for FY 2014 with proxy data regarding a hospital's share of low-income insured days for FYs 2012 and 2013 to determine Factor 3 for FY 2018. The proposal to continue to use data from three cost reporting periods to calculate Factor 3 would have the effect of transitioning from the use of the proxy data on low-income insured days toward use of uncompensated care data from Worksheet S-10. As part of this proposal, we are proposing a definition of uncompensated care costs consisting of the sum of charity care and bad debt and a trim methodology to address anomalous charges. We also are proposing that, for Puerto Rico hospitals and Indian Health Service and Tribal hospitals, we would substitute data regarding low-income insured days for FY 2013 for the Worksheet S-10 data from FY 2014 cost reports.


[top] We are proposing to continue the policies that were finalized in FY 2015 to address several specific issues concerning the process and data to be employed in determining hospitals' share of uncompensated care in the case of hospital mergers. We also are proposing to continue the policies finalized in FY 2017 concerning the methodology for calculating each hospital's relative share of uncompensated care, such as combining data from multiple cost reports beginning in the same fiscal year and averaging the sum of three individual Factor 3s by the number of cost reporting periods with data. In addition, we are proposing to annualize hospital cost reports that do not span 12 months. We also are proposing to apply a scaling factor to each hospital's uncompensated care amount so that total uncompensated care payments will be consistent with the estimated amount available to make uncompensated care payments for FY 2018. page 19808

g. Proposed Changes to the LTCH PPS

In this proposed rule, we set forth proposed changes to the LTCH PPS Federal payment rates, factors, and other payment rate policies under the LTCH PPS for FY 2018; proposed changes to the payment methodology under the short-stay outlier (SSO) policy; proposals to implement several provisions of the 21st Century Cures Act; and a proposal to adopt a 1-year regulatory delay on the full implementation of the 25-percent threshold policy for discharges occurring in FY 2018 (that is, for the fiscal year after expiration of the current statutory moratoria under the 21st Century Cures Act, which is set to expire September 30, 2017).

h. Hospital Inpatient Quality Reporting (IQR) Program

Under section 1886(b)(3)(B)(viii) of the Act, subsection (d) hospitals are required to report data on measures selected by the Secretary for a fiscal year in order to receive the full annual percentage increase that would otherwise apply to the standardized amount applicable to discharges occurring in that fiscal year. In past years, we have established measures on which hospitals must report data and the process for submittal and validation of the data.

In this proposed rule, we are proposing to make several changes. First, we are proposing to refine two previously adopted measures. Specifically, we are proposing to update the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey measure by replacing the three existing questions about Pain Management with three new questions that address Communication About Pain During the Hospital Stay, beginning with the FY 2020 payment determination. In addition, we are proposing to update the stroke mortality measure to include the use of NIH Stroke Scale claims data for risk adjustment, beginning with the FY 2023 payment determination.

Second, we are proposing to adopt the Hospital-Wide All-Cause Unplanned Readmission Hybrid Measure as a voluntary measure for the CY 2018 reporting period and note that we are considering proposing this measure as a required measure as early as the CY 2021 reporting period/FY 2023 payment determination and requiring hospitals to submit the core clinical data elements and linking variables used in the measure as early as CY 2020 to support a dry run of the measure during which hospitals would receive a confidential preview of their results in 2021.

Third, we are proposing modifications of our previously finalized eCQM reporting requirements. For the CY 2017 reporting period/FY 2019 payment determination, we are proposing that hospitals would be required to select and submit six of the available eCQMs included in the Hospital IQR Program measure set and provide two, self-selected, calendar year quarters of data. For the CY 2018 reporting period/FY 2020 payment determination, we are proposing that hospitals would be required to select and submit six of the available eCQMs, and provide data for the first three calendar quarters (Q1-Q3). These modifications are being proposed in alignment with proposals for the Medicare and Medicaid EHR Incentive Programs, and would decrease the required number of eCQMs and quarters of reporting as compared with the previously finalized requirements in the FY 2017 IPPS/LTCH PPS final rule.

Fourth, we are proposing modifications to the eCQM validation process if our proposals to modify the eCQM reporting requirements for the CY 2017 reporting period/FY 2019 payment determination and CY 2018 reporting period/FY 2020 payment determination are finalized as proposed, whereby hospitals would be required to submit a reduced number of cases for eCQM data validation for the FY 2020 and FY 2021 payment determinations. In addition, we are proposing policies related to the exclusion criteria for hospital selection and the data submission requirements for participating hospitals.

Fifth, we are proposing to modify our educational review process for chart-abstracted measures for the FY 2020 payment determination and subsequent years, such that educational reviews would be offered quarterly for the first three quarters of validation. Hospitals would be allowed 30 calendar days following the date the results of validation are posted to request an educational review. Also, we are proposing that if an educational review demonstrates that the abstraction score calculated by CMS is incorrect, we would use the corrected quarterly score to compute the final confidence interval.

Sixth, we are making proposals related to our Hospital IQR Program Extraordinary Circumstances Extension or Exemptions (ECE) policy, including a change to the name of the policy to Extraordinary Circumstances Exceptions policy.

Finally, we are inviting public comment on accounting for social risk factors in the Hospital IQR Program, the confidential and potential future public reporting of clinical quality measure data stratified by patients' dual-eligible status, and the following clinical quality measures that we are considering for future inclusion in the Hospital IQR Program: (1) Quality of Informed Consent Documents for Hospital-Performed, Elective Procedures measure; (2) four End-of-Life process and outcome measures for cancer patients; (3) two nurse staffing measures; and (4) eleven newly specified electronic clinical quality measures (eCQMs).

i. Long-Term Care Hospital Quality Reporting Program (LTCH QRP)

Section 1886(m)(5) of the Act requires LTCHs to report certain quality data to CMS in order to receive their full annual update under the LTCH PPS. In this proposed rule, we are proposing to adopt one new outcome measure related to pressure ulcers and two new measures (one process and one outcome) related to ventilator weaning. We also are proposing to define the standardized patient assessment data that LTCHs must report to comply with section 1886(m)(5)(F)(ii) of the Act, as well as the requirements for the reporting of these data. Finally, we are proposing to publicly report data on four assessment-based measures and three claims-based measures.

j. Inpatient Psychiatric Facility Quality Reporting (IPFQR) Program


[top] For the Inpatient Psychiatric Facility Quality Reporting (IPFQR) Program, we are making several proposals. First, beginning with the FY 2020 payment determination, we are proposing the Medication Continuation following Inpatient Psychiatric Discharge measure. Second, beginning with the FY 2019 payment determination (that is, for extraordinary circumstances occurring during CY 2018), we are proposing to update the IPFQR Program's extraordinary circumstances exception (ECE) policy by: (1) Allowing designated personnel to provide their contact information and sign the ECE request in lieu of the Chief Executive Officer (CEO); (2) allowing up to 90 days after the extraordinary circumstance to submit the request; and (3) stating that we will strive to respond to requests for ECEs within 90 days of receiving these requests. Third, we are proposing to change the annual data submission period from a specific date range to a 45-day period that begins at least 30 days following the end of the collection period. Fourth, we are proposing to align our deadline for submission of a Notice of Participation (NOP) or page 19809 program withdrawal with this proposed data submission timeframe. Finally, we are proposing factors by which we will evaluate measures for removal from the IPFQR Program. These factors align with those in use in other quality reporting programs.

3. Summary of Costs and Benefits

Adjustment for MS-DRG Documentation and Coding Changes. Section 414 of the MACRA replaced the single positive adjustment we intended to make in FY 2018 once the recoupment required by section 631 of the ATRA was complete with a 0.5 percent positive adjustment to the standardized amount of Medicare payments to acute care hospitals for FYs 2018 through 2023. The FY 2018 adjustment was subsequently adjusted to 0.4588 percent by section 15005 of the 21st Century Cures Act (Pub. L. 114-255). For FY 2018, we are proposing to make the 0.4588 percent positive adjustment to the standardized amount as required by these provisions.

Adjustment to IPPS Payment Rates as a Result of the 2-Midnight Policy. The removal of the adjustment to IPPS rates resulting from the 2-midnight policy will decrease IPPS payment rates by (1/1.006) for FY 2018. The (1/1.006) is a one-time factor that will be applied to the standardized amount, the hospital-specific rates, and the national capital Federal rate for FY 2018 only.

Medicare DSH Payment Adjustment and Additional Payment for Uncompensated Care. Under section 1886(r) of the Act (as added by section 3133 of the Affordable Care Act), DSH payments to hospitals under section 1886(d)(5)(F) of the Act are reduced and an additional payment for uncompensated care is made to eligible hospitals beginning in FY 2014. Hospitals that receive Medicare DSH payments receive 25 percent of the amount they previously would have received under the statutory formula for Medicare DSH payments in section 1886(d)(5)(F) of the Act. The remainder, equal to an estimate of 75 percent of what otherwise would have been paid as Medicare DSH payments, is the basis for determining the additional payments for uncompensated care after the amount is reduced for changes in the percentage of individuals that are uninsured and additional statutory adjustments. Each hospital that receives Medicare DSH payments will receive an additional payment for uncompensated care based on its share of the total uncompensated care amount reported by Medicare DSHs. The reduction to Medicare DSH payments is not budget neutral.

For FY 2018, we are proposing that the 75 percent of what otherwise would have been paid for Medicare DSH will be adjusted to approximately 58.01 percent of the amount to reflect changes in the percentage of individuals that are uninsured and additional statutory adjustments. In other words, approximately 43.51 percent (the product of 75 percent and 58.01 percent) of our estimate of Medicare DSH payments, prior to the application of section 3133 of the Affordable Care Act, would be available to make additional payments to hospitals for their relative share of the total amount of uncompensated care.

We project that estimated Medicare DSH payments, and additional payments for uncompensated care made for FY 2018, will increase payments overall by approximately 0.8 percent as compared to the estimate of overall payments, including Medicare DSH payments and uncompensated care payments, that will be distributed in FY 2017. The additional payments have redistributive effects based on a hospital's uncompensated care amount relative to the uncompensated care amount for all hospitals that are estimated to receive Medicare DSH payments, and the calculated payment amount is not directly tied to a hospital's number of discharges.

Proposed Changes to the Hospital Readmissions Reduction Program. For FY 2018 and subsequent years, the reduction is based on a hospital's risk-adjusted readmission rate during a 3-year period for acute myocardial infarction (AMI), heart failure (HF), pneumonia, chronic obstructive pulmonary disease (COPD), total hip arthroplasty/total knee arthroplasty (THA/TKA), and coronary artery bypass graft (CABG). Overall, in this proposed rule, we estimate that 2,591 hospitals would have their base operating DRG payments reduced by their determined proxy FY 2018 hospital-specific readmission adjustment. As a result, we estimate that the Hospital Readmissions Reduction Program would save approximately $564 million in FY 2018, an increase of approximately $27 million over the estimated FY 2017 savings.

Value-Based Incentive Payments Under the Hospital VBP Program. We estimate that there would be no net financial impact to the Hospital VBP Program for the FY 2018 program year in the aggregate because, by law, the amount available for value-based incentive payments under the program in a given year must be equal to the total amount of base operating MS-DRG payment amount reductions for that year, as estimated by the Secretary. The estimated amount of base operating MS-DRG payment amount reductions for the FY 2018 program year and, therefore, the estimated amount available for value-based incentive payments for FY 2018 discharges is approximately $1.9 billion.

Proposed Changes to the HAC Reduction Program. A hospital's Total HAC score and its ranking in comparison to other hospitals in any given year depends on several different factors. Any significant impact due to the proposed HAC Reduction Program changes for FY 2018, including which hospitals will receive the adjustment, will depend on actual experience.

Update to the LTCH PPS Payment Rates and Other Payment Factors. Based on the best available data for the 415 LTCHs in our database, we estimate that the proposed changes to the payment rates and factors that we are presenting in the preamble and Addendum of this proposed rule, which reflects the rolling end to the transition of the statutory application of the site neutral payment rate required by section 1886(m)(6)(A) of the Act, the proposed update to the LTCH PPS standard Federal payment rate for FY 2018, and estimated changes to the site neutral payment rate and high-cost outlier (HCO) payments would result in an estimated decrease in payments from FY 2017 of approximately $238 million.

Proposed Changes to the 25-Percent Threshold Policy. In this proposed rule, we estimate our proposal to adopt a 1-year regulatory delay of the full implementation of the 25-percent threshold policy for discharges occurring in FY 2018 would increase payments to LTCHs in FY 2018 by $50 million.


[top] • Proposed Changes to the Hospital Inpatient Quality Reporting (IQR) Program. Across 3,300 IPPS hospitals, we estimate that our policy proposals would result in the following changes to costs and benefits in the Hospital IQR Program compared to previously finalized requirements: (1) A cost reduction of $361,240 for the FY 2019 payment determination due to the proposed updates to the eCQM reporting requirements; (2) a total net cost reduction of $392,963 for the FY 2020 payment determination due to the proposed updates to the eCQM reporting requirements, the proposed updates to the eCQM validation procedures, and the proposed voluntary reporting of the new Hybrid Hospital-Wide Readmission measure; and (3) a total cost reduction of $70,048 for the FY 2021 payment determination due to page 19810 the proposed updates to the eCQM validation procedures.

Proposed Changes Related to the LTCH QRP. In this proposed rule, we are proposing one outcome measure related to pressure ulcers and two new measures (one process and one outcome) related to ventilator weaning. We also are proposing to specify the use of the standardized patient assessment data as required under section 1899B(b)(1)(B) of the Act and policies regarding public display of measure data. Overall, the cost associated with the proposed changes to the LTCH QRP is estimated at an additional $3,187.15 per LTCH annually, or $1,357,726 for all LTCHs annually.

Proposed Changes to the IPFQR Program. In this proposed rule, we are proposing to adopt one claims based measure, update our ECE process, change the specification of the data submission period, align the timeframe for submission of the NOP or program withdrawal with the data submission period, and establish criteria to evaluate measures for retention or removal. We do not believe that these policies will have any impact on the IPFQR program burden.

B. Summary

1. Acute Care Hospital Inpatient Prospective Payment System (IPPS)

Section 1886(d) of the Social Security Act (the Act) sets forth a system of payment for the operating costs of acute care hospital inpatient stays under Medicare Part A (Hospital Insurance) based on prospectively set rates. Section 1886(g) of the Act requires the Secretary to use a prospective payment system (PPS) to pay for the capital-related costs of inpatient hospital services for these "subsection (d) hospitals." Under these PPSs, Medicare payment for hospital inpatient operating and capital-related costs is made at predetermined, specific rates for each hospital discharge. Discharges are classified according to a list of diagnosis-related groups (DRGs).

The base payment rate is comprised of a standardized amount that is divided into a labor-related share and a nonlabor-related share. The labor-related share is adjusted by the wage index applicable to the area where the hospital is located. If the hospital is located in Alaska or Hawaii, the nonlabor-related share is adjusted by a cost-of-living adjustment factor. This base payment rate is multiplied by the DRG relative weight.

If the hospital treats a high percentage of certain low-income patients, it receives a percentage add-on payment applied to the DRG-adjusted base payment rate. This add-on payment, known as the disproportionate share hospital (DSH) adjustment, provides for a percentage increase in Medicare payments to hospitals that qualify under either of two statutory formulas designed to identify hospitals that serve a disproportionate share of low-income patients. For qualifying hospitals, the amount of this adjustment varies based on the outcome of the statutory calculations. The Affordable Care Act revised the Medicare DSH payment methodology and provides for a new additional Medicare payment that considers the amount of uncompensated care beginning on October 1, 2013.

If the hospital is training residents in an approved residency program(s), it receives a percentage add-on payment for each case paid under the IPPS, known as the indirect medical education (IME) adjustment. This percentage varies, depending on the ratio of residents to beds.

Additional payments may be made for cases that involve new technologies or medical services that have been approved for special add-on payments. To qualify, a new technology or medical service must demonstrate that it is a substantial clinical improvement over technologies or services otherwise available, and that, absent an add-on payment, it would be inadequately paid under the regular DRG payment.

The costs incurred by the hospital for a case are evaluated to determine whether the hospital is eligible for an additional payment as an outlier case. This additional payment is designed to protect the hospital from large financial losses due to unusually expensive cases. Any eligible outlier payment is added to the DRG-adjusted base payment rate, plus any DSH, IME, and new technology or medical service add-on adjustments.

Although payments to most hospitals under the IPPS are made on the basis of the standardized amounts, some categories of hospitals are paid in whole or in part based on their hospital-specific rate, which is determined from their costs in a base year. For example, sole community hospitals (SCHs) receive the higher of a hospital-specific rate based on their costs in a base year (the highest of FY 1982, FY 1987, FY 1996, or FY 2006) or the IPPS Federal rate based on the standardized amount. SCHs are the sole source of care in their areas. Specifically, section 1886(d)(5)(D)(iii) of the Act defines an SCH as a hospital that is located more than 35 road miles from another hospital or that, by reason of factors such as isolated location, weather conditions, travel conditions, or absence of other like hospitals (as determined by the Secretary), is the sole source of hospital inpatient services reasonably available to Medicare beneficiaries. In addition, certain rural hospitals previously designated by the Secretary as essential access community hospitals are considered SCHs.

Under current law, the Medicare-dependent, small rural hospital (MDH) program is effective through FY 2017. Through and including FY 2006, an MDH received the higher of the Federal rate or the Federal rate plus 50 percent of the amount by which the Federal rate was exceeded by the higher of its FY 1982 or FY 1987 hospital-specific rate. For discharges occurring on or after October 1, 2007, but before October 1, 2017, an MDH receives the higher of the Federal rate or the Federal rate plus 75 percent of the amount by which the Federal rate is exceeded by the highest of its FY 1982, FY 1987, or FY 2002 hospital-specific rate. MDHs are a major source of care for Medicare beneficiaries in their areas. Section 1886(d)(5)(G)(iv) of the Act defines an MDH as a hospital that is located in a rural area, has not more than 100 beds, is not an SCH, and has a high percentage of Medicare discharges (not less than 60 percent of its inpatient days or discharges in its cost reporting year beginning in FY 1987 or in two of its three most recently settled Medicare cost reporting years).

Section 1886(g) of the Act requires the Secretary to pay for the capital-related costs of inpatient hospital services in accordance with a prospective payment system established by the Secretary. The basic methodology for determining capital prospective payments is set forth in our regulations at 42 CFR 412.308 and 412.312. Under the capital IPPS, payments are adjusted by the same DRG for the case as they are under the operating IPPS. Capital IPPS payments are also adjusted for IME and DSH, similar to the adjustments made under the operating IPPS. In addition, hospitals may receive outlier payments for those cases that have unusually high costs.

The existing regulations governing payments to hospitals under the IPPS are located in 42 CFR part 412, subparts A through M.

2. Hospitals and Hospital Units Excluded From the IPPS


[top] Under section 1886(d)(1)(B) of the Act, as amended, certain hospitals and hospital units are excluded from the IPPS. These hospitals and units are: Inpatient rehabilitation facility (IRF) hospitals and units; long-term care hospitals (LTCHs); psychiatric hospitals and units; children's hospitals; cancer hospitals; long-term care neoplastic page 19811 disease hospitals (formerly LTCHs classified under section 1886(d)(1)(B)(iv)(II) of the Act and redesignated by section 15008 of Pub. L. 114-255) and hospitals located outside the 50 States, the District of Columbia, and Puerto Rico (that is, hospitals located in the U.S. Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa). Religious nonmedical health care institutions (RNHCIs) are also excluded from the IPPS. Various sections of the Balanced Budget Act of 1997 (BBA, Pub. L. 105-33), the Medicare, Medicaid and SCHIP [State Children's Health Insurance Program] Balanced Budget Refinement Act of 1999 (BBRA, Pub. L. 106-113), and the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA, Pub. L. 106-554) provide for the implementation of PPSs for IRF hospitals and units, LTCHs, and psychiatric hospitals and units (referred to as inpatient psychiatric facilities (IPFs)). (We note that the annual updates to the LTCH PPS are now included as part of the IPPS annual update document. Updates to the IRF PPS and IPF PPS are issued as separate documents.) Children's hospitals, cancer hospitals, hospitals located outside the 50 States, the District of Columbia, and Puerto Rico (that is, hospitals located in the U.S. Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa), and RNHCIs continue to be paid solely under a reasonable cost-based system subject to a rate-of-increase ceiling on inpatient operating costs.

The existing regulations governing payments to excluded hospitals and hospital units are located in 42 CFR parts 412 and 413.

3. Long-Term Care Hospital Prospective Payment System (LTCH PPS)

The Medicare prospective payment system (PPS) for LTCHs applies to hospitals described in section 1886(d)(1)(B)(iv) of the Act effective for cost reporting periods beginning on or after October 1, 2002. The LTCH PPS was established under the authority of sections 123 of the BBRA and section 307(b) of the BIPA (as codified under section 1886(m)(1) of the Act). During the 5-year (optional) transition period, a LTCH's payment under the PPS was based on an increasing proportion of the LTCH Federal rate with a corresponding decreasing proportion based on reasonable cost principles. Effective for cost reporting periods beginning on or after October 1, 2006, all LTCHs are paid 100 percent of the Federal rate. Section 1206(a) of the Pathway for SGR Reform Act of 2013 (Pub. L. 113-67) established the site neutral payment rate under the LTCH PPS, which made the LTCH PPS a dual rate payment system beginning in FY 2016. Under this statute, based on a rolling effective date that is linked to the date on which a given LTCH's Federal FY 2016 cost reporting period begins, LTCHs are paid for LTCH discharges at the site neutral payment rate unless the discharge meets the patient criteria for payment at the LTCH PPS standard Federal payment rate. The existing regulations governing payment under the LTCH PPS are located in 42 CFR part 412, subpart O. Beginning October 1, 2009, we issue the annual updates to the LTCH PPS in the same documents that update the IPPS (73 FR 26797 through 26798).

4. Critical Access Hospitals (CAHs)

Under sections 1814(l), 1820, and 1834(g) of the Act, payments made to critical access hospitals (CAHs) (that is, rural hospitals or facilities that meet certain statutory requirements) for inpatient and outpatient services are generally based on 101 percent of reasonable cost. Reasonable cost is determined under the provisions of section 1861(v) of the Act and existing regulations under 42 CFR part 413.

5. Payments for Graduate Medical Education (GME)

Under section 1886(a)(4) of the Act, costs of approved educational activities are excluded from the operating costs of inpatient hospital services. Hospitals with approved graduate medical education (GME) programs are paid for the direct costs of GME in accordance with section 1886(h) of the Act. The amount of payment for direct GME costs for a cost reporting period is based on the hospital's number of residents in that period and the hospital's costs per resident in a base year. The existing regulations governing payments to the various types of hospitals are located in 42 CFR part 413.

C. Summary of Provisions of Recent Legislation Proposed To Be Implemented in This Proposed Rule

1. The American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-240), the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015 (Pub. L. 114-10), and the 21st Century Cures Act (Pub. L. 114-255)

Section 631 of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-240) amended section 7(b)(1)(B) of Public Law 110-90 to require CMS to make a recoupment adjustment to the standardized amounts under section 1886(d) of the Act based upon the Secretary's estimates for discharges occurring from FYs 2014 through FY 2017 to fully offset $11 billion. Once the recoupment required under section 631 of the ATRA was completed, CMS had anticipated making a single positive adjustment in FY 2018 to offset the reductions required to recoup the $11 billion under section 631 of the ATRA. However, section 414 of the MACRA (enacted on April 16, 2015) replaced the single positive adjustment CMS intended to make in FY 2018 with a 0.5 percent positive adjustment for each of FYs 2018 through 2023. Section 15005 of the 21st Century Cures Act (Pub. L. 114-255, enacted December 13, 2016) further amended Public Law 110-90 to reduce the adjustment for FY 2018 from 0.5 percent point to 0.4588 percentage point.

2. Pathway for SGR Reform Act of 2013 (Pub. L. 113-67)

The Pathway for SGR Reform Act of 2013 (Pub. L. 113-67) introduced new payment rules in the LTCH PPS. Under section 1206 of this law, discharges in cost reporting periods beginning on or after October 1, 2015 under the LTCH PPS will receive payment under a site neutral rate unless the discharge meets certain patient-specific criteria. In this proposed rule, we are continuing to provide clarifications to prior policy changes that implemented provisions under section 1206 of the Pathway for SGR Reform Act.

3. Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) (Pub. L. 113-185)

The Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act (Pub. L. 113-185), enacted on October 6, 2014, made a number of changes that affect the Long-Term Care Quality Reporting Program (LTCH QRP). In this proposed rule, we are proposing to continue to implement portions of section 1899B of the Act, as added by section 2 of the IMPACT Act, which, in part, requires LTCHs, among other postacute care providers, to report standardized patient assessment data, data on quality measures, and data on resource use and other measures.

4. The Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 114-10)


[top] Section 411(g) of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA, Pub. L. 114-10) sets the annual update under the LTCH PPS to 1.0 percent for FY 2018. In this proposed rule, consistent with this requirement, we are proposing to update page 19812 the LTCH standard Federal payment rate by 1.0 percent for FY 2018.

The MACRA also extended the MDH program and changes to the payment adjustment for low-volume hospitals through FY 2017. In this proposed rule, we discuss the expiration of the MDH program and the expiration of the temporary changes to the low-volume hospital payment adjustment under current law.

5. The 21st Century Cures Act (Pub. L. 114-255)

The 21st Century Cures Act (Pub. L. 114-255), enacted on December 13, 2016, contains a number of provisions affecting payments under the LTCH PPS and the Hospital Readmissions Reduction Program and the Medicare EHR Incentive Program, which we are proposing to implement in this proposed rule:

• Section 4002(b)(1)(A) amended section 1848(a)(7)(B) of the Act to provide that the Secretary shall exempt an eligible professional from the application of the payment adjustment under section 1848(a)(7)(A) of the Act with respect to a year, subject to annual renewal, if the Secretary determines that compliance with the requirement for being a meaningful EHR user is not possible because the certified EHR technology used by such eligible professional has been decertified under the Office of the National Coordinator for Health Information Technology's (ONC) Health IT Certification Program.

• Section 4002(b)(2) amended section 1886(b)(3)(B)(ix)(II) of the Act to provide that the Secretary shall exempt a hospital from the application of the payment adjustment under section 1886(b)(3)(B)(ix)(I) with respect to a fiscal year, subject to annual renewal, if the Secretary determines that compliance with the requirement for being a meaningful EHR user is not possible because the certified EHR technology used by the hospital is decertified under ONC's Health IT Certification Program.

• Section 15002, which amended section 1886(q)(3) of the Act by adding subparagraphs (D) and (E), which requires the Secretary to develop a methodology for the calculating the excess readmissions adjustment factor for the Hospital Readmissions Reduction Program based on cohorts defined by the percentage of dual eligible patients (that is, patients who are eligible for both Medicare and full-benefit Medicaid coverage) cared for by a hospital. In this proposed rule, we are proposing to implement changes to the payment adjustment factor to assess penalties based on a hospital's performance relative to other hospitals treating a similar proportion of dual eligible patients.

• Section 15004(a), which further amended section 114(d)(7) of the MMSEA (as amended) by striking "The moratorium under paragraph (1)(A)" and inserting "[a]ny moratorium under paragraph (1)" and specified that such amendment shall take effect as if included in the enactment of section 112 of the PAMA. We are proposing to implement the exceptions to the current statutory moratorium, which is in effect through September 30, 2017, on increasing beds in an existing LTCH or an existing LTCH satellite as provided by Section 15004(a).

• Section 15004(b), which modifies high cost outlier payments to LTCH standard Federal rate cases beginning in FY 2018.

• Section 15006, which further amended section 114(c)(1)(A) of the MMSEA (as amended) by extending the moratorium on the full implementation of the 25-percent threshold policy through June 30, 2016, and for discharges occurring on or after October 1, 2016 and before October 1, 2017. In this proposed rule, we are implementing the moratorium on the full implementation of the 25-percent threshold policy for discharges occurring on or after October 1, 2016, through September 30, 2017, as provided by section 15006.

• Section 15007, which amended section 1206(a)(3) of the Pathway for SGR Reform Act by extending the exclusion of Medicare Advantage plans' and site neutral payment rate discharges from the calculation of the average length-of-stay to all LTCHs, for discharges occurring in cost reporting periods beginning on or after October 1, 2015.

• Section 15008, which provided for a change in Medicare classification for "subclause (II)" LTCHs by redesignating such hospitals from section 1886(d)(1)(B)(iv)(II) to section 1886(d)(1)(B)(vi) of the Act. In this proposed rule, we are proposing to implement the reclassification of hospitals which had previously been classified as "subclause (II)" LTCHs as their own category of IPPS-excluded hospitals as provided by the provisions of section 15008.

• Section 15009 of Public Law 114-255, which added new subparagraph (F) to section 1886(m)(6) of the Act, providing for a temporary exception to the site neutral payment rate for certain spinal cord specialty hospitals for all discharges occurring during FYs 2018 and 2019.

• Section 15010, which added a new subparagraph (G) to section 1886(m)(6) of the Act, to create a temporary exception to the site neutral payment rate for certain severe wound discharges from certain LTCHs during such LTCH's cost reporting period beginning during FY 2018.

Public Law 114-255 also amended section 1886(q)(3) of the Act by adding subparagraphs (D) and (E), which requires the Secretary to develop a methodology for the Hospital Readmissions Reduction Program that accounts for the percentage of dual-eligible patients (that is, patients who are eligible for both Medicare and full-benefit Medicaid coverage) cared for by a hospital. In this proposed rule, we are proposing to implement changes to the payment adjustment factor to assess penalties based on a hospital's performance relative to other hospitals treating a similar proportion of dual-eligible patients.

• Section 16003 amended section 1848(a)(7)(D) of the Act to provide that no payment adjustment may be made under section 1848(a)(7)(A) of the Act for 2017 and 2018 in the case of an eligible professional who furnishes substantially all of his or her covered professional services in an ambulatory surgical center (ASC). Section 1848(a)(7)(D)(iii) of the Act provides that determinations of whether an eligible professional is ASC-based may be made based on the site of service as defined by the Secretary or an attestation, but shall be made without regard to any employment or billing arrangement between the eligible professional and any other supplier or provider of services. Section 1848(a)(7)(D)(iv) of the Act provides that the ASC-based exception shall no longer apply as of the first year that begins more than 3 years after the date on which the Secretary determines, through notice-and-comment rulemaking, that certified EHR technology applicable to the ASC setting is available.

D. Summary of Provisions of This Proposed Rule


[top] In this proposed rule, we are setting forth proposed payment and policy changes to the Medicare IPPS for FY 2018 operating costs and for capital-related costs of acute care hospitals and certain hospitals and hospital units that are excluded from IPPS. In addition, we are setting forth proposed changes to the payment rates, factors, and other payment and policy-related changes to programs associated with payment rate policies under the LTCH PPS for FY 2018. page 19813

Below is a summary of the major changes that we are proposing to make:

1. Proposed Changes to MS-DRG Classifications and Recalibrations of Relative Weights

In section II. of the preamble of this proposed rule, we include-

• Proposed changes to MS-DRG classifications based on our yearly review for FY 2018.

• Proposed adjustment to the standardized amounts under section 1886(d) of the Act for FY 2018 in accordance with the amendments made to section 7(b)(1)(B) of Public Law 110-90 by section 414 of the MACRA and section 15005 of the 21st Century Cures Act.

• Proposed recalibrations of the MS-DRG relative weights.

• A discussion of the FY 2018 status of new technologies approved for add-on payments for FY 2017 and a presentation of our evaluation and analysis of the FY 2018 applicants for add-on payments for high-cost new medical services and technologies (including public input, as directed by Pub. L. 108-173, obtained in a town hall meeting).

2. Proposed Changes to the Hospital Wage Index for Acute Care Hospitals

In section III. of the preamble to this proposed rule, we are proposing to make revisions to the wage index for acute care hospitals and the annual update of the wage data. Specific issues addressed include, but are not limited to, the following:

• The proposed FY 2018 wage index update using wage data from cost reporting periods beginning in FY 2014.

• Clarification of other wage-related costs in the wage index.

• Calculation of the proposed occupational mix adjustment for FY 2018 based on the 2013 Occupational Mix Survey.

• Analysis and implementation of the proposed FY 2018 occupational mix adjustment to the wage index for acute care hospitals.

• Proposed application of the rural floor and the frontier State floor and the proposed expiration of the imputed floor.

• Proposed revisions to the wage index for acute care hospitals based on hospital redesignations and reclassifications under sections 1886(d)(8)(B), (d)(8)(E), and (d)(10) of the Act.

• Proposal to require documentation of SCH and RRC classification status approvals to be submitted to the MGCRB by the first business day after January 1.

• Clarification of special rules for SCHs and RRCs reclassifying to geographic home areas.

• Proposed changes to the 45-day notification rule.

• The proposed adjustment to the wage index for acute care hospitals for FY 2018 based on commuting patterns of hospital employees who reside in a county and work in a different area with a higher wage index.

• Determination of the labor-related share for the proposed FY 2018 wage index.

3. Proposed Revising and Rebasing of Hospital Market Basket

In section IV. of this proposed rule, we are proposing to revise and rebase the hospital market baskets for acute care hospitals and update the labor-related share.

4. Other Decisions and Proposed Changes to the IPPS for Operating Costs

In section V. of the preamble of this proposed rule, we discuss proposed changes or clarifications of a number of the provisions of the regulations in 42 CFR parts 412 and 413, including the following:

• Proposed changes to MS-DRGs subject to the postacute care transfer policy.

• Proposed changes to the inpatient hospital update for FY 2018.

• Proposed changes to the volume decrease adjustment for SCHs.

• Proposed updated national and regional case-mix values and discharges for purposes of determining RRC status.

• Expiration of the MDH program and the temporary changes to the payment adjustment for low-volume hospitals at the end of FY 2017.

• Proposed parallel low-volume hospital payment adjustment concerning hospitals operated by the Indian Health Service (IHS) or a Tribe.

• The statutorily required IME adjustment factor for FY 2018.

• Proposed changes to the methodologies for determining Medicare DSH payments and the additional payments for uncompensated care.

• Discussion of expiration of the MDH program at the end of FY 2017 and our policy to allow MDHs to apply for SCH status in advance of the expiration of the MDH program and be paid as such under certain conditions.

• Proposed changes to the rules for payment adjustments under the Hospital Readmissions Reduction Program based on hospital readmission measures and the process for hospital review and correction of those rates for FY 2018.

• Proposed changes to the requirements and provision of value-based incentive payments under the Hospital Value-Based Purchasing Program.

• Proposed requirements for payment adjustments to hospitals under the HAC Reduction Program for FY 2018.

• Discussion of and proposals relating to the additional 5-year extension of the Rural Community Hospital Demonstration Program.

• Proposals related to the provider-based status of IHS and Tribal facilities and organizations that would remove the regulatory date limitation that restricted the grandfathering provision to IHS or Tribal facilities and organizations furnishing services on or before April 7, 2000. We also are proposing to make a technical change to make the regulation text more consistent with our current rules that require these facilities to comply with all applicable Medicare conditions of participation that apply to the main provider.

5. Proposed FY 2018 Policy Governing the IPPS for Capital-Related Costs

In section VI. of the preamble to this proposed rule, we discuss the proposed payment policy requirements for capital-related costs and capital payments to hospitals for FY 2018.

6. Proposed Changes to the Payment Rates for Certain Excluded Hospitals: Rate-of-Increase Percentages

In section VII. of the preamble of this proposed rule, we discuss-

• Proposed changes to payments to certain excluded hospitals for FY 2018.

• Proposed policy changes relating to payments to hospitals-within-hospitals.

• Proposed continued implementation of the Frontier Community Health Integration Project (FCHIP) Demonstration.

7. Proposed Changes to the LTCH PPS

In section VIII. of the preamble of this proposed rule, we set forth-

• Proposed changes to the LTCH PPS Federal payment rates, factors, and other payment rate policies under the LTCH PPS for FY 2018.

• Proposed changes to the short-stay outlier (SSO) policy.

• Proposed 1-year regulatory delay of the full implementation of the 25-percent threshold policy for discharges occurring in FY 2018.


[top] • Proposed changes to implement the temporary exception to the site neutral payment rate for certain spinal cord specialty hospitals and for certain discharges with severe wounds from certain LTCHs, as provided under sections 15009 and 15010 of Public Law 114-255, respectively. page 19814

• Proposed change to the average length of stay criterion to implement section 15007 of Public Law 114-255.

• Proposed change in Medicare classification for certain hospitals to implement section 15008 of Public Law 114-255.

8. Proposed Changes Relating to Quality Data Reporting for Specific Providers and Suppliers

In section IX. of the preamble of the proposed rule, we address-

• Proposed requirements for the Hospital Inpatient Quality Reporting (IQR) Program.

• Proposed changes to the requirements for the quality reporting program for PPS-exempt cancer hospitals (PCHQR Program).

• Proposed changes to the requirements under the LTCH Quality Reporting Program (LTCH QRP).

• Proposed changes to the requirements under the Inpatient Psychiatric Facility Quality Reporting (IPFQR) Program.

• Proposed changes to requirements pertaining to the clinical quality measurement of eligible hospitals and CAHs as well as EPs participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs.

9. Proposed Changes Relating to Medicare Cost Reporting and Provider Requirements

In section X. of the preamble of this proposed rule, we present our proposals to revise the regulations to allow providers to use an electronic signature to sign the Certification and Settlement Summary page of the Medicare cost report and submit this page electronically, and clarify the rules relating to the sale or scrapping of depreciable assets disposed of on or after December 1, 1997.

10. Proposed Changes Relating to Survey and Certification Requirements

In section XI. of the preamble of this proposed rule, we present our proposals for allowing transparency in accrediting organization survey reports and plans of correction and for changing the requirement for providers to publish self-termination notices in newspapers.

11. Determining Prospective Payment Operating and Capital Rates and Rate-of-Increase Limits for Acute Care Hospitals

In section V. of the Addendum to this proposed rule, we set forth proposed changes to the amounts and factors for determining the proposed FY 2018 prospective payment rates for operating costs and capital-related costs for acute care hospitals. We are proposing to establish the threshold amounts for outlier cases. In addition, we are addressing the update factors for determining the rate-of-increase limits for cost reporting periods beginning in FY 2018 for certain hospitals excluded from the IPPS.

12. Determining Prospective Payment Rates for LTCHs

In the Addendum to this proposed rule, we set forth proposed changes to the amounts and factors for determining the proposed FY 2018 LTCH PPS standard Federal payment rate and other factors used to determine LTCH PPS payments under both the LTCH PPS standard Federal payment rate and the site neutral payment rate in FY 2018. We are proposing to establish the adjustments for wage levels, the labor-related share, the cost-of-living adjustment, and high-cost outliers, including the applicable fixed-loss amounts and the LTCH cost-to-charge ratios (CCRs) for both payment rates.

13. Impact Analysis

In Appendix A of this proposed rule, we set forth an analysis of the impact that the proposed changes would have on affected acute care hospitals, CAHs, LTCHs, PCHs, and IPFs.

14. Recommendation of Update Factors for Operating Cost Rates of Payment for Hospital Inpatient Services

In Appendix B of this proposed rule, as required by sections 1886(e)(4) and (e)(5) of the Act, we are providing our recommendations of the appropriate percentage changes for FY 2018 for the following:

• A single average standardized amount for all areas for hospital inpatient services paid under the IPPS for operating costs of acute care hospitals (and hospital-specific rates applicable to SCHs).

• Target rate-of-increase limits to the allowable operating costs of hospital inpatient services furnished by certain hospitals excluded from the IPPS.

• The LTCH PPS standard Federal payment rate and the site neutral payment rate for hospital inpatient services provided for LTCH PPS discharges.

15. Discussion of Medicare Payment Advisory Commission Recommendations

Under section 1805(b) of the Act, MedPAC is required to submit a report to Congress, no later than March 15 of each year, in which MedPAC reviews and makes recommendations on Medicare payment policies. MedPAC's March 2017 recommendations concerning hospital inpatient payment policies address the update factor for hospital inpatient operating costs and capital-related costs for hospitals under the IPPS. We address these recommendations in Appendix B of this proposed rule. For further information relating specifically to the MedPAC March 2017 report or to obtain a copy of the report, contact MedPAC at (202) 220-3700 or visit MedPAC's Web site at: http://www.medpac.gov .

II. Proposed Changes to Medicare Severity Diagnosis-Related Group (MS-DRG) Classifications and Relative Weights

A. Background

Section 1886(d) of the Act specifies that the Secretary shall establish a classification system (referred to as diagnosis-related groups (DRGs)) for inpatient discharges and adjust payments under the IPPS based on appropriate weighting factors assigned to each DRG. Therefore, under the IPPS, Medicare pays for inpatient hospital services on a rate per discharge basis that varies according to the DRG to which a beneficiary's stay is assigned. The formula used to calculate payment for a specific case multiplies an individual hospital's payment rate per case by the weight of the DRG to which the case is assigned. Each DRG weight represents the average resources required to care for cases in that particular DRG, relative to the average resources used to treat cases in all DRGs.

Section 1886(d)(4)(C) of the Act requires that the Secretary adjust the DRG classifications and relative weights at least annually to account for changes in resource consumption. These adjustments are made to reflect changes in treatment patterns, technology, and any other factors that may change the relative use of hospital resources.

B. MS-DRG Reclassifications


[top] For general information about the MS-DRG system, including yearly reviews and changes to the MS-DRGs, we refer readers to the previous discussions in the FY 2010 IPPS/RY 2010 LTCH PPS final rule (74 FR 43764 through 43766) and the FYs 2011 through 2017 IPPS/LTCH PPS final rules (75 FR 50053 through 50055; 76 FR 51485 through 51487; 77 FR 53273; 78 FR 50512; 79 FR 49871; 80 FR 49342; and 81 FR 56787 through 56872, respectively). page 19815

C. Adoption of the MS-DRGs in FY 2008

For information on the adoption of the MS-DRGs in FY 2008, we refer readers to the FY 2008 IPPS final rule with comment period (72 FR 47140 through 47189).

D. Proposed FY 2018 MS-DRG Documentation and Coding Adjustment

1. Background on the Prospective MS-DRG Documentation and Coding Adjustments for FY 2008 and FY 2009 Authorized by Public Law 110-90

In the FY 2008 IPPS final rule with comment period (72 FR 47140 through 47189), we adopted the MS-DRG patient classification system for the IPPS, effective October 1, 2007, to better recognize severity of illness in Medicare payment rates for acute care hospitals. The adoption of the MS-DRG system resulted in the expansion of the number of DRGs from 538 in FY 2007 to 745 in FY 2008. By increasing the number of MS-DRGs and more fully taking into account patient severity of illness in Medicare payment rates for acute care hospitals, MS-DRGs encourage hospitals to improve their documentation and coding of patient diagnoses.

In the FY 2008 IPPS final rule with comment period (72 FR 47175 through 47186), we indicated that the adoption of the MS-DRGs had the potential to lead to increases in aggregate payments without a corresponding increase in actual patient severity of illness due to the incentives for additional documentation and coding. In that final rule with comment period, we exercised our authority under section 1886(d)(3)(A)(vi) of the Act, which authorizes us to maintain budget neutrality by adjusting the national standardized amount, to eliminate the estimated effect of changes in coding or classification that do not reflect real changes in case-mix. Our actuaries estimated that maintaining budget neutrality required an adjustment of -4.8 percentage points to the national standardized amount. We provided for phasing in this -4.8 percentage point adjustment over 3 years. Specifically, we established prospective documentation and coding adjustments of -1.2 percentage points for FY 2008, -1.8 percentage points for FY 2009, and -1.8 percentage points for FY 2010.

On September 29, 2007, Congress enacted the TMA [Transitional Medical Assistance], Abstinence Education, and QI [Qualifying Individuals] Programs Extension Act of 2007 (Pub. L. 110-90). Section 7(a) of Public Law 110-90 reduced the documentation and coding adjustment made as a result of the MS-DRG system that we adopted in the FY 2008 IPPS final rule with comment period to -0.6 percentage point for FY 2008 and -0.9 percentage point for FY 2009.

As discussed in prior year rulemaking, and most recently in the FY 2017 IPPS/LTCH PPS final rule (81 FR 56780 through 56782), we implemented a series of adjustments required under sections 7(b)(1)(A) and 7(b)(1)(B) of Public Law 110-90, based on a retrospective review of FY 2008 and FY 2009 claims data. We completed these adjustments in FY 2013, but indicated in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53274 through 53275) that delaying full implementation of the adjustment required under section 7(b)(1)(A) of Public Law 110-90 until FY 2013 resulted in payments in FY 2010 through FY 2012 being overstated, and that these overpayments could not be recovered.

2. Recoupment or Repayment Adjustment Authorized by Section 631 of the American Taxpayer Relief Act of 2012 (ATRA)

Section 631 of the ATRA amended section 7(b)(1)(B) of Public Law 110-90 to require the Secretary to make a recoupment adjustment or adjustments totaling $11 billion by FY 2017. This adjustment represented the amount of the increase in aggregate payments as a result of not completing the prospective adjustment authorized under section 7(b)(1)(A) of Public Law 110-90 until FY 2013. As discussed earlier, this delay in implementation resulted in overstated payment rates in FYs 2010, 2011, and 2012. The resulting overpayments could not have been recovered under Public Law 110-90.

Similar to the adjustments authorized under section 7(b)(1)(B) of Public Law 110-90, the adjustment required under section 631 of the ATRA was a one-time recoupment of a prior overpayment, not a permanent reduction to payment rates. Therefore, we anticipated that any adjustment made to reduce payment rates in one year would eventually be offset by a positive adjustment in 2018, once the necessary amount of overpayment was recovered. However, section 414 of the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015, Public Law 114-10, enacted on April 16, 2015, replaced the single positive adjustment we intended to make in FY 2018 with a 0.5 percentage point positive adjustment for each of FYs 2018 through 2023. We stated in the FY 2016 IPPS/LTCH PPS final rule (80 FR 49345) that we would address this MACRA provision in future rulemaking. However, section 15005 of the 21st Century Cures Act (Pub. L. 114-255), enacted on December 13, 2016, reduced the adjustment for FY 2018 from 0.5 percentage points to 0.4588 percentage points. We are addressing these provisions of MACRA and the 21st Century Cures Act in section II.D.3. of the preamble of this proposed rule.

As we stated in the FY 2014 IPPS/LTCH PPS final rule (78 FR 50515 through 50517), our actuaries estimated that a -9.3 percentage point adjustment to the standardized amount would be necessary if CMS were to fully recover the $11 billion recoupment required by section 631 of the ATRA in FY 2014. It is often our practice to phase in payment rate adjustments over more than one year, in order to moderate the effect on payment rates in any one year. Therefore, consistent with the policies that we have adopted in many similar cases, and after consideration of the public comments we received, in the FY 2014 IPPS/LTCH PPS final rule (78 FR 50515 through 50517), we implemented a -0.8 percentage point recoupment adjustment to the standardized amount in FY 2014. We estimated that if adjustments of approximately -0.8 percentage point were implemented in FYs 2014, 2015, 2016, and 2017, using standard inflation factors, the entire $11 billion would be accounted for by the end of the statutory 4-year timeline. As estimates of any future adjustments are subject to variations in total savings, we did not provide for specific adjustments for FYs 2015, 2016, or 2017 at that time.

Consistent with the approach discussed in the FY 2014 rulemaking for recouping the $11 billion required by section 631 of the ATRA, in the FY 2015 IPPS/LTCH PPS final rule (79 FR 49874) and the FY 2016 IPPS/LTCH PPS final rule (80 FR 49345), we implemented additional -0.8 percentage point recoupment adjustments to the standardized amount in FY 2015 and FY 2016, respectively. We estimated that these adjustments, combined with leaving the prior -0.8 percentage point adjustments in place, would recover up to $2 billion in FY 2015 and another $3 billion in FY 2016. When combined with the approximately $1 billion adjustment made in FY 2014, we estimated that approximately $5 to $6 billion would be left to recover under section 631 of the ATRA by the end of FY 2016.


[top] As indicated in the FY 2017 IPPS/LTCH PPS proposed rule (81 FR 24966), due to lower than previously estimated inpatient spending, we determined that an adjustment of -0.8 percentage point in FY 2017 would not recoup the $11 billion under section 631 of the ATRA. page 19816 For the FY 2017 IPPS/LTCH PPS final rule (81 FR 56785), based on the Midsession Review of the President's FY 2017 Budget, our actuaries estimated that, to the nearest tenth of a percentage point, the FY 2017 documentation and coding adjustment factor that will recoup as closely as possible $11 billion from FY 2014 through FY 2017 without exceeding this amount is -1.5 percentage points. Based on those updated estimates by the Office of the Actuary using the Midsession Review of the President's FY 2017 Budget, we made a -1.5 percentage point adjustment for FY 2017 as the final adjustment required under section 631 of the ATRA. The estimates by our actuaries related to this finalized adjustment were included in a memorandum that we made publicly available on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2017-IPPS-Final-Rule-Home-Page-Items/FY2017-IPPS-Final-Rule-OACT.html .

3. Proposed Adjustment for FY 2018 Required Under Section 414 of Public Law 114-10 (MACRA) and Section 15005 of Public Law 114-255

As stated in the FY 2017 IPPS/LTCH PPS final rule (81 FR 56785), once the recoupment required under section 631 of the ATRA was complete, we had anticipated making a single positive adjustment in FY 2018 to offset the reductions required to recoup the $11 billion under section 631 of the ATRA. However, section 414 of the MACRA (which was enacted on April 16, 2015) replaced the single positive adjustment we intended to make in FY 2018 with a 0.5 percentage point positive adjustment for each of FYs 2018 through 2023. In the FY 2017 rulemaking, we indicated that we would address the adjustments for FY 2018 and later fiscal years in future rulemaking. As noted previously, section 15005 of the 21st Century Cures Act (Pub. L. 114-255), which was enacted on December 13, 2016, amended section 7(b)(1)(B) of the TMA, as amended by section 631 of the ATRA and section 414 of the MACRA, to reduce the adjustment for FY 2018 from a 0.5 percentage point to a 0.4588 percentage point. We believe the directive under section 15005 of Public Law 114-255 is clear. Therefore, for FY 2018, we are proposing to implement the required +0.4588 percentage point adjustment to the standardized amount. This is a permanent adjustment to payment rates. While we are not proposing future adjustments required under section 414 of the MACRA and section 15005 of Public Law 114-255 at this time, we expect to propose positive 0.5 percentage point adjustments to the standardized amounts for FYs 2019 through 2023.

E. Refinement of the MS-DRG Relative Weight Calculation

1. Background

Beginning in FY 2007, we implemented relative weights for DRGs based on cost report data instead of charge information. We refer readers to the FY 2007 IPPS final rule (71 FR 47882) for a detailed discussion of our final policy for calculating the cost-based DRG relative weights and to the FY 2008 IPPS final rule with comment period (72 FR 47199) for information on how we blended relative weights based on the CMS DRGs and MS-DRGs. We also refer readers to the FY 2017 IPPS/LTCH PPS final rule (81 FR 56785 through 56787) for a detailed discussion of the history of changes to the number of cost centers used in calculating the DRG relative weights. Since FY 2014, we calculate the IPPS MS-DRG relative weights using 19 CCRs, which now include distinct CCRs for implantable devices, MRIs, CT scans, and cardiac catheterization.

2. Discussion of Policy for FY 2018

Consistent with our established policy, we calculated the proposed MS-DRG relative weights for FY 2018 using two data sources: The MedPAR file as the claims data source and the HCRIS as the cost report data source. We adjusted the charges from the claims to costs by applying the 19 national average CCRs developed from the cost reports. The description of the calculation of the proposed 19 CCRs and the proposed MS-DRG relative weights for FY 2018 is included in section II.G. of the preamble to this FY 2018 IPPS/LTCH PPS proposed rule. As we did with the FY 2017 IPPS/LTCH PPS final rule, for this proposed rule, we are providing the version of the HCRIS from which we calculated these proposed 19 CCRs on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html . Click on the link on the left side of the screen titled, "FY 2018 IPPS Proposed Rule Home Page" or "Acute Inpatient Files for Download."

F. Proposed Changes to Specific MS-DRG Classifications

1. Discussion of Changes to Coding System and Basis for Proposed FY 2018 MS-DRG Updates

a. Conversion of MS-DRGs to the International Classification of Diseases, 10th Revision (ICD-10)

As of October 1, 2015, providers use the International Classification of Diseases, 10th Revision (ICD-10) coding system to report diagnoses and procedures for Medicare hospital inpatient services under the MS-DRG system instead of the ICD-9-CM coding system, which was used through September 30, 2015. The ICD-10 coding system includes the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) for diagnosis coding and the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) for inpatient hospital procedure coding, as well as the Official ICD-10-CM and ICD-10-PCS Guidelines for Coding and Reporting. For a detailed discussion of the conversion of the MS-DRGs to ICD-10, we refer readers to the FY 2017 IPPS/LTCH PPS final rule (81 FR 56787 through 56789).

b. Basis for FY 2018 Proposed MS-DRG Updates


[top] CMS has previously encouraged input from our stakeholders concerning the annual IPPS updates when that input is made available to us by December 7 of the year prior to the next annual proposed rule update. For example, to be considered for any updates or changes in FY 2018, comments and suggestions should have been submitted by December 7, 2016. The comments that were submitted in a timely manner for FY 2018 are discussed in this section of the preamble of this proposed rule. As CMS works with the public to examine the ICD-10 claims data used for updates to the ICD-10 MS-DRGs, we would like to examine areas where the MS-DRGs can be improved. This will require additional time for us to review requests from the public to make specific updates, analyze claims data, and consider any proposed updates. Given the need for more time to carefully evaluate requests and propose updates, we are changing the deadline to request updates to MS-DRGs to November 1 of each year. This will provide an additional 5 weeks for the data analysis and review process. Interested parties should submit any comments and suggestions for FY 2019 by November 1, 2017, via the CMS MS- page 19817 DRG Classification Change Requests Mailbox located at: MSDRGClassificationChange@cms.hhs.gov .

Following are the changes that we are proposing to the MS-DRGs for FY 2018 in this FY 2018 IPPS/LTCH PPS proposed rule. We are inviting public comments on each of the MS-DRG classification proposed changes as well as our proposals to maintain certain existing MS-DRG classifications discussed in this proposed rule. In some cases, we are proposing changes to the MS-DRG classifications based on our analysis of claims data. In other cases, we are proposing to maintain the existing MS-DRG classification based on our analysis of claims data. For this FY 2018 proposed rule, our MS-DRG analysis was based on ICD-10 claims data from the December 2016 update of the FY 2016 MedPAR file, which contains hospital bills received through September 30, 2016, for discharges occurring through September 30, 2016. In our discussion of the proposed MS-DRG reclassification changes, we referred to our analysis of claims data from the "December 2016 update of the FY 2016 MedPAR file".

As explained in previous rulemaking (76 FR 51487), in deciding whether to propose to make further modification to the MS-DRGs for particular circumstances brought to our attention, we consider whether the resource consumption and clinical characteristics of the patients with a given set of conditions are significantly different than the remaining patients represented in the MS-DRG. We evaluate patient care costs using average costs and lengths-of-stay and rely on the judgment of our clinical advisors to determine whether patients are clinically distinct or similar to other patients represented in the MS-DRG. In evaluating resource costs, we consider both the absolute and percentage differences in average costs between the cases we select for review and the remainder of cases in the MS-DRG. We also consider variation in costs within these groups; that is, whether observed average differences are consistent across patients or attributable to cases that are extreme in terms of costs or length of stay, or both. Further, we consider the number of patients who will have a given set of characteristics and generally prefer not to create a new MS-DRG unless it would include a substantial number of cases.

In our examination of the claims data, we apply the following criteria established in FY 2008 (72 FR 47169) to determine if the creation of a new complication or comorbidity (CC) or major complication or comorbidity (MCC) subgroup within a base MS-DRG is warranted:

• A reduction in variance of costs of at least 3 percent.

• At least 5 percent of the patients in the MS-DRG fall within the CC or MCC subgroup.

• At least 500 cases are in the CC or MCC subgroup.

• There is at least a 20-percent difference in average costs between subgroups.

• There is a $2,000 difference in average costs between subgroups.

In order to warrant creation of a CC or MCC subgroup within a base MS-DRG, the subgroup must meet all five of the criteria.

2. MDC 1 (Diseases and Disorders of the Nervous System)

a. Functional Quadriplegia

We received a request to reassign cases identified by diagnosis code R53.2 (Functional quadriplegia) from MS-DRGs 052 and 053 (Spinal Disorders and Injuries with and without CC/MCC, respectively). The requestor stated that because functional quadriplegia does not involve any spinal injury or pathology, cases identified by the diagnosis code should not be assigned to MS-DRGs 052 and 053. However, the requestor did not suggest an alternative MS-DRG assignment.

Section I.C.18.f. of the FY 2017 ICD-10-CM Official Coding Guidelines addresses the coding for the diagnosis of functional quadriplegia. Section I.C.18.f. states that functional quadriplegia (described by diagnosis code R53.2) is the lack of ability to use one's limbs or to ambulate due to extreme debility. The condition is not associated with neurologic deficit or injury, and diagnosis code R53.2 should not be used to identify cases of neurologic quadriplegia. In addition, the Guidelines state that the diagnosis code should only be assigned if functional quadriplegia is specifically documented by a physician in the medical record, and the diagnosis of functional quadriplegia is not associated with a neurologic deficit or injury. A physician may document the diagnosis of functional quadriplegia as occurring with a variety of conditions.

We examined claims data from the December 2016 update of the FY 2016 MedPAR file on cases reporting diagnosis code R53.2 in MS-DRGs 052 and 053. Our findings are shown in the table below.

MS-DRG Number of cases Average length of stay Average costs
MS-DRG 052-All cases 865 5.4 $10,247
MS-DRG 052-Cases reporting diagnosis code R53.2 63 4.9 6,420
MS-DRG 053-All cases 239 3.3 6,326
MS-DRG 053-Cases reporting diagnosis code R53.2 16 3.3 2,318

As shown in the table above, for MS-DRG 052, there were a total of 865 cases with an average length of stay of 5.4 days and average costs of $10,247. Of the 865 cases in MS-DRG 052, there were 63 cases that reported a principal diagnosis of functional quadriplegia, with an average length of stay of 4.9 days and average costs of $6,420. For MS-DRG 053, there were a total of 239 cases, with an average length of stay of 3.3 days and average costs of $6,326. Of the 239 cases in MS-DRG 053, there were 16 cases that reported a principal diagnosis of functional quadriplegia, with an average length of stay of 3.3 days and average costs of $2,318.


[top] To address the request to reassign cases reporting a diagnosis of functional quadriplegia to a different MS-DRG, we reviewed the data for a total of 79 cases (63 cases in MS-DRG 052 and 16 cases in MS-DRG 053) that reported a principal diagnosis of functional quadriplegia in MS-DRGs 052 and 053. As shown in the table above, our data analysis demonstrates that the average costs for these 79 cases are lower than the average costs of all cases in MS-DRGs 052 and 053 ($6,420 compared to $10,247 for all cases in MS-DRG 052, and $2,318 compared to $6,326 for all cases in MS-DRG 053), and the average page 19818 lengths of stay are shorter for cases reporting a diagnosis of functional quadriplegia in MS-DRG 052 (4.9 days compared to 5.4 days for all cases in MS-DRG 052), but equal for cases in MS-DRG 053 (3.3 days for cases reporting a diagnosis of functional quadriplegia and for all cases).

Our clinical advisors reviewed this issue and agreed that a diagnosis of functional quadriplegia does not involve a spinal disorder or injury, and may be associated with, or the result of, a variety of underlying conditions. Our clinical advisors also agreed that it is not clinically appropriate to include cases reporting a diagnosis of functional quadriplegia within MS-DRGs 052 and 053 because these cases do not involve a spinal disorder or injury. Therefore, given the fact that functional quadriplegia can be the result of a variety of other conditions, we reviewed the MS-DRGs in order to identify a more appropriate placement for cases reporting this diagnosis. Our clinical advisors recommended assigning cases representing a diagnosis of functional quadriplegia from MS-DRGs 052 and 053 to MS-DRGs 091, 092, and 093 (Other Disorders of Nervous System with MCC, with CC, and without CC/MCC, respectively). Within each MDC, there are MS-DRGs that describe a variety of other conditions that do not have the clinical characteristics of the more specific MS-DRGs. In this case, MS-DRGs 091, 092, and 093 describe a variety of other disorders of the nervous system that are not clinically similar in characteristics to the disorders described by MS-DRGs 052 and 053. Our clinical advisors believe that MS-DRGs 091, 092, and 093 are more appropriate MS-DRG assignments for cases representing a diagnosis of functional quadriplegia.

We examined claims data from the December 2016 update of the FY 2016 MedPAR file on cases in MS-DRGs 091, 092, and 093. Our findings are shown in the table below.

MS-DRG Number of cases Average length of stay Average costs
MS-DRG 091-All cases 12,607 5.6 $10,815
MS-DRG 092-All cases 19,392 3.9 6,706
MS-DRG 093-All cases 8,120 2.7 5,253

As shown in the table above, for MS-DRG 091, there were a total of 12,607 cases, with an average length of stay of 5.6 days and average costs of $10,815. For MS-DRG 092, there were a total of 19,392 cases, with an average length of stay of 3.9 days and average costs of $6,706. For MS-DRG 093, there were a total of 8,120 cases, with an average length of stay of 2.7 days and average costs of $5,253. As stated earlier, of the 865 total cases in MS-DRG 052, there were 63 cases that reported a principal diagnosis of functional quadriplegia, with an average length of stay of 4.9 days and average costs of $6,420. Of the 239 total cases in MS-DRG 053, there were 16 cases that reported a principal diagnosis of functional quadriplegia, with an average length of stay of 3.3 days and average costs of $2,318. The average lengths-of-stay for cases reporting a diagnosis of functional quadriplegia in MS-DRGs 052 and 053 are similar to the average lengths of stay for cases found in MS-DRGs 091, 092 and 093 (4.9 days and 3.3 days for cases in MS-DRGs 052 and 053, respectively, compared to 5.6 days, 3.9 days, and 2.7 days, respectively, for cases in MS-DRGs 091, 092, and 093). The average costs for cases reporting a diagnosis of functional quadriplegia in MS-DRGs 052 and 053 are $6,420 and $2,318, respectively, compared to $10,815, $6,706, and $5,253 for all cases in MS-DRGs 091, 092, and 093. The average costs for cases reporting a diagnosis of functional quadriplegia in MS-DRG 053 are lower than the average costs for all cases in MS-DRG 093 without a CC or MCC ($2,318 compared to $5,253, respectively). The average costs for cases reporting a diagnosis of functional quadriplegia in MS-DRG 052 are $6,420, which is lower than the average costs of $10,815 for all cases in MS-DRG 091, but close to the average costs of $6,706 for all cases in MS-DRG 092. While we acknowledge that the average costs for cases reporting a diagnosis of functional quadriplegia are lower than those cases within MS-DRGs 091, 092, and 093, as stated earlier, the average costs of cases reporting a diagnosis of functional quadriplegia also are lower than the average costs of all cases in MS-DRGs 052 and 053 where these cases are currently assigned.

Our clinical advisors reviewed the clinical issues as well as the claims data for MS-DRGs 052, 053, 091, 092, and 093. As a result of this review, they recommended that cases reporting a diagnosis of functional quadriplegia be reassigned from MS-DRGs 052 and 053 to MS-DRGs 091, 092, and 093 because the current MS-DRG assignment is not clinically appropriate. Our clinical advisors stated that reassigning these cases to MS-DRGs 091, 092, and 093 is more appropriate because this set of MS-DRGs includes a variety of nervous system disorders that are not appropriately classified to more specific MS-DRGs within MDC 1. Therefore, we are proposing to reassign cases identified by diagnosis code R53.2 from MS-DRGs 052 and 053 to MS-DRGs 091, 092, and 093 for FY 2018.

We are inviting public comments on our proposal.

b. Responsive Neurostimulator (RNS © ) System

We received a request to modify the MS-DRG assignment for cases involving the use of the RNS © neurostimulator, a cranially implanted neurostimulator that is a treatment option for persons diagnosed with medically intractable epilepsy. Cases involving the use of the RNS © neurostimulator are assigned to MS-DRG 023 (Craniotomy with Major Device Implant or Acute Complex Central Nervous System (CNS) Principal Diagnosis (PDX) with MCC or Chemo Implant) and MS-DRG 024 (Craniotomy with Major Device Implant or Acute Complex Central Nervous System (CNS) Principal Diagnosis (PDX) without MCC).


[top] Cases involving the use of the RNS © neurostimulator generator and leads are captured within the descriptions of four ICD-10-PCS codes. ICD-10-PCS code 0NH00NZ (Insertion of neurostimulator generator into skull, open approach) captures the use of the neurostimulator generator, and the other three ICD-10-PCS codes, 00H00MZ (Insertion of neurostimulator lead into brain, open approach), 00H03MZ (Insertion of neurostimulator lead into brain, percutaneous approach), and 00H04MZ (Insertion of neurostimulator lead into brain, percutaneous endoscopic approach) describe the insertions of the leads, depending on the approach used. The combination of an ICD-10-PCS page 19819 code capturing the use of the generator and another ICD-10-PCS code describing the specific approach used to insert the leads would capture the performance of the entire procedure.

The requestor stated that the RNS © neurostimulator received FDA pre-market approval on November 14, 2013, and is the first and only FDA-approved device used to provide responsive stimulation directly to the seizure onset zone in the brain. The RNS © neurostimulator includes a cranially implanted programmable neurostimulator connected to one or two depth and/or subdural cortical strip leads that are surgically placed in or on the brain at the seizure focus. The neurostimulator and leads are typically implanted during a single acute inpatient hospital procedure at a Comprehensive Epilepsy Center (CEC). The implanted neurostimulator continuously monitors brain electrical activity and is programmed by a physician to detect abnormal patterns of electrical activity that the physician believes may lead to seizures (epileptiform activity). In response to the detection of epileptiform activity, the device delivers brief, mild electrical pulses (responsive stimulation) to one or two epileptic foci. Detection and stimulation parameters are adjusted noninvasively by the physician to optimize control of epileptic seizures for each patient.

As the neurostimulator monitors brain activity, electrocorticograms (ECoGs) recorded immediately before and after certain events are stored for later review by the physician. The physician reviews the stored recordings to see the detections and the effects of stimulation. The physician can reprogram the neurostimulator at an in-person office appointment to change detection and stimulation settings based on this information, as well as review the patient's seizures.

The RNS © neurostimulator was approved for new technology add-on payments for FY 2015 and FY 2016, and new technology add-on payments were discontinued for FY 2017. The new technology add-on payment application was discussed in the FY 2015 IPPS/LTCH PPS proposed and final rules (79 FR 28051 through 28054 and 79 FR 49946 through 49950, respectively), the FY 2016 IPPS/LTCH PPS proposed and final rules (80 FR 24427 through 24448 and 80 FR 49442 through 49443, respectively), and the FY 2017 IPPS/LTCH PPS proposed and final rules (81 FR 25036 through 25037 and 81 FR 56882 through 56884, respectively).

The requestor suggested the following three options for MS-DRG assignment updates for cases involving the RNS © neurostimulator:

• Create new MS-DRGs for cases involving the use of the RNS © neurostimulator. The requestor suggested MS-DRG XXX (Cranially Implanted Neurostimulators with MCC) and MS-DRG XXX (Cranially Implanted Neurostimulators without MCC) as possible MS-DRG titles. The requestor acknowledged that the number of cases assigned to this MS-DRG would be low, but anticipated that the number of cases would increase in the future.

• Reassign cases involving the use of the RNS © neurostimulator to MS-DRGs 020 and 021 (Intracranial Vascular Procedures with Principal Diagnosis of Hemorrhage with MCC, with CC, respectively) and update the MS-DRG logic and titles. The requestor asked CMS to reassign all cases involving the use of the RNS © neurostimulator that currently map to MS-DRG 023 (Craniotomy with Major Device Implant/Acute Complex CNS Principal Diagnosis with MCC or Chemo Implant) to MS-DRG 20, and change the title of MS-DRG 20 to "Intracranial Vascular Procedures with Principal Diagnosis of Hemorrhage or Cranially Implanted Neurostimulator with MCC." In addition, the requestor asked CMS to reassign all cases involving the use of the RNS © neurostimulator that currently map to MS-DRG 024 (Craniotomy with Major Device Implant/Acute Complex CNS Principal Diagnosis without MCC) to MS-DRG 021, and change the title of MS-DRG 021 to "Intracranial Vascular Procedures with Principal Diagnosis of Hemorrhage with CC or Cranially Implanted Neurostimulator without MCC". The requestor believed that the majority of cases involving the use of the RNS © neurostimulator that map to MS-DRG 024 do not include a secondary diagnosis that is classified as a CC, and the average cost of cases involving the use of the RNS © neurostimulator without a CC is significantly higher than the average cost of all cases in MS-DRG 022 (Intracranial Vascular Procedures with Principal Diagnosis of Hemorrhage without CC/MCC). Therefore, the requestor stated that it would not be adequate to assign cases involving the use of the RNS © neurostimulator without a CC to MS-DRG 022.

• Reassign cases involving the use of the RNS © neurostimulator to other higher paying MS-DRGs that would provide adequate payment.

The requestor stated that it had analyzed data from two sources, which demonstrated that the average cost of cases involving the use of the RNS © neurostimulator was higher than the average cost of all cases in MS-DRGs 023 and 024 (the current MS-DRGs for cases involving the use of the RNS © neurostimulator). The requestor indicated that the data used for its analysis was obtained from hospitals performing the procedure, as well as from the FY 2015 MedPAR file.

The requestor also asked that CMS examine the cases representing cranially implanted neurostimulators and leads that were inserted for the treatment of epilepsy. The requestor pointed out that neurostimulators also are used in the treatment of movement disorders such as Parkinson's disease, essential tremor, or dystonia. The requestor asked that CMS identify those cases with a principal diagnosis of epilepsy, and identified the following ICD-10-CM codes that it believed were representative of potential epilepsy cases.

page 19820


[top] 
ICD-10-CM code ICD-10-CM code title
G40.001 Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, not intractable, with status epilepticus.
G40.009 Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, not intractable, without status epilepticus.
G40.011 Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, intractable, with status epilepticus.
G40.019 Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, intractable, without status epilepticus.
G40.101 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, not intractable, with status epilepticus.
G40.119 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, intractable, without status epilepticus.
G40.201 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, not intractable, with status epilepticus.
G40.209 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, not intractable, without status epilepticus.
G40.211 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, intractable, with status epilepticus.
G40.219 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, intractable, without status epilepticus.
G40.301 Generalized idiopathic epilepsy and epileptic syndromes, not intractable, with status epilepticus.
G40.309 Generalized idiopathic epilepsy and epileptic syndromes, not intractable, without status epilepticus.
G40.311 Generalized idiopathic epilepsy and epileptic syndromes, intractable, with status epilepticus.
G40.319 Generalized idiopathic epilepsy and epileptic syndromes, intractable, without status epilepticus.
G40.401 Other generalized epilepsy and epileptic syndromes, not intractable, with status epilepticus.
G40.409 Other generalized epilepsy and epileptic syndromes, not intractable, without status epilepticus.
G40.411 Other generalized epilepsy and epileptic syndromes, intractable, with status epilepticus.
G40.419 Other generalized epilepsy and epileptic syndromes, intractable, without status epilepticus.
G40.501 Epileptic seizures related to external causes, not intractable, with status epilepticus.
G40.509 Epileptic seizures related to external causes, not intractable, without status epilepticus.
G40.801 Other epilepsy, not intractable, with status epilepticus.
G40.802 Other epilepsy, not intractable, without status epilepticus.
G40.803 Other epilepsy, intractable, with status epilepticus.
G40.804 Other epilepsy, intractable, without status epilepticus.
G40.811 Lennox-Gastaut syndrome, not intractable, with status epilepticus.
G40.812 Lennox-Gastaut syndrome, not intractable, without status epilepticus.
G40.813 Lennox-Gastaut syndrome, intractable, with status epilepticus.
G40.814 Lennox-Gastaut syndrome, intractable, without status epilepticus.
G40.821 Epileptic spasms, not intractable, with status epilepticus.
G40.822 Epileptic spasms, not intractable, without status epilepticus.
G40.823 Epileptic spasms, intractable, with status epilepticus.
G40.824 Epileptic spasms, intractable, without status epilepticus.
G40.89 Other seizures.
G40.901 Epilepsy, unspecified, not intractable, with status epilepticus.
G40.909 Epilepsy, unspecified, not intractable, without status epilepticus.
G40.911 Epilepsy, unspecified, intractable, with status epilepticus.
G40.919 Epilepsy, unspecified, intractable, without status epilepticus.


MS-DRGs 023 and 024 contain a number of cases representing neurostimulator generator and lead code combinations that are captured under a list referred to as "Major Device Implant." The neurostimulator generators on this list are inserted into the skull, as well as into the subcutaneous areas of the chest, back, or abdomen. The leads are all inserted into the brain. The RNS © neurostimulator generators are inserted into the skull and the leads are inserted into the brain. The following three ICD-10-PCS code combinations capture the use of the RNS © neurostimulator and leads that would determine an assignment of a case to MS-DRGs 023 and 024, as shown in the "Major Device Implant" list:

• 0NH00NZ (Insertion of neurostimulator generator into skull, open approach), in combination with 00H00MZ (Insertion of neurostimulator lead into brain, open approach);

• 0NH00NZ (Insertion of neurostimulator generator into skull, open approach), in combination with 00H03MZ (Insertion of neurostimulator lead into brain, percutaneous approach); and

• 0NH00NZ (Insertion of neurostimulator generator into skull, open approach), in combination with 00H04MZ (Insertion of neurostimulator lead into brain, percutaneous endoscopic approach).

We examined claims data from the December 2016 update of the FY 2016 MedPAR file for all cases representing the use of a neurostimulator in MS-DRGs 023 and 024 listed under the "Major Device Implant" list. As requested, we also examined the cases represented by the three neurostimulator code combinations, which capture the use of the RNS © neurostimulator that are a subset of the cases listed on the "Major Device Implant" list using the code combinations listed above, and that had a principal diagnosis of epilepsy from the list supplied by the requestor. The following tables show our findings for those cases in MS-DRGs 023 and 024 as well as findings for cases in MS-DRGs 020 and 021.

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MS-DRG Number of cases Average length of stay Average costs
MS-DRG 023-All cases 6,723 10.9 $39,014
MS-DRG 023-Cases with neurostimulators (Major Device Implant list cases) 21 6.7 48,821
MS-DRG 023-Cases with neurostimulator generators inserted into skull (includes cases involving the use of the RNS © neurostimulator) and cases with a principal diagnosis of epilepsy 7 8.0 63,365
MS-DRG 024-All cases 2,275 5.5 27,574
MS-DRG 024-Cases with neurostimulators (Major Device Implant list cases) 394 2.1 31,669
MS-DRG 024-Cases with neurostimulator generators inserted into skull (includes cases involving the use of the RNS © neurostimulator) and cases with a principal diagnosis of epilepsy 54 4.3 51,041


MS-DRG Number of cases Average length of stay Average costs
MS-DRG 020-All cases 1,372 16.7 $72,926
MS-DRG 021-All cases 336 13.5 54,385

As shown by the table above, for MS-DRG 023, we identified a total of 6,723 cases, with an average length of stay of 10.9 days and average costs of $39,014. Of the 6,723 cases in MS-DRG 023, there were 21 cases representing the implantation of any type of neurostimulator generator with an average length of stay of 6.7 days, and average costs of $48,821. Of the 21 neurostimulator generator cases, there were 7 cases with the neurostimulator generators inserted into skull (including cases involving the use of the RNS © neurostimulator) and a principal diagnosis of epilepsy with an average length of stay of 8.0 days and average costs of $63,365. For MS-DRG 024, we identified a total of 2,275 cases, with an average length of stay of 5.5 days and average costs of $27,574. Of the 2,275 cases in MS-DRG 024, there were 394 cases representing the implantation of any type of neurostimulator generator with an average length of stay of 2.1 days and average costs of $31,669. Of the 394 neurostimulator generator cases, there were 54 cases with the neurostimulator generators inserted into skull (including cases involving the use of the RNS © neurostimulator) and a principal diagnosis of epilepsy with an average length of stay of 4.3 days and average costs of $51,041.

There were only 61 cases involving the use of the RNS © neurostimulator with a principal diagnosis of epilepsy in MS-DRGs 023 and 024 (7 and 54, respectively). Our clinical advisors reviewed this issue, and agreed that this number of cases is too small on which to base a rationale for creating a new MS-DRG. Basing a new MS-DRG on such a small number of cases (61) could lead to distortion in the relative payment weights for the MS-DRG because several expensive cases could impact the overall relative payment weight. Having larger clinical cohesive groups within an MS-DRG provides greater stability for annual updates to the relative payment weights.

We also examined the possibility of reassigning cases involving the use of the RNS © neurostimulator to MS-DRGs 020 and 021. As the table above shows, for MS-DRG 020, there were a total of 1,372 cases with an average length of stay of 16.7 days and average costs of $72,926. For MS-DRG 021, there were a total of 336 cases with an average length of stay of 13.5 days and average costs of $54,385. The cases in MS-DRG 023 with neurostimulator generators inserted into skull (including cases involving the use of the RNS © neurostimulator) and a principal diagnosis of epilepsy have average costs that are $9,561 lower than that for all cases in MS-DRG 020 ($63,365 compared to $72,926), and the average length of stay is 8.7 days shorter (8.0 days compared to 16.7 days). We do not believe these data support reassigning the cases in MS-DRG 023 with neurostimulator generators inserted into the skull (including cases involving the use of the RNS © neurostimulator) and a principal diagnosis of epilepsy to MS-DRG 020. While the cases in MS-DRG 024 with neurostimulator generators inserted into the skull (including cases involving the use of the RNS © neurostimulator) and a principal diagnosis of epilepsy have average costs that are similar to the average costs of cases in MS-DRG 021 ($51,041 compared to $54,385), they have an average length of stay that is 9.2 days shorter (4.3 days compared to 13.5 days). Our clinical advisors reviewed the clinical issues and the claims data, and did not support reassigning the cases with neurostimulator generators inserted into skull (including cases involving the use of the RNS © neurostimulator) and a principal diagnosis of epilepsy from MS-DRGs 023 and 024 to MS-DRGs 020 and 021. Our clinical advisors pointed out that the cases in MS-DRGs 020 and 021 have a principal diagnosis of a hemorrhage. The RNS © neurostimulator generators are not used to treat patients with diagnosis of a hemorrhage. Therefore, our clinical advisors stated that it was inappropriate to reassign cases representing a principal diagnosis of epilepsy to an MS-DRG that contains cases that represent the treatment of intracranial hemorrhage. They also stated that the differences in average length of stay and average costs support this recommendation.


[top] We then explored alternative MS-DRG assignments, as was requested. We noted that the 7 cases with the neurostimulator generators inserted into the skull (including cases involving the use of the RNS © neurostimulator) and a principal diagnosis of epilepsy had an average length of stay of 8.0 days and average costs of $63,365, as compared to the 6,723 cases in MS-DRG 023 that had an average length of stay of 10.9 days and average costs of $39,014. While these neurostimulator cases had average costs that were $24,351 higher than the average costs of all cases in MS-DRG 023, there were only a total of 7 cases. There may have been other factors contributing to the higher costs. We noted that the 54 cases with the neurostimulator generators inserted into skull (including cases involving the use of the RNS © neurostimulator) and a principal diagnosis of epilepsy in MS-DRG 024 had average costs of $51,041 and an average length of stay of 4.3 days, compared to average costs of $27,574 and average length of stay of 5.5 days for all cases in MS-DRG 024. By reassigning all cases with the neurostimulator generators inserted into the skull (including cases involving the use of the RNS © neurostimulator) and a principal diagnosis of epilepsy to MS DRG 023, even if there is not a MCC page 19822 present, the cases would receive higher payment. The average costs of MS-DRG 023 were $39,014, compared to the average costs of $51,041 for the cases with the neurostimulator generators inserted into skull (including cases involving the use of the RNS © neurostimulator) and a principal diagnosis of epilepsy in MS-DRG 024. Our clinical advisors reviewed the clinical issues and the claims data, and supported the recommendation to reassign the cases with the neurostimulator generators inserted into skull (including cases involving the use of the RNS © neurostimulator) and a principal diagnosis of epilepsy to MS-DRG 023, even if there is not a MCC reported. Therefore, we are proposing to reassign all cases with a principal diagnosis of epilepsy from the epilepsy diagnosis list provided earlier, and one of the following ICD-10-PCS code combinations capturing cases with the neurostimulator generators inserted into the skull (including cases involving the use of the RNS © neurostimulator), to MS-DRG 023, even if there is no MCC reported:

• 0NH00NZ (Insertion of neurostimulator generator into skull, open approach), in combination with 00H00MZ (Insertion of neurostimulator lead into brain, open approach);

• 0NH00NZ (Insertion of neurostimulator generator into skull, open approach), in combination with 00H03MZ (Insertion of neurostimulator lead into brain, percutaneous approach); and

• 0NH00NZ (Insertion of neurostimulator generator into skull, open approach), in combination with 00H04MZ (Insertion of neurostimulator lead into brain, percutaneous endoscopic approach).

We also are proposing to change the title of MS-DRG 023 from "Craniotomy with Major Device Implant or Acute Complex Central Nervous System (CNS) Principal Diagnosis (PDX) with MCC or Chemo Implant" to "Craniotomy with Major Device Implant or Acute Complex Central Nervous System (CNS) Principal Diagnosis (PDX) with MCC or Chemotherapy Implant or Epilepsy with Neurostimulator" to reflect the proposed modifications to MS-DRG assignments.

We are inviting public comments on our proposals.

c. Precerebral Occlusion or Transient Ischemic Attack With Thrombolytic

We received a request to add the ICD-10-CM diagnosis codes currently assigned to MS-DRGs 067 and 068 (Nonspecific CVA and Precerebral Occlusion without Infarction with MCC and without MCC, respectively) and the ICD-10-CM diagnosis codes currently assigned to MS-DRG 069 (Transient Ischemia) to the GROUPER logic for MS-DRGs 061, 062, and 063 (Acute Ischemic Stroke with Use of Thrombolytic Agent with MCC, with CC, and without CC/MCC, respectively) when those conditions are sequenced as the principal diagnosis and reported with an ICD-10-PCS procedure code describing use of a thrombolytic agent (for example, tPA).

The ICD-10-CM diagnosis codes displayed in the table below identify the conditions that are assigned to MS-DRGs 067 and 068 when reported as a principal diagnosis.

ICD-10-CM code Code description
I65.01 Occlusion and stenosis of right vertebral artery.
I65.02 Occlusion and stenosis of left vertebral artery.
I65.03 Occlusion and stenosis of bilateral vertebral arteries.
I65.09 Occlusion and stenosis of unspecified vertebral artery.
I65.1 Occlusion and stenosis of basilar artery.
I65.21 Occlusion and stenosis of right carotid artery.
I65.22 Occlusion and stenosis of left carotid artery.
I65.23 Occlusion and stenosis of bilateral carotid arteries.
I65.29 Occlusion and stenosis of unspecified carotid artery.
I65.8 Occlusion and stenosis of other precerebral arteries.
I65.9 Occlusion and stenosis of unspecified precerebral artery.
I66.01 Occlusion and stenosis of right middle cerebral artery.
I66.02 Occlusion and stenosis of left middle cerebral artery.
I66.03 Occlusion and stenosis of bilateral middle cerebral arteries.
I66.09 Occlusion and stenosis of unspecified middle cerebral artery.
I66.11 Occlusion and stenosis of right anterior cerebral artery.
I66.12 Occlusion and stenosis of left anterior cerebral artery.
I66.13 Occlusion and stenosis of bilateral anterior cerebral arteries.
I66.19 Occlusion and stenosis of unspecified anterior cerebral artery.
I66.21 Occlusion and stenosis of right posterior cerebral artery.
I66.22 Occlusion and stenosis of left posterior cerebral artery.
I66.23 Occlusion and stenosis of bilateral posterior cerebral arteries.
I66.29 Occlusion and stenosis of unspecified posterior cerebral artery.
I66.3 Occlusion and stenosis of cerebellar arteries.
I66.8 Occlusion and stenosis of other cerebral arteries.
I66.9 Occlusion and stenosis of unspecified cerebral artery.

The ICD-10-CM diagnosis codes displayed in the table below identify the conditions that are assigned to MS-DRG 069 when reported as a principal diagnosis.

page 19823


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ICD-10-CM code Code description
G45.0 Vertebro-basilar artery syndrome.
G45.1 Carotid artery syndrome (hemispheric).
G45.2 Multiple and bilateral precerebral artery syndromes.
G45.8 Other transient cerebral ischemic attacks and related syndromes.
G45.9 Transient cerebral ischemic attack, unspecified.
G46.0 Middle cerebral artery syndrome.
G46.1 Anterior cerebral artery syndrome.
G46.2 Posterior cerebral artery syndrome.
I67.81 Acute cerebrovascular insufficiency.
I67.82 Cerebral ischemia.
I67.841 Reversible cerebrovascular vasoconstriction syndrome.
I67.848 Other cerebrovascular vasospasm and vasoconstriction.
I67.89 Other cerebrovascular disease.


The ICD-10-PCS procedure codes displayed in the table below describe use of a thrombolytic agent. These procedure codes are designated as non-O.R. procedure codes affecting the MS-DRG assignment for MS-DRGs 061, 062, and 063.

ICD-10-PCS code Code description
3E03017 Introduction of other thrombolytic into peripheral vein, open approach.
3E03317 Introduction of other thrombolytic into peripheral vein, percutaneous approach.
3E04017 Introduction of other thrombolytic into central vein, open approach.
3E04317 Introduction of other thrombolytic into central vein, percutaneous approach.
3E05017 Introduction of other thrombolytic into peripheral artery, open approach.
3E05317 Introduction of other thrombolytic into peripheral artery, percutaneous approach.
3E06017 Introduction of other thrombolytic into central artery, open approach.
3E06317 Introduction of other thrombolytic into central artery, percutaneous approach.
3E08017 Introduction of other thrombolytic into heart, open approach.
3E08317 Introduction of other thrombolytic into heart, percutaneous approach.

At the onset of stroke symptoms, tPA must be given within 3 hours (or up to 4.5 hours for certain eligible patients) in an attempt to dissolve a clot and improve blood flow to the specific area affected in the brain. If, upon receiving the tPA, the stroke symptoms completely resolve within 24 hours and imaging studies (if performed) are negative, the patient has suffered what is clinically defined as a transient ischemic attack, not a stroke. According to the requestor, the current MS-DRG assignments do not account for this subset of patients who were successfully treated with tPA to prevent a stroke.

In addition, the requestor expressed concerns regarding documentation and quality of the data. For example, the requestor noted that the terms "stroke-in-evolution" and "aborted stroke" may be documented as a "workaround" for a patient exhibiting symptoms of a stroke who receives tPA and, regardless of the outcome, would result in assignment to MS-DRG 061, 062, or 063. Therefore, in cases where the patient's stroke symptoms completely resolved upon receiving tPA and the patient clinically suffered a precerebral occlusion or transient ischemia, this documentation practice is incorrectly labeling these patients as having had a stroke and ultimately leading to inaccurate data.

We analyzed claims data from the December 2016 update of the FY 2016 MedPAR file for MS-DRGs 061, 062, and 063. Our findings are shown in the tables below.

MS-DRG Number of cases Average length of stay Average costs
MS-DRG 061-All cases 4,528 6.4 $20,270
MS-DRG 062-All cases 8,600 4.2 14,124
MS-DRG 063-All cases 1,859 3.0 11,898

Our analysis also consisted of claims data for MS-DRGs 067 and 068 when reported with a procedure code describing the use of tPA. As shown in the table below, the total number of cases reported in MS-DRG 067 was 811, with an average length of stay of 4.8 days and average costs of $10,248. There were 9 cases in MS-DRG 067 with a precerebral occlusion receiving tPA, with an average length of stay of 5.2 days and average costs of $20,156. The total number of cases reported in MS-DRG 068 was 3,809, with an average length of stay of 2.8 days and average costs of $6,555. There were 33 cases in MS-DRG 068 with a precerebral occlusion receiving tPA, with an average length of stay of 4.3 days and average costs of $13,814.

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MS-DRG Number of cases Average length of stay Average costs
MS-DRG 067-All cases 811 4.8 $10,248
MS-DRG 067-Cases with tPA 9 5.2 20,156
MS-DRG 068-All cases 3,809 2.8 6,555
MS-DRG 068-Cases with tPA 33 4.3 13,814


We recognize that while the volume of cases for patients with a diagnosis of precerebral occlusion receiving tPA in MS-DRGs 067 and 068 is relatively low, the average length of stay is longer, and the average costs for this subset of patients is approximately twice the amount of the average costs in comparison to all cases in MS-DRGs 067 and 068.

We then analyzed claims data for cases in MS-DRG 069 when reported with a procedure code describing the use of tPA. As shown in the table below, the total number of cases reported in MS-DRG 069 was 50,633, with an average length of stay of 2.5 days and average costs of $5,518. There were 554 cases of transient ischemia receiving tPA, with an average length of stay of 3.2 days and average costs of $12,481.

MS-DRG Number of cases Average length of stay Average costs
MS-DRG 069-All cases 50,633 2.5 $5,518
MS-DRG 069-Cases with tPA 554 3.2 12,481

Similar to the findings for MS-DRGs 067 and 068, the number of cases for transient ischemia receiving tPA in MS-DRG 069 was relatively low in comparison to all the cases in the MS-DRG, with a longer average length of stay and approximately twice the amount of average costs in comparison to all cases in MS-DRG 069.

The results of analysis of the data and the advice of our clinical advisors support adding the ICD-10-CM diagnosis codes in MS-DRGs 067, 068, and 069 to the list of principal diagnoses in MS-DRGs 061, 062, and 063 to better account for this subset of patients who were successfully treated with tPA to prevent a stroke, to identify the increasing use of thrombolytics at the onset of symptoms of a stroke, to further encourage appropriate physician documentation for a precerebral occlusion or transient ischemic attack when patients are treated with tPA, and to reflect more appropriate payment for the resources involved in evaluating and treating these patients. We believe this approach will improve accuracy of the data and assist in addressing the concern that facilities may be reporting incorrect diagnoses for this subset of patients.

Therefore, for FY 2018, we are proposing to add the ICD-10-CM diagnosis codes listed earlier in this section that are currently assigned to MS-DRGs 067 and 068 and the ICD-10-CM diagnosis codes currently assigned to MS-DRG 069 to the GROUPER logic for MS-DRGs 061, 062, and 063 when those conditions are sequenced as the principal diagnosis and reported with an ICD-10-PCS procedure code describing use of a thrombolytic agent (for example, tPA). We are inviting public comments on our proposal.

We also are proposing to retitle MS-DRGs 061, 062, and 063 as "Ischemic Stroke, Precerebral Occlusion or Transient Ischemia with Thrombolytic Agent with MCC, with CC and without CC/MCC", respectively, and to retitle MS-DRG 069 as "Transient Ischemia without Thrombolytic". We are inviting public comments on our proposals.

3. MDC 2 (Diseases and Disorders of the Eye: Swallowing Eye Drops (Tetrahydrozoline)

We received a request to reassign the following ICD-10-CM diagnosis codes that capture swallowing eye drops from MS-DRGs 124 and 125 (Other Disorders of the Eye with and without MCC, respectively) to MS-DRGs 917 and 918 (Poisoning and Toxic Effects of Drugs with and without MCC, respectively). The requestor described a case where a patient was treated following swallowing eye drops, specifically Tetrahydrozoline, which the provider considers to be a poisoning, not a disorder of the eye.

• T49.5X1A (Poisoning by ophthalmological drugs and preparations, accidental (unintentional), initial encounter);

• T49.5X2A (Poisoning by ophthalmological drugs and preparations, intentional self-harm, initial encounter);

• T49.5X3A (Poisoning by ophthalmological drugs and preparations, assault, initial encounter); and

• T49.5X4A (Poisoning by ophthalmological drugs and preparations, undetermined, initial encounter).

We agree with the requestor that the four diagnosis codes describe a poisoning, not a disorder of the eye. We examined claims data for cases in MS-DRGs 124 and 125 from the December 2016 update of the FY 2016 MedPAR file. Our findings are shown in the table below.

MS-DRG Number of cases Average length of stay Average costs
MS-DRG 124-All cases 874 4.8 $8,826
MS-DRG 124-Cases reporting poisoning by ophthalmological drugs and preparations code 1 2.0 3,007
MS-DRG 125-All cases 3,205 3.3 5,565
MS-DRG 125-Cases reporting poisoning by ophthalmological drugs and preparations code 1 2.0 1,446


[top] page 19825

As shown in the table above, there were only 2 cases of poisoning by ophthalmological drugs and preparations-1 case in MS-DRG 124 with an average length of stay of 2 days and average costs of $3,007 and 1 case in MS-DRG 125 with an average length of stay of 2 days and average costs of $1,446. The case of poisoning by ophthalmological drugs and preparations in MS-DRG 124 had a shorter average length of stay than the average length of stay for all cases in MS-DRG 124 (2.0 days compared to 4.8 days) and lower average costs than the average costs for all cases in MS-DRG 124 ($3,007 compared to $8,826). The case of poisoning by ophthalmological drugs and preparations in MS-DRG 125 also had a shorter average length of stay than the average length of stay for all cases in MS-DRG 125 (2.0 days compared to 3.3 days) and lower average costs than the average costs for all cases in MS-DRG 125 ($1,446 compared to $5,565).

We also examined claims data on cases reported in MS-DRGs 917 and 918 from the December 2016 update of the FY 2016 MedPAR file. Our findings are shown in the table below.

MS-DRG Number of cases Average length of stay Average costs
MS-DRG 917-All cases 32,381 4.8 $9,882
MS-DRG 918-All cases 24,061 3.0 5,326

As shown in the table above, the 2 cases of poisoning by ophthalmological drugs and preparations also had shorter average lengths of stay than the average length of stay for all cases in MS-DRGs 917 and 918 (2.0 days compared to 4.8 days in MS-DRG 917 and 2.0 days compared to 3.0 days in MS-DRG 918). The average costs also were lower for the 2 cases of poisoning by ophthalmological drugs and preparations than the average costs for all cases in MS-DRGs 917 and 918 ($3,007 compared to $9,882 for all cases in MS-DRG 917 and $1,446 compared to $5,326 for all cases in MS-DRG 918). Therefore, cases with this type of poisoning had lower average lengths of stay and lower average costs than all other cases assigned to MS-DRGs 124 and 125 and cases in MS-DRGs 917 and 918 where poisonings are assigned.

Because the codes clearly capture a poisoning and not an eye disorder, we believe that these codes are more appropriately assigned to MS-DRGs 917 and 918 where other poisonings are assigned. Our clinical advisors also reviewed this issue and agreed that the codes should be moved from MS-DRGs 124 and 125 to MS-DRGs 917 and 918 because they clearly capture a poisoning and not a disorder of the eye. Because MS-DRGs 917 and 918 contain cases with multiple types of poisonings, it is expected that some types of poisoning cases will have longer lengths of stay and greater average costs than other types of poisoning cases. Therefore, we are proposing to reassign the following ICD-10-CM diagnosis codes from MS-DRGs 124 and 125 to MS-DRGs 917 and 918 for FY 2018: T49.5X1A; T49.5X2A; T49.5X3A; and T49.5X4A.

We are inviting public comments on our proposal.

4. MDC 5 (Diseases and Disorders of the Circulatory System)

a. Percutaneous Cardiovascular Procedures and Insertion of a Radioactive Element

Currently, under ICD-10-PCS, the logic for MS-DRG 246 (Percutaneous Cardiovascular Procedures with Drug-Eluting Stent with MCC or 4+ Vessels or Stents), MS-DRG 247 (Percutaneous Cardiovascular Procedures with Drug-Eluting Stent without MCC), MS-DRG 248 (Percutaneous Cardiovascular Procedures with Non-Drug-Eluting Stent with MCC or 4+ Vessels or Stents), and MS-DRG 249 (Percutaneous Cardiovascular Procedures with Non-Drug-Eluting Stent without MCC) includes six procedure codes that describe the insertion of a radioactive element. When any of these six procedure codes are reported without the reporting of a percutaneous cardiovascular procedure code, they are assigned to MS-DRG 264 (Other Circulatory System O.R. Procedures). The six specific procedure codes are shown in the table below.

ICD-10-PCS code Code description
0WHC01Z Insertion of radioactive element into mediastinum, open approach.
0WHC31Z Insertion of radioactive element into mediastinum, percutaneous approach.
0WHC41Z Insertion of radioactive element into mediastinum, percutaneous endoscopic approach.
0WHD01Z Insertion of radioactive element into pericardial cavity, open approach.
0WHD31Z Insertion of radioactive element into pericardial cavity, percutaneous approach.
0WHD41Z Insertion of radioactive element into pericardial cavity, percutaneous endoscopic approach.

Unlike procedures involving the insertion of stents, none of the procedures described by the procedure codes listed above are performed in conjunction with a percutaneous cardiovascular procedure, and two of the six procedures described by these procedure codes (ICD-10-PCS codes 0WHC01Z and 0WHD01Z) are not performed using a percutaneous approach, but rather describe an open approach to performing the specific procedure. Our clinical advisors agreed that these procedures should not be used to classify cases within MS-DRGs 246 through 249 because they are not performed in conjunction with a percutaneous cardiovascular procedure. Furthermore, the indications for the insertion of a radioactive element typically involve a diagnosis of cancer, whereas the indications for the insertion of a coronary artery stent typically involve a diagnosis of coronary artery disease.


[top] We conducted an analysis for the six procedures described by these procedure codes by reviewing the claims data for MS-DRGs 246 through 249 from the December 2016 update of page 19826 the FY 2016 MedPAR file. We did not find any cases where any one of the six procedure codes listed above was reported. As noted earlier, when any of these six procedure codes are reported without the reporting of a percutaneous cardiovascular procedure code, the case is assigned to MS-DRG 264. Therefore, our clinical advisors also agreed that it would be more appropriate to remove these six procedure codes from MS-DRGs 246 through 249, but maintain their current assignment in MS-DRG 264. Based on our analysis and the advice from our clinical advisors, for FY 2018, we are proposing to remove ICD-10-PCS procedure codes 0WHC01Z, 0WHC31Z, 0WHC41Z, 0WHD01Z, 0WHD31Z, and 0WHD41Z from MS-DRGs 246 through 249, but maintain their current assignment in MS-DRG 264.

We are inviting public comments on our proposal to remove the six procedure codes listed above from MS-DRGs 246 through 249. We also are inviting public comments on our proposal to maintain their current assignment in MS-DRG 264.

b. Proposed Modification of the Titles for MS-DRG 246 (Percutaneous Cardiovascular Procedures With Drug-Eluting Stent With MCC or 4+ Vessels or Stents) and MS-DRG 248 (Percutaneous Cardiovascular Procedures With Non-Drug-Eluting Stent with MCC or 4+ Vessels or Stents)

We are proposing to revise the titles for MS-DRGs 246 (Percutaneous Cardiovascular Procedures with Drug-Eluting Stent with MCC or 4+ Vessels or Stents) and MS-DRG 248 (Percutaneous Cardiovascular Procedures with Non-Drug-Eluting Stent with MCC or 4+ Vessels or Stents) to better reflect the ICD-10-PCS terminology of "arteries" versus "vessels" as used in the procedure code titles within the classification. Specifically, we are proposing to revise the title of MS-DRG 246 to "Percutaneous Cardiovascular Procedures with Drug-Eluting Stent with MCC or 4+ Arteries or Stents". We are proposing to revise the title of MS-DRG 248 to "Percutaneous Cardiovascular Procedures with Non-Drug-Eluting Stent with MCC or 4+ Arteries or Stents". We are inviting public comments on our proposals.

c. Transcatheter Aortic Valve Replacement (TAVR) and Left Atrial Appendage Closure (LAAC)

We received a request to create new MS-DRGs for cases involving transcatheter aortic valve replacement (TAVR) and left atrial appendage closure (LAAC) procedures when performed in combination in the same operative episode. The requestor stated that there are both clinical and financial advantages for the patient when performing concomitant procedures. For example, the requestor indicated that the clinical advantages for the patient may include single exposure to anesthesia and a reduction in overall procedure time, while the financial advantages may include lower cost-sharing. The requestor further believed that a single hospitalization for these concomitant procedures could be cost-effective for various providers and payers.

TAVR is indicated and approved as a treatment option for patients diagnosed with symptomatic aortic stenosis who are not surgical candidates for traditional open surgical techniques. Cases involving TAVR procedures are assigned to MS-DRGs 266 and 267 (Endovascular Cardiac Valve Replacement with MCC and without MCC, respectively), and are identified by the following ICD-10-PCS procedure codes shown in the table below.

ICD-10-PCS code Code description
02RF37Z Replacement of aortic valve with autologous tissue substitute, percutaneous approach.
02RF38Z Replacement of aortic valve with zooplastic tissue, percutaneous approach.
02RF3JZ Replacement of aortic valve with synthetic substitute, percutaneous approach.
02RF3KZ Replacement of aortic valve with nonautologous tissue substitute, percutaneous approach.
02RF37H Replacement of aortic valve with autologous tissue substitute, transapical, percutaneous approach.
02RF38H Replacement of aortic valve with zooplastic tissue, transapical, percutaneous approach.
02RF3JH Replacement of aortic valve with synthetic substitute, transapical, percutaneous approach.
02RF3KH Replacement of aortic valve with nonautologous tissue substitute, transapical, percutaneous approach.

LAAC is indicated and approved as a treatment option for patients diagnosed with atrial fibrillation. Cases involving LAAC procedures are assigned to MS-DRGs 273 and 274 (Percutaneous Intracardiac Procedures with MCC and without MCC, respectively), and are identified by ICD-10-PCS procedure code 02L73DK (Occlusion of left atrial appendage with intraluminal device, percutaneous approach).

The requestor suggested that the structure of the possible new MS-DRGs for TAVR procedures performed in combination with LAAC procedures could be modeled similar to the structure of MS-DRGs 266 and 267. While contemplating creation of the new MS-DRGs, the requestor asked CMS to also consider subdividing the possible new MS-DRGs into two severity levels and title them as follows:

• Suggested MS-DRG 26x (Endovascular Cardiac Valve Replacement with LAAC with MCC); and

• Suggested MS-DRG 26x (Endovascular Cardiac Valve Replacement with LAAC without MCC).


[top] We analyzed claims data from the December 2016 update of the FY 2016 MedPAR file for MS-DRGs 266 and 267 and identified the cases reporting TAVR procedures with and without an LAAC procedure. As shown in the table below, the data findings show that the total number of cases reported in MS-DRG 266 was 9,949, with an average length of stay of 7.2 days and average costs of $56,762. There were 9,872 cases involving a TAVR procedure, with an average length of stay of 7.2 days and average costs of $56,628. There was only one case identified in MS-DRG 266 where both a TAVR and an LAAC procedure were reported. This case had an average length of stay of 21.0 days and average costs of $60,226. For MS-DRG 267, the total number of cases found was 13,290, with an average length of stay of 3.5 days and average costs of $45,297. There were 13,245 cases involving a TAVR procedure, with an average length of stay of 3.5 days and average costs of $45,302. There were no cases identified in MS-DRG 267 where both a TAVR and an LAAC procedure were reported. page 19827

MS-DRG Number of cases Average length of stay Average costs
MS-DRG 266-All cases 9,949 7.2 $56,762
MS-DRG 266-Cases with TAVR 9,872 7.2 56,628
MS-DRG 266-Cases TAVR and LAAC 1 21.0 60,226
MS-DRG 267-All cases 13,290 3.5 45,297
MS-DRG 267-Cases with TAVR 13,245 3.5 45,302
MS-DRG 267-Cases TAVR and LAAC 0 0 0

We then analyzed claims data in MS-DRGs 273 and 274 for cases reporting an LAAC procedure. As shown in the table below, the data findings show that the total number of cases reported in MS-DRG 273 was 6,541, with an average length of stay of 7.7 days and average costs of $26,042. There were 179 cases involving an LAAC procedure, with an average length of stay of 3.6 days and average costs of $30,131. For MS-DRG 274, the total number of cases found was 14,441, with an average length of stay of 3.0 days and average costs of $20,267. There were 2,428 cases involving an LAAC procedure, with an average length of stay of 1.2 days and average costs of $26,213.

MS-DRG Number of cases Average length of stay Average costs
MS-DRG 273-All cases 6,541 7.7 $26,042
MS-DRG 273-Cases with LAAC 179 3.6 30,131
MS-DRG 274-All cases 14,441 3.0 20,267
MS-DRG 274-Cases with LAAC 2,428 1.2 26,213

The analysis of claims data for MS-DRGs 266, 267, 273, and 274 and input from our clinical advisors do not support creating new MS-DRGs for TAVR and LAAC procedures when performed in combination in the same operative episode. We found only one case in MS-DRG 266 where both a TAVR and an LAAC procedure were reported and the claims data for cases reporting an LAAC procedure in MS-DRGs 273 and 274 support their current assignment. Our clinical advisors agreed the current MS-DRG assignments are appropriate for each respective procedure.

Therefore, we are not proposing to create new MS-DRGs for cases involving TAVR and LAAC procedures when performed in combination in the same operative episode. We are inviting public comments on our proposal to maintain the current MS-DRG structure for TAVR procedures in MS-DRGs 266 and 267, as well as the current MS-DRG structure for LAAC procedures in MS-DRGs 273 and 274.

d. Percutaneous Mitral Valve Replacement Procedures

We received a request to reassign four ICD-10-PCS procedure codes that describe percutaneous mitral valve replacement procedures from MS-DRGs 216 through 221 (Cardiac Valve and Other Major Cardiothoracic Procedures with and without Cardiac Catheterization with MCC, with CC and without CC/MCC, respectively) to MS-DRGs 266 and 267 (Endovascular Cardiac Valve Replacement with MCC and without MCC, respectively). The requestor indicated that there are inconsistencies in the current GROUPER logic for endovascular cardiac valve replacement procedures. Specifically, the requestor stated that the procedure codes that describe both the percutaneous approach and the transapical, percutaneous approach for the aortic and pulmonary valves are included in MS-DRGs 266 and 267. However, for the mitral valve, the GROUPER logic only includes the procedure codes that describe the transapical, percutaneous approach.

The requestor also stated that when MS-DRGs 266 and 267 were created, the intent was to include percutaneous replacement procedures for all cardiac valves. Therefore, the requestor recommended that CMS reassign the four ICD-10-PCS procedure codes shown in the table below that describe mitral valve replacement procedures, performed with the percutaneous approach from MS-DRGs 216 through 221 to MS-DRGs 266 and 267 to more appropriately group these procedures within the MS-DRG structure.

ICD-10-PCS procedure code Code description
02RG37Z Replacement of mitral valve with autologous tissue substitute, percutaneous approach.
02RG38Z Replacement of mitral valve with zooplastic tissue, percutaneous approach.
02RG3JZ Replacement of mitral valve with synthetic substitute, percutaneous approach.
02RG3KZ Replacement of mitral valve with nonautologous tissue substitute, percutaneous approach.


[top] We agree with the requestor regarding the intent of the creation of MS-DRGs 266 and 267. As discussed in the FY 2015 IPPS/LTCH PPS final rule (79 FR 49890 through 49893), MS-DRGs 266 and 267 were created to uniquely classify the subset of high-risk cases representing patients who undergo a cardiac valve replacement procedure page 19828 performed by a percutaneous (endovascular) approach. As such, we agree that all cardiac valve replacement procedures should be grouped within the same MS-DRG. In FY 2015, under the ICD-9-CM classification, there was not a specific procedure code for a percutaneous mitral valve replacement procedure. Therefore, when we converted from the ICD-9 based MS-DRGs to the ICD-10 MS-DRGs, there was not a code available from which to replicate. We refer the reader to the FY 2015 IPPS/LTCH PPS final rule (79 FR 49890 through 49893) for a detailed discussion on the initial request to create new MS-DRGs for endovascular cardiac valve replacement procedures, as well as the FY 2016 IPPS/LTCH PPS final rule (80 FR 49354 through 49358) and the FY 2017 IPPS/LTCH PPS final rule (81 FR 56787 through 56790) for a detailed discussion of the conversion to ICD-10 MS-DRGs, including our analysis of claims data and the need to accurately replicate the ICD-9-CM based MS-DRGs.

The requestor also noted that a proposal was discussed at the September 13-14, 2016 ICD-10 Coordination and Maintenance Committee meeting involving the creation of procedure codes that describe percutaneous tricuspid valve replacement procedures and, if finalized, these new procedure codes would also be assigned to MS-DRGs 266 and 267.

As shown in the table below and in Table 6B.-New Procedure Codes, which is associated with this proposed rule and available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html , there are eight new procedure codes that describe tricuspid valve replacement procedures performed with percutaneous and transapical types of percutaneous approaches that will be effective October 1, 2017.

ICD-10-PCS procedure code Code description
02RJ37H Replacement of tricuspid valve with autologous tissue substitute, transapical, percutaneous approach.
02RJ37Z Replacement of tricuspid valve with autologous tissue substitute, percutaneous approach.
02RJ38H Replacement of tricuspid valve with zooplastic tissue, transapical, percutaneous approach.
02RJ38Z Replacement of tricuspid valve with zooplastic tissue, percutaneous approach.
02RJ3JH Replacement of tricuspid valve with synthetic substitute, transapical, percutaneous approach.
02RJ3JZ Replacement of tricuspid valve with synthetic substitute, percutaneous approach.
02RJ3KH Replacement of tricuspid valve with nonautologous tissue substitute, transapical, percutaneous approach.
02RJ3KZ Replacement of tricuspid valve with nonautologous tissue substitute, percutaneous approach.

We agree with the requestor and believe that, in addition to the four procedure codes that describe the percutaneous mitral valve replacement procedures listed earlier in this section, the eight codes that describe percutaneous and transapical types of percutaneous tricuspid valve replacement procedures also should be grouped with the other endovascular cardiac valve replacement procedures. Therefore, we are proposing to reassign the four percutaneous mitral valve replacement procedures described by the procedure codes listed in the table above from MS-DRGs 216 through 221 to MS-DRGs 266 and 267. In addition, we are proposing to assign the eight new procedure codes (also listed in a separate table above) that describe percutaneous and transapical, percutaneous tricuspid valve replacement procedures to MS-DRGs 266 and 267.

We are inviting public comments on our proposals.

e. Percutaneous Tricuspid Valve Repair

We received a request to reassign cases reporting ICD-10-PCS procedure code 02UJ3JZ (Supplement tricuspid valve with synthetic substitute, percutaneous approach) from MS-DRGs 216 through 221 (Cardiac Valve and Other Major Cardiothoracic Procedures with and without Cardiac Catheterization with MCC, with CC and without CC/MCC, respectively) to MS-DRGs 228 and 229 (Other Cardiothoracic Procedures with MCC and without MCC, respectively). According to the requestor, reassigning cases involving these procedures would more appropriately align the cohesiveness with other clinically similar procedures, such as percutaneous mitral valve repair (for example, procedures involving the Mitraclip) described by procedure code 02UG3JZ (Supplement mitral valve with synthetic substitute, percutaneous approach), which are assigned to MS-DRGs 228 and 229.

The requestor noted that the FORMA Tricuspid Transcatheter Repair System (herein after referred to as the FORMA system) is currently in clinical trials in the United States, Europe, and Canada, but has not received FDA approval. However, the FORMA system is presently available for compassionate use purposes. The FORMA system technology is indicated for use in the treatment of patients diagnosed with tricuspid regurgitation and occupies the regurgitant area of the affected valve, providing a surface for native leaflet coaptation. The requestor stated that the technology offers a viable alternative treatment using traditional tricuspid valve surgery. According to the requestor, the technology consists of a rail and a spacer, and the procedure to insert the device involves fluoroscopic imaging guidance.

We analyzed claims data from the December 2016 update of the FY 2016 MedPAR file for MS-DRGs 216 through 221 for cases reporting procedure code 02UJ3JZ (Supplement tricuspid valve with synthetic substitute, percutaneous approach). Our findings are shown in the following table.

page 19829


[top] 
MS-DRG Number of cases Average length of stay Average costs
MS-DRG 216-All cases 9,139 14.4 $68,304
MS-DRG 216-Cases with percutaneous tricuspid valve repair 1 5.0 14,954
MS-DRG 217-All cases 3,536 8.9 45,857
MS-DRG 217-Cases with percutaneous tricuspid valve repair 1 3.0 16,234
MS-DRG 218-All cases 498 5.9 41,274
MS-DRG 218-Cases with percutaneous tricuspid valve repair 0 0 0
MS-DRG 219-All cases 16,011 11.1 54,519
MS-DRG 219-Cases with percutaneous tricuspid valve repair 6 9.0 58,075
MS-DRG 220-All cases 18,476 6.8 37,506
MS-DRG 220-Cases with percutaneous tricuspid valve repair 1 5.0 90,155
MS-DRG 221-All cases 3,547 5.0 33,606
MS-DRG 221-Cases with percutaneous tricuspid valve repair 0 0 0


We also analyzed claims data for MS-DRGs 228 and 229. Our findings are shown in the following table below.

MS-DRG Number of cases Average length of stay Average costs
MS-DRG 228-All cases 3,466 9.8 $47,435
MS-DRG 229-All cases 4,553 4.9 33,347

The claims data show that there were very few cases reported for performing a percutaneous tricuspid valve repair procedure in MS-DRGs 216 through 221. Of the 6 cases found in MS-DRG 219, with average costs of $58,075, the average cost of these cases aligned with the average cost of all cases in the MS-DRG assignment ($54,519). The data analysis and our clinical advisors do not support reassigning cases reporting procedure code 02UJ3JZ to MS-DRGs 228 and 229. The current MS-DRG assignment for percutaneous tricuspid valve repair procedures to MS-DRGs 216 through 221 is clinically coherent with the other percutaneous procedures performed on the heart valves that are currently assigned to these MS-DRGs. Percutaneous repair of the aortic, pulmonary and tricuspid valves utilizing various tissue substitutes (autologous, nonautologous, zooplastic, and synthetic) are assigned to MS-DRGs 216 through 221. The exception is the percutaneous mitral valve repair, which, as the requestor pointed out, is assigned to MS-DRGs 228 and 229 as discussed in the FY 2017 IPPS/LTCH PPS final rule (81 FR 56809 through 56813). Our clinical advisors also agreed that the limited number of cases reported in MS-DRGs 216 through 221 does not warrant reassignment.

As a result of our review and the input from our clinical advisors, we are not proposing to reassign cases reporting procedure code 02UJ3JZ from MS-DRGs 216 through 221 to MS-DRGs 228 and 229.

We are inviting public comments on our proposal to maintain the current MS-DRG assignment for cases reporting procedure code 02UJ3JZ.

5. MDC 8 (Diseases and Disorders of the Musculoskeletal System and Connective Tissue)

a. Total Ankle Replacement (TAR) Procedures

For FY 2018, we again received two requests for the reassignment of total ankle replacement (TAR) procedures to a different MS-DRG. TAR procedures are currently assigned to MS-DRGs 469 and 470 (Major Joint Replacement or Reattachment of Lower Extremity with and without MCC, respectively). This topic was discussed previously in the FY 2015 IPPS/LTCH PPS proposed and final rules (79 FR 28013 through 28015 and 79 FR 49896 through 49899, respectively) and in the FY 2017 IPPS/LTCH PPS proposed and final rules (81 FR 24989 through 24990 and 81 FR 56814 through 56816, respectively). For FY 2015 and FY 2017, we did not change the MS-DRG assignment for TAR procedures. The requestors indicated that TAR procedures are currently assigned to MS-DRGs 469 and 470, to which total hip replacement and total knee replacement procedures also are assigned. The requestors stated that there are significant clinical and cost differences among these procedures, which results in underpayment for TAR procedures. The requestors asked CMS to examine claims data for the following six ICD-10-PCS codes within MS-DRGs 469 and 470:

• 0SRF0J9 (Replacement of right ankle joint with synthetic substitute, cemented, open approach);

• 0SRF0JA (Replacement of right ankle joint with synthetic substitute, uncemented, open approach);

• 0SRF0JZ (Replacement of right ankle joint with synthetic substitute, open approach);

• 0SRG0J9 (Replacement of left ankle joint with synthetic substitute, cemented, open approach);

• 0SRG0JA (Replacement of left ankle joint with synthetic substitute, uncemented, open approach); and

• 0SRG0JZ (Replacement of left ankle joint with synthetic substitute, open approach).

The requestors recommended that, if the claims data show a disparity in costs between TAR procedures and total hip and knee replacement procedures, the TAR procedures be reassigned to a more appropriate MS-DRG.


[top] The requestors also stated that total ankle replacement is a complicated surgery that involves the replacement of the damaged parts of the three bones that comprise the ankle joint, as compared to the two bones in hip and knee replacement procedures. Furthermore, as the smallest weight-bearing large joint in the body, the requestors stated that TAR procedures demand a complexity of implant device design, engineering, and manufacture to exacting functional specifications that is vastly different from that of total hip and knee replacement devices. One of the requestors stated that the ankle region typically has poorer circulation and thinner soft tissue coverage than the page 19830 hip and knee, leading to a higher risk of wound complications and infection that may be more challenging and expensive to treat. In addition, this requestor stated that the unique anatomical characteristics and function of the ankle joint require a specialized surgical skill set, operative technique, and level of operating room resource utilization that is vastly dissimilar from that of total hip and knee replacement procedures.

We examined claims data from the December 2016 update of the FY 2016 MedPAR file on reported cases of TAR procedures in MS-DRGs 469 and 470. Our findings are shown in the table below.

MS-DRG Number of cases Average length of stay Average costs
MS-DRG 469-All cases 25,778 6.7 $22,139
MS-DRG 469-Cases reporting TAR procedure codes 31 4.6 23,828
MS-DRG 470-All cases 461,553 2.7 14,751
MS-DRG 470-Cases reporting TAR procedure codes 2,114 1.9 20,862

As shown in the table above, for MS-DRG 469, there were a total of 25,778 cases, with an average length of stay of 6.7 days and average costs of $22,139. Of the 25,778 cases in MS-DRG 469, there were 31 cases reporting a TAR procedure, with an average length of stay of 4.6 days and average costs of $23,828. For MS-DRG 470, there were a total of 461,553 cases, with an average length of stay of 2.7 days and average costs of $14,751. Of the 461,553 cases in MS-DRG 470, there were 2,114 cases reporting a TAR procedure, with an average length of stay of 1.9 days and average costs of $20,862. As mentioned earlier, there were only 31 TAR procedure cases in MS-DRG 469, and these cases had average costs of $1,689 higher than the average costs of all cases within MS-DRG 469. The relatively small number of cases may have been impacted by other factors. Several expensive cases could impact the average costs for a very small number of patients. We also note that the average length of stay for the TAR procedure cases was 4.6 days, as compared to 6.7 days for all cases within MS-DRG 469. The 2,114 TAR procedure cases in MS-DRG 470 had average costs that were $6,111 higher than the average costs of all cases in MS-DRG 470 ($20,862 compared to $14,751 for all cases). The data support reassigning all of the TAR procedures to MS-DRG 469, even when there is no MCC reported. While the average costs of the TAR procedures in MS-DRG 470 are lower than the average costs for all cases in MS-DRG 469 ($20,862 compared to $22,139), the average costs are much closer to the average costs of TAR procedure cases in MS-DRG 470.

Our clinical advisors reviewed this clinical issue and the claims data, and agreed that it is clinically appropriate to reassign all of the TAR procedure cases from MS-DRG 470 to MS-DRG 469, even when there is no MCC reported. The claims data support the fact that these cases require more resources than other cases assigned to MS-DRG 470. Therefore, we are proposing to reassign the following TAR procedure codes from MS-DRG 470 to MS-DRG 469, even if there is no MCC reported: 0SRF0J9; 0SRF0JA; 0SRF0JZ; 0SRG0J9; 0SRG0JA; and 0SRG0JZ for FY 2018.

We are proposing to change the titles of MS-DRGs 469 and 470 to the following to reflect these proposed MS-DRG reassignments:

• Proposed retitle of MS-DRG 469: "Major Hip and Knee Joint Replacement or Reattachment of Lower Extremity with MCC or Total Ankle Replacement"; and

• Proposed retitle of MS-DRG 470: "Major Hip and Knee Joint Replacement or Reattachment of Lower Extremity without MCC."

We are inviting public comments on our proposals.

b. Revision of Total Ankle Replacement (TAR) Procedures

We received two requests to modify the MS-DRG assignment for revision of total ankle replacement (TAR) procedures, which are assigned to MS-DRGs 515, 516, and 517 (Other Musculoskeletal System and Connective Tissue O.R. Procedures with MCC, with CC, and without CC/MCC, respectively). This topic was discussed in the FY 2015 IPPS/LTCH PPS proposed and final rules (79 FR 28013 through 28015 and 79 FR 49896 through 49899, respectively) and in the FY 2017 IPPS/LTCH PPS proposed and final rules (81 FR 24992 through 24993 and 81 FR 56819 through 56820, respectively). For FY 2015 and FY 2017, we did not change the MS-DRG assignment for revision of TAR procedures.

The requestors asked that CMS examine the following eight ICD-10-PCS codes for revision of TAR procedures, which are assigned to MS-DRGs 515, 516, and 517:

• 0SWF0JZ (Revision of synthetic substitute in right ankle joint, open approach);

• 0SWF3JZ (Revision of synthetic substitute in right ankle joint, percutaneous approach);

• 0SWF4JZ (Revision of synthetic substitute in right ankle joint, percutaneous endoscopic approach);

• 0SWFXJZ (Revision of synthetic substitute in right ankle joint, external approach);

• 0SWG0JZ (Revision of synthetic substitute in left ankle joint, open approach);

• 0SWG3JZ (Revision of synthetic substitute in left ankle joint, percutaneous approach);

• 0SWG4JZ (Revision of synthetic substitute in left ankle joint, percutaneous endoscopic approach); and

• 0SWGXJZ (Revision of synthetic substitute in left ankle joint, external approach).

One requestor stated that these ICD-10-PCS codes more specifically identify the revision of TAR procedures than the prior ICD-9-CM codes. Specifically, ICD-9-CM code 81.59 (Revision of joint replacement of lower extremity, not elsewhere classified) was an unspecified code, which included toe and foot joint revision procedures in addition to revision of TAR procedures. The requestor stated that claims data reporting these ICD-10-PCS codes would allow CMS to better identify revisions of TAR procedures, and determine if the procedures are assigned to the appropriate MS-DRGs.

One requestor suggested the following three options for MS-DRG assignments:


[top] • Assign the ICD-10-PCS ankle revision procedure codes to MS-DRGs 466, 467, and 468 (Revision of Hip or Knee Replacement with MCC, with CC, and without CC/MCC, respectively), and rename MS-DRGs 466, 467, and 468 as "Revision of Hip, Knee or Ankle with MCC, with CC, and without CC/MCC", respectively); page 19831

• Assign the ICD-10-PCS ankle revision procedure codes to MS-DRG 469 (Major Joint Replacement or Reattachment of Lower Extremity with MCC) to more appropriately recognize higher hospital procedure costs associated with revision of TAR procedures; or

• Establish a new MS-DRG for the assignment of revision of TAR procedures.

The other requestor asked that CMS consider reassigning revision of TAR procedures to MS-DRGs that better address the cost-to-payment differential, such as MS-DRGs 466, 467, and 468.

We examined claims data from the December 2016 update of the FY 2016 MedPAR file on reported cases of revision of TAR procedures, as well as cases assigned to MS-DRGs 466, 467, 468, and MS-DRG 469. Our findings are shown in the tables below.

MS-DRG Number of cases Average length of stay Average costs
MS-DRG 515-All cases 5,038 8.0 $20,562
MS-DRG 515-Cases reporting revision of total ankle replacement procedure codes 0 0 0
MS-DRG 516-All cases 13,276 4.8 13,524
MS-DRG 516-Cases reporting revision of total ankle replacement procedure codes 2 2.5 11,400
MS-DRG 517-All cases 13,330 2.8 10,003
MS-DRG 517-Cases reporting revision of total ankle replacement procedure codes 4 1.5 7,423

MS-DRG Number of cases Average length of stay Average costs
MS-DRG 466-All cases 3,886 8.4 $33,720
MS-DRG 467-All cases 19,145 4.2 24,609
MS-DRG 468-All cases 16,529 2.7 20,208
MS-DRG 469-All cases 25,778 6.7 22,139

As shown in the tables above, there were only 6 cases representing revisions of TAR procedures with no cases in MS-DRG 515, two cases in MS-DRG 516, and four cases in MS-DRG 517. The limited number of six cases does not justify the creation of a new MS-DRG for the assignment of revision of TAR procedures. Our data analysis demonstrates that the average length of stay for the revision of TAR procedures was lower than that for all cases in MS-DRG 516 (2.5 days compared to 4.8 days), and the average costs were lower ($11,400 compared to $13,524). The average length of stay for the revision of TAR procedures also was lower than that for all cases in MS-DRG 517 (1.5 days compared to 2.8 days), and the average costs were lower ($7,423 compared to $10,003). The data do not support reassigning the cases from MS-DRGs 515, 516, and 517.

Furthermore, the average length of stay and average costs of cases in MS-DRGs 466, 467, 468, and 469 are significantly higher than those for the revision of TAR procedures in MS-DRG 516 and 517. The average length of stay for all cases in MS-DRGs 466, 467, 468, and 469 is 8.4, 4.2, 2.7, and 6.7 days, respectively, compared to the average length of stay of 2.5 and 1.5 days for cases representing revision of TAR procedures in MS-DRGs 516 and 517, respectively. The average costs for all cases in MS-DRGs 466, 467, 468, and 469 are $33,720, $24,609, $20,208, and $22,139, respectively, compared to the average costs of $11,400 and $7,423 for cases representing revision of TAR procedures in MS-DRGs 516 and 517, respectively. Therefore, the data do not support reassigning the cases to MS-DRGs 466, 467, 468, or 469.

Our clinical advisors reviewed the clinical issue and the claims data and agreed that the revision of TAR procedures are appropriately assigned to MS-DRGs 515, 516, and 517, along with other procedures that describe revisions of joint replacements of the lower extremities, including the foot and toe. Our clinical advisors did not support reassigning these cases to MS-DRGs 466, 467, 468, or 469, or creating a new MS-DRG. Therefore, based on the findings of our analysis of claims data and the advice of our clinical advisors, we are proposing to maintain the current MS-DRG assignment for revision of TAR procedures within MS-DRGs 515, 516, and 517 for FY 2018.

We are inviting public comments on our proposal.

c. Magnetic Controlled Growth Rods (MAGEC® System)


[top] We received a request to add six ICD-10-PCS procedure codes that describe the use of magnetically controlled growth rods for the treatment of early onset scoliosis (MAGEC® System) to MS-DRGs 456, 457, and 458 (Spinal Fusion Except Cervical with Spinal Curvature or Malignancy or Infection or Extensive Fusions with MCC, with CC or without CC/MCC, respectively). The MAGEC® System was discussed in the FY 2017 IPPS/LTCH PPS proposed rule (81 FR 25040 through 25042) and final rule (81 FR 56888 through 56891) as a new technology add-on payment application. The application was approved for FY 2017 new technology add-on payments, effective with discharges occurring on and after October 1, 2016. The request for new procedure codes to identify the MAGEC® System technology was discussed at the March 9-10, 2016 ICD-10 Coordination and Maintenance Committee meeting. Six new procedure codes were approved, effective October 1, 2016, and were displayed in Table 6B.-New Procedure Codes associated with the FY 2017 IPPS/LTCH PPS final rule (which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2017-IPPS-Final-Rule-Home-Page.html . These six procedure codes are currently assigned to MS-DRGs 518, 519, and 520 (Back and Neck Procedure Except Spinal Fusion with MCC or Disc Device/Neurostimulator, with CC, or without CC/MCC, respectively) and are shown in the table below. page 19832

ICD-10-PCS code Code description
XNS0032 Reposition of lumbar vertebra using magnetically controlled growth rod(s), open approach, new technology group 2.
XNS0432 Reposition of lumbar vertebra using magnetically controlled growth rod(s), percutaneous endoscopic approach, new technology group 2.
XNS3032 Reposition of cervical vertebra using magnetically controlled growth rod(s), open approach, new technology group 2.
XNS3432 Reposition of cervical vertebra using magnetically controlled growth rod(s), percutaneous endoscopic approach, new technology group 2.
XNS4032 Reposition of thoracic vertebra using magnetically controlled growth rod(s), open approach, new technology group 2.
XNS4432 Reposition of thoracic vertebra using magnetically controlled growth rod(s), percutaneous endoscopic approach, new technology group 2.

According to the requestor, adding these six procedure codes will allow these cases to group to MS-DRGs that more accurately reflect the diagnosis of early onset scoliosis for which the MAGEC® System is indicated. In addition, the requestor stated that because this technology is utilized on a small subset of patients with approximately 2,500 cases per year, adding these procedure codes to MS-DRGs 456, 457, and 458 would have little impact.

Because these six procedure codes shown in the table above were effective as of October 1, 2016, there are no MedPAR claims data available to analyze. More importantly, we note that cases are assigned to MS-DRGs 456, 457, and 458 when an actual spinal fusion procedure is performed. Our clinical advisors agree that use of the MAGEC® System's magnetically controlled growth rods technology alone does not constitute a spinal fusion. Therefore, because there are no claims data available at this time and based on the advice of our clinical advisors, we are not proposing to add the six procedure codes to MS-DRGs 456, 457, or 458. If a spinal fusion procedure is performed along with the procedure to insert the MAGEC® System's magnetically controlled growth rods, it would be appropriate to report that a spinal fusion was performed and the case would be assigned to one of the spinal fusion MS-DRGs.

We are inviting public comments on our proposal to maintain the current GROUPER logic for cases assigned to MS-DRGs 456, 457, and 458 and not add the six procedure codes describing the use of the MAGEC® System magnetically controlled growth rods. We also are inviting public comments on our proposal to maintain the assignment of the six procedure codes in MS-DRGs 518, 519, and 520.

d. Combined Anterior/Posterior Spinal Fusion

It was brought to our attention that 7 of the 10 new ICD-10-PCS procedure codes describing fusion using a nanotextured surface interbody fusion device were not added to the appropriate GROUPER logic list for MS-DRGs 453, 454, and 455 (Combined Anterior/Posterior Spinal Fusion with MCC, with CC and without CC/MCC, respectively), effective October 1, 2016. The logic for MS-DRGs 453, 454, and 455 is comprised of two lists: An anterior spinal fusion list and a posterior spinal fusion list. Assignment to one of the combined spinal fusion MS-DRGs requires that a code from each list be reported.

The seven new ICD-10-PCS procedure codes currently included in the posterior spinal fusion list for MS-DRGs 453, 454, and 455 are shown in the table below.

ICD-10-PCS code Code description
XRG6092 Fusion of thoracic vertebral joint using nanotextured surface interbody fusion device, open approach, new technology group 2.
XRG7092 Fusion of 2 to 7 thoracic vertebral joints using nanotextured surface interbody fusion device, open approach, new technology group 2.
XRG8092 Fusion of 8 or more thoracic vertebral joints using nanotextured surface interbody fusion device, open approach, new technology group 2.
XRGA092 Fusion of thoracolumbar vertebral joint using nanotextured surface interbody fusion device, open approach, new technology group 2.
XRGB092 Fusion of lumbar vertebral joint using nanotextured surface interbody fusion device, open approach, new technology group 2.
XRGC092 Fusion of 2 or more lumbar vertebral joints using nanotextured surface interbody fusion device, open approach, new technology group 2.
XRGD092 Fusion of lumbosacral joint using nanotextured surface interbody fusion device, open approach, new technology group 2.

We note that the remaining three new procedure codes are accurately reflected in the anterior spinal fusion list; that is, ICD-10-PCS code XRG1092 (Fusion of cervical vertebral joint using nanotextured surface interbody fusion device, open approach, new technology group 2); ICD-10-PCS code XRG2092 (Fusion of 2 or more cervical vertebral joints using nanotextured surface interbody fusion device, open approach, new technology group 2); and ICD-10-PCS code XRG4092 (Fusion of cervicothoracic vertebral joint using nanotextured surface interbody fusion device, open approach, new technology group 2).

The seven procedure codes currently included in the posterior spinal fusion list describe an anterior spinal fusion by use of the interbody fusion device. In an interbody fusion, the anterior column of the spine is being fused. The results of our review of these procedure codes discussed below and the advice of our clinical advisors support moving the seven procedure codes from the posterior spinal fusion list to the anterior spinal fusion list in the GROUPER logic for MS-DRGs 453, 454, and 455. This will improve clinical accuracy and allow appropriate assignment to these MS-DRGs when both an anterior and posterior spinal fusion is performed.


[top] During our review of the spinal fusion codes using a nanotextured surface interbody fusion device in MS-DRGs 453, 454, and 455, we identified 149 additional procedure codes that should be moved from the posterior spinal fusion list to the anterior spinal fusion page 19833 list. These codes describe spinal fusion of the anterior column with a posterior approach. As mentioned earlier, the logic for MS-DRGs 453, 454, and 455 is dependent upon a code from the anterior spinal fusion list and a code from the posterior spinal fusion list. Spinal fusion codes involving the anterior column should be included on the anterior spinal fusion list only. We are proposing to move the 149 ICD-10-PCS procedure codes listed in Table 6P.3a. associated with this proposed rule (which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) from the posterior spinal fusion list to the anterior spinal fusion list in MS-DRGs 453, 454, and 455.

In addition, we also identified 33 ICD-10-PCS procedure codes in the posterior spinal fusion list in MS-DRGs 453, 454, and 455 that describe an interbody fusion device in the posterior column and, therefore, are not considered clinically valid spinal fusion procedures. These procedure codes are shown in the table below.

ICD-10-PCS code Code description
0RG00A1 Fusion of occipital-cervical joint with interbody fusion device, posterior approach, posterior column, open approach.
0RG03A1 Fusion of occipital-cervical joint with interbody fusion device, posterior approach, posterior column, percutaneous approach.
0RG04A1 Fusion of occipital-cervical joint with interbody fusion device, posterior approach, posterior column, percutaneous endoscopic approach.
0RG10A1 Fusion of cervical vertebral joint with interbody fusion device, posterior approach, posterior column, open approach.
0RG13A1 Fusion of cervical vertebral joint with interbody fusion device, posterior approach, posterior column, percutaneous approach.
0RG14A1 Fusion of cervical vertebral joint with interbody fusion device, posterior approach, posterior column, percutaneous endoscopic approach.
0RG20A1 Fusion of 2 or more cervical vertebral joints with interbody fusion device, posterior approach, posterior column, open approach.
0RG23A1 Fusion of 2 or more cervical vertebral joints with interbody fusion device, posterior approach, posterior column, percutaneous approach.
0RG24A1 Fusion of 2 or more cervical vertebral joints with interbody fusion device, posterior approach, posterior column, percutaneous endoscopic approach.
0RG40A1 Fusion of cervicothoracic vertebral joint with interbody fusion device, posterior approach, posterior column, open approach.
0RG43A1 Fusion of cervicothoracic vertebral joint with interbody fusion device, posterior approach, posterior column, percutaneous approach.
0RG44A1 Fusion of cervicothoracic vertebral joint with interbody fusion device, posterior approach, posterior column, percutaneous endoscopic approach.
0RG60A1 Fusion of thoracic vertebral joint with interbody fusion device, posterior approach, posterior column, open approach.
0RG63A1 Fusion of thoracic vertebral joint with interbody fusion device, posterior approach, posterior column, percutaneous approach.
0RG64A1 Fusion of thoracic vertebral joint with interbody fusion device, posterior approach, posterior column, percutaneous endoscopic approach.
0RG70A1 Fusion of 2 to 7 thoracic vertebral joints with interbody fusion device, posterior approach, posterior column, open approach.
0RG73A1 Fusion of 2 to 7 thoracic vertebral joints with interbody fusion device, posterior approach, posterior column, percutaneous approach.
0RG74A1 Fusion of 2 to 7 thoracic vertebral joints with interbody fusion device, posterior approach, posterior column, percutaneous endoscopic approach.
0RG80A1 Fusion of 8 or more thoracic vertebral joints with interbody fusion device, posterior approach, posterior column, open approach.
0RG83A1 Fusion of 8 or more thoracic vertebral joints with interbody fusion device, posterior approach, posterior column, percutaneous approach.
0RG84A1 Fusion of 8 or more thoracic vertebral joints with interbody fusion device, posterior approach, posterior column, percutaneous endoscopic approach.
0RGA0A1 Fusion of thoracolumbar vertebral joint with interbody fusion device, posterior approach, posterior column, open approach.
0RGA3A1 Fusion of thoracolumbar vertebral joint with interbody fusion device, posterior approach, posterior column, percutaneous approach.
0RGA4A1 Fusion of thoracolumbar vertebral joint with interbody fusion device, posterior approach, posterior column, percutaneous endoscopic approach.
0SG00A1 Fusion of lumbar vertebral joint with interbody fusion device, posterior approach, posterior column, open approach.
0SG03A1 Fusion of lumbar vertebral joint with interbody fusion device, posterior approach, posterior column, percutaneous approach.
0SG04A1 Fusion of lumbar vertebral joint with interbody fusion device, posterior approach, posterior column, percutaneous endoscopic approach.
0SG10A1 Fusion of 2 or more lumbar vertebral joints with interbody fusion device, posterior approach, posterior column, open approach.
0SG13A1 Fusion of 2 or more lumbar vertebral joints with interbody fusion device, posterior approach, posterior column, percutaneous approach.
0SG14A1 Fusion of 2 or more lumbar vertebral joints with interbody fusion device, posterior approach, posterior column, percutaneous endoscopic approach.
0SG30A1 Fusion of lumbosacral joint with interbody fusion device, posterior approach, posterior column, open approach.
0SG33A1 Fusion of lumbosacral joint with interbody fusion device, posterior approach, posterior column, percutaneous approach.
0SG34A1 Fusion of lumbosacral joint with interbody fusion device, posterior approach, posterior column, percutaneous endoscopic approach.


[top] We are proposing to delete these 33 procedure codes from MS-DRGs 453, 454, and 455 for FY 2018. We also note that some of the above listed codes also may be included in the logic for MS-DRGs 456, 457, and 458 (Spinal Fusion Except Cervical with Spinal Curvature or Malignancy or Infection or Extensive Fusions with MCC, with CC or without page 19834 CC/MCC, respectively), MS-DRGs 459 and 460 (Spinal Fusion Except Cervical with MCC and without MCC, respectively), and MS-DRGs 471, 472, and 473 (Cervical Spinal Fusion with MCC, with CC and without CC/MCC, respectively). Therefore, we are proposing to delete the 33 procedure codes from the logic for those spinal fusion MS-DRGs as well. In addition, we are proposing to delete the 33 procedure codes from the ICD-10-PCS classification as shown in Table 6D.-Invalid Procedure Codes associated with this proposed rule (which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ).

In summary, we are inviting public comments on our proposal to move the seven procedure codes describing spinal fusion using a nanotextured surface interbody fusion device from the posterior spinal fusion list to the anterior spinal fusion list in the GROUPER logic for MS-DRGs 453, 454, and 455. We also are inviting public comments on our proposal to move the 149 procedure codes describing spinal fusion of the anterior column with a posterior approach from the posterior spinal fusion list to the anterior spinal fusion list in the GROUPER logic for MS-DRGs 453, 454, and 455. In addition, we are inviting public comments on our proposal to delete the 33 procedure codes describing spinal fusion of the posterior column with an interbody fusion device from MS-DRGs 453, 454, 455, 456, 457, 458, 459, 460, 471, 472, and 473, as well as from the ICD-10-PCS classification.

6. MDC 14 (Pregnancy, Childbirth and the Puerperium)

a. Vaginal Delivery and Complicating Diagnoses

In the FY 2017 IPPS/LTCH PPS final rule (81 FR 56854), we noted that the code list as displayed in the ICD-10 MS-DRG Version 33 Definitions Manual for MS-DRG 774 (Vaginal Delivery with Complicating Diagnoses) required further analysis to clarify what constitutes a vaginal delivery to satisfy the ICD-10 MS-DRG logic. We stated our plans to conduct further analysis of the diagnosis code lists in MS-DRG 774 for FY 2018.

We believe that the Version 34 Definitions Manual and GROUPER logic for MS-DRG 774 continue to require additional analysis to determine how best to classify a vaginal delivery. For example, under MS-DRG 774, the Definitions Manual currently states that three conditions must be met, the first of which is a vaginal delivery. To satisfy this first condition, codes that describe conditions or circumstances from among three lists of codes must be reported. The first list is comprised of ICD-10-CM diagnosis codes that may be reported as a principal diagnosis or a secondary diagnosis. These diagnosis codes describe conditions in which it is assumed that a vaginal delivery has occurred. The second list of codes is a list of ICD-10-PCS procedure codes that also describe circumstances in which it is assumed that a vaginal delivery occurred. The third list of codes identifies diagnoses describing the outcome of the delivery. Therefore, if any code from one of those three lists is reported, the first condition (vaginal delivery) is considered to be met for assignment to MS-DRG 774.

Our continued concern with the first list of ICD-10-CM diagnosis codes as currently displayed in the Definitions Manual under the first condition is that not all of the conditions necessarily reflect that a vaginal delivery occurred. Several of the diagnosis codes listed could also reflect that a cesarean delivery occurred. For example, ICD-10-CM diagnosis code O10.02 (Pre-existing essential hypertension complicating childbirth) does not specify that a vaginal delivery took place; yet it is included in the list of conditions that may be reported as a principal diagnosis or a secondary diagnosis in the GROUPER logic for a vaginal delivery. The reporting of this code also could be appropriate for a delivery that occurred by cesarean section.

As noted earlier, the second list of codes for the first condition are comprised of ICD-10-PCS procedure codes. While we agree that the current list of procedure codes in MS-DRG 774 may appropriately describe that a vaginal delivery occurred, we also believe this list could be improved and warrants closer review.

The third list of codes for the first condition in MS-DRG 774 includes conditions describing the outcome of the delivery that would be reported as secondary diagnoses. Similar to concerns with the first list of codes, we believe the conditions do not necessarily reflect that a vaginal delivery occurred because they also can be reported on claims where a cesarean delivery occurred.

For the second condition in MS-DRG 774 to be met, diagnosis codes that are identified as a complicating diagnosis from among two lists may be reported. The first list is comprised of ICD-10-CM diagnosis codes that may be reported as a principal or secondary diagnosis. The second list is comprised of ICD-10-CM diagnosis codes that may be reported as a secondary diagnosis. Currently, there is only one code listed under the secondary diagnosis list. We have concerns with these lists and what is classified as a complicating diagnosis when reviewing the code lists for this and other MS-DRGs that use that logic in MDC 14.

For the third condition in MS-DRG 774 to be met, a limited set of O.R. procedures, including both extensive and nonextensive procedures, are listed. We have concerns with this third condition as being needed to satisfy the logic for a vaginal delivery MS-DRG.

In summary, the MS-DRG logic involving a vaginal delivery under MDC 14 is technically complex as a result of the requirements that must be met to satisfy assignment to the affected MS-DRGs. Upon review and discussion, our clinical advisors recommended, and we agree, that we should solicit public comments on further refinement to the following four MS-DRGs related to vaginal delivery: MS-DRG 767 (Vaginal Delivery with Sterilization and/or D&C); MS-DRG 768 (Vaginal Delivery with O.R. Procedure Except Sterilization and/or D&C); MS-DRG 774 (Vaginal Delivery with Complicating Diagnosis); and MS-DRG 775 (Vaginal Delivery without Complicating Diagnosis).

In addition, our clinical advisors agreed that we should solicit public comments on further refinement to the conditions defined as a complicating diagnosis in MS-DRG 774 and MS-DRG 781 (Other Antepartum Diagnoses with Medical Complications).


[top] Therefore, we are soliciting public comments on which diagnosis or procedure codes, or both, should be considered in the logic to identify a vaginal delivery and which diagnosis codes should be considered in the logic to identify a complicating diagnosis. As MS-DRGs 767, 768, 774, 775, and 781 incorporate one or both aspects (vaginal delivery or complicating diagnosis), public comments that we receive from this solicitation will be helpful in determining what proposed revisions to the current logic should be made. We will review public comments received in response to this solicitation as we continue to evaluate these areas under MDC 14 and, if warranted, we would propose refinements for FY 2019. We are requesting that all comments be directed to the CMS MS-DRG Classification Change Request Mailbox located at: MSDRGClassificationChange@cms.hhs.gov by November 1, 2017. page 19835

b. MS-DRG 998 (Principal Diagnosis Invalid as Discharge Diagnosis)

The logic for MS-DRG 998 (Principal Diagnosis Invalid as Discharge Diagnosis) currently includes a list of diagnoses that are considered inappropriate for reporting as a principal diagnosis on an inpatient hospital claim. In other words, these conditions would reasonably be expected not to necessitate an inpatient admission. Examples of these diagnosis codes include what are referred to as the "Supervision of pregnancy" codes, as well as pregnancy, maternal care and fetal related codes with an "unspecified trimester". We refer the reader to the ICD-10 Version 34 Definitions Manual which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2017-IPPS-Final-Rule-Home-Page-Items/FY2017-IPPS-Final-Rule-Data-Files.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=ascending for the complete list of diagnosis codes in MS-DRG 998 under MDC 14.

In the FY 2017 IPPS/LTCH PPS final rule (81 FR 56840 through 56841), there was discussion regarding the supervision of "high-risk" pregnancy codes, including elderly primigravida and multigravida specifically, with regard to removing them from the Unacceptable principal diagnosis edit code list in the Medicare Code Editor (MCE). After consultation with the staff at the CDC's NCHS, we learned that the FY 2017 ICD-10-CM Official Guidelines for Coding and Reporting were updated to explain appropriate coding for this set of codes. As a result, the codes describing supervision of high-risk pregnancy (and other supervision of pregnancy codes) remained on the Unacceptable principal diagnosis edit code list in the MCE. Therefore, the MCE code edit is consistent with the logic of MS-DRG 998 (Principal Diagnosis Invalid as Discharge Diagnosis) for these supervision of pregnancy codes.

However, as a result of our review and consultation with our clinical advisors regarding the "unspecified trimester" codes in MS-DRG 998, we have determined that there are more appropriate MS-DRG assignments for this set of codes. Although it may seem unlikely that a patient would be admitted and ultimately discharged or transferred without the caregiver or medical personnel having any further knowledge of the exact trimester, it is conceivable that a situation may present itself. For example, the pregnant patient may be from out of town or unable to communicate effectively. The fact that the specific trimester is not known or documented does not preclude the resources required to care for the patient with the particular diagnosis.

Therefore, as shown in Table 6P.3b. associated with this proposed rule (which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ), we are proposing to remove the 314 ICD-10-CM diagnosis codes identified with "unspecified trimester" from MS-DRG 998 and reassign them to the MS-DRGs in which their counterparts (first trimester, second trimester, or third trimester) are currently assigned as specified in Column C. This would enable more appropriate MS-DRG assignments and payment for these cases. We are inviting public comments on our proposal.

c. MS-DRG 782 (Other Antepartum Diagnoses Without Medical Complications)

The following three ICD-10-CM diagnosis codes are currently on the principal diagnosis list for the MS-DRG 782 (Other Antepartum Diagnoses without Medical Complications) logic.

ICD-10-CM code Code description
O09.41 Supervision of pregnancy with grand multiparity, first trimester.
O09.42 Supervision of pregnancy with grand multiparity, second trimester.
O09.43 Supervision of pregnancy with grand multiparity, third trimester.

It was brought to our attention that these codes also are included in the MCE Unacceptable principal diagnosis code edit list. As discussed earlier in section II.F.6.b. of the preamble of this proposed rule, the supervision of pregnancy codes are accurately reflected in the MCE code edit list for Unacceptable principal diagnosis. Therefore, it is not appropriate to include the three above listed codes in MS-DRG 782.

We are proposing to remove the three codes describing supervision of pregnancy from MS-DRG 782 and reassign them to MS-DRG 998 (Principal Diagnosis Invalid as Discharge Diagnosis) to reflect a more appropriate MS-DRG assignment. We are inviting public comments on our proposal.

d. Shock During or Following Labor and Delivery

We received a request to review ICD-10-CM diagnosis code O75.1 (Shock during or following labor and delivery), which is currently assigned to MS-DRG 774 (Vaginal Delivery with Complicating Diagnosis), MS-DRG 767 (Vaginal Delivery with Sterilization and/or D&C), and MS-DRG 768 (Vaginal Delivery with O.R. Procedure Except Sterilization and/or D&C).

The requestor provided an example of a patient that delivered at Hospital A and was transferred to Hospital B for specialized care related to the diagnosis of shock. The claim for Hospital B resulted in assignment to a delivery MS-DRG, despite the fact that a delivery did not occur during that hospitalization. The requestor noted that, by not reporting the diagnosis code for shock, the claim grouped to a postpartum MS-DRG and recommended that we evaluate the issue further.


[top] Our analysis initially involved reviewing the GROUPER logic for MS-DRGs 774, 767 and 768. As discussed earlier in section II.F.14.a. of the preamble of this proposed rule, the GROUPER logic for classification and assignment to MS-DRG 774 requires that three conditions must be met, the first of which is a vaginal delivery. Similar GROUPER logic applies for assignment to MS-DRGs 767 and 768, except that only two conditions must be met, with the first condition being a vaginal delivery. For each of these three MS-DRGs, to satisfy the first condition, one code that describes a condition or circumstance from among the three separate lists of codes must be reported. The first list is comprised of ICD-10-CM diagnosis codes that may be reported as a principal or secondary diagnosis. These diagnosis codes describe conditions in which it is assumed that a vaginal delivery has occurred. Among this first list is ICD-10-CM diagnosis code O75.1, which is included in the GROUPER logic for MS-DRGs 774, 767 and 768 (under the first condition-vaginal delivery). We refer readers to the ICD-10 MS-DRG Version 34 Definitions Manual located via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatient page 19836 PPS/FY2017-IPPS-Final-Rule-Home-Page-Items/FY2017-IPPS-Final-Rule-Data-Files.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=ascending for documentation of the GROUPER logic associated with these MS-DRGs.

In addition, in MS-DRG 774, to satisfy the second condition, diagnosis codes that are identified as a complicating diagnosis from among two lists may be reported. The first list is comprised of ICD-10-CM diagnosis codes that may be reported as a principal or secondary diagnosis. The second list is comprised of ICD-10-CM diagnosis codes that may be reported as a secondary diagnosis. Currently, there is only one code listed under the secondary diagnosis list.

Next, our analysis involved reviewing the GROUPER logic for assignment to post-partum MS-DRG 769 (Postpartum and Post Abortion Diagnoses with Major Procedure) and MS-DRG 776 (Postpartum and Post Abortion Diagnoses without O.R. Procedure). The GROUPER logic for these postpartum MS-DRGs requires that a principal diagnosis be reported from a list of several conditions, such as those following pregnancy, those complicating the puerperium, conditions that occurred during or following delivery and conditions associated with lactation disorders. For assignment to MS-DRG 769, the GROUPER logic also requires that a major procedure be reported in addition to a principal diagnosis from the list of conditions.

As a result of our analysis, we agree with the requestor that ICD-10-CM diagnosis code O75.1 should be added to the GROUPER logic for assignment to the postpartum MS-DRGs. This diagnosis code is consistent with other diagnosis codes structured within the GROUPER logic for assignment to MS-DRGs 769 and 776, and clearly represents a post-partum diagnosis with the terminology "during or following labor and delivery" in the title. We believe that adding this diagnosis code to the postpartum MS-DRGs will enable more appropriate MS-DRG assignment for cases where a delivery did not occur.

Therefore, we are proposing the following:

• Removing ICD-10-CM diagnosis code O75.1 from the list of principal or secondary diagnosis under the first condition-vaginal delivery GROUPER logic in MS-DRGs 774, 767, and 768;

• Moving ICD-10-CM diagnosis code O75.1 from the list of principal or secondary diagnosis under the second condition-complicating diagnosis for MS-DRG 774 to the secondary diagnosis list only; and

• Adding ICD-10-CM diagnosis code O75.1 to the principal diagnosis list GROUPER logic in MS-DRGs 769 and 776.

We are inviting public comments on our proposals.

7. MDC 15 (Newborns and Other Neonates With Conditions Originating in Perinatal Period): Observation and Evaluation of Newborn

We received a request to add the ICD-10-CM diagnosis codes describing observation and evaluation of newborns for suspected conditions that are ruled out to MS-DRG 795 (Normal Newborn). The 14 diagnosis codes describing observation and evaluation of newborn for suspected conditions ruled out are displayed in the table below.

ICD-10-CM code Code description
Z05.0 Observation and evaluation of newborn for suspected cardiac condition ruled out.
Z05.1 Observation and evaluation of newborn for suspected infectious condition ruled out.
Z05.2 Observation and evaluation of newborn for suspected neurological condition ruled out.
Z05.3 Observation and evaluation of newborn for suspected respiratory condition ruled out.
Z05.41 Observation and evaluation of newborn for suspected genetic condition ruled out.
Z05.42 Observation and evaluation of newborn for suspected metabolic condition ruled out.
Z05.43 Observation and evaluation of newborn for suspected immunologic condition ruled out.
Z05.5 Observation and evaluation of newborn for suspected gastrointestinal condition ruled out.
Z05.6 Observation and evaluation of newborn for suspected genitourinary condition ruled out.
Z05.71 Observation and evaluation of newborn for suspected skin and subcutaneous tissue condition ruled out.
Z05.72 Observation and evaluation of newborn for suspected musculoskeletal condition ruled out.
Z05.73 Observation and evaluation of newborn for suspected connective tissue condition ruled out.
Z05.8 Observation and evaluation of newborn for other specified suspected condition ruled out.
Z05.9 Observation and evaluation of newborn for unspecified suspected condition ruled out.

The requestor expressed concern that currently when one of these ruled out codes is added to a newborn encounter with a principal diagnosis described by ICD-10-CM code Z38.00 (Single liveborn infant, delivered vaginally), the case is assigned to MS-DRG 794 (Neonate with Other Significant Problems). The requestor stated that this assignment appears to be in error and that the assignment should instead be to MS-DRG 795 (Normal Newborn).

We reviewed Section I.C.16.b. of the 2017 ICD-10-CM Official Guidelines for Coding and Reporting which includes the following instructions for the diagnosis codes listed in the table above:

• Assign a code from category Z05 (Observation and evaluation of newborns and infants for suspected conditions ruled out) to identify those instances when a healthy newborn is evaluated for a suspected condition that is determined after study not to be present. Do not use a code from category Z05 when the patient has identified signs or symptoms of a suspected problem; in such cases code the sign or symptom.

• A code from category Z05 may also be assigned as a principal or first-listed code for readmissions or encounters when the code from category Z38 code no longer applies. Codes from category Z05 are for use only for healthy newborns and infants for which no condition after study is found to be present.

• A code from category Z05 is to be used as a secondary code after the code from category Z38, Liveborn infants according to place of birth and type of delivery.


[top] After review of the guidelines and discussion with our clinical advisors, we agree with the requestor that the assignment of these codes to MS-DRG 794 is not accurate because the assignment incorrectly labels the newborns as having a significant problem when the condition does not truly exist. We and our clinical advisors also agree that the above list of diagnosis codes should be added to MS-DRG 795. Therefore, we are proposing to add the 14 diagnosis codes describing observation and evaluation of newborns for suspected conditions that are ruled out listed in the table above to the GROUPER logic for MS-DRG 795. We are inviting public comments on our proposals. page 19837

8. MDC 21 (Injuries, Poisonings and Toxic Effects of Drugs): Complication Codes

We received a request to examine the ICD-10-CM diagnosis codes in the T85.8-series of codes that describe other specified complications of internal prosthetic devices, implants and grafts, not elsewhere classified and their respective MS-DRG assignments. According to the requestor, the 7th character values in this series of codes impact the MS-DRG assignment under MDC 21 (Injuries, Poisonings and Toxic Effects of Drugs) and MDC 23 (Factors Influencing Health Status & Other Contacts with Health Services) that have resulted in inconsistencies (that is, shifts) between the MS-DRG assignments under Version 33 and Version 34 of the ICD-10 MS-DRGs.

Under ICD-10-CM, diagnosis codes in the range of S00 through T88 require a 7th character value of "A-" initial encounter, "D-" subsequent encounter, or "S-" sequela to identify if the patient is undergoing active treatment for a condition. For complication codes, active treatment refers to treatment for the condition described by the code, even though it may be related to an earlier precipitating problem.

The requestor suggested that the following list of diagnosis codes with the 7th character "A" (initial encounter) may have been inadvertently assigned to the GROUPER logic in the list of diagnoses ( Assignment of Diagnosis Codes) under MDC 23 because when one of these diagnosis codes was reported with an O.R. procedure, the requestor found claims grouping to MS-DRG 939, 940, or 941 (O.R. Procedures with Diagnoses of Other Contact with Health Services with MCC, with CC and without CC/MCC, respectively) that had previously grouped to MDC 21 under Version 33 of the ICD-10 MS-DRGs. The requestor also suggested these codes may have been inadvertently assigned to the GROUPER logic list of principal diagnoses for MS-DRGs 949 and 950 (Aftercare with CC/MCC and without CC/MCC, respectively) under MDC 23 because it found claims that grouped to these MS-DRGs (949 and 950) when one of the following diagnosis codes was reported as a principal diagnosis that had previously grouped to MDC 21 under Version 33 of the ICD-10 MS-DRGs.

ICD-10-CM diagnosis code Code description
T85.818A Embolism due to other internal prosthetic devices, implants and grafts, initial encounter.
T85.828A Fibrosis due to other internal prosthetic devices, implants and grafts, initial encounter.
T85.838A Hemorrhage due to other internal prosthetic devices, implants and grafts, initial encounter.
T85.848A Pain due to other internal prosthetic devices, implants and grafts, initial encounter.
T85.858A Stenosis due to other internal prosthetic devices, implants and grafts, initial encounter.
T85.868A Thrombosis due to other internal prosthetic devices, implants and grafts, initial encounter.
T85.898A Other specified complication of other internal prosthetic devices, implants and grafts, initial encounter.

The requestor believed that the above list of diagnosis codes with the 7th character "A" (initial encounter) would be more appropriately assigned under MDC 21 to MS-DRGs 919, 920, and 921 (Complications of Treatment with MCC, with CC and without CC/MCC, respectively), according to its review of the 2017 Official Coding Guidelines for use of the 7th character and assignment of other diagnoses of associated complications of care. The requestor also noted that these codes were new, effective October 1, 2016 (FY 2017), and the predecessor codes grouped to MS-DRGs 919, 920, and 921 in MDC 21 under Version 33 of the ICD-10 MS-DRGs in FY 2016.

In addition, the requestor suggested that the following list of diagnosis codes with the 7th character "D" (subsequent encounter) may have been inadvertently assigned to the GROUPER logic list of principal diagnoses for MS-DRG 919, 920, or 921 in MDC 21. The requestor noted that these codes were new, effective October 1, 2016 (FY 2017), and the predecessor codes grouped to MS-DRGs 949 and 950 (Aftercare with CC/MCC and without CC/MCC, respectively) in MDC 23 under Version 33 of the ICD-10 MS-DRGs in FY 2016.

ICD-10-CM diagnosis code Code description
T85.810D Embolism due to nervous system prosthetic devices, implants and grafts, subsequent encounter.
T85.820D Fibrosis due to nervous system prosthetic devices, implants and grafts, subsequent encounter.
T85.830D Hemorrhage due to nervous system prosthetic devices, implants and grafts, subsequent encounter.
T85.840D Pain due to nervous system prosthetic devices, implants and grafts, subsequent encounter.
T85.850D Stenosis due to nervous system prosthetic devices, implants and grafts, subsequent encounter.
T85.860D Thrombosis due to nervous system prosthetic devices, implants and grafts, subsequent encounter.
T85.890D Other specified complication of nervous system prosthetic devices, implants and grafts, subsequent encounter.

The requestor also suggested that the following list of additional diagnosis codes with the 7th character "D" (subsequent encounter) may have been inadvertently assigned to the GROUPER logic list of principal diagnoses for MS-DRGs 922 and 923 (Other Injury, Poisoning and Toxic Effect with MCC and without MCC, respectively) also under MDC 21. The requestor noted these codes were also new, effective October 1, 2016 (FY 2017) and that the predecessor codes grouped to MS-DRGs 949 and 950 in MDC 23 under Version 33 of the ICD-10 MS-DRGs in FY 2016.

page 19838


[top] 
ICD-10-CM diagnosis code Code description
T85.818D Embolism due to other internal prosthetic devices, implants and grafts, subsequent encounter.
T85.828D Fibrosis due to other internal prosthetic devices, implants and grafts, subsequent encounter.
T85.838D Hemorrhage due to other internal prosthetic devices, implants and grafts, subsequent encounter.
T85.848D Pain due to other internal prosthetic devices, implants and grafts, subsequent encounter.
T85.858D Stenosis due to other internal prosthetic devices, implants and grafts, subsequent encounter.
T85.868D Thrombosis due to other internal prosthetic devices, implants and grafts, subsequent encounter.
T85.898D Other specified complication of other internal prosthetic devices, implants and grafts, subsequent encounter.


The requestor believed that the lists of diagnosis codes above with 7th character "D" (subsequent encounter) would be more appropriately assigned to MS-DRGs 949 and 950 under MDC 23, according to its review of the 2017 Official Coding Guidelines for use of the 7th character and assignment of other diagnoses of associated complications of care.

We ran test cases to determine if we could duplicate the requestor's findings with regard to the shifts in MS-DRG assignment between Version 33 and Version 34 of the ICD-10 MS-DRGs. Results of our review were consistent with the requestor's findings. We found that the T85.8-series of diagnosis codes with the 7th character of "A" (initial encounter) and 7th character of "D" (subsequent encounter) were inadvertently assigned to the incorrect MDC for Version 34 of the ICD-10 MS-DRGs, which led to inconsistencies (MS-DRG shifts) when compared to Version 33 of the ICD-10 MS-DRGs. Our analysis also included review of all of the diagnosis codes in the T85.8- series and their current MDC and MS-DRG assignments, as well as review of the 2017 Official Coding Guidelines for use of the 7th character and assignment of other diagnoses of associated complications of care. Based on the results of our review, we agree with the requestor's findings.

In addition, we identified the following list of diagnosis codes with the 7th character "S" (sequela) that appear to have been inadvertently assigned to MS-DRGs 949 and 950 in MDC 23 rather than MDC 21 in MS-DRGs 922 and 923 (Other Injury, Poisoning and Toxic Effect with MCC and without MCC, respectively).

ICD-10-CM diagnosis code Code description
T85.810S Embolism due to nervous system prosthetic devices, implants and grafts, sequela.
T85.820S Fibrosis due to nervous system prosthetic devices, implants and grafts, sequela.
T85.830S Hemorrhage due to nervous system prosthetic devices, implants and grafts, sequela.
T85.840S Pain due to nervous system prosthetic devices, implants and grafts, sequela.
T85.850S Stenosis due to nervous system prosthetic devices, implants and grafts, sequela.
T85.860S Thrombosis due to nervous system prosthetic devices, implants and grafts, sequela.
T85.890S Other specified complication of nervous system prosthetic devices, implants and grafts, sequela.

We are inviting public comment on our proposals to (1) reassign the ICD-10-CM diagnosis codes with the 7th character "A" (initial encounter) from MS-DRGs 949 and 950 in MDC 23 to MS-DRGs 919, 920 and 921 in MDC 21; (2) reassign the ICD-10-CM diagnosis codes with the 7th character "D" (subsequent encounter) from MS-DRGs 919, 920, 921, 922, and 923 in MDC 21 to MS-DRGs 949 and 950 in MDC 23; and (3) reassign the ICD-10-CM diagnosis codes with the 7th character "S" (sequela) from MS-DRGs 949 and 950 in MDC 23 to MS-DRGs 922 and 923 in MDC 21 for FY 2018. The table below displays the current Version 34 MDC and MS-DRG assignments and the proposed Version 35 MDC and MS-DRG assignments that we are seeking public comment on for the respective ICD-10-CM diagnosis codes.

page 19839


[top] 
ICD-10-CM code Code description Current V34 MDC Current V34 MS-DRG Proposed V35 MDC Proposed V35 MS-DRG
T85.810D Embolism due to nervous system prosthetic devices, implants and grafts, subsequent encounter 21 919, 920, 921 23 949, 950
T85.810S Embolism due to nervous system prosthetic devices, implants and grafts, sequela 23 949, 950 21 922, 923
T85.818A Embolism due to other internal prosthetic devices, implants and grafts, initial encounter 23 949, 950 21 919, 920, 921
T85.818D Embolism due to other internal prosthetic devices, implants and grafts, subsequent encounter 21 922, 923 23 949, 950
T85.820D Fibrosis due to nervous system prosthetic devices, implants and grafts, subsequent encounter 21 919, 920, 921 23 949, 950
T85.820S Fibrosis due to nervous system prosthetic devices, implants and grafts, sequela 23 949, 950 21 922, 923
T85.828A Fibrosis due to other internal prosthetic devices, implants and grafts, initial encounter 23 949, 950 21 919, 920, 921
T85.828D Fibrosis due to other internal prosthetic devices, implants and grafts, subsequent encounter 21 922, 923 23 949, 950
T85.830D Hemorrhage due to nervous system prosthetic devices, implants and grafts, subsequent encounter 21 919, 920, 921 23 949, 950
T85.830S Hemorrhage due to nervous system prosthetic devices, implants and grafts, sequela 23 949, 950 21 922, 923
T85.838A Hemorrhage due to other internal prosthetic devices, implants and grafts, initial encounter 23 949, 950 21 919, 920, 921
T85.838D Hemorrhage due to other internal prosthetic devices, implants and grafts, subsequent encounter 21 922, 923 23 949, 950
T85.840D Pain due to nervous system prosthetic devices, implants and grafts, subsequent encounter 21 919, 920, 921 23 949, 950
T85.840S Pain due to nervous system prosthetic devices, implants and grafts, sequela 23 949, 950 21 922, 923
T85.848A Pain due to other internal prosthetic devices, implants and grafts, initial encounter 23 949, 950 21 919, 920, 921
T85.848D Pain due to other internal prosthetic devices, implants and grafts, subsequent encounter 21 922, 923 23 949, 950
T85.850D Stenosis due to nervous system prosthetic devices, implants and grafts, subsequent encounter 21 919, 920, 921 23 949, 950
T85.850S Stenosis due to nervous system prosthetic devices, implants and grafts, sequela 23 949, 950 21 922, 923
T85.858A Stenosis due to other internal prosthetic devices, implants and grafts, initial encounter 23 949, 950 21 919, 920, 921
T85.858D Stenosis due to other internal prosthetic devices, implants and grafts, subsequent encounter 21 922, 923 23 949, 950
T85.860D Thrombosis due to nervous system prosthetic devices, implants and grafts, subsequent encounter 21 919, 920, 921 23 949, 950
T85.860S Thrombosis due to nervous system prosthetic devices, implants and grafts, sequela 23 949, 950 21 922, 923
T85.868A Thrombosis due to other internal prosthetic devices, implants and grafts, initial encounter 23 949, 950 21 919, 920, 921
T85.868D Thrombosis due to other internal prosthetic devices, implants and grafts, subsequent encounter 21 922, 923 23 949, 950
T85.890D Other specified complication of nervous system prosthetic devices, implants and grafts, subsequent encounter 21 919, 920, 921 23 949, 950
T85.890S Other specified complication of nervous system prosthetic devices, implants and grafts, sequela 23 949, 950 21 922, 923
T85.898A Other specified complication of other internal prosthetic devices, implants and grafts, initial encounter 23 949, 950 21 919, 920, 921
T85.898D Other specified complication of other internal prosthetic devices, implants and grafts, subsequent encounter 21 922, 923 23 949, 950


9. MDC 23 (Factors Influencing Health Status and Other Contacts With Health Services): Updates to MS-DRGs 945 and 946 (Rehabilitation With CC/MCC and Without CC/MCC, Respectively)

In FY 2016, we received requests to modify the MS-DRG assignment for MS-DRGs 945 and 946 (Rehabilitation with CC/MCC and without CC/MCC, respectively). This issue was addressed in the FY 2017 IPPS/LTCH PPS proposed and final rules (81 FR 24998 through 25000 and 81 FR 56826 through 56831). For FY 2017, we did not change the MS-DRG assignments for MS-DRGs 945 and 946.

We did not receive a request to address this issue as part of this FY 2018 IPPS/LTCH PPS proposed rule or suggestions on how to update the MS-DRGs 945 and 946 logic. However, we did refer the FY 2016 requests for a new ICD-10-CM diagnosis code to the Centers for Disease Control and Prevention (CDC) for consideration at a future meeting of the ICD-10 Coordination and Maintenance Committee. CDC has the lead on updating and maintaining ICD-10-CM codes. CDC did not address the issue at the September 13-14, 2016 ICD-10 Coordination and Maintenance Committee meeting. When the topic was not addressed at the September 13-14, 2016 ICD-10 Coordination and Maintenance Committee meeting, we asked CDC to address the code request at the March 7-8, 2017 meeting of the ICD-10 Coordination and Maintenance Committee. The topic was on the agenda for the March 7-8, 2017 ICD-10 Coordination and Maintenance Committee meeting. The deadline for providing comments on proposals considered at this meeting was April 7, 2017. Any new codes approved after this meeting which will be implemented on October 1, 2017 will be posted on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/index.html and on the CDC Web site at: http://www.cdc.gov/nchs/icd/icd10.html in June 2017. New codes also will be included in the FY 2018 IPPS/LTCH PPS final rule.

As addressed in the FY 2017 IPPS/LTCH PPS final rule, the ICD-9-CM MS-DRGs used ICD-9-CM codes reported as the principal diagnosis that clearly identified an encounter for rehabilitation services, such as diagnosis codes V57.89 (Care involving other specified rehabilitation procedure) and V57.9 (Care involving unspecified rehabilitation procedure), and these codes were not included in ICD-10-CM. Given this lack of ICD-10-CM codes to indicate that the reason for the encounter was for rehabilitation, the ICD-10 MS-DRG logic could not reflect the logic of the ICD-9-CM MS-DRGs. Commenters on the final rule recommended that CDC create new diagnosis codes for these concepts in ICD-10-CM so that the MS-DRG logic could be updated to more closely reflect that of the ICD-9-CM MS-DRGs.


[top] If new ICD-10-CM codes are created for encounter for rehabilitation services, we would address any updates to MS-DRGs 945 and 946 utilizing these new codes in future rulemaking. In the meantime, we welcome other specific recommendations on how to update MS-DRGs 945 and 946. We are sharing the following data on these MS-DRGs from the MedPAR file. page 19840

FY 2015 MS-DRGs with ICD-9-CM codes Number of cases Average length of stay Average cost
MS-DRG 945 3,991 10.3 $8,242
MS-DRG 946 1,184 8.0 7,322

FY 2016 MS-DRGs with ICD-10-CM codes Number of cases Average length of stay Average cost
MS-DRG 945 671 10.8 $7,814
MS-DRG 946 157 7.3 7,672

As shown by the tables above, there was a decrease of 3,320 MS-DRG 945 cases (from 3,991 to 671) from FY 2015, when claims were submitted with ICD-9-CM codes, to FY 2016 when ICD-10 codes were submitted. There was a decrease of 1,027 MS-DRG 946 cases (from 1,184 to 157) from FY 2015 to FY 2016. The average length of stay increased 0.5 days (from 10.3 to 10.8 days) for MS-DRG 945 and decreased 0.7 days (from 8.0 to 7.3 days) for MS-DRG 946. The average costs decreased by $428 (from $8,242 to $7,814) for MS-DRG 945 cases and increased by $350 (from $7,322 to $7,672) for MS-DRG 946 cases. The number of cases was significantly lower in FY 2016 compared to FY 2015. However, the difference in average length of stay and average costs did not show large changes.

We also examined possible MS-DRGs where these cases may have been assigned in FY 2016 based on increases in the number of claims. Because there is not a diagnosis code that could be reported as a principal diagnosis, which would indicate if the admissions were for rehabilitation services, we are unable to determine if these were cases admitted for rehabilitation that moved from MS-DRGs 945 and 946 because of the lack of a code for encounter for rehabilitation, or if there was simply a change in the number of cases. The following tables show our findings for MS-DRG 056 (Degenerative Nervous System Disorders with MCC); MS-DRG 057 (Degenerative Nervous System Disorders without MCC); MS-DRG 079 (Hypertensive Encephalopathy without CC/MCC); MS DRG 083 (Traumatic Stupor & Coma, Coma >1 Hour with CC); MS-DRG 084 (Traumatic Stupor & Coma, Coma >1 Hour without CC/MCC); MS-DRG 092 (Other Disorders of Nervous System with MCC); and MS-DRG 093 (Other Disorders of Nervous System without CC/MCC).

FY 2015 MS-DRGs with ICD-9-CM codes Number of cases Average length of stay Average cost
MS-DRG 056 9,548 7.3 $12,606
MS-DRG 057 25,652 5.1 7,918
MS-DRG 079 618 2.7 5,212
MS-DRG 083 2,516 4.3 9,446
MS-DRG 084 1,955 2.8 6,824
MS-DRG 092 12,643 5.7 11,158
MS-DRG 093 7,928 2.8 5,182

FY 2016 MS-DRGs with ICD-10-CM codes Number of cases Average length of stay Average cost
MS-DRG 056 10,817 7.6 $12,930
MS-DRG 057 28,336 5.3 7,902
MS-DRG 079 1,233 2.7 5,579
MS-DRG 083 4,058 6.2 9,134
MS-DRG 084 3,016 2.7 6,508
MS-DRG 092 19,392 3.9 6,706
MS-DRG 093 8,120 2.7 5,253

As shown by the tables above, some of the MS-DRGs that show the largest increase in number of cases do not show significant changes in the average length of stay or average costs. For instance, MS-DRG 079 cases doubled from FY 2015 to FY 2016 (from 618 to 1,233). However, the average length of stay did not change from 2.7 days and the average costs increased only $367 (from $5,212 to $5,579). MS-DRG 083 cases increased by 1,542 (from 2,516 to 4,058) with a 1.9 day increase in the average length of stay (from 4.3 to 6.2 days); however, the average costs decreased only $312 (from $9,446 to $9,134). There were large changes for MS-DRG 092 with cases increasing by 6,749 (from 12,643 to 19,392), the average length of stay decreasing by 1.8 days (from 5.7 to 3.9) and the average costs decreasing by $4,452 (from $11,158 to $6,706). Once again, it is not possible to determine if any changes are a result of the impact of not having a code for the encounter for rehabilitation services to report as a principal diagnosis, or if other factors such as changes in types of patient admissions were involved.

Given the lack of a diagnosis code to capture the principal diagnosis of encounter for rehabilitation, we are unable to update MS-DRG 945 or MS-DRG 946 to better identify those cases in which patients are admitted for rehabilitation services. If the CDC creates a new code, we will consider proposing updates to MS-DRGs 945 and 946 in the future.

We are inviting public comments on our proposal not to update MS-DRGs 945 and 946 for FY 2018.

10. Proposed Changes to the Medicare Code Editor (MCE)


[top] The Medicare Code Editor (MCE) is a software program that detects and reports errors in the coding of Medicare page 19841 claims data. Patient diagnoses, procedure(s), and demographic information are entered into the Medicare claims processing systems and are subjected to a series of automated screens. The MCE screens are designed to identify cases that require further review before classification into an MS-DRG.

As discussed in the FY 2017 IPPS/LTCH PPS final rule (81 FR 56831 through 56844), we made available the FY 2017 ICD-10 MCE Version 34 manual file and an ICD-9-CM MCE Version 34.0A manual file (for analysis purposes only). The links to these MCE manual files, along with the links to purchase the mainframe and computer software for the MCE Version 34 (and ICD-10 MS-DRGs) are posted on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html through the FY 2017 IPPS Final Rule Home Page.

For this FY 2018 IPPS/LTCH PPS proposed rule, below we address the MCE requests we received by the December 7, 2016 deadline. We also discuss the proposals we are making based on our internal review and analysis.

a. Age Conflict Edit

In the MCE, the Age Conflict edit exists to detect inconsistencies between a patient's age and any diagnosis on the patient's record; for example, a 5-year-old patient with benign prostatic hypertrophy or a 78-year-old patient coded with a delivery. In these cases, the diagnosis is clinically and virtually impossible for a patient of the stated age. Therefore, either the diagnosis or the age is presumed to be incorrect. Currently, in the MCE, the following four age diagnosis categories appear under the Age Conflict edit and are listed in the manual and written in the software program:

• Perinatal/Newborn-Age of 0 years only; a subset of diagnoses which will only occur during the perinatal or newborn period of age 0 (for example, tetanus neonatorum, health examination for newborn under 8 days old).

• Pediatric-Age is 0 to 17 years inclusive (for example, Reye's syndrome, routine child health examination).

• Maternity-Age range is 12 to 55 years inclusive (for example, diabetes in pregnancy, antepartum pulmonary complication).

• Adult-Age range is 15 to 124 years inclusive (for example, senile delirium, mature cataract).

We received a request to provide clarification regarding the overlapping age ranges (0 to 17 years and 15 to 124 years) in the Pediatric and Adult categories under the Age Conflict edit. The requestor questioned which diagnosis code would be most appropriate to identify when a general or routine health examination is performed on patients who are within the age range of 15 to 17 years. The specific ICD-10-CM diagnosis codes that the requestor inquired about related to a child or to an adult encounter for a health examination are displayed in the table below.

ICD-10-CM code Code description
Z00.00 Encounter for general adult medical examination without abnormal findings.
Z00.01 Encounter for general adult medical examination with abnormal findings.
Z00.121 Encounter for routine child health examination with abnormal findings.
Z00.129 Encounter for routine child health examination without abnormal findings.

The age ranges defined within the Age Conflict edits were established with the implementation of the IPPS. The adult age range includes the minimum age of 15 years for those patients who are declared emancipated minors. We note that, historically, we have not provided coding advice in rulemaking with respect to policy. We collaborate with the American Hospital Association (AHA) through the Coding Clinic for ICD-10-CM and ICD-10-PCS to promote proper coding. We recommend that the requestor and other interested parties submit any questions pertaining to correct coding practices for this specific issue to the AHA.

(1) Perinatal/Newborn Diagnosis Category

Under the ICD-10 MCE, the Perinatal/Newborn Diagnosis category under the Age Conflict edit considers the age of 0 years only; a subset of diagnoses which will only occur during the perinatal or newborn period of age 0 to be inclusive. This includes conditions that have their origin in the fetal or perinatal period (before birth through the first 28 days after birth) even if morbidity occurs later. For that reason, the diagnosis codes on this Age Conflict edit list would be expected to apply to conditions or disorders specific to that age group only.

In the ICD-10-CM classification, there are two diagnosis codes that describe conditions as occurring during infancy and the neonatal period that are currently not on the Perinatal/Newborn Diagnosis category edit code list. We consulted with staff at the Centers for Disease Control's (CDC's) National Center for Health Statistics (NCHS) because NCHS has the lead responsibility for the ICD-10-CM diagnosis codes. The NCHS' staff confirmed that, although diagnosis codes D80.7 (Transient hypogammaglobulinemia of infancy) and diagnosis code E71.511 (Neonatal adrenoleukodystrophy) do occur during infancy and the neonatal period, both conditions can last beyond the 28-day timeframe which is used to define the perinatal/newborn period. These diagnosis codes are not intended to be restricted for assignment to newborn patients. Therefore, we are proposing to not add these two diagnosis codes to the Perinatal/Newborn Diagnosis category under the Age Conflict edit. We are inviting public comments on our proposal.

(2) Pediatric Diagnosis Category

Under the ICD-10 MCE, the Pediatric diagnosis category under the Age Conflict edit considers the age range of 0 to 17 years inclusive. For that reason, the diagnosis codes on this Age Conflict edit list would be expected to apply to conditions or disorders specific to that age group only.


[top] The ICD-10-CM diagnosis code list for the Pediatric diagnosis category under the Age Conflict edit currently includes a diagnosis code pertaining to dandruff that is not intended to apply to pediatric patients only. We consulted with staff at the Centers for Disease Control's (CDC's) National Center for Health Statistics (NCHS) because NCHS has the lead responsibility for the ICD-10-CM diagnosis codes. The NCHS' staff confirmed that, although diagnosis code L21.0 (Seborrhea capitis) has an inclusion term of "Cradle cap," the description of the diagnosis code is not intended to be restricted for assignment of pediatric patients. Therefore, we are proposing to remove diagnosis code L21.0 from the list of diagnosis codes for the Pediatric diagnosis category under the Age Conflict edit. We are inviting public comments on our proposal. page 19842

(3) Maternity Diagnoses

Under the ICD-10 MCE, the Maternity diagnosis category under the Age Conflict edit considers the age range of 12 to 55 years inclusive. For that reason, the ICD-10-CM diagnosis codes on this Age Conflict edit list would be expected to apply to conditions or disorders specific to that age group only.

As discussed in section II.F.12. of the preamble of this proposed rule, Table 6A.-New Diagnosis Codes lists the new ICD-10-CM diagnosis codes that have been approved to date, which will become effective with discharges occurring on and after October 1, 2017. Included on this list are a number of diagnosis codes associated with pregnancy and maternal care that we believe are appropriate to add to the list of diagnosis codes for the Maternity diagnoses category under the Age Conflict edit. We refer readers to Table 6P.1a. associated with this proposed rule (which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) for a review of the ICD-10-CM diagnosis codes that we are proposing to add to the Age Conflict edit list. We are inviting public comments on our proposal.

b. Sex Conflict Edit

In the MCE, the Sex Conflict edit detects inconsistencies between a patient's sex and any diagnosis or procedure on the patient's record; for example, a male patient with cervical cancer (diagnosis) or a female patient with a prostatectomy (procedure). In both instances, the indicated diagnosis or the procedure conflicts with the stated sex of the patient. Therefore, the patient's diagnosis, procedure, or sex is presumed to be incorrect.

(1) Diagnoses for Males Only Edit

We received a request to review the following ICD-10-CM diagnosis codes pertaining to conditions associated with males for possible inclusion on the list of diagnosis codes for the Diagnoses for Males Only edit.

ICD-10-CM code Code description
B37.42 Candidal balanitis.
N35.011 Post-traumatic bulbous urethral stricture.
N35.012 Post-traumatic membranous urethral stricture.
N35.013 Post-traumatic anterior urethral stricture.
N35.112 Postinfective bulbous urethral stricture, not elsewhere classified.
N35.113 Postinfective membranous urethral stricture, not elsewhere classified.
N35.114 Postinfective anterior urethral stricture, not elsewhere classified.
N99.115 Postprocedural fossa navicularis urethral stricture.

We agree with the requestor that diagnosis code B37.42 describes a condition that is applicable only to males. Balanitis is the inflammation of the glans (rounded head) of the penis. We also agree that the diagnosis codes listed above that align under subcategory N35.01 (Post-traumatic urethral stricture, male) and subcategory N35.11 (Postinfection urethral stricture, not elsewhere classified, male) are appropriate to add to the list of diagnosis codes for the Diagnoses for Males Only edit because these diagnosis codes include specific terminology that is applicable only to males. Further, we agree that diagnosis code N99.115 is appropriate to add to the list of diagnosis codes for the Diagnoses for Males Only edit because subcategory N99.11 (Postprocedural urethral stricture, male) includes specific terminology that is applicable to males only as well. Therefore, we are proposing to add the ICD-10-CM diagnosis codes listed in the table above to the list of diagnosis codes for the Diagnoses for Males Only edit.

We also are proposing to remove ICD-10-CM diagnosis code Q64.0 (Epispadias) from the list of diagnosis codes for the Diagnoses for Males Only edit because this rare, congenital condition involving the opening of the urethra can occur in both males and females.

In addition, as discussed in section II.F.12. of the preamble of this proposed rule, Table 6A.-New Diagnosis Codes lists the new ICD-10-CM diagnosis codes that have been approved to date, which will become effective with discharges occurring on and after October 1, 2017. Included on this list are a number of diagnosis codes associated with male body parts that we believe are appropriate to add to the list of diagnosis codes for the Diagnoses for Males Only category under the Sex Conflict edit. We refer readers to Table 6P.1b. associated with this proposed rule (which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) for a review of the ICD-10-CM diagnosis codes that we are proposing to add to the list of diagnosis codes for the Diagnoses for Males Only category.

We are inviting public comments on our proposals.

(2) Diagnoses for Females Only

We received a request to review the following ICD-10-CM diagnosis codes for possible removal from the list of diagnosis codes for the Diagnoses for Females Only edit.

ICD-10-CM code Code description
F52.6 Dyspareunia not due to a substance or known physiological condition.
J84.81 Lymphangioleiomyomatosis.
R97.1 Elevated cancer antigen 125 [CA 125].


[top] The requestor noted that, in the ICD-10-CM classification, the term "Dyspareunia" (painful sexual intercourse) has specified codes for males and females located in the Alphabetic Index to Diseases for Reporting Physiological Dyspareunia. However, the indexing for diagnosis code F52.6 (Dyspareunia not due to a substance or known physiological condition) specifies that it is not due to a physiological condition and the entry is not gender specific. According to the requestor, while the condition is most often associated with female sexual dysfunction, there is a subset of males who also suffer from this condition. page 19843

In addition, the requestor stated that diagnosis code J84.81 (Lymphangioleiomyomatosis) describes a rare form of lung disease believed to occur more often in patients with tuberous sclerosis complex (TSC), a disorder due to genetic mutation. Although the condition is described as being exclusive to women, unique cases for men with TSC have also been reported.

Lastly, the requestor indicated that diagnosis code R97.1 (Elevated cancer antigen 125 [CA 125]) describes the tumor marker that commonly identifies ovarian cancer cells in women. However, the requestor stated that high levels have also been demonstrated in men (and women) with lung cancer as well.

We reviewed ICD-10-CM diagnosis codes F52.6, J84.81, and R97.1, and we agree with the requestor that Dyspareunia, not due to a physiological condition, can also occur in males. We also agree that the condition of Lymphangioleiomyomatosis and Elevated CA 125 levels can be found in males. Therefore, we are proposing to remove these three diagnosis codes from the list of diagnosis codes for the Diagnoses for Females Only edit. We are inviting public comments on our proposals.

In addition, we are proposing to add new diagnosis code Z40.03 (Encounter for prophylactic removal of fallopian tube(s)) to the list of diagnosis codes for the Diagnoses for Females Only edit. Currently, diagnosis code Z40.02 (Encounter for prophylactic removal of ovary) is on the edit's code list; therefore, inclusion of new diagnosis code Z40.03 would be consistent. We refer readers to Table 6A.-New Diagnosis Codes associated with this proposed rule (which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) for the list of new ICD-10-CM diagnosis codes finalized to date. We are inviting public comments on our proposal.

c. Non-Covered Procedure Edit: Gender Reassignment Surgery

In the MCE, the Non-Covered Procedure edit identifies procedures for which Medicare does not provide payment. Payment is not provided due to specific criteria that are established in the National Coverage Determination (NCD) process. We refer readers to the Web site at: https://www.cms.gov/Medicare/Coverage/DeterminationProcess/howtorequestanNCD.html for additional information on this process. In addition, there are procedures that would normally not be paid by Medicare but, due to the presence of certain diagnoses, are paid.

We issued instructions on June 27, 2014, as a one-time notification, Pub. 100-03, Transmittal 169, Change Request 8825, effective May 30, 2014, announcing to MACs the invalidation of National Coverage Determination (NCD) 140.3 for Transsexual Surgery. As a result, MACs determined coverage on a case-by-case basis. The transmittal is available via the Internet on the CMS Web site at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2014-Transmittals-Items/R169NCD.html?DLPage=1&DLEntries=10&DLFilter=Transsexual&DLSort=1&DLSortDir=ascending .

It was brought to our attention that the ICD-10-PCS procedure codes shown in the table below are currently included on the list of procedure codes for the Non-Covered Procedure edit. As a result, when one of these procedure codes is reported on a claim, the edit for Non-Covered Procedure is triggered and claims are not able to process correctly.

ICD-10-CM code Code description
0W4M070 Creation of vagina in male perineum with autologous tissue substitute, open approach.
0W4M0J0 Creation of vagina in male perineum with synthetic substitute, open approach.
0W4M0K0 Creation of vagina in male perineum with nonautologous tissue substitute, open approach.
0W4M0Z0 Creation of vagina in male perineum, open approach.
0W4N071 Creation of penis in female perineum with autologous tissue substitute, open approach.
0W4N0J1 Creation of penis in female perineum with synthetic substitute, open approach.
0W4N0K1 Creation of penis in female perineum with nonautologous tissue substitute, open approach.
0W4N0Z1 Creation of penis in female perineum, open approach.

Therefore, we are proposing to remove the ICD-10-PCS procedure codes included in the table above from the list of procedure codes for the Non-Covered Procedure edit to help resolve claims processing issues associated with the reporting of these procedure codes. We are inviting public comments on our proposal.

d. Unacceptable Principal Diagnosis Edit

In the MCE, there are select codes that describe a circumstance that influences an individual's health status, but does not actually describe a current illness or injury. There also are codes that are not specific manifestations but may be due to an underlying cause. These codes are considered unacceptable as a principal diagnosis. In limited situations, there are a few codes on the MCE Unacceptable Principal Diagnosis edit code list that are considered "acceptable" when a specified secondary diagnosis is also coded and reported on the claim.

(1) Bacterial and Viral Infectious Agents (B95 Through B97)

We examined ICD-10-CM diagnosis codes in Chapter 1 (Certain Infectious and Parasitic Diseases) of the Classification Manual that fall within the range of three code categories for "Bacterial and Viral Infectious Agents" (B95 through B97). The instructional note provided at this section states that these categories are provided for use as supplementary or additional codes to identify the infectious agent(s) in diseases classified elsewhere.

We identified 45 ICD-10-CM diagnosis codes within the range of these code categories for "Bacterial and Viral Infectious Agents" (B95 through B97) that, as a result of the instructional note, are not appropriate to report as a principal diagnosis. We are proposing to add the 45 ICD-10-CM diagnosis codes shown in Table 6P.1c. associated with this proposed rule (which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) to the list of codes for the Unacceptable Principal Diagnosis edit. We are inviting public comments on our proposal.

(2) Mental Disorders Due to Known Physiological Conditions (F01 Through F09)


[top] We examined ICD-10-CM diagnosis codes in Chapter 5 (Mental and Behavioral Disorders) of the Classification Manual that fall within the range of nine code categories for "Mental Disorders Due to Known page 19844 Physiological Conditions" (F01 through F09). The instructional note provided at this section states that this block comprises a range of mental disorders grouped together on the basis of their having in common a demonstrable etiology in cerebral disease, brain injury, or other insult leading to cerebral dysfunction. The dysfunction may be primary, as in diseases, injuries, and insults that affect the brain directly and selectively; or secondary, as in systemic diseases and disorders that attack the brain only as one of the multiple organs or systems of the body that are involved.

We identified 21 ICD-10-CM diagnosis codes that fall within the range of these code categories for "Mental Disorders Due to Known Physiological Conditions" (F01 through F09). Of these nine code categories, seven have a "Code first the underlying physiological condition" note. For example, at code category F01-Vascular dementia, the note reads, "Code first the underlying physiological condition or sequelae of cerebrovascular disease." There are a total of 19 diagnosis codes that fall under these 7 code categories with a "Code first" note and, therefore, are not appropriate to report as a principal diagnosis. Therefore, we are proposing to add the 19 ICD-10-CM diagnosis codes shown in Table 6P.1d. associated with this proposed rule (which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) to the list of codes for the Unacceptable Principal Diagnosis edit. We are inviting public comments on our proposal.

(3) Other Obstetric Conditions, Not Elsewhere Classified (O94 Through O9A)

We examined ICD-10-CM diagnosis codes in Chapter 15 (Pregnancy, Childbirth and the Puerperium) of the Classification Manual that fall within the range of four code categories for "Other Obstetric Conditions, Not Elsewhere Classified" (O94 through O9A). The instructional note provided at this section under category O94 states that "this category is to be used to indicate conditions in O00 through O77, O85 through O94 and O98 through O9A as the cause of late effects. The sequelae include conditions specified as such, or as late effects, which may occur at any time after the puerperium. Code first condition resulting from (sequela) of complication of pregnancy, childbirth, and the puerperium."

We identified one ICD-10-CM diagnosis code within the range of these code categories for "Other Obstetric Conditions, Not Elsewhere Classified" (O94 through O9A) that, as a result of the instructional note, is not appropriate to report as a principal diagnosis because that code identifies the cause of the late effect. This ICD-10-CM diagnosis code is O94 (Sequelae of complication of pregnancy, childbirth, and the puerperium). We are proposing to add ICD-10-CM diagnosis code O94 to the list of codes for the Unacceptable Principal Diagnosis edit. We are inviting public comments on our proposal.

(4) Symptoms and Signs Involving Cognition, Perception, Emotional State and Behavior (R40 Through R46)

We examined ICD-10-CM diagnosis codes in Chapter 18 (Symptoms, Signs and Abnormal Findings) of the Classification Manual that fall within the range of code categories for "Symptoms and Signs Involving Cognition, Perception, Emotional State and Behavior" (R40 through R46), specifically under code category R40-Somnolence, stupor and coma. At subcategory R40.2-Coma, there is an instructional note, which states "Code first any associated: Fracture of skull (S02.-); Intracranial injury (S06.-)."

We identified 96 ICD-10-CM diagnosis codes under this subcategory that, as a result of the instructional note, are not appropriate to report as a principal diagnosis. We are proposing to add the 96 ICD-10-CM diagnosis codes shown in Table 6P.1e. associated with this proposed rule (which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) to the list of codes for the Unacceptable Principal Diagnosis edit. We are inviting public comments on our proposal.

(5) General Symptoms and Signs (R50 Through R69)

We examined ICD-10-CM diagnosis codes in Chapter 18 (Symptoms, Signs and Abnormal Findings) of the Classification Manual that fall within the range of code categories for "General Symptoms and Signs" (R50 through R69), specifically, at code category R65-Symptoms and signs associated with systemic inflammation and infection. There is an instructional note at subcategory R65.1-Systemic inflammatory response syndrome (SIRS) of non-infectious origin, which states "Code first underlying condition, such as: Heatstroke (T67.0); Injury and trauma (S00-T88)." There is also an instructional note at subcategory R65.2-Severe sepsis, which states "Code first underlying infection, such as:" and provides a list of examples.

We identified four ICD-10-CM diagnosis codes in these subcategories that, as a result of the instructional notes described above, are not appropriate to report as a principal diagnosis. These four ICD-10-CM codes are shown in the table below.

ICD-10-CM code Code description
R65.10 Systemic inflammatory response syndrome (SIRS) of non-infectious origin without acute organ dysfunction.
R65.11 Systemic inflammatory response syndrome (SIRS) of non-infectious origin with acute organ dysfunction.
R65.20 Severe sepsis without septic shock.
R65.21 Severe sepsis with septic shock.

We are proposing to add the four ICD-10-CM diagnosis codes shown in the table above to the list of codes for the Unacceptable Principal Diagnosis edit. We are inviting public comments on our proposal.

(6) Poisoning by, Adverse Effects of, and Underdosing of Drugs, Medicaments and Biological Substances (T36 Through T50)


[top] We examined ICD-10-CM diagnosis codes in Chapter 19 (Injury and Poisoning) of the Classification Manual that fall within the range of code categories for "Poisoning by, Adverse Effects of and Underdosing of Drugs, Medicaments and Biological Substances" (T36 through T50). The instructional note provided at this section states "Code first, for adverse effects, the nature of the adverse effect, such as:" and provides a list of examples. In addition, the FY 2017 ICD-10-CM Official Guidelines for Coding and Reporting at Section I.C.19.e.5.c., state that "Codes for underdosing should never be assigned as principal or first-listed codes." page 19845

We identified 996 ICD-10-CM diagnosis codes that, as a result of the instructional note for adverse effects and the guideline for reporting diagnosis codes for underdosing, are not appropriate to report as a principal diagnosis. We are proposing to add the 996 ICD-10-CM diagnosis codes shown in Table 6P.1f. associated with this proposed rule (which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) to the list of codes for the Unacceptable Principal Diagnosis edit. We are inviting public comments on our proposal.

(7) Complications of Surgical and Medical Care, Not Elsewhere Classified (T80 Through T88)

We examined ICD-10-CM diagnosis codes in Chapter 19 (Injury and Poisoning) of the Classification Manual that fall within the range of code categories for "Complications of Surgical and Medical Care, Not Elsewhere Classified" (T80 through T88), specifically, at code category T81-Complications of procedures, not elsewhere classified. There is an instructional note at subcategory T81.12x-Postprocedural septic shock, which states, "Code first underlying infection."

We identified two ICD-10-CM diagnosis codes in this subcategory that, as a result of the instructional note, are not appropriate to report as a principal diagnosis. These two ICD-10-CM codes are shown in the table below.

ICD-10-CM code Code description
T81.12XD Postprocedural septic shock, subsequent encounter.
T81.12XS Postprocedural septic shock, sequela.

We are proposing to add the two ICD-10-CM diagnosis codes shown in the table above to the list of codes for the Unacceptable Principal Diagnosis edit. We are inviting public comments on our proposal.

(8) Persons Encountering Health Services for Examinations (Z00 Through Z13)

We examined ICD-10-CM diagnosis codes in Chapter 21 (Factors Influencing Health Status) of the Classification Manual that fall within the range of code categories for "Persons Encountering Health Services for Examinations" (Z00 through Z13), specifically, at code category Z00-Encounter for general examination without complaint, suspected or reported diagnosis. The FY 2017 ICD-10-CM Official Guidelines for Coding and Reporting at Section I.C.21.c.16., state that the following ICD-10-CM Z-codes/categories may only be reported as the principal/first-listed diagnosis, except when there are multiple encounters on the same day and the medical records for the encounters are combined:

• Z00 (Encounter for general examination without complaint, suspected or reported diagnosis); except Z00.6 (Encounter for examination for normal comparison and control in clinical research program).

Therefore, diagnosis code Z00.6 should not be reported as a principal/first-listed diagnosis. We are proposing to add ICD-10-CM diagnosis code Z00.6 to the list of codes for the Unacceptable Principal Diagnosis edit. We are inviting public comments on our proposal.

To address a separate issue, we are proposing to remove the diagnosis codes under category Z05 (Encounter for observation and examination of newborn for suspected diseases and conditions ruled out) from the list of codes for the Unacceptable Principal Diagnosis edit. The FY 2017 ICD-10-CM Official Guidelines for Coding and Reporting at Section I.C.16.b. state the following:

• Assign a code from category Z05, Observation and evaluation of newborns and infants for suspected conditions ruled out, to identify those instances when a healthy newborn is evaluated for a suspected condition that is determined after study not to be present. Do not use a code from category Z05 when the patient has identified signs or symptoms of a suspected problem; in such cases code the sign or symptom.

• A code from category Z05 may also be assigned as a principal or first-listed code for readmissions or encounters when the code from category Z38 no longer applies. Codes from category Z05 are for use only for healthy newborns and infants for which no condition after study is found to be present.

• A code from category Z05 is to be used as a secondary code after the code from category Z38, Liveborn infants according to place of birth and type of delivery.

Therefore, the ICD-10-CM diagnosis codes under category Z05 are allowed to be reported as a principal diagnosis. We are proposing to remove the 14 ICD-10-CM diagnosis codes shown in the table below from the list of codes for the Unacceptable Principal Diagnosis edit.

ICD-10-CM code Code description
Z05.0 Observation and evaluation of newborn for suspected cardiac condition ruled out.
Z05.1 Observation and evaluation of newborn for suspected infectious condition ruled out.
Z05.2 Observation and evaluation of newborn for suspected neurological condition ruled out.
Z05.3 Observation and evaluation of newborn for suspected respiratory condition ruled out.
Z05.41 Observation and evaluation of newborn for suspected genetic condition ruled out.
Z05.42 Observation and evaluation of newborn for suspected metabolic condition ruled out.
Z05.43 Observation and evaluation of newborn for suspected immunologic condition ruled out.
Z05.5 Observation and evaluation of newborn for suspected gastrointestinal condition ruled out.
Z05.6 Observation and evaluation of newborn for suspected genitourinary condition ruled out.
Z05.71 Observation and evaluation of newborn for suspected skin and subcutaneous tissue condition ruled out.
Z05.72 Observation and evaluation of newborn for suspected musculoskeletal condition ruled out.
Z05.73 Observation and evaluation of newborn for suspected connective tissue condition ruled out.
Z05.8 Observation and evaluation of newborn for other specified suspected condition ruled out.
Z05.9 Observation and evaluation of newborn for unspecified suspected condition ruled out.


[top] page 19846

We are inviting public comments on our proposal.

(9) Encounters for Other Specific Health Care (Z40 Through Z53)

We examined ICD-10-CM diagnosis codes in Chapter 21 (Factors Influencing Health Status) of the Classification Manual that fall within the range of code categories for "Encounters for Other Specific Health Care" (Z40 through Z53), specifically, at code category Z52-Donors of organs and tissues. The FY 2017 ICD-10-CM Official Guidelines for Coding and Reporting at Section I.C.21.c.16. state that the following Z-codes/categories may only be reported as the principal/first-listed diagnosis, except when there are multiple encounters on the same day and the medical records for the encounters are combined:

• Z52 (Donors of organs and tissues); except Z52.9 (Donor of unspecified organ or tissue).

Therefore, ICD-10-CM diagnosis code Z52.9 should not be reported as a principal/first-listed diagnosis. We are proposing to add ICD-10-CM diagnosis code Z52.9 to the list of codes for the Unacceptable Principal Diagnosis edit. We are inviting public comments on our proposal.

(10) Persons Encountering Health Services in Other Circumstances (Z69 Through Z76)

We examined ICD-10-CM diagnosis codes in Chapter 21 (Factors Influencing Health Status) of the Classification Manual that fall within the range of code categories for "Persons Encountering Health Services in Other Circumstances" (Z69 through Z76), specifically, at subcategory Z71.8-Other specified counseling. Consistent with ICD-10-CM diagnosis codes Z71.81 (Spiritual or religious counseling) and Z71.89 (Other specified counseling), we are proposing to add new diagnosis code Z71.82 (Exercise counseling) to the list of codes for the Unacceptable Principal Diagnosis edit. We refer readers to Table 6A.-New Diagnosis Codes associated with this proposed rule (which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) for the list of new ICD-10-CM diagnosis codes finalized to date. We are inviting public comments on our proposal.

(11) Persons With Potential Health Hazards Related to Family and Personal History and Certain Conditions Influencing Health Status (Z77 Through Z99)

We examined ICD-10-CM diagnosis codes in Chapter 21 (Factors Influencing Health Status) of the Classification Manual that fall within the range of code categories for "Persons with Potential Health Hazards Related to Family and Personal History and Certain Conditions Influencing Health Status" (Z77 through Z99), specifically, at code category Z91.8-Other specified personal risk factors, not elsewhere classified. Consistent with ICD-10-CM diagnosis codes Z91.81 (History of falling), Z91.82 (Personal history of military deployment), and Z91.89 (Other specified personal risk factors, not elsewhere classified), we are proposing to add new ICD-10-CM diagnosis codes Z91.841 (Risk for dental caries, low), Z91.842 (Risk for dental caries, moderate), Z91.843 (Risk for dental caries, high), and Z91.849 (Unspecified risk for dental caries) to the list of codes for the Unacceptable Principal Diagnosis edit. We refer readers to Table 6A.-New Diagnosis Codes associated with this proposed rule (which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) for the list of new ICD-10-CM diagnosis codes finalized to date. We are inviting public comments on our proposal.

e. Future Enhancement

Similar to our discussion in the FY 2017 IPPS/LTCH PPS final rule (81 FR 56843 through 56844), with the implementation of ICD-10, it is clear that there are several new concepts in the classification. Looking ahead to the needs and uses of coded data as the data continue to evolve from the reporting, collection, processing, coverage, payment and analysis aspects, we believe the need to ensure the accuracy of the coded data becomes increasingly significant.

The purpose of the MCE is to ensure that errors and inconsistencies in the coded data are recognized during Medicare claims processing. As we continue to evaluate the purpose and function of the MCE with respect to ICD-10, we encourage public input for future discussion. As we discussed in the FY 2017 IPPS/LTCH PPS final rule, we recognize a need to further examine the current list of edits and the definitions of those edits. We encourage public comments on whether there are additional concerns with the current edits, including specific edits or language that should be removed or revised, edits that should be combined, or new edits that should be added to assist in detecting errors or inaccuracies in the coded data.

11. Proposed Changes to Surgical Hierarchies

Some inpatient stays entail multiple surgical procedures, each one of which, occurring by itself, could result in assignment of the case to a different MS-DRG within the MDC to which the principal diagnosis is assigned. Therefore, it is necessary to have a decision rule within the GROUPER by which these cases are assigned to a single MS-DRG. The surgical hierarchy, an ordering of surgical classes from most resource-intensive to least resource-intensive, performs that function. Application of this hierarchy ensures that cases involving multiple surgical procedures are assigned to the MS-DRG associated with the most resource-intensive surgical class.

Because the relative resource intensity of surgical classes can shift as a function of MS-DRG reclassification and recalibrations, for FY 2018, we reviewed the surgical hierarchy of each MDC, as we have for previous reclassifications and recalibrations, to determine if the ordering of classes coincides with the intensity of resource utilization.


[top] A surgical class can be composed of one or more MS-DRGs. For example, in MDC 11, the surgical class "kidney transplant" consists of a single MS-DRG (MS-DRG 652) and the class "major bladder procedures" consists of three MS-DRGs (MS-DRGs 653, 654, and 655). Consequently, in many cases, the surgical hierarchy has an impact on more than one MS-DRG. The methodology for determining the most resource-intensive surgical class involves weighting the average resources for each MS-DRG by frequency to determine the weighted average resources for each surgical class. For example, assume surgical class A includes MS-DRGs 001 and 002 and surgical class B includes MS-DRGs 003, 004, and 005. Assume also that the average costs of MS-DRG 001 are higher than that of MS-DRG 003, but the average costs of MS-DRGs 004 and 005 are higher than the average costs of MS-DRG 002. To determine whether surgical class A should be higher or lower than surgical class B in the surgical hierarchy, we would weigh the average costs of each MS-DRG in the class by frequency (that is, by the number of cases in the MS-DRG) to determine average resource page 19847 consumption for the surgical class. The surgical classes would then be ordered from the class with the highest average resource utilization to that with the lowest, with the exception of "other O.R. procedures" as discussed in this rule.

This methodology may occasionally result in assignment of a case involving multiple procedures to the lower-weighted MS-DRG (in the highest, most resource-intensive surgical class) of the available alternatives. However, given that the logic underlying the surgical hierarchy provides that the GROUPER search for the procedure in the most resource-intensive surgical class, in cases involving multiple procedures, this result is sometimes unavoidable.

We note that, notwithstanding the foregoing discussion, there are a few instances when a surgical class with a lower average cost is ordered above a surgical class with a higher average cost. For example, the "other O.R. procedures" surgical class is uniformly ordered last in the surgical hierarchy of each MDC in which it occurs, regardless of the fact that the average costs for the MS-DRG or MS-DRGs in that surgical class may be higher than those for other surgical classes in the MDC. The "other O.R. procedures" class is a group of procedures that are only infrequently related to the diagnoses in the MDC, but are still occasionally performed on patients with cases assigned to the MDC with these diagnoses. Therefore, assignment to these surgical classes should only occur if no other surgical class more closely related to the diagnoses in the MDC is appropriate.

A second example occurs when the difference between the average costs for two surgical classes is very small. We have found that small differences generally do not warrant reordering of the hierarchy because, as a result of reassigning cases on the basis of the hierarchy change, the average costs are likely to shift such that the higher-ordered surgical class has lower average costs than the class ordered below it.

We received a request to examine a case involving the principal procedure for excision of pituitary gland (ICD-10-PCS code 0GB00ZZ Excision of pituitary gland, open approach) with a secondary procedure for harvesting of a fat graft (ICD-10-PCS code 0JB80ZZ Excision of abdomen subcutaneous tissue and fascia, open approach) to treat a condition of pituitary adenoma (ICD-10-CM diagnosis code D35.2 (Benign neoplasm of pituitary gland)) and the resulting sella turcica defect. The requestor noted that when the procedure code for harvesting of the fat graft is reported on the claim, the case currently groups to MS-DRGs 622, 623, and 624 (Skin Grafts and Wound Debridement for Endocrine, Nutritional, and Metabolic Disorders with MCC, with CC and without CC/MCC, respectively). However, when the procedure code for harvesting of the fat graft is not reported on the claim, the case groups to MS-DRGs 614 and 615 (Adrenal and Pituitary Procedures with CC/MCC and without CC/MCC, respectively), which appears to be a more appropriate assignment. The requester expressed concern regarding the procedure code for harvesting of the fat graft in the secondary position driving the MS-DRG assignment versus the principal procedure of the excision of pituitary gland.

We analyzed the codes provided by the requestor in the GROUPER to determine if we could duplicate the requestor's findings. The findings from our analysis were consistent with the requestor's findings. Our clinical advisors reviewed this issue and agreed that it should be the procedure code for excision of the pituitary gland that is used to determine the MS-DRG assignment in this scenario and not the harvesting of the fat graft procedure code.

Therefore, in this FY 2018 IPPS/LTCH PPS proposed rule, we are proposing to move MS-DRGs 614 and 615 above MS-DRGs 622, 623, and 624 in the surgical hierarchy to enable more appropriate MS-DRG assignment for these types of cases.

We are inviting public comments on our proposal.

12. Proposed Changes to the MS-DRG Diagnosis Codes for FY 2018

a. Background of the CC List and the CC Exclusions List

Under the IPPS MS-DRG classification system, we have developed a standard list of diagnoses that are considered CCs. Historically, we developed this list using physician panels that classified each diagnosis code based on whether the diagnosis, when present as a secondary condition, would be considered a substantial complication or comorbidity. A substantial complication or comorbidity was defined as a condition that, because of its presence with a specific principal diagnosis, would cause an increase in the length-of-stay by at least 1 day in at least 75 percent of the patients. However, depending on the principal diagnosis of the patient, some diagnoses on the basic list of complications and comorbidities may be excluded if they are closely related to the principal diagnosis. In FY 2008, we evaluated each diagnosis code to determine its impact on resource use and to determine the most appropriate CC subclassification (non-CC, CC, or MCC) assignment. We refer readers to sections II.D.2. and 3. of the preamble of the FY 2008 IPPS final rule with comment period for a discussion of the refinement of CCs in relation to the MS-DRGs we adopted for FY 2008 (72 FR 47152 through 47171).

b. Proposed Additions and Deletions to the Diagnosis Code Severity Levels for FY 2018

The following tables identifying the proposed additions and deletions to the MCC severity levels list and the proposed additions and deletions to the CC severity levels list for FY 2018 are available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html .

Table 6I.1-Proposed Additions to the MCC List-FY 2018;

Table 6I.2-Proposed Deletions to the MCC List-FY 2018;

Table 6J.1-Proposed Additions to the CC List-FY 2018; and

Table 6J.2-Proposed Deletions to the CC List-FY 2018.

We are inviting public comments on our proposed severity level designations for the diagnosis codes listed in Table 6I.1. and Table 6J.1. We note that, for Table 6I.2. and Table 6J.2., the proposed deletions are a result of code expansions. Therefore, the diagnosis codes on these lists are no longer valid codes, effective FY 2018. For example, diagnosis code O00.10 (Tubal pregnancy without intrauterine pregnancy) is a current CC for FY 2017 under Version 34 of the ICD-10 MS-DRGs. Effective FY 2018, under Version 35 of the ICD-10 MS-DRGs, this single code has been expanded into three diagnosis codes to include laterality (left/right) and an unspecified option with the addition of a sixth character. Therefore, diagnosis code O00.10 is included in Table 6J.2. for deletion from the CC list because it is no longer a valid code in FY 2018.

c. Principal Diagnosis Is Its Own CC or MCC


[top] CMS' initial goal in developing the ICD-10 MS-DRGs was to ensure that a patient case was assigned to the same MS-DRG, regardless of whether the patient record was to be coded in ICD-9-CM or ICD-10. When certain ICD-10-CM combination codes are reported as a principal diagnosis, it implies that a CC or MCC is present. This occurs as a result of evaluating the cluster of ICD- page 19848 9-CM codes that would have been coded on an ICD-9-CM record. If one of the ICD-9-CM codes in the cluster was a CC or an MCC, the single ICD-10-CM combination code used as a principal diagnosis also must imply that the CC or MCC is present.

The ICD-10-CM diagnosis codes to which this logic applies are included in Appendix J of the ICD-10 MS-DRG Version 34 Definitions Manual (which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2017-IPPS-Final-Rule-Home-Page-Items/FY2017-IPPS-Final-Rule-Data-Files.html?DLPage=1&DLfxsp0;Entries=10&DLSort=0&DLSortDir=ascending ). Appendix J includes two lists: Part 1 is the list of principal diagnosis codes where the ICD-10-CM code is its own MCC. Part 2 is the list of principal diagnosis codes where the ICD-10-CM code is its own CC. Part 1 of Appendix J corresponds to Table 6L.-Principal Diagnosis Is Its Own MCC List, and Part 2 of Appendix J corresponds to Table 6M.-Principal Diagnosis Is Its Own CC List.

We received a request to add the ICD-10-CM diagnosis codes for acute myocardial infarction, decompensated heart failure and specified forms of shock, which are currently designated as a CC or an MCC when reported as a secondary diagnosis, to Table 6L.-Principal Diagnosis Is Its Own MCC List. According to the requestor, the addition of these codes to the list is necessary for bundled payment initiatives and so that facilities that accept these patients in transfer have resources to care for them.

The purpose of the Principal Diagnosis Is Its Own CC or MCC Lists was to ensure consistent MS-DRG assignment between the ICD-9-CM and ICD-10 MS-DRGs due to the clusters and combination codes. There are a number of other ICD-10-CM combination codes that, due to their prior designation as a CC or an MCC when reported as a secondary diagnosis, are not on either of these lists. Having multiple lists for CC and MCC diagnoses when reported as a principal and/or secondary diagnosis may not provide an accurate representation of resource utilization for the MS-DRGs. As discussed in further detail below, we have plans to conduct a comprehensive review of the CC and MCC lists for FY 2019. We believe the results of that review will help to inform the future of these lists.

Therefore, we are not proposing to add the ICD-10-CM diagnosis codes for acute myocardial infarction, decompensated heart failure and specified forms of shock to Table 6L.-Principal Diagnosis Is Its Own MCC List. In addition, we are not proposing any changes to Table 6L.-Principal Diagnosis Is Its Own MCC List and Table 6M.-Principal Diagnosis Is Its Own CC List. We are inviting public comments on our proposal to maintain the existing lists of principal diagnosis codes in Tables 6L. and 6M for FY 2018.

d. Proposed CC Exclusions List for FY 2018

In the September 1, 1987 final notice (52 FR 33143) concerning changes to the DRG classification system, we modified the GROUPER logic so that certain diagnoses included on the standard list of CCs would not be considered valid CCs in combination with a particular principal diagnosis. We created the CC Exclusions List for the following reasons: (1) To preclude coding of CCs for closely related conditions; (2) to preclude duplicative or inconsistent coding from being treated as CCs; and (3) to ensure that cases are appropriately classified between the complicated and uncomplicated DRGs in a pair. As previously indicated, we developed a list of diagnoses, using physician panels, to include those diagnoses that, when present as a secondary condition, would be considered a substantial complication or comorbidity.

In previous years, we made changes to the list of CCs, either by adding new CCs or deleting CCs already on the list.

In the May 19, 1987 proposed notice (52 FR 18877) and the September 1, 1987 final notice (52 FR 33154), we explained that the excluded secondary diagnoses were established using the following five principles:

• Chronic and acute manifestations of the same condition should not be considered CCs for one another;

• Specific and nonspecific (that is, not otherwise specified (NOS)) diagnosis codes for the same condition should not be considered CCs for one another;

• Codes for the same condition that cannot coexist, such as partial/total, unilateral/bilateral, obstructed/unobstructed, and benign/malignant, should not be considered CCs for one another;

• Codes for the same condition in anatomically proximal sites should not be considered CCs for one another; and

• Closely related conditions should not be considered CCs for one another.

The creation of the CC Exclusions List was a major project involving hundreds of codes. We have continued to review the remaining CCs to identify additional exclusions and to remove diagnoses from the master list that have been shown not to meet the definition of a CC. We refer readers to the FY 2014 IPPS/LTCH PPS final rule (78 FR 50541 through 50544) for detailed information regarding revisions that were made to the CC and CC Exclusion Lists under the ICD-9-CM MS-DRGs.

For FY 2018, we are proposing changes to the ICD-10 MS-DRGs Version 35 CC Exclusion List. Therefore, we have developed Table 6G.1.-Proposed Secondary Diagnosis Order Additions to the CC Exclusions List-FY 2018; Table 6G.2.-Proposed Principal Diagnosis Order Additions to the CC Exclusions List-FY 2018; Table 6H.1.-Proposed Secondary Diagnosis Order Deletions to the CC Exclusions List-FY 2018; and Table 6H.2.-Proposed Principal Diagnosis Order Deletions to the CC Exclusions List-FY 2018. Each of these principal diagnosis codes for which there is a CC exclusion is shown in Table 6G.2. with an asterisk and the conditions that will not count as a CC are provided in an indented column immediately following the affected principal diagnosis. Beginning with discharges on or after October 1 of each year, the indented diagnoses are not recognized by the GROUPER as valid CCs for the asterisked principal diagnoses. Tables 6G. and 6H. associated with this proposed rule are available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html .

To identify new, revised and deleted diagnosis and procedure codes, for FY 2018, we have developed Table 6A.-New Diagnosis Codes, Table 6B.-New Procedure Codes, Table 6C.-Invalid Diagnosis Codes, Table 6D.-Invalid Procedure Codes, Table 6E.-Revised Diagnosis Code Titles, and Table 6F.-Revised Procedure Code Titles for this proposed rule.


[top] These tables are not published in the Addendum to this proposed rule but are available via the Internet on the CMS Web site at: ( https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html as described in section VI. of the Addendum to this proposed rule. As discussed in section II.F.15. of the preamble of this proposed rule, the code titles are adopted as part of the ICD-10 (previously ICD-9-CM) Coordination and Maintenance Committee process. Therefore, although we publish the code titles in the IPPS proposed and final rules, they are not subject to comment in the proposed or final rules. We are inviting public comments on the MDC and MS-DRG assignments for the new page 19849 diagnosis and procedure codes as set forth in Table 6A.-New Diagnosis Codes and Table 6B.-New Procedure Codes. In addition, we are inviting public comments on the proposed severity level designations for the new diagnosis codes as set forth in Table 6A. and the proposed O.R. status for the new procedure codes as set forth in Table 6B.

13. Comprehensive Review of CC List for FY 2019

In the FY 2008 IPPS final rule (72 FR 47153 through 47175), we discussed our efforts to better recognize severity of illness which began with a comprehensive review of the CC list and, ultimately, the implementation of the MS-DRGs. Similar to the analysis that was performed at that time, we are providing the public with notice of our plans to conduct a comprehensive review of the CC and MCC lists for FY 2019.

As a result of the time that has elapsed since that review and changes to how inpatient care is currently delivered, we plan to analyze if further refinements to these lists are warranted. For example, over the past several years, there has been a steady increase in the proportion of cases grouping to the MS-DRGs with an MCC severity level than had previously occurred. Our evaluation will assist in determining if the conditions designated as an MCC continue to represent significant increases in resource utilization that support the MCC designation.

We currently utilize a statistical algorithm to determine the impact on resource use of each secondary diagnosis. Each diagnosis for which Medicare data are available is evaluated to determine its impact on resource use and to determine the most appropriate CC subclass (non-CC, CC, or MCC) assignment. In order to make this determination, the average costs for each subset of cases is compared to the expected costs for cases in that subset. The following format is used to evaluate each diagnosis:

Code Diagnosis Cnt1 C1 Cnt2 C2 Cnt3 C3

Count (Cnt) is the number of patients in each subset and C1, C2, and C3 are a measure of the impact on resource use of patients in each of the subsets. The C1, C2, and C3 values are a measure of the ratio of average costs for patients with these conditions to the expected average costs across all cases. The C1 value reflects a patient with no other secondary diagnosis or with all other secondary diagnoses that are non-CCs. The C2 value reflects a patient with at least one other secondary diagnosis that is a CC but none that is an MCC. The C3 value reflects a patient with at least one other secondary diagnosis that is an MCC. A value close to 1.0 in the C1 field would suggest that the code produces the same expected value as a non-CC diagnosis. That is, average costs for the case are similar to the expected average costs for that subset and the diagnosis is not expected to increase resource usage. A higher value in the C1 (or C2 and C3) field suggests more resource usage is associated with the diagnosis and an increased likelihood that it is more like a CC or major CC than a non-CC. Thus, a value close to 2.0 suggests the condition is more like a CC than a non-CC but not as significant in resource usage as an MCC. A value close to 3.0 suggests the condition is expected to consume resources more similar to an MCC than a CC or non-CC. For example, a C1 value of 1.8 for a secondary diagnosis means that for the subset of patients who have the secondary diagnosis and have either no other secondary diagnosis present, or all the other secondary diagnoses present are non-CCs, the impact on resource use of the secondary diagnoses is greater than the expected value for a non-CC by an amount equal to 80 percent of the difference between the expected value of a CC and a non-CC (that is, the impact on resource use of the secondary diagnosis is closer to a CC than a non-CC).

We are inviting public comments regarding other possible ways we can incorporate meaningful indicators of clinical severity.

14. Review of Procedure Codes in MS DRGs 981 Through 983; 984 Through 986; and 987 Through 989

Each year, we review cases assigned to MS-DRGs 981, 982, and 983 (Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively); MS-DRGs 984, 985, and 986 (Prostatic O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively); and MS-DRGs 987, 988, and 989 (Nonextensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) to determine whether it would be appropriate to change the procedures assigned among these MS-DRGs. MS-DRGs 981 through 983, 984 through 986, and 987 through 989 are reserved for those cases in which none of the O.R. procedures performed are related to the principal diagnosis. These MS-DRGs are intended to capture atypical cases, that is, those cases not occurring with sufficient frequency to represent a distinct, recognizable clinical group.

Under the ICD-10 MS-DRGs Version 34, MS-DRGs 984 through 986 are assigned when one or more of the procedures described by ICD-10-PCS codes in Table 6P.2. that is associated with this FY 2018 proposed rule (which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) are performed and are unrelated to the principal diagnosis. All remaining O.R. procedures are assigned to MS-DRGs 981 through 983 and 987 through 989, with MS-DRGs 987 through 989 assigned to those discharges in which the only procedures performed are nonextensive procedures that are unrelated to the principal diagnosis.

We refer the reader to the FY 2017 IPPS/LTCH PPS final rule (81 FR 56847 through 56848) for a discussion of the movement and redesignation of procedure codes from MS-DRGs 984 through 986 related to the transition of the ICD-10 MS-DRGs.

Our review of MedPAR claims data showed that there are no cases that merited movement or should logically be reassigned from ICD-10 MS-DRGs 984 through 986 to any of the other MDCs for FY 2018. Therefore, for FY 2018, we are not proposing to change the procedures assigned among these MS-DRGs. We are inviting public comments on our proposal to maintain the current structure of these MS-DRGs.

a. Moving Procedure Codes From MS-DRGs 981 Through 983 or MS-DRGs 987 Through 989 Into MDCs


[top] We annually conduct a review of procedures producing assignment to MS-DRGs 981 through 983 (Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) or MS-DRGs 987 through 989 (Nonextensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) on the basis of volume, by procedure, to see if it would be appropriate to move procedure codes out of these MS-DRGs page 19850 into one of the surgical MS-DRGs for the MDC into which the principal diagnosis falls. The data are arrayed in two ways for comparison purposes. We look at a frequency count of each major operative procedure code. We also compare procedures across MDCs by volume of procedure codes within each MDC.

We identify those procedures occurring in conjunction with certain principal diagnoses with sufficient frequency to justify adding them to one of the surgical MS-DRGs for the MDC in which the diagnosis falls. Upon review of the claims data from the December 2016 update of the FY 2016 MedPAR file, we did not find any cases that merited movement or that should logically be assigned to any of the other MDCs. Therefore, for FY 2018, we are not proposing to remove any procedures from MS-DRGs 981 through 983 or MS-DRGs 987 through 989 into one of the surgical MS-DRGs for the MDC into which the principal diagnosis is assigned. We are inviting public comments on our proposal to maintain the current structure of these MS-DRGs.

b. Reassignment of Procedures Among MS-DRGs 981 Through 983, 984 Through 986, and 987 Through 989

We also review the list of ICD-10-PCS procedures that, when in combination with their principal diagnosis code, result in assignment to MS-DRGs 981 through 983, 984 through 986, or 987 through 989, to ascertain whether any of those procedures should be reassigned from one of those three groups of MS-DRGs to another of the three groups of MS-DRGs based on average costs and the length of stay. We look at the data for trends such as shifts in treatment practice or reporting practice that would make the resulting MS-DRG assignment illogical. If we find these shifts, we would propose to move cases to keep the MS-DRGs clinically similar or to provide payment for the cases in a similar manner. Generally, we move only those procedures for which we have an adequate number of discharges to analyze the data.

Based on the results of our review of the December 2016 update of the FY 2016 MedPAR file, we are proposing to reassign the procedure codes currently assigned to MS-DRGs 984 through 986 (Prostatic O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC and without CC/MCC, respectively) to MS-DRGs 987 through 989 (Non-extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC and without CC/MCC, respectively). As shown in the table below, we found a total of 1,001 cases in MS-DRGs 984 through 986 with an average length-of-stay of 7.5 days and average costs of $16,539. In MS-DRGs 987 through 989, we found a total of 17,772 cases, with an average length of stay of 7.5 days and average costs of $16,193.

MS-DRG Number of cases Average length of stay Average costs
MS-DRGs 984, 985 and 986 (Prostatic O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) 1,001 7.5 $16,539
MS-DRGs 987, 988 and 989 (Non-extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) 17,772 7.5 16,193

The claims data demonstrate that it is no longer necessary to maintain a separate set of MS-DRGs specifically for the prostatic O.R. procedures. The average length of stay of 7.5 days is identical in both sets of MS-DRGs and the average costs are very similar with a difference of only $346. Our clinical advisors reviewed the data and support movement of these 1,001 cases into the nonextensive O.R. procedures MS-DRGs. They noted that treatment practices have shifted since the inception of the prostatic O.R. procedures grouping and the average costs are in alignment.

Therefore, for FY 2018, we are proposing to reassign the prostatic O.R. procedure codes from MS-DRGs 984 through 986 to MS-DRGs 987 through 989 and to delete MS-DRGs 984, 985 and 986 because they would no longer be needed as a result of this proposed movement. We are inviting public comments on our proposals.

15. Proposed Changes to the ICD-10-CM and ICD-10-PCS Coding Systems

In September 1985, the ICD-9-CM Coordination and Maintenance Committee was formed. This is a Federal interdepartmental committee, co-chaired by the National Center for Health Statistics (NCHS), the Centers for Disease Control and Prevention, and CMS, charged with maintaining and updating the ICD-9-CM system. The final update to ICD-9-CM codes was made on October 1, 2013. Thereafter, the name of the Committee was changed to the ICD-10 Coordination and Maintenance Committee, effective with the March 19-20, 2014 meeting. The ICD-10 Coordination and Maintenance Committee addresses updates to the ICD-10-CM and ICD-10-PCS coding systems. The Committee is jointly responsible for approving coding changes, and developing errata, addenda, and other modifications to the coding systems to reflect newly developed procedures and technologies and newly identified diseases. The Committee is also responsible for promoting the use of Federal and non-Federal educational programs and other communication techniques with a view toward standardizing coding applications and upgrading the quality of the classification system.

The official list of ICD-9-CM diagnosis and procedure codes by fiscal year can be found on the CMS Web site at: http://cms.hhs.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/codes.html . The official list of ICD-10-CM and ICD-10-PCS codes can be found on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/index.html .

The NCHS has lead responsibility for the ICD-10-CM and ICD-9-CM diagnosis codes included in the Tabular List and Alphabetic Index for Diseases, while CMS has lead responsibility for the ICD-10-PCS and ICD-9-CM procedure codes included in the Tabular List and Alphabetic Index for Procedures.


[top] The Committee encourages participation in the previously mentioned process by health-related organizations. In this regard, the Committee holds public meetings for discussion of educational issues and proposed coding changes. These meetings provide an opportunity for representatives of recognized organizations in the coding field, such as the American Health Information Management Association (AHIMA), the American Hospital Association (AHA), and various physician specialty groups, as well as individual physicians, health information management professionals, and other members of the public, to page 19851 contribute ideas on coding matters. After considering the opinions expressed at the public meetings and in writing, the Committee formulates recommendations, which then must be approved by the agencies.

The Committee presented proposals for coding changes for implementation in FY 2018 at a public meeting held on September 13-14, 2016, and finalized the coding changes after consideration of comments received at the meetings and in writing by November 13, 2016.

The Committee held its 2017 meeting on March 7-8, 2017. The deadline for submitting comments on these code proposals was April 7, 2017. It was announced at this meeting that any new ICD-10-CM/PCS codes for which there was consensus of public support and for which complete tabular and indexing changes would be made by May 2017 would be included in the October 1, 2017 update to ICD-10-CM/ICD-10-PCS. As discussed in earlier sections of the preamble of this proposed rule, there are new, revised, and deleted ICD-10-CM diagnosis codes and ICD-10-PCS procedure codes that are captured in Table 6A.-New Diagnosis Codes, Table 6B.-New Procedure Codes, Table 6C.-Invalid Diagnosis Codes, Table 6D.-Invalid Procedure Codes, Table 6E.-Revised Diagnosis Code Titles, and Table 6F.-Revised Procedure Code Titles for this proposed rule, which are available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html . Because of the length of these tables, they are not published in the Addendum to this proposed rule. Rather, they are available via the Internet as discussed in section VI. of the Addendum to this proposed rule.

Live Webcast recordings of the discussions of procedure codes at the Committee's September 13-14, 2016 meeting and March 7-8, 2017 meeting can be obtained from the CMS Web site at: http://cms.hhs.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/index.html?redirect=/icd9ProviderDiagnosticCodes/03_meetings.asp . The minutes of the discussions of diagnosis codes at the September 13-14, 2016 meeting and March 7-8, 2017 meeting can be found at: http://www.cdc.gov/nchs/icd/icd10cm_maintenance.html. These Web sites also provide detailed information about the Committee, including information on requesting a new code, attending a Committee meeting, and timeline requirements and meeting dates.

We encourage commenters to address suggestions on coding issues involving diagnosis codes to: Donna Pickett, Co-Chairperson, ICD-10 Coordination and Maintenance Committee, NCHS, Room 2402, 3311 Toledo Road, Hyattsville, MD 20782. Comments may be sent by Email to: nchsicd10@cdc.gov .

Questions and comments concerning the procedure codes should be addressed to: Patricia Brooks, Co-Chairperson, ICD-10 Coordination and Maintenance Committee, CMS, Center for Medicare Management, Hospital and Ambulatory Policy Group, Division of Acute Care, C4-08-06, 7500 Security Boulevard, Baltimore, MD 21244-1850. Comments may be sent by Email to: ICDProcedureCodeRequest@cms.hhs.gov.

In the September 7, 2001 final rule implementing the IPPS new technology add-on payments (66 FR 46906), we indicated we would attempt to include proposals for procedure codes that would describe new technology discussed and approved at the Spring meeting as part of the code revisions effective the following October.

Section 503(a) of Public Law 108-173 included a requirement for updating diagnosis and procedure codes twice a year instead of a single update on October 1 of each year. This requirement was included as part of the amendments to the Act relating to recognition of new technology under the IPPS. Section 503(a) amended section 1886(d)(5)(K) of the Act by adding a clause (vii) which states that the Secretary shall provide for the addition of new diagnosis and procedure codes on April 1 of each year, but the addition of such codes shall not require the Secretary to adjust the payment (or diagnosis-related group classification) until the fiscal year that begins after such date. This requirement improves the recognition of new technologies under the IPPS system by providing information on these new technologies at an earlier date. Data will be available 6 months earlier than would be possible with updates occurring only once a year on October 1.

While section 1886(d)(5)(K)(vii) of the Act states that the addition of new diagnosis and procedure codes on April 1 of each year shall not require the Secretary to adjust the payment, or DRG classification, under section 1886(d) of the Act until the fiscal year that begins after such date, we have to update the DRG software and other systems in order to recognize and accept the new codes. We also publicize the code changes and the need for a mid-year systems update by providers to identify the new codes. Hospitals also have to obtain the new code books and encoder updates, and make other system changes in order to identify and report the new codes.

The ICD-10 (previously the ICD-9-CM) Coordination and Maintenance Committee holds its meetings in the spring and fall in order to update the codes and the applicable payment and reporting systems by October 1 of each year. Items are placed on the agenda for the Committee meeting if the request is received at least 2 months prior to the meeting. This requirement allows time for staff to review and research the coding issues and prepare material for discussion at the meeting. It also allows time for the topic to be publicized in meeting announcements in the Federal Register as well as on the CMS Web site. Final decisions on code title revisions are currently made by March 1 so that these titles can be included in the IPPS proposed rule. A complete addendum describing details of all diagnosis and procedure coding changes, both tabular and index, is published on the CMS and NCHS Web sites in June of each year. Publishers of coding books and software use this information to modify their products that are used by health care providers. This 5-month time period has proved to be necessary for hospitals and other providers to update their systems.

A discussion of this timeline and the need for changes are included in the December 4-5, 2005 ICD-9-CM Coordination and Maintenance Committee Meeting minutes. The public agreed that there was a need to hold the fall meetings earlier, in September or October, in order to meet the new implementation dates. The public provided comment that additional time would be needed to update hospital systems and obtain new code books and coding software. There was considerable concern expressed about the impact this new April update would have on providers.


[top] In the FY 2005 IPPS final rule, we implemented section 1886(d)(5)(K)(vii) of the Act, as added by section 503(a) of Public Law 108-173, by developing a mechanism for approving, in time for the April update, diagnosis and procedure code revisions needed to describe new technologies and medical services for purposes of the new technology add-on payment process. We also established the following process for making these determinations. Topics considered during the Fall ICD-10 (previously ICD-9-CM) Coordination and Maintenance Committee meeting are considered for an April 1 update if a strong and convincing case is made by the requester at the Committee's public meeting. The request must identify the reason why a new code is needed in April for purposes of the new page 19852 technology process. The participants at the meeting and those reviewing the Committee meeting summary report are provided the opportunity to comment on this expedited request. All other topics are considered for the October 1 update. Participants at the Committee meeting are encouraged to comment on all such requests. There were no requests approved for an expedited April l, 2017 implementation of a code at the September 13-14, 2016 Committee meeting. Therefore, there were no new codes implemented on April 1, 2017.

ICD-9-CM addendum and code title information is published on the CMS Web site at: http://www.cms.hhs.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/index.html?redirect=/icd9ProviderDiagnosticCodes/01overview.asp#TopofPage . ICD-10-CM and ICD-10-PCS addendum and code title information is published on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/index.html . Information on ICD-10-CM diagnosis codes, along with the Official ICD-10-CM Coding Guidelines, can also be found on the CDC Web site at: http://www.cdc.gov/nchs/icd/icd10.htm . Information on new, revised, and deleted ICD-10-CM/ICD-10-PCS codes is also provided to the AHA for publication in the Coding Clinic for ICD-10. AHA also distributes information to publishers and software vendors.

CMS also sends copies of all ICD-10-CM and ICD-10-PCS coding changes to its Medicare contractors for use in updating their systems and providing education to providers.

The code titles are adopted as part of the ICD-10 (previously ICD-9-CM) Coordination and Maintenance Committee process. Therefore, although we publish the code titles in the IPPS proposed and final rules, they are not subject to comment in the proposed or final rules.

The following chart shows the number of ICD-10-CM and ICD-10-PCS codes and code changes since FY 2016 when ICD-10 was implemented.

Fiscal year Number Change
FY 2016:
ICD-10-CM 69,823
ICD-10-PCS 71,974
FY 2017:
ICD-10-CM 71,486 +1,663
ICD-10-PCS 75,789 +3,815
FY 2018:
ICD-10-CM 71,772 +286
ICD-10-PCS 78,299 +2,510

As mentioned previously, the public is provided the opportunity to comment on any requests for new diagnosis or procedure codes discussed at the ICD-10 Coordination and Maintenance Committee meeting.

At the September 12-13, 2016 and March 7-8, 2017 Committee meetings, we discussed any requests we had received for new ICD-10-CM diagnosis codes and ICD-10-PCS procedure codes that were to be implemented on October 1, 2017. We invited public comments on any code requests discussed at the September 12-13, 2016 and March 7-8, 2017 Committee meetings for implementation as part of the October 1, 2017 update. The deadline for commenting on code proposals discussed at the September 12-13, 2016 Committee meeting was November 13, 2016. The deadline for commenting on code proposals discussed at the March 7-8, 2017 Committee meeting was April 7, 2017.

16. Proposed Replaced Devices Offered Without Cost or With a Credit

a. Background

In the FY 2008 IPPS final rule with comment period (72 FR 47246 through 47251), we discussed the topic of Medicare payment for devices that are replaced without cost or where credit for a replaced device is furnished to the hospital. We implemented a policy to reduce a hospital's IPPS payment for certain MS-DRGs where the implantation of a device that has been recalled determined the base MS-DRG assignment. At that time, we specified that we will reduce a hospital's IPPS payment for those MS-DRGs where the hospital received a credit for a replaced device equal to 50 percent or more of the cost of the device.

In the FY 2012 IPPS/LTCH PPS final rule (76 FR 51556 through 51557), we clarified this policy to state that the policy applies if the hospital received a credit equal to 50 percent or more of the cost of the replacement device and issued instructions to hospitals accordingly.

b. Proposed Changes for FY 2018

For FY 2018, we are not proposing to add any MS-DRGs to the policy for replaced devices offered without cost or with a credit. We are proposing to continue to include the existing MS-DRGs currently subject to the policy as displayed in the table below.

page 19853


[top] 
MDC MS-DRG MS-DRG title
Pre-MDC 001 Heart Transplant or Implant of Heart Assist System with MCC.
Pre-MDC 002 Heart Transplant or Implant of Heart Assist System without MCC.
1 023 Craniotomy with Major Device Implant/Acute Complex CNS Principal Diagnosis with MCC or Chemo Implant.
1 024 Craniotomy with Major Device Implant/Acute Complex CNS Principal Diagnosis without MCC.
1 025 Craniotomy & Endovascular Intracranial Procedures with MCC.
1 026 Craniotomy & Endovascular Intracranial Procedures with CC.
1 027 Craniotomy & Endovascular Intracranial Procedures without CC/MCC.
1 040 Peripheral, Cranial Nerve & Other Nervous System Procedures with MCC.
1 041 Peripheral, Cranial Nerve & Other Nervous System Procedures with CC or Peripheral Neurostimulator.
1 042 Peripheral, Cranial Nerve & Other Nervous System Procedures without CC/MCC.
3 129 Major Head & Neck Procedures with CC/MCC or Major Device.
3 130 Major Head & Neck Procedures without CC/MCC.
5 215 Other Heart Assist System Implant.
5 216 Cardiac Valve & Other Major Cardiothoracic Procedure with Cardiac Catheterization with MCC.
5 217 Cardiac Valve & Other Major Cardiothoracic Procedure with Cardiac Catheterization with CC.
5 218 Cardiac Valve & Other Major Cardiothoracic Procedure with Cardiac Catheterization without CC/MCC.
5 219 Cardiac Valve & Other Major Cardiothoracic Procedure without Cardiac Catheterization with MCC.
5 220 Cardiac Valve & Other Major Cardiothoracic Procedure without Cardiac Catheterization with CC.
5 221 Cardiac Valve & Other Major Cardiothoracic Procedure without Cardiac Catheterization without CC/MCC.
5 222 Cardiac Defibrillator Implant with Cardiac Catheterization with AMI/Heart Failure/Shock with MCC.
5 223 Cardiac Defibrillator Implant with Cardiac Catheterization with AMI/Heart Failure/Shock without MCC.
5 224 Cardiac Defibrillator Implant with Cardiac Catheterization without AMI/Heart Failure/Shock with MCC.
5 225 Cardiac Defibrillator Implant with Cardiac Catheterization without AMI/Heart Failure/Shock without MCC.
5 226 Cardiac Defibrillator Implant without Cardiac Catheterization with MCC.
5 227 Cardiac Defibrillator Implant without Cardiac Catheterization without MCC.
5 242 Permanent Cardiac Pacemaker Implant with MCC.
5 243 Permanent Cardiac Pacemaker Implant with CC.
5 244 Permanent Cardiac Pacemaker Implant without CC/MCC.
5 245 AICD Generator Procedures.
5 258 Cardiac Pacemaker Device Replacement with MCC.
5 259 Cardiac Pacemaker Device Replacement without MCC.
5 260 Cardiac Pacemaker Revision Except Device Replacement with MCC.
5 261 Cardiac Pacemaker Revision Except Device Replacement with CC.
5 262 Cardiac Pacemaker Revision Except Device Replacement without CC/MCC.
5 265 AICD Lead Procedures.
5 266 Endovascular Cardiac Valve Replacement with MCC.
5 267 Endovascular Cardiac Valve Replacement without MCC.
5 268 Aortic and Heart Assist Procedures Except Pulsation Balloon with MCC.
5 269 Aortic and Heart Assist Procedures Except Pulsation Balloon without MCC.
5 270 Other Major Cardiovascular Procedures with MCC.
5 271 Other Major Cardiovascular Procedures with CC.
5 272 Other Major Cardiovascular Procedures without CC/MCC.
8 461 Bilateral or Multiple Major Joint Procedures Of Lower Extremity with MCC.
8 462 Bilateral or Multiple Major Joint Procedures of Lower Extremity without MCC.
8 466 Revision of Hip or Knee Replacement with MCC.
8 467 Revision of Hip or Knee Replacement with CC.
8 468 Revision of Hip or Knee Replacement without CC/MCC.
8 469 Major Joint Replacement or Reattachment of Lower Extremity with MCC.
8 470 Major Joint Replacement or Reattachment of Lower Extremity without MCC.


We are soliciting public comments on our proposal to continue to include the existing MS-DRGs currently subject to the policy for replaced devices offered without cost or with credit and to not add any additional MS-DRGs to the policy. We note that, as discussed in section II.F.2.b. and in section II.F.5.a. of the preamble of this proposed rule, we are proposing to revise the titles for MS-DRG 023 and MS-DRGs 469 and 470. We refer readers to those discussions of the specific proposed MS-DRG titles. The final list of MS-DRGs subject to the payment policy for devices provided at no cost or with a credit for FY 2018 will be listed in the FY 2018 IPPS/LTCH PPS final rule, as well as issued to providers through guidance and instructions in the form of a Change Request (CR).

17. Other Policy Changes: Other Operating Room (O.R.) and Non-O.R. Issues

a. O.R. Procedures to Non-O.R. Procedures

For this FY 2018 IPPS/LTCH PPS proposed rule, we continued our efforts to address the recommendations for consideration that we received in response to some of the proposals set forth in the FY 2017 IPPS/LTCH PPS proposed rule pertaining to changing the designation of ICD-10-PCS procedure codes from O.R. procedures to non-O.R. procedures. As we stated in the FY 2017 IPPS/LTCH PPS final rule (81 FR 56871), we received requests and recommendations for over 800 procedure codes that we were not able to fully evaluate and finalize for FY 2017. We discuss these requests and recommendations below.

We also are addressing separate requests that we received regarding changing the designation of specific ICD-10-PCS procedure codes. For each group summarized below, the detailed lists of procedure are shown in Tables 6P.4a. through 6P.4p. (Proposed ICD-10-CM and ICD-10-PCS Code Designations, MCE and MS-DRG Changes-FY 2018) associated with this proposed rule (which are available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ).

(1) Percutaneous/Diagnostic Drainage

One commenter identified 135 ICD-10-PCS procedure codes describing procedures involving percutaneous diagnostic and therapeutic drainage of central nervous system, vascular and other body sites that generally would not require the resources of an operating room and can be performed at the bedside. The list includes procedure codes that describe procedures involving drainage with or without placement of a drainage device. We agree with the commenter. Therefore, we are proposing that the 135 ICD-10-PCS procedure codes listed in Table 6P.4a. associated with this proposed rule (which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(2) Percutaneous Insertion of Intraluminal or Monitoring Device


[top] One commenter identified 28 ICD-10-PCS procedure codes describing procedures involving the percutaneous insertion of intraluminal and monitoring devices into central nervous system and other cardiovascular body parts that generally would not require the resources of an operating room and can be performed at the bedside. We agree with the commenter. Therefore, we are proposing that the 28 ICD-10- page 19854 PCS procedure codes listed in Table 6P.4b. associated with this proposed rule (which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(3) Percutaneous Removal of Drainage, Infusion, Intraluminal or Monitoring Device

One commenter identified 22 ICD-10-PCS procedure codes that describe procedures involving the percutaneous removal of drainage, infusion, intraluminal and monitoring devices from central nervous system and other vascular body parts that generally would not require the resources of an operating room and can be performed at the bedside. We agree with the commenter. Therefore, we are proposing that the 22 ICD-10-PCS procedure codes listed in Table 6P.4c. associated with this proposed rule (which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(4) External Removal of Cardiac or Neurostimulator Lead

One commenter identified four ICD-10-PCS procedure codes that describe procedures involving the external removal of cardiac leads from the heart and neurostimulator leads from central nervous system body parts that generally would not require the resources of an operating room and can be performed at the bedside. These four ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
00P6XMZ Removal of neurostimulator lead from cerebral ventricle, external approach.
00PEXMZ Removal of neurostimulator lead from cranial nerve, external approach.
01PYXMZ Removal of neurostimulator lead from peripheral nerve, external approach.
02PAXMZ Removal of cardiac lead from heart, external approach.

We agree with the commenter. Therefore, we are proposing that the four ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(5) Percutaneous Revision of Drainage, Infusion, Intraluminal or Monitoring Device

One commenter identified 28 ICD-10-PCS procedure codes that describe procedures involving the percutaneous revision of drainage, infusion, intraluminal and monitoring devices for vascular and heart and great vessel body parts that generally would not require the resources of an operating room and can be performed at the bedside. We agree with the commenter. Therefore, we are proposing that the 28 ICD-10-PCS procedure codes listed in Table 6P.4d. associated with this proposed rule (which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(6) Percutaneous Destruction

One commenter identified two ICD-10-PCS procedure codes that describe procedures involving the percutaneous destruction of retina body parts that generally would not require the resources of an operating room and can be performed at the bedside. These two ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
085E3ZZ Destruction of right retina, percutaneous approach.
085F3ZZ Destruction of left retina, percutaneous approach.

We agree with the commenter. Therefore, we are proposing that the two ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(7) External/Diagnostic Drainage

One commenter identified 20 ICD-10-PCS procedure codes that describe procedures involving external drainage for structures of the eye that generally would not require the resources of an operating room and can be performed at the bedside. We agree with the commenter. Therefore, we are proposing that the 20 ICD-10-PCS procedure codes listed in Table 6P.4e. associated with this proposed rule (which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(8) External Extirpation

One commenter identified four ICD-10-PCS procedure codes that describe procedures involving external extirpation of matter from eye structures that generally would not require the resources of an operating room and can be performed at the bedside. These four ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
08C0XZZ Extirpation of matter from right eye, external approach.
08C1XZZ Extirpation of matter from left eye, external approach.
08CSXZZ Extirpation of matter from right conjunctiva, external approach.
08CTXZZ Extirpation of matter from left conjunctiva, external approach.


[top] page 19855

We agree with the commenter. Therefore, we are proposing that the four ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(9) External Removal of Radioactive Element or Synthetic Substitute

One commenter identified three ICD-10-PCS procedure codes that describe procedures involving the external removal of radioactive or synthetic substitutes from the eye that generally would not require the resources of an operating room and can be performed at the bedside. These three ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
08P0X1Z Removal of radioactive element from right eye, external approach.
08P0XJZ Removal of synthetic substitute from right eye, external approach.
08P1XJZ Removal of synthetic substitute from left eye, external approach.

We agree with the commenter. Therefore, we are proposing that the three ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(10) Endoscopic/Transorifice Diagnostic Drainage

One commenter identified eight ICD-10-PCS procedure codes that describe procedures involving endoscopic/transorifice (via natural or artificial opening) drainage of ear structures that generally would not require the resources of an operating room and can be performed at the bedside. These eight ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
09977ZX Drainage of right tympanic membrane, via natural or artificial opening, diagnostic.
09978ZX Drainage of right tympanic membrane, via natural or artificial opening endoscopic, diagnostic.
09987ZX Drainage of left tympanic membrane, via natural or artificial opening, diagnostic.
09988ZX Drainage of left tympanic membrane, via natural or artificial opening endoscopic, diagnostic.
099F7ZX Drainage of right eustachian tube, via natural or artificial opening, diagnostic.
099F8ZX Drainage of right eustachian tube, via natural or artificial opening endoscopic, diagnostic.
099G7ZX Drainage of left eustachian tube, via natural or artificial opening, diagnostic.
099G8ZX Drainage of left eustachian tube, via natural or artificial opening endoscopic, diagnostic.

We agree with the commenter. Therefore, we are proposing that the eight ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(11) External Release

One commenter identified four ICD-10-PCS procedure codes that describe procedures involving the external release of ear structures that generally would not require the resources of an operating room and can be performed at the bedside. These four ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
09N0XZZ Release right external ear, external approach.
09N1XZZ Release left external ear, external approach.
09N3XZZ Release right external auditory canal, external approach.
09N4XZZ Release left external auditory canal, external approach.

We agree with the commenter. Therefore, we are proposing that the four ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(12) External Repair

One commenter identified three ICD-10-PCS procedure codes that describe procedures involving the external repair of body parts that generally would not require the resources of an operating room and can be performed at the bedside. These three ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
09QKXZZ Repair nose, external approach.
0CQ4XZZ Repair buccal mucosa, external approach.
0CQ7XZZ Repair tongue, external approach.

We agree with the commenter. Therefore, we are proposing that the three ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(13) Endoscopic/Transorifice Destruction


[top] One commenter identified eight ICD-10-PCS procedure codes that describe procedures involving the endoscopic/transorifice destruction of respiratory system body parts that generally would not require the resources of an operating room and can be performed at the bedside. These eight ICD-10-PCS codes are shown in the table below. page 19856

ICD-10-PCS code Code description
0B538ZZ Destruction of right main bronchus, via natural or artificial opening endoscopic.
0B548ZZ Destruction of right upper lobe bronchus, via natural or artificial opening endoscopic.
0B558ZZ Destruction of right middle lobe bronchus, via natural or artificial opening endoscopic.
0B568ZZ Destruction of right lower lobe bronchus, via natural or artificial opening endoscopic.
0B578ZZ Destruction of left main bronchus, via natural or artificial opening endoscopic.
0B588ZZ Destruction of left upper lobe bronchus, via natural or artificial opening endoscopic.
0B598ZZ Destruction of lingula bronchus, via natural or artificial opening endoscopic.
0B5B8ZZ Destruction of left lower lobe bronchus, via natural or artificial opening endoscopic.

We agree with the commenter. Therefore, we are proposing that the eight ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(14) Endoscopic/Transorifice Drainage

One commenter identified 40 ICD-10-PCS procedure codes that describe procedures involving endoscopic/transorifice (via natural or artificial opening) drainage of respiratory system body parts that generally would not require the resources of an operating room and can be performed at the bedside. We agree with the commenter. Therefore, we are proposing that the 40 ICD-10-PCS procedure codes listed in Table 6P.4f. associated with this proposed rule (which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(15) Endoscopic/Transorifice Extirpation

One commenter identified nine ICD-10-PCS procedure codes that describe procedures involving endoscopic/transorifice extirpation of matter from respiratory system body parts that generally would not require the resources of an operating room and can be performed at the bedside. These nine ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
0BCC8ZZ Extirpation of matter from right upper lung lobe, via natural or artificial opening endoscopic.
0BCD8ZZ Extirpation of matter from right middle lung lobe, via natural or artificial opening endoscopic.
0BCF8ZZ Extirpation of matter from right lower lung lobe, via natural or artificial opening endoscopic.
0BCG8ZZ Extirpation of matter from left upper lung lobe, via natural or artificial opening endoscopic.
0BCH8ZZ Extirpation of matter from lung lingula, via natural or artificial opening endoscopic.
0BCJ8ZZ Extirpation of matter from left lower lung lobe, via natural or artificial opening endoscopic.
0BCK8ZZ Extirpation of matter from right lung, via natural or artificial opening endoscopic.
0BCL8ZZ Extirpation of matter from left lung, via natural or artificial opening endoscopic.
0BCM8ZZ Extirpation of matter from bilateral lungs, via natural or artificial opening endoscopic.

We agree with the commenter. Therefore, we are proposing that the nine ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(16) Endoscopic/Transorifice Fragmentation

One commenter identified 16 ICD-10-PCS procedure codes that describe procedures involving endoscopic/transorifice fragmentation of respiratory system body parts that generally would not require the resources of an operating room and can be performed at the bedside. These 16 ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
0BF37ZZ Fragmentation in right main bronchus, via natural or artificial opening.
0BF38ZZ Fragmentation in right main bronchus, via natural or artificial opening endoscopic.
0BF47ZZ Fragmentation in right upper lobe bronchus, via natural or artificial opening.
0BF48ZZ Fragmentation in right upper lobe bronchus, via natural or artificial opening endoscopic.
0BF57ZZ Fragmentation in right middle lobe bronchus, via natural or artificial opening.
0BF58ZZ Fragmentation in right middle lobe bronchus, via natural or artificial opening endoscopic.
0BF67ZZ Fragmentation in right lower lobe bronchus, via natural or artificial opening.
0BF68ZZ Fragmentation in right lower lobe bronchus, via natural or artificial opening endoscopic.
0BF77ZZ Fragmentation in left main bronchus, via natural or artificial opening.
0BF78ZZ Fragmentation in left main bronchus, via natural or artificial opening endoscopic.
0BF87ZZ Fragmentation in left upper lobe bronchus, via natural or artificial opening.
0BF88ZZ Fragmentation in left upper lobe bronchus, via natural or artificial opening endoscopic.
0BF97ZZ Fragmentation in lingula bronchus, via natural or artificial opening.
0BF98ZZ Fragmentation in lingula bronchus, via natural or artificial opening endoscopic.
0BFB7ZZ Fragmentation in left lower lobe bronchus, via natural or artificial opening.
0BFB8ZZ Fragmentation in left lower lobe bronchus, via natural or artificial opening endoscopic.


[top] page 19857

We agree with the commenter. Therefore, we are proposing that the 16 ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(17) Endoscopic/Transorifice Insertion of Intraluminal Device

One commenter identified two ICD-10-PCS procedure codes that describe procedures involving an endoscopic/transorifice (via natural or artificial opening) insertion of intraluminal devices into respiratory system body parts that generally would not require the resources of an operating room and can be performed at the bedside. These two ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
0BH17DZ Insertion of intraluminal device into trachea, via natural or artificial opening.
0BH18DZ Insertion of intraluminal device into trachea, via natural or artificial opening endoscopic.

We agree with the commenter. Therefore, we are proposing that the two ICD-10-PCS procedure codes shown in the table above be designated non-O.R. procedures. We are inviting public comments on our proposal.

(18) Endoscopic/Transorifice Removal of Radioactive Element

One commenter identified two ICD-10-PCS procedure codes that describe procedures involving the endoscopic/transorifice removal of radioactive elements from respiratory system body parts that generally would not require the resources of an operating room and can be performed at the bedside. These two ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
0BPK71Z Removal of radioactive element from right lung, via natural or artificial opening.
0BPK81Z Removal of radioactive element from right lung, via natural or artificial opening endoscopic.

We agree with the commenter. Therefore, we are proposing that the two ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(19) Endoscopic/Transorifice Revision of Drainage, Infusion, Intraluminal or Monitoring Device

One commenter identified 18 ICD-10-PCS procedure codes that describe procedures involving the revision of drainage, infusion, intraluminal, or monitoring devices from respiratory system body parts that generally would not require the resources of an operating room and can be performed at the bedside. We agree with the commenter. Therefore, we are proposing that the 18 ICD-10-PCS procedure codes listed in Table 6P.4g. associated with this proposed rule (which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(20) Endoscopic/Transorifice Excision

One commenter identified one ICD-10-PCS procedure code that describes the procedure involving endoscopic/transorifice (via natural or artificial opening) excision of the digestive system body parts that generally would not require the resources of an operating room and can be performed at the bedside. This code is 0DBQ8ZZ (Excision of anus, via natural or artificial opening endoscopic. We agree with the commenter. Therefore, we are proposing that ICD-10-PCS procedure code 0DBQ8ZZ be designated as a non-O.R. procedure. We are inviting public comments on our proposal.

(21) Endoscopic/Transorifice Insertion

One commenter identified two ICD-10-PCS procedure codes that describe procedures involving the endoscopic/transorifice (via natural or artificial opening) insertion of intraluminal device into the stomach that generally would not require the resources of an operating room and can be performed at the bedside. These two ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
0DH67DZ Insertion of intraluminal device into stomach, via natural or artificial opening.
0DH68DZ Insertion of intraluminal device into stomach, via natural or artificial opening endoscopic.

We agree with the commenter. Therefore, we are proposing that the two ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(22) Endoscopic/Transorifice Removal

One commenter identified six ICD-10-PCS procedure codes that describe procedures involving endoscopic/transorifice (via natural or artificial opening) removal of feeding devices that generally would not require the resources of an operating room and can be performed at the bedside. These six ICD-10-PCS codes are shown in the table below.

page 19858


[top] 
ICD-10-PCS code Code description
0DP07UZ Removal of feeding device from upper intestinal tract, via natural or artificial opening.
0DP08UZ Removal of feeding device from upper intestinal tract, via natural or artificial opening endoscopic.
0DP67UZ Removal of feeding device from stomach, via natural or artificial opening.
0DP68UZ Removal of feeding device from stomach, via natural or artificial opening endoscopic.
0DPD7UZ Removal of feeding device from lower intestinal tract, via natural or artificial opening
0DPD8UZ Removal of feeding device from lower intestinal tract, via natural or artificial opening endoscopic.


We agree with the commenter. Therefore, we are proposing that the six ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(23) External Reposition

One commenter identified two ICD-10-PCS procedure codes that describe procedures involving external reposition of gastrointestinal body parts that generally would not require the resources of an operating room and can be performed at the bedside. These two ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
0DS5XZZ Reposition esophagus, external approach.
0DSQXZZ Reposition anus, external approach.

We agree with the commenter. Therefore, we are proposing that the two ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(24) Endoscopic/Transorifice Drainage

One commenter identified eight ICD-10-PCS procedure codes that describe procedures involving endoscopic/transorifice (via natural or artificial opening) drainage of hepatobiliary system and pancreatic body parts that generally would not require the resources of an operating room and can be performed at the bedside. These eight ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
0F9580Z Drainage of right hepatic duct with drainage device, via natural or artificial opening endoscopic.
0F958ZZ Drainage of right hepatic duct, via natural or artificial opening endoscopic.
0F9680Z Drainage of left hepatic duct with drainage device, via natural or artificial opening endoscopic.
0F968ZZ Drainage of left hepatic duct, via natural or artificial opening endoscopic.
0F9880Z Drainage of cystic duct with drainage device, via natural or artificial opening endoscopic.
0F988ZZ Drainage of cystic duct, via natural or artificial opening endoscopic.
0F9D8ZZ Drainage of pancreatic duct, via natural or artificial opening endoscopic.
0F9F8ZZ Drainage of accessory pancreatic duct, via natural or artificial opening endoscopic.

We agree with the commenter. Therefore, we are proposing that the eight ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(25) Endoscopic/Transorifice Fragmentation

One commenter identified two ICD-10-PCS procedure codes that describe procedures involving endoscopic/transorifice (via natural or artificial opening) fragmentation of hepatobiliary system and pancreatic body parts that generally would not require the resources of an operating room and can be performed at the bedside. These two ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
0FFD8ZZ Fragmentation in pancreatic duct, via natural or artificial opening endoscopic.
0FFF8ZZ Fragmentation in accessory pancreatic duct, via natural or artificial opening endoscopic.

We agree with the commenter. Therefore, we are proposing that the two ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(26) Percutaneous Alteration

One commenter identified three ICD-10-PCS procedure codes that describe procedures involving percutaneous alteration of the breast that generally would not require the resources of an operating room and can be performed at the bedside. These three ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
0H0T3JZ Alteration of right breast with synthetic substitute, percutaneous approach.
0H0U3JZ Alteration of left breast with synthetic substitute, percutaneous approach.
0H0V3JZ Alteration of bilateral breast with synthetic substitute, percutaneous approach.


[top] page 19859

We agree with the commenter. Therefore, we are proposing that the three ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(27) External Division and Excision of Skin

One commenter identified 41 ICD-10-PCS procedure codes that describe procedures involving external division and excision of the skin for body parts that generally would not require the resources of an operating room and can be performed at the bedside. We agree with the commenter. Therefore, we are proposing that the 41 ICD-10-PCS procedure codes listed in Table 6P.4h. associated with this proposed rule (which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(28) External Excision of Breast

One commenter identified six ICD-10-PCS procedure codes that describe procedures involving external excision of the breast that they believed would generally not require the resources of an operating room and can be performed at the bedside. These six ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
0HBTXZZ Excision of right breast, external approach.
0HBUXZZ Excision of left breast, external approach.
0HBVXZZ Excision of bilateral breast, external approach.
0HBWXZZ Excision of right nipple, external approach.
0HBXXZZ Excision of left nipple, external approach.
0HBYXZZ Excision of supernumerary breast, external approach.

We disagree with the commenter because these procedure codes describe various types of surgery performed on the breast or nipple (for example, partial mastectomy) that would typically involve the use of general anesthesia. Therefore, we are proposing that the six ICD-10-PCS procedure codes shown in the table above remain designated as O.R. procedures. We are inviting public comments on our proposal.

(29) Percutaneous Supplement

One commenter identified three ICD-10-PCS procedure codes that describe procedures involving percutaneous supplement of the breast with synthetic substitute that generally would not require the resources of an operating room and can be performed at the bedside. These three ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
0HUT3JZ Supplement right breast with synthetic substitute, percutaneous approach.
0HUU3JZ Supplement left breast with synthetic substitute, percutaneous approach.
0HUV3JZ Supplement bilateral breast with synthetic substitute, percutaneous approach.

We agree with the commenter. Therefore, we are proposing that the three ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(30) Open Drainage

One commenter identified 25 ICD-10-PCS procedure codes that describe procedures involving open drainage of subcutaneous tissue and fascia body parts that generally would not require the resources of an operating room and can be performed at the bedside. The list includes procedure codes for drainage with or without placement of a drainage device. We agree with the commenter. Therefore, we are proposing that the 25 ICD-10-PCS procedure codes listed in Table 6P.4i. associated with this proposed rule (which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(31) Percutaneous Drainage

One commenter identified two ICD-10-PCS procedure codes that describe procedures involving percutaneous drainage of subcutaneous tissue and fascia body parts that generally would not require the resources of an operating room and can be performed at the bedside. These two ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
0J9J3ZZ Drainage of right hand subcutaneous tissue and fascia, percutaneous approach.
0J9K3ZZ Drainage of left hand subcutaneous tissue and fascia, percutaneous approach.

We agree with the commenter. Therefore, we are proposing that the two ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(32) Percutaneous Extraction


[top] One commenter identified 22 ICD-10-PCS procedure codes that describe procedures involving percutaneous extraction of subcutaneous tissue and fascia body parts that generally would not require the resources of an operating room and can be performed at the bedside. We agree with the commenter. Therefore, we are proposing that the 22 ICD-10-PCS procedure codes listed in Table 6P.4j. associated with this proposed rule (which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) be page 19860 designated as non-O.R. procedures. We are inviting public comments on our proposal.

(33) Open Extraction

One commenter identified 22 ICD-10-PCS procedure codes that describe procedures involving open extraction of subcutaneous tissue and fascia body parts that the commenter believed would generally not require the resources of an operating room and can be performed at the bedside. We disagree with the commenter because these codes describe procedures that utilize an open approach and are being performed on the skin and subcutaneous tissue. Depending on the medical reason for the open extraction, the procedures may require an O.R. setting. Therefore, we are proposing that the 22 ICD-10-PCS procedure codes listed in Table 6P.4k. associated with this proposed rule (which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) remain designated as O.R. procedures. We are inviting public comments on our proposal.

(34) Percutaneous and Open Repair

One commenter identified 44 ICD-10-PCS procedure codes that describe procedures involving percutaneous and open repair of subcutaneous tissue and fascia body parts that generally would not require the resources of an operating room and can be performed at the bedside. We agree with the commenter. Therefore, we are proposing that the 44 ICD-10-PCS procedure codes listed in Table 6P.4l. associated with this proposed rule (which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(35) External Release

One commenter identified 28 ICD-10-PCS procedure codes that describe procedures involving external release of bursa and ligament body parts that generally would not require the resources of an operating room and can be performed at the bedside. We agree with the commenter. Therefore, we are proposing that the 28 ICD-10-PCS procedure codes listed in Table 6P.4m. associated with this proposed rule (which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(36) External Repair

One commenter identified 135 ICD-10-PCS procedure codes that describe procedures involving external repair of various bones and joints. We believe that these procedures generally would not be performed in the operating room. We are proposing that the 135 ICD-10-PCS procedure codes listed in Table 6P.4n. associated with this proposed rule (which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(37) External Reposition

One commenter identified 14 ICD-10-PCS procedure codes that describe procedures involving external reposition of various bones. These 14 ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
0NS0XZZ Reposition skull, external approach.
0NS1XZZ Reposition right frontal bone, external approach.
0NS2XZZ Reposition left frontal bone, external approach.
0NS3XZZ Reposition right parietal bone, external approach.
0NS4XZZ Reposition left parietal bone, external approach.
0NS5XZZ Reposition right temporal bone, external approach.
0NS6XZZ Reposition left temporal bone, external approach.
0NS7XZZ Reposition right occipital bone, external approach.
0NS8XZZ Reposition left occipital bone, external approach.
0PS3XZZ Reposition cervical vertebra, external approach.
0PS4XZZ Reposition thoracic vertebra, external approach.
0QS0XZZ Reposition lumbar vertebra, external approach.
0QS1XZZ Reposition sacrum, external approach.
0QSSXZZ Reposition coccyx, external approach.

We believe that these procedures generally would not be performed in the operating room. Therefore, we are proposing that the 14 ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(38) Endoscopic/Transorifice Dilation

One commenter identified eight ICD-10-PCS procedure codes that describe procedures involving endoscopic/transorifice (via natural or artificial opening) dilation of urinary system body parts that generally would not require the resources of an operating room and can be performed at the bedside. These eight ICD-10-PCS codes are shown in the table below.

page 19861


[top] 
ICD-10-PCS code Code description
0T767ZZ Dilation of right ureter, via natural or artificial opening.
0T768ZZ Dilation of right ureter, via natural or artificial opening endoscopic.
0T777ZZ Dilation of left ureter, via natural or artificial opening.
0T778ZZ Dilation of left ureter, via natural or artificial opening endoscopic.
0T7B7DZ Dilation of bladder with intraluminal device, via natural or artificial opening.
0T7B7ZZ Dilation of bladder, via natural or artificial opening.
0T7B8DZ Dilation of bladder with intraluminal device, via natural or artificial opening endoscopic.
0T7B8ZZ Dilation of bladder, via natural or artificial opening endoscopic.


We agree with the commenter. Therefore, we are proposing that the eight ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(39) Endoscopic/Transorifice Excision

One commenter identified three ICD-10-PCS procedure codes that describe procedures involving endoscopic/transorifice (via natural or artificial opening) excision of urinary system body parts that the commenter believed would generally not require the resources of an operating room and can be performed at the bedside. These three ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
0TBD7ZZ Excision of urethra, via natural or artificial opening.
0TBD8ZZ Excision of urethra, via natural or artificial opening endoscopic.
0TBDXZZ Excision of urethra, external approach.

We disagree with the commenter because, depending on the medical reason for the excision, the procedures may require an O.R. setting. Therefore, we are proposing that the three ICD-10-PCS procedure codes shown in the table above remain designated as O.R. procedures. We are inviting public comments on our proposal.

(40) External/Transorifice Repair

One commenter identified three ICD-10-PCS procedure codes that describe procedures involving external and transorifice (via natural or artificial opening) repair of the vagina body part that generally would not require the resources of an operating room and can be performed at the bedside. These three ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
0UQG7ZZ Repair vagina, via natural or artificial opening.
0UQGXZZ Repair vagina, external approach.
0UQMXZZ Repair vulva, external approach.

We agree with the commenter. Therefore, we are proposing that these three ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(41) Percutaneous Transfusion

One commenter identified 20 ICD-10-PCS procedure codes that describe procedures involving percutaneous transfusion of bone marrow and stem cells that generally would not require the resources of an operating room and can be performed at the bedside. We agree with the commenter. Therefore, we are proposing that the 20 ICD-10-PCS procedure codes listed in Table 6P.4o. associated with this proposed rule (which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(42) External/Percutaneous/Transorifice Introduction

One commenter identified 51 ICD-10-PCS procedure codes that describe procedures involving external, percutaneous and transorifice (via natural or artificial opening) introduction of substances that generally would not require the resources of an operating room and can be performed at the bedside. We agree with the commenter. Therefore, we are proposing that the 51 ICD-10-PCS procedure codes listed in Table 6P.4p. associated with this proposed rule (which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(43) Percutaneous/Diagnostic and Endoscopic/Transorifice Irrigation, Measurement and Monitoring

One commenter identified 15 ICD-10-PCS procedure codes that describe procedures involving percutaneous/diagnostic and endoscopic/transorifice (via natural or artificial opening) irrigation, measurement and monitoring of structures, pressures and flow that generally would not require the resources of an operating room and can be performed at the bedside. These 15 ICD-10-PCS codes are shown in the table below.

page 19862


[top] 
ICD-10-PCS code Code description
3E1N38X Irrigation of male reproductive using irrigating substance, percutaneous approach, diagnostic.
3E1N38Z Irrigation of male reproductive using irrigating substance, percutaneous approach.
3E1N78X Irrigation of male reproductive using irrigating substance, via natural or artificial opening, diagnostic.
3E1N78Z Irrigation of male reproductive using irrigating substance, via natural or artificial opening.
3E1N88X Irrigation of male reproductive using irrigating substance, via natural or artificial opening endoscopic, diagnostic.
3E1N88Z Irrigation of male reproductive using irrigating substance, via natural or artificial opening endoscopic.
4A0635Z Measurement of lymphatic flow, percutaneous approach.
4A063BZ Measurement of lymphatic pressure, percutaneous approach.
4A0C35Z Measurement of biliary flow, percutaneous approach.
4A0C3BZ Measurement of biliary pressure, percutaneous approach.
4A0C75Z Measurement of biliary flow, via natural or artificial opening.
4A0C7BZ Measurement of biliary pressure, via natural or artificial opening.
4A0C85Z Measurement of biliary flow, via natural or artificial opening endoscopic.
4A1635Z Monitoring of lymphatic flow, percutaneous approach.
4A163BZ Monitoring of lymphatic pressure, percutaneous approach.


We agree with the commenter. Therefore, we are proposing that the 15 ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(44) Imaging

One commenter identified six ICD-10-PCS procedure codes that describe procedures involving imaging with contrast of hepatobiliary system body parts that generally would not require the resources of an operating room and can be performed at the bedside. These six ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
BF030ZZ Plain radiography of gallbladder and bile ducts using high osmolar contrast.
BF031ZZ Plain radiography of gallbladder and bile ducts using low osmolar contrast.
BF03YZZ Plain radiography of gallbladder and bile ducts using other contrast.
BF0C0ZZ Plain radiography of hepatobiliary system, all using high osmolar contrast.
BF0C1ZZ Plain radiography of hepatobiliary system, all using low osmolar contrast.
BF0CYZZ Plain radiography of hepatobiliary system, all using other contrast.

We agree with the commenter. Therefore, we are proposing that the six ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

(45) Prosthetics

One commenter identified five ICD-10-PCS procedure codes that describe procedures involving the fitting and use of prosthetics and assistive devices that would not require the resources of an operating room. These five ICD-10-PCS codes are shown in the table below.

ICD-10-PCS code Code description
F0DZ8ZZ Prosthesis device fitting.
F0DZ9EZ Assistive, adaptive, supportive or protective devices device fitting using orthosis.
F0DZ9FZ Assistive, adaptive, supportive or protective devices device fitting using assistive, adaptive, supportive or protective equipment.
F0DZ9UZ Assistive, adaptive, supportive or protective devices device fitting using prosthesis.
F0DZ9ZZ Assistive, adaptive, supportive or protective devices device fitting.

We agree with the commenter. Therefore, we are proposing that the five ICD-10-PCS procedure codes shown in the table above be designated as non-O.R. procedures. We are inviting public comments on our proposal.

b. Revision of Neurostimulator Generator

We received a request to review three ICD-10-PCS procedure codes that describe procedures for revision of a neurostimulator generator that are currently designated as O.R. procedures and assigned to MS-DRGs 252, 253 and 254 (Other Vascular Procedures with MCC, with CC and without CC/MCC, respectively). The three codes are 0JWT0MZ (Revision of stimulator generator in trunk subcutaneous tissue and fascia, open approach), 0JWT3MZ (Revision of stimulator generator in trunk subcutaneous tissue and fascia, percutaneous approach), and 0JWTXMZ (Revision of stimulator generator in trunk subcutaneous tissue and fascia, external approach).

The requester expressed concern with the MS-DRG assignments and noted that although these codes are used to report revision of a carotid sinus stimulator pulse generator and appropriately assigned to MS-DRGs 252, 253 and 254 in MDC 5 (Diseases and Disorders of the Circulatory System), they also are very frequently used for the revision of the more common (for example, gastric, intracranial, sacral and spinal) neurostimulator generators that would generally not require the resources of an operating room.

The requestor also stated that the indication for revision of a neurostimulator generator is typically due to a complication, which would be reflected in a complication code such as ICD-10-CM diagnosis code T85.734A (Infection and inflammatory reaction due to implanted electronic neurostimulator, generator, initial encounter) or T85.890A (Other specified complication of nervous system prosthetic devices, implants and grafts, initial encounter). Because both of these diagnosis codes are assigned to MDC 1 (Diseases and Disorders of the Nervous System), when either code is reported in combination with one of the three procedure codes that describe revision of neurostimulator generator codes (currently assigned to MDC 5), the resulting MS-DRG assignment is to MS-DRGs 981, 982 and 983 (Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC and without CC/MCC, respectively).

The requestor presented the following three options for consideration.


[top] • Reclassify the ICD-10-PCS procedure codes from O.R. Procedures to non-O.R. procedures that affect MS-DRG assignment only in MDC 5. The requestor stated that, under this option, the procedure codes would continue to appropriately group to MDC 5 when representing cases involving carotid page 19863 sinus stimulators and the other types of neurostimulator cases would appropriately group to medical MS-DRGs.

• Add the ICD-10-PCS procedure codes to MDC 1, such as to MS-DRGs 040, 041 and 042 (Peripheral, Cranial Nerve and Other Nervous System Procedures with MCC, with CC or Peripheral Neurostimulator and without CC/MCC, respectively) under MDC 1. The requestor stated that this option would resolve the inconsistency between a revision of a carotid sinus stimulator generator being classified as an O.R. procedure, while the other comparable procedures involving a revision of a regular neurostimulator generator are not. The requestor also stated that this option would preclude cases being assigned to MS-DRGs 981 through 983.

• Stop classifying the ICD-10-PCS procedure codes as O.R. procedures entirely. The requestor stated that, under this option, all cases would then group to medical MS-DRGs, regardless of the type of neurostimulator generator.

We analyzed claims data for the three revision of neurostimulator generator procedure codes from the December 2016 update of the FY 2016 MedPAR file and identified cases under MDC 1 (Diseases and Disorders of the Nervous System) in MS-DRGs 025, 026, and 027 (Craniotomy and Endovascular Intracranial Procedures with MCC, with CC and without CC/MCC, respectively); MS-DRGs 029 and 030 (Spinal Procedures with CC or Neurostimulators and Spinal Procedures without CC/MCC), respectively); and MS-DRGs 041 and 042 (Peripheral, Cranial Nerve and Other Nervous System Procedures with CC or Peripheral Neurostimulator and without CC/MCC, respectively). We also identified cases in MS-DRGs 982 and 983 (Extensive O.R. Procedure Unrelated to Principal Diagnosis with CC and without CC/MCC, respectively). Lastly, we identified cases under MDC 5 (Diseases and Disorders of the Circulatory System) in MS-DRGs 252, 253 and 254 (Other Vascular Procedures with MCC, with CC and without CC/MCC, respectively). Our findings are shown in the table below.

MS-DRG Number of cases Average length of stay Average costs
MS-DRG 025-All cases 18,442 9.1 $29,984
MS-DRG 025-Cases with revision of neurostimulator generator 1 12.0 73,716
MS-DRG 026-All cases 8,415 5.6 21,557
MS-DRG 026-Cases with revision of neurostimulator generator 1 6.0 4,537
MS-DRG 027-All cases 10,089 2.9 17,320
MS-DRG 027-Cases with revision of neurostimulator generator 4 1.8 13,906
MS-DRG 029-All cases 3,192 5.9 23,145
MS-DRG 029-Cases with revision of neurostimulator generator 6 3.5 32,799
MS-DRG 030-All cases 1,933 2.9 14,901
MS-DRG 030-Cases with revision of neurostimulator generator 11 2.2 18,294
MS-DRG 041-All cases 5,154 5.5 16,633
MS-DRG 041-Cases with revision of neurostimulator generator 1 1.0 14,145
MS-DRG 042-All cases 2,099 3.2 13,725
MS-DRG 042-Cases with revision of neurostimulator generator 2 2.0 28,587
MS-DRG 982-All cases 15,216 6.6 17,341
MS-DRG 982-Cases with revision of neurostimulator generator 11 3.0 15,336
MS-DRG 983-All cases 3,508 3.2 11,627
MS-DRG 983-Cases with revision of neurostimulator generator 9 4.2 19,951
MS-DRG 252-All cases 33,817 7.6 23,384
MS-DRG 252-Cases with revision of neurostimulator generator 1 7.0 18,740
MS-DRG 253-All cases 27,456 5.5 18,519
MS-DRG 253-Cases with revision of neurostimulator generator 7 2.4 19,078
MS-DRG 254-All cases 13,036 2.9 13,253
MS-DRG 254-Cases with revision of neurostimulator generator 3 3.0 11,981

As shown in the table above, the overall volume of cases reporting revision of neurostimulator generator is low, with a total of only 57 cases found across all of the MS-DRGs reviewed. The average length of stay for these cases reporting revision of neurostimulator generators is, in most cases, consistent with the average length of stay for all cases in the respective MS-DRG, with the majority having an average length of stay below the average length of stay of all cases in the respective MS-DRG. Finally, the average costs for cases reporting revision of neurostimulator generator reflect a wide range, with a low of $4,537 in MS-DRG 026 to a high of $73,716 in MS-DRG 025. It is clear that, for MS-DRG 025 where the average costs of all cases were $29,984 and the average costs of the one case reporting revision of a neurostimulator generator was $73,716, this is an atypical case. It is also clear from the data that there were other procedures reported on the claims where a procedure code for a revision of a neurostimulator generator was assigned due to the various MS-DRG assignments.

After review of the claims data and discussion with our clinical advisors, we agree with and support the requestor's first option-to reclassify the three ICD-10-PCS procedure codes for revision of neurostimulator generators from O.R. procedures to non-O.R. procedures that affect the assignment for MS-DRGs 252, 253 and 254 to account for the subset of patients undergoing revision of a carotid sinus neurostimulator generator specifically. In cases where one of the more common (for example, gastric, intracranial, sacral and spinal) neurostimulator generators are undergoing revision, in the absence of another O.R. procedure, these cases would group to a medical MS-DRG. We are inviting public comments on our proposal.

c. External Repair of Hymen


[top] We received a request to examine ICD-10-PCS procedure code 0UQKXZZ (Repair Hymen, External Approach). This procedure code is currently designated as an O.R. procedure in MS-DRGs 746 and 747 (Vagina, Cervix and Vulva Procedures with CC/MCC and without CC/MCC, respectively) under page 19864 MDC 13. The requestor provided examples and expressed concern that procedure code 0UQKXZZ was assigned to MS-DRG 987 (Non-Extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC) when reported on a maternal delivery claim. The requestor noted that when a similar code was reported with an external approach (for example, procedure code 0UQMXZZ (Repair vulva, external approach)), the case was appropriately assigned to MS-DRG 774 (Vaginal Delivery with Complicating Diagnosis). The requestor stated that the physician documentation was simply more specific to the location of the repair and this should not affect assignment to one of the MS-DRGs for vaginal delivery.

We reviewed claims data involving the examples provided by the requestor involving ICD-10-PCS procedure code 0UQKXZZ (Repair hymen, external approach). Our clinical advisors agree with the requestor that reporting of this procedure code should not affect assignment to one of the MS-DRGs for vaginal delivery. As discussed earlier in section II.F.15.a. of the preamble of this proposed rule, we are proposing to change the designation for a number of procedure codes from O.R. procedures to non-O.R. procedures. Included in that proposal are ICD-10-PCS procedure codes 0UQGXZZ (Repair vagina, external approach) and 0UQMXZZ (Repair vulva, external approach). Consistent with the change in designation for these procedure codes, we also are proposing to designate ICD-10-PCS procedure code 0UQKXZZ (Repair hymen, external approach) as a non-O.R. procedure. The procedure by itself would generally not require the resources of an operating room. If the procedure is performed following a vaginal delivery, it is the vaginal delivery procedure code 10E0XZZ (Delivery of products of conception) that determines the MS-DRG assignment because this code is designated as a non-O.R. procedure affecting the MS-DRG.

Therefore, we are proposing to change the designation of ICD-10-PCS procedure code 0UQKXZZ (Repair hymen, external approach) to a non-O.R. procedure. This redesignation will enable more appropriate MS-DRG assignment for these cases by eliminating erroneous assignment to MS-DRGs 987 through 989. We are inviting public comments on our proposal.

d. Non-O.R. Procedures in MDC 17 (Myeloproliferative Diseases and Disorders, Poorly Differentiated Neoplasms)

Under MDC 17 (Myeloproliferative Diseases and Disorders, Poorly Differentiated Neoplasms), there are 11 surgical MS-DRGs. Of these 11 surgical MS-DRGs, there are 5 MS-DRGs containing GROUPER logic that includes ICD-10-PCS procedure codes designated as O.R. procedures as well as non-O.R. procedures that affect the MS-DRG. These five MS-DRGs are MS-DRGs 823, 824, and 825 (Lymphoma and Non-Acute Leukemia with Other O.R. Procedure with MCC, with CC and without CC/MCC, respectively) and MS-DRGs 829 and 830 (Myeloproliferative Disorders or Poorly Differentiated Neoplasms with Other O.R. Procedure with CC/MCC and without CC/MCC, respectively). We refer the reader to the ICD-10 Version 34 MS-DRG Definitions Manual which is available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2017-IPPS-Final-Rule-Home-Page-Items/FY2017-IPPS-Final-Rule-Data-Files.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=ascending for the complete list of ICD-10-PCS procedure codes assigned to these five MS-DRGs under MDC 17.

We reviewed the list of 244 ICD-10-PCS non-O.R. procedure codes currently assigned to these 5 MS-DRGs. Of these 244 procedure codes, we determined that 55 of the procedure codes do not warrant being designated as non-O.R. procedures that affect these MS-DRGs because they describe procedures that would generally not require a greater intensity of resources for facilities to manage the cases included in the definition (logic) of these MS-DRGs. Therefore, we are proposing that the 55 ICD-10-PCS procedure codes listed in Table 6P.3c. associated with this proposed rule (which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html ) be removed from the logic for MS-DRGs 823, 824, 825, 829 and 830 as non-O.R. procedures affecting the MS-DRG. We also are proposing to revise the titles for these five MS-DRGs by deleting the reference to "O.R." in the title. Specifically, we are proposing to revise the titles for MS-DRGs 823, 824, and 825 to "Lymphoma and Non-Acute Leukemia with Other Procedure with MCC, with CC and without CC/MCC", respectively and we are proposing to revise the titles for MS-DRGs 829 and 830 to "Myeloproliferative Disorders or Poorly Differentiated Neoplasms with Other Procedure with CC/MCC and without CC/MCC", respectively. We are inviting public comments on our proposals.

G. Recalibration of the Proposed FY 2018 MS-DRG Relative Weights

1. Data Sources for Developing the Proposed Relative Weights


[top] In developing the proposed FY 2018 system of weights, we used two data sources: Claims data and cost report data. As in previous years, the claims data source is the MedPAR file. This file is based on fully coded diagnostic and procedure data for all Medicare inpatient hospital bills. The FY 2016 MedPAR data used in this proposed rule include discharges occurring on October 1, 2015, through September 30, 2016, based on bills received by CMS through December 31, 2016, from all hospitals subject to the IPPS and short-term, acute care hospitals in Maryland (which at that time were under a waiver from the IPPS). The FY 2016 MedPAR file used in calculating the proposed relative weights includes data for approximately 9,607,103 Medicare discharges from IPPS providers. Discharges for Medicare beneficiaries enrolled in a Medicare Advantage managed care plan are excluded from this analysis. These discharges are excluded when the MedPAR "GHO Paid" indicator field on the claim record is equal to "1" or when the MedPAR DRG payment field, which represents the total payment for the claim, is equal to the MedPAR "Indirect Medical Education (IME)" payment field, indicating that the claim was an "IME only" claim submitted by a teaching hospital on behalf of a beneficiary enrolled in a Medicare Advantage managed care plan. In addition, the December 31, 2016 update of the FY 2016 MedPAR file complies with version 5010 of the X12 HIPAA Transaction and Code Set Standards, and includes a variable called "claim type." Claim type "60" indicates that the claim was an inpatient claim paid as fee-for-service. Claim types "61," "62," "63," and "64" relate to encounter claims, Medicare Advantage IME claims, and HMO no-pay claims. Therefore, the calculation of the proposed relative weights for FY 2018 also excludes claims with claim type values not equal to "60." The data exclude CAHs, including hospitals that subsequently became CAHs after the period from which the data were taken. We note that the proposed FY 2018 relative weights are based on the ICD- page 19865 10-CM diagnoses and ICD-10-PCS procedure codes from the FY 2016 MedPAR claims data, grouped through the ICD-10 version of the proposed FY 2018 GROUPER (Version 35).

The second data source used in the cost-based relative weighting methodology is the Medicare cost report data files from the HCRIS. Normally, we use the HCRIS dataset that is 3 years prior to the IPPS fiscal year. Specifically, we used cost report data from the December 31, 2016 update of the FY 2015 HCRIS for calculating the proposed FY 2018 cost-based relative weights.

2. Methodology for Calculation of the Proposed Relative Weights

As we explain in section II.E.2. of the preamble of this proposed rule, we calculated the proposed FY 2018 relative weights based on 19 CCRs, as we did for FY 2017. The methodology we are proposing to use to calculate the FY 2018 MS-DRG cost-based relative weights based on claims data in the FY 2016 MedPAR file and data from the FY 2015 Medicare cost reports is as follows. We note that we have provided additional precision in our description of the methodology for FY 2018.

• To the extent possible, all the claims were regrouped using the proposed FY 2018 MS-DRG classifications discussed in sections II.B. and II.F. of the preamble of this proposed rule.

• The transplant cases that were used to establish the proposed relative weights for heart and heart-lung, liver and/or intestinal, and lung transplants (MS-DRGs 001, 002, 005, 006, and 007, respectively) were limited to those Medicare-approved transplant centers that have cases in the FY 2016 MedPAR file. (Medicare coverage for heart, heart-lung, liver and/or intestinal, and lung transplants is limited to those facilities that have received approval from CMS as transplant centers.)

• Organ acquisition costs for kidney, heart, heart-lung, liver, lung, pancreas, and intestinal (or multivisceral organs) transplants continue to be paid on a reasonable cost basis. Because these acquisition costs are paid separately from the prospective payment rate, it is necessary to subtract the acquisition charges from the total charges on each transplant bill that showed acquisition charges before computing the average cost for each MS-DRG and before eliminating statistical outliers.

• Claims with total charges or total lengths of stay less than or equal to zero were deleted. Claims that had an amount in the total charge field that differed by more than $30.00 from the sum of the routine day charges, intensive care charges, pharmacy charges, implantable devices charges, supplies and equipment charges, therapy services charges, operating room charges, cardiology charges, laboratory charges, radiology charges, other service charges, labor and delivery charges, inhalation therapy charges, emergency room charges, blood and blood products charges, anesthesia charges, cardiac catheterization charges, CT scan charges, and MRI charges were also deleted.

• At least 92.2 percent of the providers in the MedPAR file had charges for 14 of the 19 cost centers. All claims of providers that did not have charges greater than zero for at least 14 of the 19 cost centers were deleted. In other words, a provider must have no more than five blank cost centers. If a provider did not have charges greater than zero in more than five cost centers, the claims for the provider were deleted.

• Statistical outliers were eliminated by removing all cases that were beyond 3.0 standard deviations from the geometric mean of the log distribution of both the total charges per case and the total charges per day for each MS-DRG.

• Effective October 1, 2008, because hospital inpatient claims include a POA indicator field for each diagnosis present on the claim, only for purposes of relative weight-setting, the POA indicator field was reset to "Y" for "Yes" for all claims that otherwise have an "N" (No) or a "U" (documentation insufficient to determine if the condition was present at the time of inpatient admission) in the POA field.

Under current payment policy, the presence of specific HAC codes, as indicated by the POA field values, can generate a lower payment for the claim. Specifically, if the particular condition is present on admission (that is, a "Y" indicator is associated with the diagnosis on the claim), it is not a HAC, and the hospital is paid for the higher severity (and, therefore, the higher weighted MS-DRG). If the particular condition is not present on admission (that is, an "N" indicator is associated with the diagnosis on the claim) and there are no other complicating conditions, the DRG GROUPER assigns the claim to a lower severity (and, therefore, the lower weighted MS-DRG) as a penalty for allowing a Medicare inpatient to contract a HAC. While the POA reporting meets policy goals of encouraging quality care and generates program savings, it presents an issue for the relative weight-setting process. Because cases identified as HACs are likely to be more complex than similar cases that are not identified as HACs, the charges associated with HAC cases are likely to be higher as well. Therefore, if the higher charges of these HAC claims are grouped into lower severity MS-DRGs prior to the relative weight-setting process, the relative weights of these particular MS-DRGs would become artificially inflated, potentially skewing the relative weights. In addition, we want to protect the integrity of the budget neutrality process by ensuring that, in estimating payments, no increase to the standardized amount occurs as a result of lower overall payments in a previous year that stem from using weights and case-mix that are based on lower severity MS-DRG assignments. If this would occur, the anticipated cost savings from the HAC policy would be lost.

To avoid these problems, we reset the POA indicator field to "Y" only for relative weight-setting purposes for all claims that otherwise have an "N" or a "U" in the POA field. This resetting "forced" the more costly HAC claims into the higher severity MS-DRGs as appropriate, and the relative weights calculated for each MS-DRG more closely reflect the true costs of those cases.


[top] In addition, in the FY 2013 IPPS/LTCH PPS final rule, for FY 2013 and subsequent fiscal years, we finalized a policy to treat hospitals that participate in the Bundled Payments for Care Improvement (BPCI) initiative the same as prior fiscal years for the IPPS payment modeling and ratesetting process without regard to hospitals' participation within these bundled payment models (that is, as if hospitals were not participating in those models under the BPCI initiative). The BPCI initiative, developed under the authority of section 3021 of the Affordable Care Act (codified at section 1115A of the Act), is comprised of four broadly defined models of care, which link payments for multiple services beneficiaries receive during an episode of care. Under the BPCI initiative, organizations enter into payment arrangements that include financial and performance accountability for episodes of care. For FY 2018, we are are proposing to continue to include all applicable data from subsection (d) hospitals participating in BPCI Models 1, 2, and 4 in our IPPS payment modeling and ratesetting calculations. We refer readers to the FY 2013 IPPS/LTCH PPS final rule for a complete discussion on our final policy for the treatment of hospitals participating in the BPCI initiative in our ratesetting process. For additional information on page 19866 the BPCI initiative, we refer readers to the CMS' Center for Medicare and Medicaid Innovation's Web site at: http://innovation.cms.gov/initiatives/Bundled-Payments/index.html and to section IV.H.4. of the preamble of the FY 2013 IPPS/LTCH PPS final rule (77 FR 53341 through 53343).

The charges for each of the 19 cost groups for each claim were standardized to remove the effects of differences in proposed area wage levels, IME and DSH payments, and for hospitals located in Alaska and Hawaii, the applicable proposed cost-of-living adjustment. Because hospital charges include charges for both operating and capital costs, we standardized total charges to remove the effects of differences in proposed geographic adjustment factors, cost-of-living adjustments, and DSH payments under the capital IPPS as well. Charges were then summed by MS-DRG for each of the 19 cost groups so that each MS-DRG had 19 standardized charge totals. Statistical outliers were then removed. These charges were then adjusted to cost by applying the proposed national average CCRs developed from the FY 2015 cost report data.

The 19 cost centers that we used in the proposed relative weight calculation are shown in the following table. The table shows the lines on the cost report and the corresponding revenue codes that we used to create the proposed 19 national cost center CCRs. If stakeholders have comments about the groupings in this table, we may consider those comments as we finalize our policy.

page 19867


[top] 
Cost center group name (19 total) MedPAR charge field Revenue codes contained in MedPAR charge field Cost report line description Cost from HCRIS (Worksheet C, Part 1, Column 5 and line number) Form CMS-2552-10 Charges from HCRIS (Worksheet C, Part 1, Column 6 & 7 and line number) Form CMS-2552-10 Medicare charges from HCRIS (Worksheet D-3, Column & line number) Form CMS-2552-10
Routine Days Private Room Charges 011X and 014X Adults & Pediatrics (General Routine Care) C_1_C5_30 C_1_C6_30 D3_HOS_C2_30
Semi-Private Room Charges 012X, 013X and 016X-0?CCRs>>X
Ward Charges 015X
Intensive Days Intensive Care Charges 020X Intensive Care Unit C_1_C5_31 C_1_C6_31 D3_HOS_C2_31
Coronary Care Charges 021X Coronary Care Unit C_1_C5_32 C_1_C6_32 D3_HOS_C2_32
Burn Intensive Care Unit C_1_C5_33 C_1_C6_33 D3_HOS_C2_33
Surgical Intensive Care Unit C_1_C5_34 C_1_C6_34 D3_HOS_C2_34
Other Special Care Unit C_1_C5_35 C_1_C6_35 D3_HOS_C2_35
Drugs Pharmacy Charges 025X, 026X and 063X Intravenous Therapy C_1_C5_64 C_1_C6_64 D3_HOS_C2_64
C_1_C7_64
Drugs Charged to Patient C_1_C5_73 C_1_C6_73 D3_HOS_C2_73
C_1_C7_73
Supplies and Equipment Medical/Surgical Supply Charges 0270, 0271, 0272, 0273, 0274, 0277, 0279, and 0621, 0622, 0623 Medical Supplies Charged to Patients C_1_C5_71 C_1_C6_71 D3_HOS_C2_71
C_1_C7_71
Durable Medical Equipment Charges 0290, 0291, 0292 and 0294-0299 DME-Rented C_1_C5_96 C_1_C6_96 D3_HOS_C2_96
C_1_C7_96
Used Durable Medical Charges 0293 DME-Sold C_1_C5_97 C_1_C6_97 D3_HOS_C2_97
C_1_C7_97
Implantable Devices 0275, 0276, 0278, 0624 Implantable Devices Charged to Patients C_1_C5_72 C_1_C6_72 D3_HOS_C2_72
C_1_C7_72
Therapy Services Physical Therapy Charges 042X Physical Therapy C_1_C5_66 C_1_C6_66 D3_HOS_C2_66
C_1_C7_66
Occupational Therapy Charges 043X Occupational Therapy C_1_C5_67 C_1_C6_67 D3_HOS_C2_67
C_1_C7_67
Speech Pathology Charges 044X and 047X Speech Pathology C_1_C5_68 C_1_C6_68 D3_HOS_C2_68
C_1_C7_68
Inhalation Therapy Inhalation Therapy Charges 041X and 046X Respiratory Therapy C_1_C5_65 C_1_C6_65 D3_HOS_C2_65
C_1_C7_65
Operating Room Operating Room Charges 036X Operating Room C_1_C5_50 C_1_C6_50 D3_HOS_C2_50
C_1_C7_50
071X Recovery Room C_1_C5_51 C_1_C6_51 D3_HOS_C2_51
C_1_C7_51
Labor & Delivery Operating Room Charges 072X Delivery Room and Labor Room C_1_C5_52 C_1_C6_52 D3_HOS_C2_52
C_1_C7_52
Anesthesia Anesthesia Charges 037X Anesthesiology C_1_C5_53 C_1_C6_53 D3_HOS_C2_53
C_1_C7_53
Cardiology Cardiology Charges 048X and 073X Electrocardiology C_1_C5_69 C_1_C6_69 D3_HOS_C2_69
C_1_C7_69
Cardiac Catheterization 0481 Cardiac Catheterization C_1_C5_59 C_1_C6_59 D3_HOS_C2_59
C_1_C7_59
Laboratory Laboratory Charges 030X, 031X, and 075X Laboratory C_1_C5_60 C_1_C6_60 D3_HOS_C2_60
C_1_C7_60
PBP Clinic Laboratory Services C_1_C5_61 C_1_C6_61 D3_HOS_C2_61
C_1_C7_61
074X, 086X Electroencephalography C_1_C5_70 C_1_C6_70 D3_HOS_C2_70
C_1_C7_70
Radiology Radiology Charges 032X, 040X Radiology-Diagnostic C_1_C5_54 C_1_C6_54 D3_HOS_C2_54
C_1_C7_54
028x, 0331, 0332, 0333, 0335, 0339, 0342 Radiology-Therapeutic C_1_C5_55 C_1_C6_55 D3_HOS_C2_55
0343 and 344 Radioisotope C_1_C5_56 C_1_C6_56 D3_HOS_C2_56
C_1_C7_56
Computed Tomography (CT) Scan CT Scan Charges 035X Computed Tomography (CT) Scan C_1_C5_57 C_1_C6_57 D3_HOS_C2_57
C_1_C7_57
Magnetic Resonance Imaging (MRI) MRI Charges 061X Magnetic Resonance Imaging (MRI) C_1_C5_58 C_1_C6_58 D3_HOS_C2_58
C_1_C7_58
Emergency Room Emergency Room Charges 045x Emergency C_1_C5_91 C_1_C6_91 D3_HOS_C2_91
C_1_C7_91
Blood and Blood Products Blood Charges 038x Whole Blood & Packed Red Blood Cells C_1_C5_62 C_1_C6_62 D3_HOS_C2_62
C_1_C7_62
Blood Storage/Processing 039x Blood Storing, Processing, & Transfusing C_1_C5_63 C_1_C6_63 D3_HOS_C2_63
C_1_C7_63
Other Services Other Service Charge 0002-0099, 022X, 023X, 024X,052X,053X
055X-060X, 064X-070X, 076X-078X, 090X-095X and 099X
Renal Dialysis 0800X Renal Dialysis C_1_C5_74 C_1_C6_74 D3_HOS_C2_74
ESRD Revenue Setting Charges 080X and 082X-088X C_1_C7_74
Home Program Dialysis C_1_C5_94 C_1_C6_94 D3_HOS_C2_94
C_1_C7_94
Outpatient Service Charges 049X ASC (Non Distinct Part) C_1_C5_75 C_1_C6_75 D3_HOS_C2_75
Lithotripsy Charge 079X C_1_C7_75
Other Ancillary C_1_C5_76 C_1_C6_76 D3_HOS_C2_76
C_1_C7_76
Clinic Visit Charges 051X Clinic C_1_C5_90 C_1_C6_90 D3_HOS_C2_90
C_1_C7_90
Observation beds C_1_C5_92.01 C_1_C6_92.01 D3_HOS_C2_92.01
C_1_C7_92.01
Professional Fees Charges 096X, 097X, and 098X Other Outpatient Services C_1_C5_93 C_1_C6_93 D3_HOS_C2_93
C_1_C7_93
Ambulance Charges 054X Ambulance C_1_C5_95 C_1_C6_95 D3_HOS_C2_95
C_1_C7_95
Rural Health Clinic C_1_C5_88 C_1_C6_88 D3_HOS_C2_88
C_1_C7_88
FQHC C_1_C5_89 C_1_C6_89 D3_HOS_C2_89
C_1_C7_89


3. Development of Proposed National Average CCRs

We developed the proposed national average CCRs as follows:


[top] Using the FY 2015 cost report data, we removed CAHs, Indian Health Service hospitals, all-inclusive rate hospitals, and cost reports that represented time periods of less than 1 year (365 days). We included hospitals located in Maryland because we include their charges in our claims database. We then created CCRs for each provider for each cost center (see prior table for line items used in the calculations) and removed any CCRs that were greater than 10 or less than 0.01. We normalized the departmental CCRs by dividing the CCR for each department by the total CCR for the hospital for the page 19868 purpose of trimming the data. We then took the logs of the normalized cost center CCRs and removed any cost center CCRs where the log of the cost center CCR was greater or less than the mean log plus/minus 3 times the standard deviation for the log of that cost center CCR. Once the cost report data were trimmed, we calculated a Medicare-specific CCR. The Medicare-specific CCR was determined by taking the Medicare charges for each line item from Worksheet D-3 and deriving the Medicare-specific costs by applying the hospital-specific departmental CCRs to the Medicare-specific charges for each line item from Worksheet D-3. Once each hospital's Medicare-specific costs were established, we summed the total Medicare-specific costs and divided by the sum of the total Medicare-specific charges to produce national average, charge-weighted CCRs.

After we multiplied the total charges for each MS-DRG in each of the 19 cost centers by the corresponding national average CCR, we summed the 19 "costs" across each MS-DRG to produce a total standardized cost for the MS-DRG. The average standardized cost for each MS-DRG was then computed as the total standardized cost for the MS-DRG divided by the transfer-adjusted case count for the MS-DRG. The average cost for each MS-DRG was then divided by the national average standardized cost per case to determine the proposed relative weight.

The proposed FY 2018 cost-based relative weights were then normalized by a proposed adjustment factor of 1.736047 so that the average case weight after recalibration was equal to the average case weight before recalibration. The proposed normalization adjustment is intended to ensure that recalibration by itself neither increases nor decreases total payments under the IPPS, as required by section 1886(d)(4)(C)(iii) of the Act.

The proposed 19 national average CCRs for FY 2018 are as follows:

Group CCR
Routine Days 0.449
Intensive Days 0.375
Drugs 0.197
Supplies & Equipment 0.300
Implantable Devices 0.327
Therapy Services 0.314
Laboratory 0.116
Operating Room 0.186
Cardiology 0.108
Cardiac Catheterization 0.115
Radiology 0.149
MRIs 0.077
CT Scans 0.037
Emergency Room 0.166
Blood and Blood Products 0.309
Other Services 0.352
Labor & Delivery 0.363
Inhalation Therapy 0.163
Anesthesia 0.080

Since FY 2009, the relative weights have been based on 100 percent cost weights based on our MS-DRG grouping system.

When we recalibrated the DRG weights for previous years, we set a threshold of 10 cases as the minimum number of cases required to compute a reasonable weight. We are proposing to use that same case threshold in recalibrating the MS-DRG relative weights for FY 2018. Using data from the FY 2016 MedPAR file, there were 10 MS-DRGs that contain fewer than 10 cases. For FY 2018, because we do not have sufficient MedPAR data to set accurate and stable cost relative weights for these low-volume MS-DRGs, we are proposing to compute proposed relative weights for the low-volume MS-DRGs by adjusting their final FY 2017 relative weights by the percentage change in the average weight of the cases in other MS-DRGs. The crosswalk table is shown:

Low-volume MS-DRG MS-DRG title Crosswalk to MS-DRG
016 Autologous bone marrow transplant w CC/MCC Final FY 2017 relative weight (adjusted by percent change in average weight of the cases in other MS-DRGs).
017 Autologous bone marrow transplant w/o CC/MCC Final FY 2017 relative weight (adjusted by percent change in average weight of the cases in other MS-DRGs).
789 Neonates, Died or Transferred to Another Acute Care Facility Final FY 2017 relative weight (adjusted by percent change in average weight of the cases in other MS-DRGs).
790 Extreme Immaturity or Respiratory Distress Syndrome, Neonate Final FY 2017 relative weight (adjusted by percent change in average weight of the cases in other MS-DRGs).
791 Prematurity with Major Problems Final FY 2017 relative weight (adjusted by percent change in average weight of the cases in other MS-DRGs).
792 Prematurity without Major Problems Final FY 2017 relative weight (adjusted by percent change in average weight of the cases in other MS-DRGs).
793 Full-Term Neonate with Major Problems Final FY 2017 relative weight (adjusted by percent change in average weight of the cases in other MS-DRGs).
794 Neonate with Other Significant Problems Final FY 2017 relative weight (adjusted by percent change in average weight of the cases in other MS-DRGs).
795 Normal Newborn Final FY 2017 relative weight (adjusted by percent change in average weight of the cases in other MS-DRGs).

We are inviting public comments on our proposals.

H. Proposed Add-On Payments for New Services and Technologies for FY 2018

1. Background

Sections 1886(d)(5)(K) and (L) of the Act establish a process of identifying and ensuring adequate payment for new medical services and technologies (sometimes collectively referred to in this section as "new technologies") under the IPPS. Section 1886(d)(5)(K)(vi) of the Act specifies that a medical service or technology will be considered new if it meets criteria established by the Secretary after notice and opportunity for public comment. Section 1886(d)(5)(K)(ii)(I) of the Act specifies that a new medical service or technology may be considered for new technology add-on payment if, based on the estimated costs incurred with respect to discharges involving such service or technology, the DRG prospective payment rate otherwise applicable to such discharges under this subsection is inadequate. We note that, beginning with discharges occurring in FY 2008, CMS transitioned from CMS-DRGs to MS-DRGs.


[top] The regulations at 42 CFR 412.87 implement these provisions and specify three criteria for a new medical service or technology to receive the additional payment: (1) The medical service or technology must be new; (2) the medical service or technology must be costly such that the DRG rate otherwise page 19869 applicable to discharges involving the medical service or technology is determined to be inadequate; and (3) the service or technology must demonstrate a substantial clinical improvement over existing services or technologies. Below we highlight some of the major statutory and regulatory provisions relevant to the new technology add-on payment criteria, as well as other information. For a complete discussion on the new technology add-on payment criteria, we refer readers to the FY 2012 IPPS/LTCH PPS final rule (76 FR 51572 through 51574).

Under the first criterion, as reflected in §?412.87(b)(2), a specific medical service or technology will be considered "new" for purposes of new medical service or technology add-on payments until such time as Medicare data are available to fully reflect the cost of the technology in the MS-DRG weights through recalibration. We note that we do not consider a service or technology to be new if it is substantially similar to one or more existing technologies. That is, even if a technology receives a new FDA approval or clearance, it may not necessarily be considered "new" for purposes of new technology add-on payments if it is "substantially similar" to a technology that was approved or cleared by FDA and has been on the market for more than 2 to 3 years. In the FY 2010 IPPS/RY 2010 LTCH PPS final rule (74 FR 43813 through 43814), we established criteria for evaluating whether a new technology is substantially similar to an existing technology, specifically: (1) Whether a product uses the same or a similar mechanism of action to achieve a therapeutic outcome; (2) whether a product is assigned to the same or a different MS-DRG; and (3) whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population. If a technology meets all three of these criteria, it would be considered substantially similar to an existing technology and would not be considered "new" for purposes of new technology add-on payments. For a detailed discussion of the criteria for substantial similarity, we refer readers to the FY 2006 IPPS final rule (70 FR 47351 through 47352), and the FY 2010 IPPS/LTCH PPS final rule (74 FR 43813 through 43814).

Under the second criterion, §?412.87(b)(3) further provides that, to be eligible for the add-on payment for new medical services or technologies, the MS-DRG prospective payment rate otherwise applicable to discharges involving the new medical service or technology must be assessed for adequacy. Under the cost criterion, consistent with the formula specified in section 1886(d)(5)(K)(ii)(I) of the Act, to assess the adequacy of payment for a new technology paid under the applicable MS-DRG prospective payment rate, we evaluate whether the charges for cases involving the new technology exceed certain threshold amounts. Table 10 that was released with the FY 2017 IPPS/LTCH PPS final rule contains the final thresholds that we used to evaluate applications for new medical service and new technology add-on payments for FY 2018. We refer readers to the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2017-IPPS-Final-Rule-Home-Page-Items/FY2017-IPPS-Final-Rule-Tables.html to download and view Table 10.

In the September 7, 2001 final rule that established the new technology add-on payment regulations (66 FR 46917), we discussed the issue of whether the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule at 45 CFR parts 160 and 164 applies to claims information that providers submit with applications for new medical service and new technology add-on payments. We refer readers to the FY 2012 IPPS/LTCH PPS final rule (76 FR 51573) for complete information on this issue.

Under the third criterion, §?412.87(b)(1) of our existing regulations provides that a new technology is an appropriate candidate for an additional payment when it represents an advance that substantially improves, relative to technologies previously available, the diagnosis or treatment of Medicare beneficiaries. For example, a new technology represents a substantial clinical improvement when it reduces mortality, decreases the number of hospitalizations or physician visits, or reduces recovery time compared to the technologies previously available. (We refer readers to the September 7, 2001 final rule for a more detailed discussion of this criterion (66 FR 46902).)

The new medical service or technology add-on payment policy under the IPPS provides additional payments for cases with relatively high costs involving eligible new medical services or technologies, while preserving some of the incentives inherent under an average-based prospective payment system. The payment mechanism is based on the cost to hospitals for the new medical service or technology. Under §?412.88, if the costs of the discharge (determined by applying cost-to-charge ratios (CCRs) as described in §?412.84(h)) exceed the full DRG payment (including payments for IME and DSH, but excluding outlier payments), Medicare will make an add-on payment equal to the lesser of: (1) 50 percent of the estimated costs of the new technology or medical service (if the estimated costs for the case including the new technology or medical service exceed Medicare's payment); or (2) 50 percent of the difference between the full DRG payment and the hospital's estimated cost for the case. Unless the discharge qualifies for an outlier payment, the additional Medicare payment is limited to the full MS-DRG payment plus 50 percent of the estimated costs of the new technology or new medical service.

Section 503(d)(2) of Public Law 108-173 provides that there shall be no reduction or adjustment in aggregate payments under the IPPS due to add-on payments for new medical services and technologies. Therefore, in accordance with section 503(d)(2) of Public Law 108-173, add-on payments for new medical services or technologies for FY 2005 and later years have not been subjected to budget neutrality.

In the FY 2009 IPPS final rule (73 FR 48561 through 48563), we modified our regulations at §?412.87 to codify our longstanding practice of how CMS evaluates the eligibility criteria for new medical service or technology add-on payment applications. That is, we first determine whether a medical service or technology meets the newness criterion, and only if so, do we then make a determination as to whether the technology meets the cost threshold and represents a substantial clinical improvement over existing medical services or technologies. We amended §?412.87(c) to specify that all applicants for new technology add-on payments must have FDA approval or clearance for their new medical service or technology by July 1 of each year prior to the beginning of the fiscal year that the application is being considered.


[top] The Council on Technology and Innovation (CTI) at CMS oversees the agency's cross-cutting priority on coordinating coverage, coding and payment processes for Medicare with respect to new technologies and procedures, including new drug therapies, as well as promoting the exchange of information on new technologies and medical services between CMS and other entities. The CTI, composed of senior CMS staff and clinicians, was established under section 942(a) of Public Law 108-173. The Council is co-chaired by the Director of the Center for Clinical Standards and Quality (CCSQ) and the Director of the Center for Medicare page 19870 (CM), who is also designated as the CTI's Executive Coordinator.

The specific processes for coverage, coding, and payment are implemented by CM, CCSQ, and the local Medicare Administrative Contractors (MACs) (in the case of local coverage and payment decisions). The CTI supplements, rather than replaces, these processes by working to assure that all of these activities reflect the agency-wide priority to promote high-quality, innovative care. At the same time, the CTI also works to streamline, accelerate, and improve coordination of these processes to ensure that they remain up to date as new issues arise. To achieve its goals, the CTI works to streamline and create a more transparent coding and payment process, improve the quality of medical decisions, and speed patient access to effective new treatments. It is also dedicated to supporting better decisions by patients and doctors in using Medicare-covered services through the promotion of better evidence development, which is critical for improving the quality of care for Medicare beneficiaries.

To improve the understanding of CMS' processes for coverage, coding, and payment and how to access them, the CTI has developed an "Innovator's Guide" to these processes. The intent is to consolidate this information, much of which is already available in a variety of CMS documents and in various places on the CMS Web site, in a user-friendly format. This guide was published in 2010 and is available on the CMS Web site at: http://www.cms.gov/CouncilonTechInnov/Downloads/InnovatorsGuide5_10_10.pdf .

As we indicated in the FY 2009 IPPS final rule (73 FR 48554), we invite any product developers or manufacturers of new medical services or technologies to contact the agency early in the process of product development if they have questions or concerns about the evidence that would be needed later in the development process for the agency's coverage decisions for Medicare.

The CTI aims to provide useful information on its activities and initiatives to stakeholders, including Medicare beneficiaries, advocates, medical product manufacturers, providers, and health policy experts. Stakeholders with further questions about Medicare's coverage, coding, and payment processes, or who want further guidance about how they can navigate these processes, can contact the CTI at CTI@cms.hhs.gov .

We note that applicants for add-on payments for new medical services or technologies for FY 2019 must submit a formal request, including a full description of the clinical applications of the medical service or technology and the results of any clinical evaluations demonstrating that the new medical service or technology represents a substantial clinical improvement, along with a significant sample of data to demonstrate that the medical service or technology meets the high-cost threshold. Complete application information, along with final deadlines for submitting a full application, will be posted as it becomes available on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html . To allow interested parties to identify the new medical services or technologies under review before the publication of the proposed rule for FY 2019, the CMS Web site also will post the tracking forms completed by each applicant.

2. Public Input Before Publication of a Notice of Proposed Rulemaking on Add-On Payments

Section 1886(d)(5)(K)(viii) of the Act, as amended by section 503(b)(2) of Public Law 108-173, provides for a mechanism for public input before publication of a notice of proposed rulemaking regarding whether a medical service or technology represents a substantial clinical improvement or advancement. The process for evaluating new medical service and technology applications requires the Secretary to-

• Provide, before publication of a proposed rule, for public input regarding whether a new service or technology represents an advance in medical technology that substantially improves the diagnosis or treatment of Medicare beneficiaries;

• Make public and periodically update a list of the services and technologies for which applications for add-on payments are pending;

• Accept comments, recommendations, and data from the public regarding whether a service or technology represents a substantial clinical improvement; and

• Provide, before publication of a proposed rule, for a meeting at which organizations representing hospitals, physicians, manufacturers, and any other interested party may present comments, recommendations, and data regarding whether a new medical service or technology represents a substantial clinical improvement to the clinical staff of CMS.

In order to provide an opportunity for public input regarding add-on payments for new medical services and technologies for FY 2018 prior to publication of the FY 2018 IPPS/LTCH PPS proposed rule, we published a notice in the Federal Register on November 9, 2016 (81 FR 78814), and held a town hall meeting at the CMS Headquarters Office in Baltimore, MD, on February 14, 2017. In the announcement notice for the meeting, we stated that the opinions and presentations provided during the meeting would assist us in our evaluations of applications by allowing public discussion of the substantial clinical improvement criterion for each of the FY 2018 new medical service and technology add-on payment applications before the publication of the FY 2018 IPPS/LTCH PPS proposed rule.

Approximately 66 individuals registered to attend the town hall meeting in person, while additional individuals listened over an open telephone line. We also live-streamed the town hall meeting and posted the town hall on the CMS YouTube Web page at: https://www.youtube.com/watch?v=9niqfxXe4oA&t=217s . We considered each applicant's presentation made at the town hall meeting, as well as written comments submitted on the applications that were received by the due date of February 24, 2017, in our evaluation of the new technology add-on payment applications for FY 2018 in this proposed rule.


[top] In response to the published notice and the February 14, 2017 New Technology Town Hall meeting, we received written comments regarding the applications for FY 2018 new technology add-on payments. We note that we do not summarize comments that are unrelated to the "substantial clinical improvement" criterion. As explained above and in the Federal Register notice announcing the New Technology Town Hall meeting (81 FR78814 through 78816), the purpose of the meeting was specifically to discuss the substantial clinical improvement criterion in regard to pending new technology add-on payment applications for FY 2018. Therefore, we are not summarizing these comments in this proposed rule. We summarize below a general comment that does not relate to a specific application for FY 2018 new technology add-on payments. We also summarize comments regarding individual applications, or, if applicable, indicate that there were no comments received in section II.H.5. of the preamble of this proposed rule at the end of each discussion of the individual applications. page 19871

Comment: One commenter recommended that CMS: (1) Prohibit local MACs from denying coverage and add-on payments for new medical services or technologies approved by the Secretary; and (2) broaden the criteria applied in making substantial clinical improvement determinations to require, in addition to existing criteria, that the Secretary consider whether the new technology or medical service meets one or more of the following criteria: (a) Results in a reduction of the length of a hospital stay; (b) improves patient quality of life; (c) creates long-term clinical efficiencies in treatment; (d) addresses patient-centered objectives as defined by the Secretary; or (e) meets such other criteria as the Secretary may specify.

Response: We appreciate the commenter's comments and will consider them in future rulemaking.

3. ICD-10-PCS Section "X" Codes for Certain New Medical Services and Technologies

As discussed in the FY 2016 IPPS/LTCH final rule (80 FR 49434), the ICD-10-PCS includes a new section containing the new Section "X" codes, which began being used with discharges occurring on or after October 1, 2015. Decisions regarding changes to ICD-10-PCS Section "X" codes will be handled in the same manner as the decisions for all of the other ICD-10-PCS code changes. That is, proposals to create, delete, or revise Section "X" codes under the ICD-10-PCS structure will be referred to the ICD-10 Coordination and Maintenance Committee. In addition, several of the new medical services and technologies that have been, or may be, approved for new technology add-on payments may now, and in the future, be assigned a Section "X" code within the structure of the ICD-10-PCS. We posted ICD-10-PCS Guidelines on the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD10/2016-ICD-10-PCS-and-GEMs.html , including guidelines for ICD-10-PCS Section "X" codes. We encourage providers to view the material provided on ICD-10-PCS Section "X" codes.

4. Proposal To Revise the Reference to an ICD-9-CM Code in §?412.87(b)(2) of the Regulations

The existing regulations under §?412.87(b)(2) state that a medical service or technology may be considered new within 2 or 3 years after the point at which data begin to become available reflecting the ICD-9-CM code assigned to the new service or technology (depending on when a new code is assigned and data on the new service or technology become available for DRG recalibration). After CMS has recalibrated the DRGs, based on available data, to reflect the costs of an otherwise new medical service or technology, the medical service or technology will no longer be considered "new" under the criterion of this section.

As discussed in the FY 2016 IPPS/LTCH final rule (80 FR 49454), HIPAA covered entities are required, as of October 1, 2015, to use the ICD-10 coding system (ICD-10-PCS codes for procedures and ICD-10-CM codes for diagnoses), instead of the ICD-9-CM coding system, to report diagnoses and procedures for Medicare hospital inpatient services provided to Medicare beneficiaries as classified under the MS-DRG system and paid for under the IPPS. The language in §?412.87(b)(2) only references an "ICD-9-CM code." Therefore, we are proposing to revise the regulations at §?412.87(b)(2) to replace the term "ICD-9-CM code" with the term "inpatient hospital code," as defined in section 1886(d)(5)(K)(iii) of the Act. Section 1886(d)(5)(K)(iii) of the Act defines an "inpatient hospital code" as any code that is used with respect to inpatient hospital services for which payment may be made under this subsection of the Act and includes an alphanumeric code issued under the International Classification of Diseases, 9th Revision, Clinical Modification ("ICD-9-CM") and its subsequent revisions. We are inviting public comments on our proposal.

5. Proposed FY 2018 Status of Technologies Approved for FY 2017 Add-On Payments

a. CardioMEMS TM HF (Heart Failure) Monitoring System

CardioMEMS, Inc. submitted an application for new technology add-on payments for FY 2015 for the CardioMEMS TM HF (Heart Failure) Monitoring System, which is an implantable hemodynamic monitoring system comprised of an implantable sensor/monitor placed in the distal pulmonary artery. Pulmonary artery hemodynamic monitoring is used in the management of heart failure. The CardioMEMS TM HF Monitoring System measures multiple pulmonary artery pressure parameters for an ambulatory patient to measure and transmit data via a wireless sensor to a secure Web site.

The CardioMEMS TM HF Monitoring System utilizes radiofrequency (RF) energy to power the sensor and to measure pulmonary artery (PA) pressure and consists of three components: An Implantable Sensor with Delivery Catheter, an External Electronics Unit, and a Pulmonary Artery Pressure Database. The system provides the physician with the patient's PA pressure waveform (including systolic, diastolic, and mean pressures) as well as heart rate. The sensor is permanently implanted in the distal pulmonary artery using transcatheter techniques in the catheterization laboratory where it is calibrated using a Swan-Ganz catheter. PA pressures are transmitted by the patient at home in a supine position on a padded antenna, pushing one button which records an 18-second continuous waveform. The data also can be recorded from the hospital, physician's office, or clinic.

The hemodynamic data, including a detailed waveform, are transmitted to a secure Web site that serves as the Pulmonary Artery Pressure Database, so that information regarding PA pressure is available to the physician or nurse at any time via the Internet. Interpretation of trend data allows the clinician to make adjustments to therapy and can be used along with heart failure signs and symptoms to adjust medications.


[top] The applicant received FDA approval on May 28, 2014. After evaluation of the newness, costs, and substantial clinical improvement criteria for new technology add-on payments for the CardioMEMS TM HF Monitoring System and consideration of the public comments we received in response to the FY 2015 IPPS/LTCH PPS proposed rule, we approved the CardioMEMS TM HF Monitoring System for new technology add-on payments for FY 2015 (79 FR 49940). Cases involving the CardioMEMS TM HF Monitoring System that are eligible for new technology add-on payments are identified by either ICD-10-PCS procedure code 02HQ30Z (Insertion of pressure sensor monitoring device into right pulmonary artery, percutaneous approach) or ICD-10-PCS procedure code 02HR30Z (Insertion of pressure sensor monitoring device into left pulmonary artery, percutaneous approach). With the new technology add-on payment application, the applicant stated that the total operating cost of the CardioMEMS TM HF Monitoring System is $17,750. Under §?412.88(a)(2), we limit new technology add-on payments to the lesser of 50 percent of the average cost of the device or 50 percent of the costs in excess of the MS-DRG payment for the case. As a result, the maximum new technology add-on payment for a case involving the CardioMEMS TM HF Monitoring System is $8,875. We refer the reader to the FY 2015 IPPS/LTCH PPS final rule (79 FR 49937) for complete details on the CardioMEMS TM HF Monitoring System. page 19872

Our policy is that a medical service or technology may be considered new within 2 or 3 years after the point at which data begin to become available reflecting the inpatient hospital code assigned to the new service or technology. Our practice has been to begin and end new technology add-on payments on the basis of a fiscal year, and we have generally followed a guideline that uses a 6-month window before and after the start of the fiscal year to determine whether to extend the new technology add-on payment for an additional fiscal year. In general, we extend add-on payments for an additional year only if the 3-year anniversary date of the product's entry onto the U.S. market occurs in the latter half of the fiscal year (70 FR 47362).

With regard to the newness criterion for the CardioMEMS TM HF Monitoring System, we considered the beginning of the newness period to commence when the CardioMEMS TM HF Monitoring System was approved by the FDA on May 28, 2014. The 3-year anniversary date of the entry of the CardioMEMS TM HF Monitoring System onto the U.S. market (May 28, 2017) will occur prior to the beginning of FY 2018. Therefore, we are proposing to discontinue new technology add-on payments for this technology for FY 2018. We are inviting public comments on this proposal.

b. Defitelio® (Defibrotide)

Jazz Pharmaceuticals submitted an application for new technology add-on payments for FY 2017 for defibrotide (Defitelio®), a treatment for patients diagnosed with hepatic veno-occlusive disease (VOD) with evidence of multiorgan dysfunction. VOD, also known as sinusoidal obstruction syndrome (SOS), is a potentially life-threatening complication of hematopoietic stem cell transplantation (HSCT), with an incidence rate of 8 percent to 15 percent. Diagnoses of VOD range in severity from what has been classically defined as a disease limited to the liver (mild) and reversible, to a severe syndrome associated with multi-organ dysfunction or failure and death. Patients treated with HSCT who develop VOD with multi-organ failure face an immediate risk of death, with a mortality rate of more than 80 percent when only supportive care is used. The applicant asserted that Defitelio® improves the survival rate of patients diagnosed with VOD with multi-organ failure by 23 percent.

Defitelio® was granted Orphan Drug Designation for the treatment of VOD in 2003 and for the prevention of VOD in 2007. It has been available to patients as an investigational drug through an expanded access program since 2007. The applicant's New Drug Application (NDA) for Defitelio® received FDA approval on March 30, 2016. The applicant confirmed that Defitelio® was not available on the U.S. market as of the FDA NDA approval date of March 30, 2016. According to the applicant, commercial packaging could not be completed until the label for Defitelio® was finalized with FDA approval, and that commercial shipments of Defitelio® to hospitals and treatment centers began on April 4, 2016. Therefore, we agreed that, based on this information, the newness period for Defitelio® begins on April 4, 2016, the date of its first commercial availability.

The applicant received unique ICD-10-PCS procedure codes to describe the use of Defitelio® that became effective October 1, 2016. The approved procedure codes are XW03392 (Introduction of defibrotide sodium anticoagulant into peripheral vein, percutaneous approach) and XW04392 (Introduction of defibrotide sodium anticoagulant into central vein, percutaneous approach).

After evaluation of the newness, costs, and substantial clinical improvement criteria for new technology add-on payments for Defitelio® and consideration of the public comments we received in response to the FY 2017 IPPS/LTCH PPS proposed rule, we approved Defitelio® for new technology add-on payments for FY 2017 (81 FR 56906). With the new technology add-on payment application, the applicant estimated that the average Medicare beneficiary would require a dosage of 25 mg/kg/day for a minimum of 21 days of treatment. The recommended dose is 6.25 mg/kg given as a 2-hour intravenous infusion every 6 hours. Dosing should be based on a patient's baseline body weight, which is assumed to be 70 kg for an average adult patient. All vials contain 200 mg at a cost of $825 per vial. Therefore, we determined that cases involving the use of the Defitelio® technology would incur an average cost per case of $151,800 (70 kg adult × 25 mg/kg/day × 21 days = 36,750 mg per patient/200 mg vial = 184 vials per patient × $825 per vial = $151,800). Under §?412.88(a)(2), we limit new technology add-on payments to the lesser of 50 percent of the average cost of the technology or 50 percent of the costs in excess of the MS-DRG payment for the case. As a result, the maximum new technology add-on payment amount for a case involving the use of Defitelio® is $75,900.

Because the 3-year anniversary date of the entry of Defitelio® onto the U.S. market will occur after FY 2018 (April 4, 2019), we are proposing to continue new technology add-on payments for this technology for FY 2018. The maximum payment for a case involving Defitelio® would remain at $75,900 for FY 2018. We are inviting public comments on our proposal to continue new technology add-on payments for Defitelio®.

c. GORE® EXCLUDER® Iliac Branch Endoprosthesis (Gore IBE Device)

W. L. Gore and Associates, Inc. submitted an application for new technology add-on payments for the GORE® EXCLUDER® Iliac Branch Endoprosthesis (GORE IBE device) for FY 2017. The device consists of two components: The Iliac Branch Component (IBC) and the Internal Iliac Component (IIC). The applicant indicated that each endoprosthesis is pre-mounted on a customized delivery and deployment system allowing for controlled endovascular delivery via bilateral femoral access. According to the applicant, the device is designed to be used in conjunction with the GORE® EXCLUDER® AAA Endoprosthesis for the treatment of patients requiring repair of common iliac or aortoiliac aneurysms. When deployed, the GORE IBE device excludes the common iliac aneurysm from systemic blood flow, while preserving blood flow in the external and internal iliac arteries.


[top] With regard to the newness criterion, the applicant received pre-market FDA approval of the GORE IBE device on February 29, 2016. The applicant submitted a request for an unique ICD-10-PCS procedure code and was granted approval for the following procedure codes to describe to use of this technology: 04VC0EZ (Restriction of right common iliac artery with branched or fenestrated intraluminal device, one or two arteries, open approach); 04VC0FZ (Restriction of right common iliac artery with branched or fenestrated intraluminal device, three or more arteries, open approach); 04VC3EZ (Restriction of right common iliac artery with branched or fenestrated intraluminal device, one or two arteries, percutaneous approach); 04VC3FZ (Restriction of right common iliac artery with branched or fenestrated intraluminal device, three or more arteries, percutaneous approach); 04VC4EZ (Restriction of right common iliac artery with branched or fenestrated intraluminal device, one or two arteries, percutaneous approach); 04VC4FZ (Restriction of right common iliac artery with branched or fenestrated intraluminal device, three or more, arteries, percutaneous endoscopic, approach); 04VD0EZ (Restriction of left page 19873 common iliac artery with branched or fenestrated intraluminal device, one or two arteries, open approach); 04VD0FZ (Restriction of left common iliac artery with branched or fenestrated, intraluminal device, three or more arteries, open approach); 04VD3EZ (Restriction of left common iliac artery with branched or fenestrated intraluminal device, one or two arteries, percutaneous approach); 04VD3FZ (Restriction of left common iliac artery with branched or fenestrated intraluminal device, three or more arteries, percutaneous approach); 04VD4EZ (Restriction of left common iliac artery with branched or fenestrated intraluminal device, one or two arteries, percutaneous endoscopic approach); and 04VD4FZ (Restriction of left common iliac artery with branched or fenestrated intraluminal device, three or more arteries, percutaneous endoscopic approach). These new ICD-10-PCS procedure codes became effective on October 1, 2016.

After evaluation of the newness, costs, and substantial clinical improvement criteria for new technology add-on payments for the GORE IBE device and consideration of the public comments we received in response to the FY 2017 IPPS/LTCH PPS proposed rule, we approved the GORE IBE device for new technology add-on payments for FY 2017 (81 FR 56909). With the new technology add-on payment application, the applicant indicated that the total operating cost of the GORE IBE device is $10,500. Under §?412.88(a)(2), we limit new technology add-on payments to the lesser of 50 percent of the average cost of the device or 50 percent of the costs in excess of the MS-DRG payment for the case. As a result, the maximum new technology add-on payment for a case involving the GORE IBE device is $5,250.

With regard to the newness criterion for the GORE IBE device, we considered the beginning of the newness period to commence when the GORE IBE device received FDA approval on February 29, 2016. Because the 3-year anniversary date of the entry of the GORE IBE device onto the U.S. market will occur after FY 2018 (February 28, 2019), we are proposing to continue new technology add-on payments for this technology for FY 2018. The maximum payment for a case involving the GORE IBE device would remain at $5,250 for FY 2018. We are inviting public comments on our proposal to continue new technology add-on payments for the GORE IBE device.

d. Praxbind® Idarucizumab

Boehringer Ingelheim Pharmaceuticals, Inc. submitted an application for new technology add-on payments for FY 2017 for Praxbind® Idarucizumab (Idarucizumab), a product developed as an antidote to reverse the effects of PRADAXAR (Dabigatran), which is also manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.

Dabigatran is an oral direct thrombin inhibitor currently indicated to: (1) Reduce the risk of stroke and systemic embolism in patients who have been diagnosed with nonvalvular atrial fibrillation (NVAF); (2) treat deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been administered a parenteral anticoagulant for 5 to 10 days; and (3) reduce the risk of recurrence of DVT and PE in patients who have been previously diagnosed with NVAF. Currently, unlike the anticoagulant Warfarin, there is no specific way to reverse the anticoagulant effect of Dabigatran in the event of a major bleeding episode. Idarucizumab is a humanized fragment antigen binding (Fab) molecule, which specifically binds to Dabigatran to deactivate the anticoagulant effect, thereby allowing thrombin to act in blood clot formation. The applicant stated that Idarucizumab represents a new pharmacologic approach to neutralizing the specific anticoagulant effect of Dabigatran in emergency situations.

Idarucizumab was approved by the FDA on October 16, 2015. Based on the FDA indication for Idarucizumab, the product can be used in the treatment of patients who have been diagnosed with NVAF and administered Dabigatran to reverse life-threatening bleeding events, or who require emergency surgery or medical procedures and rapid reversal of the anticoagulant effects of Dabigatran is necessary and desired.

The applicant received unique ICD-10-PCS procedure codes that became effective October 1, 2016, to describe the use of this technology. The approved procedure codes are XW03331 (Introduction of Idarucizumab, Dabigatran reversal agent into peripheral vein, percutaneous approach, New Technology Group 1) and XW04331 (Introduction of Idarucizumab, Dabigatran reversal agent into central vein, percutaneous approach, New Technology Group 1).

After evaluation of the newness, costs, and substantial clinical improvement criteria for new technology add-on payments for Idarucizumab and consideration of the public comments we received in response to the FY 2017 IPPS/LTCH PPS proposed rule, we approved Idarucizumab for new technology add-on payments for FY 2017 (81 FR 56897). With the new technology add-on payment application, the applicant indicated that the total operating cost of Idarucizumab is $3,500. Under §?412.88(a)(2), we limit new technology add-on payments to the lesser of 50 percent of the average cost of the technology or 50 percent of the costs in excess of the MS-DRG payment for the case. As a result, the maximum new technology add-on payment for a case involving Idarucizumab is $1,750.

With regard to the newness criterion for Idarucizumab, we considered the beginning of the newness period to commence when Idarucizumab was approved by the FDA on October 16, 2015. Because the 3-year anniversary date of the entry of Idarucizumab onto the U.S. market will occur after FY 2018 (October 15, 2018), we are proposing to continue new technology add-on payments for this technology for FY 2018. The maximum payment for a case involving Idarucizumab would remain at $1,750 for FY 2018. We are inviting public comments on our proposal to continue new technology add-on payments for Idarucizumab.

e. Lutonix® Drug Coated Balloon PTA Catheter and In.PACT TM Admiral TM Paclitaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter


[top] Two manufacturers, CR Bard Inc. and Medtronic, submitted applications for new technology add-on payments for FY 2016 for LUTONIX® Drug-Coated Balloon (DCB) Percutaneous Transluminal Angioplasty (PTA) Catheter (LUTONIX®) and IN.PACT TM Admiral TM Paclitaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (IN.PACT TM Admiral TM ), respectively. Both of these technologies are drug-coated balloon angioplasty treatments for patients diagnosed with peripheral artery disease (PAD). Typical treatments for patients with PAD include angioplasty, stenting, atherectomy and vascular bypass surgery. PAD most commonly occurs in the femoropopliteal segment of the peripheral arteries, is associated with significant levels of morbidity and impairment in quality of life, and requires treatment to reduce symptoms and prevent or treat ischemic events.1 page 19874 Treatment options for symptomatic PAD include noninvasive treatment such as medication and life-style modification (for example, exercise programs, diet, and smoking cessation) and invasive options, which include endovascular treatment and surgical bypass. The 2013 American College of Cardiology and American Heart Association (ACC/AHA) guidelines for the management of PAD recommend endovascular therapy as the first-line treatment for femoropopliteal artery lesions in patients suffering from claudication (Class I, Level A recommendation).2

Footnotes:

1 ?Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U., Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg, N Engl J Med 2008, 358: 689-99.

2 ?Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK., Management of patients with peripheral artery disease (compilation of 2005 and 2011 ACCF/AHA guideline recommendations): A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, J Am Coll Cardiol 2013, 61:1555-70. Available at: http://dx.doi.org/10.1016/j.jacc.2013.01.004 .

According to both applicants, LUTONIX® and IN.PACT TM Admiral TM are the first drug coated balloons that can be used for treatment of patients who are diagnosed with PAD. In the FY 2016 IPPS/LTCH PPS final rule, we stated that because cases eligible for the two devices would group to the same MS-DRGs and we believe that these devices are substantially similar to each other (that is, they are intended to treat the same or similar disease in the same or similar patient population and are purposed to achieve the same therapeutic outcome using the same or similar mechanism of action), we evaluated both technologies as one application for new technology add-on payments under the IPPS. The applicants submitted separate cost and clinical data, and we reviewed and discussed each set of data separately. However, we made one determination regarding new technology add-on payments that applied to both devices. We believe that this is consistent with our policy statements in the past regarding substantial similarity. Specifically, we have noted that approval of new technology add-on payments would extend to all technologies that are substantially similar (66 FR 46915), and we believe that continuing our current practice of extending a new technology add-on payment without a further application from the manufacturer of the competing product or a specific finding on cost and clinical improvement if we make a finding of substantial similarity among two products is the better policy because we avoid-

• Creating manufacturer-specific codes for substantially similar products;

• Requiring different manufacturers of substantially similar products from having to submit separate new technology add-on payment applications;

• Having to compare the merits of competing technologies on the basis of substantial clinical improvement; and

• Bestowing an advantage to the first applicant representing a particular new technology to receive approval (70 FR 47351).

CR Bard, Inc. received FDA approval for LUTONIX® on October 9, 2014. Commercial sales in the U.S. market began on October 10, 2014. Medtronic received FDA approval for IN.PACT TM Admiral TM on December 30, 2014. Commercial sales in the U.S. market began on January 29, 2015.

In accordance with our policy, we stated in the FY 2016 IPPS\LTCH final rule (80 FR 49463) that we believe it is appropriate to use the earliest market availability date submitted as the beginning of the newness period. Accordingly, for both devices, we stated that the beginning of the newness period will be October 10, 2014.

After evaluation of the newness, costs, and substantial clinical improvement criteria for new technology add-on payments for the LUTONIX® and IN.PACT TM Admiral TM technologies and consideration of the public comments we received in response to the FY 2016 IPPS/LTCH PPS proposed rule, we approved the LUTONIX® and IN.PACT TM Admiral TM technologies for new technology add-on payments for FY 2016 (80 FR 49469). Cases involving the LUTONIX® and IN.PACT TM Admiral TM technologies that are eligible for new technology add-on payments are identified using one of the ICD-10-PCS procedure codes in the following table:

page 19875


[top] 
ICD-10-PCS code Code description
047K041 Dilation of right femoral artery with drug-eluting intraluminal device using drug-coated balloon, open approach.
047K0D1 Dilation of right femoral artery with intraluminal device using drug-coated balloon, open approach.
047K0Z1 Dilation of right femoral artery using drug-coated balloon, open approach.
047K341 Dilation of right femoral artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous approach.
047K3D1 Dilation of right femoral artery with intraluminal device using drug-coated balloon, percutaneous approach.
047K3Z1 Dilation of right femoral artery using drug-coated balloon, percutaneous approach.
047K441 Dilation of right femoral artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous endoscopic approach.
047K4D1 Dilation of right femoral artery with intraluminal device using drug-coated balloon, percutaneous endoscopic approach.
047K4Z1 Dilation of right femoral artery using drug-coated balloon, percutaneous endoscopic approach.
047L041 Dilation of left femoral artery with drug-eluting intraluminal device using drug-coated balloon, open approach.
047L0D1 Dilation of left femoral artery with intraluminal device using drug-coated balloon, open approach.
047L0Z1 Dilation of left femoral artery using drug-coated balloon, open approach.
047L341 Dilation of left femoral artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous approach.
047L3D1 Dilation of left femoral artery with intraluminal device using drug-coated balloon, percutaneous approach.
047L3Z1 Dilation of left femoral artery using drug-coated balloon, percutaneous approach.
047L441 Dilation of left femoral artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous endoscopic approach.
047L4D1 Dilation of left femoral artery with intraluminal device using drug-coated balloon, percutaneous endoscopic approach.
047L4Z1 Dilation of left femoral artery using drug-coated balloon, percutaneous endoscopic approach.
047M041 Dilation of right popliteal artery with drug-eluting intraluminal device using drug-coated balloon, open approach.
047M0D1 Dilation of right popliteal artery with intraluminal device using drug-coated balloon, open approach.
047M0Z1 Dilation of right popliteal artery using drug-coated balloon, open approach.
047M341 Dilation of right popliteal artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous approach.
047M3D1 Dilation of right popliteal artery with intraluminal device using drug-coated balloon, percutaneous approach.
047M3Z1 Dilation of right popliteal artery using drug-coated balloon, percutaneous approach.
047M441 Dilation of right popliteal artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous endoscopic approach.
047M4D1 Dilation of right popliteal artery with intraluminal device using drug-coated balloon, percutaneous endoscopic approach.
047M4Z1 Dilation of right popliteal artery using drug-coated balloon, percutaneous endoscopic approach.
047N041 Dilation of left popliteal artery with drug-eluting intraluminal device using drug-coated balloon, open approach.
047N0D1 Dilation of left popliteal artery with intraluminal device using drug-coated balloon, open approach.
047N0Z1 Dilation of left popliteal artery using drug-coated balloon, open approach.
047N341 Dilation of left popliteal artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous approach.
047N3D1 Dilation of left popliteal artery with intraluminal device using drug-coated balloon, percutaneous approach.
047N3Z1 Dilation of left popliteal artery using drug-coated balloon, percutaneous approach.
047N441 Dilation of left popliteal artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous endoscopic approach.
047N4D1 Dilation of left popliteal artery with intraluminal device using drug-coated balloon, percutaneous endoscopic approach.
047N4Z1 Dilation of left popliteal artery using drug-coated balloon, percutaneous endoscopic approach.


As discussed in the FY 2016 IPPS/LTCH final rule (80 FR 49469), each of the applicants submitted operating costs for its DCB. The manufacturer of the LUTONIX® stated that a mean of 1.37 drug-coated balloons was used during the LEVANT 2 clinical trial. The acquisition price for the hospital will be $1,900 per drug-coated balloon, or $2,603 per case (1.37 × $1,900). The applicant projected that approximately 8,875 cases will involve use of the LUTONIX® for FY 2016. The manufacturer for the IN.PACT TM Admiral TM stated that a mean of 1.4 drug-coated balloons was used during the IN.PACT TM Admiral TM DCB arm. The acquisition price for the hospital will be $1,350 per drug-coated balloon, or $1,890 per case (1.4 × $1,350). The applicant projected that approximately 26,000 cases will involve use of the IN.PACT TM Admiral TM for FY 2016.

For FY 2016, we based the new technology add-on payment for cases involving these technologies on the weighted average cost of the two DCBs described by the ICD-10-PCS procedure codes listed above (which are not manufacturer specific). Because ICD-10 codes are not manufacturer specific, we cannot set one new technology add-on payment amount for IN.PACT TM Admiral TM and a different new technology add-on payment amount for LUTONIX®; both technologies will be captured by using the same ICD-10-PCS procedure code. As such, we stated that we believe that the use of a weighted average of the cost of the standard DCBs based on the projected number of cases involving each technology to determine the maximum new technology add-on payment would be most appropriate. To compute the weighted cost average, we summed the total number of projected cases for each of the applicants, which equaled 34,875 cases (26,000 plus 8,875). We then divided the number of projected cases for each of the applicants by the total number of cases, which resulted in the following case-weighted percentages: 25 percent for the LUTONIX® and 75 percent for the IN.PACT TM Admiral TM . We then multiplied the cost per case for the manufacturer specific DCB by the case-weighted percentage (0.25 * $2,603 = $662.41 for LUTONIX® and 0.75 * $1,890 = $1,409.03 for the IN.PACT TM Admiral TM ). This resulted in a case-weighted average cost of $2,071.45 for DCBs. Under §?412.88(a)(2), we limit new technology add-on payments to the lesser of 50 percent of the average cost of the device or 50 percent of the costs in excess of the MS-DRG payment for the case. As a result, the maximum payment for a case involving the LUTONIX® or IN.PACT TM Admiral TM DCBs is $1,035.72.

With regard to the newness criterion for the LUTONIX® and IN.PACT TM Admiral TM technologies, we considered the beginning of the newness period to commence when LUTONIX® gained entry onto the U.S. market on October 10, 2014. As discussed previously in this section, in general, we extend new technology add-on payments for an additional year only if the 3-year anniversary date of the product's entry onto the U.S. market occurs in the latter half of the upcoming fiscal year. Because the 3-year anniversary date of the entry of LUTONIX® onto the U.S. market (October 10, 2017) will occur in the first half of FY 2018, we are proposing to discontinue new technology add-on payments for both the LUTONIX® and IN.PACT TM Admiral TM technologies for FY 2018. We are inviting public comments on this proposal.

f. MAGEC® Spinal Bracing and Distraction System (MAGEC® Spine)

Ellipse Technologies, Inc. submitted an application for new technology add-on payments for FY 2017 for the MAGEC® Spine. According to the applicant, the MAGEC® Spine has been developed for use in the treatment of children diagnosed with severe spinal deformities, such as scoliosis. The system can be used in the treatment of skeletally immature patients less than 10 years of age who have been diagnosed with severe progressive spinal deformities associated with or at risk of Thoracic Insufficiency Syndrome (TIS).

The MAGEC® Spine consists of a (spinal growth) rod that can be lengthened through the use of magnets that are controlled by an external remote controller (ERC). The rod(s) can be implanted into children as young as 2 years of age. According to the applicant, use of the MAGEC® Spine has proven to be successfully used in the treatment of patients diagnosed with scoliosis who have not been responsive to other treatments.

The MAGEC® Spine initially received FDA clearance for use of the predicate device, which used a Harrington Rod on February 27, 2014. The applicant verified that, due to manufacturing delays, the MAGEC® Spine was not available for implant until April 1, 2014. Specifically, the complete MAGEC® Spine system was produced and available for shipment for the first implant on April 1, 2014. Therefore, the newness period for the MAGEC® Spine began on April 1, 2014. Subsequent FDA clearance was granted for use of the modified device, which uses a shorter 70 mm rod on September 18, 2014. After minor modification of the product, the MAGEC® Spine received FDA clearances on March 24, 2015, and May 29, 2015, respectively.


[top] After evaluation of the newness, costs, and substantial clinical improvement criteria for new technology add-on payments for the MAGEC® Spine and consideration of the public comments we received in response to the FY 2017 IPPS/LTCH PPS proposed rule, we approved the MAGEC® Spine for new technology add-on payments for FY 2017 (81 FR 56891). Cases involving the MAGEC® Spine that are eligible for new technology add-on payments are identified by ICD-10-PCS procedure codes XNS0032 (Reposition of lumbar vertebra using magnetically controlled growth rod(s), open approach); XNS0432 (Reposition of lumbar vertebra using magnetically controlled growth page 19876 rod(s), percutaneous endoscopic approach); XNS3032 (Reposition of cervical vertebra using magnetically controlled growth rod(s), open approach); XNS3432 (Reposition of cervical vertebra using magnetically controlled growth rod(s), percutaneous endoscopic approach); XNS4032 (Reposition of thoracic vertebra using magnetically controlled growth rod(s), open approach); and XNS4432 (Reposition of thoracic vertebra using magnetically controlled growth rod(s).

With the new technology add-on payment application, the applicant stated that the total operating cost of the MAGEC® Spine was $17,500 for a single rod and $35,000 for a dual rod. It is historical practice for CMS to make the new technology add-on payment based on the average cost of the technology and not the maximum. For example, in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53358), we approved new technology add-on payments for DIFICID TM based on the average dosage of 6.2 days, rather than the maximum 10-day dosage. The applicant noted that 20 percent of cases use a single rod, while 80 percent of cases use a dual rod. As a result, the weighted average cost for a single and dual MAGEC® Spine is $31,500 (((0.2 * $17,500) + (0.8 * $35,000))). Under §?412.88(a)(2), we limit new technology add-on payments to the lesser of 50 percent of the average cost of the device or 50 percent of the costs in excess of the MS-DRG payment for the case. As a result, the maximum new technology add-on payment for a case involving the MAGEC® Spine is $15,750. We refer the reader to the FY 2017 IPPS/LTCH PPS final rule (81 FR 56888) for complete details on the MAGEC® Spine.

With regard to the newness criterion for the MAGEC® Spine, we considered the beginning of the newness period to commence when the MAGEC® Spine was produced and available for shipment for the first implant on April 1, 2014. As discussed previously in this section, in general, we extend new technology add-on payments for an additional year only if the 3-year anniversary date of the product's entry onto the U.S. market occurs in the latter half of the upcoming fiscal year. Because the 3-year anniversary date of the entry of the MAGEC® Spine onto the U.S. market (April 1, 2017) will occur prior to the beginning of FY 2018, we are proposing to discontinue new technology add-on payments for this technology for FY 2018. We are inviting public comments on this proposal.

g. VistogardTM (Uridine Triacetate)

BTG International Inc., submitted an application for new technology add-on payments for the Vistogard TM for FY 2017. Vistogard TM was developed as an antidote to Fluorouracil toxicity.

Chemotherapeutic agent 5-fluorouracil (5-FU) is used to treat specific solid tumors. It acts upon deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) in the body, as uracil is a naturally occurring building block for genetic material. Fluorouracil is a fluorinated pyrimidine. As a chemotherapy agent, Fluorouracil is absorbed by cells and causes the cell to metabolize into byproducts that are toxic and used to destroy cancerous cells. According to the applicant, the byproducts fluorodoxyuridine monophosphate (F-dUMP) and floxuridine triphosphate (FUTP) are believed to do the following: (1) Reduce DNA synthesis; (2) lead to DNA fragmentation; and (3) disrupt RNA synthesis. Fluorouracil is used to treat a variety of solid tumors such as colorectal, head and neck, breast, and ovarian cancer. With different tumor treatments, different dosages, and different dosing schedules, there is a risk for toxicity in these patients. Patients may suffer from fluorouracil toxicity/death if 5-FU is delivered in slight excess or at faster infusion rates than prescribed. The cause of overdose can happen for a variety of reasons including: Pump malfunction, incorrect pump programming or miscalculated doses, and accidental or intentional ingestion.

Vistogard TM is an antidote to Fluorouracil toxicity and is a prodrug of uridine. Once the drug is metabolized into uridine, it competes with the toxic byproduct FUTP in binding to RNA, thereby reducing the impact FUTP has on cell death.

The Vistogard TM received FDA approval on December 11, 2015. In the FY 2017 IPPS/LTCH PPS final rule (81 FR 56910), we stated that we agreed with the manufacturer that, due to the delay in availability, the date the newness period begins for Vistogard TM is March 2, 2016, instead of December 11, 2015.

The applicant noted that the Vistogard TM is the first FDA-approved antidote used to reverse fluorouracil toxicity. The applicant received a unique ICD-10-PCS procedure code that became effective October 1, 2016, to describe the use of this technology. The approved procedure code is XW0DX82 (Introduction of Uridine Triacetate into Mouth and Pharynx, External Approach, New Technology Group 2).

After evaluation of the newness, costs, and substantial clinical improvement criteria for new technology add-on payments for Vistogard TM and consideration of the public comments we received in response to the FY 2017 IPPS/LTCH PPS proposed rule, we approved Vistogard TM for new technology add-on payments for FY 2017 (81 FR 56912). With the new technology add-on payment application, the applicant stated that the total operating cost of Vistogard TM is $75,000. Under §?412.88(a)(2), we limit new technology add-on payments to the lesser of 50 percent of the average cost of the technology or 50 percent of the costs in excess of the MS-DRG payment for the case. As a result, the maximum new technology add-on payment for a case involving Vistogard TM is $37,500.

As noted previously, with regard to the newness criterion for the Vistogard TM , we considered the beginning of the newness period to commence on March 2, 2016. Because the 3-year anniversary date of the entry of the Vistogard TM onto the U.S. market (March 2, 2019) will occur after FY 2018, we are proposing to continue new technology add-on payments for this technology for FY 2018. The maximum payment for a case involving the Vistogard TM would remain at $37,500 for FY 2018. We are inviting public comments on our proposal to continue new technology add-on payments for the Vistogard TM .

h. Blinatumomab (BLINCYTO®)


[top] Amgen, Inc. submitted an application for new technology add-on payments for FY 2016 for Blinatumomab (BLINCYTO®), a bi-specific T-cell engager (BiTE) used for the treatment of Philadelphia chromosome-negative(Ph-) relapsed or refractory (R/R) B-cell precursor acute-lymphoblastic leukemia (ALL), which is a rare aggressive cancer of the blood and bone marrow. Approximately 6,050 individuals are diagnosed with Ph- R/R B-cell precursor ALL in the United States each year, and approximately 2,400 individuals, representing 30 percent of all new cases, are adults. Ph- R/R B-cell precursor ALL occurs when there are malignant transformations of B-cell or T-cell progenitor cells, causing an accumulation of lymphoblasts in the blood, bone marrow, and occasionally throughout the body. As a bi-specific T-cell engager, the BLINCYTO® technology attaches to a molecule on the surface of the tumorous cell, as well as to a molecule on the surface of normal T-cells, bringing the two into closer proximity and allowing the normal T-cell to destroy the tumorous cell. page 19877 Specifically, the BLINCYTO® technology attaches to a cell identified as CD19, which is present on all of the cells of the malignant transformations that cause Ph- R/R B-cell precursor ALL and helps attract the cell into close proximity of the T-cell CD3 with the intent of getting close enough to allow the T-cell to inject toxins that destroy the cancerous cell. According to the applicant, the BLINCYTO® technology is the first, and the only, bi-specific CD19-directed CD3 T-cell engager single-agent immunotherapy approved by the FDA.

BLINCYTO® is administered as a continuous IV infusion delivered at a constant flow rate using an infusion pump. A single cycle of treatment consists of 28 days of continuous infusion, and each treatment cycle is followed by 2 weeks without treatment prior to administering any further treatments. A course of treatment would consist of two phases. Phase 1 consists of initial inductions or treatments intended to achieve remission followed by additional inductions and treatments to maintain consolidation; or treatments given after remission has been achieved to prolong the duration. During Phase 1 of a single treatment course, up to two cycles of BLINCYTO® are administered, and up to three additional cycles are administered during consolidation. The recommended dosage of BLINCYTO® administered during the first cycle of treatment is 9 mcg per day for the first 7 days of treatment. The dosage is then increased to 28 mcg per day for 3 weeks until completion. During Phase 2 of the treatment course, all subsequent doses are administered as 28 mcg per day throughout the entire duration of the 28-day treatment period.

With regard to the newness criterion, the BLINCYTO® technology received FDA approval on December 3, 2014, for the treatment of patients diagnosed with Ph- R/R B-cell precursor ALL, and the product gained entry onto the U.S. market on December 17, 2014.

After evaluation of the newness, costs, and substantial clinical improvement criteria for new technology add-on payments for BLINCYTO® and consideration of the public comments we received in response to the FY 2016 IPPS/LTCH PPS proposed rule, we approved BLINCYTO® for new technology add-on payments for FY 2016 (80 FR 49449). Cases involving BLINCYTO® that are eligible for new technology add-on payments are identified using one of the following ICD-10-PCS procedure codes: XW03351 (Introduction of Blinatumomab antineoplastic immunotherapy into peripheral vein, percutaneous approach, New Technology Group 1), or XW04351 (Introduction of Blinatumomab antineoplastic immunotherapy into central vein, percutaneous approach, New Technology Group 1).

As discussed in the FY 2016 IPPS/LTCH PPS final rule (80 FR 49449), the applicant recommended that CMS consider and use the cost of the full 28-day inpatient treatment cycle as the expected length of treatment when determining the maximum new technology add-on payment for cases involving the BLINCYTO®, rather than the average cost of lesser number of days used as other variables. For the reasons discussed, we disagreed with the applicant and established the maximum new technology add-on payment amount for a case involving the BLINCYTO® technology for FY 2016 using the weighted average of the cycle 1 and cycle 2 observed treatment length. Specifically, in the Phase II trial, the most recent data available, 92 patients received cycle 1 treatment for an average length of 21.2 days, and 52 patients received cycle 2 treatment for an average length of 10.2 days. The weighted average of cycle 1 and cycle 2 treatment length is 17 days. We noted that a small number of patients also received 3 to 5 treatment cycles. However, based on the data provided, these cases do not appear to be typical at this point and we excluded them from this calculation. We noted that, if we included all treatment cycles in this calculation, the weighted average number of days of treatment is much lower, 10 days. Using the clinical data provided by the applicant, we stated that we believe setting the maximum new technology add-on payment amount for a case involving the BLINCYTO® technology for FY 2016 based on a 17-day length of treatment cycle is representative of historical and current practice. We also stated that, for FY 2017, if new data on length of treatment are available, we would consider any such data in evaluating the maximum new technology add-on payment amount. However, we did not receive any new data from the applicant to evaluate for FY 2017.

In the application, the applicant estimated that the average Medicare beneficiary would require a dosage of 9mcg/day for the first 7 days under the first treatment cycle, followed by a dosage of 28mcg/day for the duration of the treatment cycle, as well as all days included in subsequent cycles. All vials contain 35mcg at a cost of $3,178.57 per vial. The applicant noted that all vials are single-use. Therefore, we determined that cases involving the use of the BLINCYTO® technology would incur an average cost per case of $54,035.69 (1 vial/day × 17 days × $3,178.57/vial). Under §?412.88(a)(2), we limit new technology add-on payments to the lesser of 50 percent of the average cost of the technology or 50 percent of the costs in excess of the MS-DRG payment for the case. As a result, the maximum new technology add-on payment amount for a case involving the use of the BLINCYTO® is $27,017.85.

With regard to the newness criterion for BLINCYTO®, we consider the beginning of the newness period to commence when the product gained entry onto the U.S. market on December 17, 2014. As discussed previously in this section, in general, we extend new technology add-on payments for an additional year only if the 3-year anniversary date of the product's entry onto the U.S. market occurs in the latter half of the upcoming fiscal year. Because the 3-year anniversary date of the entry of the BLINCYTO® onto the U.S. market will occur in the first half of FY 2018 (December 17, 2017), we are proposing to discontinue new technology add-on payments for this technology for FY 2018. We are inviting public comments on this proposal.

6. FY 2018 Applications for New Technology Add-On Payments

We received nine applications for new technology add-on payments for FY 2018. In accordance with the regulations under §?412.87(c), applicants for new technology add-on payments must have received FDA approval or clearance by July 1 of the year prior to the beginning of the fiscal year that the application is being considered. Three applicants withdrew their applications prior to the issuance of this proposed rule. We are addressing the remaining six applications below.

a. Bezlotoxumab (ZINPLAVA TM )

Merck & Co., Inc. submitted an application for new technology add-on payments for ZINPLAVA TM for FY 2018. ZINPLAVA TM is indicated for use in adult patients who are receiving antibacterial drug treatment for a diagnosis of Clostridium difficile infection (CDI) who are at high risk for CDI recurrence. ZINPLAVA TM is not indicated for the treatment of the presenting episode of CDI and is not an antibacterial drug.


[top] Clostridium difficile ( C-diff ) is a disease-causing anaerobic, spore forming bacteria that can affect the gastrointestinal (GI) tract. Some people carry the C-diff bacterium in their intestines, but never develop symptoms page 19878 of an infection. The difference between asymptomatic colonization and pathogenicity is caused primarily by the production of an enterotoxin (Toxin A) and/or a cytotoxin (Toxin B). The presence of either or both toxins can lead to symptomatic CDI, which is defined as the acute onset of diarrhea with a documented infection with toxigenic C-diff, or the presence of either toxin A or B. The GI tract contains millions of bacteria, commonly referred to as "normal flora" or "good bacteria," which play a role in protecting the body from infection. Antibiotics can kill these good bacteria and allow the C-diff bacteria to multiply and release toxins that damage the cells lining the intestinal wall, resulting in a CDI. CDI is a leading cause of hospital-associated gastrointestinal illnesses. Persons at increased risk for CDI include people who are treated with current or recent antibiotic use, people who have encountered current or recent hospitalization, people who are older than 65 years, immunocompromised patients, and people who have recently had a diagnosis of CDI. CDI symptoms include, but are not limited to, diarrhea, abdominal pain, and fever. CDI symptoms range in severity from mild (abdominal discomfort, loose stools) to severe (profuse, watery diarrhea, severe pain, and high fevers). Severe CDI can be life-threatening and, in rare cases, can cause bowel rupture, sepsis and organ failure. CDI is responsible for 14,000 deaths per year in the United States.

C-diff produces two virulent, pro-inflammatory toxins, Toxin A and Toxin B, which target host colonocytes (that is, large intestine endothelial cells) by binding to endothelial cell surface receptors via combined repetitive oligopeptide (CROP) domains. These toxins cause the release of inflammatory cytokines leading to intestinal fluid secretion and intestinal inflammation. The applicant asserted that ZINPLAVA TM targets Toxin B sites within the CROP domain rather than the C-diff organism itself. According to the applicant, by targeting C-diff Toxin B, ZINPLAVA TM neutralizes Toxin B, prevents large intestine endothelial cell inflammation, symptoms associated with CDI, and reduces the recurrence of CDI. ZINPLAVA TM binds to sites within the CROP domain, which prevents Toxin B from binding to the host cell, thereby preventing the inflammation and symptoms associated with CDI. ZINPLAVA TM is used concomitantly with standard of care (SOC) antibiotics. Typical treatment of CDI includes antibiotic therapy using vancomycin, metronidazole, fidaxomicin, or other antibiotics. Alternative therapies include fecal microbiota transplant (FMT) and the use of probiotics.

The primary goal of CDI treatment is resolving the infection. Antibacterial drug treatment remains the cornerstone of treatment of CDI. However, this treatment option alone may not be adequate for patients diagnosed with recurrent CDI. A major concern with respect to a CDI is that even when treatment with an antibacterial drug of a primary infection is successful, generally, 25 percent to 30 percent of patients experience a recurrence of the infection within days or weeks of the presenting episode's symptom resolution. The risk of recurrence increases to 65 percent with subsequent CDI episodes. Disease recurrence results from continued disruption of the intestinal microbiota by SOC CDI antibiotics (or use of other antibiotics used to treat non-gastrointestinal conditions), combined with persistence of resistant C-diff spores (relapse) or acquisition of new spores from the environment (reinfection).

Antibacterial drug use may inhibit the intestinal microbiota from reestablishing itself, allowing C-diff spores potentially to germinate and colonize the intestines when the antibacterial drug is discontinued. If regrowth of C-diff overtakes the reestablishment of the intestinal microbiota, then spore germination and toxin production from vegetative C-diff may restart the cycle of CDI and the need for subsequent treatment. These challenges highlight the need for nonantibiotic therapies. ZINPLAVA TM targets Toxin B rather than the C-diff bacteria itself. According to the applicant, unlike antibacterial drugs, ZINPLAVA TM is a human monoclonal antibody and does not affect the microbiota. According to the applicant, ZINPLAVA TM neutralizes C-diff Toxin B and reduces recurrence of CDI. ZINPLAVA TM is given concomitantly during the course of SOC antibacterial treatment of a CDI.

With respect to the newness criterion, ZINPLAVA TM received FDA approval on October 21, 2016, for reduction of recurrence of CDI in patients receiving antibacterial drug treatment for CDI and who are at high risk of CDI recurrence. ZINPLAVA TM is anticipated to be commercially available as of February 2017. We note that the applicant anticipates submitting a request for a unique ICD-10-PCS code for the administration of ZINPLAVA TM . Currently, there is a pending ICD-10-CM request to differentiate CDI recurrence. If approved, the codes will become effective on October 1, 2017 (FY 2018).

As discussed above, if a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and would not be considered "new" for purposes of new technology add-on payments.

With regard to the first criterion, whether a product uses the same or a similar mechanism of action to achieve a therapeutic outcome, according to the applicant, ZINPLAVA TM is a human monoclonal antibody with an innovative mechanism of action. The applicant asserted that ZINPLAVA TM is a novel treatment, with a unique mechanism of action relative to SOC CDI antibiotics that target C-diff. The applicant explained that ZINPLAVA TM is the first human monoclonal antibody that targets and neutralizes C. diff Toxin B because the technology specifically binds to and neutralizes C-diff Toxin B (which is an exotoxin that contributes to intestinal tissue damage and immune system effects that underlie the symptoms of CDI) and inhibits binding of the toxin to mammalian cells. The applicant further asserted that the administration of ZINPLAVA TM, in addition to standard of care antibacterial drug treatment, reduces CDI recurrence by providing passive immunity against Toxin B resulting from persistent or newly acquired C-diff spores. According to the applicant, ZINPLAVA TM is the only FDA-approved treatment indicated for reducing CDI recurrence as adjunctive therapy in adult patients who are receiving antibacterial drug treatment for CDI and who are at high risk for CDI recurrence.


[top] With respect to the second criterion, whether a product is assigned to the same or a different MS-DRG, the applicant maintained that patients who may be eligible to receive treatment using ZINPLAVA TM could be in an acute-care hospital setting for a wide variety of reasons and may develop a secondary CDI as a hospital-acquired infection and, therefore, cases representing patients that may be eligible for treatment using the technology can map to a wide range of MS-DRGs. ZINPLAVA TM is indicated for patients receiving SOC treatment for CDI and who are at a high risk for CDI recurrence. In order to identify the range of MS-DRGs for which cases representing patients that may be eligible for treatment using ZINPLAVA TM may map to, the applicant identified all MS-DRGs containing cases that represent patients presenting with CDI as a primary or secondary diagnosis. The applicant used page 19879 FY 2015 MedPAR data to map the identified cases to 543 MS-DRGs, with 12 MS-DRGs accounting for approximately 40 percent of all cases. The applicant segmented these cases based on age because patients 65 years and older are at higher risk for CDI recurrence. Based on the FY 2015 MedPAR data, MS-DRG distribution was found to be similar, irrespective of CDI status (primary or secondary), for patients over 65 years of age and those under 65 years of age. The top 7 MS-DRGs across both age groups account for nearly 54 percent (over 65 years of age) and 49 percent (under 65 years of age). The applicant further segmented these cases to determine if status of CDI as a primary or secondary diagnosis influenced MS-DRG mapping. Regardless of age, when CDI is the primary diagnosis, approximately 98 percent of patient cases map to the same 3 MS-DRGs: MS-DRG 371 (Major Gastrointestinal Disorders and Peritoneal Infections with MCC); MS-DRG 372 (Major Gastrointestinal Disorders and Peritoneal Infections with CC); and MS-DRG 373 (Major Gastrointestinal Disorders and Peritoneal Infections without CC/MCC), respectively. Potential cases representing patients who may be eligible for treatment with ZINPLAVA TM would be assigned to the same MS-DRGs as cases representing patients who receive SOC treatment for a diagnosis of CDI.

With respect to the third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population, according to the applicant, ZINPLAVA TM is administered concomitantly or as adjunctive therapy with SOC antibacterial treatment for recurrent CDI. The applicant stated that ZINPLAVA TM is indicated to reduce recurrence of CDI in adult patients at high risk of CDI recurrence who are receiving antibacterial drug treatment for CDI. According to the applicant, the addition of ZINPLAVA TM to SOC antibacterial drug treatment reduces CDI recurrence by providing passive immunity against Toxin B resulting from persistent or newly acquired C-diff spores. ZINPLAVA TM is used to treat the same or similar type of disease (recurrent CDI) and a similar patient population receiving SOC therapy for the treatment of recurrent CDI.

Based on the applicant's statements presented above, because ZINPLAVA TM has a unique mechanism of action, we do not believe that the technology is substantially similar to existing technologies and, therefore, meets the newness criterion. We are inviting public comments on whether ZINPLAVA TM meets the newness criterion.

With regard to the cost criterion, the applicant conducted the following analysis to demonstrate that the technology meets the cost criterion. In order to identify the range of MS-DRGs that cases representing potential patients who may be eligible for treatment using ZINPLAVA TM may map to, the applicant identified all MS-DRGs for patients diagnosed with CDI as a primary or secondary diagnosis. Specifically, the applicant searched the FY 2015 MedPAR file for claims that included target patients over 65 years of age and identified cases reporting diagnoses of CDI by ICD-9-CM diagnosis code 008.45 (Intestinal infection due to Clostridium difficile) as a primary or secondary diagnosis. This resulted in 139,135 cases across 543 MS-DRGs, with approximately 40 percent of all cases mapping to the following 12 MS-DRGs: MS-DRG 177 (Respiratory Infections and Inflammations with MCC); MS-DRG 193 (Simple Pneumonia and Pleurisy with MCC); MS-DRG 291(Heart Failure and Shock with MCC); MS-DRGs 371, 372, and 373 (Major Gastrointestinal Disorders and Peritoneal Infections with MCC, with CC, and without CC/MCC, respectively); MS-DRGs 682 and 683 (Renal Failure with MCC and with CC, respectively); MS-DRG 853 (Infectious and Parasitic Diseases with O.R. Procedure with MCC); MS-DRGs 870, 871, and 872 (Septicemia or Severe Sepsis with Mechanical Ventilation >96 Hours, with MCC, and without MCC, respectively).

Using the 139,135 identified cases, the average unstandardized case-weighted charge per case was $80,677. The applicant then standardized the charges. The applicant did not remove charges for the current treatment because, as discussed above, ZINPLAVA TM will be used concomitantly with SOC antibacterial treatments for the treatment of CDI as an additive, or adjunctive treatment option, to reduce the recurrence of CDI infection. The applicant then applied the 2-year inflation factor of 1.098446 from the FY 2017 IPPS/LTCH final rule (81 FR 57286) to inflate the charges from FY 2015 to FY 2017. The applicant noted that the anticipated price for ZINPLAVA TM has yet to be determined; therefore, no charges for ZINPLAVA TM were added in the analysis. Based on the FY 2017 IPPS/LTCH PPS Table 10 thresholds, the average case-weighted threshold amount was $56,871. The inflated average case-weighted standardized charge per case was $78,929. Because the inflated average case-weighted standardized charge per case exceeds the average case-weighted threshold amount, the applicant maintained that the technology meets the cost criterion. The applicant noted that the inflated average case-weighted standardized charge per case exceeds the average case-weighted threshold amount without the average per patient cost of the technology. As such, the applicant anticipated that the inclusion of the cost of ZINPLAVA TM , at any price point, will further increase charges above the average case-weighted threshold amount. We are inviting public comments on whether ZINPLAVA TM meets the cost criterion.

With respect to the substantial clinical improvement criterion, the applicant asserted that the addition of ZINPLAVA TM to SOC antibacterial drug treatment reduces CDI recurrence because it provides passive immunity against Toxin B resulting from persistent or newly acquired C-diff spores.

The applicant conducted two Phase III studies, MODIFY I and MODIFY II. The primary endpoint of the studies was recurrent CDI within 12 weeks after completion of treatment with ZINPLAVA TM . The first study design initially included actoxumab, an antitoxin A monoclonal antibody treatment arm that was later discontinued due to a high failure rate and increase in mortality compared to other treatment arms.3 Clinical data on ZINPLAVA TM is provided exclusively from the FDA briefing document available on the FDA Web site at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee . Information is also provided in the package insert by the manufacturer, Merck & Company, Inc. The FDA briefing provided data on the safety and efficacy of ZINPLAVA TM . The FDA considered sustained clinical responses defined as clinical cure of the initial CDI episode and the absence of CDI recurrence as an appropriate endpoint to assess the efficacy of ZINPLAVA TM in the prevention of CDI recurrences.

Footnotes:

3 ?Wilcox MH et al. Bezlotoxumab for Prevention of Recurrent Clostridium difficile Infection. N Engl J Med. 2017 Jan 26;376(4):305-317.


[top] In MODIFY I trial, the clinical cure rate of the presenting CDI episode was lower in the ZINPLAVA TM arm as compared to the placebo arm, whereas in MODIFY II trial the clinical cure rate was lower in the placebo arm as compared to the ZINPLAVA TM arm. Additional analyses showed that, by 3 page 19880 weeks post study drug infusion, the clinical cure rates of the presenting CDI episode were similar between treatment arms.

In MODIFY I, the rate of sustained clinical response was numerically in favor of ZINPLAVA TM (60.1 percent) in comparison to placebo (55.2 percent) with an adjusted difference and 95 percent CI of 4.8 percent (-2.1 percent; 11.7 percent). In MODIFY II, the proportion of subjects with sustained clinical response in the ZINPLAVA TM arm (66.8 percent) was also higher than in the placebo arm (52.1 percent) with an adjusted difference of 14.6 percent and 95 percent CI (7.8 percent; 21.4 percent). The treatment did not significantly decrease mortality. Recurrence rates, including CDI-related hospital readmission rates, reportedly were between 10 and 25 percent. No clinically meaningful differences in the exposure of bezlotoxumab were found between patients 65 years of age and older and patients under 65 years of age.

In the Phase III trials, the safety profile of ZINPLAVA TM was similar overall to that of placebo. However, heart failure was reported more commonly in the two Phase III clinical trials of ZINPLAVA TM -treated patients compared to placebo-treated patients. These adverse reactions occurred primarily in patients with underlying congestive heart failure (CHF). In patients with a history of CHF, 12.7 percent (15/118) of ZINPLAVA TM -treated patients and 4.8 percent (5/104) of placebo-treated patients had the serious adverse reaction of heart failure during the 12-week study period. In addition, in patients with a history of CHF, there were more deaths in ZINPLAVA TM -treated patients (19.5 percent (23/118)) than in placebo-treated patients (12.5 percent (13/104)) during the 12-week study period. We are concerned regarding the safety of ZINPLAVA TM in patients diagnosed with CHF. In regard to safety, data from the MODIFY I and MODIFY II studies suggest few adverse events associated with ZINPLAVA TM , with no significant differences in the number of serious adverse events, deaths or discontinuations of study drug that occurred between the ZINPLAVA TM and the placebo groups. However, both the ZINPLAVA TM and the ZINPLAVA TM plus actoxumab treatment groups experienced more episodes of cardiac failure (defined as acute or chronic cardiac failure) then compared to the placebo group (2.2 percent versus 1 percent). We are unsure if the cardiac failure reported in the studies may be the result of a higher number of baseline patients with heart failure in the treatment arms or the result of an adverse effect to ZINPLAVA TM . Therefore, we are concerned with regard to the adverse event of cardiac failure of ZINPLAVA TM .

We are inviting public comments on whether ZINPLAVA TM meets the substantial clinical improvement criterion.

We did not receive any written public comments in response to the New Technology Town Hall meeting notice regarding the application of ZINPLAVA TM for new technology add-on payments.

b. EDWARDS INTUITY Elite TM Valve System (INTUITY) and LivaNova Perceval Valve (Perceval)

Two manufacturers, Edwards Lifesciences and LivaNova, submitted applications for new technology add-on payments for FY 2018 for the INTUITY Elite TM Valve System (INTUITY) and the Perceval Valve (Perceval), respectively. Both of these technologies are prosthetic aortic valves inserted using surgical aortic valve replacement (AVR). We note that, while Edwards Lifesciences submitted an application for new technology add-on payments for FY 2017 for the INTUITY valve, FDA approval was not received by July 1, 2016, and, therefore, the device was not eligible for consideration for new technology add-on payments for FY 2017.

Aortic valvular disease is relatively common, primarily manifested by aortic stenosis. Most aortic stenosis is due to calcification of the valve, either on a normal tri-leaflet valve or on a congenitally bicuspid valve. The resistance to outflow of blood is progressive over time, and as the size of the aortic orifice narrows, the heart must generate increasingly elevated pressures to maintain blood flow. Symptoms such as angina, heart failure, and syncope eventually develop, and portend a very serious prognosis. There is no effective medical therapy for aortic stenosis, so the diseased valve must be replaced or, less commonly, repaired.

The INTUITY valve incorporates the expansion feature of a catheter implanted valve, but is designed to be placed during cardiac surgery. The manufacturer explained that the INTUITY valve requires fewer stitches to hold the device in place because of the balloon expanded design and, therefore, can be inserted more quickly than a standard valve, and also facilitates minimally invasive cardiac surgery; that is, use of a smaller incision to allow faster recovery. The manufacturer of the INTUITY valve indicated that the device is comprised of: (1) A bovine pericardial aortic bioprosthetic valve; (2) a balloon expandable stainless steel frame; and (3) a textured sealing cloth. The manufacturer of the Perceval valve indicated that the Perceval valve device is comprised of: (1) Sizers used to determine the correct size of the prosthesis; (2) a dual holder used for positioning and deployment (available in two models, one for sternal approaches and one for MIS); (3) a "smart clip" to assist during assembly of the valve on the dual holder to prevent release during positioning; (4) a dual collapser used to evenly reduce the diameter of the prosthesis allowing it to mount onto the holder prior to implantation; (5) a dual collapser base used to allow proper positioning; and (6) a postdilation catheter used for in situ dilation of the prosthesis after implantation (available in two models, one for sternal approaches and one for MIS). According to both applicants, the INTUITY valve and the Perceval valve are the first sutureless, rapid deployment aortic valves that can be used for the treatment of patients who are candidates for surgical AVR. The applicants indicated that the two new device innovations facilitate MIS approaches through: (1) The device rapid deployment mechanisms; and (2) the design of the prosthetic valve that allows for markedly fewer to no sutures to securely fasten the prosthetic valve to the aortic orifice. The applicants explained that both of these aspects of their devices are credited with the reduction of operating time.

As noted, according to both applicants, the INTUITY valve and the Perceval valve are the first sutureless, rapid deployment aortic valves that can be used for the treatment of patients who are candidates for surgical AVR. Because potential cases representing patients who are eligible for treatment using the INTUITY and the Perceval aortic valve devices would group to the same MS-DRGs, and we believe that these devices are intended to treat the same or similar disease in the same or similar patient population, and are purposed to achieve the same therapeutic outcome using the same or similar mechanism of action, we believe these two devices are substantially similar to each other and that it is appropriate to evaluate both technologies as one application for new technology add-on payments under the IPPS.


[top] With respect to the newness criterion, the INTUITY valve received FDA approval on August 12, 2016, and was commercially available on the U.S. market on August 19, 2016. The Perceval valve received FDA approval page 19881 on January 8, 2016, and was commercially available on the U.S. market on February 29, 2016. We believe that, in accordance with our policy, it is appropriate to use the earliest market availability date submitted as the beginning of the newness period. Therefore, based on our policy, with regard to both devices, if the technologies are approved for new technology add-on payments, we believe that the beginning of the newness period would be February 29, 2016. In addition, both applicants indicated that ICD-10-PCS code X2RF032 (Replacement of Aortic Valve using Zooplastic Tissue, Rapid Deployment Technique, Open Approach, New Technology Group 2) would identify procedures involving the use of the devices when surgically implanted.

We previously stated that, because we believe these two devices are substantially similar to each other, we believe it is appropriate to evaluate both technologies as one application for new technology add-on payment under the IPPS. The applicants submitted separate cost and clinical data, and we reviewed and discuss each set of data separately. However, we intend to make one determination regarding new technology add-on payments that will apply to both devices. We believe that this is consistent with our policy statements in the past regarding substantial similarity. Specifically, we have noted that approval of new technology add-on payments would extend to all technologies that are substantially similar (66 FR 46915), and we believe that continuing our current practice of extending new technology add-on payments without a further application from the manufacturer of the competing product, or a specific finding on cost and clinical improvement if we make a finding of substantial similarity among two products is the better policy because we avoid-

• Creating manufacturer-specific codes for substantially similar products;

• Requiring different manufacturers of substantially similar products to submit separate new technology applications;

• Having to compare the merits of competing technologies on the basis of substantial clinical improvement; and

• Bestowing an advantage to the first applicant representing a particular new technology to receive approval (70 FR 47351).

If these substantially similar technologies were submitted for review in different (and subsequent) years, rather than the same year, we would evaluate and make a determination on the first application and apply that same determination to the second application. However, because the technologies have been submitted for review in the same year, we believe that it is appropriate to consider both sets of cost data and clinical data in making a determination and we do not believe that it is possible to choose one set of data over another set of data in an objective manner.

As stated above, we believe that the INTUITY valve and the Perceval valve are substantially similar to each other for purposes of analyzing these two applications as one application. We also need to determine whether the INTUITY valve and the Perceval valve are substantially similar to existing technologies prior to their approval by the FDA and their release on the market. As discussed earlier, if a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and would not be considered "new" for purposes of new technology add-on payments.

With respect to the first criterion, whether a product uses the same or a similar mechanism of action to achieve a therapeutic outcome, the applicant for the INTUITY valve asserted that its unique design, which utilizes features that were not previously included in conventional aortic valves, constitutes a new mechanism of action. The deployment mechanism allows for rapid deployment. The expandable frame can reshape the native valve's orifice, creating a larger and more efficiently shaped effective orifice area. In addition, the expandable skirt allows for structural differentiation upon fixation of the valve requiring 3 permanent, guiding sutures rather than the 12 to 18 permanent sutures used to fasten standard prosthetic aortic valves. The applicant for the Perceval valve described the Perceval valve's mechanism of action as including: (a) No permanent sutures; (b) a dedicated delivery system that increases the surgeon's visibility; (c) an enabler of minimally invasive approach; (d) a complexity reduction and reproducibility of the procedure; and (e) a unique device assembly and delivery systems.

With respect to the second and third criteria, whether a product is assigned to the same or a different MS-DRG and whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population, the applicant for the INTUITY valve indicated that the technology is used in the treatment of the same patient population and potential cases representing patients that may be eligible for treatment using the INTUITY valve would be assigned to the same MS-DRGs as cases involving the use of other prosthetic aortic valves (that is, MS-DRGs 216 (Cardiac Valve & Other Major Cardiothoracic Procedures with Cardiac Catheterization with MCC), 217 (Cardiac Valve & Other Major Cardiothoracic Procedures with Cardiac Catheterization with CC), 218 (Cardiac Valve & Other Major Cardiothoracic Procedures with Cardiac Catheterization without CC/MCC), 219 (Cardiac Valve & Other Major Cardiothoracic Procedures without Cardiac Catheterization with MCC), 220 (Cardiac Valve & Other Major Cardiothoracic Procedures without Cardiac Catheterization with CC), and 221 (Cardiac Valve & Other Major Cardiothoracic Procedures without Cardiac Catheterization without CC/MCC). The applicant for the Perceval valve also indicated that the Perceval valve device is used in the treatment of the same patient population and potential cases representing patients that may be eligible for treatment using the technology would be assigned to the same MS-DRGs (MS-DRGs 216 through 221) as cases involving the use of other prosthetic aortic valves.

After considering the materials included with both applications, we remain concerned as to whether the mechanism of action described by the applicants represents an improvement to an existing surgical technique and technology or a new technology. While the INTUITY and Perceval valves address some of the challenges posed by implantation of existing valves, including improving the visibility of the orifice and the physiological function of the valves, we do not believe that their mechanisms of action are fundamentally different from that of other aortic valves. As one of the applicants stated in its application, the goal of the prosthetic aortic valve is to mimic the native valve that it has replaced via the incorporation of three leaflets that open and close in response to pressure gradients developed during the cardiac cycle. We believe that the INTUITY and Perceval valves are the same or similar to other prosthetic aortic valves used to treat the same or similar diagnoses.

We are inviting public comments on whether the mechanisms of action of the sutureless, rapid deployment of the INTUITY and Perceval valves differs from the mechanism of action of standard AVR valves and whether the technologies meet the newness criterion.


[top] As we stated above, each applicant submitted separate analyses regarding the cost criterion for each of their devices, and both applicants maintained page 19882 that their device meets the cost criterion. We summarize each analysis below.

With regard to the cost criterion, the INTUITY valve's applicant researched the FY 2015 MedPAR claims data file to identify cases representing patients who may be potential recipients of treatment using the INTUITY valve. The applicant identified claims that reported an ICD-9-CM diagnosis code of 424.1 (Aortic valve disorder), in combination with an ICD-9-CM procedure code of 35.21 (Replacement of aortic valve with tissue) or 35.22 (Open and other replacement of aortic valve). The applicant also identified cases with or without a coronary artery bypass graft (CABG) using the ICD-9-CM procedure codes in the table below.

ICD-9-CM code Code description
36.10 Aortocoronary bypass for heart revascularization, not otherwise specified.
36.11 (Aorto)coronary bypass of one coronary artery.
36.12 (Aorto)coronary bypass of two coronary arteries.
36.13 (Aorto)coronary bypass of three coronary arteries.
36.14 (Aorto)coronary bypass of four or more coronary arteries.
36.15 Single internal mammary-coronary artery bypass.
36.16 Double internal mammary-coronary artery bypass.
36.17 Abdominal-coronary artery bypass.

The applicant identified a total of 25,173 cases that mapped to MS-DRGs 216 through 221. Of these cases, the applicant identified 10,251 CABG cases and 14,922 non-CABG cases. According to the applicant, patients that undergo a procedure without need of a concomitant CABG are more likely to receive treatment with the INTUITY valve than patients in need of a concomitant CABG. Therefore, the applicant weighted the non-CABG cases at 90 percent of total cases and the CABG cases at 10 percent of total cases under each of the six MS-DRGs. The final case count is a weighted average of 14,455 cases.

The applicant calculated an average unstandardized charge per case of $192,506 for all cases. The applicant then removed 100 percent of the charges for pacemakers, investigational devices, and other implants that would not be required for patients receiving treatment using the INTUITY valve. The applicant standardized the charges and then applied an inflation factor of 1.098446, which is the 2-year inflation factor in the FY 2017 IPPS/LTCH PPS final rule (81 FR 57286), to update the charges from FY 2015 to FY 2017. The applicant calculated the average expected charge for the INTUITY valve based on the current list price of the device. Although the applicant submitted data related to the cost of the INTUITY valve, the applicant noted that the cost of the device is proprietary information. To add charges for the device, the applicant assumed a hospital mark-up of approximately 3.00 percent, based on the current average CCR for implantable devices (0.331) as reported in the FY 2017 IPPS/LTCH PPS final rule (81 FR 56876). Based on the FY 2017 IPPS/LTCH PPS Table 10 thresholds, the average case-weighted threshold amount was $170,321. The applicant computed an inflated average case-weighted standardized charge per case of $194,291, which is $23,970 above the average case-weighted threshold amount. Because the inflated average case-weighted standardized charge per case exceeds the average case-weighted threshold amount, the applicant maintained that the technology meets the cost criterion.

We thank the applicant for the analysis above. However, we would like more information from the applicant regarding how it decided upon which cases to include in the sensitivity analysis, as well as further details about how and on what basis the applicant weighted CABG and non-CABG cases. We are inviting public comments on whether the INTUITY valve meets the cost criterion.

With regard to the cost criterion in reference to the Perceval valve, the applicant conducted the following analysis. The applicant examined FY 2015 MedPAR claims data that included cases reporting an ICD-9 procedure code of 35.21 or 35.22, in combination with diagnosis code: 424.1. Noting that MS-DRGs 216 through 221 contained 97 percent of these cases, the applicant limited its analysis to these 6 MS-DRGs. The applicant identified 25,193 cases across these MS-DRGs, resulting in an average case-weighted unstandardized charge per case of $173,477. The applicant then standardized charges using FY 2015 standardization factors and applied an inflation factor of 1.089846 from the FY 2017 IPPS/LTCH proposed rule (81 FR 25271). The applicant indicated that the technology meets the cost criterion by applying the inflation factor from the proposed rule and, therefore, would meet the cost criterion by applying the higher inflation factor from the final rule.

Included in the average case-weighted standardized charge per case were charges for the current valve prosthesis. Therefore, the applicant removed all charges associated with revenue center 0278, and calculated the adjusted average case-weighted standardized charge per case by subtracting these charges from the standardized charge per case. The applicant then added the charge for the new technology by taking the anticipated hospital cost of the new technology and dividing it by the national average implantable devices CCR of 0.331. The applicant then added the charge for the new technology to the inflated average case-weighted standardized charges per case to arrive at the final inflated average case-weighted standardized charge per case, which was then case-weighted based on the distribution of cases within the six MS-DRGs. This resulted in an inflated average case-weighted standardized charge per case of $206,109. Using the FY 2017 IPPS Table 10 thresholds, the average case-weighted threshold amount was $173,477. Because the inflated average case-weighted standardized charge per case exceeds the average case-weighted threshold amount, the applicant maintained that the technology meets the cost criterion. We are inviting public comments on whether the Perceval technology meets the cost criterion.


[top] With regard to substantial clinical improvement for the INTUITY valve, the applicant asserted that several aspects of the valve system represent a substantial clinical improvement over existing technologies. The applicant believed that the flexible deployment arm allows improved surgical access and visualization, making the surgery less challenging for the surgeon, improving the likelihood that the surgeon can use a minimally invasive approach. According to the applicant, the assembly of the device only allows the correct valve size to be fitted, which ensures that the valve does not slip or page 19883 migrate, which prevents paravalvular leaks and patient prosthetic mismatch. The applicant indicated that the device improves clinical outcomes for patients undergoing minimally invasive AVR and full-sternotomy AVR. The applicant stated that the rapid deployment technology enables reduced operative time, specifically cross-clamp time, thereby reducing the period of myocardial ischemia. In addition, the applicant indicated that the device offers a reduction in operative time for full-sternotomy AVR. The applicant noted that clinical results document significant patient outcome and utilization improvements, including improved patient satisfaction, faster return to normal activity, decreased post-operative pain, reduced mortality and decreased complications, including need for reoperation due to bleeding, reduced recovery time, reduced length of stay (both ICU and overall), more access to minimally invasive surgery, and improved hemodynamics.

The INTUITY valve has been tested clinically in several trials. In the TRITON trial (Kocher et al., 2013?4), 287 patients diagnosed with aortic stenosis underwent surgery in 1 of 6 European centers. The first 149 patients received the first generation Model 8300A valve, and the next 138 patients received the second generation Model 8300AB. The average age of the patients was 75.7 years. Early, 30-day mortality was 1.7 percent (5/287), the post-op valve gradient was low, and 75 percent of the patients improved functionally. A total of 4 valves were explanted in the final 30 days due to bleeding, and 3 were explanted later for paravalvular leak, endocarditis, and aortic root aneurysms. Follow-up extended to 3 years (mean 1.8 years).

Footnotes:

4 ?Kocher AA, Laufer G, Haverich A, et al. One-year outcomes of the surgical treatment of aortic stenosis with a next generation surgical aortic valve (TRITON) trial: A prospective multicenter study of rapid-deployment aortic valve replacement with the EDWARDS INTUITY valve system. J Thorac Cardiovasc Surg 2013;145:110-116.

Implantation of the INTUITY valve using minimally invasive surgery was compared with conventional aortic valve replacement via full sternotomy in the CADENCE-MIS randomized trial (Borger et al., 2015?5) of 100 patients treated in 1 of 5 centers in Germany. The authors found no significant difference in 30-day mortality, the need for pacemaker implantation, significant paravalvular regurgitation, and quality of life scores at 3 months. Aortic cross-clamp time was significantly reduced from 54.0 to 41.3 minutes (p < 0.0001), and cardiopulmonary bypass time was reduced from 74.4 to 68.8 minutes (p = 0.21). Early clinical outcomes were similar: No significant differences in mortality, reoperation, or other clinical outcomes. The aortic valve gradient was significantly lower in the MIS group: 8.5 versus 10.3 mmHg.

Footnotes:

5 ?Borger MA, Moustafine V, Conradi L, et al. A randomized multicenter trial of minimally invasive rapid deployment versus conventional full sternotomy aortic valve replacement. Ann Thorac Surg 2015; 99:17-25.

The TRANSFORM trial (Barnhart et al. 2017?6) was a single-arm, non-randomized, multicenter trial, in which 839 patients underwent rapid deployment AVR surgery. The average age of the patients was 73.5 years. The mean cross-clamp time and cardiopulmonary bypass times for full sternotomy were 49.3 ± 26.9 min and 69.2 ± 34.7 min, respectively, and for MIS, 63.1 ± 25.4 min and 84.6 ± 33.5 min, respectively. The authors compared these times to STS database comparators: For full sternotomy, 76.3 minutes and 104.2 minutes, respectively, and for MIS, 82.9 minutes and 111.4 minutes, respectively. All cause early mortality was 0.8 percent, mean EOA at 1 year was 1.7 cm2 ; mean gradient, 10.3 mmHg; and moderate and severe PVL, 1.2 percent and 0.4 percent, respectively. The authors indicated that the INTUITY valve ". . . may lead to a relative reduction in aortic cross-clamp time and cardiopulmonary bypass time" and "may confer benefits to patients, such as decreased mortality and morbidity." The authors noted the possibility of potential bias resulting from the level of experience of the study surgeons relative to typical cardiac surgeons. In addition, long-term follow-up is not available, and study comparators from the Society of Thoracic Surgeons (STS) database were not matched.

Footnotes:

6 ?Barnhart, G. A. et al. (2017). TRANSFORM (Multicenter Experience with Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve. The Journal of Thoracic and Cardiovascular Surgery, 153, 241-251.

In the FY 2017 IPPS/LTCH PPS proposed rule (81 FR 25057), after reviewing the studies provided by the applicant with its application for FY 2017, we expressed some specific concerns. We indicated that we were concerned that the INTUITY valve does not have sufficient advantages over alternative surgically implanted valves to constitute a substantial clinical improvement. We noted that, while some of the studies included with the application demonstrate reduced aortic cross-clamp time, conventional aortic valve replacement was used in the comparison group. Therefore, it is unclear whether the reduced aortic cross-clamp time is associated with the use of the INTUITY valve or as a result of the MIS surgery in general.

In response to these concerns, the INTUITY valve's applicant stated that the INTUITY valve is associated with significant clinical benefits outside of the benefits achieved by use of an MIS approach. The applicant referenced the sub-study of the TRANSFORM trial, which compared the MISAVR with the INTUITY valve to MISAVR with a conventional valve, stating that the results indicated reduced cross-clamp time and other benefits that are not simply a function of the MIS approach. The applicant also referenced trials that indicated that the INTUITY valve had excellent hemodynamic performance (Haverich et al.,7 Borger et al.,8 Barnhart et al.9), one of which found a significant improvement in functional status (Haverich et al.).

Footnotes:

7 ?Haverich, A, et al. (2014), Three-year hemodynamic performance, left ventricular mass regression, and prosthetic-patient mismatch after rapid deployment aortic valve replacement in 287 patients. J Thorac Cardiovasc Surg, 148(6), 2854-60.

8 ?Borger MA, Moustafine V, Concadi L, et al. A randomized multicenter trial of minimally invasive rapid deployment versus conventional full sternotomy aortic valve replacement. Ann Thorac Surg 2015; 99:17-25.

9 ?Barnhart, G.A. et al. (2017). TRANSFORM (Multicenter Experience with Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve. The Journal of Thoracic and Cardiovascular Surgery, 153, 241-251.

After considering the studies provided by the INTUITY valve applicant, we are concerned about the possibility of potential bias resulting from the level of experience of the study surgeons relative to typical cardiac surgeons, as well as the lack of long-term follow-up in these studies.

With regard to substantial clinical improvement for the Perceval valve, the applicant submitted several studies examining the Perceval valve. The following discussion summarizes some of these studies.


[top] Pollari and colleagues?10 (2014) utilized a propensity score analysis to examine 82 matched pairs as part of a larger trial that included 566 patients treated with bioprosthetic aortic valve replacement, 166 of which received treatment using the Perceval sutureless valve and 400 of which received treatment using a stented valve. Aortic cross-clamp, cardiopulmonary bypass, and operation times were significantly shorter in the group that received treatment using the Perceval sutureless page 19884 valve. The Perceval sutureless group also had shorter ICU stays, hospital stays, and intubation times, and lower incidence of postoperative atrial fibrillation and respiratory insufficiency. The authors noted that, despite the promising preliminary results, longer follow-up is warranted before drawing definite conclusions.

Footnotes:

10 ?Pollari, F. (2014), Better short-term outcome by using sutureless valves: a propensity-matched score analysis, Ann Thorac Surg, 98; 611-6.

In a nonrandomized trial of 100 patients in a German hospital, Santarpino and colleagues?11 (2013) found that procedures completed using the Perceval valve were associated with significantly shorter cross-clamp and cardiopulmonary bypass times (40 ± 13.8 and 69 ± 19.1 versus 66 ± 20.4 and 105 ± 34.8) relative to conventional stented bioprosthetic valves, as well as less frequent use of blood transfusions, shorter ICU stays and shorter use of intubation. In contrast, Gilmanov and colleagues?12 (2013) found that a MIS approach resulted in improved outcomes, albeit longer aortic cross-clamp times. A meta-analysis by Hurley and colleagues?13 (2015) found reduced cross-clamp and cardiopulmonary bypass times, but found a significantly higher permanent pacemaker rate with the use of Perceval sutureless valves.

Footnotes:

11 ?Santarpino, G. et al. (2013), The Perceval S aortic valve has the potential of shortening surgical time: Does it also result in improved outcome?, Ann Thorac Surg, 96, 77-81.

12 ?Gilmanov, D. (2013), Minimally invasive and conventional aortic valve replacement: a propensity score analysis, Ann Thorac Surg, 96, 837-843.

13 ?Hurley et al, "A Meta-Analysis Examining Differences in Short-Term Outcomes Between Sutureless and Conventional Aortic Valve Prostheses," Innovations 2015; 10:375-382.

A study conducted by Dalen and colleagues?14 (2015) used propensity score matching to examine early post-operative outcomes and 2-year survival between 171 pairs of patients who underwent ministernotomy using the Perceval device or a full sternotomy with stented prosthesis. There were no differences in 30-day mortality or 2-year survival between the groups. The aortic cross-clamp time and cardiopulmonary bypass time were shorter, and there were fewer blood transfusions in the group that received treatment using the Perceval device. However, this group was also at higher risk for post-operative permanent pacemaker implantation.

Footnotes:

14 ?Dalén, M. (2015), Aortic valve replacement through full sternotomy with a stented bioprosthesis versus minimally invasive sternotomy with a sutureless bioprosthesis, Eur J Cardiothorac Surg 2015; doi:10.1093/ejcts/ezv014.

After reviewing the publications submitted by the applicant, we are concerned that the lack of randomization and blinded investigators may have influenced the outcomes in many of the studies provided. For example, in the discussion following Santarpino et al.'s 2013 study, one of the participants suggested that medical decision-making regarding ventilation times, ICU times, and blood transfusions may be affected by the knowledge of investigators as to which valve the patient received treatment using. Also, as indicated above with respect to the INTUITY valve, the experience of the surgeons in these studies may be confounding factors that may have influenced the length of surgical procedures and/or surgical outcomes.

We are inviting public comments on whether rapid deployment valves, specifically the INTUITY and Perceval valves, meet the substantial clinical improvement criterion.

We did not receive any written public comments regarding the INTUITY and Perceval valves in response to the New Technology Town Hall meeting notice.

c. Ustekinumab (Stelara®)

Janssen Biotech submitted an application for new technology add-on payments for the Stelara® induction therapy for FY 2018. Stelara® received FDA approval as an intravenous (IV) infusion treatment of Crohn's disease (CD) on September 23, 2016, which added a new indication for the use of Stelara® and route of administration for this monoclonal antibody. IV infusion of Stelara® is indicated for the treatment of adult patients (18 years and older) diagnosed with moderately to severely active CD who have: (1) Failed or were intolerant to treatment using immunomodulators or corticosteroids, but never failed a tumor necrosis factor (TNF) blocker; or (2) failed or were intolerant to treatment using one or more TNF blockers. Stelara® for IV infusion has only one purpose, induction therapy. Stelara® must be administered intravenously by a health care professional in either an inpatient hospital setting or an outpatient hospital setting.

Stelara® for IV infusion is packaged in single 130mg vials. Induction therapy consists of a single IV infusion dose using the following weight-based dosing regimen: Patients weighing less than (<) 55kg are administered 260mg of Stelara® (2 vials); patients weighing more than (>) 55kg, but less than (<) 85kg are administered 390mg of Stelara® (3 vials); and patients weighing more than (>) 85kg are administered 520mg of Stelara® (4 vials). An average dose of Stelara® administered through IV infusion is 390mg (3 vials). Maintenance doses of Stelara® are administered at 90mg, subcutaneously, at 8-week intervals and may occur in the outpatient hospital setting.

CD is an inflammatory bowel disease of unknown etiology, characterized by transmural inflammation of the gastrointestinal (GI) tract. Symptoms of CD may include fatigue, prolonged diarrhea with or without bleeding, abdominal pain, weight loss and fever. CD can affect any part of the GI tract including the mouth, esophagus, stomach, small intestine, and large intestine.

Conventional pharmacologic treatments of CD include antibiotics, mesalamines, corticosteroids, immunomodulators, tumor necrosis alpha (TNFa) inhibitors, and anti-integrin agents. Surgery may be necessary for some patients diagnosed with CD in which conventional therapies have failed. The applicant asserted that use of Stelara® offers an alternative to conventional pharmacologic treatments, and has been shown to be successful in the treatment of patients who have failed treatment using the conventional agents currently being used for a diagnosis of CD, including TNFa inhibitors.

Although the precise cause of CD is unknown, the environment, genetics, and the patient's immune system are thought to play a role in this form of inflammatory bowel disease (IBD). Conventional pharmacologic therapy is directed against many different inflammatory mediators that produce inflammation and ultimately lead to gastrointestinal damage. The applicant asserted that it is of paramount importance to have a variety of pharmacologic agents that can address the proper inflammatory mediator for a particular patient. The applicant also asserted that, while the currently available anti-inflammatory agents used in the treatment of a diagnosis of CD are excellent medications, these agents do not successfully treat all patients diagnosed with CD, nor do they reliably sustain disease remission once a response has been achieved. The applicant believed that the use of Stelara® offers an alternative to currently available treatment options.


[top] With regard to the newness criterion, Stelara® is not a newly formulated drug. Stelara®, administered subcutaneously, received FDA approval in 2009 (September 25, 2009) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults. Its IV use for the treatment of patients diagnosed with CD was approved by the FDA in 2016 (September 23, 2016). With regard to the new use of an existing technology, in the September 1, 2001 final rule (66 FR 46915), we stated that if the new use of an existing technology was for treating patients not expected to page 19885 be assigned to the same MS-DRG as the patients receiving the existing technology, it may be considered for approval, but it must also meet the cost and substantial clinical improvement criteria in order to qualify for the new technology add-on payment. We do not believe that potential cases representing patients that may be eligible for treatment with the new use of the Stelara® for IV treatment of a diagnosis of CD would be assigned to the same MS-DRGs as cases treated using the prior indications.

As discussed above, if a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and would not be considered "new" for purposes of new technology add-on payments.

With regard to the first criterion, whether a product uses the same or a similar mechanism of action to achieve a therapeutic outcome, we are concerned that Stelara®'s mechanism of action does not appear to differ from the mechanism of action of other monoclonal antibodies, which also target unique gastrointestinal-selective cytokines. The applicant believed that the Stelara® uses a different mechanism of action than other medications currently available for the treatment of patients diagnosed with CD. However, we believe that the mechanism of action for the new use of the Stelara® may be similar to the mechanism of action of other cytokine-selective monoclonal antibodies that disrupt cytokine mediated signals crucial to the inflammatory process in patients diagnosed with CD.

The applicant stated that the Stelara® is a human IgG1? monoclonal antibody that binds with specificity to the p40 protein subunit, which is common to both the interleukin-12 (IL-12) and interleukin (IL-23) cytokines. IL-12 and IL-23 are naturally occurring cytokines that are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. In in vitro models, the Stelara® was shown to disrupt IL-12 and IL-23 mediated signaling and cytokine cascades by blocking the interaction of these cytokines with a shared cell-surface receptor chain, IL-12Rß1. The cytokines IL-12 and IL-23 have been implicated as important contributors to chronic inflammation. According to the applicant, IV induction therapy quickly achieves optimal blood levels of Stelara® so that blockade of IL-12 and IL-23 is most effective. This level of blockade is not achieved with subcutaneous administration.

The applicant further stated that other available CD anti-inflammatory or immune modulator therapies do not target the IL-12/IL-23p40 substrate. Rather, these therapies may target other integrin pairs such as the alpha4- beta7 integrins. Therefore, the applicant believed that the Stelara® drug is not substantially similar to any other approved drug for the treatment of moderately to severely active CD. As previously noted, the applicant asserted that, while the currently available agents are excellent medications, these agents do not successfully treat all patients diagnosed with CD, nor do these agents reliably sustain remission once a clinical response has been achieved. According to the applicant, the new use of the Stelara® offers an alternative to currently available treatment options, and has been shown to be successful in the treatment of patients who have failed treatment with the conventional agents currently being used for a diagnosis of CD, including TNF blockers. We are concerned that the Stelara®'s mechanism of action is similar to that of other immune system suppressors used in the treatment of patients diagnosed with moderately to severely active CD because other cytokine-selective monoclonal antibodies also disrupt cytokine mediated signals crucial to the inflammatory process in patients diagnosed with CD.

With respect to the second criterion, whether a product is assigned to the same or a different MS-DRG, the applicant maintained that MS-DRGs 386, 387, and 385 (Inflammatory Bowel Disease with CC, without CC/MCC, and with MCC, respectively) and MS-DRGs 330, 329 and 331 (Major Small and Large Bowel Procedures with CC, without CC/MCC, and with MCC, respectively) are used to identify cases representing patients who may potentially be eligible for treatment using the Stelara®. The applicant researched claims data from the FY 2015 MedPAR file and found 10,344 cases. About 85 percent of potentially eligible cases mapped to MS-DRGs for inflammatory bowel disease and most of the remainder of cases mapped to MS-DRGs for bowel surgery. We believe that potential cases involving Stelara® induction therapy may be assigned to the same MS-DRGs as cases representing patients who have been treated using currently available treatment options.


[top] With respect to the third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population, according to the applicant, currently available pharmacologic treatments include antibiotics, mesalamines, corticosteroids, immunomodulators, tumor necrosis alfa (TNFa) inhibitors and anti-integrins. The applicant stated that the new use of the Stelara® for IV infusion is indicated for the treatment of adults (18 years and older) diagnosed with moderately to severely active CD who have: (1) Failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed treatment using a TNF blocker; or (2) failed or were intolerant to treatment with one or more TNF blockers. The applicant asserted that Stelara® for induction therapy is not substantially similar to other treatment options because it does not involve the treatment of the same or similar type of patient population. Patients who are eligible for treatment using the Stelara® induction therapy have failed other CD treatment modalities. The applicant believed that the subset of primary and secondary nonresponder patients to TNF inhibitor treatments is a patient population unresponsive to, or ineligible for, currently available treatments for diagnoses of moderate to severe CD. Based on the indications for the use of Stelara®, there is a class of patients who failed, or were intolerant to, treatment using immunomodulators or corticosteroids, but never failed treatment using a TNF blocker. The applicant indicated that, for those patients who never failed treatment with a TNF blocker, this class of patients can be recognized as two separate patient populations: One population of patients who have never received treatment using a TNF blocker, or the other population of patients who have received and responded to treatment using a TNF blocker. We believe that, if the new use of the Stelara® has the same mechanism of action as other immune system suppressors such as TNF blockers, the patient population that did not receive treatment using a TNF blocker may not be a new patient population because those patients may be able to receive treatment using, and would successfully respond to treatment using, a TNF blocker. Moreover, if the mechanism of action is the same as other immune system suppressors, we believe that the new use of the Stelara® may be targeted at a new patient population in some circumstances and instances, but we are concerned that it may not be targeted at a new patient population in all circumstances and instances. page 19886

We are inviting public comments on whether the Stelara® meets the newness criterion.

With regard to the cost criterion, the applicant conducted the following analysis to demonstrate that Stelara® meets the cost criterion. The applicant searched claims from the FY 2015 MedPAR file for cases with a principal ICD-9-CM diagnosis of 555.x (Regional Enteritis), which are cases of a diagnosis of Crohn's Disease that may be eligible for treatment using Stelara®.

The applicant identified 10,344 cases that mapped to 35 MS-DRGs. Approximately 85 percent of cases mapped to the following Inflammatory Bowel MS-DRGs: MS-DRGs 385 (Inflammatory Bowel Disease with MCC), 386 (Inflammatory Bowel Disease with CC), and 387 (Inflammatory Bowel Disease without CC/MCC). Similarly, 11 percent of the cases mapped to the following MS-DRGs for bowel surgery: MS-DRGs 329 (Major Small and Large Bowel Procedures with MCC), 330 (Major Small and Large Bowel Procedures with CC), and 331 (Major Small and Large Bowel Procedures without CC/MCC). The remaining cases (4 percent) represented all other digestive system disorders.

Using the 10,344 identified cases, the average unstandardized case-weighted charge per case was $39,935. The applicant then standardized the charges. The applicant did not remove charges for the current treatment because as discussed above Stelara® is indicated for use in patients who fail other treatments. The applicant then applied the 2-year inflation factor of 1.098446 from the FY 2017 IPPS/LTCH final rule (81 FR 57286) to inflate the charges from FY 2015 to FY 2017. The applicant then added charges for the Stelara® technology. Specifically, the applicant assumed that hospitals would mark up Stelara® IV to the same extent that they currently mark-up Stelara® SC (J3357, ustekinumab, 1 mg). The applicant used the actual hospital mark-up based on charges in the 2017 OPPS proposed rule file (OPPS claims incurred and paid in CY 2015). Based on the FY 2017 IPPS/LTCH PPS Table 10 thresholds, the average case-weighted threshold amount was $55,023. The inflated average case-weighted standardized charge per case was $69,826. Because the inflated average case-weighted standardized charge per case exceeds the average case-weighted threshold amount, the applicant maintained that the technology meets the cost criterion. We are inviting public comments whether Stelara® meets the cost criterion.

With regard to the third criterion, whether a technology represents a substantial clinical improvement over existing technologies, according to the applicant, the new use of the Stelara® has been shown to produce clinical response and remission in patients diagnosed with moderate to severe CD who have failed treatment using conventional therapies, including antibiotics, mesalamine, corticosteroids, immunomodulators, and TNFa inhibitors. Stelara® has been commercially available on the U.S. market for the treatment of patients diagnosed with psoriasis (PsO) since 2009 and the treatment of patients diagnosed with psoriatic arthritis (PsA) since 2013, and the applicant has maintained a safety registry, which enrolled over 12,000 patients since 2007. According to the applicant, the drug has been extremely well-tolerated, and the safety profile in patients diagnosed with CD has been consistent with that experienced in cases representing patients diagnosed with PsO and PsA.

The applicant presented the results of three pivotal trials involving over 1,300 patients diagnosed with moderate to severe CD. All three trials utilized a multicenter, double-blind, placebo controlled study design. There were two single-dose IV induction trials, which included patients who had failed treatment using one or more TNFa inhibitors (UNITI-1) (N= 741), and patients who had failed treatment using corticosteroids and/or immunomodulators (UNITI-2) (N =628). Responders to the single IV induction dose were then eligible to be enrolled in a maintenance trial (IM-UNITI) (N= 397), which began 8 weeks after administration of the single IV induction dose. IM-UNITI patients were given subcutaneous Stelara® and were treated for 44 weeks. Over half of the patients treated with 90mg of Stelara® every 12 weeks were able to achieve remission; a highly significant response compared to placebo, according to the applicant. The results of these trials have been published by the New England Journal of Medicine and the applicant provided the published studies.15 The published study supported the applicant's assertion that Stelara® single IV dose induces response and remission in patients diagnosed with moderately to severely active CD that is refractory to either TNF antagonists or conventional therapy. Of the patients in the IM-UNITI trial receiving subcutaneous Stelara® at 8 weeks or 12 weeks, 53.1 percent and 48 percent, respectively, were in remission at week 44 as compared with 35.9 percent of those patients receiving treatment using placebo.

Footnotes:

15 ?Feagan, W.J., et al. (2016) Ustekinumab as Induction and Maintenance Therapy for Crohn' Disease. The New England Journal of Medicine. 2016 Nov 17; 3745(20):1946-60.

The applicant submitted published results of a multicenter, double-blind, placebo controlled Phase III study of Stelara®.16 We are concerned that the study did not effectively establish the need for Stelara® induction therapy. Also, the median age of patients in the study was 37 years, and we are concerned that the study did not include a significant amount of older patients.

Footnotes:

16 ?Ibid.

We also are concerned that we do not have enough information to determine that the new use of the Stelara® is a substantial clinical improvement over existing technologies for the treatment of moderate to severe CD. We note that the UNITI-1, UNITI-2, and IMUNITI trials were completed to evaluate efficacy and safety of Stelara®, not superiority of Stelara® to current conventional therapy. Our concerns are based on a lack of head-to-head trials comparing IV induction and maintenance Stelara® therapy with conventional therapy in patients diagnosed with moderate to severe CD that are also primary and secondary nonresponders to treatment using TNF alpha inhibitor?17 therapy. We recognize the subset of primary and secondary nonresponder patients to

Footnotes:

17 ?Ibid.


[top] TNF inhibitor treatments as a patient population unresponsive to, or ineligible for, currently available treatments for diagnoses of moderate to severe CD. However, we believe that this primary and secondary TNF alpha inhibitor non-responder patient population represents patients that experience a gap in treatment for diagnoses of moderate to severe CD. Specifically, we recognize the nonresponder patient population as described by Simon et al.18 as those patients who are TNF inhibitor immunogenicity failures, pharmacokinetic failures, and/or pharmacodynamics failures. We also note the supplement data in Feagan et al.'s publication?19 summarized the primary and secondary nonresponders in UNITI-1. However, we are not clear how the inclusion of the TNF alpha page 19887 inhibitor intolerant patients with primary and secondary TNF alpha inhibitor failure patients impacts the final comparison of the placebo and treatment arms. In addition, we note that in the UNITI-1, UNITI-2, and IMUNITI studies all treatment arms were allowed to continue conventional treatments for diagnoses of CD throughout the study. We are concerned that it is difficult to determine whether the new use of the Stelara® represents a substantial clinical improvement over existing technologies with the concomitant use of other conventional CD medications throughout the duration of the UNITI-1, UNITI-2, and IMUNITI studies.

Footnotes:

18 ?Simon E.G., et al., (2016) Ustekinumab for the treatment of Crohn's disease: can it find its niche? Therapeutic Advances in Gastroenterology. 2016 Jan; 9(1):26-36.

19 ?Feagan, W.J., et al. (2016) Ustekinumab as Induction and Maintenance Therapy for Crohn' Disease. The New England Journal of Medicine. 2016 Nov 17; 3745(20):1946-60.

Also, as mentioned earlier, based on the indications for the use of the Stelara®, there is a class of patients who failed, or were intolerant to, treatment with immunomodulators or corticosteroids, but never failed treatment using a TNF blocker. According to the applicant, for those patients who never failed treatment using a TNF blocker, this patient population can be recognized as two separate patient populations: one patient population representing patients who never received treatment using a TNF blocker, or the other patient population representing patients who received and responded to treatment using a TNF blocker. In the patient population that did not receive treatment using a TNF blocker, we are unsure if the new use of the Stelara® represents a substantial clinical improvement because it is possible that some patients will have a positive response to treatment using a TNF blocker and will not respond successfully to treatment using Stelara®, or some patients may have a positive response to both treatment using a TNF blocker and using Stelara®, or some patients may not respond to treatment using a TNF blocker, but will have a positive response to treatment using Stelara®.

We are inviting public comments on whether the Stelara® meets the substantial clinical improvement criterion.

We did not receive any written public comments in response to the New Technology Town Hall meeting notice regarding the application of Stelara® for new technology add-on payments.

d. KTE-C19 (Axicabtagene Ciloleucel)

Kite Pharma, Inc. submitted an application for new technology add-on payments for KTE-C19 (axicabtagene ciloleucel) for FY 2018. The KTE-C19 technology has not received FDA approval as of the time of the development of this proposed rule. KTE-C19 is an engineered autologous T-cell immunotherapy used for the treatment of adult patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT). KTE-C19 is a single intravenous infusion of T-cell immunotherapy.

The applicant noted that KTE-C19 was granted Breakthrough Therapy Designation by the FDA on December 3, 2015, for the treatment of patients with refractory DLBCL, PMBCL, and TFL forms of aggressive B-cell NHL. The applicant submitted a request for priority review by the FDA in December 2016. The applicant stated that, when approved by the FDA, KTE-C19 would represent the only FDA-approved treatment for adult patients with relapsed refractory aggressive B-cell NHL who are ineligible for ASCT. Currently, there are no ICD-10-CM/PCS codes that describe the administration and use of KTE-C19. The applicant has submitted an application for a unique ICD-10-PCS procedure code to uniquely identify KTE-C19. If approved, the code will be effective October 1, 2017 (FY 2018).

According to the applicant, adult NHL represents by a heterogeneous group of B-cell malignancies with varying patterns of behavior and response to treatment. B-cell NHL can be classified as either aggressive, or indolent disease, with aggressive variants including diffuse large B-cell lymphoma (DLBCL); primary mediastinal large B cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL). Within NHL, DLBCL is the most common subtype of NHL, accounting for approximately 30 percent of patients with NHL, and survival without treatment is measured in months. 20?21

Footnotes:

20 ?Food and Drug Administration. Available at: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/ .

21 ?SEER Stat Fact Sheets-NHL. (2016). Available at: http://seer.cancer.gov/statfacts/html/nhl.html .


[top] The applicant stated that, since the 1970s, cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) has been the mainstay of therapy with more intensive regimens failing to show improved overall survival. The applicant further stated that the approval in 2006 of the anti-CD20 monoclonal antibody rituximab and its addition to the traditional CHOP regimen, R-CHOP, for patients with newly diagnosed aggressive NHL resulted in a dramatic improvement in NHL therapy. The combination of CHOP and R-CHOP is now first-line therapy for treatment of patients diagnosed with DLBCL with complete response rates upwards of 76 percent.22 Data from the Surveillance, Epidemiology and End Results (SEER) registries have reflected an observed increase of the median overall survival from 20 to 47 months over the last two decades. Despite the improved therapies, only 50 to 70 percent of newly diagnosed patients are cured by standard first-line therapy alone.23 Furthermore, relapsed or refractory (r/r) disease continues to carry a poor prognosis because only 50 percent of patients are eligible for more intensive second-line regimens, followed by high dose chemotherapy (HDT) and ASCT. Second-line chemotherapy regimens studied to date include rituximab, ifosfamide, carboplatin and etoposide (R-ICE) and rituximab, dexamethasone, cytarabine, and cisplatin (R-DHAP), followed by consolidative HDT/ASCT. Both regimens offer similar overall response rates (ORR) of 51 percent with 1 in 4 patients achieving long-term complete response (CR) at the expense of increased toxicity.24 Given the modest response to second line therapy and/or HDT/ASCT, the population of patients with the highest unmet need is those with chemorefractory disease, which include DLBCL, PMBCL and TFL. These patients are defined as either progressive disease (PD) as best response to chemotherapy, stable disease as best response following 4 cycles of first-line or 2 cycles of later-line therapy, or relapse within 12 months of ASCT. 25?26 Based on these definitions and available data from a multicenter retrospective study (SCHOLAR-1), chemorefractory disease treated with current and historical standards of care has consistently poor page 19888 outcomes with an ORR of 26 percent and median OS of 6.6 months.

Footnotes:

22 ?Coiffier B et al. (2002). CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large B-cell lymphoma. N Eng. J Med 2002; 346(4): 235-242.

23 ?Crump M, et al. (2016). Outcomes in refractory aggressive diffuse large B-cell lymphoma (DLBCL): results from the international SCHOLAR-1 study. Abstract 7516, poster and oral presentation at American Society of Clinical Oncology (ASCO) conference, June 2016

24 ?Matasar M, et al. (2013). Ofatumumab in combination with ICE or DHAP chemotherapy in relapsed or refractory intermediate grade B-cell lymphoma. Blood. 25 July 2013. Vol 122, No 4.

25 ?Crump M, et al. (2016). Outcomes in patients with refractory aggressive diffuse large B-cell lymphoma (DLBCL): results from the international scholar-1 study. Abstract and poster presented at Pan Pacific Lymphoma Conference (PPLC), July 2016

26 ?Gisselbrecht C, et al. (2016). Results from SCHOLAR-1: Outcomes in patients with refractory aggressive diffuse large B-cell lymphoma (DLBCL). Oral presentation at European Hematology Association conference, July 2016

According to the applicant, KTE-C19 is a different pathway to treat patients diagnosed with relapsed or refractory disease. KTE-C19 is supplied as a T-cell suspension for infusion. With KTE-C19 treatment, a patient's own T-cells are harvested and engineered ex vivo by retroviral transduction of a chimeric antigen receptor (CAR) construct encoding an anti-CD19 CD28/CD3-zeta. The anti-CD19 CAR T-cells are expanded and infused back into the patient. The new anti-CD19 CAR T-cells can recognize and eliminate CD19 antigen expressing target cells, an antigen also expressed on the cell surface of B-cell lymphomas and leukemias. According to the applicant, prior to KTE-C19 immunotherapy, the patient would have received outpatient administration of a non-myeloablative conditioning chemotherapy regimen consisting of cyclophosphamide 500 mg/m2 IV and fludarabine 30 mg/m2 IV for 3 days at days -5, -4, and -3 before the infusion of KTE-C19 at Day 0. The applicant noted that, if KTE-C19 infusion is delayed more than 2 weeks, readministration of the conditioning chemotherapy regimen may be required. Hospitalization is recommended for the infusion of KTE-C19.

As discussed earlier, if a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and would not be considered "new" for purposes of new technology add-on payments.

With regard to the first criterion, the applicant stated that KTE-C19 does not use the same or similar mechanism of action to achieve a therapeutic outcome as any other drug or therapy assigned to the same or a different MS-DRG. The applicant further stated that KTE-C19 is the first engineered autologous cellular immunotherapy comprised of CAR T-cells that recognizes CD19 express cancer cells and normal B-cells; therefore, the applicant believed that KTE-C19's mechanism of action is distinct and unique from any other cancer drug or biologic that is currently approved for use in the treatment of aggressive B-cell NHL, namely single-agent or combination chemotherapy regimens.

With regard to the second criterion, whether a product is assigned to the same or a different MS-DRG, the applicant noted that based on the 2014 and 2015 100 Percent Inpatient Standard Analytic files, cases potentially eligible for treatment using the KTE-C19 and representing the target patient population span 50 unique MS-DRGs and 73 percent of all of the cases within these 50 unique MS-DRGs that represent potentially eligible cases for treatment using KTE-C19 map to the following 4 MS-DRGs: MS-DRG 840 (Lymphoma & Non-Acute Leukemia with MCC); MS-DRG 841 (Lymphoma & Non-Acute Leukemia with CC); MS-DRG 846 (Chemotherapy without Acute Leukemia as Secondary Diagnosis with MCC); and MS-DRG 847 (Chemotherapy without Acute Leukemia as Secondary Diagnosis with CC). The applicant stated that, with the assignment of the unique KTE-C19-specific ICD-10-PCS code, patient cases where KTE-C19 is used will be distinguishable. However, patient cases where KTE-C19 is used and patient cases that are treated for DLBCL map to the same MS-DRGs.

With regard to the third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population, the applicant asserted that when approved by the FDA, KTE-C19 would represent the only FDA-approved treatment for adult patients diagnosed with relapsed or refractory aggressive B-cell NHL who are ineligible for ASCT. As a result, the applicant stated that KTE-C19 is not substantially similar to any existing technology and meets the newness criterion. CMS is concerned the CAR technology used in KTE-C19 may have a mechanism of action similar to that seen with the use of bispecific T cell engager (BiTE) technology.

We are inviting public comments on whether KTE-C19 meets the substantial similarity criteria and the newness criterion.

With respect to the cost criterion, the applicant provided an analysis to demonstrate that KTE-C19 meets the cost criterion. The applicant used the 2014 and 2015 100 Percent Inpatient Standard Analytic File (SAF) to assess the MS-DRGs that are most relevant to patients that may be potentially eligible for treatment using KTE-C19. The sample was restricted to patients discharged in FY 2015. The applicant searched for cases with an ICD-9-CM diagnosis code from the series of 200.7x (large cell lymphoma).

The applicant sought to ensure that claims included in the cost criterion analysis reflected charges for treating patients diagnosed with DLBCL and, therefore, minimized the chance that charges were related to other conditions. Therefore, the applicant searched for cases with the following criteria:

• A primary diagnosis with a ICD-9-CM diagnosis code from the series of 200.7x (large cell lymphoma) to identify cases of DLBCL with or without chemotherapy; or

• A secondary diagnosis with a ICD-9-CM diagnosis code from the series of 200.7x (large cell lymphoma) combined with an ICD-9-CM diagnosis code of V58.11, or V58.12, or ICD-9-CM procedure code 99.25, 99.28, 00.15 or 00.10 to identify cases of DLBCL that received chemotherapy during their hospitalization.

The applicant excluded claims where the MS-DRG was missing, Medicare was not the primary payer, there were zero covered charges or zero covered days, or the provider was not in the FY 2017 IPPS/LTCH PPS Final Rule Impact File. Additionally, patients under age 18 were excluded to align with the proposed label that is being prepared for submission with the KTE-C19 Biologics License Application (BLA). After applying the trims above, the results showed 762 cases that mapped to 50 MS-DRGs with 11 MS-DRGs containing more than 10 cases. The 11 MS-DRGs contained a total of 702 cases.

The applicant noted that MS-DRGs 840, 841, 846, and 847 accounted for 554 (73 percent) of the 762 cases in the cohort.

Using the 702 identified cases, the average unstandardized case-weighted charge per case was $71,725. The applicant then standardized the charges. The applicant noted that adult patients with relapsed/refractory aggressive B-cell NHL who are ineligible for ASCT would generally not be receiving treatment with both chemotherapy and KTE-C19. Therefore, all charges listed in the chemotherapy revenue centers (331, 332, and 335) were removed. The applicant then applied the 2-year inflation factor of 1.098446 from the FY 2017 IPPS/LTCH final rule (81 FR 57286) to inflate the charges from FY 2015 to FY 2017. Based on the FY 2017 IPPS/LTCH PPS Table 10 thresholds, the average case-weighted threshold amount was $55,023. The inflated average case-weighted standardized charge per case was $69,826. Because the inflated average case-weighted standardized charge per case exceeds the average case-weighted threshold amount, the applicant maintained that the technology meets the cost criterion. The applicant noted that it was not necessary to take into account the average per patient cost of the technology because the inflated average case-weighted standardized charge per case exceeds the average case-weighted threshold amount without the average per patient cost of the technology.


[top] The applicant provided the following three sensitivity analyses to further demonstrate that the technology meets page 19889 the cost criterion. The three sensitivity analyses consisted of: (1) cases representing patients identified with an ICD-9-CM diagnosis code 200.7x (large cell lymphoma) and cases representing patients identified with a secondary DLBCL diagnosis who did not receive chemotherapy; (2) cases representing patients identified with a primary or secondary ICD-9-CM diagnosis code from the series of 200.7x (large cell lymphoma) who received chemotherapy; and (3) cases representing patients under a broader ICD-9-CM diagnosis code range to capture other types of lymphoma. In all three of the sensitivity analyses, the inflated average case-weighted standardized charge per case exceeded the average case-weighted threshold amount. We are inviting public comments on whether KTE-C19 meets the cost criterion.

According to the applicant, KTE-C19 represents a substantial clinical improvement over existing technologies used in the treatment of patients with aggressive B-cell NHL. The applicant asserted that KTE-C19 can benefit the patient population with the highest unmet need, patients with refractory or relapsed disease after failure of first-line or second-line therapy, and patients who have failed or are ineligible for ASCT. These patients otherwise have adverse outcomes as demonstrated by historical control data.

Regarding clinical data for KTE-C19, the applicant stated that historical control data was the only ethical and feasible comparison information for these chemorefractory, aggressive NHL patients who have no other available treatment options and have a very short lifespan without therapy. According to the applicant, based on meta-analysis of outcomes in chemorefractory DLBCL, there are no curative options for aggressive B-cell NHL patients regardless of refractory subgroup, line of therapy, and disease stage with their median overall survival being 6.6 months.

The applicant provided clinical data from the pivotal Study 1 (ZUMA-1, KTE-C19-101), Phase I and II. The applicant also provided supportive evidence from Study 2 (NCI 009-C-0082). Study 1 is a Phase I-II multicenter, open label study evaluating the safety and efficacy of the use of KTE-C19 in patients diagnosed with aggressive refractory NHL. The trial consists of two distinct phases designed as Phase I (n=7) and Phase II (n=92). Phase II is a multi-cohort open label study evaluating the efficacy of KTE-C19. Study 1 subjects were treated with cyclophosphamide and fludarabine conditioning chemotherapy, followed by a target dose of 2 × 10 anti-CD19 CAR T-cells per kg body weight. Study 2 subjects were treated with cryopreserved autologous anti-CD19 CAR T cells, which were manufactured by a similar, but different process than that used for KTE-C19. The applicant noted that, as of the analysis cutoff date for the interim analysis, the results of Study 1 demonstrated rapid and substantial improvement in objective, or overall response rate. The overall response rate was 79 percent (49 responders among 62 subjects), with 76 percent overall response rate in Cohort 1 (39 responders among 51 subjects) and 91 percent in Cohort 2 (10 responders among 11 subjects) versus historical control of 26 percent. According to the applicant, Study 1 overall response rates were consistent across all age groups, with those patients greater than 65 years of age responding at the rates consistent with those under age 65 years and consistent with earlier, positive results from Study 2. The applicant further stated that pre-specified criteria for demonstration of early efficacy were met and an independent safety monitoring board (DSMB) confirmed the efficacy results and found no additional safety signals.

The applicant further stated that evidence of substantial improvement regarding the efficacy of KTE-C19 for the treatment of chemorefractory, aggressive B-cell NHL is supported by the complete response rates of KTE-C19 in Study 1 (52 percent) versus the historical control (8 percent). Additionally, the applicant noted that the results of Study 1 have demonstrated that treated patients experienced a rapid response to KTE-C19 with 52 percent showing complete response at 3 months, and 41 percent at 1 month.

As noted above, the applicant cited data results from Study 2, which is an ongoing Phase 1 safety and efficacy study in which anti-CD19 CAR T-cells were manufactured using a process similar to, but different from, KTE-C19 to yield cryopreserved autologous anti-CD19 CAR T cells. From Study 2, a subset of 13 patients with a diagnosis of DLBCL/PMBCL was noted to be comparable to those treated in Study 1. The applicant noted that all patients were diagnosed with refractory DLBCL, received similar doses of conditioning chemotherapy, and were infused with the cryopreserved autologous anti-CD19 CAR T-cells (which have been shown to result in an immunotherapy comparable to KTE-C19). The applicant noted that the results from Study 2 demonstrated the following: (a) an overall response rate of 69 percent (9 responders among 13 patients) (95 percent CI 38.6, 90.9); (b) 47 percent of patients had complete response at month 3 (ongoing 6+ to 20+ months); and (c) complete response was observed as early as 1 month in 57 percent of patients in Study 2. According to the applicant, further results will be reported in February 2017.


[top] The applicant also cited safety results from the pivotal Study 1, Phase II. According to the applicant, almost all patients in Study 1 (95 percent) experienced Grade 3 or higher adverse events with onset on or after commencement of conditioning chemotherapy, including cytopenias (Grade 3 and 4 anemia, neutropenia, thrombocytopenia, and lymphopenia were 40 percent, 40 percent, 29 percent, and 5 percent respectively), and infection (Grade 3 or worse urinary tract infection, clostridium difficile colitis and lung infection were 5 percent, 5 percent, and 6 percent respectively). All patients were treated according to standard of care. The clinical trial protocol stipulated that patients were infused with KTE-C19 in the hospital inpatient setting and were monitored in the inpatient setting for at least 7 days for early identification and treatment of KTE-C19 related toxicities, which primarily include cytokine release syndrome and neurotoxicities. The applicant stated that KTE-C19 is expected to be administered in the hospital inpatient setting to assure appropriate monitoring of patient adverse events. The applicant noted that the interim analysis of Study 1 showed the following: length of stay following KTE-C19 infusion was a median of 15 days; cytokine release syndrome (Grade 3 or higher, 18 percent) and neurotoxicity (Grade 3 or higher, 34 percent) were self-limiting and generally reversible; two patients died from KTE-C19 related adverse events (hemophagocytic lymphohistiocytosis and cardiac arrest in the setting of cytokine release syndrome). The medications most often used to treat KTE-C19 clinical trial complications included growth factors, blood products, anti-infectives, steroids, tocilizumab, and vasopressors. In the majority of patients (92 percent), the applicant noted that predominant toxicities associated with the use of KTE-C19, cytokine release syndrome and neurologic events, resolved by data cutoff. Median days to resolution of cytokine release syndrome complications post-KTE-C19 infusion was 9 days, with median days to resolution of KTE-C19-related page 19890 neurologic events post-KTE-C19 infusion of 18 days. According to the applicant, there were no clinically important differences in adverse event rates across age groups (younger than 65; 65 or older), including cytokine release syndrome and neurotoxicity, and KTE-C19-related adverse events in Study 1 were consistent with the earlier Study 2 experience.

The applicant further noted that by the cutoff date for the interim analysis of Study 1, among all KTE-C19 treated patients, 12 patients in Study 1, Phase II, including 10 from Cohort 1 and 2 from Cohort 2, died. Eight of these deaths were due to disease progression. One subject had disease progression after KTE-C19 treatment and subsequently had ASCT. After ASCT, the subject died due to sepsis. Two subjects (3 percent) died due to KTE-C19 related AEs (Grade 5 hemophagocytic lymphohistiocytosis event and Grade 5 anoxic brain injury), and one died due to an AE deemed unrelated to KTE-C19 (Grade 5 pulmonary embolism), without disease progression.

We are concerned that there are no published results showing any survival benefit from the treatment. We also are concerned with the limited number of subjects (n=82) that were studied after infusion of KTE-C19 T-cell immunotherapy. Although the applicant references Study 2, we are concerned that the applicant has included data on DLBCL/PMBCL patients that did not specifically receive KTE-C19. Additionally, we are concerned that Study 2 was based on 13 patients which can result in skewed outcomes due to a small patient population. Finally, we note that, for Study 1 and Study 2, the data on overall survival are not reported.

We are inviting public comments on whether KTE-C19 meets the substantial clinical improvement criterion.

Comment: The applicant stated that it has been notified by the United States Adopted Names Council (USAN Council) that the technology's name for KTE-C19 has been revised from "axicabtagene ciloretroleucel" to "axicabtagene ciloleucel." In addition, the applicant requested that all references by CMS to the technology's name of KTE-C19 use this final naming convention of "axicabtagene ciloleucel."

Response: We appreciate the applicant's updated information and have correlated the name of the technology throughout the discussion above.

e. VYXEOS TM (Cytarabine and Daunorubicin Liposome for Injection)

Celator Pharmaceuticals, Inc. submitted an application for new technology add-on payments for VYXEOS TM for FY 2018. The proposed indication for the use of VYXEOS TM , which has not received FDA approval as of the time of the development of this proposed rule, is the treatment of adult patients diagnosed with acute myeloid leukemia (AML).

AML is a type of cancer in which the bone marrow makes abnormal myeloblasts (immature bone marrow white blood cells), red blood cells, and platelets. If left untreated, AML progresses rapidly. Normally, the bone marrow makes blood stem cells that develop into mature blood cells over time. Stem cells have the potential to develop into many different cell types in the body. Stem cells can act as an internal repair system, dividing, essentially without limit, to replenish other cells. When a stem cell divides, each new cell has the potential to either remain a stem cell or become a specialized cell, such as a muscle cell, a red blood cell or a brain cell, etc. A blood stem cell may become a myeloid stem cell or a lymphoid stem cell. Lymphoid stem cells become white blood cells. A myeloid stem cell becomes one of three types of mature blood cells: (1) red blood cells that carry oxygen and other substances to body tissues; (2) white blood cells that fight infection; or (3) platelets that form blood clots and help to control bleeding. In patients diagnosed with AML, the myeloid stem cells usually become a type of myeloblast. The myeloblasts in patients diagnosed with AML are abnormal and do not become healthy white blood cells. Sometimes in patients diagnosed with AML, too many stem cells become abnormal red blood cells or platelets. These abnormal cells are called leukemia cells or blasts.

AML is defined by the World Health Organization (WHO) as >20 percent blasts in the bone marrow or blood. AML can also be diagnosed if the blasts are found to have a chromosome change that occurs only in a specific type of AML, even if the blast percentage does not reach 20 percent. Leukemia cells can build up in the bone marrow and blood, resulting in less room for healthy white blood cells, red blood cells, and platelets. When this occurs, infection, anemia, or increased risk for bleeding may result. Leukemia cells can spread outside the blood to other parts of the body, including the central nervous system (CNS), skin, and gums.

Treatment of AML diagnoses usually consists of two phases; remission induction and post-remission therapy. Phase one, remission induction, is aimed at eliminating as many myeloblasts as possible. The most common used remission induction regimens for AML diagnoses are the "7+3" regimens using an antineoplastic and an anthracycline. Cytarabine and daunorubicin are two commonly used drugs for "7+3" remission induction therapy. Cytarabine is continuously administered intravenously over the course of 7 days, while daunorubicin is intermittently administered intravenously for the first 3 days. The "7+3" regimen typically achieves a 70 to 80 percent complete remission (CR) rate in most patients under 60 years of age.

High rates of CR are not generally seen in older patients for a number of reasons, such as different leukemia biology, much higher incidence of adverse cytogenetic abnormalities, higher rate of multidrug resistant leukemic cells, and comparatively lower patient performance status (the standard criteria for measuring how the disease impacts a patient's daily living abilities). Intensive induction therapy has worse outcomes in this patient population.27 The applicant asserted that many older adults diagnosed with AML have a poor performance status?28 at presentation and multiple medical comorbidities that make the use of intensive induction therapy quite difficult or contraindicated altogether. Moreover, the CR rates of poor-risk patients diagnosed with AML are substantially higher in patients >60 years old; owing to a higher proportion of secondary AML, disease developing in the setting of a prior myeloid disorder, or prior cytotoxic chemotherapy. Therefore, less than half of older adults diagnosed with AML achieve CR with combination induction regimens.29

Footnotes:

27 ?Juliusson G, Lazarevic V, Horstedt AS, Hagberg O, Hoglund M. Acute myeloid leukemia in the real world: why population-based registries are needed. Blood. 2012 Apr 26; 119(17):3890-9.

28 ?Stone RM, et al. (2004). Acute myeloid leukemia. Hematology Am Soc Hematol Educ Program. 2004:98-117.

29 ?Appelbaum FR, Gundacker H, Head DR. "Age and acute myeloid leukemia." Blood 2006; 107:3481-3485.


[top] The combination of cytarabine and an anthracycline, either as "7+3" regimens or as part of a different regimen incorporating other cytotoxic agents, may be used as so-called "salvage" induction therapy in the treatment of adults diagnosed with AML who experience relapse in an attempt to page 19891 achieve CR. According to the applicant, while CR rates of success vary widely depending on underlying disease biology and host factors, there is a lower success rate overall in achievement of CR with "7+3" regimens compared to VYXEOS TM therapy. In addition, "7+3" regimens produce a CR rate of approximately 50 percent in younger adult patients who have relapsed, but were in CR for at least 1 year.30

Footnotes:

30 ?Kantarjian H, Rayandi F, O'Brien S et al. "Intensive chemotherapy does not benefit most older patients (age 70 years and older) with acute myeloid leukemia." Blood 2010; 116(22):4422.

VYXEOS TM is a nano-scale liposomal formulation containing a fixed combination of cytarabine and daunorubicin in a 5:1 molar ratio. This formulation was developed by the applicant using a proprietary system known as CombiPlex. According to the applicant, CombiPlex addresses several fundamental shortcomings of conventional combination regimens, specifically the conventional "7+3" free drug dosing, as well as the challenges inherent in combination drug development, by identifying the most effective synergistic molar ratio of the drugs being combined in vitro, and fixing this ratio in a nano-scale drug delivery complex to maintain the optimized combination after administration and ensuring exposure of this ratio to the tumor.

Cytarabine and daunorubicin are co-encapsulated inside the VYXEOS TM liposome at a fixed ratiometrically, optimized 5:1 cytarabine:daunorubicin molar ratio. According to the applicant, encapsulation maintains the synergistic ratios, reduces degradation, and minimizes the impact of drug transporters and the effect of known resistant mechanisms. The applicant stated that the 5:1 molar ratio has been shown, in vitro, to maximize synergistic antitumor activity across multiple leukemic and solid tumor cell lines, including AML, and in animal model studies to be optimally efficacious compared to other cytarabine:daunorubicin ratios. In addition, the applicant stated that in clinical studies, the use of VYXEOS TM has demonstrated consistently more efficacious results than the conventional "7+3" free drug dosing. VYXEOS TM is intended for intravenous administration after reconstitution with 19 mL sterile water for injection. VYXEOS TM is administered as a 90-minute intravenous infusion on days 1, 3, and 5 (induction therapy), as compared to the "7+3" free drug dosing, which consists of two individual drugs administered on different days, including 7 days of continuous infusion.

With regard to the "newness" criterion, the applicant indicated that the rolling New Drug Application (NDA) submission to the FDA for VYXEOS TM began on September 30, 2016. The applicant stated that it intends to request Priority Review from the FDA. VYXEOS TM is currently available in the United States only on an investigational basis, under an Investigational New Drug (IND) designation. Breakthrough Therapy designation was granted on May 19, 2016, for the treatment of adults diagnosed with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Fast Track designation was granted by the FDA in January 2015 for the treatment of elderly patients diagnosed with secondary AML. Orphan Drug designation was granted by the FDA on August 22, 2008, for the treatment of acute AML. VYXEOS TM had not received pre-market (PMA) approval from the FDA at the time of development of this proposed rule. However, the applicant anticipates receiving approval from the FDA by July 1, 2017. The applicant also has submitted a request for a unique ICD-10-PCS code, beginning with FY 2018.

As discussed earlier, if a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and would not be considered "new" for purposes of new technology add-on payments.

With regard to the first criterion, whether a product uses the same or a similar mechanism of action to achieve a therapeutic outcome, the applicant asserted that VYXEOS TM does not use the same or similar mechanism of action to achieve a therapeutic outcome as any other drug assigned to the same or a different DRG. The applicant stated that no other AML treatment is designed, nor is able, to deliver a fixed, ratiometrically optimized and synergistic drug:drug ratio of 5:1 cytarabine to daunorubicin, and selectively target and accumulate at the site of malignancy, while minimizing unwanted exposure, which the applicant based on the data results of preclinical and clinical studies of the use of VYXEOS TM . The applicant indicated that VYXEOS TM is a nano-scale liposomal formulation of a fixed combination of cytarabine and daunorubicin. Further, the applicant stated that the rationale for the development of VYXEOS TM is based on prolonged delivery of synergistic drug ratios utilizing the applicant's proprietary, ratiometric CombiPlex technology. According to the applicant, conventional "7+3" free drug dosing has no delivery complex, and these individual drugs are administered without regard to their ratio dependent interaction. According to the applicant, enzymatic inactivation and imbalanced drug efflux and transporter expression reduce drug levels in the cell. Decreased cytotoxicity leads to cell survival, emergence of drug resistant cells, and decreased overall survival.

The applicant provided the results of clinical studies to demonstrate that the CombiPlex technology and the ratiometric dosing of VYXEOS TM represent a shift in anticancer agent delivery, whereby the fixed, optimized dosing provides less drug to achieve improved efficacy, while maintaining a favorable risk-benefit profile. The results of this ratiometric dosing approach are in contrast to the typical combination chemotherapy development that establishes the recommended dose of one agent and then adds subsequent drugs to the combination at increasing concentrations until the aggregate effects of toxicity are considered to be limiting (the "7+3" drug regimen). According to the applicant, this current approach to combination chemotherapy development assumes that maximum therapeutic activity will be achieved with maximum dose intensity for all drugs in the combination, and ignores the possibility that more subtle concentration-dependent drug interactions could result in frankly synergistic outcomes.

The applicant maintained that, while VYXEOS TM contains no novel active agents, its innovative drug delivery mechanism appears to be a superior way to deliver the two active compounds in an effort to optimize their efficacy in killing leukemic blasts. However, we are concerned it is possible that VYXEOS TM may use a similar mechanism of action compared to current treatment because both the current treatment regimen and VYXEOS TM are used in the treatment of AML by intravenous administration of cytarabin and daunorubicin.


[top] With respect to the second criterion, whether a product is assigned to the same or a different MS-DRG, the applicant maintained that based on the 2014 and 2015 100 Percent Inpatient Standard Analytic files, cases representing patients potentially eligible for treatment using VYXEOS TM and the target patient population span 134 unique MS-DRGs, and 78 percent of all of the cases within these 134 unique MS-DRGs map to the following 4 MS-DRGs: 834 (Acute Leukemia Without Major O.R. Procedure With MCC), 837 (Chemotherapy With Acute Leukemia as SDX or With High Dose Chemotherapy page 19892 Agent with MCC), 838 (Chemotherapy With Acute Leukemia as SDX With CC or High Dose Chemotherapy Agent), and 839 (Chemotherapy With Acute Leukemia as SDX Without CC/MCC). We believe that these are the same MS-DRGs that identify cases representing patients who are treated for AML.

With respect to the third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population, the applicant asserted that VYXEOS TM is indicated for the use in patients diagnosed with high-risk AML. However, we believe that VYXEOS TM involves the treatment of the same patient population as other AML treatment therapies.

We are inviting public comments on whether VYXEOS TM is substantially similar to existing technology, including whether the mechanism of action of VYXEOS TM differs from the mechanism of action of the current treatment regimen. We also are inviting public comments on whether VYXEOS TM meets the newness criterion.

With regard to the cost criterion, the applicant conducted the following analysis. The applicant used the 2014 and 2015 100 Percent Inpatient Standard Analytic Files (SAFs) to assess the MS-DRGs assigned for hospitalizations most likely to represent patients that may be eligible for treatment with VYXEOS TM . The sample of claims was limited to discharges occurring in FY 2015 (that is, from October 1, 2014 to September 30, 2015).

The applicant identified patients as potential VYXEOS TM candidates by searching for cases indicating a diagnosis of AML. Specifically, the applicant searched for cases that met the following criteria:

• Had an ICD-9-CM diagnosis code of 205.00 (Acute myeloid leukemia, without mention of having achieved remission), or 205.02 (Acute myeloid leukemia, in relapse); or

• The patient received chemotherapy during their hospital stay as indicated by the following principal/secondary ICD-9-CM diagnosis codes or ICD-9-CM procedure codes: V58.11 (Encounter for antineoplastic chemotherapy); V58.12 (Encounter for antineoplastic immunotherapy; 00.10 (Implantation of chemotherapeutic agent); 00.15 (High-Dose infusion interleukin-2); 99.25 (Injection or Infusion of cancer chemotherapeutic substance); or 99.28 (Injection or infusion of biological response modifier as an antineoplastic agent); and

• Excluded cases that had a bone marrow transplant based on the following ICD-9-CM procedure codes: 41.00 (Bone marrow transplant, not otherwise specified); 41.01 (Autologous bone marrow transplant without purging); 41.02 (Allogeneic bone marrow transplant with purging); 41.03 (Allogeneic bone marrow transplant without purging); 41.04 (Autologous hematopoietic stem cell transplant without purging); 41.05 (Allogeneic hematopoietic stem cell transplant without purging); 41.06 (Cord blood stem cell transplant); 41.07 (Autologous hematopoietic stem cell transplant with purging); 41.08 (Allogeneic hematopoietic stem cell transplant); and 41.09 (Autologous bone marrow transplant with purging).

According to the applicant, the eligible cases span 134 unique MS-DRGs, 14 of which contain more than 10 cases. The most common MS-DRGs are MS-DRGs 834, 837, 838, and 839. These 4 MS-DRGs account for 3,601 (78 percent) of the 4,613 potential eligible cases.

Using the 4,613 identified cases, the average unstandardized case-weighted charge per case was $203,234. The applicant then standardized the charges. The applicant removed charges for the current treatment. The applicant then applied the 2-year inflation factor of 1.098446 from the FY 2017 IPPS/LTCH final rule (81 FR 57286) to inflate the charges from FY 2015 to FY 2017. Based on the FY 2017 IPPS/LTCH PPS Table 10 thresholds, the average case-weighted threshold amount was $84,639. The inflated average case-weighted standardized charge per case was $178,392. Because the inflated average case-weighted standardized charge per case exceeds the average case-weighted threshold amount, the applicant maintained that the technology meets the cost criterion.

The applicant noted that the average case-weighted standardized charge per case for the applicable MS-DRGs exceeds the average case-weighted threshold amount without taking into account the average per patient cost of the technology to the hospital. Therefore, the analysis above did not include the cost of VYXEOS TM .

As previously stated, according to the applicant, the potentially eligible cases used for the cost criterion analysis included patients diagnosed with AML who received chemotherapy during their hospital stay, but did not receive a bone marrow transplant. The applicant asserted that this patient cohort is inclusive of all likely potential patients that may be eligible for treatment using VYXEOS TM . The applicant conducted the same analysis, but excluded all pharmacy and IV therapy charges. Additionally, to test the sensitivity of cohort specification, the applicant conducted the following four additional sensitivity analyses that used alternative cohort definitions: (1) Included AML cases with ICD-9-CM diagnosis code 205.00 and chemotherapy; (2) included AML cases with ICD-9-CM diagnosis code 205.02 and chemotherapy; (3) included cases with AML principal diagnosis and chemotherapy; and (4) included AML cases without requiring chemotherapy. In all of these analyses, the inflated average case-weighted standardized charge per case exceeded the average case-weighted threshold amount. We are inviting public comments whether VYXEOS TM meets the cost criterion.

With regard to substantial clinical improvement, according to the applicant, clinical data results have shown that the use of VYXEOS TM represents a substantial clinical improvement for the treatment of AML in newly diagnosed high-risk, older (60 years and older) patients, marked by statistically significant improvements in overall survival, event free survival and response rates, and in relapsed patients age 18 to 65 years of age, where a statistically significant improvement in overall survival was documented for the poor-risk subset of patients as defined by the European Prognostic Index. In both groups of patients, the applicant stated that there was significant improvement in survival for the high-risk patient group. The applicant provided the following specific clinical data results.


[top] • The applicant stated the clinical data results show that treatment with VYXEOS TM in older patients (60 years of age and older) diagnosed with untreated, high-risk AML will result in superior survival rates, as compared to patients treated with conventional "7+3" free drug dosing. The applicant provided a summary of the pivotal Phase III Study 301 in which 309 patients were enrolled, with 153 patients randomized to the VYXEOS TM arm and 156 to the "7+3" free drug dosing arm. Among patients aged 60 to 69 years, there were 96 patients in the VYXEOS TM arm and 102 in the "7+3" free drug dosing arm; for patients aged 70 to 75 years, there were 57 and 54 patients in each arm, respectively. The applicant noted that the data results from the Phase III Study 301 demonstrated that first-line treatment of patients diagnosed with high-risk AML in the VYXEOS TM arm resulted in substantially greater median overall survival of 9.56 months versus 5.95 months in the "7+3" free drug dosing arm (hazard ratio of 0.69; p =0.005). page 19893

• The applicant further asserted that high-risk, older patients (60 years of age and older) previously untreated for diagnoses of AML will have a lower risk of early death when treated with VYXEOS TM than those treated with the conventional "7+3" free drug dosing. The applicant cited Medeiros, et al. 2015,31 which reported a large observational study of Medicare beneficiaries and noted the following: The data result of the study showed that 50 to 60 percent of elderly patients diagnosed with AML remain untreated following diagnosis; treated patients were more likely younger, male, and married, and less likely to have secondary diagnoses of AML, poor performance indicators, and poor comorbidity scores compared to untreated patients; and in multivariate survival analyses, treated patients exhibited a significant 33 percent lower risk of death compared to untreated patients.

Footnotes:

31 ?Medeiros B, et al. (2015). Big data analysis of treatment patterns and outcomes among elderly acute myeloid leukemia patients in the United States. Ann Hematol. 2015; 94(7): 1127-1138.

Based on data from the Phase III Study 301,32 the applicant cited the following results: The rate of 60-day mortality was less in the VYXEOS TM arm (13.7 percent) versus the "7+3" free drug dosing arm (21.2 percent); the reduction in early mortality was due to fewer deaths from refractory AML (3.3 percent versus 11.3 percent), with very similar rates of 60-day mortality due to adverse events (10.4 percent versus 9.9 percent); there were fewer deaths in the VYXEOS TM arm versus the "7+3" free drug dosing arm during the treatment phase (7.8 percent versus 11.3 percent); and there were fewer deaths in the VYXEOS TM arm during the follow-up phase than in the "7+3" free drug dosing arm (59.5 percent versus 71.5 percent).

Footnotes:

32 ?Lancet J, et al. (2016). Final results of a Phase III randomized trial of VYXEOS (CPX-351) versus 7+3 in older patients with newly diagnosed, high-risk (secondary) AML. Abstract and oral presentation at American Society of Clinical Oncology (ASCO), June 2016.

• The applicant asserted that high-risk, older patients (60 years of age and older) previously untreated for a diagnosis of AML exhibited statistically significant improvements in response rates after treatment with VYXEOS TM versus treatment with the conventional "7+3" free drug chemotherapy dosing, suggesting that the use of VYXEOS TM is a superior pre-transplant induction treatment versus "7+3" free drug dosing. Restoration of normal hematopoiesis is the ultimate goal of any therapy for AML diagnoses. The first phase of treatment consists of induction chemotherapy, in which the goal is to "empty" the bone marrow of all hematopoietic elements (both benign and malignant), and to allow repopulation of the marrow with normal cells, thereby yielding remission. According to the applicant, post-induction response rates were significantly higher following the use of VYXEOS TM , which elicited a 47.7 percent total response rate and a 37.3 percent rate for CR, whereas the total response and CR rates for the "7+3" free drug dosing arm were 33.3 percent and 25.6 percent, respectively. The CR + CRi rates for patients aged 60 to 69 years were 50.0 percent in the VYXEOS TM arm and 36.3 percent in the "7+3" free drug dosing arm, with an odds ratio of 1.76 (95 percent CI, 1.00-3.10). For patients aged 70 to 75, the rates of CR + CRi were 43.9 percent in the VYXEOS TM arm and 27.8 percent in the "7+3" free drug dosing arm.

• The applicant asserted that VYXEOS TM treatment will enable high-risk, older patients (60 years of age and older) to bridge to allogeneic transplant, and VYXEOS TM responding patients will have markedly better outcomes following transplant. The applicant stated that diagnoses of secondary AML are considered incurable with standard chemotherapy approaches and, as with other high-risk hematological malignancies, transplantation is a useful treatment alternative. The applicant further stated that autologous HSCT has limited effectiveness and at this time, only allogeneic HSCT with full intensity conditioning has been reported to produce long-term remissions. However, the applicant stated that the clinical study by Medeiros et al., 2015, reported that, while the use of allogeneic HSCT is considered a potential cure for AML, its use is limited in older patients because of significant baseline comorbidities and increased transplant-related morbidity and mortality. Patients in either arm of the Phase III Study 301 responding to induction with a CR or CR+CRi (n=125) were considered for allogeneic hematopoietic cell transplant (HCT) when possible. In total, 91 patients were transplanted: 52 (34 percent) from the VYXEOS TM arm and 39 (25 percent) from the "7+3" free drug dosing arm. Patient and AML characteristics were similar according to randomized arm, including percentage of patients in each arm that underwent transplant in CR+CRi status. However, the applicant noted that the VYXEOS TM arm contained a higher percentage of older patients (aged 70 or greater) who were transplanted (VYXEOS TM , 31 percent; "7+3" free drug dosing, 15 percent).33

Footnotes:

33 ?Stone Hematology 2004; Gordon AACR 2016; NCI, cancer.gov.

According to the applicant, patient outcome following transplant strongly favored patients in the VYXEOS TM arm. The Kaplan-Meier analysis of the 91 transplanted patients landmarked at the time of HCT showed that patients in the VYXEOS TM arm had markedly better overall survival (hazard ratio 0.46; p =0.0046). The time-dependent Adjustment Model (Cox proportional hazard ratio) was used to evaluate the contribution of VYXEOS TM to overall survival rate after adjustment for transplant and showed that VYXEOS TM remained a significant contributor, even after adjusting for transplant. The time-dependent Cox hazard ratio for overall survival rates in the VYXEOS TM arm versus the "7+3" free drug dosing arm was 0.51 (95 percent CI, 0.35-0.75; P =.0007).

• The applicant asserted that VYXEOS TM treatment of previously untreated older patients (60 years of age and older) diagnosed with high-risk AML increases the response rate and improves survival compared to conventional "7+3" free drug dosing in patients diagnosed with FLT3 mutation. The applicant noted the following: approximately 20 to 30 percent of AML patients harbor some form of FLT3 mutation, AML patients with a FLT3 mutation have a higher relapse rate and poorer prognosis than the overall population diagnosed with AML, and the most common type of mutation is internal tandem duplication (ITD) mutation localized to a membrane region of the receptor.


[top] The applicant cited Gordon et al., 2016,34 which reported on the significant anti-leukemic activity of VYXEOS TM in AML blasts exhibiting high-risk characteristics, including FLT3-ITD, that are typically associated with poor outcomes when treated with conventional "7+3" free drug dosing. To determine whether the improved complete remission and overall survival rates of VYXEOS TM as compared to conventional "7+3" free drug dosing are attributable to liposome-mediated altered drug PK or direct cellular interactions with specific AML blast samples, the authors evaluated cytotoxicity in 53 AML patient specimens. Cytotoxicity results were correlated with patient characteristics, page 19894 as well as VYXEOS TM cellular uptake and molecular phenotype status including FLT3-ITD, which is a predictor of poor patient outcomes to conventional "7+3" free drug dosing. The applicant stated that a notable result from this research was the observation that AML blasts exhibiting the FLT3-ITD phenotype exhibited some of the lowest IC 50 (the 50 percent inhibitory concentration) values and, as a group, were five-fold more sensitive to VYXEOS TM than those with wild type FLT3. In addition, there was evidence that increased sensitivity to VYXEOS TM was associated with increased uptake of the drug-laden liposomes by the patient-derived AML blasts. The applicant noted that Gordon, et al. 2016, concluded taken together, the data are consistent with clinical observations where VYXEOS TM retains significant anti-leukemic activity in AML patients exhibiting high-risk characteristics. The applicant also noted that a sub analysis of Phase III Study 301 identified 22 patients diagnosed with FLT3 mutation in the VYXEOS TM arm and 20 in the "7+3" free drug dosing arm, which resulted in the following response rates of FLT3 mutated patients, which were higher with VYXEOS TM (15 of 22, 68.2 percent) versus "7+3" free drug dosing (5 of 20, 25.0 percent); and the Kaplan-Meier analysis of the 42 FLT3 mutated patients showed that patients in the VYXEOS TM arm had a trend towards better overall survival rates (hazard ratio 0.57; p =0.093).

Footnotes:

34 ?Gordon M, Tardi P, Lawrence MD et al. "CPX-351 cytotoxicity against fresh AML blasts increased for FLT3-ITD+ cells and correlates with drug uptake and clinical outcomes." Abstract 287 and poster presented at AACR (American Association for Cancer Research). April 2016.

• The applicant asserted that younger patients (18 to 65 years of age) with poor risk first relapse AML have shown higher response rates with VYXEOS TM versus conventional "salvage" chemotherapy. Overall, the applicant stated that the use of VYXEOS TM had an acceptable safety profile in this patient population based on 60-day mortality data. Study 205?35 was a randomized study comparing VYXEOS TM against the investigator's choice of first "salvage" chemotherapy in patients diagnosed with relapsed AML after a first remission lasting greater than 1 month (VYXEOS TM arm, n=81 and "7+3" free drug dosing arm, n=44; ages 18 to 65 year of age). Investigator's choice was almost always based on cytarabine + anthracycline, usually with the addition of one or two new agents. According to the applicant, VYXEOS TM demonstrated a higher rate of morphological leukemia clearance among all patients, 43.2 percent versus 40.0 percent, and the advantage was most apparent in poor-risk patients, 78.7 percent versus 44.4 percent, as defined by the European Prognostic Index (EPI). In the subset analysis of this EPI poor-risk patient subset, the applicant stated there was a significant improvement in survival rate (6.6 versus 4.2 months median, hazard ratio=0.55, p=0.02) and improved response rate (39.3 percent versus 27 percent). The applicant also noted the following: the safety profile for the use of VYXEOS TM was qualitatively similar to that of control "salvage" therapy, with nearly identical 60-day mortality rates (14.8 percent versus 15.9 percent); among VYXEOS TM treated patients, those with no history of prior HSCT (n=59) had higher response rates (54.2 percent versus 37.8 percent) and lower 60-day mortality (10.2 percent versus 16.2 percent); overall, the use of VYXEOS TM had acceptable safety based on 60-day mortality data, with somewhat higher frequency of neutropenia and thrombocytopenia-related grade 3-4 adverse events. Even though these patients are younger (18 to 65 years of age) than the population studied in Phase III Study 301 (60 years and older), Study 205 patients were at a later stage of disease and almost all had responded to first-line therapy (cytarabine + anthracycline) and had relapsed. The applicant also cited Cortes, et al. 2015,36 which reported that patients diagnosed with first relapse AML have limited likelihood of response and short expected survival following "salvage" treatment with the results from literature showing that:

Footnotes:

35 ?Cortes J, et al. (2011). Significance of prior HSCT on the outcome of salvage therapy with CPX-351 or conventional chemotherapy among first relapse AML patients. Abstract and poster presented at ASH 2011.

36 ?Cortes J, et al. (2015). Phase II, multicenter, randomized trial of CPX-351 (cytarabine:daunorubicin) liposome injection versus intensive salvage therapy in adults with first relapse AML. Cancer. January 2015, 234-42.

• Mitoxantrone, etoposide, and cytarabine induced response in 23 percent of patients, with median overall survival of only 2 months.

• Modulation of deoxycitidine kinase by fludarabine led to the combination of fludarabine and cytarabine, resulting in a 36 percent CR rate with median remission duration of 39 weeks.

• First salvage gemtuzumab ozogamicin induced CR+CRp (or CR+CRi) response in 30 percent of patients with CD33+ AML and, for patients with short first CR durations, appeared to be superior to cytarabine-based therapy.

The applicant noted that Study 205 results showed the use of VYXEOS TM retained greater anti-leukemic efficacy in patients diagnosed with poor-risk first relapse AML, and produced higher morphological leukemia clearance rates (78.7 percent) compared to conventional "salvage" therapy (44 percent). The applicant further noted that, overall, the use of VYXEOS TM had acceptable safety profile in this patient population based on 60-day mortality data.

Based on all of the data presented above, the applicant concluded that VYXEOS TM represents a substantial clinical improvement over existing technologies. However, we are concerned that, although there was an improvement in a number of outcomes in Phase III Study 301, specifically overall survival rate, lower risk of early death, improved response rates, better outcomes following transplant, increased response rate and overall survival in patients diagnosed with FLT3 mutation, and higher response rates versus conventional "salvage" chemotherapy in younger patients diagnosed with poor-risk first relapse, the improved outcomes may not be statistically significant. Furthermore, we are concerned that the overall improvement in survival from 5.95 months to 9.56 months may not represent a substantial clinical improvement. In addition, the rate of adverse events in both arms of Study 205, given the theoretical benefit of reduced toxicity with the liposomal formulation, was similar for both the VYXEOS TM and "7+3" free drug treatment groups. Therefore, we also are concerned that there is a similar rate of adverse events, such as febrile neutropenia (68 percent versus 71 percent), pneumonia (20 percent versus 15 percent), and hypoxia (13 percent versus 15 percent), with the use of VYXEOS TM as compared with the conventional "7+3" free drug regimen.

We are inviting public comments on whether the VYXEOS TM meets the substantial clinical improvement criterion.

Below we summarize and respond to comments submitted on VYXEOS TM during the open comment period in response to the New Technology Town Hall meeting notice.


[top] Comment: The applicant provided a written response regarding the definition of "free drug" as "Unbound drug pharmacology;" an active drug or other compound that is not bound to a carrier protein-for example, albumin or alpha-1-acid glycoprotein. The applicant explained that the term "free-drug dosing" is used to describe the two different non-encapsulated, separately administered drugs in the "7+3" free drug regimen (cytarabine and daunorubicin), each an unrestricted uniform aqueous solution of the drug in water for continuous administration of cytarabine and separate intravenous page 19895 administration of daunorubicin according to the "7+3" dosing schedule. The applicant then stated that the fixed molar drug ratio delivered by VYXEOS TM is not relevant to the conventional dosing of the two free drugs, cytarabine and daunorubicin. The applicant explained that the doses of cytarabine and daunorubicin used in the conventional "7+3" free drug dosing regimen were based on the maximum tolerated dose of the two agents, not on any concept related to a drug ratio that provides optimal synergy. Finally, the ratio of cytarabine and daunorubicin administered in free (non-liposomal) form is irrelevant because the administered ratio cannot be maintained when these drugs are infused separately. This is because the drugs will be distributed and eliminated differentially and independently of one another and the ratio will change rapidly and continuously. Consequently, according to the applicant, the inability to control drug ratios following administration in conventional dosage forms likely results in exposure of tumor cells to antagonistic drug ratios with a corresponding loss of therapeutic activity.

Response: We appreciate the applicant's comments. We will take these comments into consideration when deciding whether to approve new technology add-on payments for VYXEOS TM .

f. GammaTile TM

Isoray Medical, Inc. & GammaTile, LLC submitted an application for new technology add-on payments for FY 2018 for the GammaTile TM . The GammaTile TM is a brachytherapy technology for use in the treatment of patients diagnosed with brain tumors using cesium-131 radioactive sources embedded in a collagen matrix. GammaTile TM is designed to provide adjuvant radiation therapy to eliminate remaining tumor cells in patients who required surgical resection of brain tumors. According to the applicant, the GammaTile TM is a new vehicle of delivery for and inclusive of cesium-131 brachytherapy sources embedded within the product. The applicant stated that the technology has been manufactured for use in the setting of a craniotomy resection site where there is a high chance of local recurrence of a CNS or dual-based tumor. The applicant asserted that the use of GammaTile TM provides a new, unique modality for treating patients who require radiation therapy to augment surgical resection of malignancies of the brain. By offsetting the radiation sources with a 3mm gap of a collagen matrix, the applicant asserted that the use of GammaTile TM resolves issues with "hot" and "cold" spots associated with brachytherapy, improves safety, and potentially offers a treatment option for patients with limited, or no other, available options. The GammaTile TM is biocompatible and bioabsorbable, and is left in the body permanently without need for future surgical removal. The applicant asserted that the commercial manufacturing of the product will significantly improve on the process of constructing customized implants with greater speed, efficiency, and accuracy than is currently available, and require less surgical expertise in placement of the radioactive sources, allowing a greater number of surgeons to utilize brachytherapy techniques in a wider variety of hospital settings.

The applicant for GammaTile TM has applied for FDA approval and anticipated FDA approval by the spring of 2017. In its application, the applicant indicated that it anticipated that the product would be approved by the FDA for use in both the primary and salvage treatment of radiosensitive malignances of the brain. However, the applicant had not received FDA approval at the time of development of this proposed rule. In subsequent discussions with the applicant, the applicant indicated that it is only seeking FDA approval for use in the salvage treatment of recurrent radiosensitive malignances of the brain. The applicant submitted a request for a unique ICD-10-PCS code for the administration of GammaTile TM . If approved, the procedure codes will be effective October 1, 2017 (FY 2018).

As discussed earlier, if a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and would not be considered "new" for purposes of new technology add-on payments.

With regard to the first criterion, whether a product uses the same or a similar mechanism of action to achieve a therapeutic outcome, the applicant stated that when compared to treatment using external beam radiation therapy, GammaTile TM uses a new and unique mechanism of action to achieve a therapeutic outcome. The applicant explained that the GammaTile TM is fundamentally different in structure, function, and safety from all external beam radiation therapies, and delivers treatment through a different mechanism of action. In contrast to external beam radiation modalities, the applicant further explained that the GammaTile TM is a form of internal radiation termed brachytherapy. Brachytherapy treatments are performed using radiation sources positioned very close to the area requiring radiation treatment and only deliver radiation to the tissues that are immediately adjacent to the margin of the surgical resection. For this reason, brachytherapy is a current standard of care treatment for many non-central nervous system tumors, including breast, cervical, and prostate cancers.

Due to the custom positioning of the radiological sources and the use of the cesium-131 isotope, the applicant noted that the GammaTile TM focuses therapeutic levels of radiation on an extremely small area of the brain. Unlike all external beam techniques, the applicant stated that this radiation does not pass externally inward through the skull and healthy areas of the brain to reach the targeted tissue and, therefore, may limit neurocognitive deficits seen with the use of external beam techniques. Because of the rapid reduction in radiation intensity that is characteristic of cesium-131, the applicant asserted that the GammaTile TM can target the margin of the excision with greater precision than any alternative treatment option, while sparing healthy brain tissue from unnecessary and potentially damaging radiation exposure.

The applicant also stated that, when compared to other types of brain brachytherapy, GammaTile TM uses a new and unique mechanism of action to achieve a therapeutic outcome. The applicant explained that cancerous cells at the margins of a tumor resection cavity can also be irradiated with the placement of brachytherapy sources in the tumor cavity. However, the applicant asserted that the GammaTile TM is a pioneering form of brachytherapy for the treatment of brain tumors that uses the isotope cesium-131 embedded in a collagen implant that is customized to the geometry of the brain cavity. According to the applicant, use of cesium-131 and the custom distribution of seeds in a three-dimensional collagen device result in a unique and highly effective delivery of radiation therapy to brain tissue.


[top] With regard to the second criterion, whether a product is assigned to the same or a different MS-DRG, GammaTile TM is a treatment option for patients diagnosed with brain tumors that progress locally after initial treatment with external beam radiation therapy, and cases representing patients that may be eligible for treatment involving this technology are assigned to the same MS-DRGs (MS-DRGs 25, 26, and 27 (Craniotomy & Endovascular Intracranial Procedure with MCC, with CC, and without CC/MCC), respectively) page 19896 as other current treatment forms of brachytherapy and external beam radiation therapy.

With regard to third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population, the applicant stated that the GammaTile TM offers a treatment option for a patient population with limited, or no other, available treatment options. The applicant explained that treatment options for patients diagnosed with brain tumors that progress locally after initial treatment with external beam radiation therapy are limited, and there is no current standard of care in this setting. According to the applicant, surgery alone for recurrent tumors may provide symptom relief, but does not remove all of the cancer cells. The applicant further stated that repeating external beam radiation therapy for adjuvant treatment is hampered by an increasing risk of brain injury because additional external beam radiation therapy will increase the total dose of radiation to brain tissue, as well as increase the total volume of irradiated brain tissue. Secondary treatment with external beam radiation therapy is often performed with a reduced and, therefore, less effective dose. The applicant asserted that brachytherapy with GammaTile TM may be the only effective treatment option for these patients.

Based on the above, the applicant concluded that the GammaTile TM is not substantially similar to other existing technologies and meets the newness criterion. However, we are concerned that the mechanism of action for this device may be the same or similar to current forms of radiation or brachytherapy. Specifically, while the placement of the cesium-131 source (or any radioactive source) in a collagen matrix offset may constitute a new delivery vehicle, we are concerned that this sort of improvement in brachytherapy for use in the salvage treatment of radiosensitive malignances of the brain may not represent a new mechanism of action. We also have concerns as to whether GammaTile TM would represent the first approved use of offset radioactive material in brachytherapy for recurrent brain malignancies. The applicant cited studies that used a similar predicate device, but did not indicate whether these researchers or institutions are seeking separate FDA approval.

We are inviting public comments on whether GammaTile TM meets the substantial similarity criteria and the newness criterion.

With regard to the cost criterion, the applicant conducted the following analysis. The applicant worked with the Barrow Neurological Institute at St. Joseph's Hospital and Medical Center (St. Joseph's) to obtain actual claims for craniotomies using a prototype brain brachytherapy device of stranded cesium-131 seeds held in place with a collagen tile. The application found a total of 23 claims from FY 2001 through FY 2016 data that used a cesium-131 brachytherapy predicate device. All 23 claims were assigned to MS-DRGs 25 through 27. Of the 23 cases, 13 cases were assigned to MS-DRG 25, 4 cases were assigned to MS-DRG 26, and 6 cases were assigned to MS-DRG 27. Using hospital data, the applicant estimated and then subtracted all charges for the predicate device and all charges for ancillary services associated with the device delivery for each case. The applicant standardized the remaining charges for each case and inflated each case's charges by applying the FY 2017 IPPS/LTCH PPS final rule outlier charge inflation factor of 1.043957 by the age of each case (that is, the factor was applied to FY 2011 claims six times, to FY 2012 claims five times, etc.). The applicant then calculated the average inflated standardized charges for the cases assigned to MS-DRG 25 ($124,064), MS-DRG 26 ($131,677) and MS-DRG 27 ($90,615). The applicant then calculated an estimate for ancillary charges associated with placement of the GammaTile TM device, as well as standardized charges for the GammaTile TM device itself. The applicant determined it meets the cost criterion because the final average case-weighted standardized charge per case (including the charges associated with the GammaTile TM device) of $226,741 exceeds the average case-weighted threshold amount of $95,783.

We are concerned that the applicant submitted a small sample of cases to determine it meets the cost criterion. A small sample size may not be statistically significant to determine if the GammaTile TM meets the cost criterion. We also note that, while the applicant has attributed reduced operating room times as a significant benefit to the GammaTile TM , a reduction in the associated costs does not appear to be reflected in its calculations. We are inviting public comments on whether the GammaTile TM meets the cost criterion.

With regard to substantial clinical improvement, the applicant stated that the GammaTile TM offers a treatment option for a patient population unresponsive to, or ineligible for, currently available treatments and significantly improves clinical outcomes when compared to currently available treatment options. The applicant explained that therapeutic options for patients diagnosed with large or recurrent brain metastases are limited. However, according to the applicant, the GammaTile TM provides a treatment option for patients diagnosed with radiosensitive recurrent brain tumors that are not eligible for treatment with any other currently available treatment option. Specifically, the applicant stated that GammaTile TM may provide the only radiation treatment option for patients diagnosed with tumors located close to sensitive vital brain sites (for example, brain stem); patients diagnosed with recurrent brain tumors may not be eligible for additional treatment involving the use of external beam radiation therapy. There is a lifetime limit for the amount of radiation therapy a specific area of the body can receive. Patients whose previous treatment includes external beam radiation therapy may be precluded from receiving high doses of radiation associated with subsequent external beam radiation therapy, and the GammaTile TM can also be used to treat tumors that are too large for treatment with external beam radiation therapy. These large tumors are not eligible for treatment with external beam radiation therapy because the radiation dose to healthy brain tissue would be too high.

The applicant described how the GammaTile TM improves clinical outcomes compared to existing treatment options, including external beam radiation therapy and other forms of brain brachytherapy. To demonstrate that the GammaTile TM represents a substantial clinical improvement over existing technologies, the applicant submitted data from three abstracts, with one associated paper demonstrating feasibility or superior progression-free survival compared to the patient's own historical control rate.


[top] In a presentation at the Society for Neuro-Oncology in November 2014 (Dardis, Christopher; Surgery and permanent intraoperative brachytherapy improves time to progression of recurrent intracranial neoplasms), the outcomes of 20 patients diagnosed with 27 tumors covering a variety of histological types treated with the GammaTile TM prototype were presented. The applicant noted the following with regard to the patients: (1) All tumors were intracranial, supratentorial masses and included low and high-grade meningiomas, metastases from various primary cancers, high-grade gliomas, and others; page 19897 (2) all treated masses were recurrent following treatment with surgery and/or radiation and the group averaged two prior craniotomies and two prior courses of external beam radiation treatment; and (3) following surgical excision, prototype GammaTiles TM were placed in the resection cavity to deliver a dose of 60 Gray to a depth of 5 mm of tissue; and all patients had previously experienced re-growth of their tumors at the site of treatment and the local control rate of patients entering the study was 0 percent.

With regard to outcomes, the applicant stated that, after their initial treatment, patients had a median progression-free survival time of 5.8 months; post treatment with prototype GammaTiles TM , at the time of this analysis, only one patient had progressed at the treatment site, for a local control rate of 96 percent; and median progression-free survival time, a measure of how long a patient lives without recurrence of the treated tumor, has not been reached (as this value can only be calculated when more than 50 percent of treated patients have failed the prescribed treatment).

A second set of outcomes on prototype GammaTiles TM was presented at the Society for Neuro-Oncology Conference on Meningioma in June 2016 (Brachman, David; Surgery and permanent intraoperative brachytherapy improves time to progress of recurrent intracranial neoplasms). This study enrolled 16 patients with 20 recurrent grade 2 or 3 meningiomas, who had undergone prior surgical excision external beam radiation therapy. These patients underwent surgical excision of the tumor, followed by adjuvant radiation therapy with prototype GammaTiles TM . The applicant noted the following outcomes: (1) Of the 20 treated tumors, 19 showed no evidence of radiographic progression at last follow-up, yielding a local control rate of 95 percent; two of the 20 patients exhibited radiation necrosis (one symptomatic, one asymptomatic); and (2) the median time to failure from the prior treatment with external beam radiation therapy was 10.3 months and after treatment with prototype GammaTiles TM only one patient failed at 18.2 months. Therefore, the median time to same site failure after prototype GammaTile TM treatment has not yet been reached (average follow up of 16.7 months, range 1-37 months).

A third prospective study was accepted for presentation at the November 2016 Society for Neuro-Oncology annual meeting (Youssef, Emad; Cs131 implants for salvage therapy of recurrent high grade gliomas). In this study, 13 patients diagnosed with recurrent high-grade gliomas (9 with glioblastoma and 4 with grade 3 astrocytoma) were treated in an identical manner to the cases described above. Previously, all patients had failed the international standard treatment for high-grade glioma, a combination of surgery, radiation therapy, and chemotherapy referred to as the "Stupp regimen." For the prior therapy, the median time to failure was 9.2 months (range 1-40 months). After therapy with a prototype GammaTile TM , the applicant noted the following: (1) The median time to same site local failure has not been reached and one failure was seen at 18 months (local control 92 percent); and (2) with a median follow-up time of 8.1 months (range 1-23 months) one symptomatic patient (8 percent) and two asymptomatic patients (15 percent) had radiation-related MRI changes. However, no patients required re-operation for radiation necrosis or wound breakdown.

The applicant asserted that, when considered in total, the data reported in these three studies support the conclusion that a significant therapeutic effect results from the addition of GammaTile TM radiation therapy to the site of surgical removal. According to the applicant, the fact that these patients had failed prior best available treatments (aggressive surgical and adjuvant radiation management) presents the unusual scenario of a salvage therapy outperforming the current standard-of-care. The applicant noted that follow-up data continues to accrue on these patients. The applicant further noted that, although these reported experiences with the GammaTile TM are as a salvage therapy in patients who currently have no standard treatment options, it is anticipated GammaTile TM will also be used as first-line therapy due to these promising results.

The applicant stated that the use of GammaTile TM reduces rates of mortality compared to alternative treatment options. The applicant explained that clinical studies on GammaTile TM have shown improved local control of tumor recurrence. According to the applicant, the results of these studies showed local control rates of 92 percent to 96 percent for tumor sites that had local control rates of 0 percent from previous treatment. The applicant noted that these studies also have not reached median progression-free survival time with follow-up times ranging from 1 to 37 months. Previous treatment at these same sites resulted in median progression-free survival times of 5.8 to 10.3 months.

The applicant further stated that the use of GammaTile TM reduces rates of radiation necrosis compared to alternative treatment options. The applicant explained that the rate of symptomatic radiation necrosis in the GammaTile TM clinical studies of 5 to 8 percent is substantially lower than the 26 percent to 57 percent rate of symptomatic radiation necrosis requiring re-operation historically associated with brain brachytherapy, and lower than the rates reported for initial treatment of similar tumors with modern external beam and stereotactic radiation techniques. The applicant indicated that this is consistent with the customized and ideal distribution of radiation therapy provided by GammaTile TM .

The applicant also asserted that the use of GammaTile TM reduces the need for re-operation compared to alternative treatment options. The applicant explained that patients receiving a craniotomy, followed by external beam radiation therapy or brachytherapy, could require re-operation in the following three scenarios:

• Tumor recurrence at the excision site could require additional surgical removal;

• Symptomatic radiation necrosis could require excision of the affected tissue; and

• Certain forms of brain brachytherapy require the removal of brachytherapy sources after a given period of time.

However, according to the applicant, because of the high local control rates, low rates of symptomatic radiation necrosis, and short half-life of cesium-131, GammaTile TM will reduce the need for re-operation compared to external beam radiation therapy and other forms of brain brachytherapy.

Additionally, the applicant stated that the use of GammaTile TM reduces the need for additional hospital visits and procedures compared to alternative treatment options. The applicant noted that the GammaTile TM is placed during surgery, and does not require any additional visits or procedures. The applicant contrasted this improvement with external beam radiation therapy, which is often delivered in multiple fractions that must be administered over multiple days. The applicant provided an example where WBRT is delivered over 2 to 3 weeks, while the placement of GammaTile TM occurs during the craniotomy and does not add any time to a patient's recovery.


[top] The applicant further stated that the GammaTile TM 's high local control rates and low rates of symptomatic radiation necrosis will reduce the need for page 19898 additional hospital visits and procedures, and provides a more rapid initiation and complement of the treatment compared to alternative treatment options.

Based on consideration of all of the data presented above, the applicant believed that the use of GammaTile TM represents a substantial clinical improvement over existing technologies. The studies were limited to patients diagnosed with recurrent tumors after previous surgical rescission. As previously discussed, the applicant explained that it is seeking FDA approval for the use of the GammaTile TM in the treatment of recurrent malignancies.

We are inviting public comments on whether GammaTile TM meets the substantial clinical improvement criterion.

We did not receive any written public comments in response to the New Technology Town Hall meeting notice regarding the application of GammaTile TM for new technology add-on payments.

III. Proposed Changes to the Hospital Wage Index for Acute Care Hospitals

A. Background

1. Legislative Authority

Section 1886(d)(3)(E) of the Act requires that, as part of the methodology for determining prospective payments to hospitals, the Secretary adjust the standardized amounts for area differences in hospital wage levels by a factor (established by the Secretary) reflecting the relative hospital wage level in the geographic area of the hospital compared to the national average hospital wage level. We currently define hospital labor market areas based on the delineations of statistical areas established by the Office of Management and Budget (OMB). A discussion of the proposed FY 2018 hospital wage index based on the statistical areas appears under sections III.A.2. and G. of the preamble of this proposed rule.

Section 1886(d)(3)(E) of the Act requires the Secretary to update the wage index annually and to base the update on a survey of wages and wage-related costs of short-term, acute care hospitals. (CMS collects these data on the Medicare cost report, CMS Form 2552-10, Worksheet S-3, Parts II, III, and IV. The OMB control number for approved collection of this information is 0938-0050.) This provision also requires that any updates or adjustments to the wage index be made in a manner that ensures that aggregate payments to hospitals are not affected by the change in the wage index. The proposed adjustment for FY 2018 is discussed in section II.B. of the Addendum to this proposed rule.

As discussed in section III.J. of the preamble of this proposed rule, we also take into account the geographic reclassification of hospitals in accordance with sections 1886(d)(8)(B) and 1886(d)(10) of the Act when calculating IPPS payment amounts. Under section 1886(d)(8)(D) of the Act, the Secretary is required to adjust the standardized amounts so as to ensure that aggregate payments under the IPPS after implementation of the provisions of sections 1886(d)(8)(B), 1886(d)(8)(C), and 1886(d)(10) of the Act are equal to the aggregate prospective payments that would have been made absent these provisions. The proposed budget neutrality adjustment for FY 2018 is discussed in section II.A.4.b. of the Addendum to this proposed rule.

Section 1886(d)(3)(E) of the Act also provides for the collection of data every 3 years on the occupational mix of employees for short-term, acute care hospitals participating in the Medicare program, in order to construct an occupational mix adjustment to the wage index. A discussion of the occupational mix adjustment that we are proposing to apply to the FY 2018 wage index, appears under sections III.E.3. and F. of the preamble of this proposed rule.

2. Core-Based Statistical Areas (CBSAs) for the Proposed FY 2018 Hospital Wage Index

The wage index is calculated and assigned to hospitals on the basis of the labor market area in which the hospital is located. Under section 1886(d)(3)(E) of the Act, beginning with FY 2005, we delineate hospital labor market areas based on OMB-established Core-Based Statistical Areas (CBSAs). The current statistical areas (which were implemented beginning with FY 2015) are based on revised OMB delineations issued on February 28, 2013, in OMB Bulletin No. 13-01. OMB Bulletin No. 13-01 established revised delineations for Metropolitan Statistical Areas, Micropolitan Statistical Areas, and Combined Statistical Areas in the United States and Puerto Rico based on the 2010 Census, and provided guidance on the use of the delineations of these statistical areas using standards published on June 28, 2010 in the Federal Register (75 FR 37246 through 37252). We refer readers to the FY 2015 IPPS/LTCH PPS final rule (79 FR 49951 through 49963) for a full discussion of our implementation of the OMB labor market area delineations beginning with the FY 2015 wage index.

Generally, OMB issues major revisions to statistical areas every 10 years, based on the results of the decennial census. However, OMB occasionally issues minor updates and revisions to statistical areas in the years between the decennial censuses through OMB Bulletins. On July 15, 2015, OMB issued OMB Bulletin No. 15-01, which provides updates to and supersedes OMB Bulletin No. 13-01 that was issued on February 28, 2013. The attachment to OMB Bulletin No. 15-01 provides detailed information on the update to statistical areas since February 28, 2013. The updates provided in OMB Bulletin No. 15-01 are based on the application of the 2010 Standards for Delineating Metropolitan and Micropolitan Statistical Areas to Census Bureau population estimates for July 1, 2012 and July 1, 2013. In the FY 2017 IPPS/LTCH PPS final rule (81 FR 56913), we adopted the updates set forth in OMB Bulletin No. 15-01 effective October 1, 2016, beginning with the FY 2017 wage index. For a complete discussion of the adoption of the updates set forth in OMB Bulletin No. 15-01, we refer readers to the FY 2017 IPPS/LTCH PPS final rule.

For FY 2018, we are continuing to use the OMB delineations that we adopted beginning with FY 2015 to calculate the area wage indexes, with updates as reflected in OMB Bulletin No. 15-01 specified in the FY 2017 IPPS/LTCH PPS final rule.

3. Codes for Constituent Counties in CBSAs


[top] CBSAs are made up of one or more constituent counties. Each CBSA and constituent county has its own unique identifying codes. There are two different lists of codes associated with counties: Social Security Administration (SSA) codes and Federal Information Processing Standard (FIPS) codes. Historically, CMS has listed and used SSA and FIPS county codes to identify and crosswalk counties to CBSA codes for purposes of the hospital wage index. We have learned that SSA county codes are no longer being maintained and updated. However, the FIPS codes continue to be maintained by the U.S. Census Bureau. The Census Bureau's most current statistical area information is derived from ongoing census data received since 2010; the most recent data are from 2015. For the purposes of crosswalking counties to CBSAs, we are proposing to discontinue the use of SSA county codes and begin using only the FIPS county codes. page 19899

The Census Bureau maintains a complete list of changes to counties or county equivalent entities on the Web site at: https://www.census.gov/geo/reference/county-changes.html . In our proposed transition to using only FIPS codes for counties for the hospital wage index, we are proposing to update the FIPS codes used for crosswalking counties to CBSAs for the hospital wage index to incorporate changes to the counties or county equivalent entities included in the Census Bureau's most recent list. Based on information included in the Census Bureau's Web site, since 2010, the Census Bureau has made the following updates to the FIPS codes for counties or county equivalent entities:

• Petersburg Borough, AK (FIPS State County Code 02-195), CBSA 02, was created from part of former Petersburg Census Area (02-195) and part of Hoonah-Angoon Census Area (02-105). The CBSA code remains 02.

• The name of La Salle Parish, LA (FIPS State County Code 22-059), CBSA 14, is now LaSalle Parish, LA (FIPS State County Code 22-059). The CBSA code remains as 14.

• The name of Shannon County, SD (FIPS State County Code 46-113), CBSA 43, is now Oglala Lakota County, SD (FIPS State County Code 46-102). The CBSA code remains as 43.

We believe that it is important to use the latest counties or county equivalent entities in order to properly crosswalk hospitals from a county to a CBSA for purposes of the hospital wage index used under the IPPS. In addition, we believe that using the latest FIPS codes will allow us to maintain a more accurate and up-to-date payment system that reflects the reality of population shifts and labor market conditions. Therefore, we are proposing to implement these FIPS code updates, effective October 1, 2017, beginning with the FY 2018 wage indexes. We are proposing to use these update changes to calculate area wage indexes in a manner that is generally consistent with the CBSA-based methodologies finalized in the FY 2005 IPPS final rule and the FY 2015 IPPS/LTCH PPS final rule. We note that while the county update changes listed earlier changed the county names, the CBSAs to which these counties map did not change from the prior counties. Therefore, there is no impact or change to hospitals in these counties; they continue to be considered rural for the hospital wage index under these changes. For FY 2018, Tables 2 and 3 associated with this proposed rule and the County to CBSA Crosswalk File and Urban CBSAs and Constituent Counties for Acute Care Hospitals File posted on the CMS Web site reflect these county changes. We are inviting public comments on our proposals.

B. Worksheet S-3 Wage Data for the Proposed FY 2018 Wage Index

The proposed FY 2018 wage index values are based on the data collected from the Medicare cost reports submitted by hospitals for cost reporting periods beginning in FY 2014 (the FY 2017 wage indexes were based on data from cost reporting periods beginning during FY 2013).

1. Included Categories of Costs

The proposed FY 2018 wage index includes all of the following categories of data associated with costs paid under the IPPS (as well as outpatient costs):

• Salaries and hours from short-term, acute care hospitals (including paid lunch hours and hours associated with military leave and jury duty);

• Home office costs and hours;

• Certain contract labor costs and hours, which include direct patient care, certain top management, pharmacy, laboratory, and nonteaching physician Part A services, and certain contract indirect patient care services (as discussed in the FY 2008 final rule with comment period (72 FR 47315 through 47317)); and

• Wage-related costs, including pension costs (based on policies adopted in the FY 2012 IPPS/LTCH PPS final rule (76 FR 51586 through 51590)) and other deferred compensation costs.

2. Excluded Categories of Costs

Consistent with the wage index methodology for FY 2017, the proposed wage index for FY 2018 also excludes the direct and overhead salaries and hours for services not subject to IPPS payment, such as skilled nursing facility (SNF) services, home health services, costs related to GME (teaching physicians and residents) and certified registered nurse anesthetists (CRNAs), and other subprovider components that are not paid under the IPPS. The proposed FY 2018 wage index also excludes the salaries, hours, and wage-related costs of hospital-based rural health clinics (RHCs), and Federally qualified health centers (FQHCs) because Medicare pays for these costs outside of the IPPS (68 FR 45395). In addition, salaries, hours, and wage-related costs of CAHs are excluded from the wage index for the reasons explained in the FY 2004 IPPS final rule (68 FR 45397 through 45398).

3. Use of Wage Index Data by Suppliers and Providers Other Than Acute Care Hospitals Under the IPPS

Data collected for the IPPS wage index also are currently used to calculate wage indexes applicable to suppliers and other providers, such as SNFs, home health agencies (HHAs), ambulatory surgical centers (ASCs), and hospices. In addition, they are used for prospective payments to IRFs, IPFs, and LTCHs, and for hospital outpatient services. We note that, in the IPPS rules, we do not address comments pertaining to the wage indexes of any supplier or provider except IPPS providers and LTCHs. Such comments should be made in response to separate proposed rules for those suppliers and providers.

C. Verification of Worksheet S-3 Wage Data

The wage data for the proposed FY 2018 wage index were obtained from Worksheet S-3, Parts II and III of the Medicare cost report (Form CMS-2552-10) for cost reporting periods beginning on or after October 1, 2013, and before October 1, 2014. For wage index purposes, we refer to cost reports during this period as the "FY 2014 cost report," the "FY 2014 wage data," or the "FY 2014 data." Instructions for completing the wage index sections of Worksheet S-3 are included in the Provider Reimbursement Manual (PRM), Part 2 (Pub. No. 15-2), Chapter 40, Sections 4005.2 through 4005.4. The data file used to construct the proposed FY 2018 wage index includes FY 2014 data submitted to us as of February 10, 2017. As in past years, we performed an extensive review of the wage data, mostly through the use of edits designed to identify aberrant data.


[top] We asked our MACs to revise or verify data elements that result in specific edit failures. For the proposed FY 2018 wage index, we identified and excluded 51 providers with aberrant data that should not be included in the wage index, although if data elements for some of these providers are corrected, we intend to include data from those providers in the final FY 2018 wage index. We also adjusted certain aberrant data and included these data in the proposed wage index. For example, in situations where a hospital did not have documentable salaries, wages, and hours for housekeeping and dietary services, we imputed estimates, in accordance with policies established in the FY 2015 IPPS/LTCH PPS final rule (79 FR 49965 through 49967). We instructed MACs to complete their data verification of questionable data elements and to transmit any changes to page 19900 the wage data no later than March 24, 2017. The revised data will be reflected in the FY 2018 IPPS/LTCH PPS final rule.

In constructing the proposed FY 2018 wage index, we included the wage data for facilities that were IPPS hospitals in FY 2014, inclusive of those facilities that have since terminated their participation in the program as hospitals, as long as those data did not fail any of our edits for reasonableness. We believed that including the wage data for these hospitals is, in general, appropriate to reflect the economic conditions in the various labor market areas during the relevant past period and to ensure that the current wage index represents the labor market area's current wages as compared to the national average of wages. However, we excluded the wage data for CAHs as discussed in the FY 2004 IPPS final rule (68 FR 45397 through 45398). For the this proposed rule, we removed 7 hospitals that converted to CAH status on or after January 22, 2016, the cut-off date for CAH exclusion from the FY 2017 wage index, and through and including January 23, 2017, the cut-off date for CAH exclusion from the FY 2018 wage index. After excluding CAHs and hospitals with aberrant data, we calculated the proposed wage index using the Worksheet S-3, Part II and III wage data of 3,325 hospitals.

For the proposed FY 2018 wage index, we allotted the wages and hours data for a multicampus hospital among the different labor market areas where its campuses are located in the same manner that we allotted such hospitals' data in the FY 2017 wage index (81 FR 56915). Table 2, which contains the proposed FY 2018 wage index associated with proposed rule (available via the Internet on the CMS Web site), includes separate wage data for the campuses of 9 multicampus hospitals.

D. Method for Computing the Proposed FY 2018 Unadjusted Wage Index

1. Proposed Methodology for FY 2018

The method used to compute the proposed FY 2018 wage index without an occupational mix adjustment follows the same methodology that we used to compute the proposed wage indexes without an occupational mix adjustment since FY 2012 (76 FR 51591 through 51593).

As discussed in the FY 2012 IPPS/LTCH PPS final rule, in "Step 5," for each hospital, we adjust the total salaries plus wage-related costs to a common period to determine total adjusted salaries plus wage-related costs. To make the wage adjustment, we estimate the percentage change in the employment cost index (ECI) for compensation for each 30-day increment from October 14, 2013, through April 15, 2015, for private industry hospital workers from the BLS' Compensation and Working Conditions. We have consistently used the ECI as the data source for our wages and salaries and other price proxies in the IPPS market basket, and we are not proposing any changes to the usage of the ECI for FY 2018. The factors used to adjust the hospital's data were based on the midpoint of the cost reporting period, as indicated in the following table.

After Before Adjustment factor
10/14/2013 11/15/2013 1.02310
11/14/2013 12/15/2013 1.02155
12/14/2013 01/15/2014 1.02004
01/14/2014 02/15/2014 1.01866
02/14/2014 03/15/2014 1.01740
03/14/2014 04/15/2014 1.01615
04/14/2014 05/15/2014 1.01482
05/14/2014 06/15/2014 1.01339
06/14/2014 07/15/2014 1.01193
07/14/2014 08/15/2014 1.01048
08/14/2014 09/15/2014 1.00905
09/14/2014 10/15/2014 1.00761
10/14/2014 11/15/2014 1.00614
11/14/2014 12/15/2014 1.00463
12/14/2014 01/15/2015 1.00309
01/14/2015 02/15/2015 1.00155
02/14/2015 03/15/2015 1.00000
03/14/2015 04/15/2015 0.99845

For example, the midpoint of a cost reporting period beginning January 1, 2014, and ending December 31, 2014, is June 30, 2014. An adjustment factor of 1.01193 would be applied to the wages of a hospital with such a cost reporting period.

Using the data as previously described, the proposed FY 2018 national average hourly wage (unadjusted for occupational mix) is $42.0043.

Previously, we also would provide a Puerto Rico overall average hourly wage. As discussed in the FY 2017 IPPS/LTCH PPS final rule (81 FR 56915), prior to January 1, 2016, Puerto Rico hospitals were paid based on 75 percent of the national standardized amount and 25 percent of the Puerto Rico-specific standardized amount. As a result, we calculated a Puerto Rico-specific wage index that was applied to the labor share of the Puerto Rico-specific standardized amount. Section 601 of the Consolidated Appropriations Act, 2016 (Pub. L. 114-113) amended section 1886(d)(9)(E) of the Act to specify that the payment calculation with respect to operating costs of inpatient hospital services of a subsection (d) Puerto Rico hospital for inpatient hospital discharges on or after January 1, 2016, shall use 100 percent of the national standardized amount. As we stated in the FY 2017 IPPS/LTCH PPS final rule (81 FR 56915 through 56916), because Puerto Rico hospitals are no longer paid with a Puerto Rico-specific standardized amount as of January 1, 2016, under section 1886(d)(9)(E) of the Act, as amended by section 601 of the Consolidated Appropriations Act, 2016, there is no longer a need to calculate a Puerto Rico-specific average hourly wage and wage index. Hospitals in Puerto Rico are now paid 100 percent of the national standardized amount and, therefore, are subject to the national average hourly wage (unadjusted for occupational mix) (which is $42.0043 for this FY 2018 proposed rule) and the national wage index, which is applied to the national labor share of the national standardized amount. For FY 2018, we are not proposing a Puerto Rico-specific overall average hourly wage or wage index.

2. Clarification of Other Wage Related Costs in the Wage Index


[top] Section 1886(d)(3)(E) of the Act requires the Secretary to update the wage index based on a survey of hospitals' costs that are attributable to wages and wage-related costs. In the September 1, 1994 IPPS final rule (59 FR 45356), we developed a list of "core" wage-related costs that hospitals may report on Worksheet S-3, Part II of the Medicare hospital cost report in order to include those costs in the wage index. Core wage-related costs include categories of retirement cost, plan administrative costs, health and insurance costs, taxes, and other specified costs such as tuition reimbursement. In addition to these categories of core wage-related costs, we allow hospitals to report wage-related costs other than those on the core list if the other wage-related costs meet certain criteria. The criteria for including other wage-related costs in the wage index are discussed in the September 1, 1994 IPPS final rule (59 FR 45357) and also are listed in the Provider Reimbursement Manual (PRM), Part II, Chapter 40, Sections 4005.2 through 4005.4), Line 18 of the Medicare cost report (Form CMS-2552-10, OMB control number 0938-0050). Specifically, "other" wage-related costs are allowable for the wage index if the cost for employees whose services are paid under the IPPS exceeds 1 percent of the total adjusted salaries net of page 19901 excluded area salaries, is a fringe benefit as defined by the IRS and has been reported to the IRS (as income to the employees or contractors), is not being furnished for the convenience of the provider, and is not listed on Worksheet S-3, Part IV.

We note that other wage-related costs are not to include benefits already included in Line 1 salaries on Worksheet S-3, Part II (refer to the cost report instructions for Worksheet S-3, Part II, Line 18, which state, "?'Other' wage-related costs do not include wage-related costs reported on line 1 of this worksheet."). We also note that the 1-percent test is conducted by dividing each individual category of the other wage-related cost (that is, the numerator) by the sum of the following lines on the Medicare hospital cost report (Form CMS-2552-10): Worksheet S-3, Part II, Lines 11, 12, 13, and 14, Column 4, and Worksheet S-3, Part III, Line 3, Column 4 (that is, the denominator). The other wage-related costs associated with contract labor and home office/related organization personnel are included in the numerator because these other wage-related costs are allowed in the wage index (in addition to other wage related costs for direct employees), assuming the requirements for inclusion in the wage index are met. For example, if a hospital is trying to include a parking garage as an other-wage related cost that is reported on the W-2 or 1099 form, when running the 1-percent test, include in the numerator all the parking garage other wage-related cost for direct salary employees, contracted employees, and home office employees and divide by the sum of Worksheet S-3, Part II, Lines 11, 12, 13, and 14, Column 4, and Worksheet S-3, Part III, Line 3, Column 4. For the category of parking other wage-related costs, the 1-percent test would be run only one time, inclusive of other wage related costs for employee salaries, contracted employees, and home office employees. We intend to clarify the hospital cost report instructions to reflect that contract labor and home office/related organization salaries should be added to the subtotal of salaries on Worksheet S-3, Part III, Line 3, Column 4 (Line 3 is the difference of net salaries minus excluded area salaries) for purposes of performing the 1-percent test. If a hospital has more than one other wage-related cost, the 1-percent must be conducted separately for each other wage-related cost (for example, parking and cafeteria separately; do not sum all the different types of other wage-related costs together and then run the 1-percent test). If the 1-percent test is met for a particular type of other wage-related costs, and the other criteria listed earlier are met as well, the other wage-related cost may be reported on Worksheet S-3, Part II, Line 18 of the hospital cost report.

We originally allowed for the inclusion of wage-related costs other than those on the core list because we were concerned that individual hospitals might incur unusually large wage-related costs that are not reflected on the core list but that may represent a significant wage-related cost. However, we are reconsidering allowing other wage-related costs to be included in the wage index because recent internal reviews of the FY 2018 wage data show that only a small minority of hospitals are reporting other wage-related costs that meet the 1-percent test described earlier. In the calculation of the proposed FY 2018 wage index, for each hospital reporting other wage-related costs on Line 18 of Worksheet S-3, we performed the 1-percent test. We then made internal edits removing other wage-related costs on Line 18 where hospitals reported data that failed to meet the mathematical requirement that other wage-related costs must exceed 1 percent of total adjusted salaries net of excluded area salaries. After this review, only approximately 80 hospitals of approximately 3,320 hospitals had other wage-related costs on Line 18 meeting the 1-percent test. We believe that such a limited number of hospitals nationally reporting and meeting the 1-percent test may indicate that other wage-related costs might not constitute an appropriate part of a relative measure of wage costs in a particular labor market area, a longstanding tenet of the wage index. In other words, while other wage-related costs may represent costs that may have an impact on an individual hospital's average hourly wage, we do not believe that costs reported by only a very small minority of hospitals accurately reflect the economic conditions of the labor market areas in which those hospitals are located. Therefore, it is possible that inclusion of other wage-related costs in the wage index in such a limited manner may distort the average hourly wage of a particular labor market area so that its wage index does not accurately represent that labor market area's current wages relative to national wages.

Furthermore, the open-ended nature of the types of other wage-related costs that may be included on Line 18 of Worksheet S-3, in contrast to the concrete list of core wage-related costs, may hinder consistent and proper reporting of fringe benefits. Our internal review indicates widely divergent types of costs that hospitals are reporting as other wage-related costs on Line 18. We are concerned that inconsistent reporting of other wage-related costs on Line 18 further compromises the accuracy of the wage index as a representation of the relative average hourly wage for each labor market area. Our intent in creating a core list of wage-related costs in the September 1, 1994 IPPS final rule was to promote consistent reporting of fringe benefits, and we are increasingly concerned that inconsistent reporting of wage-related costs on Line 18 of Worksheet S-3 undermines this effort. Specifically, we expressed in the September 1, 1994 IPPS final rule that since we began including fringe benefits in the wage index, we have been concerned with the inconsistent reporting of fringe benefits, whether because of a lack of provider proficiency in identifying fringe benefit costs or varying interpretations across fiscal intermediaries of the definition for fringe benefits in PRM-I, Section 2144.1 (59 FR 45356).

We believe that the limited and inconsistent use of Line 18 of Worksheet S-3 for reporting wage-related costs other than the core list might indicate that including other wage-related costs in the wage index compromises the accuracy of the wage index as a relative measure of wages in a given labor market area. Therefore, we are seeking public comments on whether we should, in future rulemaking, propose to only include the wage-related costs on the core list in the calculation of the wage index and not to include any other wage-related costs in the calculation of the wage index.


[top] Meanwhile, in this FY 2018 IPPS/LTCH PPS proposed rule, we are clarifying that, under our current policy, an other wage-related cost (which we define as the value of a benefit) must be a fringe benefit as described by the IRS (refer to IRS Publication 15-B) and must be reported to the IRS on employees' or contractors' W-2 or 1099 forms as taxable income in order to be considered an other wage-related cost on Line 18 of Worksheet S-3 and for the wage index. That is, other wage-related costs that are not reported to the IRS on employees' or contractors' W-2 or 1099 forms as taxable income, even if not required to be reported to the IRS according to IRS requirements, will not be included in the wage index. This is consistent with current cost report instructions for Line 18 of Worksheet S-3, Part II of the Medicare cost report, Form 2552-10, which state that, to be considered an allowable other wage-related costs, the cost "has been page 19902 reported to the IRS." We will apply this policy to the process for calculating the wage index for FY 2019, including the FY 2019 desk reviews beginning in September 2017.

We believe this clarification is necessary because some hospitals have incorrectly interpreted prior manual and existing preamble language to mean that a cost could be considered an other wage-related cost if the provider's reporting (or not reporting) of the cost was in accordance with IRS requirements, rather than if the cost was actually reported on an employee's or contractor's W-2 or 1099 form as taxable income. We believe that such an interpretation of our policy would require an analysis of whether the reporting or not reporting of the cost to the IRS was done properly in accordance with IRS regulations and guidance in order to allow the cost as an other wage-related cost. We believe that the determinations regarding the proper or improper reporting of certain other wage-related costs to the IRS for the purpose of inclusion in the Medicare wage index are impractical for CMS and the MACs because we do not have the expertise and fluency in IRS regulations and tax law sufficient to perform such technical reviews of hospital wage-related costs. In contrast, our current policy of including an amount as an other wage-related cost for wage index purposes only if the amount was actually reported to the IRS on employees' or contractors' W-2 or 1099 forms as taxable income is a straightforward policy that we believe provides clarity to all involved parties. The brightline test of allowing an other wage-related cost to be included in the wage index only if it has been reported on an employee's or contractor's W-2 or 1099 form as taxable income helps ensure consistent treatment of other wage-related costs for all hospitals. Considering the variety of types of costs that may be included on Line 18 of Worksheet S-3 of the cost report for other wage-related costs (assuming the 1-percent test is met and other criteria are met), we believe that a straightforward policy that is simple for hospitals and CMS to apply is particularly important.

In addition, we believe the policy we are clarifying in this proposed rule, that an other wage-related cost can be included in the wage index only if it was reported to the IRS as taxable income on the employee's or contractor's W-2 or 1099, is consistent with CMS' longstanding position that a fringe benefit is not furnished for the convenience of the employer or otherwise excludable from income as a fringe benefit (such as a working condition fringe) and that inappropriate types of costs may not be included in the wage index. In response to a comment when we finalized the criteria for other wage-related costs in the September 1, 1994 IPPS final rule (59 FR 45359), we stated that "items such as the unrecovered cost of employee meals, tuition reimbursement, and auto allowances will only be allowed as a wage-related cost for purposes of the wage index if properly reported to the IRS on an employee's W-2 form as a fringe benefit." (We note that the September, 1 1994 IPPS final rule does not mention the 1099 form for contractors, as contract labor was not allowed at that time in the wage index. Consistent with our treatment of costs for contract labor similar to that of employees for the wage index, we are clarifying that the requirement that a cost be reported to the IRS to be allowed as a wage-related cost for the wage index also applies to contract labor, which must be reported on the contractor's 1099 to be allowed as a wage-related cost for the wage index.) We believe that requiring other wage-related costs to be reported on employees' or contractors' W-2 or 1099 forms to be allowable for Line 18 of Worksheet S-3 of the Medicare cost report is consistent with the requirement that the cost is not being furnished for the convenience of the employer. A cost reported on an employee's or contractor's W-2 or 1099 form as taxable income is clearly a wage-related cost that is provided solely for the benefit of the employee. We believe that the requirement that other wage-related costs be a benefit to the employee also guarantees that administrative costs such as overhead and capitalized costs are excluded from other wage-related costs in the wage index.

Therefore, for the reasons discussed above, we are clarifying that a cost must be a fringe benefit as described by the IRS and must be reported to the IRS on employees' or contractors' W-2 or 1099 forms as taxable income in order to be considered an other wage-related cost on Line 18 of Worksheet S-3 and for the wage index. In addition, as discussed earlier, we are seeking public comments on whether we should consider in future rulemaking removing other wage-related costs from the wage index.

Because some hospitals have incorrectly interpreted prior manual and existing preamble language, as stated earlier, we are restating the criteria from the September 1, 1994 IPPS final rule (59 FR 45357) for allowing other wage-related costs for the wage index, with clarifications. The criteria follow below, and we intend to update the manual with these clarifications:

Other Wage-Related Costs. A hospital may be able to report a wage-related cost (defined as the value of the benefit) that does not appear on the core list if it meets all of the following criteria:

• The wage-related cost is provided at a significant financial cost to the employer. To meet this test, the individual wage-related cost must be greater than 1 percent of total salaries after the direct excluded salaries are removed (the sum of Worksheet S-3, Part II, Lines 11, 12, 13, 14, column 4, and Worksheet S-3, Part III, Line 3, Column 4).

• The wage-related cost is a fringe benefit as described by the IRS and is reported to the IRS on an employee's or contractor's W-2 or 1099 form as taxable income.

• The wage-related cost is not furnished for the convenience of the provider or otherwise excludable from income as a fringe benefit (such as a working condition fringe).

We note that those wage-related costs reported as salaries on Line 1 (for example, loan forgiveness and sick pay accruals) should not be included as other wage-related costs on Line 18.

E. Proposed Occupational Mix Adjustment to the FY 2018 Wage Index

As stated earlier, section 1886(d)(3)(E) of the Act provides for the collection of data every 3 years on the occupational mix of employees for each short-term, acute care hospital participating in the Medicare program, in order to construct an occupational mix adjustment to the wage index, for application beginning October 1, 2004 (the FY 2005 wage index). The purpose of the occupational mix adjustment is to control for the effect of hospitals' employment choices on the wage index. For example, hospitals may choose to employ different combinations of registered nurses, licensed practical nurses, nursing aides, and medical assistants for the purpose of providing nursing care to their patients. The varying labor costs associated with these choices reflect hospital management decisions rather than geographic differences in the costs of labor.

1. Use of 2013 Occupational Mix Survey for the FY 2018 Wage Index


[top] Section 304(c) of the Consolidated Appropriations Act, 2001 (Pub. L. 106-554) amended section 1886(d)(3)(E) of the Act to require CMS to collect data every 3 years on the occupational mix of employees for each short-term, acute care hospital participating in the page 19903 Medicare program. We collected data in 2013 to compute the occupational mix adjustment for the FY 2016, FY 2017, and FY 2018 wage indexes. A new measurement of occupational mix is required for FY 2019.

The 2013 survey included the same data elements and definitions as the previous 2010 survey and provided for the collection of hospital-specific wages and hours data for nursing employees for calendar year 2013 (that is, payroll periods ending between January 1, 2013 and December 31, 2013). We published the 2013 survey in the Federal Register on February 28, 2013 (78 FR 13679 through 13680). This survey was approved by OMB on May 14, 2013, and is available on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Wage-Index-Files-Items/Medicare-Wage-Index-Occupational-Mix-Survey2013.html. The 2013 Occupational Mix Survey Hospital Reporting Form CMS-10079 for the Wage Index Beginning FY 2016 (in Excel format) is available on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Wage-Index-Files-Items/Medicare-Wage-Index-Occupational-Mix-Survey2013.html. Hospitals were required to submit their completed 2013 surveys to their MACs by July 1, 2014. The preliminary, unaudited 2013 survey data were posted on the CMS Web site on July 11, 2014. As with the Worksheet S-3, Parts II and III cost report wage data, we asked our MACs to revise or verify data elements in hospitals' occupational mix surveys that result in certain edit failures.

2. Use of the 2016 Medicare Wage Index Occupational Mix Survey for the FY 2019 Wage Index

As stated earlier, a new measurement of occupational mix is required for FY 2019. The FY 2019 occupational mix adjustment will be based on a new calendar year (CY) 2016 survey. The CY 2016 survey (CMS Form CMS-10079) received OMB approval on September 27, 2016. The final CY 2016 Occupational Mix Survey Hospital Reporting Form is available on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Wage-Index-Files-Items/2016-Occupational-Mix-Survey-Hospital-Reporting-Form-CMS-10079-for-the-Wage-Index-Beginning-FY-2019.html. Hospitals are required to submit their completed 2016 surveys to their MACs by July 3, 2017. The preliminary, unaudited CY 2016 survey data will be posted on the CMS Web site in mid-July 2017. As with the Worksheet S-3, Parts II and III cost report wage data, as part of the FY 2019 desk review process, the MACs will revise or verify data elements in hospitals' occupational mix surveys that result in certain edit failures.

3. Calculation of the Proposed Occupational Mix Adjustment for FY 2018

For FY 2018, we are proposing to calculate the occupational mix adjustment factor using the same methodology that we have used since the FY 2012 wage index (76 FR 51582 through 51586) and to apply the occupational mix adjustment to 100 percent of the FY 2018 wage index. Because the statute requires that the Secretary measure the earnings and paid hours of employment by occupational category not less than once every 3 years, all hospitals that are subject to payments under the IPPS, or any hospital that would be subject to the IPPS if not granted a waiver, must complete the occupational mix survey, unless the hospital has no associated cost report wage data that are included in the FY 2018 wage index. For the proposed FY 2018 wage index, we are using the Worksheet S-3, Parts II and III wage data of 3,325 hospitals, and we are using the occupational mix surveys of 3,128 hospitals for which we also have Worksheet S-3 wage data, which represented a "response" rate of 94 percent (3,128/3,325). For the proposed FY 2018 wage index, we are applying proxy data for noncompliant hospitals, new hospitals, or hospitals that submitted erroneous or aberrant data in the same manner that we applied proxy data for such hospitals in the FY 2012 wage index occupational mix adjustment (76 FR 51586). As a result of applying this methodology, the proposed FY 2018 occupational mix adjusted national average hourly wage is $41.9599.

F. Analysis and Implementation of the Proposed Occupational Mix Adjustment and the Proposed FY 2018 Occupational Mix Adjusted Wage Index

As discussed in section III.E. of the preamble of this proposed rule, for FY 2018, we are proposing to apply the occupational mix adjustment to 100 percent of the FY 2018 wage index. We calculated the proposed occupational mix adjustment using data from the 2013 occupational mix survey data, using the methodology described in the FY 2012 IPPS/LTCH PPS final rule (76 FR 51582 through 51586). Using the occupational mix survey data and applying the occupational mix adjustment to 100 percent of the FY 2017 wage index results in a proposed national average hourly wage of $41.9599.

The proposed FY 2018 national average hourly wages for each occupational mix nursing subcategory as calculated in Step 2 of the occupational mix calculation are as follows:

Occupational mix nursing subcategory Average hourly wage
National RN $38.84760578
National LPN and Surgical Technician 22.72715122
National Nurse Aide, Orderly, and Attendant 15.94890269
National Medical Assistant 17.97139786
National Nurse Category 32.84544016

The proposed national average hourly wage for the entire nurse category as computed in Step 5 of the occupational mix calculation is $32.84544016. Hospitals with a nurse category average hourly wage (as calculated in Step 4) of greater than the national nurse category average hourly wage receive an occupational mix adjustment factor (as calculated in Step 6) of less than 1.0. Hospitals with a nurse category average hourly wage (as calculated in Step 4) of less than the national nurse category average hourly wage receive an occupational mix adjustment factor (as calculated in Step 6) of greater than 1.0.

Based on the 2013 occupational mix survey data, we determined (in Step 7 of the occupational mix calculation) that the national percentage of hospital employees in the nurse category is 42.6 percent, and the national percentage of hospital employees in the all other occupations category is 57.4 percent. At the CBSA level, the percentage of hospital employees in the nurse category ranged from a low of 25.7 percent in one CBSA to a high of 73.5 percent in another CBSA.


[top] We compared the FY 2018 proposed occupational mix adjusted wage indexes for each CBSA to the unadjusted wage indexes for each CBSA. As a result of applying the proposed occupational mix adjustment to the wage data, the proposed wage index values for 223 (54.7 percent) urban areas and 23 (48.9 percent) rural areas would increase. The proposed wage index values for 108 (26.5 percent) urban areas would increase by greater than or equal to 1 percent but less than 5 percent, and the proposed wage index values for 6 (1.5 percent) urban areas would increase by 5 percent or more. The proposed wage index values for 10 (21.3 percent) rural areas would increase by greater than or equal to 1 percent but less than 5 page 19904 percent, and no rural areas' proposed wage index values would increase by 5 percent or more. However, the proposed wage index values for 184 (45.1 percent) urban areas and 24 (51.1 percent) rural areas would decrease. The proposed wage index values for 85 (20.8 percent) urban areas would decrease by greater than or equal to 1 percent but less than 5 percent, and no urban areas' final wage index value would decrease by 5 percent or more. The proposed wage index values of 8 (17.0 percent) rural areas would decrease by greater than or equal to 1 percent and less than 5 percent, and no rural areas' final wage index values would decrease by 5 percent or more. The largest proposed positive impacts would be 17.4 percent for an urban area and 2.9 percent for a rural area. The largest proposed negative impacts would be 4.9 percent for an urban area and 2.3 percent for a rural area. One urban area's proposed wage index, but no rural area wage indexes, would remain unchanged by application of the occupational mix adjustment. These results indicate that a larger percentage of urban areas (54.7 percent) would benefit from the occupational mix adjustment than would rural areas (48.9 percent).

G. Proposed Application of the Rural, Imputed, and Frontier Floors

1. Proposed Rural Floor

Section 4410(a) of Public Law 105-33 provides that, for discharges on or after October 1, 1997, the area wage index applicable to any hospital that is located in an urban area of a State may not be less than the area wage index applicable to hospitals located in rural areas in that State. This provision is referred to as the "rural floor". Section 3141 of Public Law 111-148 also requires that a national budget neutrality adjustment be applied in implementing the rural floor. Based on the proposed FY 2018 wage index associated with this proposed rule (which is available via the Internet on the CMS Web site), we estimated that 366 hospitals would receive an increase in their FY 2018 proposed wage index due to the application of the rural floor.

2. Proposed Expiration of the Imputed Floor Policy

In the FY 2005 IPPS final rule (69 FR 49109 through 49111), we adopted the "imputed floor" policy as a temporary 3-year regulatory measure to address concerns from hospitals in all-urban States that have argued that they are disadvantaged by the absence of rural hospitals to set a wage index floor for those States. Since its initial implementation, we have extended the imputed floor policy seven times, the last of which was adopted in the FY 2017 IPPS/LTCH PPS final rule and is set to expire on September 30, 2017. (We refer readers to further discussions of the imputed floor in the FY 2014, FY 2015, FY 2016, and FY 2017 IPPS/LTCH PPS final rules (78 FR 50589 through 50590, 79 FR 49969 through 49970, 80 FR 49497 through 49498, and 81 FR 56921 through 56922, respectively) and to the regulations at 42 CFR 412.64(h)(4).) Currently, there are three all-urban States-Delaware, New Jersey, and Rhode Island-with a range of wage indexes assigned to hospitals in these States, including through reclassification or redesignation. (We refer readers to discussions of geographic reclassifications and redesignations in section III.J. of the preamble of this proposed rule.)

In computing the imputed floor for an all-urban State under the original methodology, which was established beginning in FY 2005, we calculated the ratio of the lowest-to-highest CBSA wage index for each all-urban State as well as the average of the ratios of lowest-to-highest CBSA wage indexes of those all-urban States. We then compared the State's own ratio to the average ratio for all-urban States and whichever is higher is multiplied by the highest CBSA wage index value in the State-the product of which established the imputed floor for the State. As of FY 2012, there were only two all-urban States-New Jersey and Rhode Island- and only New Jersey benefitted under this methodology. Under the previous OMB labor market area delineations, Rhode Island had only one CBSA (Providence-New Bedford-Fall River, RI-MA) and New Jersey had 10 CBSAs. Therefore, under the original methodology, Rhode Island's own ratio equaled 1.0, and its imputed floor was equal to its original CBSA wage index value. However, because the average ratio of New Jersey and Rhode Island was higher than New Jersey's own ratio, this methodology provided a benefit for New Jersey, but not for Rhode Island.

In the FY 2013 IPPS/LTCH PPS final rule (77 FR 53368 through 53369), we retained the imputed floor calculated under the original methodology as discussed above, and established an alternative methodology for computing the imputed floor wage index to address the concern that the original imputed floor methodology guaranteed a benefit for one all-urban State with multiple wage indexes (New Jersey) but could not benefit the other all-urban State (Rhode Island). The alternative methodology for calculating the imputed floor was established using data from the application of the rural floor policy for FY 2013. Under the alternative methodology, we first determined the average percentage difference between the post-reclassified, pre-floor area wage index and the post-reclassified, rural floor wage index (without rural floor budget neutrality applied) for all CBSAs receiving the rural floor. (Table 4D associated with the FY 2013 IPPS/LTCH PPS final rule (which is available via the Internet on the CMS Web site) included the CBSAs receiving a State's rural floor wage index.) The lowest postreclassified wage index assigned to a hospital in an all-urban State having a range of such values then is increased by this factor, the result of which establishes the State's alternative imputed floor. We amended §?412.64(h)(4) of the regulations to add new paragraphs to incorporate the finalized alternative methodology, and to make reference and date changes. In summary, for the FY 2013 wage index, we did not make any changes to the original imputed floor methodology at §?412.64(h)(4) and, therefore, made no changes to the New Jersey imputed floor computation for FY 2013. Instead, for FY 2013, we adopted a second, alternative methodology for use in cases where an all-urban State has a range of wage indexes assigned to its hospitals, but the State cannot benefit under the original methodology.

In the FY 2014 IPPS/LTCH PPS final rule (78 FR 50589 through 50590), we extended the imputed floor policy (both the original methodology and the alternative methodology) for 1 additional year, through September 30, 2014, while we continued to explore potential wage index reforms.

In the FY 2015 IPPS/LTCH PPS final rule (79 FR 49969 through 49970), for FY 2015, we adopted a policy to extend the imputed floor policy (both the original methodology and alternative methodology) for another year, through September 30, 2015, as we continued to explore potential wage index reforms. In that final rule, we revised the regulations at §?412.64(h)(4) and (h)(4)(vi) to reflect the 1-year extension of the imputed floor.


[top] As discussed in section III.B. of the preamble of that FY 2015 final rule, we adopted the new OMB labor market area delineations beginning in FY 2015. Under the new OMB delineations, Delaware became an all-urban State, along with New Jersey and Rhode Island. Under the new OMB delineations, Delaware has three CBSAs, New Jersey has seven CBSAs, and Rhode Island continues to have only one CBSA (Providence-Warwick, RI-MA). We refer readers to a detailed discussion of our adoption of the new page 19905 OMB labor market area delineations in section III.B. of the preamble of the FY 2015 IPPS/LTCH PPS final rule. Therefore, under the adopted new OMB delineations discussed in section III.B. of the preamble of the FY 2015 IPPS/LTCH PPS final rule, Delaware became an all-urban State and was subject to an imputed floor as well for FY 2015.

In the FY 2016 IPPS/LTCH PPS final rule (80 FR 49497 through 49498), for FY 2016, we extended the imputed floor policy (under both the original methodology and the alternative methodology) for 1 additional year, through September 30, 2016. In that final rule, we revised the regulations at §?412.64(h)(4) and (h)(4)(vi) to reflect this additional 1-year extension.

In the FY 2017 IPPS/LTCH PPS final rule (81 FR 56921 through 56922), for FY 2017, we extended the imputed floor policy (under both the original methodology and the alternative methodology) for 1 additional year, through September 30, 2017. In that final rule, we revised the regulations at §?412.64(h)(4) and (h)(4)(vi) to reflect this additional 1-year extension.

The imputed floor is set to expire effective October 1, 2017, and we are not proposing to extend the imputed floor policy. In the FY 2005 IPPS final rule (69 FR 49110), we adopted the imputed floor policy for all-urban States under the authority of section 1886(d)(3)(E) of the Act, which gives the Secretary broad authority to adjust the proportion (as estimated by the Secretary from time to time) of hospitals' costs which are attributable to wages and wage-related costs of the DRG prospective payment rates for area differences in hospital wage levels by a factor (established by the Secretary). However, we have expressed reservations about establishment of an imputed floor, considering that the imputed rural floor methodology creates a disadvantage in the application of the wage index to hospitals in States with rural hospitals but no urban hospitals receiving the rural floor (72 FR 24786 and 72 FR 47322). As we discussed in the FY 2008 IPPS final rule (72 FR 47322), the application of the rural and imputed floors requires transfer of payments from hospitals in States with rural hospitals but where the rural floor is not applied to hospitals in States where the rural or imputed floor is applied. For this reason, in this proposed rule, we are proposing not to apply an imputed floor to wage index calculations and payments for hospitals in all-urban States for FY 2018 and subsequent years. That is, hospitals in New Jersey, Delaware, and Rhode Island (and in any other all-urban State) would receive a wage index that is calculated without applying an imputed floor for FY 2018 and subsequent years. Therefore, only States containing both rural areas and hospitals located in such areas (including any hospital reclassified as rural under the provisions of §?412.103 of the regulations) would benefit from the rural floor, in accordance with section 4410 of Public Law 105-33. In addition, we would no longer include the imputed floor as a factor in the national budget neutrality adjustment. Therefore, the proposed wage index and impact tables associated with this FY 2018 IPPS/LTCH PPS proposed rule (which are available via the Internet on the CMS Web site) do not reflect the imputed floor policy, and there is no proposed national budget neutrality adjustment for the imputed floor for FY 2018. We are inviting public comments on our proposal not to extend the imputed floor for FY 2018 and subsequent years.

3. Proposed State Frontier Floor for FY 2018

Section 10324 of Public Law 111-148 requires that hospitals in frontier States cannot be assigned a wage index of less than 1.0000. (We refer readers to the regulations at 42 CFR 412.64(m) and to a discussion of the implementation of this provision in the FY 2011 IPPS/LTCH PPS final rule (75 FR 50160 through 50161).) Fifty-two hospitals would receive the frontier floor value of 1.0000 for their FY 2018 wage index in this proposed rule. These hospitals are located in Montana, Nevada, North Dakota, South Dakota, and Wyoming. We are not proposing any changes to the frontier floor policy for FY 2018. The areas affected by the proposed rural and frontier floor policies for the proposed FY 2018 wage index are identified in Table 2 associated with this proposed rule, which is available via the Internet on the CMS Web site.

H. Proposed FY 2018 Wage Index Tables

In the FY 2016 IPPS/LTCH PPS final rule (80 FR 49498 and 49807 through 49808), we finalized a proposal to streamline and consolidate the wage index tables associated with the IPPS proposed and final rules for FY 2016 and subsequent fiscal years. Prior to FY 2016, the wage index tables had consisted of 12 tables (Tables 2, 3A, 3B, 4A, 4B, 4C, 4D, 4E, 4F, 4J, 9A, and 9C) that were made available via the Internet on the CMS Web site. Effective beginning FY 2016, with the exception of Table 4E, we streamlined and consolidated 11 tables (Tables 2, 3A, 3B, 4A, 4B, 4C, 4D, 4F, 4J, 9A, and 9C) into 2 tables (Tables 2 and 3). We refer readers to section VI. of the Addendum to this proposed rule for a discussion of the proposed wage index tables for FY 2018.

I. Revisions to the Wage Index Based on Hospital Redesignations and Reclassifications

1. General Policies and Effects of Reclassification and Redesignation

Under section 1886(d)(10) of the Act, the Medicare Geographic Classification Review Board (MGCRB) considers applications by hospitals for geographic reclassification for purposes of payment under the IPPS. Hospitals must apply to the MGCRB to reclassify not later than 13 months prior to the start of the fiscal year for which reclassification is sought (usually by September 1). Generally, hospitals must be proximate to the labor market area to which they are seeking reclassification and must demonstrate characteristics similar to hospitals located in that area. The MGCRB issues its decisions by the end of February for reclassifications that become effective for the following fiscal year (beginning October 1). The regulations applicable to reclassifications by the MGCRB are located in 42 CFR 412.230 through 412.280. (We refer readers to a discussion in the FY 2002 IPPS final rule (66 FR 39874 and 39875) regarding how the MGCRB defines mileage for purposes of the proximity requirements.) The general policies for reclassifications and redesignations and the policies for the effects of hospitals' reclassifications and redesignations on the wage index are discussed in the FY 2012 IPPS/LTCH PPS final rule for the FY 2012 final wage index (76 FR 51595 and 51596). In addition, in the FY 2012 IPPS/LTCH PPS final rule, we discussed the effects on the wage index of urban hospitals reclassifying to rural areas under 42 CFR 412.103. Hospitals that are geographically located in States without any rural areas are ineligible to apply for rural reclassification in accordance with the provisions of 42 CFR 412.103.


[top] On April 21, 2016, we published an interim final rule with comment period (IFC) in the Federal Register (81 FR 23428 through 23438) that included provisions amending our regulations to allow hospitals nationwide to have simultaneous §?412.103 and MGCRB reclassifications. For reclassifications effective beginning FY 2018, a hospital may acquire rural status under §?412.103 and subsequently apply for a reclassification under the MGCRB using distance and average hourly wage criteria designated for rural hospitals. In page 19906 addition, we provided that a hospital that has an active MGCRB reclassification and is then approved for redesignation under §?412.103 will not lose its MGCRB reclassification; such a hospital receives a reclassified urban wage index during the years of its active MGCRB reclassification and is still considered rural under section 1886(d) of the Act and for other purposes.

We discussed that when there is both a §?412.103 redesignation and an MGCRB reclassification, the MGCRB reclassification controls for wage index calculation and payment purposes. We exclude hospitals with §?412.103 redesignations from the calculation of the reclassified rural wage index if they also have an active MGCRB reclassification to another area. That is, if an application for urban reclassification through the MGCRB is approved, and is not withdrawn or terminated by the hospital within the established timelines, we consider the hospital's geographic CBSA and the urban CBSA to which the hospital is reclassified under the MGCRB for the wage index calculation. We refer readers to the April 21, 2016 IFC (81 FR 23428 through 23438) and the FY 2017 IPPS/LTCH PPS final rule (81 FR 56922 through 56930) for a full discussion of the effect of simultaneous reclassifications under both the §?412.103 and the MGCRB processes on wage index calculations.

2. MGCRB Reclassification and Redesignation Issues for FY 2018

a. FY 2018 Reclassification Requirements and Approvals

As previously stated, under section 1886(d)(10) of the Act, the MGCRB considers applications by hospitals for geographic reclassification for purposes of payment under the IPPS. The specific procedures and rules that apply to the geographic reclassification process are outlined in regulations under 42 CFR 412.230 through 412.280.

At the time this proposed rule was constructed, the MGCRB had completed its review of FY 2018 reclassification requests. Based on such reviews, there are 375 hospitals approved for wage index reclassifications by the MGCRB starting in FY 2018. Because MGCRB wage index reclassifications are effective for 3 years, for FY 2018, hospitals reclassified beginning in FY 2016 or FY 2017 are eligible to continue to be reclassified to a particular labor market area based on such prior reclassifications for the remainder of their 3-year period. There were 257 hospitals approved for wage index reclassifications in FY 2016 that will continue for FY 2018, and 274 hospitals approved for wage index reclassifications in FY 2017 that will continue for FY 2018. Of all the hospitals approved for reclassification for FY 2016, FY 2017, and FY 2018, based upon the review at the time of this proposed rule, 906 hospitals are in a MGCRB reclassification status for FY 2018.

Under the regulations at 42 CFR 412.273, hospitals that have been reclassified by the MGCRB are permitted to withdraw their applications if the request for withdrawal is received by the MGCRB within 45 days of the publication of CMS' annual notice of proposed rulemaking concerning changes to the inpatient hospital prospective payment system and proposed payment rates for the fiscal year for which the application has been filed. (We note that in section III.I.4. of the preamble of this proposed rule, we are proposing to revise the above described regulation text to specify that written notice to the MGCRB must be provided within 45 days from the date of public display of the proposed rule at the Office of the Federal Register. If finalized, that proposal would be effective beginning with the FY 2019 IPPS/LTCH PPS proposed rule.) For information about withdrawing, terminating, or canceling a previous withdrawal or termination of a 3-year reclassification for wage index purposes, we refer readers to §?412.273, as well as the FY 2002 IPPS final rule (66 FR 39887 through 39888) and the FY 2003 IPPS final rule (67 FR 50065 through 50066). Additional discussion on withdrawals and terminations, and clarifications regarding reinstating reclassifications and "fallback" reclassifications were included in the FY 2008 IPPS final rule (72 FR 47333).

Changes to the wage index that result from withdrawals of requests for reclassification, terminations, wage index corrections, appeals, and the Administrator's review process for FY 2018 will be incorporated into the wage index values published in the FY 2018 IPPS/LTCH PPS final rule. These changes affect not only the wage index value for specific geographic areas, but also the wage index value that redesignated/reclassified hospitals receive; that is, whether they receive the wage index that includes the data for both the hospitals already in the area and the redesignated/reclassified hospitals. Further, the wage index value for the area from which the hospitals are redesignated/reclassified may be affected.

Applications for FY 2019 reclassifications are due to the MGCRB by September 1, 2017 (the first working day of September 2017). We note that this is also the deadline for canceling a previous wage index reclassification, withdrawal, or termination under 42 CFR 412.273(d). Applications and other information about MGCRB reclassifications may be obtained, beginning in mid-July 2017, via the Internet on the CMS Web site at: https://www.cms.gov/Regulations-and-Guidance/Review-Boards/MGCRB/index.html, or by calling the MGCRB at (410) 786-1174. The mailing address of the MGCRB is: 2520 Lord Baltimore Drive, Suite L, Baltimore, MD 21244-2670.

Under previous regulations at 42 CFR 412.256(a)(1), applications for reclassification were required to be mailed or delivered to the MGCRB, with a copy to CMS, and were not allowed to be submitted through the facsimile (FAX) process or by other electronic means. Because we believed this previous policy was outdated and overly restrictive and to promote ease of application for FY 2018 and subsequent years, in the FY 2017 IPPS/LTCH PPS final rule (81 FR 56928), we revised this policy to require applications and supporting documentation to be submitted via the method prescribed in instructions by the MGCRB, with an electronic copy to CMS. We revised §?412.256(a)(1) to specify that an application must be submitted to the MGCRB according to the method prescribed by the MGCRB, with an electronic copy of the application sent to CMS. We specified that CMS copies should be sent via email to wageindex@cms.hhs.gov.

In the FY 2017 IPPS/LTCH PPS final rule (81 FR 56928), we reiterated that MGCRB application requirements will be published separately from the rulemaking process, and paper applications will likely still be required. The MGCRB makes all initial determinations for geographic reclassification requests, but CMS requests copies of all applications to assist in verifying a reclassification status during the wage index development process. We stated that we believed that requiring electronic versions would better aid CMS in this process, and would reduce the overall burden upon hospitals.

b. Extension of PRA Information Collection Requirement Approval for MGCRB Applications


[top] As stated earlier, under section 1886(d)(10) of the Act, the MGCRB considers applications by hospitals for geographic reclassification for purposes of payment under the IPPS. The specific page 19907 procedures and rules that apply to the geographic reclassification process are outlined in the regulations under 42 CFR 412.230 through 412.280. The current information collection requirements for the MGCRB procedures and criteria and supporting regulations in 42 CFR 412.256 subject to the Paperwork Reduction Act provisions are currently approved under OMB Control Number 0938-0573 and expired on February 28, 2017. An extension of the currently approved collection is required in time for applications due to the MGCRB September 1, 2017 for FY 2019 reclassifications. As discussed in section XIII.B. of the preamble of this proposed rule, a request for an extension of the current information collection requirements for the MGCRB procedures and criteria and supporting regulations is currently awaiting approval by OMB and can be accessed at: https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201612-0938-023.

c. Proposed Deadline for Submittal of Documentation of Sole Community Hospital (SCH) and Rural Referral Center (RRC) Classification Status to the MGCRB

The regulations at 42 CFR 412.230(a)(3), consistent with section 1886(d)(10)(D)(i)(III) of the Act, set special rules for sole community hospitals (SCHs) and rural referral centers (RRCs) that are reclassifying under the MGCRB. Specifically, a hospital that is an RRC or an SCH, or both, does not have to demonstrate a close proximity to the area to which it seeks redesignation. If a hospital that is an RRC or an SCH, or both, qualifies for urban redesignation, it is redesignated to the urban area that is closest to the hospital. If the hospital is closer to another rural area than to any urban area, it may seek redesignation to either the closest rural or the closest urban area.

In addition, section 1886(d)(10)(D)(iii) of the Act, as implemented in the regulations at §?412.230(d)(3)(i), provides an exception to certain wage comparison criteria for RRCs and former RRCs reclassifying under the MGCRB. Under §?412.230(d)(3)(i), if a hospital was ever an RRC, it does not have to demonstrate that it meets the average hourly wage criterion at §?412.230(d)(1)(iii), which would require that the hospital's average hourly wage be at least 106 percent for rural hospitals and at least 108 percent for urban hospitals of the average hourly wage of all other hospitals in the area in which the hospital is located. Rather, as codified at §?412.230(d)(3)(ii), consistent with our authority under section 1886(d)(10)(D)(i) of the Act, if a hospital was ever an RRC, it is required to meet only the criterion for rural hospitals at §?412.230(d)(1)(iv), which requires that the hospital's average hourly wage is equal to at least 82 percent of the average hourly wage of hospitals in the area to which it seeks redesignation. The regulations at §?412.96 set forth the criteria that a hospital must meet in order to qualify as an RRC.

For a hospital to use the special rules at §?412.230(a)(3) for SCHs and RRCs, the existing regulation at §?412.230(a)(3) requires that the hospital be an active SCH or an RRC as of the date of the MGCRB's review. In addition, for a hospital to use the RRC exceptions at §?412.230(d)(3), a hospital must either be an RRC at the time of the MGCRB's review or have previously been classified as an RRC in the past. In other words, under the existing regulations, if a hospital is approved by CMS as an SCH or an RRC but the approval is not yet effective at the time of the MGCRB's review, the hospital's status as an SCH or an RRC would not be considered in the MGCRB's decision, unless the hospital was a former RRC, in which case it would be able to use the RRC exceptions at §?412.230(d)(3).

The MGCRB currently accepts supporting documentation of SCH and RRC classification (the CMS approval letter) up until the date of MGCRB's review, which varies annually. A hospital may apply at any time for classification as an SCH, and the classification is effective 30 days after the date of CMS' written notification of approval, in accordance with §?412.92. Considering that the MGCRB usually meets in early February, hospitals typically seek to obtain SCH approval letters no later than early January (30 days prior to the date of MGCRB review) for the SCH status to be effective as of the date of the MGCRB's review. However, consistent with section 1886(d)(5)(C)(i) of the Act, a hospital must submit its application for RRC status during the quarter before the first quarter of the hospital's cost reporting period, to be effective at the beginning of the next cost reporting period. The existing regulation at §?412.230(a)(3), combined with the statutory timeframe for RRC classification, require that a hospital's cost reporting period as an RRC begin on or before the date of the MGCRB's review in order to be considered an RRC by the MGCRB for purposes of the special rules under §?412.230(a)(3). Similarly, in order to use the RRC exceptions under §?412.230(d)(3), a hospital's RRC status must be effective on the date of the MGCRB's review, or (unlike §?412.230(a)(3)) the hospital must have had RRC status in the past. For example, a hospital with a cost reporting period beginning in March would obtain RRC approval, in accordance with the statutory timeframe, during the December through February quarter (potentially before the MGCRB's decision), but would not be considered an RRC by the MGCRB because the approval would not be effective until the next cost reporting period begins in March, after the MGCRB's decision (unless, for purposes of §?412.230(d)(3), the hospital had previously been classified as an RRC in the past).

The current practice of accepting SCH and RRC approvals up until the date of MGCRB review does not ensure adequate time for the MGCRB to include SCH and RRC approvals in its review. We note that many hospitals now obtain SCH or RRC status based on a §?412.103 reclassification in order to reclassify using the special rules and exceptions under the MGCRB following the April 21, 2016 IFC (81 FR 23428), which revised the regulations to allow hospitals nationwide to reclassify based on acquired rural status. We believe that the additional volume of SCH and RRC approvals submitted to the MGCRB increases the need for an earlier deadline for documentation of SCH and RRC classifications to be submitted to the MGCRB for purposes of the special rules at §?412.230(a)(3) and the exception for RRCs at §?412.230(d)(3). In addition, because the date of the MGCRB's review varies annually, we believe hospitals would benefit from the certainty of a set date by which documentation of RRC or SCH status must be submitted in order to have that status considered by the MGCRB under 412.230(a)(3) and §?412.230(d)(3).


[top] Therefore, to ensure sufficient time for the MGCRB to include SCH and RRC status approvals in its review and increase clarity for hospitals, while allowing as much time and flexibility as possible for hospitals applying for RRC status to be considered RRCs by the MGCRB, we are proposing to revise the regulations at §?412.230(a)(3) and §?412.230(d)(3). We are proposing to revise the regulations at §?412.230(a)(3) in two ways. First, we are proposing to establish a deadline of the first business day after January 1 for hospitals to submit to the MGCRB documentation of SCH or RRC status approval (the CMS approval letter) in order to take advantage of the special rules under §?412.230(a)(3) when reclassifying under the MGCRB. We believe that this date of the first business day after January 1 would provide sufficient time for the MGCRB to consider documentation of page 19908 SCH or RRC status approval in its review, without negatively affecting hospitals seeking to obtain SCH or RRC status, as explained below. Second, we are proposing to revise §?412.230(a)(3) to require hospitals to submit documentation of SCH or RRC status approval (the CMS approval letter) by the deadline above, rather than to have SCH or RRC classification that is effective as of the date of MGCRB review, in order to use the special rules for SCHs and RRCs under §?412.230(a)(3). Likewise, we are proposing to revise the regulations at §?412.230(d)(3) so that a hospital qualifies for these RRC exceptions if it was ever approved as a RRC. In other words, the exceptions at §?412.230(d)(3) would continue to apply to hospitals that were ever classified as RRCs, but consistent with our authority under section 1886(d)(10)(D)(i) of the Act to publish guidelines to be utilized by the MGCRB, we would also extend these exceptions to hospitals that were ever approved as RRCs. Similar to §?412.230(a)(3), we also are proposing to establish a deadline of the first business day after January 1 for hospitals to submit documentation of RRC status approval (the CMS approval letter) in order to take advantage of the exception under §?412.230(d)(3) when reclassifying under the MGCRB. These proposed revisions would more appropriately allow the MGCRB to prepare for its review and would allow hospitals obtaining SCH or RRC status approval as late as the first business day after January 1 to have these classifications considered by the MGCRB under §?412.230(a)(3) and (d)(3), irrespective of the effective date of these classifications. These proposals would not substantially affect hospitals seeking SCH classification for purposes of reclassifying under the MGCRB because a hospital must obtain SCH status approval by early January under the existing regulation in order to have that classification effective 30 days later by the time the Board usually meets in early February. For hospitals seeking RRC classification for purposes of reclassifying under the MGCRB, however, the proposed deadline of no later than the first business day after January 1, in concert with our proposal to accept documentation of approval (the CMS approval letter) instead of requiring the hospital to be an active RRC at the time of the MGCRB review in order to take advantage of the special rules and exceptions under §?412.230(a)(3) and (d)(3), is beneficial. The proposed revisions to the regulations at §?412.230(a)(3) and (d)(3) accommodate more hospitals with various cost reporting year ends by allowing hospitals with cost reporting periods beginning soon after the MGCRB's decision to have RRC status approvals included in the MGCRB's review. Under the proposals, the MGCRB would consider an RRC status approval obtained as late as the first business day after January 1 instead of requiring the RRC classification to be effective by the time the Board meets, which has been in February in past years. For example, a hospital with a cost reporting period beginning as late as March, which could apply for RRC status approval in accordance with the statutory timeframe starting in December, would be considered an RRC by the MGCRB if it submits documentation of approval of RRC status no later than the first business day after January 1, even though the approval would not be effective until after the MGCRB's decision.

For the reasons discussed above, consistent with our authority under section 1886(d)(10)(D)(i) of the Act to publish guidelines to be utilized by the MGCRB, we are proposing to revise the regulations at §?412.230(a)(3) to specify that, to be redesignated under the special rules in that paragraph, the hospital must submit documentation of the approval of SCH or RRC status to the MGCRB no later than the first business day after January 1. In addition, we are proposing conforming revisions to paragraphs (a)(3)(i) and (ii) of §?412.230 to reflect that these paragraphs apply to hospitals with SCH and RRC approval as specified above (and not only effective status). Specifically, we are proposing to revise §?412.230(a)(3)(i) to specify that a hospital that is approved as an RRC or SCH, or both, does not have to demonstrate a close proximity to the area to which it seeks redesignation; and to revise §?412.230(a)(3)(ii) to specify that this paragraph applies if a hospital that is approved as an RRC or SCH, or both, qualifies for urban redesignation. We note that we are proposing additional revisions to §?412.230(a)(3)(ii) as discussed in section III.I.2.d. of the preamble of this proposed rule.

In addition, for the reasons discussed above, consistent with our authority under section 1886(d)(10)(D)(i) of the Act to publish guidelines to be utilized by the MGCRB, we are proposing to revise the regulations at §?412.230(d)(3). Specifically, we are proposing to add introductory language to §?412.230(d)(3) to specify that for the exceptions in this paragraph to apply, the hospital must submit documentation of the approval of RRC status (current or past) to the MGCRB no later than the first business day after January 1. In addition, we are proposing to revise §?412.230(d)(3)(i) to specify that if a hospital was ever approved as an RRC, it does not have to demonstrate that it meets the average hourly wage criterion set forth in §?412.230(d)(1)(iii); and to revise §?412.230(d)(3)(ii) to specify that if a hospital was ever approved as an RRC, it is required to meet only the criterion that applies to rural hospitals under §?412.230(d)(1)(iv), regardless of its actual location in an urban or rural area.

We are inviting public comments on these proposals.

d. Clarification of Special Rules for SCHs and RRCs Reclassifying to Geographic Home Area

Following issuance of the April 21, 2016 IFC (81 FR 23428), hospitals may simultaneously be redesignated as rural under §?412.103 and reclassified under the MGCRB. An urban hospital seeking benefits of rural status, such as rural payments for disproportionate share hospitals (DSH) and eligibility for the 340B Drug Pricing Program administered by HRSA, without the associated rural wage index may be redesignated as rural under §?412.103 (if it meets the applicable requirements) and also reclassify under the MGCRB to an urban area (again, if it meets the applicable requirements). As discussed earlier and in the FY 2017 IPPS/LTCH PPS final rule (81 FR 56922 through 56927), a hospital with simultaneous §?412.103 redesignation and MGCRB reclassification receives the wage index of the CBSA to which it is reclassified under the MGCRB while still maintaining §?412.103 reclassified rural status for other purposes.


[top] Hospitals that are redesignated under §?412.103 may seek MGCRB reclassification to their geographic home area. Such hospitals automatically meet the criteria for proximity, but must still demonstrate that they meet the wage comparison requirements using the criteria for rural hospitals at §?412.230(d). Specifically, a hospital with a §?412.103 redesignation seeking reclassification under the MGCRB must demonstrate that its average hourly wage is at least 106 percent of the average hourly wage of all other hospitals in the area in which the hospital is located in accordance with §?412.230(d)(1)(iii), and the hospital's average hourly wage is equal to at least 82 percent of the average hourly wage of hospitals in the area to which it seeks redesignation, in accordance with §?412.230(d)(1)(iv). In this case, both the area in which the hospital is located and page 19909 the area to which it seeks redesignation are the geographic home area.

If a hospital with a §?412.103 rural redesignation also has SCH or RRC status based on its acquired rural status, the hospital may use the exception at §?412.230(d)(3) for RRCs seeking reclassification under the MGCRB and the special reclassification rules at §?412.230(a)(3) for SCHs and RRCs. Specifically, under §?412.230(d)(3)(ii), an RRC or former RRC must only demonstrate that its average hourly wage is equal to at least 82 percent of the average hourly wage of hospitals in the area to which it seeks redesignation. In other words, a hospital with RRC status based on a §?412.103 rural redesignation that is seeking additional reclassification under the MGCRB to its geographic home area must only demonstrate that its average hourly wage is equal to at least 82 percent of the average hourly wage of hospitals in its geographic home area. The proximity requirement is waived under §?412.230(a)(3) for SCHs and RRCs, and SCHs and RRCs are redesignated to the urban area that is closest to the hospital (or if the hospital is closer to another rural area than to any urban area, it may seek redesignation to either the closest rural area or the closest urban area).

The existing regulation at §?412.230(a)(3)(ii) states that if an SCH or RRC qualifies for urban redesignation, it is redesignated to the urban area that is closest to the hospital. As currently worded, we believe it is unclear how this provision would apply to a hospital with a §?412.103 rural redesignation and SCH or RRC status. If the urban area that is closest to the hospital is interpreted to mean the hospital's geographic home area, a hospital with a §?412.103 rural redesignation and SCH or RRC status would not be able to reclassify to any closest area outside of the hospital's geographic home area, but would only be allowed to reclassify to the geographic home area. Alternatively, if the urban area that is closest to the hospital is interpreted to mean the closest urban area to the hospital's geographic home area, the hospital would seem to be precluded from reclassifying under the MGCRB to its geographic home area. In other words, under the existing language of this regulation, the urban area that is closest to the hospital can either be interpreted to mean the hospital's geographic home area, or the closest area outside of the hospital's geographic home area.

We believe it would be appropriate to revise §?412.230(a)(3)(ii) to clarify that it allows for redesignation to either the hospital's geographic home area or to the closest area outside of the hospital's geographic home area. Prior to the April 21, 2016 interim final rule with comment period (IFC) (81 FR 23428), it was not possible for a hospital with §?412.103 rural redesignation to seek reclassification to its geographic home area or to the closest area outside its geographic home area under the MGCRB because dual reclassification under §?412.103 and under the MGCRB was not permitted. However, the IFC allowed dual §?412.103 and MGCRB reclassifications, so a hospital may now reclassify to a rural area under §?412.103 and then reclassify back to its geographic home area or another area under the MGCRB for wage index purposes (if it meets all criteria). Thus, depending on the circumstances, a hospital may seek to reclassify to either its geographic home area or the closest area outside of its geographic home area.

Therefore, we are proposing to revise the regulations at §?412.230(a)(3)(ii) to clarify that a hospital with a §?412.103 rural redesignation and SCH or RRC approval may reclassify under the MGCRB to its geographic home area or to the closest area outside of its geographic home area. Specifically, we are proposing to revise §?412.230(a)(3)(ii) to state that if a hospital that is approved as an RRC or an SCH, or both, qualifies for urban redesignation, it is redesignated to the urban area that is closest to the hospital or to the hospital's geographic home area. If the hospital is closer to another rural area than to any urban area, it may seek redesignation to either the closest rural or the closest urban area.

3. Redesignations Under Section 1886(d)(8)(B) of the Act

In the FY 2012 IPPS/LTCH PPS final rule (76 FR 51599 through 51600), we adopted the policy that, beginning with FY 2012, an eligible hospital that waives its Lugar status in order to receive the out-migration adjustment has effectively waived its deemed urban status and, thus, is rural for all purposes under the IPPS effective for the fiscal year in which the hospital receives the out-migration adjustment. In addition, we adopted a minor procedural change that would allow a Lugar hospital that qualifies for and accepts the out-migration adjustment (through written notification to CMS within 45 days from the publication of the proposed rule) to waive its urban status for the full 3-year period for which its out-migration adjustment is effective. (We note that, in section III.I.4. of the preamble of this proposed rule, we are proposing to revise this policy to require a Lugar hospital that qualifies for and accepts the out-migration adjustment, or that no longer wishes to accept the out-migration adjustment and instead elects to return to its deemed urban status, to notify CMS within 45 days from the date of public display of the proposed rule at the Office of the Federal Register.) By doing so, such a Lugar hospital would no longer be required during the second and third years of eligibility for the out-migration adjustment to advise us annually that it prefers to continue being treated as rural and receive the out-migration adjustment. In the FY 2017 IPPS/LTCH PPS final rule (81 FR 56930), we again clarified that such a request to waive Lugar status, received within 45 days of the publication of the proposed rule, is valid for the full 3-year period for which the hospital's out-migration adjustment is effective. We further clarified that if a hospital wishes to reinstate its urban status for any fiscal year within this 3-year period, it must send a request to CMS within 45 days of publication of the proposed rule for that particular fiscal year. We indicated that such reinstatement requests may be sent electronically to wageindex@cms.hhs.gov . We wish to further clarify that both requests to waive and to reinstate "Lugar" status may be sent to this mailbox. To ensure proper accounting, we request hospitals to include their CCN, and either "waive Lugar" or "reinstate Lugar", in the subject line of these requests.

4. Proposed Changes to the 45-Day Notification Rules


[top] Certain Medicare regulations specify that hospitals have 45 days from the publication of the annual proposed rule for the hospital inpatient prospective payment system to inform CMS or the MGCRB of certain requested reclassification/redesignation and out-migration adjustment changes relating to the development of the hospital wage index. Specifically, 42 CFR 412.64(i)(3)(iii), which provides for adjusting the wage index to account for commuting patterns of hospital workers, and 42 CFR 412.211(f)(3)(iii), which provides for the same adjustment for hospitals in Puerto Rico, state that a hospital may waive the application of this wage index adjustment by notifying CMS in writing within 45 days after the publication of the annual notice of proposed rulemaking for the hospital inpatient prospective payment system. The regulations at §?412.273(c) concerning withdrawing an MGCRB application, terminating an approved 3-year reclassification, or canceling a previous withdrawal or termination, also state (specifically §?412.273(c)(1)(ii) page 19910 and (2)) that a request for withdrawal or termination must be received by the MGCRB within 45 days of publication of CMS' annual notice of proposed rulemaking concerning changes to the inpatient hospital prospective payment system and proposed payment rates. Similarly, the policy outlined in the FY 2012 IPPS/LTCH PPS final rule (76 FR 51599 through 51600) allows a Lugar hospital that qualifies for and accepts the out-migration adjustment, or that no longer wishes to accept the out-migration adjustment and instead elects to return to its deemed urban status to notify CMS within 45 days from the publication of the proposed rule.

We are proposing to revise the above described regulation text and policies as follows to specify that written notification to CMS or the MGCRB (as applicable) must be provided within 45 days from the date of public display of the annual proposed rule for the hospital inpatient prospective payment system at the Office of the Federal Register. We believe that the public has access to the necessary information from the date of public display of the proposed rule at the Office of the Federal Register and on its Web site in order to make the decisions at issue. Specifically, we are proposing to revise the regulations at §?412.64(i)(3)(iii) and §?412.211(f)(3)(iii) to provide that a hospital may waive the application of the wage index adjustment by notifying CMS within 45 days of the date of public display of the annual notice of proposed rulemaking for the hospital inpatient prospective payment system at the Office of the Federal Register. In addition, we are proposing to revise the regulations at §?412.273(c)(1)(ii) and (c)(2) to provide that a request for withdrawal or termination of an MGCRB reclassification must be received by the MGCRB within 45 days of the date of public display at the Office of the Federal Register of the annual notice of proposed rulemaking concerning changes to the inpatient hospital prospective payment system and proposed payment rates for the fiscal year for which the application has been filed (in the case of a withdrawal under §?412.273(c)(1)(ii)), or for the fiscal year for which the termination is to apply (under §?412.273(c)(2)). We also are proposing to revise our policy outlined in the FY 2012 IPPS/LTCH PPS final rule (76 FR 51599 through 51600) (as described above) to require a Lugar hospital that qualifies for and accepts the out-migration adjustment, or that no longer wishes to accept the out-migration adjustment and instead elects to return to its deemed urban status to notify CMS within 45 days from the date of public display of the proposed rule at the Office of the Federal Register. We are inviting public comments on these proposals.

J. Proposed Out-Migration Adjustment Based on Commuting Patterns of Hospital Employees

In accordance with section 1886(d)(13) of the Act, as added by section 505 of Pub. L. 108-173, beginning with FY 2005, we established a process to make adjustments to the hospital wage index based on commuting patterns of hospital employees (the "out-migration" adjustment). The process, outlined in the FY 2005 IPPS final rule (69 FR 49061), provides for an increase in the wage index for hospitals located in certain counties that have a relatively high percentage of hospital employees who reside in the county but work in a different county (or counties) with a higher wage index.

Section 1886(d)(13)(B) of the Act requires the Secretary to use data the Secretary determines to be appropriate to establish the qualifying counties. When the provision of section 1886(d)(13) of the Act was implemented for the FY 2005 wage index, we analyzed commuting data compiled by the U.S. Census Bureau that were derived from a special tabulation of the 2000 Census journey-to-work data for all industries (CMS extracted data applicable to hospitals). These data were compiled from responses to the "long-form" survey, which the Census Bureau used at the time and which contained questions on where residents in each county worked (69 FR 49062). However, the 2010 Census was "short form" only; information on where residents in each county worked was not collected as part of the 2010 Census. The Census Bureau worked with CMS to provide an alternative dataset based on the latest available data on where residents in each county worked in 2010, for use in developing a new out-migration adjustment based on new commuting patterns developed from the 2010 Census data beginning with FY 2016.

To determine the out-migration adjustments and applicable counties for FY 2016, we analyzed commuting data compiled by the Census Bureau that were derived from a custom tabulation of the American Community Survey (ACS), an official Census Bureau survey, utilizing 2008 through 2012 (5-Year) Microdata. The data were compiled from responses to the ACS questions regarding the county where workers reside and the county to which workers commute. As we discussed in the FY 2016 and FY 2017 IPPS/LTCH PPS final rules (80 FR 49501 and 81 FR 56930, respectively), the same policies, procedures, and computation that were used for the FY 2012 out-migration adjustment were applicable for FY 2016 and FY 2017, and we are proposing to use them again for FY 2018. We have applied the same policies, procedures, and computations since FY 2012, and we believe they continue to be appropriate for FY 2018. We refer readers to the FY 2016 IPPS/LTCH PPS final rule (80 FR 49500 through 49502) for a full explanation of the revised data source.

For FY 2018, until such time that CMS finalizes out-migration adjustments based on the next Census, the out-migration adjustment continues to be based on the data derived from the custom tabulation of the ACS utilizing 2008 through 2012 (5-Year) Microdata. For FY 2018, we are not proposing any changes to the methodology or data source that we used for FY 2016 (81 FR 25071). (We refer readers to a full discussion of the out-migration adjustment, including rules on deeming hospitals reclassified under section 1886(d)(8) or section 1886(d)(10) of the Act to have waived the out-migration adjustment, in the FY 2012 IPPS/LTCH PPS final rule (76 FR 51601 through 51602).) Table 2 associated with this proposed rule (which is available via the Internet on the CMS Web site) includes the proposed out-migration adjustments for the FY 2018 wage index.

K. Reclassification From Urban to Rural Under Section 1886(d)(8)(E) of the Act, Implemented at 42 CFR 412.103


[top] Under section 1886(d)(8)(E) of the Act, a qualifying prospective payment hospital located in an urban area may apply for rural status for payment purposes separate from reclassification through the MGCRB. Specifically, section 1886(d)(8)(E) of the Act provides that, not later than 60 days after the receipt of an application (in a form and manner determined by the Secretary) from a subsection (d) hospital that satisfies certain criteria, the Secretary shall treat the hospital as being located in the rural area (as defined in paragraph (2)(D)) of the State in which the hospital is located. We refer readers to the regulations at 42 CFR 412.103 for the general criteria and application requirements for a subsection (d) hospital to reclassify from urban to rural status in accordance with section 1886(d)(8)(E) of the Act. The FY 2012 IPPS/LTCH PPS final rule (76 FR 51595 through 51596) includes our policies page 19911 regarding the effect of wage data from reclassified or redesignated hospitals.

Hospitals must meet the criteria to be reclassified from urban to rural status under §?412.103, as well as fulfill the requirements for the application process. There may be one or more reasons that a hospital applies for the urban to rural reclassification, and the timeframe that a hospital submits an application is often dependent on those reason(s). Because the wage index is part of the methodology for determining the prospective payments to hospitals for each fiscal year, we believe there should be a definitive timeframe within which a hospital should apply for rural status in order for the reclassification to be reflected in the next Federal fiscal year's wage data used for setting payment rates.

Therefore, after notice of proposed rulemaking and consideration of public comments, in the FY 2017 IPPS/LTCH PPS final rule (81 FR 56931 through 56932), we revised §?412.103(b) by adding paragraph (6) to specify that, in order for a hospital to be treated as rural in the wage index and budget neutrality calculations under §?412.64(e)(1)(ii), (e)(2), (e)(4), and (h) for payment rates for the next Federal fiscal year, the hospital's filing date must be no later than 70 days prior to the second Monday in June of the current Federal fiscal year and the application must be approved by the CMS Regional Office in accordance with the requirements of §?412.103. We refer readers to the FY 2017 IPPS/LTCH PPS final rule for a full discussion of this policy. We clarified that the lock-in date does not affect the timing of payment changes occurring at the hospital-specific level as a result of reclassification from urban to rural under §?412.103. This lock-in date also does not change the current regulation that allows hospitals that qualify under §?412.103(a) to request, at any time during a cost reporting period, to reclassify from urban to rural. A hospital's rural status and claims payment reflecting its rural status continue to be effective on the filing date of its reclassification application, which is the date the CMS Regional Office receives the application, in accordance with §?412.103(d). The hospital's IPPS claims will be paid reflecting its rural status on the filing date (the effective date) of the reclassification, regardless of when the hospital applies.

L. Clarification of Application Deadline for Rural Referral Center (RRC) Classification

Section 1886(d)(5)(C)(i) of the Act, implemented at 42 CFR 412.96, provides for the classification and special treatment of rural referral centers (RRCs). The regulations at §?412.96 set forth the criteria that a hospital must meet in order to qualify as an RRC. Under §?412.96(b)(1)(ii), a hospital may qualify as an RRC if it is located in a rural area and has 275 or more beds during its most recently completed cost reporting period. The hospital also can obtain RRC status by showing that at least 50 percent of its Medicare patients are referred from other hospitals or from physicians not on the staff of the hospital, and at least 60 percent of the hospital's Medicare patients live more than 25 miles from the hospital, and at least 60 percent of all the services that the hospital furnishes to Medicare beneficiaries are furnished to beneficiaries who live more than 25 miles from the hospital (§?412.96(b)(2)), or by showing that the hospital meets the alternative criteria at §?412.96(c). We refer readers to 42 CFR 412.96 for a full description of the criteria for classification as an RRC.

Consistent with section 1886(d)(5)(C)(i) of the Act, the hospital must submit its application for RRC status during the last quarter of the hospital's cost reporting period, to be effective with the beginning of the next cost reporting period. Specifically, section 1886(d)(5)(C)(i) of the Act provides that an appeal allowed under this paragraph must be submitted to the Secretary (in such form and manner as the Secretary may prescribe) during the quarter before the first quarter of the hospital's cost reporting period (or, in the case of a cost reporting period beginning during October 1984, during the first quarter of that period), and the Secretary must make a final determination with respect to such appeal within 60 days after the date the appeal was submitted. Any payment adjustments necessitated by a reclassification based upon the appeal will be effective at the beginning of such cost reporting period. Therefore, in this proposed rule, we are clarifying that applications for RRC status must be submitted during this timeframe. That is, applications for RRC status must be submitted during the last quarter of the cost reporting period before the first quarter of a hospital's cost reporting year. If approved, the RRC status is effective with the beginning of the hospital's cost reporting period occurring after the last quarter of the cost reporting period in which the hospital submits an application.

We also are clarifying in this proposed rule that, while RRC applications must be submitted only within the timeframe described above, applications for urban-to-rural reclassification under §?412.103 may be submitted at any time for the hospital to be approved for rural reclassification. This includes hospitals seeking rural reclassification under §?412.103(a)(3), which states that a hospital meets criteria for urban-to-rural reclassification if the hospital would qualify as a RRC as set forth in §?412.96, or as an SCH as set forth in §?412.92, if the hospital were located in a rural area. A hospital seeking RRC status based on a rural reclassification under §?412.103, including §?412.103(a)(3), must still submit an application for RRC status during the last quarter of its cost reporting year before the next cost reporting period in accordance with section 1886(d)(5)(C)(i) of the Act. While the §?412.103 rural redesignation would be effective as of the date of filing the application, in accordance with §?412.103(d), the RRC status would be effective beginning with the hospital's cost reporting period occurring after the last quarter of the cost reporting period in which the hospital submits an application.

Because a hospital may only apply for RRC status during the last quarter of its cost reporting year in accordance with section 1886(d)(5)(C)(i) of the Act, hospitals seeking RRC status, in order to reclassify through the MGCRB using the special rules for SCHs and RRCs at §?412.230(a)(3) and the exceptions at §?412.230(d)(3) for RRCs, may be disadvantaged due to their cost reporting year end. As discussed in section III.I.2. of the preamble of this proposed rule, we are proposing to revise the regulations at §?412.230(a)(3) and (d)(3) to allow hospitals to submit documentation of the approval of SCH or RRC status (as applicable) to the MGCRB no later than the first business day after January 1. We believe our proposal to accept documentation of approval of RRC classification, instead of requiring that the hospital be classified as a RRC at the time of Board review, would accommodate more hospitals with various cost reporting period endings. We refer readers to section III.I.2. of the preamble of this proposed rule for further discussion of this proposal.

M. Process for Wage Index Data Corrections

1. Process for Hospitals To Request Wage Index Data Corrections


[top] The preliminary, unaudited Worksheet S-3 wage data files for the proposed FY 2018 wage index were made available on May 16, 2016, and the preliminary CY 2013 occupational page 19912 mix data files on May 16, 2016, through the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Wage-Index-Files-Items/FY2018-Wage-Index-Home-Page.html.

On January 30, 2017, we posted a public use file (PUF) at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Wage-Index-Files-Items/FY2018-Wage-Index-Home-Page.html containing FY 2018 wage index data available as of January 29, 2017. This PUF contains a tab with the Worksheet S-3 wage data (which includes Worksheet S-3, Parts II and III wage data from cost reporting periods beginning on or after October l, 2013 through September 30, 2014; that is, FY 2014 wage data), a tab with the occupational mix data (which includes data from the CY 2013 occupational mix survey, Form CMS-10079), a tab containing the Worksheet S-3 wage data of hospitals deleted from the January 30, 2017 wage data PUF, and a tab containing the CY 2013 occupational mix data (if any) of the hospitals deleted from the January 30, 2017 wage data PUF. In a memorandum dated January 27, 2017, we instructed all MACs to inform the IPPS hospitals that they service of the availability of the January 30, 2017 wage index data PUFs, and the process and timeframe for requesting revisions in accordance with the FY 2018 Wage Index Timetable.

In the interest of meeting the data needs of the public, beginning with the proposed FY 2009 wage index, we post an additional PUF on our Web site that reflects the actual data that are used in computing the proposed wage index. The release of this file does not alter the current wage index process or schedule. We notify the hospital community of the availability of these data as we do with the current public use wage data files through our Hospital Open Door Forum. We encourage hospitals to sign up for automatic notifications of information about hospital issues and about the dates of the Hospital Open Door Forums at the CMS Web site at: http://www.cms.gov/Outreach-and-Education/Outreach/OpenDoorForums/index.html.

In a memorandum dated May 16, 2016, we instructed all MACs to inform the IPPS hospitals that they service of the availability of the wage index data files and the process and timeframe for requesting revisions. We also instructed the MACs to advise hospitals that these data were also made available directly through their representative hospital organizations.

If a hospital wished to request a change to its data as shown in the May 16, 2016 wage data files and May 16, 2016 occupational mix data files, the hospital had to submit corrections along with complete, detailed supporting documentation to its MAC by September 2, 2016. Hospitals were notified of this deadline and of all other deadlines and requirements, including the requirement to review and verify their data as posted in the preliminary wage index data files on the Internet, through the letters sent to them by their MACs.

November 4, 2016 was the date by when MACs notified State hospital associations regarding hospitals that failed to respond to issues raised during the desk reviews. The MACs notified the hospitals by mid-January 2017 of any changes to the wage index data as a result of the desk reviews and the resolution of the hospitals' revision requests. The MACs also submitted the revised data to CMS by January 20, 2017. CMS published the wage index PUFs that included hospitals' revised wage index data on January 30, 2017. Hospitals had until February 17, 2017, to submit requests to the MACs for reconsideration of adjustments made by the MACs as a result of the desk review, and to correct errors due to CMS' or the MAC's mishandling of the wage index data. Hospitals also were required to submit sufficient documentation to support their requests.

After reviewing requested changes submitted by hospitals, MACs were required to transmit to CMS any additional revisions resulting from the hospitals' reconsideration requests by March 24, 2017. Under our current policy, the deadline for a hospital to request CMS intervention in cases where a hospital disagreed with a MAC's policy interpretation was April 5, 2017. Beginning next year (that is, April 2018 for wage data revisions for the FY 2019 wage index), we are proposing to require that a hospital that seeks to challenge the MAC's handling of wage data on any basis (including a policy, factual, or any other dispute) must request CMS to intervene by the date in April that is specified as the deadline for hospitals to appeal MAC determinations and request CMS' intervention in cases where the hospital disagrees with the MAC's determination (the wage index timetable would be updated to reflect the specified date). We note that, as we did for the FY 2017 wage index, for the FY 2018 wage index, in accordance with the FY 2018 wage index timeline posted on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Wage-Index-Files-Items/FY2018-Wage-Index-Home-Page.html, the April appeals have to be sent via mail and email. We refer readers to the wage index timeline for complete details.

Hospitals are given the opportunity to examine Table 2, which is listed in section VI. of the Addendum to this proposed rule and available via the Internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Wage-Index-Files-Items/FY2018-Wage-Index-Home-Page.html. Table 2 contains each hospital's proposed adjusted average hourly wage used to construct the wage index values for the past 3 years, including the FY 2014 data used to construct the proposed FY 2018 wage index. We note that the proposed hospital average hourly wages shown in Table 2 only reflect changes made to a hospital's data that were transmitted to CMS by early February 2017.

We plan to post the final wage index data PUFs in late April 2017 on the Internet at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Wage-Index-Files-Items/FY2018-Wage-Index-Home-Page.html. The April 2017 PUFs are made available solely for the limited purpose of identifying any potential errors made by CMS or the MAC in the entry of the final wage index data that resulted from the correction process previously described (revisions submitted to CMS by the MACs by March 24, 2017).

After the release of the April 2017 wage index data PUFs, changes to the wage and occupational mix data can only be made in those very limited situations involving an error by the MAC or CMS that the hospital could not have known about before its review of the final wage index data files. Specifically, neither the MAC nor CMS will approve the following types of requests:

• Requests for wage index data corrections that were submitted too late to be included in the data transmitted to CMS by the MACs on or before March 24, 2017.

• Requests for correction of errors that were not, but could have been, identified during the hospital's review of the January 30, 2017 wage index PUFs.

• Requests to revisit factual determinations or policy interpretations made by the MAC or CMS during the wage index data correction process.


[top] If, after reviewing the April 2017 final wage index data PUFs, a hospital believes that its wage or occupational page 19913 mix data were incorrect due to a MAC or CMS error in the entry or tabulation of the final data, the hospital is given the opportunity to notify both its MAC and CMS regarding why the hospital believes an error exists and provide all supporting information, including relevant dates (for example, when it first became aware of the error). The hospital is required to send its request to CMS and to the MAC no later than May 30, 2017. Similar to the April appeals, beginning with the FY 2015 wage index, in accordance with the FY 2018 wage index timeline posted on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Wage-Index-Files-Items/FY2018-Wage-Index-Home-Page.html, the May appeals must be sent via mail and email to CMS and the MACs. We refer readers to the wage index timeline for complete details.

Verified corrections to the wage index data received timely by CMS and the MACs (that is, by May 30, 2017) will be incorporated into the final FY 2018 wage index, which will be effective October 1, 2017.

We created the processes previously described to resolve all substantive wage index data correction disputes before we finalize the wage and occupational mix data for the FY 2018 payment rates. Accordingly, hospitals that do not meet the procedural deadlines set forth above will not be afforded a later opportunity to submit wage index data corrections or to dispute the MAC's decision with respect to requested changes. Specifically, our policy is that hospitals that do not meet the procedural deadlines set forth above (requiring requests to MACs by the specified date in February and, where such requests are unsuccessful, requests for intervention by CMS by the specified date in April) will not be permitted to challenge later, before the PRRB, the failure of CMS to make a requested data revision. We refer readers also to the FY 2000 IPPS final rule (64 FR 41513) for a discussion of the parameters for appeals to the PRRB for wage index data corrections.

Again, we believe the wage index data correction process described earlier provides hospitals with sufficient opportunity to bring errors in their wage and occupational mix data to the MAC's attention. Moreover, because hospitals have access to the final wage index data PUFs by late April 2017, they have the opportunity to detect any data entry or tabulation errors made by the MAC or CMS before the development and publication of the final FY 2018 wage index by August 2017, and the implementation of the FY 2018 wage index on October 1, 2017. Given these processes, the wage index implemented on October 1 should be accurate. Nevertheless, in the event that errors are identified by hospitals and brought to our attention after May 30, 2017, we retain the right to make midyear changes to the wage index under very limited circumstances.

Specifically, in accordance with 42 CFR 412.64(k)(1) of our regulations, we make midyear corrections to the wage index for an area only if a hospital can show that: (1) The MAC or CMS made an error in tabulating its data; and (2) the requesting hospital could not have known about the error or did not have an opportunity to correct the error, before the beginning of the fiscal year. For purposes of this provision, "before the beginning of the fiscal year" means by the May deadline for making corrections to the wage data for the following fiscal year's wage index (for example, May 30, 2017 for the FY 2018 wage index). This provision is not available to a hospital seeking to revise another hospital's data that may be affecting the requesting hospital's wage index for the labor market area. As indicated earlier, because CMS makes the wage index data available to hospitals on the CMS Web site prior to publishing both the proposed and final IPPS rules, and the MACs notify hospitals directly of any wage index data changes after completing their desk reviews, we do not expect that midyear corrections will be necessary. However, under our current policy, if the correction of a data error changes the wage index value for an area, the revised wage index value will be effective prospectively from the date the correction is made.

In the FY 2006 IPPS final rule (70 FR 47385 through 47387 and 47485), we revised 42 CFR 412.64(k)(2) to specify that, effective on October 1, 2005, that is, beginning with the FY 2006 wage index, a change to the wage index can be made retroactive to the beginning of the Federal fiscal year only when CMS determines all of the following: (1) The MAC or CMS made an error in tabulating data used for the wage index calculation; (2) the hospital knew about the error and requested that the MAC and CMS correct the error using the established process and within the established schedule for requesting corrections to the wage index data, before the beginning of the fiscal year for the applicable IPPS update (that is, by the May 30, 2017 deadline for the FY 2018 wage index); and (3) CMS agreed before October 1 that the MAC or CMS made an error in tabulating the hospital's wage index data and the wage index should be corrected.

In those circumstances where a hospital requested a correction to its wage index data before CMS calculated the final wage index (that is, by the May 30, 2017 deadline for the FY 2018 wage index), and CMS acknowledges that the error in the hospital's wage index data was caused by CMS' or the MAC's mishandling of the data, we believe that the hospital should not be penalized by our delay in publishing or implementing the correction. As with our current policy, we indicated that the provision is not available to a hospital seeking to revise another hospital's data. In addition, the provision cannot be used to correct prior years' wage index data; and it can only be used for the current Federal fiscal year. In situations where our policies would allow midyear corrections other than those specified in 42 CFR 412.64(k)(2)(ii), we continue to believe that it is appropriate to make prospective-only corrections to the wage index.

We note that, as with prospective changes to the wage index, the final retroactive correction will be made irrespective of whether the change increases or decreases a hospital's payment rate. In addition, we note that the policy of retroactive adjustment will still apply in those instances where a final judicial decision reverses a CMS denial of a hospital's wage index data revision request.

2. Process for Data Corrections by CMS After the January Public Use File (PUF)


[top] The process set forth with the wage index timeline discussed in section III.M.1. of the preamble of this proposed rule allows hospitals to request corrections to their wage index data within prescribed timeframes. In addition to hospitals' opportunity to request corrections of wage index data errors or MACs' mishandling of data, CMS has the authority under section 1886(d)(3)(E) of the Act to make corrections to hospital wage index and occupational mix data in order to ensure the accuracy of the wage index. As we explained in the FY 2016 IPPS/LTCH PPS final rule (80 FR 49490 through 49491) and the FY 2017 IPPS/LTCH PPS final rule (81 FR 56914), section 1886(d)(3)(E) of the Act requires the Secretary to adjust the proportion of hospitals' costs attributable to wages and wage-related costs for area differences reflecting the relative hospital wage level in the geographic areas of the hospital compared to the national average hospital wage level. We believe that, under section 1886(d)(3)(E) of the Act, we have discretion to make page 19914 corrections to hospitals' data to help ensure that the costs attributable to wages and wage-related costs in fact accurately reflect the relative hospital wage level in the hospitals' geographic areas.

We have an established multistep, 15-month process for the review and correction of the hospital wage data that is used to create the IPPS wage index for the upcoming fiscal year. Since the origin of the IPPS, the wage index has been subject to its own annual review process, first by the MACs, and then by CMS. As a standard practice, after each annual desk review, CMS reviews the results of the MACs' desk reviews and focuses on items flagged during the desk review, requiring that, if necessary, hospitals provide additional documentation, adjustments, or corrections to the data. This ongoing communication with hospitals about their wage data may result in the discovery by CMS of additional items that were reported incorrectly or other data errors, even after the posting of the January PUF, and throughout the remainder of the wage index development process. In addition, the fact that CMS analyzes the data from a regional and even national level, unlike the review performed by the MACs that review a limited subset of hospitals, can facilitate additional editing of the data that may not be readily apparent to the MACs. In these occasional instances, an error may be of sufficient magnitude that the wage index of an entire CBSA is affected. Accordingly, CMS uses its authority to ensure that the wage index accurately reflects the relative hospital wage level in the geographic area of the hospital compared to the national average hospital wage level, by continuing to make corrections to hospital wage data upon discovering incorrect wage data, distinct from instances in which hospitals request data revisions.

We note that CMS corrects errors to hospital wage data as appropriate, regardless of whether that correction will raise or lower a hospital's average hourly wage. For example, as discussed in section III.D.2. of the preamble of this proposed rule, in the calculation of the proposed FY 2018 wage index, upon discovering that hospitals reported other wage-related costs on Line 18 of Worksheet S-3, despite those other wage-related costs failing to meet the requirement that other wage related costs must exceed 1 percent of total adjusted salaries net of excluded area salaries, CMS made internal edits to remove those other wage-related costs from Line 18. Conversely, if CMS discovers after conclusion of the desk review, for example, that a MAC inadvertently failed to incorporate positive adjustments resulting from a prior year's wage index appeal to a hospital's wage related costs such as pension, CMS would correct that data error and the hospital's average hourly wage would likely increase as a result.

While we maintain CMS' authority to conduct additional review and make resulting corrections at any time during the wage index development process, we are proposing a process for hospitals to request further review of a correction made by CMS starting with the FY 2019 wage index. In order to allow opportunity for input from hospitals concerning corrections made by CMS after the posting of the January PUF, we are proposing a process similar to the existing process in which hospitals may request corrections to wage index data displayed in the January PUF. Instances where CMS makes a correction to a hospital's data after the January PUF based on a different understanding than the hospital about certain reported costs, for example, could potentially be resolved using this proposed process before the final wage index is calculated. We believe this proposed process and timeline (as descrbed above) would bring additional transparency to instances where CMS makes data corrections after the January PUF, and would provide opportunities for hospitals to request further review of CMS changes in time for the most accurate data to be reflected in the final wage index calculations.

Effective beginning with the FY 2019 wage index development cycle, we are proposing to use existing appeal deadlines (in place for hospitals to appeal determinations made by the MAC during the desk review process) for hospitals to dispute corrections made by CMS after posting of the January PUF that do not arise from a hospital request for a wage data revision. Starting with the April appeal deadline, hospitals would use the soonest approaching appeal deadline to dispute any adjustments made by CMS. However, if a hospital was notified of an adjustment within 14 days of an appeal deadline, the hospital would have until the next appeal deadline to dispute any adjustments. We believe this would give hospitals sufficient time to prepare an appeal of adjustments made by CMS after the January PUF. Specifically, for any adjustments made by CMS between the date the January PUF is posted and at least 14 calendar days before the April appeals deadline, we are proposing that hospitals would have until the April appeals deadline (which, for example, is April 5 in the FY 2018 Wage Index Timetable) to dispute the adjustments. For any adjustments made by CMS between 13 calendar days before the April appeals deadline and 14 calendar days before the May appeals deadline, we are proposing that hospitals would have until the May appeals deadline (which, for example, is May 30 in the FY 2018 Wage Index Timetable) to dispute the adjustments. In cases where hospitals disagree with CMS adjustments of which they were notified 13 calendar days before the May appeals deadline or later, the hospitals could appeal to the PRRB with no need for further review by CMS before such appeal.

We are using dates from the FY 2018 Wage Index Timetable in the following example (we reiterate that this appeals process would be effective beginning with the FY 2019 wage index cycle, but for illustrative purposes, we are using dates from the FY 2018 Wage Index Timetable, the most recently published wage index timetable): A hospital that is notified by the MAC or CMS of an adjustment to its wage data after the release of the January 30, 2017 PUF could use the April 5, 2017 appeals deadline to dispute the adjustment. If the hospital is notified of an adjustment by CMS or the MAC to its wage data after March 22, 2017 (that is, less than 14 days prior to the April 5 appeals deadline), it could use the May 30, 2017 appeals deadline to dispute the adjustment. If the hospital is first notified about the adjustment after May 16, 2017 (that is, less than 14 days prior to the May 30 deadline), and disagrees with the adjustment, the hospital could appeal directly to the PRRB.


[top] As with the existing process for requesting wage data corrections, we are proposing that a hospital disputing an adjustment made by CMS after the posting of the January PUF would be required to request a correction by the first applicable deadline. For example, if a hospital was notified on March 20 of an adjustment to its data by CMS and does not appeal by April 5, the hospital would not be able to appeal by May 30 or bring the case before the PRRB. That is, hospitals that did not meet the procedural deadlines set forth above would not be afforded a later opportunity to submit wage index data corrections or to dispute CMS' decision with respect to requested changes. As with the existing process for hospitals to request wage data corrections, our policy is that hospitals that do not meet the procedural deadlines set forth earlier would not be permitted to challenge later, before the PRRB, the failure of CMS to make a requested data revision. page 19915

In summary, under the statute, CMS has discretion to make corrections and revisions to hospitals' wage data throughout the multistep wage index development process, and we are proposing a pathway for hospitals to request additional review of corrections to their wage data made by CMS. Beginning with the development of the FY 2019 wage index, we are proposing a process whereby CMS could continue to correct data after the posting of the January PUF, while allowing hospitals to appeal changes made by CMS using existing deadlines from the process for hospitals to request wage data corrections. As with the existing process, a hospital would be required to appeal by the first applicable deadline, if relevant, to maintain the right to appeal to the PRRB to dispute a correction to its wage data made by CMS.

We are inviting public comments on our proposals.

N. Proposed Labor Market Share for the Proposed FY 2018 Wage Index

Section 1886(d)(3)(E) of the Act directs the Secretary to adjust the proportion of the national prospective payment system base payment rates that are attributable to wages and wage-related costs by a factor that reflects the relative differences in labor costs among geographic areas. It also directs the Secretary to estimate from time to time the proportion of hospital costs that are labor-related and to adjust the proportion (as estimated by the Secretary from time to time) of hospitals' costs which are attributable to wages and wage-related costs of the DRG prospective payment rates. We refer to the portion of hospital costs attributable to wages and wage-related costs as the labor-related share. The labor-related share of the prospective payment rate is adjusted by an index of relative labor costs, which is referred to as the wage index.

Section 403 of Public Law 108-173 amended section 1886(d)(3)(E) of the Act to provide that the Secretary must employ 62 percent as the labor-related share unless this would result in lower payments to a hospital than would otherwise be made. However, this provision of Public Law 108-173 did not change the legal requirement that the Secretary estimate from time to time the proportion of hospitals' costs that are attributable to wages and wage-related costs. Thus, hospitals receive payment based on either a 62-percent labor-related share, or the labor-related share estimated from time to time by the Secretary, depending on which labor-related share resulted in a higher payment.

In the FY 2014 IPPS/LTCH PPS final rule (78 FR 50596 through 50607), we rebased and revised the hospital market basket. We established a FY 2010-based IPPS hospital market basket to replace the FY 2006-based IPPS hospital market basket, effective October 1, 2013. In that final rule, we presented our analysis and conclusions regarding the frequency and methodology for updating the labor-related share for FY 2014. Using the FY 2010-based IPPS market basket, we finalized a labor-related share for FY 2014, FY 2015, FY 2016, and FY 2017 of 69.6 percent. In addition, in FY 2014, we implemented this revised and rebased labor-related share in a budget neutral manner (78 FR 51016). However, consistent with section 1886(d)(3)(E) of the Act, we did not take into account the additional payments that would be made as a result of hospitals with a wage index less than or equal to 1.0000 being paid using a labor-related share lower than the labor-related share of hospitals with a wage index greater than 1.0000.

For FY 2018, as described in section IV. of the preamble of this proposed rule, we are proposing to rebase and revise the IPPS market basket reflecting 2014 data. We also are proposing to recalculate the labor-related share for discharges occurring on or after October 1, 2017 using the proposed 2014-based IPPS market basket. As discussed in Appendix A of this proposed rule, we are proposing this revised and rebased labor-related share in a budget neutral manner. However, consistent with section 1886(d)(3)(E) of the Act, we did not take into account the additional payments that would be made as a result of hospitals with a wage index less than or equal to 1.0000 being paid using a labor-related share lower than the labor-related share of hospitals with a wage index greater than 1.0000.

The labor-related share is used to determine the proportion of the national IPPS base payment rate to which the area wage index is applied. We include a cost category in the labor-related share if the costs are labor intensive and vary with the local labor market. As described in section IV. of the preamble of this proposed rule, we are proposing to include in the labor-related share the national average proportion of operating costs that are attributable to Wages and Salaries, Employee Benefits, Professional Fees: Labor-Related, Administrative and Facilities Support Services, Installation, Maintenance, and Repair Services, and All Other: Labor-Related Services as measured in the proposed 2014-based IPPS market basket. Therefore, for FY 2018, we are proposing to use a labor-related share of 68.3 percent for discharges occurring on or after October 1, 2017.

Prior to January 1, 2016, Puerto Rico hospitals were paid based on 75 percent of the national standardized amount and 25 percent of the Puerto Rico-specific standardized amount. As a result, we applied the Puerto Rico-specific labor-related share percentage and nonlabor-related share percentage to the Puerto Rico-specific standardized amount. Section 601 of the Consolidated Appropriations Act, 2016 (Pub. L. 114-113) amended section 1886(d)(9)(E) of the Act to specify that the payment calculation with respect to operating costs of inpatient hospital services of a subsection (d) Puerto Rico hospital for inpatient hospital discharges on or after January 1, 2016, shall use 100 percent of the national standardized amount. Because Puerto Rico hospitals are no longer paid with a Puerto Rico-specific standardized amount as of January 1, 2016, under section 1886(d)(9)(E) of the Act as amended by section 601 of the Consolidated Appropriations Act, 2016, there is no longer a need for us to calculate a Puerto Rico-specific labor-related share percentage and nonlabor-related share percentage for application to the Puerto Rico-specific standardized amount. Hospitals in Puerto Rico are now paid 100 percent of the national standardized amount and, therefore, are subject to the national labor-related share and nonlabor-related share percentages that are applied to the national standardized amount. Accordingly, for FY 2018, we are not proposing a Puerto Rico-specific labor-related share percentage or a nonlabor-related share percentage.


[top] Tables 1A and 1B, which are published in section VI. of the Addendum to this FY 2018 IPPS/LTCH PPS proposed rule and available via the Internet on the CMS Web site, reflect the proposed national labor-related share, which is also applicable to Puerto Rico hospitals. For FY 2018, for all IPPS hospitals (including Puerto Rico hospitals) whose wage indexes are less than or equal to 1.0000, we are proposing to apply the wage index to a labor-related share of 62 percent of the national standardized amount. For all hospitals (including Puerto Rico hospitals) whose wage indexes are greater than 1.0000, for FY 2018, we are proposing to apply the wage index to a proposed labor-related share of 68.3 percent of the national standardized amount. page 19916

IV. Proposed Rebasing and Revising of the Hospital Market Baskets for Acute Care Hospitals

A. Background

Effective for cost reporting periods beginning on or after July 1, 1979, we developed and adopted a hospital input price index (that is, the hospital market basket for operating costs). Although "market basket" technically describes the mix of goods and services used in providing hospital care, this term is also commonly used to denote the input price index (that is, cost category weights and price proxies combined) derived from that market basket. Accordingly, the term "market basket" as used in this document refers to the hospital input price index.

The percentage change in the market basket reflects the average change in the price of goods and services hospitals purchase in order to provide inpatient care. We first used the market basket to adjust hospital cost limits by an amount that reflected the average increase in the prices of the goods and services used to provide hospital inpatient care. This approach linked the increase in the cost limits to the efficient utilization of resources.

Since the inception of the IPPS, the projected change in the hospital market basket has been the integral component of the update factor by which the prospective payment rates are updated every year. An explanation of the hospital market basket used to develop the prospective payment rates was published in the Federal Register on September 1, 1983 (48 FR 39764). We also refer readers to the FY 2014 IPPS/LTCH PPS final rule (78 FR 50596) in which we discussed the most recent previous rebasing of the hospital input price index.

The hospital market basket is a fixed-weight, Laspeyres-type price index. A Laspeyres-type price index measures the change in price, over time, of the same mix of goods and services purchased in the base period. Any changes in the quantity or mix of goods and services (that is, intensity) purchased over time are not measured.

The index itself is constructed in three steps. First, a base period is selected (in this proposed rule, we are proposing to use 2014 as the base period) and total base period expenditures are estimated for a set of mutually exclusive and exhaustive spending categories, with the proportion of total costs that each category represents being calculated. These proportions are called "cost weights" or "expenditure weights." Second, each expenditure category is matched to an appropriate price or wage variable, referred to as a "price proxy." In almost every instance, these price proxies are derived from publicly available statistical series that are published on a consistent schedule (preferably at least on a quarterly basis). Finally, the expenditure weight for each cost category is multiplied by the level of its respective price proxy. The sum of these products (that is, the expenditure weights multiplied by their price index levels) for all cost categories yields the composite index level of the market basket in a given period. Repeating this step for other periods produces a series of market basket levels over time. Dividing an index level for a given period by an index level for an earlier period produces a rate of growth in the input price index over that timeframe.

As noted above, the market basket is described as a fixed-weight index because it represents the change in price over time of a constant mix (quantity and intensity) of goods and services needed to provide hospital services. The effects on total expenditures resulting from changes in the mix of goods and services purchased subsequent to the base period are not measured. For example, a hospital hiring more nurses to accommodate the needs of patients would increase the volume of goods and services purchased by the hospital, but would not be factored into the price change measured by a fixed-weight hospital market basket. Only when the index is rebased would changes in the quantity and intensity be captured, with those changes being reflected in the cost weights. Therefore, we rebase the market basket periodically so that the cost weights reflect recent changes in the mix of goods and services that hospitals purchase (hospital inputs) to furnish inpatient care between base periods.

We last rebased the hospital market basket cost weights effective for FY 2014 (78 FR 50596), with FY 2010 data used as the base period for the construction of the market basket cost weights. For this FY 2018 IPPS/LTCH PPS proposed rule, we are proposing to rebase the cost structure for the IPPS hospital index from FY 2010 to 2014, as discussed below.

B. Rebasing and Revising the IPPS Market Basket

The terms "rebasing" and "revising," while often used interchangeably, actually denote different activities. "Rebasing" means moving the base year for the structure of costs of an input price index (for example, in this proposed rule, we are proposing to shift the base year cost structure for the IPPS hospital index from FY 2010 to 2014). We note that we are no longer referring to the market basket as a "FY 2014-based" market basket and instead refer to the proposed market basket as simply "2014-based". We are proposing this change in naming convention for the market basket because the base year cost weight data for the proposed market basket does not reflect only fiscal year data. For example, the proposed 2014-based IPPS market basket uses Medicare cost report data and other government data that reflect 2014 fiscal year, 2014 calendar year, and 2014 State fiscal year expenses to determine the base year cost weights. Given that it is based on a mix of classifications of 2014 data, we are proposing to refer to the market basket as "2014-based" instead of "FY 2014-based" or "CY 2014-based".

"Revising" means changing data sources or price proxies used in the input price index. As published in the FY 2006 IPPS final rule (70 FR 47387), in accordance with section 404 of Public Law 108-173, CMS determined a new frequency for rebasing the hospital market basket. We established a rebasing frequency of every 4 years and, therefore, for the FY 2018 IPPS update, we are proposing to rebase and revise the IPPS market basket from FY 2010 to 2014. We are inviting public comments on our proposed methodology.

1. Development of Cost Categories and Weights

a. Use of Medicare Cost Report Data


[top] The major source of expenditure data for developing the proposed rebased and revised hospital market basket cost weights is the 2014 Medicare cost reports. These 2014 Medicare cost reports are for cost reporting periods beginning on and after October 1, 2013 and before October 1, 2014. We note that while these dates appear to reflect fiscal year data, in order to be classified as a "2014 cost report," a hospital's cost reporting period must begin between these dates. For example, we found that of the 2014 Medicare cost reports for IPPS hospitals, approximately 40 percent of the reports had a begin date on January 1, 2014, approximately 30 percent had a begin date on July 1, 2014, and approximately 18 percent had a begin date on October 1, 2013. For this reason, we are defining the base year of the market basket as "2014-based" instead of "FY 2014-based". We are proposing to use 2014 as the base year because we believe that the 2014 Medicare cost reports represent the most recent, complete set of Medicare cost report data available to develop cost weights for IPPS hospitals. As was done page 19917 in previous rebasings, these cost reports are from IPPS hospitals only (hospitals excluded from the IPPS and CAHs are not included) and are based on IPPS Medicare-allowable operating costs. IPPS Medicare-allowable operating costs are costs that are eligible to be paid under the IPPS. For example, the IPPS market basket excludes home health agency (HHA) costs as these costs would be paid under the HHA PPS and, therefore, these costs are not IPPS Medicare-allowable costs.

We are proposing to derive costs for eight major expenditures or cost categories for the 2014-based IPPS market basket from the CMS Medicare cost reports (Form 2552-10, OMB Control Number 0938-0050): Wages and Salaries, Employee Benefits, Contract Labor, Pharmaceuticals, Professional Liability Insurance (Malpractice), Blood and Blood Products, Home Office Contract Labor, and a residual "All Other" category. The residual "All Other" category reflects all remaining costs that are not captured in the other seven cost categories. We are proposing that, for the 2014-based IPPS market basket, we obtain costs for one additional major cost category from the Medicare cost reports compared to the FY 2010-based IPPS market basket-Home Office Contract Labor Costs. We describe below the detailed methodology for obtaining costs for each of the seven cost categories directly determined from the Medicare cost reports.

(1) Wages and Salaries Costs

To derive wages and salaries costs for the Medicare allowable cost centers, we are proposing to first calculate total unadjusted wages and salaries costs as reported on Worksheet S-3, part II. We are then proposing to remove the wages and salaries attributable to non-Medicare allowable cost centers (that is, excluded areas) as well as a portion of overhead wages and salaries attributable to these excluded areas. Specifically, wages and salaries costs are equal to total wages and salaries as reported on Worksheet S-3, Part II, Column 4, Line 1, less excluded area wages and salaries (reported on Worksheet S-3, Part II, Column 4, Lines 3 and 5 through 10) and less overhead wages and salaries attributable to the excluded areas.

Overhead wages and salaries are attributable to the entire IPPS facility. Therefore, we are proposing to only include the proportion attributable to the Medicare allowable cost centers. We are proposing to estimate the proportion of overhead wages and salaries that are not attributable to Medicare allowable costs centers (that is, excluded areas) by multiplying the ratio of excluded area wages and salaries (as defined earlier) to total wages and salaries (Worksheet S-3, part II, Column 4, Line 1) by total overhead wages and salaries (Worksheet A, Column 1, Lines 4 through 18). A similar methodology was used to derive wages and salaries costs in the FY 2010-based IPPS market basket.

(2) Employee Benefits Costs

We are proposing to derive employee benefits costs using a similar methodology as the wages and salaries costs; that is, reflecting employee benefits costs attributable to the Medicare allowable cost centers. First, we calculate total unadjusted employee benefits costs as the sum of Worksheet S-3, Part II, Column 4, Lines 17, 18, 20, and 22. We then exclude those employee benefits attributable to the overhead wages and salaries for the non-Medicare allowable cost centers (that is, excluded areas). Employee benefits attributable to the non-Medicare allowable cost centers are derived by multiplying the ratio of total employee benefits (equal to the sum of Worksheet S-3, Part II, Column 4, Lines 17 through 25) to total wages and salaries (Worksheet S-3, Part II, Column 4, Line 1) by excluded overhead wages and salaries (as derived above for wages and salaries costs). A similar methodology was used in the FY 2010-based IPPS market basket.

(3) Contract Labor Costs

Contract labor costs are primarily associated with direct patient care services. Contract labor costs for services such as accounting, billing, and legal are estimated using other government data sources as described below. We are proposing to derive contract labor costs for the 2014-based IPPS market basket as the sum of Worksheet S-3, Part II, Column 4, Lines 11, 13 and 15. A similar methodology was used in the FY 2010-based IPPS market basket.

(4) Professional Liability Insurance Costs

We are proposing that professional liability insurance (PLI) costs (often referred to as malpractice costs) be equal to premiums, paid losses, and self-insurance costs reported on Worksheet S-2, Part I, Columns 1 through 3, Line 118.01. A similar methodology was used for the FY 2010-based IPPS market basket.

(5) Pharmaceuticals Costs

We are proposing to calculate pharmaceuticals costs using nonsalary costs reported for the Pharmacy cost center (Worksheet A, Column 2, Line 15) and Drugs Charged to Patients cost center (Worksheet A, Column 2, Line 73) less estimated employee benefits attributable to these two cost centers. We are proposing to estimate these employee benefits costs by multiplying the ratio of total employee benefits (equal to the sum of Worksheet S-3, Part II, Column 4, Lines 17 through 25) to total wages and salaries (Worksheet S-3, Part II, Column 4, Line 1) by total wages and salaries costs for the Pharmacy and Drugs Charged to Patients cost centers (equal to the sum of Worksheet A, Column 1, Lines 15 and 73). A similar methodology was used for the FY 2010-based IPPS market basket.

(6) Blood and Blood Products Costs

We are proposing to calculate blood and blood products costs using nonsalary costs reported for the Whole Blood & Packed Red Blood Cells cost center (Worksheet A, Column 2, Line 62) and the Blood Storing, Processing, & Transfusing cost center (Worksheet A, Column 2, Line 63) less estimated employee benefits attributable to these two cost centers. We estimate these employee benefits costs by multiplying the ratio of total employee benefits (equal to the sum of Worksheet S-3, Part II, Column 4, Lines 17 through 25) to total wages and salaries (Worksheet S-3, Part II, Column 4, Line 1) by total wages and salaries for the Whole Blood & Packed Red Blood Cells and Blood Storing, Processing, & Transfusing cost centers (equal to the sum of Worksheet A, Column 1, Lines 62 and 63). A similar methodology was used for the FY 2010-based IPPS market basket.

(7) Home Office Contract Labor Costs


[top] We are proposing to determine home office contract labor costs using data reported on Worksheet S-3, Part II, Column 4, line 14. Specifically, we are proposing to determine the Medicare allowable portion of these costs by multiplying them by the ratio of total Medicare allowable operating costs (as defined below in section IV.B.1.b. of the preamble to this proposed rule) to total operating costs (calculated as Worksheet B, Part I, Column 26, Line 202, less Worksheet B, Part I, Column 0, Lines 1 through 3). Home office contract labor costs in the FY 2010-based IPPS market basket were calculated using the U.S. Census Bureau's Bureau of Economic Analysis (BEA) Benchmark Input-Output (I-O) data, as described below in section IV.B.1.c. of the preamble to this proposed rule. page 19918

b. Final Major Cost Category Computation

After we derived costs for the seven major cost categories for each provider using the Medicare cost report data as previously described, we address data outliers using the following steps. First, we divide the costs for each of the seven categories by total Medicare allowable operating costs calculated for the provider to obtain cost weights for each PPS hospital. We are proposing that total Medicare allowable operating costs are equal to noncapital costs (Worksheet B, part I, Column 26 less Worksheet B, part II, Column 26) that are attributable to the Medicare allowable cost centers of the hospital. Medicare allowable cost centers are Lines 30 through 35, 50, 51, 53 through 60, 62 through 76, 90, 91, 92.01 and 93.

We then remove those providers whose derived cost weights fall in the top and bottom five percent of provider-specific cost weights to ensure the removal of outliers. After the outliers have been removed, we sum the costs for each category across all remaining providers. We then divide this by the sum of total Medicare allowable operating costs across all remaining providers to obtain a cost weight for the proposed 2014-based IPPS market basket for the given category. Finally, we calculate the residual "All Other" cost weight that reflects all remaining costs that are not captured in the seven cost categories listed.

Table IV-01 below shows the major cost categories and their respective cost weights as derived from the Medicare cost reports for this proposed rule.

Major cost categories FY 2010 Proposed 2014
Wages and Salaries 45.8 42.1
Employee Benefits 12.7 12.0
Contract Labor 1.8 1.8
Professional Liability Insurance (Malpractice) 1.3 1.2
Pharmaceuticals 5.4 5.9
Blood and Blood Products 1.1 0.8
Home Office Contract Labor?* 4.2
"All Other" Residual 31.9 32.0
*?Home office contract labor costs were included in the "All Other" residual cost weight of the FY 2010-based IPPS market basket.

From FY 2010 to 2014, the Wages and Salaries and Employee Benefits cost weights as calculated directly from the Medicare cost reports decreased by approximately 3.7 and 0.7 percentage points, respectively, while the Contract Labor cost weight was unchanged. The decrease in the Wages and Salaries cost weight occurred among most cost centers and in aggregate for the General Service (overhead), Inpatient Routine Service, Ancillary Service, and Outpatient Service cost centers.

As we did for the FY 2010-based IPPS market basket (78 FR 50597), we are proposing to allocate contract labor costs to the Wages and Salaries and Employee Benefits cost weights based on their relative proportions for employed labor under the assumption that contract labor costs are comprised of both wages and salaries and employee benefits. The contract labor allocation proportion for wages and salaries is equal to the Wages and Salaries cost weight as a percent of the sum of the Wages and Salaries cost weight and the Employee Benefits cost weight. Using the 2014 Medicare cost report data, this percentage is 78 percent. Therefore, we are proposing to allocate approximately 78 percent of the Contract Labor cost weight to the Wages and Salaries cost weight and 22 percent to the Employee Benefits cost weight. The FY 2010-based IPPS market basket also allocated 78 percent of the Contract Labor cost weight to the Wages and Salaries cost weight.

Table IV-02 below shows the Wages and Salaries and Employee Benefits cost weights after contract labor allocation for the FY 2010-based IPPS market basket and the proposed 2014-based IPPS market basket.

Major cost categories FY 2010-based IP