89 FR 20 pgs. 5897-5907 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—October Through December 2023

Type: NOTICEVolume: 89Number: 20Pages: 5897 - 5907
Docket number: [CMS-9145-N]
FR document: [FR Doc. 2024-01785 Filed 1-29-24; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Medicare & Medicaid Services
Official PDF Version:  PDF Version
Pages: 5897, 5898, 5899, 5900, 5904, 5905, 5906, 5907

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Centers for Medicare & Medicaid Services

[CMS-9145-N]

Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2023

AGENCY:

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

ACTION:

Notice.

SUMMARY:

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published in the 3-month period, relating to the Medicare and Medicaid programs and other programs administered by CMS.

FOR FURTHER INFORMATION CONTACT:

It is possible that an interested party may need specific information and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing contact persons to answer general questions concerning each of the addenda published in this notice.

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Addenda Contact Phone No.
I. CMS Manual Instructions Ismael Torres (410) 786-1864
II. Regulation Documents Published in the Federal Register Terri Plumb (410) 786-4481
III. CMS Rulings Tiffany Lafferty (410) 786-7548
IV. Medicare National Coverage Determinations Wanda Belle, MPA (410) 786-7491
V. FDA-Approved Category B IDEs John Manlove (410) 786-6877
VI. Collections of Information William Parham (410) 786-4669
VII. Medicare-Approved Carotid Stent Facilities Sarah Fulton, MHS (410) 786-2749
VIII. American College of Cardiology-National Cardiovascular Data Registry Sites Sarah Fulton, MHS (410) 786-2749
IX. Medicare's Active Coverage-Related Guidance Documents Lori Ashby, MA (410) 786-6322
X. One-time Notices Regarding National Coverage Provisions JoAnna Baldwin, MS (410) 786-7205
XI. National Oncologic Positron Emission Tomography Registry Sites David Dolan, MBA (410) 786-3365
XII. Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities David Dolan, MBA (410) 786-3365
XIII. Medicare-Approved Lung Volume Reduction Surgery Facilities Sarah Fulton, MHS (410) 786-2749
XIV. Medicare-Approved Bariatric Surgery Facilities Sarah Fulton, MHS (410) 786-2749
XV. Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials David Dolan, MBA (410) 786-3365
All Other Information Annette Brewer (410) 786-6580


SUPPLEMENTARY INFORMATION:

I. Background

The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs and coordination and oversight of private health insurance. Administration and oversight of these programs involves the following: (1) furnishing information to Medicare and Medicaid beneficiaries, health care providers, and the public; and (2) maintaining effective communications with CMS regional offices, state governments, state Medicaid agencies, state survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, National Association of Insurance Commissioners (NAIC), health insurers, and other stakeholders. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act) and Public Health Service Act. We also issue various manuals, memoranda, and statements necessary to administer and oversee the programs efficiently.

Section 1871(c) of the Act requires that we publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the Federal Register .

II. Format for the Quarterly Issuance Notices

This quarterly notice provides only the specific updates that have occurred in the 3-month period along with a hyperlink to the full listing that is available on the CMS website or the appropriate data registries that are used as our resources. This is the most current up-to-date information and will be available earlier than we publish our quarterly notice. We believe the website list provides more timely access for beneficiaries, providers, and suppliers. We also believe the website offers a more convenient tool for the public to find the full list of qualified providers for these specific services and offers more flexibility and "real time" accessibility. In addition, many of the websites have listservs; that is, the public can subscribe and receive immediate notification of any updates to the website. These listservs avoid the need to check the website, as notification of updates is automatic and sent to the subscriber as they occur. If assessing a website proves to be difficult, the contact person listed can provide information.

III. How To Use the Notice

This notice is organized into 15 addenda so that a reader may access the subjects published during the quarter covered by the notice to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals should view the manuals at http://www.cms.gov/manuals.

The Director of the Office of Strategic Operations and Regulatory Affairs of the Centers for Medicare & Medicaid Services (CMS), Kathleen Cantwell, having reviewed and approved this document, authorizes Trenesha Fultz-Mimms, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register .

Trenesha Fultz-Mimms,

Federal Register Liaison, Department of Health and Human Services.

Publication Dates for the Previous Four Quarterly Notices

We publish this notice at the end of each quarter reflecting information released by CMS during the previous quarter. The publication dates of the previous four Quarterly Listing of Program Issuances notices are: February 1, 2023 (88 FR 6729), May 12, 2023 (88 FR 30752), August 4, 2023 (88 FR 51814) and October 26, 2023 (88 FR 73591). We are providing only the specific updates that have occurred in the 3-month period along with a hyperlink to the website to access this information and a contact person for questions or additional information.

Addendum I: Medicare and Medicaid Manual Instructions (October Through December 2023)

The CMS Manual System is used by CMS program components, partners, providers, contractors, Medicare Advantage organizations, and State Survey Agencies to administer CMS programs. It offers day-to-day operating instructions, policies, and procedures based on statutes and regulations, guidelines, models, and directives. In 2003, we transformed the CMS Program Manuals into a web user-friendly presentation and renamed it the CMS Online Manual System.

How To Obtain Manuals

The internet-only Manuals (IOMs) are a replica of the Agency's official record copy. Paper-based manuals are CMS manuals that were officially released in hardcopy. The majority of these manuals were transferred into the internet-only manual (IOM) or retired. Pub 15-1, Pub 15-2 and Pub 45 are exceptions to this rule and are still active paper-based manuals. The remaining paper-based manuals are for reference purposes only. If you notice policy contained in the paper-based manuals that was not transferred to the IOM, send a message via the CMS Feedback tool.

Those wishing to subscribe to old versions of CMS manuals should contact the National Technical Information Service, Department of Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone (703-605-6050). You can download copies of the listed material free of charge at: http://cms.gov/manuals.

How To Review Transmittals or Program Memoranda


[top] Those wishing to review transmittals and program memoranda can access this information at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL. This information is available at http://www.gpo.gov/libraries/. page 5899

In addition, individuals may contact regional depository libraries that receive and retain at least one copy of most federal government publications, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library. CMS publication and transmittal numbers are shown in the listing entitled Medicare and Medicaid Manual Instructions. To help FDLs locate the materials, use the CMS publication and transmittal numbers. For example, to find the manual Updates to Medicare Benefit Policy Manual and Medicare Claims Processing Manual for Opioid Treatment Programs (OTPs) (CMS-Pub. 100-02) Transmittal No. 12418.

Addendum I lists a unique CMS transmittal number for each instruction in our manuals or program memoranda and its subject number. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with information currently in the manual.

Fee-For Service Transmittal Numbers

Please Note: Beginning Friday, March 20, 2020, there will be the following change regarding the Advance Notice of Instructions due to a CMS internal process change. Fee-For Service Transmittal Numbers will no longer be determined by Publication. The Transmittal numbers will be issued by a single numerical sequence beginning with Transmittal Number 10000.

For the purposes of this quarterly notice, we list only the specific updates to the list of manual instructions that have occurred in the 3-month period. This information is available on our website at www.cms.gov/Manuals.

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Transmittal No. Manual/subject/publication No.
Medicare General Information (CMS-Pub. 100-01)
12037 Update to Medicare Deductible, Coinsurance and Premium Rates for Calendar Year (CY) 2024.
12341 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12425 Enforcing Billing Requirements for Intensive Outpatient Program (IOP) Services with New Condition Code 92-Additional Publication Update.
Medicare Benefit Policy (CMS-Pub. 100-02)
12283 Internet Only Manual Updates to Pub. 100-02 and 100-04 to Implement Consolidated Appropriations Act 2023 Changes for Skilled Nursing Facility (SNF).
12291 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction.
12299 An Omnibus CR to Implement Policy Updates in the CY 2023 PFS Final Rule, Including (1) Removal of Selected NCDs (NCD 160.22 Ambulatory EEG Monitoring), and, (2) Expanding Coverage of Colorectal Cancer Screening-Full Agile Pilot CR.
12385 Hospice Benefit Policy Manual Updates Related to the Addition of Marriage and Family Therapists (MFTs) or Mental Health Counselors (MHCs) to the Hospice Interdisciplinary Team.
12400 Hospice Benefit Policy Manual Updates Related to the Addition of Marriage and Family Therapists (MFTs) or Mental Health Counselors (MHCs) to the Hospice Interdisciplinary Team.
12418 Updates to Medicare Benefit Policy Manual and Medicare Claims Processing Manual for Opioid Treatment Programs (OTPs).
12421 January 2024 Update of the Hospital Outpatient Prospective Payment System (OPPS).
12425 Enforcing Billing Requirements for Intensive Outpatient Program (IOP) Services with New Condition Code 92-Additional Publication Update.
Medicare National Coverage Determination (CMS-Pub. 100-03)
12299 An Omnibus CR to Implement Policy Updates in the CY 2023 PFS Final Rule, Including (1) Removal of Selected NCDs (NCD 160.22 Ambulatory EEG Monitoring), and, (2) Expanding Coverage of Colorectal Cancer Screening-Full Agile Pilot CR.
12352 Manual Updates for Coverage of Intravenous Immune Globulin (IVIG) For Treatment of Primary Immune Deficiency Diseases in the Home.
Medicare Claims Processing (CMS-Pub. 100-04)
12283 Internet Only Manual Updates to Pub. 100-02 and 100-04 to Implement Consolidated Appropriations Act 2023 Changes for Skilled Nursing Facility (SNF) Physician's Services and Other Professional Services Excluded From Part A PPS Payment and the Consolidated Billing Requirement.
12284 Deleting Internet Only Manuals (IOM) Pub. 100-04, Chapter 4, Section 190, Payer Only Codes Utilized by Medicare Payer Only Codes Utilized by Medicare.
12287 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12288 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction.
12289 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12290 Diagnosis Code Update for Add-on Payments for Blood Clotting Factor Administered to Hemophilia Inpatients Payment for Blood Clotting Factor Administered to Hemophilia Inpatients.
12291 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction.
12298 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction.
12299 An Omnibus CR to Implement Policy Updates in the CY 2023 PFS Final Rule, Including (1) Removal of Selected NCDs (NCD 160.22 Ambulatory EEG Monitoring), and, (2) Expanding Coverage of Colorectal Cancer Screening-Full Agile Pilot CR.
12301 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12305 Calendar Year (CY) 2024 Participation Enrollment and Medicare Participating Physicians and Suppliers Directory (MEDPARD) Procedures.
12306 Processing Claims When the Dates of Service Are Beyond the Time Limit for the Patient Assessment Actions When a Claim Does Not Match the Inpatient Rehabilitation Facility-Patient Assessment Instrument (IRF-PAI) Payment Adjustments-Applying OASIS Assessment Items to Determine HIPPS Codes.
12315 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12316 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12321 Implementation of Rural Emergency Hospital (REH) Provider Type.
12322 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12325 Update to the Internet Only Manual (IOM) Publication (Pub.) 100-04, Chapter 18 Section 50.3-50.4, To Remove 0359U Per The International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)-October 2023.
12326 Internet-Only Manual Update, Pub. 100-04, Chapter 23 (Fee Schedule Administration and Coding Requirements), Section 50.6.
12337 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12339 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction.
12342 April 2024 Healthcare Common Procedure Coding System (HCPCS) Quarterly Update Reminder.
12343 Quarterly Update to Home Health (HH) Grouper.
12344 File Conversions Related to the Spanish Translation of the Healthcare Common Procedure Coding System (HCPCS) Descriptions.
12347 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12354 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12357 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12359 Implementation of New Benefit Category for Lymphedema Compression Treatment Items.
12360 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12361 Updates to Chapter 1 of the Medicare Claims Processing Manual (Publication (Pub.) 100-04) to Include Newly Created and Utilized Payer Only Codes.
12364 NCD 220.6.20-Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease.
12369 Implementation of Rural Emergency Hospital (REH) Provider Type.
12375 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction.
12389 Calendar Year (CY) 2024 Annual Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment.
12391 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12396 Update to the Internet Only Manual (IOM) Publication (Pub.) 100-04, Chapter 32 Sections 320.3.3 and 370.1 for Coding Revisions to the National Coverage Determinations (NCDs)-April 2024 Change Request (CR) 13390.
12398 Calendar Year 2024 Update for Durable Medical Equipment, Orthotics and Supplies (DMEPOS) Fee Schedule.
12399 April 2024 Bi-Annual Update of the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM).
12401 Instructions for Retrieving the 2024 Pricing and Healthcare Common Procedure Coding System (HCPCS) Data Files through CMS' Mainframe Telecommunications Systems.
12402 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction.
12403 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction.
12404 Instructions for Downloading the Medicare ZIP Code File for April 2024 Files.
12406 CY 2024 Home Infusion Therapy (HIT) Payment Rates and Instructions for Retrieving the January 2024 Home Infusion Therapy (HIT) Services Payment Rates Through the CMS Mainframe Telecommunications System.
12407 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12411 New Place of Service (POS) Code 27-"Outreach Site/Street".
12413 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12414 Ambulance Inflation Factor (AIF) for Calendar Year (CY) 2024 and Productivity Adjustment.
12415 New Waived Tests.
12416 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12418 Updates to Medicare Benefit Policy Manual and Medicare Claims Processing Manual for Opioid Treatment Programs (OTPs).
12419 January 2024 Integrated Outpatient Code Editor (I/OCE) Specifications Version 25.0.
12420 January 2024 Update of the Ambulatory Surgical Center (ASC) Payment System.
12421 January 2024 Update of the Hospital Outpatient Prospective Payment System (OPPS).
12422 April 2024 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing.
12423 Enforcing Billing Requirements for Intensive Outpatient Program (IOP) Services with New Condition Code 92.
12424 Implement Edits to Prevent Payment of Complexity Add-On Code G2211 When Associated Office/Outpatient Evaluation and Management Visit (Codes 99202-99205, 99211-99215) is Reported With Modifier 25.
12426 Calendar Year (CY) 2024 Annual Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment.
Medicare Secondary Payer (CMS-Pub. 100-05)
12304 Changes to The Electronic Correspondence Referral System (ECRS) Web, Including Modified Medicare Secondary Payer (MSP) Health Insurance Master Record (HIMR) Screen and Remote Identity Process (RIDP).
Attachment 1-ECRS Web User Guide, Software Version 7.4 2023/October 2.
Attachment 2-ECRS Web Quick Reference Card Version 7.4 2023/October 2.
Medicare Financial Management (CMS-Pub. 100-06)
12297 Notice of New Interest Rate for Medicare Overpayments and Underpayments-1st Qtr Notification for FY 2024.
12323 Revisions and Deletions to the Internet Only Manual (IOM), Publication 100-06, Chapter 4, Debt Collection Related to Extended Repayment Schedules (ERS) and Debt Management.
Rates of Interest.
Procedures for Applying Interest During Overpayment Recoupment.
Recoupment by Withholding Payments.
Establishing an Extended Repayment Schedule.
Extended Repayment Schedule (ERS) Required Documentation-Physician is a Sole Proprietor.
Extended Repayment Schedule (ERS) Required Documentation-Provider is an Entity Other Than a Sole Proprietor.
Extended Repayment Schedule (ERS) Approval Process.
Sending the Extended Repayment Schedule (ERS) Request to the Regional Office (RO).
Monitoring an Approved Extended Repayment Schedule (ERS) and Reporting Requirement.
Requests from Terminated Providers or Debts that are Pending Referral to Department of Treasury.
12329 The Fiscal Intermediary Shared System (FISS) Submission of Copybook Files to the Provider and Statistical Reimbursement (PS&R) System.
12346 Revisions and Deletions to the Internet Only Manual (IOM), Publication 100-06, Chapter 4, Debt Collection Related to Extended Repayment Schedules (ERS) and Debt Management.
Rates of Interest.
Procedures for Applying Interest During Overpayment Recoupment.
Recoupment by Withholding Payments.
Establishing an Extended Repayment Schedule (ERS).
Extended Repayment Schedule (ERS) Required Documentation-Physician is a Sole Proprietor.
Extended Repayment Schedule (ERS) Required Documentation-Provider is an Entity Other Than a Sole Proprietor.
4/50.3/Extended Repayment Schedule (ERS) Approval Process.
4/50.4/Sending the Extended Repayment Schedule (ERS) Request to the Regional Office (RO).
Monitoring an Approved Extended Repayment Schedule (ERS) and Reporting Requirements.
Requests from Terminated Providers or Debts that are Pending Referral to Department of Treasury.
Medicare State Operations Manual (CMS-Pub. 100-07)
None.
Medicare Program Integrity (CMS-Pub. 100-08)
12279 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12280 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12281 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12295 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12296 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12300 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12302 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction.
12333 Updates of Chapter 4 and Chapter 8 in Publication (Pub.) 100-08, Including Adding Guidance Regarding Handling of Freedom Information Act (FOIA) Requests.
Requests for Information From Outside Organizations.
Duration of the Payment Suspension.
DME Payment Suspensions (MACs and UPICs).
Non-DME National Payment Suspensions (MACs and UPICs).
12336 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12356 Incorporation of Recent Provider Enrollment Regulatory Changes into Chapter 10 of CMS Publication (Pub.) 100-08-Physician Fee Schedule (PFS) Final Rule.
Additional Definitions.
Marriage and Family Therapists (MFTs).
Mental Health Counselors (MHCs).
Medicare Diabetes Prevention Program (MDPP) Suppliers.
Providers/Suppliers Not Eligible to Enroll.
Denials-General Principles.
Denial Reasons.
Additional Denial Policies.
Changes of Information.
Revocation Effective Dates.
Revocation Reasons.
Reenrollment Bar.
Additional Revocation Policies.
Establishing Effective Dates.
Opting-Out of Medicare.
Appeals Process.
Revalidation Notification Letters.
12358 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12393 Incorporation of Recent Provider Enrollment Regulatory Changes into Chapter 10 of CMS Publication (Pub.) 100-08-Home Health Prospective Payment System (HH PPS) Final Rule.
12394 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12395 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction.
12408 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
Medicare Contractor Beneficiary and Provider Communications (CMS-Pub. 100-09)
None.
Medicare Quality Improvement Organization (CMS-Pub. 100-10)
None.
Medicare Program of All-Inclusive Care for the Elderly (CMS-Pub. 100-11)
12338 Update to the Internet Only Manual (IOM) Publication (Pub.) 100-11, IOM Chapter 4 Enrollment and Disenrollment.
Medicare End Stage Renal Disease Network Organizations (CMS Pub 100-14)
None.
Medicaid Program Integrity Disease Network Organizations (CMS Pub 100-15)
None.
Medicare Managed Care (CMS-Pub. 100-16).
None.
Medicare Business Partners Systems Security (CMS-Pub. 100-17).
None.
Medicare Prescription Drug Benefit (CMS-Pub. 100-18)
None.
Demonstrations (CMS-Pub. 100-19).
12320 Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction.
12348 Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction.
12365 Guiding an Improved Dementia Experience (GUIDE) Model Implementation.
12366 Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction.
12383 Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction.
12390 Making Care Primary (MCP) Model Implementation.
12412 Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction.
One Time Notification (CMS-Pub. 100-20).
12286 Patient Driven Payment Model (PDPM) Corrections to Interrupted Stay Edits.
12292 Implementation to Expand Monetary Amount Fields Related to Billing and Payment to Accommodate 10-Digits in Length ($99,999,999.99)-Phase 2.
12303 Adjustment to Fraud Prevention System (FPS) and Unified Program Integrity Contractor (UPIC) Edits to Increase Billing Increments From 30 Days to 90 Days for Continuous Glucose Monitor (CGM) Supplies.
12308 User Enhancement Change Request (UECR): ViPS Medicare System (VMS)-Hold Data on the Program Integrity Management Reporting (PIMR) Audit Record History Screen (BUDS19).
12309 Fiscal Intermediary Shared System (FISS) User Enhancement Change Request (UECR)-Expiration of a Unique Tracking Number (UTN) on the Prior Authorization (PA) Tracking File.
12310 Fiscal Intermediary Shared System (FISS) User Enhancement Change Request (UECR)-New Reason Code to Prevent Adjustments and Cancels From Being Submitted for the Same Claim, on the Same Day.
12313 User Enhancement Change Request (UECR)-Update the Multi-Carrier System (MCS) to Add a Location Field to the Data Correction Window in the MCS Desktop Tool (MCSDT).
12314 User Enhancement Request (UECR)-Update the Multi-Carrier System (MCS) to Create a Summary Report for Healthcare Integrated General Ledger Accounting System (HIGLAS) Interface File Errors.
12317 User Enhancement Change Request (UECR): New Multi-Carrier System (MCS) Inquiry Search Screen Using a Procedure Code to Display an Associated Edit or Audit.
12318 International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)-April 2024 Update-CR 1 of 2.
12319 International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)-April 2024 Update-CR 2 of 2.
12324 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12327 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12328 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction.
12330 Implement Edits on Hospice Claims.
12331 Report of Hospice Election for Part D (Response File).
12334 Remittance Advice (RA) Changes due to Durable Medical Equipment Medicare Administrative Contractors (DME MACs) Transition to Healthcare Integrated General Ledger Accounting System (HIGLAS).
12335 Allowing Audiologists to Furnish Certain Diagnostic Tests Without a Physician Order.
12340 Implementation to Expand Monetary Amount Fields Related to Billing and Payment to Accommodate 10-Digits in Length ($99,999,999.99)-Phase 3.
12345 Implementation of a National Fee Schedule for Medicare Part B Vaccine Administration CMS.
12349 Pricing and Coding Services (PCS) Application Programming Interface (API) Report Dissemination Proof of Concept.
12350 International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)-April 2024 Update-CR 2 of 2.
12351 Requirements for a Provider Direct Mailing and Education & Outreach for Behavioral Health Initiatives.
12353 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12355 International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)-January 2024 Update.
12362 User Enhancement Change Request (UECR): ViPS Medicare System (VMS)-Fix Beneficiary Update and Display System (BUDS) Queries for Remark Code and Biller Number.
12363 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12367 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12368 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
12392 Enforcing Billing Requirements for Intensive Outpatient Program (IOP) Services with Revenue Code 0905 for Federally Qualified Health Centers (FQHC) and Rural Health Clinics (RHC).
12397 Payment of Codes for Chemotherapy Administration and Nonchemotherapy Injections and Infusions.
12405 Direct Mailing Notification to Hospice Providers Regarding the Value-Based Insurance Design (VBID) Model, Hospice Benefit Component, Participating Medicare Advantage Organizations.
12410 Updating Calendar Year (CY) 2024 Medicare Diabetes Prevention Program (MDPP) Payment Rates.
12428 Provider Education for the Review Choice Demonstration (RCD) for Inpatient Rehabilitation Facility Services (IRFs).
Medicare Quality Reporting Incentive Programs (CMS-Pub. 100-22)
12293 Payments to Home Health Agencies That Do Not Submit Required Quality Data This CR Rescinds and Fully Replaces CR 10874.
12294 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction.
State Payment of Medicare Premiums (CMS-Pub. 100-24).
None.
Information Security Acceptable Risk Safeguards (CMS-Pub. 100-25).
None.


For questions or additional information, contact Ismael Torres (410-786-1864).

Addendum II: Regulation Documents Published in the Federal Register (October Through December 2023)

Regulations and Notices

Regulations and notices are published in the daily Federal Register . To purchase individual copies or subscribe to the Federal Register , contact GPO at www.gpo.gov/fdsys. When ordering individual copies, it is necessary to cite either the date of publication or the volume number and page number.

The Federal Register is available as an online database through GPO Access. The online database is updated by 6 a.m. each day the Federal Register is published. The database includes both text and graphics from Volume 59, Number 1 (January 2, 1994) through the present date and can be accessed at http://www.gpoaccess.gov/fr/index.html. The following website http://www.archives.gov/federal-register/ provides information on how to access electronic editions, printed editions, and reference copies.

For questions or additional information, contact Terri Plumb (410-786-4481).

Addendum III: CMS Rulings (October Through December 2023)

CMS Rulings are decisions of the Administrator that serve as precedent final opinions and orders and statements of policy and interpretation. They provide clarification and interpretation of complex or ambiguous provisions of the law or regulations relating to Medicare, Medicaid, Utilization and Quality Control Peer Review, private health insurance, and related matters.

The rulings can be accessed at http://www.cms.gov/Regulations-and-Guidance/Guidance/Rulings.

For questions or additional information, contact Tiffany Lafferty (410-786-7548).

Addendum IV: Medicare National Coverage Determinations (October Through December 2023)

Addendum IV includes completed national coverage determinations (NCDs), or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the NCD Manual (NCDM) in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. An NCD is a determination by the Secretary for whether or not a particular item or service is covered nationally under the Medicare Program (title XVIII of the Act), but does not include a determination of the code, if any, that is assigned to a particular covered item or service, or payment determination for a particular covered item or service. The entries below include information concerning completed decisions, as well as sections on program and decision memoranda, which also announce decisions or, in some cases, explain why it was not appropriate to issue an NCD. Information on completed decisions as well as pending decisions has also been posted on the CMS website. For the purposes of this quarterly notice, there were no specific updates to national coverage determinations (NCDs), or reconsiderations of completed NCDs published in the 3-month period. This information is available at: www.cms.gov/medicare-coverage-database/.

For questions or additional information, contact Wanda Belle, MPA (410-786-7491).

Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (October Through December 2023)

(Inclusion of this addenda is under discussion internally.)

Addendum VI: Approval Numbers for Collections of Information (October Through December 2023)


[top] All approval numbers are available to the public at Reginfo.gov . Under the review process, approved information collection requests are assigned OMB control numbers. A single control number may apply to several related information collections. This page 5904 information is available at www.reginfo.gov/public/do/PRAMain.

For questions or additional information, contact William Parham (410-786-4669).

Addendum VII: Medicare-Approved Carotid Stent Facilities (October Through December 2023)

Addendum VII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS standards for performing carotid artery stenting for high risk patients. On March 17, 2005, we issued our decision memorandum on carotid artery stenting. We determined that carotid artery stenting with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. We have created a list of minimum standards for facilities modeled in part on professional society statements on competency. All facilities must at least meet our standards in order to receive coverage for carotid artery stenting for high risk patients. For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3-month period. This information is available at: http://www.cms.gov/MedicareApprovedFacilitie/CASF/list.asp#TopOfPage.

For questions or additional information, contact Sarah Fulton, MHS (410-786-2749).

Facility Provider No. Date approved State
The following facilities are new listings for this quarter
HCA Florida Englewood Hospital, 700 Medical Boulevard, Englewood, FL 34223 1639122864 09/09/2023 FL
Kaiser Permanente San Francisco, Medical Center, 2425 Geary Blvd Provider, San Francisco, CA 94115 050076 09/09/2023 CA
Sanford Bemidji Medical Center, 1300 Anne Street NW, Bemidji, MN 56601 240100 09/09/2023 MN
The following facilities have editorial changes (in bold)
From: Galichia Heart Hospital, To: Wesley Woodlawn Hospital, 2610 N. Woodlawn Boulevard, Wichita, KS 67220-2729 170123 05/16/2005 KS
From: Presence Resurrection Medical Center, To: Ascension Resurrection, 7435 West Talcott Avenue, Chicago, IL 60631 140117 04/12/2005 IL
From: Fort Walton Beach Medical Center, To: HCA Fort Walton-Destin Hospital, 1000 Mar Walt Drive, Fort Walton Beach, FL 32547 100223 04/14/2005 FL
From: Trumbull Memorial Hospital, To: Trumbull Regional Medical Center, 1350 E Market Street, Warren, OH 44483 1053844671 03/14/2013 OH

Addendum VIII: American College of Cardiology's National Cardiovascular Data Registry Sites (October Through December 2023)

The initial data collection requirement through the American College of Cardiology's National Cardiovascular Data Registry (ACC-NCDR) has served to develop and improve the evidence base for the use of ICDs in certain Medicare beneficiaries. The data collection requirement ended with the posting of the final decision memo for Implantable Cardioverter Defibrillators on February 15, 2018.

For questions or additional information, contact Sarah Fulton, MHS (410-786-2749).

Addendum IX: Active CMS Coverage-Related Guidance Documents (October Through December 2023)

CMS issued a guidance document on November 20, 2014 titled "Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development Document". Although CMS has several policy vehicles relating to evidence development activities including the investigational device exemption (IDE), the clinical trial policy, national coverage determinations and local coverage determinations, this guidance document is principally intended to help the public understand CMS's implementation of coverage with evidence development (CED) through the national coverage determination process. The document is available at http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=27.

CMS published three proposed guidance documents on June 22, 2023 to provide a framework for more predictable and transparent evidence development and encourage innovation and accelerate beneficiary access to new items and services. The documents are available at:

https://www.cms.gov/medicare-coverage-database/view/medicare-coverage-document.aspx?mcdid=35&docTypeId=1&sortBy=title&bc=16.

https://www.cms.gov/medicare-coverage-database/view/medicare-coverage-document.aspx?mcdid=34&docTypeId=1&sortBy=title&bc=16.

https://www.cms.gov/medicare-coverage-database/view/medicare-coverage-document.aspx?mcdid=33&docTypeId=1&sortBy=title&bc=16.

For questions or additional information, contact Lori Ashby, MA (410 786 6322).

Addendum X: List of Special One-Time Notices Regarding National Coverage Provisions (October Through December 2023)

There were no special one-time notices regarding national coverage provisions published in the 3-month period. This information is available at http://www.cms.gov .

For questions or additional information, contact JoAnna Baldwin, MS (410-786 7205).

Addendum XI: National Oncologic PET Registry (NOPR)

Addendum XI includes a listing of National Oncologic Positron Emission Tomography Registry (NOPR) sites. We cover positron emission tomography (PET) scans for particular oncologic indications when they are performed in a facility that participates in the NOPR.


[top] In January 2005, we issued our decision memorandum on positron emission tomography (PET) scans, which stated that CMS would cover PET scans for particular oncologic indications, as long as they were performed in the context of a clinical study. We have since recognized the National Oncologic PET Registry as one of these clinical studies. Therefore, in order for a beneficiary to receive a Medicare-covered PET scan, the beneficiary must receive the scan in a facility that participates in the registry. There were no additions, deletions, or editorial changes to the listing of National Oncologic Positron Emission Tomography Registry (NOPR) in the 3-month period. This information is available at http://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage. page 5905

For questions or additional information, contact David Dolan, MBA (410-786-3365).

Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (October Through December 2023)

Addendum XII includes a listing of Medicare-approved facilities that receive coverage for ventricular assist devices (VADs) used as destination therapy. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. On October 1, 2003, we issued our decision memorandum on VADs for the clinical indication of destination therapy. We determined that VADs used as destination therapy are reasonable and necessary only if performed in facilities that have been determined to have the experience and infrastructure to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy.

For the purposes of this quarterly notice, we are providing only the specific updates to the list of Medicare-approved facilities that meet our standards that have occurred in the 3-month period. This information is available at http://www.cms.gov/MedicareApprovedFacilitie/VAD/list.asp#TopOfPage.

For questions or additional information, contact David Dolan, MBA, (410-786-3365).

page 5906


[top] 
Facility Provider No. Date of initial certification Date of re-certification State
The following facility is a new listing.
St. Bernard's Medical Center, 225 East Washington, Jonesboro, AR 72401 040020 08/31/2023 AR
Other information: DNV-GL ID #: C624530
Previous Re-certification Dates: n/a
The following facilities have editorial changes (in bold).
Sentara Norfolk General Hospital, 600 Gresham Drive, Norfolk, VA 23507 49-0007 11/13/2008 09/05/2023 VA
Other information: DNV-GL ID #: C592382
Previous Re-certification Dates: 11/13/2008; 12/21/2010; 02/05/2013; 01/13/2015; 03/14/2017; 4/20/2019; 10/07/2021
Presbyterian Medical Center of the UPHS, 51 North 39th Street, Philadelphia, PA 19104 390223 10/05/2010 06/28/2023 PA
Other information: Joint Commission ID #6145
Previous Re-certification Dates: 10/05/2010; 11/07/2012; 12/09/2014; 03/21/2017; 4/17/2019; 07/29/2021
University of Alabama at Birmingham, 619 19th S. South, Birmingham, AL 35249-1900 010033 10/29/2003 07/27/2023 AL
Other information: Joint Commission ID # 2814
Previous Re-certification Dates: 12/09/2008; 04/22/2011; 04/09/2013; 04/07/2015; 05/16/2017; 7/3/2019; 08/21/2021
Virginia Commonwealth University Health System Authority, 1250 East Marshall Street, Richmond, VA 23298-051 490032 04/08/2004 07/19/2023 VA
Other information: Joint Commission ID # 6381
Previous Re-certification Dates: 11/04/2008; 12/14/2010; 12/21/2012;12/16/2014; 02/14/2017; 04/10/2019; 08/07/2021
Fresno Community Hospital and Medical Center, 2823 Fresno St., Fresno, CA 93721 050060 01/04/2014 08/09/2023 CA
Other information: Joint Commission ID # 9832
Previous Re-certification Dates: 1/04/2014; 12/13/2016; 2/13/2019; 08/11/2021
University Hospital (Stony Brook), Health Sciences Center Suny Stony Brook, Stony Brook, NY 11794-8503 330393 03/02/2011 08/09/2023 NY
Other information: Joint Commission ID # 5188
Previous Re-certification Dates: 01/30/2013; 01/15/2015; 03/14/2017; 05/08/2019; 09/17/2021
Maimonides Medical Center, 4802 Tenth Avenue, Brooklyn, NY 11219-2916 330194 08/23/2012 10/18/2023 NY
Other information: Joint Commission ID #5734
Previous Re-certification Dates: 08/23/2012; 07/29/2014; 09/13/2016; 10/11/2018; 10/27/2021
The General Hospital Corporation, 55 Fruit Street, Boston, MA 02114 220071 12/15/2003 09/07/2023 MA
Other information: Joint Commission ID# 5513
Previous Re-certification Dates: 12/08/2008; 01/19/2011; 02/13/2013; 01/06/2015; 02/28/2017; 05/22/2019; 10/14/2021
Montefiore Health System, 111 East 210th StreetM Bronx, NY 10467 330059 11/14/2003 10/04/2023 NY
Other information: Joint Commission ID #2514
Previous Re-certification Dates: 09/23/2008; 10/08/2010; 10/23/2012; 09/23/2014; 10/08/2016; 11/07/2018; 10/29/2021
Bryan Medical Center, 1600 South 48th Street, Lincoln, NE 68506 280003 03/05/2013 08/23/2023 NE
Other information: Joint Commission ID # 244330
Previous Re-certification Dates: 03/05/2013; 02/12/2015; 04/18/2017; 07/17/2019; 09/22/2021
Nebraska Medical Center, 987400 Nebraska Medical Center, Omaha, NE 68198-7400 280013 02/02/2011 08/16/2023 NE
Other information: Joint Commission ID # 186313
Previous Re-certification Dates: 01/20/2011; 01/29/2013; 02/24/2015; 02/14/2017; 04/17/2019; 09/09/2021
Dignity Health, 350 West Thomas Road, Phoenix, AZ 85013 030024 05/08/2019 08/26/2023 AZ
Other information: Joint Commission ID # 9494
Previous Re-certification Dates: 05/08/2019; 08/19/2021
From: Norton Hospitals Inc. 180088 09/17/2020 10/13/2023 KY
To: Norton Audubon Hospital, 1 Audubon Plaza Drive, Louisville, KY 40217
Other information: DNV ID #: C553570
Previous Re-certification Dates: 09/17/2020
From: University of Virginia Medical Center 490009 02/12/2010 09/15/2023 VA
To: Rector & Visitors of the University of Virginia, 1215 Lee Street, Charlottesville, VA 22903
Other information: Joint Commission ID #: 6329
Previous Re-certification Dates: 03/21/2012; 05/06/2014; 06/07/2016; 06/06/2018; 10/13/2021
Temple University Hospital, Inc., 3401 North Broad Street, Philadelphia, PA 19140 390027 02/08/2012 09/13/2023 PA
Other information: Joint Commission ID #: 6152
Previous Re-certification Dates: 02/08/2012; 02/11/2014; 04/07/2016; 04/04/2018; 10/13/2021
Prisma Health Richland, 5 Richland Medical Park Drive, Columbia, SC 29203 420018 03/07/2013 09/13/2023 SC
Other information: Joint Commission ID #: 6588
Previous Re-certification Dates: 03/06/2013; 04/21/2015; 06/06/2017; 6/28/2019; 10/08/2021
Hillcrest Medical Center, 1120 S. Utica, Tulsa, OK 74104 370001 12/04/2017 11/17/2023 OK
Other information: DNV #: C584663
Previous Re-certification Dates: 12/04/2017; 11/25/2020
Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215 220086 04/25/2017 09/29/2023 MA
Other information: Joint Commission ID #: 5501
Previous Re-certification Dates: 4/25/2017; 05/22/2019; 11/04/2021
Yale New Haven Hospital, 20 York Street, New Haven, CT 06510-3203 070022 01/25/2011 12/13/2023 CT
Other information: Joint Commission ID #: 5677
Previous Re-certification Dates: 01/25/2011; 01/15/2013; 12/16/2014; 02/28/2017; 5/22/2019; 11/24/2021
UMass Memorial Health Care, Inc, One Biotech Park 365 Plantation Street, Worcester, MA 01605 220163 02/06/2019 10/27/2023 MA
Other information: Joint Commission ID #: 5640
Previous Re-certification Dates: 02/06/2019; 11/06/2021
North Carolina Baptist Hospital, dba Atrium Health Wake Forest Baptist, Medical Center Boulevard, Winston Salem, NC 27157 340047 06/28/2011 10/25/2023 NC
Other information: Joint Commission ID #: 6571
Previous Re-certification Dates: 06/28/2011; 08/13/2013; 08/04/2015; 08/18/2017; 10/9/2019; 10/16/2021
Memorial Hermann-Texas Medical Center, 6411 Fannin Street, Houston, TX 77030-1501 450068 03/19/2013 12/22/2023 TX
Other information: Joint Commission ID #: 9081
Previous Re-certification Dates: 03/19/2013; 04/14/2015; 05/24/2017; 06/26/2019; 12/23/2021
Cleveland Clinic Florida, 3100 Weston Road, Weston, FL 33331 100289 05/19/2015 11/02/2023 FL
Other information: Joint Commission ID #: 334451
Previous Re-certification Dates: 05/19/2015; 06/20/2017; 7/24/2019; 11/04/2021


Addendum XIII: Lung Volume Reduction Surgery (LVRS) (October Through December 2023)

Addendum XIII includes a listing of Medicare-approved facilities that are eligible to receive coverage for lung volume reduction surgery. Until May 17, 2007, facilities that participated in the National Emphysema Treatment Trial were also eligible to receive coverage. The following three types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (LVRS):

• National Emphysema Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer automatically qualify and can qualify only with the other programs);

• Credentialed by the Joint Commission (formerly, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)) under their Disease Specific Certification Program for LVRS; and

• Medicare approved for lung transplants.

Only the first two types are in the list. For the purposes of this quarterly notice, there are no additions and deletions to a listing of Medicare-approved facilities that are eligible to receive coverage for lung volume reduction surgery. This information is available at www.cms.gov/MedicareApprovedFacilitie/LVRS/list.asp#TopOfPage.

For questions or additional information, contact Sarah Fulton, MHS (410-786-2749).

Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (October Through December 2023)


[top] Addendum XIV includes a listing of Medicare-approved facilities that meet minimum standards for facilities modeled in part on professional society statements on competency. All facilities must meet our standards in order to receive coverage for bariatric surgery page 5907 procedures. On February 21, 2006, we issued our decision memorandum on bariatric surgery procedures. We determined that bariatric surgical procedures are reasonable and necessary for Medicare beneficiaries who have a body-mass index (BMI) greater than or equal to 35, have at least one co-morbidity related to obesity and have been previously unsuccessful with medical treatment for obesity. This decision also stipulated that covered bariatric surgery procedures are reasonable and necessary only when performed at facilities that are: (1) certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006); or (2) certified by the American Society for Bariatric Surgery (ASBS) as a Bariatric Surgery Center of Excellence (BSCOE) (program standards and requirements in effect on February 15, 2006).

There were no additions, deletions, or editorial changes to Medicare-approved facilities that meet CMS' minimum facility standards for bariatric surgery that have been certified by ACS and/or ASMBS in the 3-month period. This information is available at www.cms.gov/MedicareApprovedFacilitie/BSF/list.asp#TopOfPage.

For questions or additional information, contact Sarah Fulton, MHS (410-786-2749).

Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (October Through December 2023)

There were no FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials published in the 3-month period.

This information is available on our website at www.cms.gov/MedicareApprovedFacilitie/PETDT/list.asp#TopOfPage.

For questions or additional information, contact David Dolan, MBA (410-786-3365).

[FR Doc. 2024-01785 Filed 1-29-24; 8:45 am]

BILLING CODE 4120-01-P