90 FR 90 pgs. 20166-20169 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
Type: NOTICEVolume: 90Number: 90Pages: 20166 - 20169
Pages: 20166, 20167, 20168, 20169Docket number: [Document Identifier: CMS-209, CMS-R-52, CMS-10538, CMS-10171, and CMS-10780]
FR document: [FR Doc. 2025-08307 Filed 5-9-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Medicare & Medicaid Services
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-209, CMS-R-52, CMS-10538, CMS-10171, and CMS-10780]
Agency Information Collection Activities: Submission for OMB Review; Comment Request
AGENCY:
Centers for Medicare & Medicaid Services, Health and Human Services (HHS).
ACTION:
Notice.
SUMMARY:
[top] The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments
DATES:
Comments on the collection(s) of information must be received by the OMB desk officer by June 11, 2025.
ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain . Find this particular information collection by selecting "Currently under 30-day Review-Open for Public Comments" or by using the search function.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing .
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term "collection of information" is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:
1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Laboratory Personnel Report (CLIA) and Supporting Regulations; Use: The information collected on this survey form is used in the administrative pursuit of the Congressionally-mandated program with regard to regulation of laboratories participating in CLIA. The surveyor will provide the laboratory with the CMS-209 form. While the surveyor performs other aspects of the survey, the laboratory will complete the CMS-209 by recording the personnel data needed to support their compliance with the personnel requirements of CLIA. For this submission, we are making minor revisions to the collection instrument. We revised the instructions for clarity and removed the references to specific regulations. Form Number: CMS-209 (OMB control number 0938-0151); Frequency: Biennially; Affected Public: Private Sector-State, Local, or Tribal Governments; and Federal Government; Number of Respondents: 16,404; Total Annual Responses: 8,202; Total Annual Hours: 4,101. (For policy questions regarding this collection contact Penny Keller at 410-786-2035.)
2. Type of Information Collection Request: Reinstatement with change of a previously approved collection; Title of Information Collection: End Stage Renal Disease (ESRD) Conditions for Coverage and Supporting Regulations; Use: The Centers for Medicare and Medicaid Services (CMS) is requesting reinstatement of OMB Control number 0938-0386 (CMS-R-52) in compliance with the Paperwork Reduction Act (PRA). This package applies to existing Medicare End-stage Renal Disease (ESRD) conditions for coverage (CfCs) at 42 CFR 494. Section 299I of the Social Security Amendments of 1972 (Pub. L. 92-603) originally extended Medicare coverage to insured individuals, their spouses, and their dependent children with ESRD who require dialysis or transplantation. Subsequently, the ESRD Amendments of 1978 (Pub. L. 95-292) amended title XVIII of the Social Security Act (the Act) by adding section 1881. Section 1881(b)(1) of the Act authorizes the Secretary to prescribe health and safety requirements (known as conditions for coverage) that a facility providing dialysis and transplantation services to patients must meet to qualify for Medicare reimbursement. Final regulations were published June 3, 1976. Subsequent to the publication of the final regulations, the ESRD Amendments of 1978 were enacted to amend title XVIII of the Act to include section 1881(c). This section establishes ESRD network areas and Network organizations to assure the effective and efficient administration of ESRD program benefits. The requirements from section 1881(b) and (c) are implemented in regulations at 42 CFR part 405, subpart U, Conditions for Coverage for dialysis facilities.
On April 7, 1986, the Consolidated Omnibus Budget Reconciliation Act of 1975 (COBRA) (P.L. 99-272) was enacted which requires the Secretary to maintain renal disease Network organizations as authorized under section 1881(c) of the Act, and not merge the Network organizations into other organizations or entities. On April 15, 1986, we published a notice of proposed rulemaking to implement section 9214 of Public Law 99-272. A final rule (HSQ-115) was published August 26, 1986, which included information collection requirements at §?405.2112(e). This rule revised the requirements in regulations pertaining to the ESRD networks and organizations and establishes new, more efficient Network organizations.
Revisions resulting from two additional rules: HSQ-137-ESRD: Responsibilities of Network Organizations, published January 21, 1988; and BERC-434-Medicare Program: Standards for the Reuse of Hemodialyzer Filters and Other Dialysis Supplies, published October 2, 1987, are also included. HSQ-137-ESRD approved information collection requirements at §§?405.2112(f) and (j). BERC-434 approved information collection requirements stemming from the following historical sections of the CFR including §§?405.2136(b), 405.2138(a), 405.2139(a), and 405.2140(b) and (c).
Major revisions to the CFR established new ESRD CfCs at 42 CFR 494 issued in a final rule, " Medicare and Medicaid Programs; Conditions for Coverage for End-Stage Renal Disease Facilities, " published on April 15, 2008 (CMS-3818-F). This rule modified, removed, added, and redesigned CfCs that dialysis facilities must meet to be certified under the Medicare program. This rule approved information collection requirements at §§?494.30, 494.40, 494.50, 494.60, 494.70, 494.80, 494.90, 494.100, 494.110, 494.120, 494.150, 494.170, and 494.180.
[top] An additional revision to the ESRD CfCs at 42 CFR 494 was precipitated by CMS-3818-F at 414.330(a)(2)(iii)(C). The burden to ESRD home dialysis suppliers associated with this requirement would be the time and effort necessary to collect all data for each patient receiving home dialysis care with respect to services and items furnished. However, the payment method that covered these suppliers
An additional revision to the ESRD CfCs at 42 CFR 494 was precipitated by interim final rule, " Medicare Program; Conditions for Coverage for End-Stage Renal Disease Facilities-Third Party Payment, " published on December 14, 2016 (CMS-3337-IFC). This rule established new requirements for Medicare-certified dialysis facilities that make payments of premiums for individual market health plans. This interim final rule established additional burden associated with §§?494.70(c) and 494.180(k); these were quantified in the preceding information collection which expired in 2024 (OMB control number 0938-0386). Since these regulations were not finalized due to litigation, they are no longer in effect. Therefore, we took out these sections from this package as they do not impose any burden.
An additional revision to the ESRD CfCs at 42 CFR 494 was precipitated by final rule, " Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, " published September 16, 2016 (CMS-3178-F). This rule established the creation and maintenance of an Emergency Preparedness Plan at 494.62(a), an Emergency Preparedness Policies and Procedures document at 494.62(b), an Emergency Preparedness Communication Plan at 494.62(c), a training program 494.62(d), and documentation of training exercises 494.62(e). These information collections are in separate package, OMB Control number 0938-1325.
On July 5, 2024, revisions to the CfC were proposed in " Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, Conditions for Coverage for End-Stage Renal Disease Facilities, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model, " (CMS-1805-P). This rule proposed to expand coverage of home dialysis services to patients with acute kidney injury (AKI). Since the ESRD CfCs apply to dialysis facilities, not to people with ESRD, this rule proposes to revise language in the CfCs to allow beneficiaries with AKI to utilize home dialysis. Specifically, we refer to facilities abiding by the ESRD CfCs as `dialysis facilities' opposed to `ESRD facilities and all patients seeking services from dialysis facilities as `patients' rather than `ESRD patients.' There is no ICR burden associated with these changes however we made confirming changes to the language in this package.
The CfCs are used by Federal (CMS), State surveyors (employed by State survey agencies), or CMS authorized accrediting organizations as a basis for determining whether a dialysis facility qualifies for approval or re-approval under Medicare. Surveyors make an in-person visit to the dialysis facility to perform the complete survey.
The preceding information collection, which expired on March 31, 2024, estimated the total annual hourly burden as 1,260,491 hours at a cost of $64,839,657. We revise this to 800,621 hours at a cost of $49,638,502. The reduction in hours and cost is largely due to removing the burden estimates that no longer apply. Form Number: CMS-R-52 (OMB control number: 0938-0386); Frequency: Annually; Affected Public: Private sector-Business or other for-profit; Number of Respondents: 8,048; Total Annual Responses: 215,591; Total Annual Hours: 800,621 (For policy questions regarding this collection contact Claudia Molinar at 410-786-8445.)
3. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: Hospice Information for Medicare Part D Plans; Use: The Social Security Act in section 1861(dd) and Federal regulations in 42 CFR 418.106 and §?418.202(f) require hospice programs to provide individuals under hospice care with drugs and biologicals related to the palliation and management of the terminal illness as defined in the hospice plan of care. Medicare payment is made to the hospice for each day an eligible beneficiary is under the hospice's care, regardless of the amount of services provided on any given day. Because hospice care is a Medicare Part A benefit, drugs provided by the hospice and covered under the Medicare payment to the hospice program are not covered under Part D.
The form would be completed by the prescriber or the beneficiary's hospice, or if the prescriber or hospice provides the information verbally to the Part D sponsor, the form would be completed by the sponsor. Information provided on the form would be used by the Part D sponsor to establish coverage of the drug under Medicare Part D. Per statute, drugs that are necessary for the palliation and management of the terminal illness and related conditions are not eligible for payment under Part D. The standard form provides a vehicle for the hospice provider, prescriber or sponsor to document that the drug prescribed is "unrelated" to the terminal illness and related conditions. It also gives a hospice organization the option to communicate a beneficiary's change in hospice status and/care plan to Part D sponsors. Form Number: CMS-10538 (OMB control number: 0938-1296); Frequency: Yearly; Affected Public: Private Sector (business or other for-profits); Number of Respondents: 319; Number of Responses: 57,027; Total Annual Hours: 2,329. (For policy questions regarding this collection, contact Chad Buskirk at (410) 786-1630 or chad.buskirk@cms.hhs.gov. )
4. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: Part D Coordination of Benefits Data; Use: Sections 1860D-23 and 1860D-24 of the Act require the Secretary to establish requirements for prescription drug plans to promote effective coordination between Part D plans and SPAPs and other payers. These Part D Coordination of Benefits (COB) requirements have been codified into the Code of Federal Regulations at 42 CFR 423.464. In particular, CMS' requirements relate to the following elements: (1) enrollment file sharing; (2) claims processing and payment; (3) claims reconciliation reports; (4) application of the protections against high out-of-pocket expenditures by tracking TrOOP expenditures; and (5) other processes that the Secretary determines.
This information collection request assists CMS, pharmacists, Part D plans, and other payers coordinate prescription drug benefits at the point-of-sale and track beneficiary True out-of-pocket (TrOOP) expenditures using the Part D Transaction Facilitator (PDTF). Form Number: CMS-10171 (OMB control number: 0938-0978); Frequency: Yearly; Affected Public: State, Local, or Tribal Government; Number of Respondents: 67,043; Total Annual Responses: 935,730,342; Total Annual Hours: 1,011,740. (For policy questions regarding this collection contact Chad Buskirk at 410-786-1630 or chad.buskirk@cms.hhs.gov. )
[top] 5. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Requirements
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-08307 Filed 5-9-25; 8:45 am]
BILLING CODE 4120-01-P