Agency Information Collection Activities: Proposed Collection; Comment Request

Issuing agencies

Abstract

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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Full Text

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<title>Federal Register, Volume 91 Issue 161 (Friday, August 21, 2026)</title>
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[Federal Register Volume 91, Number 161 (Friday, August 21, 2026)]
[Notices]
[Pages 54330-54331]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-17128]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-2728 and CMS-10110]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

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SUMMARY: 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 60 days for public comment on 
the proposed action. Interested persons are invited to send comments 
regarding our burden estimates or any other aspect of this collection 
of information, including the necessity and utility of the proposed 
information collection for the proper performance of the agency's 
functions, the accuracy of the estimated burden, ways to enhance the 
quality, utility, and clarity of the information to be collected, and 
the use of automated collection techniques or other forms of 
information technology to minimize the information collection burden.

DATES: Comments must be received by October 20, 2026.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
<a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier: 
__/OMB Control Number: __, Room C4-26-05, 7500 Security Boulevard, 
Baltimore, Maryland 21244-1850.
    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: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</a>.

FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION:

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).
    Under the 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 requires federal agencies 
to publish a 60-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.

Information Collections

    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: End Stage Renal 
Disease Medical Evidence Report Medicare Entitlement and/or Patient 
Registration; Use: Section 226A (2) of the Social Security Act 
specifically states that a person must be ``medically determined to 
have end stage renal disease . . . .'' Similarly, Section 188(a) of the 
law states ``The benefits provided by parts A and B of this title shall 
include benefits for individuals who have been determined to have end 
stage renal disease as provided in Section 226A''. The End Stage Renal 
Disease (ESRD) Medical Evidence (CMS-2728) is completed for all ESRD 
patients either by the first treatment facility or by a Medicare-
approved ESRD facility when it is determined by a physician that the 
patient's condition has reached that stage of renal impairment that a 
regular course of kidney dialysis or a kidney transplant is necessary 
to maintain life.
    The data reported on the CMS-2728 is used by the Federal 
Government, ESRD Networks, treatment facilities, researchers and others 
to monitor and assess the quality and type of care provided to end 
stage renal disease beneficiaries. The data collection captures the 
specific medical information required to determine the Medicare medical 
eligibility of End Stage Renal Disease claimants. It also collects data 
for research and policy on this population.
    The three main data systems available for evaluating the ESRD 
program and for monitoring epidemiology, access, and quality and 
reimbursement effects on quality are: (1) The United States Renal Data 
System (USRDS) provides basic data on patterns of incidence of ESRD in 
the United States. The USRDS database is intended to be used for 
biomedical research by investigators throughout the United States and 
abroad. The USRDS data is intended to supplement (and not replace) 
public use files produced by CMS. (2) United Network for Organ Sharing 
(UNOS) focus is on organ donation, transplantation and educational 
activities. (3) The ESRD Program Management and Medical System (PMMIS), 
maintained by CMS, provide the foundation data for the USRDS. This 
system, as required by Public Law 95-292, section C(1) (A), is designed 
to serve the needs of the Department of Health and Human Services in 
support of program analysis, policy development, and epidemiological 
research.
    The ESRD PMMIS includes information on both Medicare and non-
Medicare ESRD patients and on Medicare approved ESRD hospitals and 
dialysis facilities. The methods of ESRD

[[Page 54331]]

data collection (e.g., use of same forms, sharing of analysis) by CMS, 
UNOS, and USRDS have all agreed on a common data collection process 
that will provide needed additional information on the ESRD population.
    In October 2024, SDOH questions were formally activated within EQRS 
as part of the form. Concurrently, and in coordination with the Quality 
Incentive Program (QIP), questions 19, 21, 23, 24, and 25 were made 
unavailable for batch submission by dialysis organizations to reduce 
duplication with the QIP SDOH Screening Tool. Due to feedback from the 
stakeholder community the CMS-2728 form has been revised to remove SDOH 
vulnerability questions. Stakeholders unanimously agreed that SDOH 
questions are misplaced on the CMS-2728 since the form is a one-time 
admission document and is not designated to capture the dynamic, 
ongoing nature of social needs. Clinics already conduct SDOH 
assessments through established social worker workflows, and including 
questions on the CMS-2728 adds operational burden. Form Number: CMS-
2728 (OMB control number: 0938-0046); Frequency: Yearly; Affected 
Public: Private Sector (Business or other for-profits, Not-for-Profit 
Institutions); Number of Respondents: 7,478; Total Annual Responses: 
123,460; Total Annual Hours: 123,460. (For policy questions regarding 
this collection contact Christina Goatee at (410) 786-6689).
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Manufacturer 
Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs 
and Biologicals and Supporting Regulations in 42 CFR 414.800-806; Use: 
Section 1847A of the Social Security Act (the Act) requires that the 
Medicare Part B payment amounts for covered drugs and biologicals not 
paid on a cost or prospective payment basis be based upon 
manufacturers' average sales price (ASP) data submitted quarterly to 
CMS. The reporting requirements are specified in 42 CFR part 414, 
subpart J. Section 1193(a)(5) of the Act requires a manufacturer that 
chooses to participate in the Medicare Drug Price Negotiation Program 
to comply with requirements determined by the Secretary to be necessary 
for purposes of administering the Medicare Drug Price Negotiation 
Program and monitoring compliance with the Medicare Drug Price 
Negotiation Program. Use of ASP reporting for a selected drug is part 
of CMS' Medicare Drug Price Negotiation Program administration and 
oversight of manufacturer compliance, under sections 1193(a)(5) and 
1196(a)(1)-(3), (b) of the Act. This July 2026 iteration proposes to 
revise CMS' use of ASP data to support manufacturer effectuation of the 
maximum fair price for selected drugs payable under Part B for the 
purposes of the Medicare Drug Price Negotiation Program. Form Number: 
CMS-10110 (OMB control number: 0938-0921); Frequency: Quarterly; 
Affected Public: Private Sector; Number of Respondents: 500; Total 
Annual Responses: 4,500; Total Annual Hours: 49,500. (For policy 
questions regarding this collection contact: Elisabeth Daniel at 667-
290-8793.)

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2026-17128 Filed 8-20-26; 8:45 am]
BILLING CODE 4169-69-P


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