[Federal Register Volume 87, Number 240 (Thursday, December 15, 2022)]
[Notices]
[Pages 76625-76626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27233]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-2728]


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 February 13, 2023.

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 
http://www.regulations.gov. 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: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

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).

CMS-2728 End Stage Renal Disease Medical Evidence Report Medicare 
Entitlement and/or Patient Registration

    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 Collection

    1. Type of Information Collection Request: Reinstatement with 
change of a previously 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 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.
    Due to response by the provider community the CMS-2728 form has 
been revised by adding questions, clarifying questions, updating 
reasons for kidney failure, updating comorbidities to be more 
reflective of pediatric patients, and providing additional guidance and 
clarity in the instructions. Form Number: CMS-2728

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(OMB control number: 0938-0046); Frequency: Yearly; Affected Public: 
Private Sector (Business or other for-profits, Not-for-Profit 
Institutions); Number of Respondents: 7,828; Total Annual Responses: 
138,000; Total Annual Hours: 138,000. (For policy questions regarding 
this collection contact Lisa Rees at (816) 426-6353).

    Dated: December 12, 2022.
William N. Parham, III
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2022-27233 Filed 12-14-22; 8:45 am]
BILLING CODE 4120-01-P