Notice2022-27233
Agency Information Collection Activities: Proposed Collection; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 15, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
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 87 Issue 240 (Thursday, December 15, 2022)</title>
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[Federal Register Volume 87, Number 240 (Thursday, December 15, 2022)]
[Notices]
[Pages 76625-76626]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-27233]
[[Page 76625]]
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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
<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).
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
[[Page 76626]]
(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
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