Notice2024-28077
Agency Information Collection Activities: Submission for OMB Review; 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
November 29, 2024
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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 89 Issue 230 (Friday, November 29, 2024)</title>
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[Federal Register Volume 89, Number 230 (Friday, November 29, 2024)]
[Notices]
[Pages 94731-94732]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-28077]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-290 and CMS-10443]
Agency Information Collection Activities: Submission for OMB
Review; 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 a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate 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 on the collection(s) of information must be received by
the OMB desk officer by December 30, 2024.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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: <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>.
[[Page 94732]]
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: Reinstatement without
change of a previously approved collection; Title: Medicare Program:
Procedures for Making National Coverage Decisions; Use: This collection
is required by a notice (78 FR 48164-69) published on August 7, 2013
which delineates the process for making a national coverage
determination (NCD) including information for external parties to
submit a formal request for a new NCD or a reconsideration of an
existing NCD. An NCD is defined in 1862(l) of the Social Security Act
(the Act) as ``a determination by the Secretary with respect to whether
or not a particular item or service is covered nationally under this
title.'' This information collection will assist us in obtaining the
information we require to make a national coverage determination in a
timely manner and ensuring that the Medicare program continues to meet
the needs of its beneficiaries. Form Number: CMS-R-290 (OMB control
number: 0938-0776); Frequency: Annual; Affected Public: Private Sector:
Business or other for-profits; Number of Respondents: 30; Total Annual
Responses: 30; Total Annual Hours: 1,200. (For policy questions
regarding this collection contact Lori M. Ashby at 410-786-6322.)
2. Type of Information Collection Request: Reinstatement without
change of a previously approved collection: Title of Information
Collection: Transcatheter Valve Therapy (TVT) Registry; Use: The data
collection is required by the Centers for Medicare and Medicaid
Services (CMS) National Coverage Determination (NCD) entitled,
``Transcatheter Aortic Valve Replacement (TAVR)''. The TAVR device is
only covered when specific conditions are met including that the heart
team and hospital are submitting data in a prospective, national,
audited registry. The data includes patient, practitioner and facility
level variables that predict outcomes such as all cause mortality and
quality of life. CMS finds that the Society of Thoracic Surgery/
American College of Cardiology Transcatheter Valve Therapy (STS/ACC
TVT) Registry, one registry overseen by the National Cardiovascular
Data Registry, meets the requirements specified in the NCD on TAVR. The
TVT Registry will support a national surveillance system to monitor the
safety and efficacy of the TAVR technologies for the treatment of
aortic stenosis.
The data will also include the variables on the eight item Kansas
City Cardiomyopathy Questionnaire (KCCQ-10) to assess heath status,
functioning and quality of life. In the KCCQ, an overall summary score
can be derived from the physical function, symptoms (frequency and
severity), social function and quality of life domains. For each
domain, the validity, reproducibility, responsiveness and
interpretability have been independently established. Scores are
transformed to a range of 0-100, in which higher scores reflect better
health status.
The conduct of the STS/ACC TVT Registry and the KCCQ-10 is in
accordance with Section 1142 of the Social Security Act (the Act) that
describes the authority of the Agency for Healthcare Research and
Quality (AHRQ). Under section 1142, research may be conducted and
supported on the outcomes, effectiveness, and appropriateness of health
care services and procedures to identify the manner in which disease,
disorders, and other health conditions can be prevented, diagnosed,
treated, and managed clinically. Section 1862(a)(1)(E) of the Act
allows Medicare to cover under coverage with evidence development (CED)
certain items or services for which the evidence is not adequate to
support coverage under section 1862(a)(1)(A) and where additional data
gathered in the context of a clinical setting would further clarify the
impact of these items and services on the health of beneficiaries.
The data collected and analyzed in the TVT Registry will be used by
CMS to determine if the TAVR is reasonable and necessary (e.g.,
improves health outcomes) for Medicare beneficiaries under Section
1862(a)(1)(A) of the Act. Furthermore, data from the Registry will
assist the medical device industry and the Food and Drug Administration
(FDA) in surveillance of the quality, safety and efficacy of new
medical devices to treat aortic stenosis. For purposes of the TAVR NCD,
the TVT Registry has contracted with the Data Analytic Centers to
conduct the analyses. In addition, data will be made available for
research purposes under the terms of a data use agreement that only
provides de-identified datasets. Form Number: CMS-10443 (OMB control
number: 0938-1202); Frequency: Annual; Affected Public: Individuals,
Households and Private Sector; Number of Respondents: 49,704; Total
Annual Responses: 198,816; Total Annual Hours: 63,790. (For policy
questions regarding this collection contact Nina Arya at 667-290-9456).
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-28077 Filed 11-27-24; 8:45 am]
BILLING CODE 4120-01-P
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