Notice2024-20400
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
September 10, 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 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
<html>
<head>
<title>Federal Register, Volume 89 Issue 175 (Tuesday, September 10, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 175 (Tuesday, September 10, 2024)]
[Notices]
[Pages 73420-73421]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-20400]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10141, CMS-10913, CMS-R-290 and CMS-10443]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
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 November 12, 2024.
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-10141 Medicare Prescription Drug Benefit Program
CMS-10913 Medicare Part C Utilization Management Annual Data Submission
and Audit Protocol Data Request
CMS-R-290 Medicare Program: Procedures for Making National Coverage
Decisions
CMS-10443 Transcatheter Valve Therapy (TVT) Registry
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 information collection; Title of Information Collection:
Medicare Prescription Drug Benefit Program; Use: CMS will use this
information from plan sponsors and States to approve contract
applications, monitor compliance with contract requirements, make
proper payment to plans, and ensure that correct information is
disclosed to potential and current enrollees. Form Number: CMS-10141
(OMB control number: 0938-0964); Frequency: Annually; Affected Public:
Private Sector, State, Local, or Tribal Governments; Number of
Respondents: 4,633,032; Total Annual Responses: 87,014,803; Total
Annual Hours: 25,409,037. (For policy questions regarding this
collection contact Chad Buskirk at 410-786-1630 or
<a href="/cdn-cgi/l/email-protection#33505b52571d514640585a415873505e401d5b5b401d545c45"><span class="__cf_email__" data-cfemail="1c7f747d78327e696f77756e775c7f716f3274746f327b736a">[email protected]</span></a>).
2. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection:
Medicare Part C Utilization Management Annual Data Submission and Audit
Protocol Data Request; Use: Section 1857(d) of the Act, added by the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
and implementing regulations at 42 CFR 422.503 and 422.504 state that
CMS must oversee an MA organization's continued compliance with the
requirements for a MA organization. Additionally, per Sec. 422.516(a),
MA organizations are required to compile and report to CMS information
related to the utilization of services, and other matters as CMS may
require.
The information gathered during this annual data collection and
audit will be used by the Medicare Parts C and D Oversight and
Enforcement Group (MOEG) within the Center for Medicare (CM) to assess
Sponsoring organizations' compliance with Medicare UM requirements. CMS
will utilize the data submitted during the annual data submission to
assess the number of items and services that have associated internal
coverage criteria, and to develop a landscape of items and services
across the nation to assess
[[Page 73421]]
trends related to the development and utilization of internal coverage
criteria. Additionally, CMS will use the annual submission to select a
number of Sponsoring organizations to undergo UM audits each year, and
to select specific items and services to audit. Annual UM data
submissions, for all Sponsoring organizations, will be due to CMS by
January 31 of each calendar year. Form Number: CMS-10913 (OMB control
number: 0938-new); Frequency: Yearly; Affected Public: Private Sector,
Business or other for-profits, Not-for-profits institutions; Number of
Respondents: 179; Total Annual Responses: 179; Total Annual Hours:
19,180. (For policy questions regarding this collection contact
Caroline Zeman at 410-786-1564).
3. 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.)
4. 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. 2024-20400 Filed 9-9-24; 8:45 am]
BILLING CODE 4120-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on September 10, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.