Agency Information Collection Activities: Submission for OMB Review; Comment Request, 3222-3223 [2025-00589]
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Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices
researchers or CMS contractors request
CMS PII/PHI data, they enter into a Data
Use Agreement (DUA) with CMS. The
DUA stipulates that the recipient of
CMS data must properly protect the data
according to all applicable data security
standards and provide for its
appropriate destruction at the
completion of the project/study or the
expiration date of the DUA.
CMS is permitted to disclose data files
for approved research purposes in
compliance with 45 CFR 164.512(I).
Researchers requesting limited data set
files (LDS) must, as part of the request
process, complete a research request
packet that provides CMS with
information pertaining to the research
study, including describing how the
research results/findings will be
disseminated, as well as the data files
being requested. Should CMS approve
the research request, the data requestor
enters into a Data Use Agreement
(DUA). This data collection is necessary
to ensure that disclosures of data for
research purposes comply with Federal
laws and regulations as well as CMS
policy. Form Number: CMS–R–235
(OMB control number 0938–0734);
Frequency: Occasionally; Affected
Public: Private Sector—State, Local, or
Tribal Governments; and Business or
other for-profits, Not-for-profits
institutions and Federal Government
Number of Respondents: 7,805; Total
Annual Responses: 7,805; Total Annual
Hours: 4,234. (For policy questions
regarding this collection contact
Rebecca Dorman at 410–786–2095 or
rebecca.dorman@cms.hhs.gov.)
3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Administrative
Simplification HIPAA Compliance
Review; Use: The purpose of this
collection is to retrieve information
necessary to conduct a compliance
review and carry out the authority
delegated to CMS as described in CMS–
0014–N (68 FR 60694). These forms will
be submitted to the Centers for Medicare
& Medicaid Services (CMS), National
Standards Group, from entities covered
by HIPAA Administrative
Simplification regulations. This
collection is not applicable to HIPAA
Privacy and Security Rules. Form
Number: CMS–10662 (OMB control
number 0938–1390); Frequency:
Annually; Affected Public: Private
Sector—State, Local, or Tribal
Governments; and Business or other forprofits, Not-for-profits institutions and
Federal Government; Number of
Respondents: 100; Total Annual
Responses: 140; Total Annual Hours:
3,040. (For policy questions regarding
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this collection contact Kevin Stewart at
410–786–6149 or Kevin.stewart@
cms.hhs.gov.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2025–00593 Filed 1–13–25; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10203]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
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 February 13, 2025.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
SUMMARY:
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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/PRAListing.
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: Revision of a currently
approved collection; Title of
Information Collection: Medicare Health
Outcomes Survey; Use: The HOS is a
longitudinal patient-reported outcome
measure (PROM) that assesses selfreported beneficiary quality of life and
daily functioning. As a PROM, the HOS
measures the impact of services
provided by MAOs, whereas process
and patient experience measures only
provide a snapshot of activities or
experiences at a specific point in time.
PROM data collected by the HOS allows
CMS to continue to assess the health of
the Medicare Advantage population.
This older population is at increased
risk of adverse health outcomes,
including chronic diseases and mobility
impairments that may significantly
hamper quality of life. The HOS
supports CMS’s commitment to improve
health outcomes for beneficiaries while
reducing burden on providers. CMS
accomplishes this by focusing on highpriority areas for quality measurement
and improvement established in the
agency’s Meaningful Measures
Framework. The HOS uses quality
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Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices
measures that ask beneficiaries about
health outcomes related to specific
mental and Physical Conditions. Form
Number: CMS–10203 (OMB control
number: 0938–0701); Frequency: Yearly;
Affected Public: Individuals and
Households; Number of Respondents:
1,275; Total Annual Responses:
663,150; Total Annual Hours: 212,208.
(For policy questions regarding this
collection contact Alyssa Rosen at 410–
786–8559 or Alyssa.Rosen@
cms.hhs.gov.)
William N. Parham, III
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2025–00589 Filed 1–13–25; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3472–N]
Medicare Program; Request for
Nominations for Members for the
Medicare Evidence Development &
Coverage Advisory Committee
Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
This notice announces the
request for nominations for membership
on the Medicare Evidence Development
& Coverage Advisory Committee
(MEDCAC). Among other duties, the
MEDCAC provides advice and guidance
to the Secretary of the Department of
Health and Human Services (the
Secretary) and the Administrator of the
Centers for Medicare & Medicaid
Services (CMS) concerning the
adequacy of scientific evidence
available to CMS in making coverage
determinations under the Medicare
program.
The MEDCAC’s fundamental purpose
is to support the principles of an
evidence-based determination process
for Medicare’s coverage policies.
MEDCAC panels provide advice to CMS
on the strength of the evidence available
for specific medical treatments and
technologies through a public,
participatory, and accountable process.
DATES: Nominations must be received
by Monday, February 17, 2025.
ADDRESSES: You may send in
nominations for membership via email
to MEDCACnomination@cms.hhs.gov.
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SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Leah Cromwell, 410–786–2243,
MEDCAC Coordinator, via email at
Leah.Cromwell1@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Secretary signed the initial
charter for the Medicare Coverage
Advisory Committee (MCAC) on
November 24, 1998. A notice in the
Federal Register (63 FR 68780)
announcing establishment of the MCAC
was published on December 14, 1998.
The MCAC name was updated to more
accurately reflect the purpose of the
committee and on January 26, 2007, the
Secretary published a notice in the
Federal Register (72 FR 3853),
announcing that the Committee’s name
changed to the Medicare Evidence
Development & Coverage Advisory
Committee (MEDCAC). The current
Secretary’s Charter for the MEDCAC is
available on the CMS website at: https://
www.cms.gov/Regulations-andGuidance/Guidance/FACA/Downloads/
medcaccharter.pdf or you may obtain a
copy of the charter by submitting a
request to the contact listed in the FOR
FURTHER INFORMATION section of this
notice.
The MEDCAC is governed by
provisions of the Federal Advisory
Committee Act, Pub. L. 92–463, as
amended (5 U.S.C. App. 2), which sets
forth standards for the formulation and
use of advisory committees, and is
authorized by section 222 of the Public
Health Service Act as amended (42
U.S.C. 217A).
We are requesting nominations for
candidates to serve on the MEDCAC.
Nominees are selected based upon their
individual qualifications and not solely
as representatives of professional
associations or societies. We wish to
ensure adequate representation of those
enrolled in the Medicare program
including but not limited to, racial and
ethnic groups, individuals with
disabilities, and from across the gender
spectrum. Therefore, we encourage
nominations of qualified candidates
who can represent these lived
experiences.
The MEDCAC consists of a pool of
100 appointed members including: 90
at-large standing members (20 of whom
are patient advocates), and 10
representatives of industry interests.
Members generally are recognized
authorities in clinical medicine
including subspecialties, administrative
medicine, public health, biological and
physical sciences, epidemiology and
biostatistics, clinical trial design, health
care data management and analysis,
patient advocacy, health care
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3223
economics, health disparities, medical
ethics, geriatrics those with an
understanding of sociodemographic bias
and resulting limitations of scientific
evidence, or other relevant professions.
The MEDCAC works from an agenda
provided by the Designated Federal
Official. The MEDCAC reviews and
evaluates medical literature and
technology assessments, and hears
public testimony on the evidence
available to address the impact of
medical items and services on health
outcomes of Medicare beneficiaries. The
MEDCAC may also advise the Centers
for Medicare & Medicaid Services (CMS)
as part of Medicare’s ‘‘coverage with
evidence development’’ initiative.
II. Provisions of the Notice
As of December 2025, there will be a
total of 20 membership terms expiring.
Of the 20 memberships expiring, 2 are
industry representatives, 10 are patient
advocates and the remaining 8
membership openings are for the atlarge standing MEDCAC membership.
All nominations must be
accompanied by curricula vitae.
Nomination packages should be
addressed to Leah Cromwell and sent to
the email address listed in the
ADDRESSES section of this notice.
Nominees are selected based upon their
individual qualifications.
Nominees for membership must have
expertise and experience in one or more
of the following fields:
• Clinical medicine including
subspecialties
• Administrative medicine
• Public health
• Health disparities
• Biological and physical sciences
• Epidemiology and biostatistics
• Clinical trial design
• Health care data management and
analysis
• Patient advocacy
• Health care economics
• Medical ethics
• Geriatrics
• Other relevant professions
We are looking particularly for
experts in a number of fields. These
include health disparities, cancer
screening, genetic testing, clinical
epidemiology, psychopharmacology,
screening and diagnostic testing
analysis, and vascular surgery. We also
need experts in biostatistics in clinical
settings, dementia treatment,
observational research design, stroke
epidemiology, geriatrics, and women’s
health.
The nomination letter must include a
statement that the nominee is willing to
serve as a member of the MEDCAC and
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]]>Agencies
[Federal Register Volume 90, Number 8 (Tuesday, January 14, 2025)]
[Notices]
[Pages 3222-3223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00589]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10203]
Agency Information Collection Activities: Submission for OMB
Review; 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 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 February 13, 2025.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. 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: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.
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: Revision of a currently
approved collection; Title of Information Collection: Medicare Health
Outcomes Survey; Use: The HOS is a longitudinal patient-reported
outcome measure (PROM) that assesses self-reported beneficiary quality
of life and daily functioning. As a PROM, the HOS measures the impact
of services provided by MAOs, whereas process and patient experience
measures only provide a snapshot of activities or experiences at a
specific point in time. PROM data collected by the HOS allows CMS to
continue to assess the health of the Medicare Advantage population.
This older population is at increased risk of adverse health outcomes,
including chronic diseases and mobility impairments that may
significantly hamper quality of life. The HOS supports CMS's commitment
to improve health outcomes for beneficiaries while reducing burden on
providers. CMS accomplishes this by focusing on high-priority areas for
quality measurement and improvement established in the agency's
Meaningful Measures Framework. The HOS uses quality
[[Page 3223]]
measures that ask beneficiaries about health outcomes related to
specific mental and Physical Conditions. Form Number: CMS-10203 (OMB
control number: 0938-0701); Frequency: Yearly; Affected Public:
Individuals and Households; Number of Respondents: 1,275; Total Annual
Responses: 663,150; Total Annual Hours: 212,208. (For policy questions
regarding this collection contact Alyssa Rosen at 410-786-8559 or
[email protected].)
William N. Parham, III
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-00589 Filed 1-13-25; 8:45 am]
BILLING CODE 4120-01-P
