Agency Information Collection Activities: Submission for OMB Review; Comment Request, 85539-85540 [2024-25015]
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Federal Register / Vol. 89, No. 208 / Monday, October 28, 2024 / Notices
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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–10912 Medicare Transaction
Facilitator for 2026 and 2027 under
Sections 11001 and 11002 of the
Inflation Reduction Act (IRA)
Information Collection Request
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: New Collection; Title of
Information Collection: Medicare
Transaction Facilitator for 2026 and
2027 under Sections 11001 and 11002 of
the Inflation Reduction Act (IRA)
Information Collection Request; Use:
Under the authority in sections 11001
and 11002 of the Inflation Reduction
Act of 2022 (Pub. L. 117–169), the
Centers for Medicare & Medicaid
Services (CMS) is implementing the
Medicare Drug Price Negotiation
Program, codified in sections 1191
through 1198 of the Social Security Act
(‘‘the Act’’). The Act establishes the
Negotiation Program to negotiate
maximum fair prices (‘‘MFPs’’), defined
at 1191(c)(3) of the Act, for certain high
expenditure, single source selected
drugs covered under Medicare Part B
and Part D (‘‘selected drugs’’). In
accordance with section 1193(a) of the
Act, any Primary Manufacturer of a
selected drug that continues to
participate in the Negotiation Program
and reaches agreement upon an MFP
must provide access to the MFP to MFPeligible individuals, defined in section
1191(c)(2)(A) of the Act, and to
pharmacies, mail order services, other
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dispensing entities, providers and
suppliers with respect to such MFPeligible individuals who are dispensed
that selected drug during a price
applicability period. The purpose of this
information collection request (ICR) is
for CMS to collect information from
manufacturers of drugs covered under
Part D selected for negotiation under the
Inflation Reduction Act for the initial
price applicability years 2026 and 2027
and the dispensing entities that
dispense the selected drugs to MFPeligible individuals. To facilitate the
effectuation of the MFP, CMS will
engage a Medicare Transaction
Facilitator (‘‘MTF’’). The MTF system
will be composed of two modules: the
MTF Data Module (MTF DM), and the
MTF Payment Module (MTF PM).
Medicare Transaction Facilitator Data
Elements: The MTF system will be
composed of two modules: the MTF
Data Module (MTF DM), and the MTF
Payment Module (MTF PM). Primary
Manufacturers participating in the
Negotiation Program are required to
participate in the MTF DM. Further,
CMS intends to propose in future
rulemaking to require Part D plan
sponsors to include in their pharmacy
agreements provisions requiring
dispensing entities to participate in the
MTF DM for purposes of data exchange.
As such, for the purposes of this ICR,
CMS assumes full participation in the
MTF DM by affected Primary
Manufacturers and dispensing entities.
Meanwhile, participation in the MTF
PM, for use in passing through payment
from the Primary Manufacturer to
dispensing entities, will be optional for
Primary Manufacturers; as a result,
dispensing entities may receive fund
transfers from the MTF PM, or via an
alternative process established by a
Primary Manufacturer. As discussed in
section 40.4 of the Medicare Drug Price
Negotiation Program: Final Guidance,
Implementation of Sections 1191–1198
of the Social Security Act for Initial
Price Applicability Year 2027 and
Manufacturer Effectuation of the
Maximum Fair Price (MFP) in 2026 and
2027 (‘‘final guidance’’), CMS will
engage the MTF DM to facilitate the
exchange of certain claim-level data
elements and payment elements for
selected drugs. The data exchange
component of the MTF will involve
both the transmission of certain claimlevel data elements to the Primary
Manufacturer and receipt of claim-level
payment elements from the Primary
Manufacturer. Both Primary
Manufacturers and dispensing entities
will need to provide certain information
at the onset of their enrollment in the
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85539
MTF DM system to facilitate
effectuation of the MFP via refunds from
Primary Manufacturers. Both Primary
Manufacturers and dispensing entities
will be able to submit complaints and
disputes through their participation in
the MTF DM. Primary Manufacturers
will also submit information to fulfill
their requirement to provide an MFP
Effectuation Plan and transmit recurring
data submissions reflecting their
payment elements, as described in the
final guidance. Given these information
collection requirements, this ICR
includes the following forms: (A) Drug
Price Negotiation Program MTF DM
Dispensing Entity and Third-Party
Support Enrollment Form; (B) Drug
Price Negotiation Program MTF DM
Primary Manufacturer Maximum Fair
Price (MFP) Effectuation Plan Form; (C)
Drug Price Negotiation Program MTF
DM Primary Manufacturer Payment
Elements Form; and (D) Drug Price
Negotiation Program Complaint and
Dispute Intake Form. Form Number:
CMS–10912 (OMB control number:
0938-New); Frequency: Once and Daily;
Affected Public: Private sector, Business
or other for-profit, and individuals;
Number of Respondents: 85,853; Total
Annual Responses: 93,120; Total
Annual Hours: 821,560. (For policy
questions regarding this collection
contact Brennan Folsom at 667–414–
0014.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–25009 Filed 10–25–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10261]
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
SUMMARY:
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85540
Federal Register / Vol. 89, No. 208 / Monday, October 28, 2024 / Notices
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.
Comments on the collection(s) of
information must be received by the
OMB desk officer by November 27,
2024.
DATES:
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/PRAListing.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
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
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SUPPLEMENTARY INFORMATION:
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Jkt 265001
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 with change of a
currently approved collection; Title of
Information Collection: Part C Medicare
Advantage Reporting Requirements;
Use: The Centers for Medicare and
Medicaid Services (CMS) established
reporting requirements for Medicare
Advantage Organizations (MAOs) under
the authority described in 42 CFR
422.516(a). Each MAO must have an
effective procedure to develop, compile,
evaluate, and report to CMS, to its
enrollees, and to the general public at
the times and in the manner that CMS
requires. At the same time, each MAO
must, in accordance with 42 CFR
422.516(a), safeguard the confidentiality
of the provider-patient relationship.
Health plans can use this information
to measure and benchmark their
performance. CMS receives inquiries
from the industry and other interested
stakeholders about the beneficiary use
of available benefits, including
supplemental benefits, grievance and
appeals rates, cost, and other factors
pertaining to use of government funds,
as well the performance of MA plans.
Form Number: CMS–10261 (OMB
control number: 0938–1054); Frequency:
Yearly; Affected Public: Business or
other for-profits; Number of
Respondents: 783; Total Annual
Responses: 7,830; Total Annual Hours:
225,575. (For policy questions regarding
this collection contact Lucia Patrone at
410–786–8621 or Lucia.Patrone@
cms.hhs.gov).
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–25015 Filed 10–25–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Request for Information:
Administration for Children and
Families Development of
Interoperability Standards for Human
Service Programs
Office of the Chief Technology
Officer, Administration of Children and
Families, Department of Health and
Human Services.
ACTION: Request for information (RFI).
AGENCY:
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The Administration for
Children and Families (ACF), in the
U.S. Department of Health and Human
Services (HHS), invites public
comments to inform the use or adoption
of interoperability standards for human
services programs. ACF and state, local,
and tribal governments all provide a
number of health and human services
programs for children, youth, families,
communities, and individuals. ACF
seeks public comment on the most
effective approaches, technical
standards, and technological tools that
currently or could promote
interoperability between health and
human services programs. ACF
collaborates with the Assistant Secretary
for Technology Policy/Office of the
National Coordinator for Health
Information Technology (ASTP/ONC) as
a critical steward and advisor for human
services interoperability with
responsibility for leading the
development and harmonization of
interoperability standards between
health and human services in line with
the HHS Data Strategy. The potential of
interoperability across the full spectrum
of health and human services is
immense—it can enable efficient
delivery of government services,
enhance access to critical non-profit
programs, and most importantly,
improve overall individual and
community outcomes. ACF has
authority under the Title IV of the
Social Security Act to designate use of
interoperable data standards for several
of its programs (e.g., Temporary
Assistance for Needy Families (TANF),
child support, child welfare, and foster
care). The purpose of this RFI is to
understand how ACF, in collaboration
with ASTP/ONC, can better support
interoperability between human
services within and across states and
local community resources, between
states, and ACF.
DATES: Comments are due within 60
days of publication.
ADDRESSES: Submit responses to
DataRx@acf.hhs.gov, a federal mailbox
allowing the public to submit comments
on documents agencies have published
in the Federal Register and are open for
comment. Simply type ‘‘ACF-2024Interoperability-RFI’’ in the Comment or
Submission search box, click Go, and
follow the instructions for submitting
comments.
Comments submitted in response to
this notice are subject to the Freedom of
Information Act and may be made
available to the public. For this reason,
please do not include any information
of a confidential nature, such as
sensitive personal information or
SUMMARY:
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]]>Agencies
[Federal Register Volume 89, Number 208 (Monday, October 28, 2024)]
[Notices]
[Pages 85539-85540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25015]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10261]
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
[[Page 85540]]
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 November 27, 2024.
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 with change of
a currently approved collection; Title of Information Collection: Part
C Medicare Advantage Reporting Requirements; Use: The Centers for
Medicare and Medicaid Services (CMS) established reporting requirements
for Medicare Advantage Organizations (MAOs) under the authority
described in 42 CFR 422.516(a). Each MAO must have an effective
procedure to develop, compile, evaluate, and report to CMS, to its
enrollees, and to the general public at the times and in the manner
that CMS requires. At the same time, each MAO must, in accordance with
42 CFR 422.516(a), safeguard the confidentiality of the provider-
patient relationship.
Health plans can use this information to measure and benchmark
their performance. CMS receives inquiries from the industry and other
interested stakeholders about the beneficiary use of available
benefits, including supplemental benefits, grievance and appeals rates,
cost, and other factors pertaining to use of government funds, as well
the performance of MA plans. Form Number: CMS-10261 (OMB control
number: 0938-1054); Frequency: Yearly; Affected Public: Business or
other for-profits; Number of Respondents: 783; Total Annual Responses:
7,830; Total Annual Hours: 225,575. (For policy questions regarding
this collection contact Lucia Patrone at 410-786-8621 or
[email protected]).
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-25015 Filed 10-25-24; 8:45 am]
BILLING CODE 4120-01-P
