Notice2021-23748
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
November 1, 2021
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 (the 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 86 Issue 208 (Monday, November 1, 2021)</title>
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[Federal Register Volume 86, Number 208 (Monday, November 1, 2021)]
[Notices]
[Pages 60245-60246]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23748]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers CMS-R-235 and CMS-R-262]
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 (the 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 January 3, 2022.
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, you may make
your request using one of following:
1. Access CMS' website address at website address at <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html</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-R-235 Data Use Agreement (DUA) Form, Research Identifiable Files
Request Packet
CMS-R-262 CMS Plan Benefit Package (PBP) and Formulary CY 2023
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain
approval from the Office of Management
[[Page 60246]]
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: Revision of a currently
approved collection; Title of Information Collection: Data Use
Agreement (DUA) Form, Research Identifiable Files Request Packet; Use:
Coverage for the prescription drug benefit is provided through
contracted prescription drug plans (PDPs) or through Medicare Advantage
(MA) plans that offer integrated prescription drug and health care
coverage (MA-PD plans). Cost Plans that are regulated under Section
1876 of the Social Security Act, and Employer Group Waiver Plans (EGWP)
may also provide a Part D benefit. Organizations wishing to provide
services under the Prescription Drug Benefit Program must complete an
application, negotiate rates, and receive final approval from CMS.
Existing Part D Sponsors may also expand their contracted service area
by completing the Service Area Expansion (SAE) application.
Collection of this information is mandated in Part D of the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA) in Subpart 3. The application requirements are codified in
Subpart K of 42 CFR 423 entitled ``Application Procedures and Contracts
with PDP Sponsors.''
The information will be collected under the solicitation of
proposals from PDP, MA-PD, Cost Plan, Program of All Inclusive Care for
the Elderly (PACE), and EGWP applicants. The collected information will
be used by CMS to: (1) Ensure that applicants meet CMS requirements for
offering Part D plans (including network adequacy, contracting
requirements, and compliance program requirements, as described in the
application), (2) support the determination of contract awards. Form
Numbers: CMS-R-235 (OMB control number: 0938-0734); Frequency:
Occasionally; Affected Public: Private Sector, State, Local, or Tribal
Governments, Federal Government (Business or for-profits and Not-for-
profit institutions); Number of Respondents: 8,445; Total Annual
Responses: 8,445; Total Annual Hours: 2,396. (For policy questions
regarding this collection contact Kari A. Gaare at 410-786-8612.)
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Contract Year
2023 Plan Benefit Package (PBP) Software and Formulary Submission; Use:
Under the Medicare Modernization Act (MMA), Medicare Advantage (MA) and
Prescription Drug Plan (PDP) organizations are required to submit plan
benefit packages for all Medicare beneficiaries residing in their
service area. The plan benefit package submission consists of the Plan
Benefit Package (PBP) software, formulary file, and supporting
documentation, as necessary. MA and PDP organizations use the PBP
software to describe their organization's plan benefit packages,
including information on premiums, cost sharing, authorization rules,
and supplemental benefits. They also generate a formulary to describe
their list of drugs, including information on prior authorization, step
therapy, tiering, and quantity limits.
CMS requires that MA and PDP organizations submit a completed PBP
and formulary as part of the annual bidding process. During this
process, organizations prepare their proposed plan benefit packages for
the upcoming contract year and submit them to CMS for review and
approval. CMS uses this data to review and approve the benefit packages
that the plans will offer to Medicare beneficiaries. This allows CMS to
review the benefit packages in a consistent way across all submitted
bids during with incredibly tight timeframes. This data is also used to
populate data on Medicare Plan Finder, which allows beneficiaries to
access and compare Medicare Advantage and Prescription Drug plans. Form
Number: CMS-R-262 (OMB control number: 0938-0763); Frequency: Yearly;
Affected Public: Private sector (Business or other for-profits and Not-
for-profit institutions), State, Local, or Tribal Governments; Number
of Respondents: 785; Total Annual Responses: 8,405; Total Annual Hours:
76,378. (For policy questions regarding this collection contact Kristy
L. Holtje at 410-786-2209.)
Dated: October 27, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2021-23748 Filed 10-29-21; 8:45 am]
BILLING CODE 4120-01-P
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