[Federal Register Volume 86, Number 208 (Monday, November 1, 2021)]
[Notices]
[Pages 60245-60246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 
http://www.regulations.gov. 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 https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.

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