[Federal Register Volume 86, Number 118 (Wednesday, June 23, 2021)]
[Notices]
[Pages 32935-32936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13194]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10137 and CMS-10174]


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 August 23, 2021.

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-10137 Solicitation for Applications for Medicare Prescription Drug 
Plan 2023 Contracts
CMS-10174 Collection of Prescription Drug Data from MA-PD, PDP and 
Fallout Plans/Sponsors for Medicare Part D Payments

    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain

[[Page 32936]]

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 Collection

    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Solicitation for 
Applications for Medicare Prescription Drug Plan 2023 Contracts; 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 
Number: CMS-10137 (OMB control number: 0938-0936); Frequency: Yearly; 
Affected Public: Businesses or other for-profits, Not-for-profit 
institutions; Number of Respondents: 716; Total Annual Responses: 382; 
Total Annual Hours: 1,716. (For policy questions regarding this 
collection contact Arianne Spaccarelli at 410-786-5715.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Collection of 
Prescription Drug Event Data From Contracted Part D Providers for 
Payment; Use: The PDE data is used in the Payment Reconciliation System 
to perform the annual Part D payment reconciliation, any PDE data 
within the Coverage Gap Phase of the Part D benefit is used for 
invoicing in the CGDP, and the data are part of the report provided to 
the Secretary of the Treasury for Section 9008.
    CMS has used PDE data to create summarized dashboards and tools, 
including the Medicare Part D Drug Spending Dashboard & Data, the Part 
D Manufacturer Rebate Summary Report, and the Medicare Part D Opioid 
Prescribing Mapping Tool. The data are also used in the Medicare 
Trustees Report. Due to the market sensitive nature of PDE data, 
external uses of the data are subject to significant limitations. 
However, CMS does analyze the data on a regular basis to determine drug 
cost and utilization patterns in order to inform programmatic patterns 
and to develop informed policy in the Part D program.
    The information users will be Pharmacy Benefit Managers (PBMs), 
third party administrators and pharmacies, and the PDPs, MA-PDs, 
Fallbacks and other plans that offer coverage of outpatient 
prescription drugs under the Medicare Part D benefit to Medicare 
beneficiaries. The statutorily required data is used primarily for 
payment and is used for claim validation as well as for other 
legislated functions such as quality monitoring, program integrity and 
oversight. Form Number: CMS-10174 (OMB control number: 0938-0982); 
Frequency: Yearly; Affected Public: Businesses or other for-profits, 
Not-for-profit institutions; Number of Respondents: 739; Total Annual 
Responses: 1,499,238,090; Total Annual Hours: 2,998. (For policy 
questions regarding this collection contact Ivan Iveljic at 410-786-
3312.)

    Dated: June 17, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2021-13194 Filed 6-22-21; 8:45 am]
BILLING CODE 4120-01-P