Notice2021-13194
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
June 23, 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 118 (Wednesday, June 23, 2021)</title>
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[Federal Register Volume 86, Number 118 (Wednesday, June 23, 2021)]
[Notices]
[Pages 32935-32936]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<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-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
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