86 FR 208 pgs. 60245-60246 - Agency Information Collection Activities: Proposed Collection; Comment Request
Type: NOTICEVolume: 86Number: 208Pages: 60245 - 60246
Pages: 60245, 60246Docket number: [Document Identifiers CMS-R-235 and CMS-R-262]
FR document: [FR Doc. 2021-23748 Filed 10-29-21; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Medicare & Medicaid Services
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid 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.
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
[top] Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management
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