2024-17773. Agency Information Collection Activities: Proposed Collection; Comment Request

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Department of Health and Human Services

Centers for Medicare & Medicaid Services

1. [Document Identifiers: CMS-10147 and CMS-10905]

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 (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 October 8, 2024.

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, please access the CMS PRA website by copying and pasting the following web address into your web browser: https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.

FOR FURTHER INFORMATION CONTACT:

William N. Parham at [phone].

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-10147 Medicare Drug Coverage and Your Rights

CMS-10905 Service Level Data Collection for Initial Determinations and Appeals

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

1. Type of Information Collection Request: Revision of a currently approved information collection; Title of Information Collection: Medicare Drug Coverage and Your Rights; Use: Section 423.562(a)(3) and an associated regulatory provision at § 423.128(b)(7)(iii) require that Part D plan sponsors' network pharmacies provide Part D enrollees with a printed copy of our standardized pharmacy notice “Medicare Drug Coverage and Your Rights” (hereafter, “notice”) if an enrollee's prescription cannot be filled.

The purpose of this notice is to provide enrollees with information about how to contact their Part D plans to request a coverage determination, including a request for an exception to the Part D plan's formulary. The notice reminds enrollees about certain rights and protections related to their Medicare prescription drug benefits, including the right to receive a written explanation from the drug plan about why a prescription drug is not covered. Through delivery of this standardized notice, a Part D plan sponsor's network pharmacies are in the best position to inform enrollees at point of sale about how to contact their Part D plan if the prescription cannot be filled. Form Number: CMS-10147 (OMB control number: 0938-0975); Frequency: Yearly; Affected Public: Private Sector, Business or other for-profits, Not for-profits; Number of Respondents: 72,900; Number of Responses: 55,215,940; Total Annual Hours: 919,898. (For policy questions regarding this collection contact Sabrina Edmonston at 410-786-3209 or [e-mail]).

2. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: Service Level Data Collection for Initial Determinations and Appeals; Use: The Part C and D Reporting Requirements, as set forth in §§ 422.516(a) and 423.514(a), provide CMS with the ability to collect more granular data related to all plan activities regarding adjudicating requests for coverage and plan procedures related to making service utilization decisions. This includes collecting more timely data with greater frequency or closer in real-time. The proposed data elements listed in the Technical Specifications document in this proposed PRA would provide key data to CMS on the utilization of benefits, enhance audit activities to ensure plans are operating in accordance with CMS guidelines, and ensure appropriate access to covered services and benefits.

CMS staff will use this information to monitor health plans and to hold them accountable for their performance. CMS users include group managers, division managers, branch managers, account managers, and researchers. Health plans can use this information to measure and benchmark their performance. CMS receives inquiries from the industry and other interested stakeholders about beneficiary access to the items, services, and drugs, including service level data for initial determinations and appeals, and other factors pertaining to use of government funds, as well the performance of MA plans. Form Number: CMS-10905 (OMB control number: 0938-New); Frequency: Quarterly; Affected Public: Private Sector, Business or other for-profits, Not for-profits and Federal Government State, Local; Number of Respondents: 728; Number of Responses: 2,912; Total Annual Hours: 728. (For policy questions regarding this collection contact Sabrina Edmonston at 410-786-3209 or [e-mail]).

William N. Parham, III,

Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs.