2024-07429. Agency Information Collection Activities: Submission for OMB Review; 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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 on the collection(s) of information must be received by the OMB desk officer by May 8, 2024.

ADDRESSES:

Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

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 Parham at [phone].

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (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 (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to publish a 30-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 that summarizes the following proposed collection(s) of information for public comment:

1. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: The Medicare Advantage and Prescription Drug Programs: Part C and Part D Medicare Advantage Prescription Drug (MARx) System Updates for the Medicare Prescription Payment Plan Program; Use: The IRA amended the Act by adding section 1860D-2(b)(2)(E) which, beginning January 1, 2025, establishes the Medicare Prescription Payment Plan program (hereinafter referred to as the “program”). Under this program, MA Organizations offering Part D coverage and Part D sponsors (collectively “Part D plans” or “Plans”) are required to offer enrollees the option to pay their Part D cost sharing in monthly amounts spread out over the plan year based on the formulae described in section 1860D-2(b)(2)(E)(iv) of the Act.

To effectively monitor the program, Part D plans will be required to report data elements related to the program at the beneficiary, contract, and Plan Benefit Package (PBP)1 levels beginning in Contract Year (CY) 2025. In this information collection package, CMS addresses the proposal to require Part D plans to submit beneficiary-level data elements into the MARx system via a program-specific transaction (separate from the enrollment file). In accordance with the Plan Communication User Guide (PCUG), plans may submit multiple transaction files during any CMS business day, Monday through Friday. Plan transactions are processed as received; there is no minimum or maximum limit to the number of files that Plans may submit in a day. In general, transaction and processing occur throughout the Current Calendar Month (CCM). For CY 2025, CMS will not require independent data validation for this new MARx reporting requirement. Form Number: CMS-10887 (OMB control number: 0938-New); Frequency: Monthly; Affected Public: Private, Federal Government, Business or other for profits, Not-for-profits institutions; Number of Respondents: 856; Total Annual Responses: 3,200,856; Total Annual Hours: 59,958. (For policy questions regarding this collection contact Michael Brown at [phone] or [e-mail].)

2. Type of Information Collection Request: Revision with change of a currently approved collection; Title of Information Collection: Application to be a Qualified Entity to Receive Medicare Data for Performance Measurement/Reapplication/Annual Report Worksheet; Use: The Patient Protection and Affordable Care Act (ACA) was enacted on March 23, 2010 (Pub. L. 111-148). ACA amends section 1874 of the Social Security Act by adding a new subsection (e) to make standardized extracts of Medicare claims data under Parts A, B, and D available to QEs to evaluate the performance of providers of services and suppliers. This is the Application, Reapplication, and ARW which provides CMS with the information it needs to determine whether an organization earns approval and continues as a QE.

CMS established the Qualified Entity Certification Program (QECP) to evaluate an organization's eligibility across three areas: (1) organizational and governance capabilities, (2) addition of claims data from other sources (as required in the statute), and (3) data privacy and security. QE certification lasts for 3 years. Organizations that are interested in remaining in the QE program must submit a Reapplication that is reviewed and approved by QECP. In addition, each year QEs must submit an annual report to QECP that provides information required by statute. Form Number: CMS-10394 (OMB control number: 0938-1144); Frequency: Yearly; Affected Public: Business or other for-profits; Number of Respondents: 40; Total Annual Responses: 210; Total Annual Hours: 17,400. (For policy questions regarding this collection contact Kari Gaare at [e-mail].)

William N. Parham, III,

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