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Feb 2 -- The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment by April 2, 2024 on the proposed revisions in Medicare Part D Reporting Requirements (CMS-10185).

Section 1860D–12(b)(3)(D) of the Act provides broad authority for the Secretary to add terms to the contracts with Part D sponsors, including terms that require the sponsor to provide the Secretary with information as the Secretary may find necessary and appropriate. Pursuant to our statutory authority, we codified these information collection requirements for Part D sponsors in regulation at 42 CFR 423.514(a).

Data collected via the Medicare Part D reporting requirements will be an integral resource for oversight, monitoring, compliance, and auditing activities necessary to ensure quality provision of the Medicare Prescription Drug Benefit to beneficiaries. For all reporting sections (Enrollment and Disenrollment, Medication Therapy Management (MTM) Programs, Grievances, Improving Drug Utilization Review Controls, Coverage Determinations and Redeterminations, and Employer/Union Sponsored Sponsors, and Medicare Prescription Payment Plan), data are reported electronically to CMS. The data collected via the MTM and Grievances reporting sections are used in the Medicare Part C and D Star Ratings and Display Measures. The other reporting sections' data are analyzed for program oversight to ensure the availability, accessibility, and acceptability of sponsors' services, such as coverage determinations and appeals processes, and opioid safety edits at the time of dispensing.

The Center for Medicare (CM) has identified the appropriate data needed to effectively monitor the Medicare Prescription Drug Benefit through these Part D reporting requirements. Changes to the currently approved data collection instrument reflect new executive orders, legislation, as well as recent changes to Agency policy and guidance. One example is the reporting section, Medicare Prescription Payment Plan, which will support the Inflation Reduction Act’s (Section 1860D-2(b)(2)(E) of the Social Security Act, as added by section 11202 of the IRA) provision that all Medicare Part D sponsors offer their Part D enrollees the option to pay their out-ofpocket (OOP) Part D drug costs through monthly payments over the course of the plan year.

42 CFR §423.514(a) requires each Part D sponsor to have a procedure to develop, compile, evaluate, and report to CMS, to its enrollees, and to the general public, at the times and in the manner that CMS requires, statistics indicating the following:

(1) The cost of its operations.
(2) The patterns of utilization of its services.
(3) The availability, accessibility, and acceptability of its services.
(4) Information demonstrating that the Part D sponsor has a fiscally sound operation.
(5) Pharmacy performance measures.
(6) Other matters that CMS may require.

42 CFR §423.505 establishes contract provisions that Part D sponsors must comply with the disclosure and reporting requirements in §423.514.

Part D Reporting Requirements: https://www.cms.gov/medicare/coverage/prescription-drug-coverage-contracting/part-d-reporting-requirements
Draft data collection instrument and technical documentation: https://www.cms.gov/regulations-and-guidance/legislation/paperworkreductionactof1995/pra-listing-items/cms-10185
FRN: https://www.federalregister.gov/d/2024-02095

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