The Centers for Medicare & Medicaid Services (CMS) has proposed to require manufacturers to refund CMS for discarded amounts of single-dose container and single-use package drugs payable under Medicare Part B. On July 7, 2022, CMS included the proposal in an advance copy of the calendar year (CY) 2023 Physician Fee Schedule Proposed Rule (Proposed Rule). The Proposed Rule would implement Section 90004 of the Infrastructure Investment and Jobs Act (Pub. L. 117-9) passed in November 2021 (Infrastructure Act). The Infrastructure Act requires manufacturers to provide a refund to CMS for certain discarded amounts from a refundable single-dose container or single-use package drug payable under Medicare Part B (Refund Program). Consistent with the statute, the Proposed Rule states that refunds under the Refund Program would first apply to applicable Medicare Part B claims data beginning on January 1, 2023.
CMS requests comments on a number of issues, discussed below. The Proposed Rule is scheduled to be published in the Federal Register on July 27, and comments are due September 6, 2022. Various aspects of the proposal are vague and ripe for comment. Aspects of the program may be subject to legal challenge depending on the agency’s final rule and implementation.
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