Lexology May 17, 2024
The Centers for Medicare & Medicaid Services (CMS) announced on May 15, 2024 that it will not finalize, at this time, the proposed stacking provision set forth in the agency’s May 2023 Medicaid Drug Rebate Program proposed rule (Proposed Rule).
As discussed in a prior alert, the Proposed Rule would implement a variety of drug pricing reforms under the Medicaid Drug Rebate Program, such as authorizing the Department of Health and Human Services to identify certain “high-cost drugs” that would be subject to potential CMS information requests for pricing, production cost, and utilization data; adopting an expanded definition of the term “manufacturer”; and addressing certain “misclassification” considerations for purposes of rebate calculations. One of the troubling provisions in that Proposed...
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