The Centers for Medicare and Medicaid Services (CMS) Announced on May 15, 2024 that will not end, at this time, the proposed accrual provision set forth in the agency's May 2023 Medicaid Drug Rebate Program. proposed rule (Proposed rule).
As discussed in a advance warning, 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 drug information requests. CMS prices. production costs and utilization data; adopt an expanded definition of the term "manufacturer"; and address certain “misclassification” considerations for purposes of reimbursement calculations. One of the concerning provisions of that proposed rule from a legal perspective was that drug manufacturers would “stack” cumulative price concessions given to different entities to determine the best final price obtained by the manufacturer.
The proposed stacking provision would have modified existing better pricing regulations to require manufacturers to “stack” discounts, rebates or other cumulative deals “provided to different [best price] eligible entities” for the purposes of determining the best final price understood by the manufacturer, rather than identifying the best price available From the manufacturer. If finalized, the proposal would have marked a marked reversal of CMS's previous guidance on the methodology for calculating the best price and would likely be subject to legal challenge.
CMS May 15, 2024 Press release states that the agency will not finalize the best price accumulation proposal. Instead, the agency plans to gather additional information from manufacturers on the best price accumulation methodologies "to better understand and inform future rulemaking."
The press release indicates that CMS is finalizing the other components of the proposed rule. The final rule was submitted to the Office of Management and Budget on March 22, 2024 and is expected to be published next month according to the Unified agenda.
Manufacturers should continue to closely monitor the release of the final rule and any supplemental requests for comments related to best price accrual methodologies.
