On May 15, 2024, the Centers for Medicare & Medicaid Services (CMS) released a statement on the Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (MDRP) Proposed Rule (link). 

Below, ADVI provides a summary of this statement.

As part of the proposed rule (link), CMS proposed revisions for the determination of best price at § 447.505(d)(3) “to make clearer that the manufacturer must adjust the best price for a drug for a rebate period if cumulative discounts, rebates, or other arrangements to best price eligible entities subsequently adjust the prices available from the manufacturer, and that those discounts, rebates, or other arrangements must be ‘stacked’ for a single transaction to determine a final price realized by the manufacturer for a drug.” 

In today’s statement, CMS notes that while the Agency is still working on finalizing other proposals from the proposed rule, they are not finalizing the proposal regarding rebate stacking at this time. Instead, CMS will “pursue the collection of additional information from manufacturers related to best price stacking methodologies to better understand and inform future rulemaking.”

ADVI will continue monitoring developments and the next steps. This is a delayed release. ADVI Instant content is distributed in real-time for retainer clients. Get in touch to learn more about how we can support your commercialization, market access, and policy needs.