On February 14, 2023, the U.S. Department of Health and Human Services (HHS) published a report identifying three models that the Center for Medicare & Medicaid Services’ (CMS) Center.
If proposed and finalized as described, this profound policy shift would inevitably chill incentives for leveraging the FDA’s game-changing expedited regulatory avenue, which has served patients with life-threatening diseases for decades. Later approvals and access delays would follow.
The Centers for Medicaid and Medicare Services (CMS) announced a model on February 14, 2023 that would allow CMS to pay less for drugs approved via FDA’s accelerated approval pathway.