The Centers for Medicare and Medicaid Services (CMS) recently announced that the Secretary of Health and Human Services (HHS) had selected three new payment model concepts for testing by the CMS Innovation Center “to help lower the high cost of drugs, promote accessibility to life-changing drug therapies, and improve quality of care.” The model concepts are in response to President Biden’s Executive Order 14087, Lowering Prescription Drug Costs for Americans, which called for the HHS Secretary to select Innovation Center payment and delivery models “that would lower drug costs and promote access to innovative drug therapies for beneficiaries enrolled in the Medicare and Medicaid programs.” HHS Secretary Xavier Becerra selected three drug affordability and accessibility model concepts for testing, impacting Medicare Part D, Medicaid, and Medicare Part B, respectively:
- Medicare High-Value Drug List;
- Cell & Gene Therapy Access; and
- Accelerating Clinical Evidence.
This Center for Healthcare Regulatory Insight Brief summarizes the model concepts, their stated objectives, their anticipated timelines, and next steps for implementation.