Medicare Will Test Payment Model For Accelerated Approvals To ‘Expedite’ Confirmatory Trials
The Center for Medicare and Medicaid Innovation also will develop demonstrations focused on payment arrangements for cell and gene therapy in Medicaid and promoting generic drugs in Medicare Part D.
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Private Payers Have ‘Significant’ Role In Ensuring Confirmatory Trials Get Done, FDA’s Califf Says
In an unusual appearance at AHIP annual conference on Medicare and Medicaid, the US FDA commissioner discusses accelerated approvals and argues that payers should be more than ‘passive recipients’ of research. Insurers should help develop the confirmatory data for drugs, Califf says.
FDA, CMS And Accelerated Approval: Flipping The Script
The US Medicare agency’s restrictive coverage policy for Alzheimer’s antibodies is a clear threat to the FDA accelerated approval pathway. Now the payor is going to try a different approach to strengthen the pathway.
President Biden’s Proposal To Expand Medicare Price Controls A Sign Of Things To Come
Even though it is unlikely that the policies will succeed in the currently divided Congress, the proposal reinforces industry’s concerns that once a foundation for Medicare price negotiation is established, policymakers will try to build on it.