Accelerated Approvals In Medicaid: Drug Coverage Exclusion Authority Sought In Oregon
If approved, Oregon would be the first state granted the authority to exclude coverage of accelerated approval drugs, even if manufacturers provide the statutory rebates required for Medicaid.
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Biden Administration nixes Trump-era plan that would have allowed the state to exclude drugs from coverage even as it collected mandatory Medicaid rebates from manufacturers.
The bill, some version of which is undoubtedly destined for the FDA user fee package, also would codify existing labeling guidance for products cleared through the pathway.
The unexpectedly tight fight to get Robert Califf confirmed as FDA commissioner is giving lawmakers additional leverage to extract commitments. However, the Senate Finance Chair may be overestimating FDA’s ability to swiftly pull accelerated approvals without new legislation.