The Congress should require the Secretary to cap the Medicare payment rate for Part B drugs and biologics that are approved under the accelerated approval program (with limited circumstances for the Secretary to waive the payment cap) if:
- postmarketing confirmatory trials for the product are not completed within the deadline established by the manufacturer and the Food and Drug Administration,
- the product’s clinical benefit is not confirmed in postmarketing confirmatory trials, or
- the product is covered under a “coverage with evidence development” policy.
In addition, the Congress should give the Secretary the authority to cap the Medicare payment rate of Part B drugs and biologics that are approved under the accelerated approval program if their price is excessive relative to the upper-bound estimates of value.