Accelerated Approval For Medicare Coverage? FDA Model Could Be Useful For Value-Based Agreements
Centers for Medicare & Medicaid Innovation could enable outcomes-based contracting for novel, 'curative' therapies follow something like the FDA’s Accelerated Approval model, former top HHS official suggests.
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US proposed rule establishing new safe harbors from anti-kickback rules for value-based and outcomes-based contracts limits protections to clinicians, providers and certain other groups and expressly excludes pharmaceutical manufacturers. But HHS suggests a separate safe harbor for prescription drug contracts may be forthcoming.
Absent any legislative remedy, an administrative fix could provide manufacturers with confidence that value-based arrangements won’t trigger a new best price, Duke Margolis policy experts propose.
Upcoming transition in HHS drug pricing policy staff reinforces the Trump Administration's shift away from the 2018 "Blueprint” and towards engaging with bipartisan Congressional legislation – and spotlighting executive action as coming from the White House in the context of the upcoming Presidential campaign.