HHS Safe Harbor For Value-Based Drug Contracts May Be On Horizon
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.
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Health and Human Services Department Deputy Secretary Eric Hargan invites biopharma companies to submit proposals on how to modify or create safe harbors that would be suitable for innovative reimbursement contracts involving prescription drugs.
All three areas need work following enactment of the original 21st Century Cures Act, authors Fred Upton and Diana DeGette write in vision statement.
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.