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No More Rebates: HHS Proposed Rule Revises Anti-Kickback Safe Harbor

 
• By Cathy Kelly

Proposed US rule would establish two new safe harbors against anti-kickback enforcement, one covering price reductions at the point of sale and the other protecting flat service fees paid by manufacturers to pharmacy benefit managers. But rebates to "PBMs to buy formulary position" in Medicare/Medicaid would lose protection.

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The US HHS Office of Inspector General proposes to amend the current Anti-Kickback statute "safe harbors" for drug discounts in a way that would exclude rebates widely used by biopharma companies from protection – with the expected result of lower prices for prescription drugs.

The proposal  applies to rebates drug makers now provide voluntarily to Medicare Part D drug plans and Medicaid managed care plans

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