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HHS Advancing Attack On Rebates With Proposal To Revoke Safe Harbor

Executive Summary

Upcoming proposed rule could also provide new anti-kickback safe harbor to facilitate value-based contracts, as manufacturers and payers have urged.

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HHS proposal to eliminate the “safe harbor” that allows for prescription drug rebates took a long time to clear White House review. Its release sends a clear message that US HHS Secretary Azar wants to lead the drug pricing debate in 2019.

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

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.

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

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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