A First Look At New HHS Prescription Drug Safe Harbors

Law360 (February 15, 2019, 1:13 PM EST) -- On Jan. 31, 2019, the Office of Inspector General of the U.S. Department of Health and Human Services released a proposed rule that would narrow the existing regulatory discount safe harbor under the Anti-Kickback Statute and create two new safe harbors.

If finalized, the proposed rule would (1) exclude from the existing discount safe harbor discounts provided to Medicare Part D plans (including Medicare Advantage plans with a drug benefit), Medicaid managed care organizations (MCOs), and pharmacy benefit managers (PBMs); (2) add a new safe harbor to protect certain discounts passed along to federal health care program beneficiaries; and (3) add...

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