Proposed Rule Affecting Safe Harbors for Prescription Drug Rebates

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March 2019

On February 6, 2019, the U.S. Department of Health and Human Services Office of the Inspector General released a proposed rule to amend the discount safe harbor regulations that define conduct protected from liability under the federal anti-kickback statute. The proposed rule would eliminate protection for prescription drug rebates for Medicare Part D plans and Medicaid managed care organizations, including pharmacy benefit managers (PBMs) acting under contract with these plans. It would create two new safe harbors for manufacturer discounts provided at the point of sale and certain fixed-fee payments to PBMs. The slide presentation includes a summary of the provisions of the proposed rule and the accompanying actuarial analyses, as well as potential issues on which the Commission may want to comment.

Publication Type: Presentations

From: March 2019 MACPAC Public Meeting

Tags: carve in/carve out, cost sharing, managed care, Medicare, prescription drugs