On January 31, 2019, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) released an advance-print copy of a much-anticipated proposed rule that sets forth significant changes to the federal Anti-Kickback Statute (AKS) regulatory safe harbors. The proposed regulation, if finalized, would (1) exclude from discount safe harbor protection rebates paid by pharmaceutical manufacturers to pharmacy benefit managers (PBMs), Medicare Part D plans, and Medicaid managed care organizations (MCOs); (2) create a new safe harbor protecting prescription drug discounts offered to patients at the point-of-sale; and (3) create a new safe harbor to protect certain fixed-fee service arrangements between pharmaceutical manufacturers and PBMs.
The proposed rule is the most recent development in connection with the Trump administration’s efforts to lower drug prices and reduce patient out-of-pocket costs for prescription pharmaceuticals, as outlined in the President’s May 2018 American Patients First Blueprint. If finalized, the proposal will undoubtedly disrupt the existing supply chain for prescription drugs and leave stakeholders little time to come into compliance with its provisions. The proposed rule is scheduled for publication in the Federal Register on February 6, and stakeholder comments must be submitted no later than April 8, 2019.
The following is an overview of key aspects of the proposed rule.
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