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Changes Proposed for Drug Discount Safe Harbor Protections

Comments due April 8

The Department of Health & Human Services’ Office of Inspector General (OIG) has issued a proposed rule that would remove the Anti-Kickback Statute safe harbor protection for drug rebates paid by drug makers to pharmacy benefit managers (PBMs), Part D plans and Medicaid managed care organizations.

The proposed rule would also create new safe harbors to protect discounts offered to patients at the pharmacy and for fixed fee service arrangements between manufacturers and PBMs.

CHA is currently reviewing the proposed rule and has issued a summary, prepared by Health Policy Alternatives. Comments are due to OIG by 2 p.m. (PT) on April 8.