The Department of Health and Human Services’ Office of Inspector General yesterday proposed excluding from safe harbor protection under the Anti-Kickback Statute rebates paid by prescription drug makers to pharmacy benefit managers, Medicare Part D plans and Medicaid managed care organizations. The proposed rule also would create new safe harbor protections under the law for prescription drug discounts offered directly to patients at the pharmacy and fixed-fee service arrangements between drug makers and PBMs. The administration’s blueprint to lower drug prices called for revisiting the AKS safe harbor for drug rebates. 
 

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