In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs, the Trump administration has proposed a series of changes to the anti-kickback statute's (AKS) safe harbor rules that seek to eliminate the use of rebates in Medicare Part D and Medicaid managed care plans.
The stated goals of the highly anticipated proposed rule from the Department of Health and Human Services (HHS) Office of Inspector General (OIG) are to realign incentives among drug manufacturers, health plans, and pharmacy benefit managers (PBMs) to reduce list prices or curb price increases, reduce financial burdens on patients, lower federal expenditures by encouraging the use of lower-cost brand or generic drugs, improve transparency, and reduce the likelihood that rebates would serve to inappropriately induce Medicare Part D and Medicaid managed care business. But in seeking to use the blunt instrument of the anti-kickback statute to achieve broad drug pricing reform, even the administration has recognized that it's uncertain whether the proposed rule can meet these stated goals.
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