Lowering Drug Prices with the Anti-Kickback Statute: Future and Impact of HHS Final Rule to Disrupt Drug Formulary Rebates

American Health Law Association (AHLA)

Alan J. Arville and Alexis Boaz, attorneys in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, co-authored an article for the American Health Law Association (AHLA), titled “Lowering Drug Prices with the Anti-Kickback Statute: Future and Impact of HHS Final Rule to Disrupt Drug Formulary Rebates.” (Read the full version – subscription required.)

Following is an excerpt:

2019 may seem like ages ago, but before COVID-19, a top, if not the top, health policy priority of the Trump administration (administration) was to address rising prescription drug costs. A key policy initiative championed by Alex Azar, Secretary of the Department of Health and Human Services (HHS), to curb drug prices was to eliminate the current structure of formulary rebates paid by drug manufacturers to pharmacy benefit managers (PBMs) and health plans. To this end, on January 31, 2019, the HHS Office of Inspector General (OIG) issued the proposed rule to restrict safe harbor protection for formulary rebates under the Anti-Kickback Statute (Proposed Rule).