HHS OIG Proposed Rule on the Safe Harbor for Pharmaceutical Rebates: The Issues and Impact
Presented by Epstein Becker Green Attorneys:
Alan Arville, Constance Wilkinson, John Linehan, Stephanie Kanwit
On January 31, 2019, the U.S. Department of Health and Human Services’ Office of Inspector General issued a proposed rule that would restrict safe harbor protection under the federal Anti-Kickback Statute for pharmaceutical rebates, while introducing new safe harbors that would protect certain pharmaceutical manufacturer price reductions at the pharmacy point of sale and certain pharmacy benefit manager (“PBM”) service fees. As rebates paid by pharmaceutical manufacturers to health plan sponsors and PBMs are a central feature of the U.S. drug distribution and reimbursement system, the proposed rule represents a groundbreaking reform measure that could dramatically impact consumers and supply chain stakeholders.
In this on-demand webinar, we discuss the key takeaways of the proposed rule, including its potential impact, if finalized, on various stakeholders, including PBMs, health plans, drug manufacturers, and pharmacies.
For more information, please contact Whitney Krebs at [email protected].