The Department of Health and Human Services (HHS) and the HHS Office of Inspector General (OIG) recently released a Special Advisory Bulletin regarding direct-to-consumer prescription drug sales. This advisory bulletin clarifies when these sales are “low risk” under the federal anti-kickback statute (AKS).  In a new insight, Director of Health Care Policy Michael Baker discusses the significance of this announcement.

Key points:

• The guidance is meant to give manufacturers clearer compliance terrain to offer lower cash prices directly to patients, including federal program enrollees, without turning those discounts into unlawful “remuneration” intended to induce federally reimbursable business.
• The issuance of this bulletin is notable because of the impending launch of TrumpRx, the Trump Administration’s heavily pushed DTC platform, as well as the proliferation of company-specific DTC offerings.
• While neither a formal legal opinion nor an identification of wrongdoing, the bulletin clearly notes the risks associated with pushing DTC sales as an alternative to high prescription drug prices, furthering fragmentation in the U.S. health care system.

Read the analysis.