DC Cir Backs Broad Anti-Kickback Law, Nixes HHS Opinion Deadline Rules
In a mixed ruling for the life sciences industry, the D.C. Circuit upheld an expansive view of the Anti-Kickback Statute while finding HHS unlawfully extends its 60-day deadline to issue advisory opinions.
The U.S. Court of Appeals for the D.C. Circuit affirmed the government’s broad interpretation of the federal Anti-Kickback Statute (AKS), but invalidated the HHS Office of Inspector General's (OIG) practice of extending its deadline for issuing advisory opinions. In Vertex Pharmaceuticals Inc. v. HHS, the court found that a drugmaker’s patient support program for fertility services constituted prohibited "remuneration" intended to "induce" the purchase of its therapy. The ruling confirms that the AKS covers a wide range of commercial arrangements that influence patient choice, even if they are not inherently corrupt.
For life sciences companies, this decision reinforces the significant compliance risks associated with patient assistance programs. However, the court handed the industry a major procedural victory by striking down HHS regulations that tolled or delayed the start of the statutory 60-day clock for issuing an advisory opinion. The court held that the plain language of the statute requires the OIG to respond within 60 days of receiving a request. This provides greater certainty for companies seeking regulatory guidance and may serve as a precedent to challenge similar deadline extensions by other federal agencies. Companies should continue to structure patient support programs carefully while leveraging the newly-enforced timeline for OIG feedback.