DC Circuit Affirms Broad AKS Reach, Invalidates OIG Tolling Rules
A D.C. Circuit decision affirmed a broad interpretation of the Anti-Kickback Statute in a case involving a patient support program and invalidated HHS rules that illegally tolled the 60-day OIG advisory opinion deadline.
The D.C. Circuit, in Vertex v. HHS, affirmed a broad interpretation of the federal Anti-Kickback Statute (AKS), holding that a manufacturer's proposed program to pay for fertility services for patients on its gene therapy constituted prohibited remuneration. The court rejected the argument that the AKS is limited to corrupt transactions, aligning with the Second and Fourth Circuits and creating a more challenging landscape for patient support programs.
Critically for regulatory practice, the court also invalidated Office of Inspector General (OIG) regulations that delayed or tolled the 60-day statutory deadline for issuing advisory opinions, a key compliance tool. The ruling establishes that the 60-day clock starts upon receipt of a request and cannot be extended by the agency. The court also faulted OIG for failing to meaningfully address evidence under the Beneficiary Inducement Statute, holding that conclusory denials violate the Administrative Procedure Act.
Companies should re-evaluate patient support programs under the broad AKS standard. Requestors of OIG advisory opinions now have a stronger basis to demand a timely, reasoned decision, potentially altering engagement strategies with the agency. The ruling's logic on statutory deadlines may also be used to challenge delays in other HHS processes.