In an article authored for Law360, Bass, Berry & Sims attorney Jennifer Michael detailed issues related to the federal government’s oversight on contributions to patient assistance programs (PAPs), including how pharmaceutical manufacturers may wish to align their compliance policies and procedures with those outlined in the U.S. Department of Justice’s corporate integrity agreements.

“The government and pharmaceutical manufacturers have taken opposing sides on an issue that pits the welfare of individual beneficiaries against the sustainability of the Medicare program as a whole,” Jennifer said. “The rapidly increasing costs of prescription drugs have caused Medicare beneficiaries to become more dependent than ever on patient assistance programs, which provide financial assistance for cost-sharing obligations.”

While pharmaceutical manufacturers are PAPs’ primary donors, those that directly or indirectly subsidize cost-sharing obligations for their own products risk violating the federal Anti-Kickback Statute.

In addition to summarizing guidance from the HHS Office of Inspector General on PAPs and recent enforcement actions involving financial assistance, Jennifer outlined best practices for manufacturers that wish to contribute to PAPs in the current enforcement environment. The article also described how recent developments and legal challenges have the potential to change the way pharmaceutical manufacturers provide financial assistance to federal healthcare program beneficiaries in the future.

The full article, “Pharma Products’ Uncertain Path to Patient Assistance,” was published May 16 by Law360 and is available online.