Emerging Enforcement Trends For Patient Support Programs

By Brett Friedman, Alison Fethke and Jamie Darch (May 15, 2018, 12:43 PM EDT) -- Over the past year, a growing number of governmental investigations and settlements call into question the practice of pharmaceutical companies donating to independent charities that provide financial assistance with out-of-pocket drug costs to patients. This trend is most recently exemplified by Jazz Pharmaceuticals PLC's securities disclosure in May 2018 of its pending settlement with the U.S. Department of Justice, which comes only months after similar conduct was settled by United Therapeutics Corporation.[1] In particular, these government investigations and settlements have examined whether donations to independent charity-run patient assistance programs, or independent PAPs, violate the Federal Anti-Kickback Statute, or AKS,[2] by inducing patients to purchase certain products and forcing federal health care programs to subsidize the costs of such products. Settlements from these investigations are based on the government's theory of liability that independent PAPs are being used as conduits to funnel impermissible financial support for the companies' products.[3]...

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