On December 17, 2020, the DOJ announced that Biogen agreed to pay $22 million to resolve allegations that it violated the False Claims Act by illegally using two non-profit foundations as a conduit to pay the copays for Medicare patients taking Biogen’s multiple sclerosis drugs, Avonex and Tysabri.  As part of the alleged scheme, Biogen identified for its vendor, Advanced Care Scripts (ACS), certain patients in Biogen’s Avonex or Tysabri free drug program.  Biogen then allegedly worked with ACS to transfer these patients to the non-profit foundations, which received contemporaneous payments from Biogen that covered the costs of the Medicare copays for most of these patients. Biogen’s vendor, ACS, separately agreed to pay $1.4 million for its role in the alleged conduct.

According to the DOJ, copays were intended by Congress to be a primary method of constraining rising Medicare costs, and as such, enforcement against companies who use patient assistance programs to circumvent cost-prohibitive copays will be a key enforcement initiative for the DOJ moving forward.

Despite agreeing to the settlement, Biogen has adamantly denied that its conduct was improper.  According to a Biogen spokesperson, the company “does not agree with the government’s view of the facts and believes that its conduct was appropriate” and that “independent charitable assistance programs help patients lead healthier lives.”

Related links available at: DOJ Press Release; Press Coverage.