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What's New/Significant
Actelion Pharmaceuticals US, Inc. (Actelion), and the United States Department of Justice (DOJ) and the Office of Inspector General (OIG-HHS) entered into a settlement agreement to resolve charges that Actelion paid a copay assistance program to help Medicare patients buy certain Actelion drugs from January 1, 2014, through December 31, 2015.
Allegations
Actelion instituted a policy of not permitting Medicare patients to participate in its free drug program, which was open to other patients in financial need, even if the Medicare patients could not afford their copays for drugs.
Knowing that its drug prices were a barrier to purchase for many Medicare patients, Actelion referred Medicare patients to Caring Voice Coalition (CVC), a copay assistance provider to which Actelion had made donations.
CVC used the donations to pay the copay obligations of Medicare patients taking the drugs and to induce those patients’ purchases of drugs.
Actelion routinely obtained information from CVC through funding requests, telephone calls and written reports regarding:
- The number of patients on each drug
- How much CVC had spent on those patients
- How much CVC expected to spend on those patients in the future
Actelion used the information to budget for future payments to CVC on a drug-specific basis and to confirm that its contribution amounts were sufficient to cover the copays of patients taking the drugs.
Actelion’s referral of Medicare patients to CVC induced purchases of drugs and resulted in claims to federal healthcare programs to cover the cost of the drugs.
Scope of Settlement
The settlement amount includes $180M in restitution to OIG-HHS.
The settlement does not release Actelion from (i) liability under the Internal Revenue Code, (ii) exclusion from federal healthcare programs, or (iii) liability for criminal conduct.