On May 24, 2018, the U.S. Department of Justice announced a $23.85 million settlement with Pfizer, Inc., to settle anti-kickback claims against the company. The settlement arose after an investigation led by U.S. Attorney Andrew Lelling, which looked into the drug industry’s support of patient assistance charities. Pfizer is now among a group of multiple drug companies (Celgene Corp., Aegerion Pharmaceuticals, and Jazz Pharmaceuticals) who have settled with the Department of Justice for their use of patient assistance charities. Pfizer also signed a five-year monitoring agreement with the Department of Health and Human Services Office of Inspector General, and is required to implement measures to ensure that its arrangements with patient assistance charities are in compliance with the law
Pfizer was allegedly using an “independent” charity to pay illegal kickbacks to Medicare patients, covering out of pocket costs for prescription drugs. Pfizer made donations to Patient Access Network Foundation (PAN), a copay assistance nonprofit organization, and used a specialty pharmacy, Advanced Care Scripts, to direct Medicare patients taking its drugs toward the foundation to cover their copays.
The scheme centered around three drugs, two for kidney cancer (Sutent and Inyalta), and one for arrhythmia (Tikosyn). Pfizer was allegedly aware that PAN used their donations to cover the copays of patients taking these drugs. In fact, PAN and the pharmacy would notify Pfizer when patients using these drugs got the copay assistance. Price increases of the drugs were concealed from patients but left Medicare with a higher bill.
The scheme enabled Pfizer to boost prices and revenue, violating the federal Anti-Kickback Statute. Although drug companies may donate to charities that provide copay assistance, they may not decide which drugs their donations can be used on. The federal Anti-Kickback Statute bars drug companies from subsidizing copay assistance for Medicare patients.
Pfizer is maintaining that the settlement is not an admission of liability, but reflected its “desire to put this legal matter behind [them] and focus on needs of patients. The Company believes all individuals deserve access to medicines prescribed by their physicians.”
Wachler & Associates will continue to stay up to date with Anti-Kickback statute settlements and other current healthcare topics. If you or your healthcare entity has any questions pertaining to healthcare compliance, please contact an experienced healthcare attorney at (248) 544-0888, or via email at email@example.com. You may also subscribe to our health law blog by adding your email at the top right of this page.