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Court Decision Upholding OIG’s Rejection of Pharmaceutical Company’s Drug Co-Pay Assistance Program

By Jennifer Michael on July 27, 2022
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I commented on the recent ruling by the Second Circuit Court of Appeals, which upheld the district court’s rejection of Pfizer’s argument that liability under the Anti-Kickback Statute requires an element of “corrupt” intent.

Pfizer brought the lawsuit in 2020, challenging the government’s rejection of its proposed program to help cover heart drug costs for Medicare patients.

The decision will have implications for other companies looking to help subsidize drug payments for Medicare patients. “It would be extremely risky for any manufacturer to move forward with that type of arrangement, given this opinion,” said Jennifer.

The full article, “Pfizer Loses Court Battle Over Drug Copay Assistance Program with Big Implications for Medicare Spending,” was published by MarketWatch on July 27 and is available online.

Photo of Jennifer Michael Jennifer Michael

Jennifer Michael draws on her experience as the former Chief of the Industry Guidance Branch at the U.S. Department of Health and Human Services (HHS), Office of Counsel to the Inspector General (OCIG) to help healthcare providers and life science companies avoid potential…

Jennifer Michael draws on her experience as the former Chief of the Industry Guidance Branch at the U.S. Department of Health and Human Services (HHS), Office of Counsel to the Inspector General (OCIG) to help healthcare providers and life science companies avoid potential fraud and abuse landmines and defend them in fraud and abuse investigations. Jennifer helps her clients structure their arrangements to comply with the federal Anti-Kickback Statute (AKS), the federal Civil Monetary Penalty (CMP) law, and other state and federal fraud and abuse laws and navigate government investigations under the federal False Claims Act (FCA).

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  • Posted in:
    Health Care and Life Sciences
  • Blog:
    Inside the False Claims Act
  • Organization:
    Bass, Berry & Sims PLC
  • Article: View Original Source

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