The increase in enforcement activity related to donations made by pharmaceutical manufacturers to nonprofit patient charitable assistance organizations has resulted in a number of whistleblower or Qui Tam lawsuits. Those lawsuits have hinged on the idea that such donations may be viewed as illegal kickbacks because they could be seen as a means to steer…

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In late November, the U.S. Department of Health and Human Services Office of the Inspector General revoked an Advisory Opinion that previously protected a patient-assistance charity from becoming the target of kickback charges. In a follow-up to that ruling this month, the OIG has sent a letter to Pharmaceutical Research and Manufacturers of America (PhRMA)…

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