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Patient Assistance Programs & Government Enforcement: What You Need to Know

Mintz Levin


Date: May 16, 2017

Time: 9:00AM - 10:00AM

For more than 10 years, patient assistance programs have operated within a defined set of parameters established by a series of guidance documents issued by the Office of the Inspector General (OIG). Given the wealth of agency structuring guidance, patient assistance programs have not historically been viewed as government enforcement targets.

That perception has changed in the last two years as multiple health care providers, including many pharmaceutical manufacturers, have disclosed receipt of government subpoenas investigating their contributions to patient assistance charities.

This webinar will address the following questions:

  • What does existing OIG guidance require with respect to the structuring and operation of patient assistance programs?
  • What theories underlie current government investigations of patient assistance programs?
  • What do providers, payors, pharmacy benefit managers (PBMs), and pharmacies working with manufacturers and patient assistance programs need to know in light of these investigations?


Theresa advises clients on all aspects of the pharmaceutical supply chain, including counseling industry stakeholders on a range of business, legal, transactional, and compliance matters. She provides clients with strategic counseling and creative business modeling that considers legal restrictions and regulatory risk in light of innovation and business goals.
Professional Cropped Berson Susan Mintz

Susan W. Berson