Skip to main content

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 C. Carnegie is a Mintz attorney who advises health care clients on a wide array of transactional, regulatory, compliance, fraud and abuse matters, and health law issues. She counsels health plans, pharmacy benefit managers, pharmacies, device manufacturers, and distributors.
Professional Cropped Berson Susan Mintz

Susan W. Berson


Susan W. Berson is part of Mintz's leadership team. She's an attorney who advises managed care organizations, pharmaceutical services providers, industry investors, and other health care clients. She also provides counsel on the Medicare and Medicaid programs.
Ellyn L. Sternfield is a Mintz Special Counsel with an extensive background in government health care enforcement. She provides insight to clients with compliance concerns and helps clients facing potential state or federal investigations.