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Charitable Patient Assistance Programs: Ensuring Compliance

Establishing and Maintaining Arrangements With PAPs, Monitoring and Auditing PAPs

Recording of a 90-minute CLE video webinar with Q&A

This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

Conducted on Tuesday, February 2, 2021

Recorded event now available

or call 1-800-926-7926

This CLE course will provide healthcare counsel with guidance on charitable patient assistance programs (PAPs). The panel will discuss establishing PAPs and ensuring appropriate donation activities with independent PAPs. The panel will discuss traditional government concerns, OIG guidance, compliance considerations, and potential risks. The panel will offer best practices for structuring PAP arrangements and compliance.


PAPs provide financial assistance to patients using free products and copayment assistance through programs run by drug manufacturers and independent charities that assist with copays and other out-of-pocket costs. With rising drug prices, many patients rely on PAPs to afford necessary medications.

Over the past two decades, contributions to PAP programs from the pharmaceutical industry have skyrocketed from $376 million to over $6 billion. In the recent past, a growing number of governmental investigations and settlements have raised questions about pharmaceutical companies' practice of donating to independent charities that provide financial assistance with out-of-pocket drug costs to patients.

In September 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable advisory opinion, declining to approve a pharmaceutical manufacturer's proposal to provide cost-sharing assistance directly to Medicare beneficiaries who are prescribed the manufacturer's drugs.

Listen as our authoritative panel of healthcare attorneys examines the legal issues surrounding PAPs. The panel will discuss establishing and maintaining arrangements with PAPs. The panel will discuss traditional government concerns, including fraud and abuse, and OIG guidance, as well as compliance considerations and potential risks. The panel will offer best practices for structuring a PAP and compliance, including monitoring and auditing PAPs.



  1. Arrangements with PAPs
  2. Governmental concerns
  3. OIG guidance
  4. Best practices for structuring a PAP
    1. Compliance
    2. Auditing
    3. Monitoring


The panel will review these and other relevant issues:

  • What key considerations should manufacturers keep in mind when establishing sponsored PAPs?
  • What are the potential risks of donations to independent PAPs?
  • What lessons can be learned from recent OIG guidance and settlements?


Fethke, Alison
Alison Fethke

Ropes & Gray

Ms. Fethke provides regulatory advice on a wide range of issues, including healthcare and FDA regulatory matters and...  |  Read More

Mathias, William
William T. (Bill) Mathias

Baker Donelson Bearman Caldwell & Berkowitz

Mr. Mathias represents clients across the U.S. in all areas of the health care industry, with a particular emphasis on...  |  Read More

Michael, Jennifer
Jennifer E. Michael

Epstein Becker & Green

Ms. Michael’s practice focuses on fraud and abuse and federal and state regulatory compliance. Before joining the...  |  Read More

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