Charitable Patient Assistance Programs: Ensuring Compliance – Establishing and Maintaining Arrangements with PAPs, Monitoring, and Auditing PAPs

Next Week
Webinar (ET)

Jennifer E. Michael, Member of the Firm, will participate in the panel, "Charitable Patient Assistance Programs: Ensuring Compliance - Establishing and Maintaining Arrangements with PAPs, Monitoring, and Auditing PAPs," a live CLE webinar hosted by Strafford.

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.

The panel will discuss establishing and maintaining arrangements with PAPs. The panel will also 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.

Learning objectives:

  • 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?

For more information, please visit StraffordPub.com.