In today's challenging health care environment, Charitable Patient Assistance Programs (Charitable PAPs) have emerged to meet the needs of the nearly 30 million Americans who are underinsured and have difficulty paying out-of-pocket medical costs. As potential donors make strategic decisions to invest in Charitable PAPs, there are many elements which must be considered to ensure compliance with all applicable laws and regulations. For the previous alerts in the series, please refer here.

There are many examples of successful Charitable PAPs, however, one important indicator of their dedication to the patients they serve is their fund design. Thus, when considering donations to a Charitable PAP, it is important to assess their ability to manage funds that maximize the scope of assistance available to eligible patients.

  • How are the Charitable PAP's funds defined? Is the fund too specific to exclude key therapies or treatments? In some rare instances, a single drug therapy may be available to treat a disease. However, where several drugs are available to treat a disease, the fund would ideally offer as many treatment options as possible.
  • Does the Charitable PAP manage non-disease funds? Patients often need assistance for cost areas outside of specific treatments. Noting the ability of the Charitable PAP to offer non-disease specific funds can offer perspective into the organization's mission and focus on patients.

If more information is needed regarding Charitable PAP compliance procedures, please do not hesitate to contact the professionals at ML Strategies.

For those interesting in learning more about Charitable PAPs, please note the Mintz Levin Center for Health Law and Policy will host a best practices workshop on September 17th in Washington, DC.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.