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 that 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.

When examining Charitable PAPs, the most important thing to question is whether the organization serves the patients who depend on it. Thus, when considering donations to a Charitable PAP, assessing how disease funds are organized can be a telling insight into how well and efficiently patients are served.

  • Does the Charitable PAP define its disease funds in accordance with widely recognized clinical standards? In most cases, disease funds should be defined such that multiple products are covered under the fund. In cases where only one FDA-approved product currently exists related to treatment of the disease, the fund definition should allow additional products to be added following FDA approval.
  • Does the Charitable PAP use qualifiers in its fund definitions? Reference to specific symptoms, severity of symptoms, mode of administration or payment methodology may be cause for concern.
  • What is the process the organization uses to define its funds? Across all Charitable PAPs, defining funds should be done at arm’s length from the donor.