Patients Assistance Programs (PAPs)

Patients Assistance Programs (PAPs) are elective programs administered by pharmaceutical manufacturers to aid needy patients in obtaining prescription drugs that they may otherwise be unable to afford. This assistance can be provided through the provision of free drugs or through financial assistance for insurance co-payments. Eligibility requirements vary by manufacturer, however, generally individuals with incomes less than 200% of the Federal Poverty Level are eligible. Some companies require that patients have no health insurance, while other companies do allow for certain levels/types of insurance.

As a manufacturer, the creation of clear policies and procedures with regards to the administration of a Patients Assistance Program is critical. Inconsistent application of a PAP policy could be seen as discriminatory or even a violation of the False Claims Act. In order to ensure adherence to all applicable laws, regulations, and guidance, commercial compliance should be considered.

CIS partners with clients to provide assistance in developing and/or assessing Patient Assistance Programs. Well versed in the statutes, regulations, and industry guidance, CIS commercial compliance experts work with clients to explore implications of various types of PAP programs. Further, CIS’s knowledge with regards to other areas of the business affected by PAP programs can help ensure a complete assessment of business implications.