Facility Requirements
- Be registered as a nonprofit organization that provides health care to patients regardless of their ability to pay (e.g., free and charitable clinics, charitable pharmacies, Federally Qualified Health Centers (FQHCs), FQHC look-alikes, etc.)
- Maintain effective systems, policies and controls to:
- Comply with the rules and regulations for dispensing medications defined by the applicable state board of pharmacy
- Manage donated inventory through a physical or virtual process
- Perform and document patient eligibility screening and enrollment, as well as reverification of eligibility
- Retain patient eligibility and dispensing records for at least six years
- Ensure patients and insurers, such as Medicare and Medicaid, are not billed for donated products
- Adhere to all ReplenishRx requirements
- Have a medical director with a valid state license
- Consent to periodic program audits by Direct Relief
Patient Requirements
- Be registered as a patient of a participating facility
- Be uninsured with no public or private coverage for medications, including Medicare, Medicare Part D, state or private insurance
- Have an annual income at or below 300 percent of the federal poverty level, adjusted for household size
- Reside in the United States (undocumented patients residing in the U.S. are eligible)
- Complete application and submit required documentation, including income verification and proof of residency, to participating facility
- Consent to the release of certain personal information for auditing purposes
- For individuals without permanent or stable housing, submit a documented attestation of lack of fixed, regular residence
- Possess a valid prescription for one or more of the medications available through ReplenishRx