Independent Patient Assistance Foundations: An Overview
What independent charitable patient assistance foundations do, how disease-specific funds and OIG compliance rules work, the major national foundations, and how the 2026 PAF–PAN merger and the Part D redesign are changing the landscape.
Published
Independent patient assistance foundations are 501(c)(3) charities that pay out-of-pocket drug and healthcare costs — copays, coinsurance, deductibles, insurance premiums, and sometimes travel — for patients who cannot afford them. They matter because they are the only compliant way for financial assistance funded largely by pharmaceutical manufacturers to reach Medicare and other federally insured patients: manufacturer copay cards are barred from federal programs under the Anti-Kickback Statute, but manufacturers may donate to independent charities that assist those same populations, provided strict federal rules on donor independence are followed. The foundations run disease-specific funds that open and close with available donations, award grants based on financial need, and operate under individual advisory opinions from the HHS Office of Inspector General (OIG).
How foundations differ from manufacturer programs
Three mechanisms are commonly confused:
| Mechanism | Funded by | Who it can help | Key constraint |
|---|---|---|---|
| Manufacturer copay card | The brand’s manufacturer | Commercially insured patients only | Prohibited for federal beneficiaries |
| Manufacturer patient assistance program (PAP) | The manufacturer | Typically uninsured/underinsured patients; free product | Manufacturer sets eligibility; supplies its own drug |
| Independent charitable foundation | Donations (largely from manufacturers), managed independently | Insured patients including Medicare — usually the core population | Donors cannot control or track how funds are used |
The independence in the third row is the legal linchpin. A foundation may accept a manufacturer’s donation to, say, a multiple sclerosis fund, but it must assist patients regardless of which company’s drug they take, and it cannot report back to the donor how its money was spent at the product level.
How disease funds actually work
Foundations organize assistance into disease-specific funds — a metastatic breast cancer fund, a hemophilia fund, and so on. Each fund has:
- Eligibility criteria, typically an income ceiling expressed as a multiple of the federal poverty level (often in the range of 300–500% FPL, varying by foundation and fund), plus diagnosis and insurance-status requirements.
- A defined grant, usually an annual dollar amount toward cost sharing or premiums.
- A funding-dependent status. Funds are first-come, first-served: when donations run out, the fund closes to new applicants and reopens only when new money arrives. Providers and hub teams track fund status daily because openings can be brief.
This open/close dynamic is the single most important operational fact about foundations. A patient who qualifies in theory may find every relevant fund closed in practice, which is why financial navigation platforms and hub programs monitor multiple foundations simultaneously.
The compliance framework
The OIG’s 2005 Special Advisory Bulletin on patient assistance programs, supplemented in 2014, sets out how manufacturer donations to independent charities can avoid Anti-Kickback Statute liability. In practice, each foundation operates under its own OIG advisory opinion specifying the guardrails, which consistently include:
- Donors may not influence which disease funds exist, how they are defined, or which patients or products they cover.
- Funds must not be narrowly drawn so that they effectively cover only the donor’s drug.
- Assistance must be awarded on verifiable financial need, without regard to the prescribed treatment or provider.
- Foundations may not share data with donors that would let them trace donations to use of their own products.
These rules have teeth. Between 2017 and 2019, the Department of Justice reached settlements with multiple manufacturers and several foundations over arrangements that steered donations to the donors’ own drugs — a period that reshaped how conservatively both sides now behave.
The framework continues to evolve. OIG Advisory Opinion 24-02 (April 2024) approved a rare-disease assistance arrangement but — notably — set its approval to expire on January 1, 2027, two years after full implementation of the Part D out-of-pocket cap, signaling that the agency expects the affordability landscape to change. In September 2025, AO 25-10 favorably reviewed a healthcare company’s donations to a charitable foundation, again emphasizing the familiar safeguards: no earmarking, no data flowing back to the donor, and uniform need-based eligibility.
The major national foundations
Listed alphabetically; most run dozens of disease funds each:
- Accessia Health — formerly Patient Services, Inc.; copay, premium, medical-expense, and travel assistance for rare and chronic conditions, plus case management and legal aid.
- CancerCare Co-Payment Assistance Foundation — oncology-focused copay assistance launched by CancerCare in 2008.
- Good Days — legally Chronic Disease Fund, Inc.; copay, premium, travel, and diagnostic assistance across chronic and life-altering conditions.
- HealthWell Foundation — founded in 2003; copay, premium, and out-of-pocket assistance for underinsured patients, operating under an OIG advisory opinion originally issued in 2007 and modified in 2011 and 2015.
- Patient Advocate Foundation and the PAN Foundation — now one organization (see below), combining PAF’s case management and Co-Pay Relief program with PAN’s disease-fund portfolio.
- The Assistance Fund — more than 90 disease-specific programs covering copays, premiums, and other health-related expenses.
Adjacent nonprofits fill related niches: NeedyMeds maintains a free directory of thousands of assistance programs, and Rx Outreach operates a nonprofit mail-order pharmacy for low-cost generics.
2026: consolidation arrives
The sector’s biggest structural change in years came on March 3, 2026, when Patient Advocate Foundation and the PAN Foundation announced a merger creating the nation’s largest nonprofit dedicated to helping patients navigate, access, and afford care. The combined organization — operating under the Patient Advocate Foundation name — reports having helped more than 3.8 million patients and granted over $7 billion in assistance across the two organizations’ histories, including $640 million awarded to nearly 200,000 people in 2025 alone. Its unified charitable assistance program, TotalAssist, began enrolling patients in July 2026 with roughly 150 disease funds plus case management available regardless of insurance status.
What the IRA changes
The Inflation Reduction Act’s Part D redesign capped Medicare beneficiaries’ annual out-of-pocket drug costs at $2,000 in 2025 ($2,100 in 2026). Since Part D patients facing catastrophic cost sharing have historically been the foundations’ core copay-assistance population, the cap meaningfully reduces the size of individual grants needed for drug cost sharing — though premiums, non-drug expenses, and cost sharing below the cap remain real burdens for low-income patients. The OIG has explicitly flagged the cap as a factor in its forward-looking analysis of assistance arrangements. Expect foundations to continue diversifying toward premium assistance, travel, and non-pharmacy medical expenses.
Practical guidance
For manufacturers, the rule of thumb is simple: donate generously, influence nothing. Route foundation strategy through compliance counsel, document donor-independence controls, and never request product-level utilization data. For providers and hub teams, treat fund status as perishable intelligence — monitor openings across multiple foundations (directly or through financial navigation platforms such as Annexus Health, Atlas Health, or TailorMed) and screen every federally insured patient who cannot use a copay card. And for anyone evaluating the landscape in 2026: verify current fund availability and program terms on the foundations’ own sites, because both the funds and the organizations behind them are changing faster than at any point in the past decade.
Sources
- HHS OIG — Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs
- Morgan Lewis — Patient Assistance Programs: The Dos and Don’ts from HHS OIG (February 2025)
- Baker McKenzie — HHS Issues Favorable Opinion on Donations to Charitable Foundation (October 2025)
- PR Newswire — Patient Advocate Foundation and PAN Foundation Announce Merger (March 2026)
- TotalAssist — Patient Advocate Foundation’s charitable patient assistance program
- HealthWell Foundation — Compliance & Commitment