The HHS Office of Inspector General has issued Advisory Opinion 26-17, offering a favorable ruling on a proposed independent charity patient assistance program.
The program was put forward by a nonprofit, tax-exempt organisation seeking to provide health insurance premium assistance and copayment assistance to federal healthcare program beneficiaries.
Beneficiaries covered under the proposal would be those diagnosed with certain rare and chronic diseases, with assistance available across a broad range of FDA-approved prescription medications.
The program would be largely funded by donations from pharmaceutical manufacturers of drugs that treat the diseases in question.
HHS-OIG acknowledged that patient assistance programs relying on donations from pharmaceutical manufacturers create potential for inflated drug costs and improper steering.
Despite those concerns, the agency concluded the proposed arrangement carried a sufficiently low risk of fraud and abuse under the federal Anti-Kickback Statute.
Central to that conclusion was the structure of the program, which would award assistance on a first-come, first-served basis under a reasonable, verifiable, and uniformly applied financial need policy.
The OIG’s analysis also rested on the requestor’s independence from manufacturer donors, broad disease fund definitions based on widely recognised clinical standards, and the absence of data sharing that could allow donors to correlate donations to product use.
In a notable move, OIG referenced the Inflation Reduction Act’s Part D redesign provisions, including the $2,000 annual out-of-pocket cap and manufacturer inflation rebates, as relevant factors shaping its assessment.
The agency reserved the right to reassess the arrangement in approximately two years and to seek additional information to ensure the program is operating as intended.
OIG also concluded the proposed arrangement would not violate the Beneficiary Inducements Civil Monetary Penalty provisions, because the requestor is not a provider, practitioner, or supplier.
The assistance offered under the program is available without regard to a beneficiary’s choice of provider, practitioner, or supplier, which further supported the favourable outcome.
Advisory Opinion 26-17 reinforces the continued importance of traditional patient assistance program safeguards while introducing new considerations tied to the IRA’s Part D redesign.
As with all advisory opinions, this ruling is limited to the requestor and the specific facts and circumstances presented, but it offers meaningful guidance for the broader industry.
Organisations contributing to or evaluating patient assistance programs should assess whether their arrangements include the safeguards highlighted in Advisory Opinion 26-17 and consider how Part D reforms may affect program structure and demand going forward.