The HHS Office of Inspector General (OIG) issued Advisory Opinion No. 24-02 on April 8, regarding patient assistance funds associated with 12 specific diseases (disease funds) operated by the “requestor.” Specifically, the requestor inquired as to whether the proposed “arrangement,” as discussed below, would warrant sanctions under Sections 1128A(a)(7), 1128B(b) 1128A(a)(5), 1128(b)(7) of the Social Security Act (SSA), as they relate to the federal Anti-Kickback Statute (AKS) and the beneficiary inducements civil monetary penalties (CMP). Effective from the date of issuance to Jan. 1, 2027 (the effective period), the opinion concludes that although the proposed arrangement, if undertaken, would generate prohibited remuneration under the AKS (if the requisite intent were present), the OIG would not impose administrative sanctions on the requestor; and the arrangement does not constitute grounds for imposition of sanctions under the beneficiary inducements CMP.

Factual Background and Proposed Arrangement

The requestor, a nonprofit eligible to receive tax-deductible charitable contributions, provides financial support to patients with certain medical conditions and demonstrated financial need through various patient assistance programs. The requestor’s disease funds are intended to assist patients with out-of-pocket costs associated with the treatment of the disease, as well as side effects of treatment. Each disease fund has a single pharmaceutical manufacturer donor that manufactures or markets a drug to treat the relevant disease.