Vasilios J. Kalogredis of Lamb McErlane. Courtesy photo
The HHS Office of Inspector General (OIG) issued Advisory Opinion No. 24-03 (opinion) on June 12 regarding assistance for certain travel, lodging, meals, and associated expenses for qualifying patients receiving a gene therapy product (product) manufactured 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), or 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).
The opinion concludes that although the proposed arrangement 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 generate prohibited remuneration under the beneficiary inducements CMP.
