HHS-OIG Issues Favorable Opinion on Drug Manufacturer’s Travel Assistance Program for Single-Use Tumor Treatment
Highlights
The HHS-OIG recently released Advisory Opinion No. 24-13, a favorable opinion involving assistance with patient expenses by a manufacturer of a single-use treatment
The proposed arrangement is consistent with previous agency guidance on patient assistance that promotes access to care
The HHS-OIG determined the risk of fraud and abuse is sufficiently low under the Anti-Kickback Statute and that there was no prohibited renumeration under civil monetary penalty laws against beneficiary inducements
The U.S. Department of Health and Human Services’ Office of Inspector General (HHS-OIG) recently released Advisory Opinion No. 24-13, a favorable opinion assessing the federal Anti-Kickback Statute (AKS) and civil monetary penalty laws against beneficiary inducements (CMP) as applied to assistance for certain travel, lodging, meals, and associated expenses for qualifying patients receiving a cell therapy product targeting tumors. To qualify patients must: 1) be residents of the United States or a U.S. territory, 2) have income at or below 600 percent of the federal poverty level, 3) meet program distance requirements, and 4) have an on-label prescription. The advisory opinion was requested by the manufacturer of the cell therapy product.
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