OIG Does Not Impose Sanctions on Drug Manufacturers for Providing Financial Assistance to Pediatric Patients with Rare Immunodeficiency Disorder
3/30/2023
In advisory opinion No. 23-01, issued on February 17, 2023, the Office of Inspector General (OIG) declined to impose sanctions on a drug manufacturer that provided financial assistance for transportation, lodging, and meals to financially needy pediatric patients and their caregivers in connection with the drug manufacturer’s drug. The advisory opinion analyzed whether the arrangement implicated the Anti-Kickback Statute (AKS) and the beneficiary inducement civil monetary penalty rules (Beneficiary Inducements CMP).
Although the OIG determined that the arrangement implicated the AKS because it would generate prohibited remuneration if the requisite intent were present, the OIG did not impose sanctions under the AKS because the unique facts presented collectively reduced the risk of potential for fraud and abuse. Such facts included the following:
•The drug is a one-time potentially curative treatment.
•The drug is the only treatment available to rebuild the patient’s immune system.
•The condition is very rare.
