HHS-OIG Declines to Impose Sanctions on Drug Manufacturer for Financial Assistance to Pediatric Patients With Rare Disease
Highlights
HHS-OIG declined to impose administrative sanctions on drug manufacturer for providing financial assistance to beneficiaries in specific and limited circumstances
HHS-OIG highlighted the FDA limitation on administering the drug to a single site as reducing the likelihood that financial assistance will induce beneficiaries to use a specific provider
The drug’s status as the only curative treatment for the severely immunocompromised population reduces the risk that the assistance creates risk under the Anti-Kickback Statute
On Feb. 23, 2023, the Office of Inspector General of the U.S. Department of Health and Human Services (HHS-OIG) issued Advisory Opinion No. 23-01 regarding sanctions against a drug manufacturer for providing transportation, lodging and meals assistance to needy pediatric patients and their caregivers in connection with using the manufacturer’s drug.
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