HHS-OIG Issues Favorable Opinion on Free Vaccines Offered by Drug Manufacturer to Patients Receiving Its Treatments
Highlights
A favorable opinion from HHS-OIG involves a drug manufacturer covering the costs of meningococcal vaccines for patients with increased risk of infections due to the manufacturer’s drug treatments
The HHS-OIG found the proposed arrangement improved patient safety and access to treatment for several different rare disorders
The proposed arrangement included several factors that limited risk under the CMP and Anti-Kickback Statutes
The U.S. Department of Health and Human Services’ Office of Inspector General (HHS-OIG) recently released Advisory Opinion 24-11, a favorable opinion regarding the federal Anti-Kickback Statute (AKS) and civil monetary penalty laws against beneficiary inducements (CMP) as applied to free meningococcal vaccines provided by a drug manufacturer for patients who receive its treatments. The advisory opinion was requested by the manufacturer of infusion treatments for rare disorders whose treatments greatly increase a patient’s risk of meningococcal infections.
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