HHS-OIG Draws Legal Boundaries for Patient Caregiver Support Provided by Biotech Company
Highlights
The HHS-OIG released a favorable opinion regarding a biotechnology company providing travel support and an unfavorable opinion regarding the company providing fertility services support
The travel support satisfies the “promote access to care exception” to the civil monetary penalty against beneficiary inducements (CMP) and includes factors that limit risk under CMP and Anti-Kickback Statute
The fertility support does not qualify for any exception, and includes prohibited remuneration under both the CMP and Anti-Kickback Statute
The HHS-OIG determined there was insufficient data regarding the fertility support to conclude a low risk of fraud and abuse
The U.S. Department of Health and Human Services’ Office of Inspector General (HHS-OIG) recently released Advisory Opinion No. 24-05, a favorable opinion regarding the federal Anti-Kickback Statute (AKS) and civil monetary penalty laws against beneficiary inducements (CMP) as applied to travel, lodging, meals, and other travel expense assistance to patients and caregivers provided by a biotechnology company, and an unfavorable opinion regarding the company’s provisions of fertility preservation services.
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