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Key Takeaways
The OIG’s recent guidance serves as an important reminder that:
- Satisfying the Stark Law or one of its exceptions does not automatically eliminate AKS risk;
- Safe harbor protection only exists when every element of the safe harbor is satisfied; and
- The OIG continues to focus heavily on intent and the totality of the circumstances when evaluating health care arrangements.
The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) recently published updates to FAQ #4 of its FAQs on Fraud and Abuse Authorities, emphasizing key considerations for the analysis of potential Anti-Kickback Statute violations.
The OIG reiterated an arrangement is only afforded safe harbor protection if it satisfies every element of the applicable safe harbor. The OIG stated unequivocally that there is “no safe harbor protection for partial compliance.”1 If an arrangement fails to meet even one required element, the arrangement falls outside the safe harbor and must instead be evaluated based on the totality of the circumstances, including the intent of the parties. Additionally, an arrangement with fair market value remuneration is good practice, but alone, is insufficient to ensure compliance with the Anti-Kickback Statute and its accompanying safe harbors.
Further, the OIG underscored that compliance with the Stark Law, or one of its exceptions, does not ensure compliance with the Anti-Kickback Statute. The OIG gave the example of sporting event tickets. Under the Stark Law, providing tickets to a physician who makes referrals for designated health services may fit under the non-monetary compensation exception. However, there is no such exception under the Anti-Kickback Statute, and the OIG would look to the intent of the parties and totality of the circumstances. The fact that an arrangement satisfies the Stark Law is not dispositive when considering compliance with the Anti-Kickback Statute. Although frequently paired, the two fraud and abuse statutes remain wholly independent of each other.
The OIG’s position is clear: parties to any financial arrangement must ensure compliance with the separate and distinct requirements of the Stark Law and the Anti-Kickback Statute. While not required, if a party wants full protection under an Anti-Kickback Statute safe harbor, it must meet every element of the safe harbor.
Footnote
1. https://oig.hhs.gov/faqs/general-questions-regarding-certain-fraud-and-abuse-authorities/
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