Although the Anti-Kickback Statute (AKS) aims to prevent financial incentives that could influence medical decision-making, its enforcement can be misguided. Attempts to thwart illegal kickbacks can unintentionally deter arrangements made with the best of intentions — high quality patient care. This is particularly true when it comes to arrangements between lab owners and physicians.
What do lab owners need to know about the application of the AKS in these types of arrangements?
In 2015, the Office of Inspector General (OIG) issued an advisory opinion highlighting potential violations related to exclusive arrangements between laboratories and physician practices. The opinion involved a proposal from a laboratory seeking exclusive arrangements with physician practices. The lab intended to provide all lab services for these practices, waiving out-of-network fees for patients whose insurance might direct them elsewhere.
The OIG’s response was clear: such arrangements could be seen as kickbacks, as they offer benefits to physicians that might influence their choice of lab services. This decision added complexity to existing regulations, emphasizing that kickbacks encompass more than just gifts or direct payments.
How does this apply to current arrangements?
Officials continue to crackdown on potential AKS violations. As such, it is important for lab owners to conduct regular internal audits to review current arrangements for compliance. Key indicators that can flag a potential violation can include:
- Exclusive arrangements: Offering exclusive services to physician practices can trigger investigations, especially if these arrangements include financial incentives or benefits.
- Fee waivers: Waiving fees for out-of-network patients might be perceived as a kickback, as it provides a financial advantage to physicians and their patients.
- Volume-based incentives: Providing discounts or benefits based on the volume of referrals can violate the statute, as it encourages increased referrals for financial gain.
It is important to keep the OIG’s 2015 advisory opinion in mind when reviewing current and putting together new arrangements. Remember that kickbacks can take many forms, extending beyond traditional gifts or payments. Lab owners must remain informed and proactive in identifying potential violations of the AKS. Legal guidance from an attorney with experience in this niche area of law can help to better ensure compliance.
Attorney John Rivas is responsible for this communication.
