Long-Awaited Stark and Anti-Kickback Regulations Published

On Friday, November 20, the U.S. Department of Health and Human Services (HHS) published the long-awaited final rules revising regulations related to the Physician Self-Referral Law (known commonly as the Stark Law), the Anti-Kickback Statute (AKS), and the Civil Monetary Penalty Law (CMP). The revised regulatory framework for these two laws is intended to reduce barriers to care coordination and promote alternative payment models that focus on increasing value and delivering care in a more efficient and coordinated way.  

This effort was referred to by HHS as the “Regulatory Sprint to Coordinated Care.” Even though the rules may have been delayed in part by the current pandemic, they still are being finalized roughly 30 months after HHS first sought comment from healthcare community stakeholders – a remarkable achievement given the breadth and scope of changes.

Among the items addressed in the final rules:

• Final versions of three new value-based exceptions to the Stark Law, and corresponding new AKS safe harbors and guidance from OIG, intended to incentivize stakeholders to provide better-coordinated care to patients through alternative payment models. 

• Changes to key Stark Law definitions of “fair market value,” “commercial reasonableness,” and the “volume or value” standard. 

• New broader AKS safe harbor for cybersecurity technology to assist with the urgent problem of cyber threats facing the healthcare industry.  

• Clarifying key profit-sharing provisions in the Stark Law’s Group Practice definition and related provisions.

The final rules take effect on January 19, and given the intervening holiday season, we recommend that industry stakeholders quickly evaluate which transactions might be affected or require adjustment ahead of the effective date. 

If you have questions about how Stark and Anti-Kickback regulations will affect your facility’s operations and/or transactions, please contact us.