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CAA Includes New Stark Law Exception/Anti-Kickback Statute Safe Harbor for Physician Wellness Programs 

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The Consolidated Appropriations Act (CAA) of 2023 includes a new Stark Law exception and Anti-Kickback Statute (AKS) safe harbor that allows hospitals and other health care entities with formal medical staffs to offer physicians a “bona fide mental health or behavioral health improvement or maintenance program.” (See CAA, §4126.)  

To qualify for this new Stark Law exception/AKS safe harbor, a physician wellness program must meet requirements that include:  

  1. The program’s primary purpose is to prevent suicide, improve mental health and resiliency, or provide training to promote mental health and resiliency. 
  1. The program consists of counseling, mental health services, a suicide prevention program, or a substance use disorder prevention and treatment program. 
  1. The program is set out in a written policy adopted in advance of the program’s operation by the entity’s governing body. This written policy must, among other things, describe the content and duration of the program, the evidence-based support for the design of the program, its estimated cost, the personnel conducting it and their qualifications, and the method by which the entity will evaluate the use and success of the program. Notably, the program may not be limited only to physicians who are members of the entity’s medical staff; rather, it must be offered to all physicians practicing in the geographic area served by the entity, including members of the medical staff. Finally, the program must be offered to all physicians on the same terms and conditions and without regard to the volume or value of referrals or other business generated by a physician for the entity. 

This new exception and safe harbor align with last year’s Lorna Breen Health Care Provider Protection Act, which authorizes the federal Department of Health and Human Services to award grants to hospitals and other health care entities for evidence-based programs to improve mental health and resiliency for health care professionals. Consequently, entities can use Lorna Breen Act grant funds for these physician wellness programs without violating the Stark Law or AKS.