Healthcare Law Alert: Updates to Stark and Anti-kickback Laws Support Wellness Programs for Physicians and Other Health Care Providers

The Consolidated Appropriations Act for 2023 (H.R.2617, 117th Cong.), which was signed into law in late December 2022, contains two changes in federal statutes that regulate financial relationships between physicians and other health care providers and entities to which they refer patients whose care is covered by certain federally funded health care programs, like Medicare.  A new exception to the federal physician self-referral prohibition, or “Stark” law, and a new carveout from the federal Anti-kickback statute, permit the affected entities to provide “a bona fide mental health or behavioral health improvement or maintenance program” to physicians (for purposes of the Stark law) and to a broad range of health care providers (for purposes of the Antikickback statute).  These changes, along with many others in this massive spending package, reflect the Biden Administration’s focus on mental health supports.

Both changes permit entities to provide free counseling, mental health services, suicide prevention programs and/or substance use disorder prevention and treatment programs to health care professionals for free or at reduced costs.  The primary purpose of such programs must be to prevent suicide, improve mental health and resiliency, or provide training in appropriate strategies that promote the mental health and resiliency of the applicable health care providers. To be protected by the new laws, programs must be set out in a written policy and approved in advance (i.e. before implementation) by the governing body of the sponsoring entity.  There are fairly prescriptive requirements for the written policies, including descriptions of the “evidence-based support” for the design of the program and how its use and success will be evaluated.  The program must also be open to all similarly situated physicians and other clinicians who practice in the geographic area served by the sponsoring entity (including those who are not bona fide members of the entity’s medical staff) on the same terms and conditions and without regard to the volume or value of the physician’s or clinician’s referrals to the sponsoring entity.

Currently, only programs offered by hospitals, ambulatory surgical centers, community health centers, rural emergency hospitals and skilled nursing facilities are entitled to the protections afforded by the new laws.  However, the statutes grant the Secretary of Health and Human Services authority to expand eligible entities by regulation.

This communication is for informational purposes and is not intended as legal advice.