The Consolidated Appropriations Act, 2023 (CAA) includes new exceptions to the Physician Self-Referral Law (Stark Law) and the federal Anti-Kickback Statute (AKS), allowing certain healthcare entities to provide mental health or behavioral health improvement and/or maintenance programs to physicians and other clinicians. The Stark Law prohibits physicians from referring patients for certain designated health services payable by Medicare to an entity with which the physician (or an immediate family member) has a financial relationship, unless an exception applies, and prohibits such entities from filing claims with Medicare for the referred designated health services. Similarly, the AKS makes it a crime for any person to knowingly and willfully offer, pay, solicit or receive any remuneration to induce a person to make referrals for items or services that may be covered by Medicare or another federal healthcare program.
The new exceptions under the CAA apply to wellness programs offered on or after December 29, 2022. To qualify for the Stark wellness program exception, codified at 42 U.S.C. 1395nn(e)(9), the program must be a bona fide mental health or behavioral health improvement or maintenance program offered to a physician by an eligible entity, such as hospitals, ambulatory surgical centers, community health centers, rural emergency hospitals, rural health clinics, skilled nursing facilities or similar entities, as determined by the HHS Secretary. The program must meet specific requirements, including being evidence-based, conducted by a qualified health professional, and set out in a written policy approved in advance by the governing body.
The AKS wellness program exception largely matches the language and program types set out in the Stark wellness program exception but includes clinicians in addition to physicians. Parties to potential transactions with eligible entities should inquire about such programs in due diligence and make sure such programs comply with the applicable requirements.
AUTHOR: Ayesha Mehdi is a partner in the healthcare group at Spencer Fane, LLP, and provides legal counsel to healthcare practitioners and closely-held healthcare businesses in the Las Vegas Greater Area. With expertise in corporate, transactional, regulatory, and licensure matters, Ayesha offers comprehensive support to clients in the Nevada healthcare industry. Ayesha has authored multiple publications on healthcare law and is also a sought-after speaker at regional and national seminars and conferences organized by legal and healthcare associations. If you require legal assistance for your healthcare business or practice, Ayesha is available to help. You can reach her at amehdi@spencerfane.com or 7
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