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The federal prohibitions on self-referrals and kickbacks, known as the Stark Law and Anti-Kickback Statute (“AKS”), have received new changes for calendar year (“CY”) 2023. Significant among the changes are (1) a new Stark Law exception and AKS safe harbor for healthcare entities offering mental health programs to physicians, and (2) updated disclosure protocols for physician practices who failed to qualify as “group practices” as defined under the Stark Law.
Stark Law Exception for Physician-Focused Mental Health Programs
Section 4126 of the 2023 Consolidated Appropriations Act (P.L. No: 117-328) introduced a new Stark Law exception and AKS safe harbor for physician wellness programs. Under the exception and safe harbor, healthcare entities are allowed to provide certain mental and behavioral health programs to physicians and other clinicians.
Under the new exception, the program must be offered by a healthcare entity with a formal medical staff to all physicians who practice in the geographic area served by the entity. This includes physicians who hold bona fide staff appointments or clinical privileges at the entity. The program must further:
- Be offered on the same terms and conditions to all such physicians and without regard to the volume or value of referrals or other business generated by a physician for the entity;
- Consist of counseling, mental health services, a suicide prevention program, or a substance use disorder prevention and treatment program; and
- Have a written policy that includes a description of the program’s content and duration and evidence-based support for the design of the program, estimated cost of the program, personnel conducting the program, and a method for evaluating the program’s use and success.
The AKS safe harbor essentially mirrors the Stark Law exception. However, the new safe harbor also applies to non-physician clinicians, thereby permitting healthcare entities to provide bona fide mental health or behavioral health improvement or maintenance programs to physicians and other clinicians. Notably, however, the safe harbor does not statutorily apply to rural health clinics.
Although the text of the 2023 Consolidated Appropriations Act appears to make the exception and safe harbor immediately effective and was signed into law in December 2022, the corresponding provisions of the United States Code (“U.S.C.”) do not yet reflect the changes.
New Stark Law Disclosure Protocol – Failure to Qualify as a “Group Practice”
The Centers for Medicare & Medicaid Services (“CMS”) recently updated its Voluntary Self-Referral Disclosure Protocol (“SRDP”) to reflect new disclosure requirements for practices that fail to qualify as a “group practice” under the Stark Law. The SRDP is the self-reporting mechanism by which Medicare providers and suppliers can notify CMS of an actual or potential violation of the Stark Law, which may have resulted in an overpayment. Failure to qualify as a “group practice” under the meaning of the Stark Law may be a self-reportable event if the practice determines it improperly relied upon the group practice exception despite failing to meet the requisite criteria.
Effective March 1, 2023, with certain exceptions, self-disclosure for physician practices who failed to qualify as a group practice under 42 C.F.R. § 411.352 must include: (1) the SRDP Disclosure Form; (2) the Group Practice Information Form; (3) a Financial Analysis Worksheet; and (4) an acceptable Certification. Moreover, CMS has issued updated disclosure forms that require different information and supporting documentation than previous SRDP forms. Accordingly, a practice seeking to utilize the SRDP to report their failure to qualify as a group practice must use updated forms in support of their SRDP submission.
Additional information regarding the recent changes to the CMS SRDP may be found here.
