Lorna Breen Act leads to new physician wellness Stark exception and AKS safe harbor

Although the issue of physician burnout and its impact on physicians and health systems has been a well-recognized problem in recent years, like many other areas of behavioral health, it was brought to the forefront during the pandemic.

The Lorna Breen Act

Lorna Breen, MD was an experienced emergency room physician in New York, who, according to family members, had no known history of mental illness. However, she took her own life after months of dealing with the COVID-19 pandemic. Unfortunately, she was not alone among healthcare providers who were on the front lines of COVID-related complications and deaths, requiring unrelenting hours of work and resulting physical and emotional fatigue. This exacerbated burnout and caused a spike in suicides among healthcare professionals, which led to the passage of the Lorna Breen Act in March 2022, as part of President Biden's larger plan to tackle a national mental health crisis.

Among other initiatives, the Lorna Breen Act established grants that are available to healthcare entities (including hospitals) for training health care professionals in evidence-informed strategies to reduce and prevent suicide, burnout, mental health conditions and substance use disorders, and provide peer-support programming and behavioral health treatment.

Congress continues to prioritize the behavioral health of healthcare professionals. Among various other mental health initiatives, the 2023 Consolidated Appropriations Act (signed into law at the end of 2022) included a new exception to the Stark Law and a new safe harbor to the Anti-Kickback Statute, which help facilitate the goals of the Lorna Breen Act. The new exception and safe harbor aim to remove barriers a provider may face when seeking to provide wellness programs to physicians and other clinicians free of charge.

The New Stark Law Exception and AKS Safe Harbor

Under the new Stark Law exception (added at Section 1877(e) of the Social Security Act (42 U.S.C. 1395nn(e)(9)), hospitals and certain other types of providers with formal medical staffs may offer evidence-based wellness programs to physicians without running afoul of the Stark Law. Key requirements of the new exception include that the wellness program (i) be set forth in a written policy that includes the estimated costs of the program, (ii) consist of counseling, mental health services, a suicide prevention program, or a substance use disorder prevention and treatment program and (iii) be made available to a physician for the primary purpose of preventing suicide, improving mental health and resiliency, or providing training in strategies to promote the mental health and resiliency of such physician.

It is notable that the new exception also requires that such programs be offered to all physicians who practice in the geographic area served by the provider and not just physicians who hold appointments to the provider's medical staff. A safe harbor with similar provisions was also added to the Anti-Kickback Statute (Section 1128B(b)(3) of the Social Security Act (42 U.S.C. 1320a-7b(b)(3)(L)), except such safe harbor also protects programs offered to non-physician clinicians.

Creating a program that will be offered to all physicians (and, per the safe harbor, non-physician clinicians) that practice in the community, even those who are not on the provider's medical staff, may be difficult for entities to operationalize. Providers will want to evaluate the feasibility of this, and consider how it could market such programs beyond its medical staff. Additionally, many providers already offer wellness programs to employed physicians, and hospital medical staffs are required by the Joint Commission to establish early intervention processes to manage practitioner health issues.

While there may be some limitations to the new exception and safe harbor, such regulations will offer health systems with an additional tool to address burnout and other mental health issues that arise among its staff. Regulations for the new Stark exception may come in late summer/early fall, in either the CY 2024 Medicare Physician Fee Schedule or CY 2024 Medicare Hospital Outpatient Prospective Payment System proposed rules. Ideally the corresponding regulations for the new safe harbor will be issued contemporaneously with the CMS regulations so that the public can compare and contrast any additional requirements.