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The COVID-19 Public Health Emergency (PHE) is set to officially end on May 11, 2023 and with it several extraordinary regulatory flexibilities will end as well. In the early days of COVID-19, the Department of Health and Human Services (HHS), Centers for Medicare and Medicaid Services (CMS), and other related agencies waived or modified numerous health regulations that were tied to the public health emergency.
While some waivers and exemptions were extended in the recent Consolidated Appropriations Act of 20231, like the waivers related to provision of telehealth services, others did not receive the same treatment. Notably, following the termination of the PHE, Stark Law2 blanket waivers and related anti-kickback statute (AKS)3 discretion are set to end. As such, healthcare providers will once again be required to comply with all Stark Law and AKS requirements.
The Stark Law, also known as the physician self-referral law, generally prohibits any person from billing Medicare for designated health services furnished by an entity with whom the referring physician has a financial relationship. The COVID-19 era waivers exempted providers from sanctions for certain arrangements that were solely COVID-19 related, namely, diagnosis, treatment, and ensuring access to medical care and related services. The Stark Law blanket waivers exempted 18 types of remuneration and referrals. These exemptions included remuneration for personal services and office space that were above or below fair market value as well as physician referrals to home health agencies and in-office ancillary services.
The AKS is a criminal statute that prohibits the knowing and willful exchange of anything of value in an effort to induce or reward the referral of items or services reimbursable by federal healthcare programs. While the PHE did not generate AKS waivers, the OIG issued a policy statement in 2020 that it would not impose sanctions under the AKS on arrangements that satisfied the Stark Law waivers.
The end of these waivers means that providers will not be able to rely on the flexibilities that have been in place for the past several years. The current iterations of the Stark Law and the AKS are not the same as they were pre-pandemic. The Stark Law and AKS have been in place for many years and are amended periodically to adapt to the changing healthcare landscape. For example, the Consolidated Appropriations Act of 2023 has introduced exceptions for physician wellness programs.4 It is highly recommended that all providers evaluate their financial arrangements with physicians for compliance with Stark Law and the AKS and remediate or terminate any deficient arrangements.