CMS Punts on Revisions to the Stark Anti Kickback Regulations

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The Centers for Medicare & Medicaid Services (CMS) issued a notice extending the deadline to finalize significant proposed changes to the Physician Self-Referral Law, commonly known as the Stark Law, that were announced last year. Originally, CMS published a proposed rule on the issue in October 2019.

The proposal offered a number of changes designed to reduce regulatory burden associated with the Stark Law. The proposed rule would create more exceptions to the Stark Law that enables private sector and other arrangements. The rule would require providers to spell out the arrangements, indicate the patient population affected, and what the outcomes will be.

Stakeholders and CMS

Stakeholders have been pressing CMS to issue both long-awaited final rules. Although CMS announced on June 30, 2020, that it would issue the final rule in August 2020, CMS is pushing the timeframe for finalizing the CMS rule until August 2021. The CMS notice published on the Federal Register said that the agency is “still working through the complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date.” However, Administrator Verma disputes that characterization, tweeting that the agency is “not delaying the Stark rule and is working hard to finalize it.

As described the above, CMS’s proposed rule includes sweeping changes and clarifications to the Stark Law welcomed by health care providers. CMS proposed new value-based enterprise Stark Law exceptions, as well as a number of modifications to existing exceptions frequently relied upon by health care providers, including the rental of office space and rental equipment exception and the fair market value exception. Additionally, the proposed rule includes a number of proposed changes to several key requirements that appear in numerous Stark Law exceptions, including the volume or value standard, the referral requirement, the AKS compliance requirement, and the writing and signature requirements.

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