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CMS Extends Deadline for Publishing Stark Final Rules

  • August 28, 2020

The Centers for Medicare & Medicaid Services (CMS) announced this week a one-year extension to August 31, 2021 of the timeline for finalizing proposed changes to the Stark Law.

The Spring 2020 unified agenda indicated the final rule would be issued in August 2020, but CMS said in an August 27 Federal Register notice (85 Fed. Reg. 52940) that it was “still working through the complexity of the issues raised by comments received on the proposed rule” and wouldn’t be able to issue the rule by August 31. 

On Twitter, CMS Administrator Seema Verma signaled the extension shouldn't be viewed as a delay of the Stark rule and said that the agency "is working hard to finalize it." 

Efforts to clarify and modernize the fraud and abuse laws began in 2018 as part of the Regulatory Sprint to Coordinated Care initiative to facilitate the shift to a value-based health care system. CMS and the Department of Health and Human Services Office of Inspector General (OIG) issued proposed rules to reform the Stark Law and Anti-Kickback Statute in October 2019.

The changes are aimed at offering health care providers more flexibility to coordinate and improve care for patients, while maintaining important guardrails for preventing overutilization and fraud and abuse.

The Stark proposed rule, among other things, would create new, permanent exceptions to the Stark Law for value-based arrangements and includes additional clarifications and guidance on key statutory terms and other technical compliance requirements.

For an overview of the proposed rules, see Julie E. Kass and Kristin M. Bohl, Extensive Changes to the Stark and Anti-Kickback Statute Regulations Are Designed to Remove Barriers to Innovation and Create Clarity, Health Law Weekly (Oct. 11, 2019).

The final rules for the Stark and AKS have been under review at the Office of Management and Budget since July 21.

A number of health care organizations recently urged the administration to issue the final Stark and AKS rules as soon as possible. Seventy House lawmakers issued a similar plea in a bipartisan letter to OMB.

“While the final rules were an important consideration before the current public health emergency, the emergence of COVID-19 across the nation has further highlighted the urgent need for improved coordination and alignment among health care stakeholders to achieve the best result for patients while restraining cost. Now more than ever, completing the final rules can provide critical support to our healthcare system,” the letter said.

OIG has not issued a similar notice regarding the AKS final rule.