HHS Delays Stark Law Reforms One Year

HHS says "complexity of the issues raised by comments received on the proposed rule" pushed the date back to August 2021.

The much-anticipated final rule updating physician self-referral and anti-kickback laws has been pushed back for one year, the Department of Health and Human Services announced this week.

"We are still working through the complexity of the issues raised by comments received on the proposed rule," HHS Deputy Executive Secretary Wilma M. Robinson wrote in a public notice, "and therefore we are not able to meet the announced publication target date."

Instead, she said, the timeline has been pushed back to August 31, 2021.

The news was a disappointment for the American Hospital Association, which earlier this month had urged the Office of Management and Budget for an "expeditious review and release of the Physician Self-Referral and Anti-Kickback Statute final regulations" that the Centers For Medicare & Medicaid Services had submitted in July.

The AHA has long complained that the Stark Law prohibiting physician self-referrals is a major hindrance in the transition to value-based care, and that the proposed reforms would “provide space for the types of innovative arrangements among hospitals and physicians that can enhance care coordination, improve quality and reduce costs." 

The proposal would create new and permanent exceptions to the 30-year-old Stark Law for value-based arrangements, permitting physicians and other providers to try innovating solutions without fear that their legitimate efforts to coordinate care might violate the law, according to an agency fact sheet.

Those new exceptions would apply for Medicare and non-Medicare populations alike.

AHA General Counsel Melinda Hatton on Wednesday "strongly urged CMS to move more quickly to finalize these improvements."

"This is an extremely disappointing setback for hospital and health system efforts to continue to innovate coordinated care arrangements, which have great potential to benefit patients, lower costs and make care more accessible for everyone," she said.

The proposed rule was first unveiled in October 2019, as part of the Trump administration's "Patients Over Paperwork" initiative.

"We serve patients poorly when government regulations gather dust in the attic: they become ever more stale and liable to wreak havoc throughout the healthcare system," CMS Administrator Seema Verma said at the time.