Potential Delay in Long-Awaited Stark Law and Anti-Kickback Statute Rules

A January 20, 2021 memo issued by the Biden Administration may freeze the implementation of the Stark Law and Anti-kickback Statute (“AKS”) final rules that went into effect on January 19, 2021. According to the U.S. Government Accountability Office (“GAO”), the final rules did not meet the 60-day delay required by the Congressional Review Act (“CRA”). The 60-day delay provides members of Congress the opportunity to oppose rules issued by federal agencies.

While the health care industry has anticipated the implementation of the new rules meant to allow greater flexibility for providers to engage in value-based care, it is unclear whether the Biden Administration will freeze the final rules, re-issue the final rules with new effective dates or attempt to revise the rules. Until clarity is provided, providers should not rely on the new Stark Law exceptions or AKS safe harbors when evaluating compensation arrangements.

Please contact the authors of this alert or a member of the Health Care Team with any questions.