HHS released two long-awaited final rules that revise the Physician Self-Referral Law (Stark Law), and the Anti-Kickback Statute (AKS). The rules seek to promote value-based arrangements by creating new exceptions to the Stark Law, additional safe harbors under the AKS and new definitions of key terms. The changes are effective January 19, 2021, with the exception of the Stark Law’s definition of “group practice,” which is set for January 1, 2022. While President-elect Biden may put a hold on these rules until his Administration reviews them, a total reversal is unlikely given the bipartisan support for regulatory modernization. Efforts to continue perfecting these rules are more likely; for example, members from the House’s Health Care Innovation Caucus announced that they will pursue additional changes. For a detailed summary of the new rule on Stark, click here and for AKS, here. [Included are] key highlights from the rules…

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