UPDATE as of January 27, 2021

While neither the AKS Final Rule nor the Stark Final Rule addressed in the below Client Resources have been withdrawn by CMS, the effective dates of each of the Final Rules is unclear and may be subject to a regulatory postponement and further review by the new Administration. Following publication in the Federal Register, the Government Accountability Office (GAO) has since found that the effective dates identified in each of the AKS and Stark Final Rules (January 19, 2021) violate the Congressional Review Act (requiring major rules to take effect 60 days after publication in the Federal Register or after Congress receives the rules, whichever is later). As a result, per the GAO, the effective dates for each of the Final Rules should have been a date following President Biden’s inauguration, which would subject the Final Rules to the Memorandum for the Heads of Executive Departments and Agencies issued by Chief of Staff Ronald Klain on January 20, 2021. The Memorandum requests that heads of agencies postpone the effective dates for rules that have not taken effect prior to noon on January 20, 2021.  As of this update, neither the OIG nor CMS has published further guidance in the Federal Register related to either of the Final Rules. 

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As part of its efforts under the Regulatory Sprint, CMS and the OIG issued new exceptions and safe harbors through the Stark Law Final Rule and the AKS Final Rule, respectively (the “Final Rules”). The Final Rules generally become effective January 19, 2021; however, changes under the Stark Law Final Rule to the group practice rules relating to profit shares and productivity bonuses will become effective on January 1, 2022. 

We have authored a White Paper and two supplemental client resources (all linked below) to provide a thorough overview of the upcoming changes under the Final Rules.

White Paper

VBA Exceptions and Safe Harbors Under the Stark Law and AKS Final Rules

Client Resources

Something Good from 2020: Greater Stark Law Flexibility
Expanded Availability of Anti-Kickback Statute Safe Harbors

If you have any questions regarding these resources, please contact one of the authors, listed below, or any member of Kutak Rock’s National Healthcare Practice Group.