Anti-Kickback Statute and Stark Law Final Rules

December 7, 2020


The agencies modified the final regulations in a manner that accepted a number of the AMA's recommended changes from the proposed rule, including not limiting a target patient population to patients with at least one chronic condition; extending the “pre-risk” period from six months as proposed, to 12 months in the full financial risk exception; and not requiring the value-based enterprise or its accountable body or responsible person to have a compliance program or to review patient medical records periodically. The Stark and AKS final rules give an effective date of January 19, 2021, for most of the provisions, with the exception of certain changes to the definition of a “group practice,” which have an effective date of January 1, 2022, to give physician practices additional time to adjust their compensation methodologies.

NOTE: There are fundamental differences in the statutory structure, operation, and penalties between the Stark Law and the AKS, and as a result, complete alignment between the exceptions to the Stark Law and safe harbors to the AKS is not feasible. The differences between the two rules create somewhat of a dual regulatory environment, where a value-based arrangement could meet the requirements for protection under one law but not the other, which could hinder the transition to a value-based health care delivery and payment system. CMS, in the final rule, acknowledged the “dual regulatory environment” and the challenges for stakeholders in ensuring compliance with both. The AMA strongly recommends physicians consult with health care counsel experienced in the federal Stark Law and AKS laws and regulations prior to taking any actions in association with the CMS and OIG final published rules.

The text of the final CMS rule can be accessed here.

The text of the final OIG rule can be accessed here.

More detailed information will be provided as it is developed.