Member Article

The White House has completed the final review to clear a path for the Department of Health and Human Services (HHS) to publish the final rule to modernize and clarify regulations promulgated for the Stark Law and Anti-Kickback Statute.

In June 2018, HHS Deputy Secretary Eric Hargan announced a regulatory reform initiative entitled the “Sprint to Coordinated Care.” The effort focused on the barriers within the Stark and Anti-Kickback Laws that have created obstacles to care coordination and new value-based models.

In furtherance of the HHS’s Regulatory Sprint to Coordinated Care, the Office of Inspector General (OIG) and Centers for Medicare and Medicaid (CMS) issued proposed rules in October 2019 found here and here.The proposed rules included changes to address the regulatory impact and burden of Stark Law and the Anti-Kickback Statute. Public comments on the proposal were due by last December.

CMS and OIG initially announced that the final rule would be issued in August and the Office of Management and Budget website indicated that the final rules were received for review in July. However, in August, the agencies extended the timeline for publication of the final rule to August 31, 2021, found here.The agencies stated the delay to the final rule was to help regulators work “through the complexity of the issues raised by comments received on the proposed rule.”

Ahead of schedule, the Office of Management and Budget completed the final review on November 18, 2020, found here. With the White House review completed, the new rules should be published at any time.

Click here to read more.