HHS issues significant changes to Stark and Anti-Kickback Statute

November 21, 2020 

Yesterday, the U.S. Department of Health and Human Services published the most promising changes to the Stark Law and the Anti-Kickback Statute (AKS) in a generation. Modernizing these laws has been a priority for LUGPA for years and this represents a culmination of years of effort by LUGPA’s Health Policy and Political Affairs apparatus. LUGPA has been front and center of a broad coalition of aligned stakeholders in achieving this goal. Without this victory, independent practices would continue to be at a disadvantage as value-based compensation systems gain steam. LUGPA's efforts promoting Stark reform have been comprehensive, and have included developing and introducing reform legislation in Congress which has highlighted this issue, and engaging the administration at the highest levels within HHS and CMS. This rule is a major victory not only for LUGPA, but the independent physician community as a whole.

For historical context, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) signaled a shift away from fee-for-service payment structures to Alternative Payment Models and other value-based care and payment systems, but most of the original flexibilities created under federal fraud and abuse laws focused on ACOs and hospitals. On initial review, it appears that the Stark and AKS Final Rules will provide important protections for independent physicians entering into value-based payment arrangements.

Specifically, The Stark Final Rule establishes a series of new exceptions to Stark’s self-referral prohibitions to protect value-based arrangements (VBAs). Those exceptions will apply regardless of whether the arrangement relates to care furnished to Medicare beneficiaries or other patients. These exceptions will apply to protect VBAs without the medical provider needing to obtain pre-approval from a government agency in order to develop, implement and participate in the VBA. These are self-executing exceptions. In other words, if the participants in the VBA comply with the terms of the exceptions, they are protected from Stark’s self-referral prohibitions.  

You can find brief descriptions of the new exceptions in the CMS Stark Law Final Rule Fact Sheet.
The AKS Final Rule implements seven new safe harbors, modifies four existing safe harbors, and codifies one new exception under the Beneficiary Inducements Civil Monetary Penalty. These safe harbors and exception are meant, in large part, to parallel the new Stark exceptions—for the purpose of promoting coordinated, value-based care. 

You can find brief descriptions of the new and modified safe harbors in the HHS-OIG AKS Final Rule Fact Sheet.  

For those interested in reviewing the Final Rules themselves, you can find them here:

Stark Final Rule (627 pages): https://public-inspection.federalregister.gov/2020-26140.pdf
AKS Final Rule (1,049 pages): https://public-inspection.federalregister.gov/2020-26072.pdf

LUGPA is continuing to closely monitor regulatory activity and will continue to keep you updated on breaking news.