Almost to the Finish Line: Proposed Stark and Anti-Kickback Rules Await Finalization

As the health care system moves from volume-based to value-based care models, the industry is eager to modify federal laws and regulations to enhance patient-centered collaboration. HHS, CMS and OIG have been considering changes to the Stark Law and Anti-Kickback Statute regulations for several years now and finally came out with the proposed rules in October of 2019. Hall Render analyzed the implications of this proposed rule in this article. The comment period for the proposed rule ended on December 31, 2019.

HHS delivered the Stark and Anti-Kickback proposed rules to the Office of Management and Budget (“OMB”) on July 21 for final review. However, OMB’s timeline for finalizing them is uncertain. Providers, and other supporters of the rule, want the OMB to clear the changes as soon as possible as the likelihood of final regulations greatly decreases the closer we get to the November election.

Industry stakeholders are rallying to push the administration to move forward. For example, more than 120 health care companies, associations and patient advocacy groups recently submitted a letter to President Trump to intervene and bring this critical work across the regulatory finish line. As the Healthcare Leadership Council-led letter puts it, with the finalization of these rules, “victory can be claimed in the name of helping patients get better coordinated care and (by) reducing overall healthcare costs.”

Why Is This Important?

The Stark Law and the Anti-Kickback Statute were created in the era of fee-for-service medicine. In the current transition to value-based care, though, they are serving as daunting legal barriers to the kind of working relationships that deliver optimal health outcomes. If finalized, the new rules would be a step in the right direction to help modernize and streamline these laws and regulations while offering health care providers additional flexibility to provide patient-centered and value-based care.

For more information on the Stark and Anti-Kickback Statute proposed rules or to learn about the advocacy effort to finalize the rules, contact: