HHS Encourages Value-Based Arrangements with New Exceptions to the Stark Law and Anti-Kickback Statute

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On October 9, 2019, the U.S. Department of Health and Human Services (HHS) released two proposed rules that aim to modernize the Anti-Kickback Statute and the Stark Law that allow greater utilization of value-based arrangements and encourage care coordination. The Anti-Kickback Statute is a federal law that prohibits the exchange of anything of value for referrals of health care services, while the Stark Law is a federal law that prohibits health care providers from referring Medicare and Medicaid patients to an entity that they have a financial interest in. These proposals follow the request for information that the agency issued last year regarding changes to the Anti-Kickback Statute and are responsive to many of the issues raised by stakeholders.

To address confusion over compliance with the Stark Law, HHS has included clarification on when a referral can be excepted from the law’s prohibition on self-referral. Additionally, HHS has created new exceptions that would provide greater flexibility for health care providers to enter into mutually beneficial arrangements, such as cybersecurity. Regarding the Anti-Kickback Statute, HHS has proposed to create new safe harbors that will exclude value-based arrangements from the law’s prohibitions with the goal of improving care coordination between providers. Additionally, HHS has proposed to create a new safe harbor for arrangements that improve patient engagement and arrangements that include outcomes-based payments.

The regulations will be open for comment until December 31, 2019.

Read the press release from HHS here.

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