October 15, 2019

HHS Releases Proposed Rules Reforming Stark and Anti-Kickback Regulations

Holland & Knight Healthcare Blog
Miranda A. Franco

The U.S. Department of Health and Human Services (HHS) released long-awaited proposed rules intended to reduce regulatory barriers to healthcare arrangements, including value-based care models. Over the last 30 years, HHS has issued a series of regulations establishing exceptions and safe harbors that limit the reach of the Stark Laws civil penalties and the Anti-Kickback Statute's (AKS) criminal; however, until now, these rules have not reflected the significant shift in healthcare delivery from fee-for-service to models based on improving value.

The proposed rules would create new protections under the AKS and Stark Law for healthcare entities engaging in value-based arrangements, allowing "value-based enterprises" to design and participate in certain "value-based activities."A value-based arrangement would be required to have a "value-based purpose" related to coordinating and managing care, improving quality of care, reducing the cost, and/or transitioning to healthcare delivery and payment mechanisms based on the quality of care and control of costs of care. The proposed rules define these terms in greater detail as they apply to the AKS and Stark Law.

Read the full memo from Holland & Knight Senior Policy Advisor Miranda Franco to learn more.

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