By Kim Stanger, J. Malcolm DeVoy, and Amber Ellis

On November 20, 2020, CMS and the OIG published their much anticipated amendments to the federal Stark and Anti-Kickback laws. As summarized in our recent client alert, the changes open the door to value-based contracting with potential referral sources. They also modify existing regulations and create new safe harbors applicable to provider relationships.

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By Amber Ellis and J. Malcolm DeVoy

On November 20, 2020 the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of the Inspector General (OIG) issued two final rules to modernize and clarify the Physician Self-Referral regulations (the Stark Law, or Stark) and the Anti-Kickback Statute (AKS) safe harbor regulations. These new final rules generally take effect on January 19, 2021.

The prior Stark and AKS regulations were developed in a volume-based health care delivery and payment system. Over time, and with the rise of data that could be used by providers and payers to better anticipate patient needs and payment for them, concern arose that the existing regulations and policies would potentially inhibit the innovation necessary for moving toward a value-based system of care and payment. These new final rules aim to alleviate those concerns and advance the transition to value-based care and encourage the coordination of care among providers, while continuing to provide important safeguards to protect against fraud, abuse, and overutilization. Continue reading →