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CMS issues long-awaited Stark proposed rulemaking

Hannah L. Cross ( is a Health Law Attorney in the Washington, DC offices of Nelson Mullins.

On October 17, 2019, the Centers for Medicare & Medicaid Services (CMS) published a notice of proposed rulemaking (the proposed rule) to update and amend the Stark Law regulations.[1] Stakeholders have long awaited this proposed rule after CMS issued a Request for Information (RFI) on June 25, 2018, for public input on how to address the regulatory burdens of the Stark Law. Considering those comments, CMS issued this proposed rule to introduce new exceptions addressing value-based care arrangements, and to clarify and introduce new exceptions addressing non-abusive compensation arrangements. More than 330 pages long, the proposed rule is the first stand-alone Stark rulemaking in over a decade. This article explores a selection of aspects of the proposed rule.

Simultaneously with the proposed rule, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) issued a companion notice of proposed rulemaking introducing new exceptions, amendments, and clarifications to the Anti-Kickback Statute (AKS) and Civil Monetary Penalties (CMP) regulations. A companion article summarizing and discussing the OIG proposed rule (“OIG proposed rule revises federal Anti-Kickback Statute and CMP Law”) can be found in this issueof Compliance Today.

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