HHS tackles barriers to value-based care: Part two – Substantial Stark Law regulatory revisions proposed

Along with proposed Stark Law exceptions designed to accommodate value-based care models, the Centers for Medicare & Medicaid Services (CMS or the agency) proposed additional revisions to the Stark Law regulations (the proposed rule) on 9 October 2019.

The proposed revisions, which include extensive clarifications on many Stark Law requirements that have long been viewed as unduly burdensome for compliance-oriented health care providers, are part of the Trump administration's goal to reduce regulatory compliance burdens through a "Regulatory Sprint to Coordinated Care." They follow and incorporate feedback from corresponding requests for information the agency issued in summer 2018.

These additional proposals and guidance do not expressly relate to value-based care, but help clarify or reduce some of the more difficult hurdles and technical pitfalls of the Stark Law that hinder greater collaboration among providers and physicians. This alert (part two) summarizes these important Stark Law proposals. Part one of this client alert, available here, focused on the administration's proposals to allow and encourage the shift toward value-based payment under both the anti-kickback statute (AKS) and Stark Law, as well as other key AKS proposals.

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