CMS recently published a proposed rule that, if finalized, would fundamentally change and alleviate the manner in which the Stark Law regulatory framework has traditionally applied.
I. Proposed New Exception for Arrangements That Facilitate Value-Based Health Care Delivery and Payment
Current Regulatory Text: None
Proposed New Regulatory Definitions: CMS proposes to codify, at 42 CFR §411.357(aa), a new regulatory exception potentially applicable to “value-based arrangements” that satisfy the following proposed new regulatory definitions, which would be codified at 42 CFR §411.351:
“Value-based arrangement means an arrangement for the provision of at least one ‘value-based activity’ for a ‘target patient population’ between or among—
(1) The ‘value-based enterprise’ and one or more of its ‘VBE participants’; or
(2) VBE participants in the same value-based enterprise.