ARTICLE
11 November 2019

Critical Analysis Of CMS' Proposed Stark Law Changes

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Sheppard Mullin Richter & Hampton

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Sheppard Mullin is a full service Global 100 firm with over 1,000 attorneys in 16 offices located in the United States, Europe and Asia. Since 1927, companies have turned to Sheppard Mullin to handle corporate and technology matters, high stakes litigation and complex financial transactions. In the US, the firm’s clients include more than half of the Fortune 100.
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.
United States Food, Drugs, Healthcare, Life Sciences

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.

Linked here is your complimentary copy of Sheppard Mullin's Critical Analysis of the proposed changes, as well as operational and structural changes that your organization could consider to harness the flexibility offered by the potential changes. While comprehensively discussing the proposed rule, the Critical Analysis focuses on CMS' most important proposals, among which include (1) a broad and flexible exception for 'value-based arrangements', (2) confining definitions of when compensation 'takes into account' the volume or value of referrals, and is 'commercially reasonable', (3) limiting the scope of the Stark Law's application to only those compensation arrangements that 'relate' to the provision of DHS, and (4) a new exception for annual, undocumented remuneration of up to $3,500. The Critical Analysis also describes the two Stark Law proposals that may imperil your organization's current operations, i.e., the limitation on the methodologies by which Group Practices may distribute DHS-related profit shares and productivity bonuses, and the restriction on the use of the Isolated Transactions exception to shelter one-time payments for services previously rendered.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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