Despite efforts to closely coordinate the proposed changes to the Stark law and the Anti-Kickback Statute, healthcare providers may still be left interpreting and navigating two sets of slightly different rules and standards.
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February 2020
It also stated that “an arrangement may be commercially reasonable even if it does not result in profit for one or more of the parties,” indicating that no party has to actually profit from an arrangement to infer commercial reasonableness.
The OIG’s proposed definition places emphasis on the reasonableness of an arrangement itself, setting aside any referrals generated, and states that a “commercially reasonable arrangement is an arrangement that would make commercial sense if entered into by reasonable entities of a similar type and size, even without the potential for referrals.”
Public Comment Period Closed
The proposed changes to the Stark law and AKS were open for public comment through Dec. 31, 2019. Although the proposed rules aim to clarify these confusing laws, considerable ambiguity remains. Healthcare providers should continue to exercise caution in forming value-based arrangements and business relationships that don’t fit neatly into a Stark exception or one of the AKS safe harbors.
Steven M. Harris, Esq., is a nationally recognized healthcare attorney with McDonald Hopkins LLC. Contact him at sharris@mcdonaldhopkins.com.
Reprinted with permission from the American College of Rheumatology.