By Kristin M. Bohl and Samantha C. Flanzer
CMS issued a Request for Information (RFI), seeking input from the public on how best to address and mitigate any “undue regulatory impact and burden” of the physician self-referral law (“Stark Law”). The RFI, filed on June 20, 2018, signals a willingness on the part of CMS to consider revisions of the Stark Law to accommodate new payment models. While the RFI is largely focused on the intersection of the Stark Law and care coordination models, it also seeks public input on potential changes to core tenants of the Stark Law – e.g., regarding the definition of “commercial reasonableness” and when compensation should be considered to “take into account other business generated” between parties to an arrangement.
Highlights of those areas CMS is requesting public input include:
- To what extent the Stark Law currently impacts commercial alternative payment models, and to what extent additional Stark Law exceptions may be necessary to protect such arrangements;
- The current utility of the risk-sharing arrangement Stark Law exception;
- To what extent it may be prudent for CMS to add a “special rule for compensation under a physician incentive plan” within the current Stark Law personal services arrangements exception;
- Possible approaches to defining “commercial reasonableness” and “fair market value”;
- When compensation should be considered to “take into account the volume or value of referrals” by a physician or “take into account other business generated” between parties to an arrangement (both inside and outside the context of alternative payment models);
- What barriers exist to qualifying as a “group practice” under the Stark Law;
- How CMS could interpret the exception for remuneration unrelated to designated health services (DHS) to cover a broader array of arrangements; and
- The role of transparency in the context of the Stark Law, (e.g., how transparency about a physician’s financial relationship may reduce or eliminate harms to the Medicare program and its beneficiaries that the Stark Law is intended to address).
While this is certainly not the first time CMS has requested public input on potential revamps to the Stark Law, this RFI may nonetheless signal increasing momentum for Stark Law reform within the government.
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