Last week, the U.S. Centers for Medicare & Medicaid Services (“CMS”) released a Request for Information (“RFI”) that seeks feedback from stakeholders in the healthcare industry on possible regulatory changes to the Stark Law. CMS has expressed concern that the Stark Law may have a negative effect on alternative payment models, integrated delivery models, and other novel value-based arrangements. According to a CMS press release, this RFI is part of efforts to remove “unnecessary government obstacles to care coordination” and to “put[] value and results at the forefront of care.” This effort appears to be consistent with concerns expressed by CMS Administrator Seema Verma in a blog post earlier this year, in which she noted that the Stark Law “may prohibit some relationships that are designed to enhance care coordination, improve quality, and reduce waste.”

The goal of the RFI, per CMS, is to collect comments relating to “reducing regulatory burden and dismantling barriers to value-based care transformation, while also protecting the integrity of the Medicare program.” In the RFI, CMS requests information in 20 different specific areas, focusing on the following major themes:

  • the structure of arrangements between parties that participate in alternative payment models or other novel financial arrangements
  • the need for revisions or additions to exceptions to the physician self-referral law
  • terminology related to alternative payment models and the physician self-referral law

This RFI reflects ongoing attempts to modernize and liberalize the Stark Law, including significant regulatory changes in 2015 that were designed to provide relief from some of the technical requirements in various Stark exceptions. Courts are beginning to grapple with how these changes impact health care providers, including in a False Claims Act decision we covered on this blog last year.

CMS is accepting comments via an electronic docket from now through August 24, 2018.

*Special thanks to Hayley White for assistance in preparing this post.