There has been a recent groundswell of support for modifying or eliminating the federal physician self-referral law, commonly known as the Stark Law. Last month’s Request for Information by the Centers for Medicare & Medicaid Services (CMS), seeking public comment, was the most prominent example. However, the wave of changes and proposed changes began slowly picking up steam a few years ago, with some changes to Stark going into effect on January 1, 2016.At present, there appears to be a general industry consensus that Stark reform, as well as potentially revising the Medicare and Medicaid Anti-Kickback Statute, is necessary in order for the ongoing shift from fee-for-service medicine to value-based care to continue unimpeded. Notably, two former Department of Health and Human Services Secretaries, Kathleen Sebelius and Tommy Thompson, authored a July 17 opinion piece in The Hill, “Overcoming health-care challenges by moving from volume to value,” urging changes to the Stark Law and Anti-Kickback Statute. The authors advocate that unaffiliated healthcare providers must be free to collaborate financially, as in “bundled payment” models, to offer or receive financial incentives without them being considered unlawful inducements to refer patients, and to coordinate patient care with one another in order to reduce costs to the system as a whole.
Most recently, CMS’s proposed rule containing revisions to the Medicare Physician Fee Schedule for 2019, released on July 12, included proposed revisions to CMS’s regulations enforcing the Stark Law. The proposals primarily address liberalization of Stark’s writing and signature requirements, such as allowing a collection of informal written materials to evidence compliance with Stark even when no single, definitive written agreement exists between two parties. While not earthshaking in themselves, these proposals illustrate CMS’s desire to continue whittling away at the periphery of the Stark Law, pending potential Congressional action to amend Stark in a more sweeping manner.