On June 25, 2018, the Centers for Medicare & Medicaid Services (CMS) published a request for information (the RFI) regarding the federal Physician Self-Referral (Stark Law) law, aiming to reduce barriers to value-based and coordinated-care arrangements. Comments are due by 5 p.m. EDT on August 24, 2018.
The RFI represents one of the first major opportunities for stakeholders to seek new, favorable exceptions and adjustments to the Stark Law in several years. CMS’ request comes as the Trump Administration continues to push coordinated and value-based care models, and to identify regulatory barriers to the move from fee-for-service.
The Stark Law is intended to limit the effect of physician financial incentives on utilization, patient choice, and competition. However, due to its strict and ambiguous regulatory scheme, CMS identified aspects of the Stark Law that it suspects could create regulatory burdens and barriers to parties participating in or considering participation in integrated delivery models, alternative payment models, and arrangements that incentivize improvements in outcomes and reductions in cost.
Specifically, CMS identified numerous areas that could implicate the Stark Law and its regulations, as currently written, including: alternative payment models (e.g., accountable care organizations and bundled payment models); care integration and coordination between providers; and risk-sharing arrangements. Furthermore, CMS signaled willingness to address typical Stark Law stumbling blocks, including how to determine “commercial reasonableness” and “fair market value,” as well as what it means to “take into account the volume or value of referrals” in the value-based care context.
Thus, CMS is requesting information on 20 separate topics related to the Stark Law and value-based care, ranging from requests for additional Stark Law exceptions to Stark Law specific definitions of value-based care terminology, compliance costs and effectiveness of the Stark Law in its current form. This wide range of questions will allow commenters to address virtually any Stark Law provision, or lack of exception, as they relate to value-based care.