As part of its “Regulatory Sprint to Coordinated Care,” the Centers for Medicare & Medicaid Services (CMS) is seeking input on how it can address “unnecessary obstacles to coordinated care, real or perceived, caused by the physician self-referral law.” CMS Administrator Seema Verma acknowledged in a recent blog post that “[i]n its current form, the physician self-referral law may prohibit some relationships that are designed to enhance care coordination, improve quality, and reduce waste.”  To that end, CMS has published a notice soliciting comments on the effect the physician self-referral law, also known as the Stark Act, may have on participation in integrated delivery models, alternative payment models (APMs), and other coordinated care arrangements.

The notice poses 20 detailed questions covering such areas as:

  • The structure of existing or potential arrangements that involve designated health services (DHS) and referring physicians that participate in APMs or other novel financial arrangements, including how risk is apportioned.
  • Whether/how “the arrangement mitigates the financial incentives for inappropriate self-referrals, and/or overutilization of items and services, and patient choice.”
  • The need for revisions or additions to the Stark exceptions to apply to APMs and novel financial arrangements, including whether any such exceptions should address individual DHS referrals, ownership or investment interests, and/or compensation arrangements.
  • Terminology under the physician self-referral law, including both new definitions for such terms as APMs and care coordination, and possible modifications to exiting terminology (e.g., fair market value, and how, in the context of APMs, compensation should be considered to ‘‘take into account” the volume or value of referrals or other business generated).
  • The appropriate role of transparency in the context of the physician self-referral law.

CMS will accept comments until August 24, 2018.  CMS does not commit to undertaking future rulemaking in response to this request for information.  However, Administrator Verma does expect the input will “help the agency better understand provider concerns and target its regulatory efforts to address those concerns.”