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HHS Seeks Comments on Easing Stark Law Burdens

HHS Seeks Comments on Easing Stark Law Burdens

The Centers for Medicare & Medicaid Services has requested public input on how the physician self-referral law, or Stark Law, may be interfering with care coordination. To help accelerate the transformation to a value-based system that includes care coordination, HHS has launched a Regulatory Sprint to Coordinated Care. The Regulatory Sprint is focused on identifying regulatory requirements or prohibitions that may act as barriers to coordinated care, assessing whether those regulatory provisions are unnecessary obstacles to coordinated care, and issuing guidance or revising regulations to address such obstacles and, as appropriate, encouraging and incentivizing coordinated care.

On June 25, 2018, HHS published in the Federal Register a Request for Information seeking comments on the structure of arrangements between parties that participate in alternative payment models or other novel financial arrangements and the need to revise or expand exceptions to the Stark Law. CMS states “CMS is aware of the effect the physician self-referral law may have on parties participating or considering participation in integrated delivery models, alternative payment models, and arrangements to incent improvements in outcomes and reductions in cost.” CMS has also engaged stakeholders through comment solicitations in several recent rulemakings. In 2017, through the annual payment rules, CMS asked for comments on improvements that can be made to the health care delivery system that reduce unnecessary burdens for clinicians, other providers, and patients and their families.

CMS is interested in the public’s thoughts on issues that include 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, and terminology related to alternative payment models and the physician self-referral law. Specifically, CMS requested stakeholders’ thoughts on important definitions and/or concepts such as defining “commercial reasonableness,” “fair market value” and “take into account the volume or value of referrals” by a physician.

While the Request for Information does not mean HHS will make any changes to Stark, it is encouraging that CMS recognizes the many roadblocks Stark causes to legitimate arrangements involving physicians.

The Request of Information is available online at https://federalregister.gov/d/2018-13529.

Jim Hoover is a partner at Burr & Forman LLP practicing exclusively in the firm’s Health Care Industry Group. Burr & Forman LLP is a partner with the Medical Association.

Posted in: Legal Watch

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