CMS is seeking input on ways to reduce the regulatory burdens of the physician self-referral law (commonly known as the Stark Law), particularly as it relates to the ongoing effort to transition from a fee-for-service to a value-based system. On June 20, 2018, the Centers for Medicare & Medicaid Services ("CMS") issued a request for information ("RFI"), acknowledging that certain aspects of the Stark Law may serve as barriers to participation in newer integrated delivery or alternative payment models.
Specifically, CMS is soliciting public comment on 20 areas covering a variety of key Stark Law concepts, including:
Examples of commercial alternative payment models or other novel financial arrangements that may be adversely impacted by the requirements of the Stark Law;
Additional exceptions to the Stark Law that may be necessary to protect such financial arrangements;
Identifying and suggesting possible modifications to the law's definitions of "commercial reasonableness," "fair market value," "volume or value of referrals," and "other business generated";
Comments on any barriers to qualifying as a "group practice" under existing regulations; and
General comments pertaining to the effectiveness of the law in preventing unnecessary utilization and referrals relative to the regulatory cost burden imposed on the health care industry.
As you can see, public comment and CMS's responses have the potential to fundamentally alter the application of the Stark Law (and related laws like the Anti-Kickback Statute and False Claims Act). We recommend interested parties take advantage of this unique opportunity to voice their opinions on the regulatory costs and burdens imposed by the Stark Law.
Public comments on the RFI will be accepted until 11:59 p.m. on August 24, 2018, and can be electronically submitted at http://www.regulations.gov by following the "Submit a comment" instructions, or may be mailed to:
Centers for Medicare & Medicaid Services,
Department of Health and Human Services,
P.O. Box 8013,
Baltimore, MD 21244-8013.