The Centers for Medicare and Medicaid Services (CMS) is seeking public comment on the burdens imposed by the Stark Law. Specifically, on June 25, 2018, CMS published in the Federal Register a Request for Information (RFI) on how to address “any undue impact and burden” that Stark Law places on providers. Comments on the RFI must be received by CMS by no later than 5 p.m. on August 24, 2018.

Beginning in 2017, CMS sought comments through the annual payment rules on how to improve the healthcare delivery system and reduce unnecessary burdens. CMS notes in the RFI that one of the top areas of concern identified in the over 2,600 comments received to date is compliance with the Stark Law and its accompanying regulations. CMS states that as “a result of our review of these comments, and with a goal of reducing regulatory burden and dismantling barriers to value-based care transformation, while also protecting the integrity of the Medicare program, we are requesting additional information in this RFI.”

CMS is seeking input on a range of Stark Law issues “to help better understand provider concerns and target its regulatory efforts to address those concerns.”  In particular, the RFI identifies the following twenty (20) areas for provider feedback and comment, several of which involve alternative payment models:

1. Existing or potential arrangements that involve DHS entities and referring physicians that participate in alternative payment models or other novel financial arrangements;
2. What, if any, additional exceptions to the Stark Law are necessary to protect financial arrangements between DHS entities and referring physicians who participate in the same alternative payment model;
3. Possible approaches to address the application of the Stark Law to financial arrangements among participants in alternative payment models;
4. Definitions of critical terminology such as alternative payment model, care coordination, clinical integration, risk and risk sharing, among others;
5. What, if any, additional exceptions to the Stark Law are necessary to protect financial arrangements that involve integrating and coordinating care outside of an alternative payment model;
6. When, in the context of alternative payment models and other novel financial arrangements, compensation should be considered to “take into account the volume or value of referrals” by a physician or “take into account other business generated” between parties to an arrangement;
7. The utility of the current exception at 42 C.F.R. § 411.357(n) for risk-sharing arrangements;
8. The utility of the special rule for compensation under a physician incentive plan within the exception at 42 C.F.R. § 411.357(d) for personal service arrangements;
9. The identification and suggestion of definitions for other terminology relevant to the comments requested in the RFI;
10. Possible approaches to defining “commercial reasonableness” in the Stark Law exceptions;
11. Possible approaches to modifying the definition of “fair market value” in the Stark Law exceptions consistent with the statute;
12. When compensation should be considered to “take into account the volume or value of referrals” by a physician or “take into account other business generated” between parties to an arrangement;
13. Whether barriers exist to qualifying as a “group practice” under the regulations at 42 C.F.R. § 411.352;
14. The application and utility of the current exception at 42 C.F.R. § 411.357(g) for remuneration unrelated to DHS;
15. Any provisions, definitions, and/or exceptions in the regulations at 42 C.F.R. §§ 411.351 through 411.357 for which additional clarification would be useful;
16. The role of transparency in the Stark Law;
17. Whether and how CMS could design a model to test whether transparency safeguards (other than those currently contained in the Stark Law) could effectively address the impact of financial self-interest on physician medical decision-making;
18. Compliance costs for regulated entities;
19. Identifying any recent studies assessing the positive or negative effects of the Stark Law on the healthcare industry; and
20. Whether CMS should measure the effectiveness of the Stark Law in preventing unnecessary utilization and other forms of program abuse relative to the cost burden on the regulated industry and, if so, how CMS could estimate this.

CMS notes that HHS “is working to transform the healthcare system into one that pays for value” and that “[c]are coordination is a key aspect of systems that deliver value.”  As a part of this process, HHS has launched what it calls a “Regulatory Sprint to Coordinated Care” that includes the RFI. Specifically, CMS states that “[a]ddressing unnecessary obstacles to coordinated care, real or perceived, caused by the physician self-referral law is one of CMS's goals in this Regulatory Sprint.”

The RFI is available in its entirety here. CMS’s press release regarding the RFI can be found here. CMS Administrator Seema Verma also posted on CMS’s blog a discussion about CMS’s intent on issuing the current RFI, which can be found here.