CMS seeks input on Stark Law and other regulatory issues

07.03.18

The Centers for Medicare and Medicaid Services (CMS) recently issued a Request for Information (RFI) seeking public comment regarding aspects of the Stark Law and alternative payment models. In 2017, CMS published an RFI asking for comments about how to reduce unnecessary regulatory burdens in the healthcare system. Based on comments received from that RFI, CMS has now crafted an RFI specifically tailored to the Stark Law. This RFI notes that both the Department of Health and Human Services (HHS) and CMS are committed to transforming the healthcare system into one that pays for value. According to HHS and CMS, care coordination is a key aspect of a value-based delivery system, and they are looking for ways to reduce barriers to care coordination. 

While the RFI seeks comments on 20 issues, the key elements can largely be sorted into three categories:

1. Stark Law

• Suggested additions or changes to the following aspects of the Stark Law:
• Additional exceptions needed to protect those who participate in alternative payment models
• Additional exceptions needed to protect those who participate in integrating and coordinating care outside of an alternative payment model
• The utility of the existing exception for risk-sharing arrangements
• General approaches to address the application of the Stark Law in the context of alternative payment models and novel financial arrangements
• Barriers to qualifying as a group practice
• Costs of compliance with the Stark Law

2. Alternative Payment Models and Novel Financial Arrangements

• Explanation of existing or potential arrangements, including a discussion of the following:
• Scope of the arrangement
• Items/services provided through the arrangement
• How the arrangement mitigates the financial incentives for inappropriate self-referrals

3. Definitions

• Suggested additions or changes to the definitions of a variety of terms, including the following:
• Clinical integration
• Risk-sharing
• Commercial reasonableness
• Fair Market Value

Of course, not many stakeholders would object to the goals of enhancing value and improving coordination of care, however, the “devil will be in the details” of what is proposed and ultimately adopted. To be sure, interest groups will seek modifications that benefit their constituents, and there will be winners and losers when the process is complete. It is critical for organizations impacted by the Stark Law to participate in this process and effectively communicate their perspectives. Depending on which proposals gain traction, stakeholders will need to find additional opportunities to engage with policymakers.

The period for public comment is open until 5:00 pm on August 24, 2018. Waller is available to assist stakeholders in preparing and filing comments related to this RFI and provide additional advocacy as needed.