Reed Smith Client Alerts

The Centers for Medicare & Medicaid Services (CMS) recently released proposed new regulations (the Proposed Rule) under the Ethics in Patient Referrals Act (known as the Stark Law) that include numerous consequential interpretations of and changes to the Stark Law regulations that are of general applicability and will have a widespread effect on health care providers. These proposals, if finalized, should reduce the burden of compliance and the risks of noncompliance with the Stark Law; however, they will not resolve all ambiguities under the highly technical Stark Law, and health care industry participants may want to submit comments to help CMS address those areas.

The release of CMS's proposal was coordinated with the contemporaneous release by the Office of Inspector General (OIG) of the Department of Health and Human Services of proposed new regulations under the Anti-Kickback Statute (AKS) and the Civil Monetary Penalties law. Together, these proposals represent sweeping changes to current federal fraud and abuse laws. In addition to the Stark Law proposals that are of general applicability, the proposals include new and revised Stark Law exceptions and AKS safe harbors for value-based arrangements and for donations of electronic health records and cybersecurity technologies.

Reed Smith is providing a series of client alerts and teleseminars that focus on analyzing key aspects of the CMS and OIG proposals and significant areas for comment. This client alert is Part Two of that series, and addresses the Stark Law proposals of general applicability. Our teleseminar discussing these proposals will take place on November 12, 2019 and you can register through Webinar Requests. Part One, which focuses on the proposed AKS safe harbors and Stark Law exceptions for value-based arrangements, is available on demand and was discussed on our teleseminar on November 5, 2019. The Part Three client alert will examine the OIG and CMS proposals involving donations of electronic health records and cybersecurity technologies, with a teleseminar following on November 21, 2019. We hope this series will give clients the context needed to consider and submit comments before December 31, 2019, the date on which comments are due.