Reed Smith Client Alerts

In an age when health information is moving online at lightning speed through increasingly interconnected and interoperable systems and products, the Centers for Medicare & Medicaid Services (CMS) and the HHS Office of Inspector General (OIG), have offered protections to cybersecurity tools, electronic health records (EHRs), and other digital health technologies under the proposed regulations to modernize the Physician Self-Referral Law (the Stark Law), the Federal Anti-Kickback Statute (AKS), and the Civil Monetary Penalties Law (CMP Law). Below we offer the key takeaways from the proposed regulations that, if finalized, would protect donations of EHRs and cybersecurity technology and services under the AKS and Stark Law - by both expanding existing protections and creating new ones. We also examine protections offered under the new value-based arrangement framework to companies providing digital health technologies, and the potential impact on those companies that may be excluded as value-based participants.

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. Part One, which focused on the proposed AKS safe harbors and Stark Law exceptions for value-based arrangements, is available at and was discussed during our teleseminar on November 5, 2019. Part Two, which examined the Stark Law proposals of general applicability, is available at and was discussed during our teleseminar on November 12, 2019. 

This client alert is Part Three of that series and considers the digital health perspective. Specifically, we analyze below (1) whether and how digital health companies can participate in value-based arrangements, (2) the creation of a new safe harbor and exception for the donation of cybersecurity technology and services, and (3) revisions to the EHR donation safe harbor and exception (including removal of the sunset provision). Our teleseminar discussing these proposals will take place on November 21, 2019, and you can register through Webinar Requests

We hope this series will give clients the context needed to consider and submit comments before we ring in the New Year on December 31, 2019 (the comment due date).