“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…”
“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)…” Read the full article here.
Source: OIG and CMS propose sweeping changes to fraud and abuse regulations – Nancy Bonifant Halstead, Kimberly J. Gold, Vicki J. Tankle, and Rebecca E. Dittrich, November 20, 2019. Reed Smith.
