United States: OIG And CMS Modify AKS Safe Harbor And Stark Law Exception For EHR Donations - Jones Day

United States: OIG And CMS Modify AKS Safe Harbor And Stark Law Exception For EHR Donations - Jones Day

This  Commentary is part of a series of nine  Commentaries on the newly finalized Stark Law and Anti-Kickback Statute exceptions and safe harbors seeking to remove regulatory barriers to care coordination.


In Short


The Situation: In light of the now widespread adoption of electronic health records ("EHR") technology, the U.S. Department of Health and Human Services Office of Inspector General ("OIG") and Centers for Medicare & Medicaid Services ("CMS") proposed modifications in October 2019 to modernize protections for EHR donations under the Anti-Kickback Statute ("AKS") and the Stark Law. The goal of the proposed modifications was to expand EHR donation protections in the regulatory safe harbor and exception and to realign them with industry needs regarding EHR technology.


The Action: OIG and CMS coordinated to finalize similar revisions to the EHR items and services safe harbor under the AKS (42 C.F.R. § 1001.953(y)) and exception under the Stark Law (42 C.F.R. § 411.357(w)) ("Final Rules"). These Final Rules encourage the broader adoption and increased interoperability of EHR technology.


Looking Ahead: Finalized revisions modernize the AKS safe harbor and Stark Law exception for EHR technology donations to bring EHR protections in line with current industry practices and to encourage the continued adoption of the most current technology. 



On November 20, 2020, following months of coordination, OIG and CMS issued their Final Rules revising the AKS safe harbor and the Stark Law exception, respectively, for donations of EHR items and services. Although the agencies adopted some of the revisions they had proposed in October 2019 in connection with EHR donations, their final revisions are more modest. Because of the agencies' coordination, however, the revisions are consistent across both ..

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