This post was also written by John Wyand. On December 27, 2013, the Office of Inspector General and the Centers for Medicare & Medicaid Services each published, in the Federal Register, a final rule that amends regulations protecting, from the Anti-Kickback Statute and Stark law, certain arrangements involving the donation of interoperable electronic health records (EHR) software or information technology and training services related to such EHR software. The final rules:

  • Extend the protections of the Stark law exception (42 C.F.R. § 411.357(w)) and the Anti-Kickback safe harbor (42 C.F.R. § 1001.952(y)) from December 31, 2013 to December 31, 2021 (the “sunset” provisions)
  • Exclude laboratory companies from the types of entities that may donate EHR items and services
  • Update the provisions under which an EHR donor or recipient can ascertain, with certainty, that EHR is interoperable pursuant to the exception and safe harbor (the “deeming” provisions)
  • Remove the requirements that donated EHR include electronic prescribing capability
  • Clarify the requirement prohibiting any action that limits or restricts the use, compatibility, or interoperability of donated items or services

Click here to view the amendment to the Stark law exception; and click here to view the amendment to the Anti-Kickback safe harbor. With the exception of the amendments to the sunset provisions, which go into effect December 31, 2013, the amended regulations will be effective as of March 27, 2014. Reed Smith will prepare a comprehensive Client Alert on the final rules, which will be published shortly. Reed Smith lawyers have significant experience advising clients on EHR technology issues and will continue to monitor regulatory changes in this area. For more information regarding how we can assist you, please contact your principal Reed Smith lawyer or a lawyer listed in this publication.