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Final Rules Published in the Federal Register Extend Protections of Electronic Health Record Donations

electronic health record donationsOn Dec. 27, 2013, final rules were published in the Federal Register by the Office of Inspector General and the Centers for Medicare & Medicaid Services. These rules amend regulations protecting certain arrangements involving the donation of electronic health records (EHR) software or information technology and training services related to such EHR software from the Anti-Kickback Statute and Stark law. The final rules are nearly identical to one another and make five primary changes to the EHR provisions:

  • Extend the protections for EHR donations until Dec. 31, 2021
  • Exclude laboratory companies from the types of protected entities that may donate EHR items and services
  • Update the provisions pursuant to which an EHR donor or recipient can determine if the EHR is interoperable; software is now deemed interoperable “if, on the date it is provided to the [physician or other] recipient, it has been certified by a certifying body authorized by the National Coordinator for Health Information Technology to an edition of the electronic health record certification criteria identified in the then- applicable version of 45 CFR part 170.”
  • Eliminate the provisions that require donated EHR software to include electronic prescribing capability
  • Clarify the requirement that prohibits donors from taking any action that limits or restricts the use, compatibility, or interoperability of donated items or services

The amendments to the Anti-Kickback safe harbor are available here. (We have identified that the following link is no longer active, and it has been removed)

Other than the sunset provisions that extend the EHR protections to Dec. 31, 2021 - which go into effect Dec. 31, 2013 - the amended regulations will be effective as of March 27, 2014.

For more information regarding the changes please contact Gary McRay at gmcray@fosterswift.comor Nicole Stratton at

Categories: Electronic Health Records, Providers

Photo of Gary J. McRay

Gary has nearly 40 years of experience and has earned a reputation for handling sophisticated transactions for hospitals, managed care organizations, HMOs, health insurers, physician groups and other provider entities and for helping his clients stay on top of complex regulatory issues, such as Anti-Kickback Statute, Stark II, Medicare, Medicaid, and BCBSM reimbursement appeals. 

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