Final Rules Published in the Federal Register Extend Protections of Electronic Health Record Donations
On 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 (We have identified that the following link is no longer active, and it has been removed)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 nstratton@fosterswift.com.
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Best Lawyers® 2021
Congratulations to the attorneys of the Health Care practice group at Foster Swift Collins & Smith, PC for their inclusion in the Best Lawyers in America 2021 edition. Firm-wide, 44 lawyers were listed. Best Lawyers lists are compiled based on an exhaustive peer-review evaluation and as lawyers are not required or allowed to pay a fee to be listed; inclusion in Best Lawyers is considered a singular honor. Health Care practice group members listed in Best Lawyers are as follows:
- Jennifer B. Van Regenmorter, Holland
To see the full list of Foster Swift attorneys listed in Best Lawyers 2021, click here.