CMS and OIG Issue Final Rules Extending EHR Stark Law Exception and AKS Safeharbor to December 31, 2021


On December 27, 2013, CMS published a final rule in the Federal Register revising the previously enacted exception to the Stark law that permits certain arrangements involving the donation of electronic health records (EHR) items and services.  On the same day, the Department of Health and Human Services Office of Inspector General (OIG) finalized almost identical changes to the EHR safe harbor under the Federal Anti-Kickback Statute (AKS).  The Stark EHR exception and the AKS EHR safe harbor had been scheduled to sunset on December 31, 2013.  Among other things, the final rules extend the expiration date of the exception and safe harbor to December 31, 2021.

Except as noted below, both the CMS and OIG final rules are effective March 27, 2014.  In the final rules, CMS and OIG have:

  • extended the expiration date of the exception and safe harbor to December 31, 2021.  This change is effective December 31, 2013.
  • excluded laboratory companies from the types of entities that may donate EHR items and services.  
  • updated the provision under which EHR software is deemed interoperable.
  • clarified regulatory requirements that prohibit any action that limits or restricts the use, compatibility, or interoperability of donated items or services.
  • removed from the exception and safe harbor the requirement related to electronic prescribing capability.

Access to CMS’s Final Rule governing the EHR Stark law exception is available by clicking here.  Access to the OIG’s Final Rule governing the EHR AKS safe harbor is available by clicking here.

Reporter, Ramsey Prather, Atlanta, + 1 404 572 4624,

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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