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OIG, CMS release Final Rule for the Stark Exception, Anti-Kickback Safe Harbor for Electronic Health Records (EHR) Donation

While the donation of a valuable item such as an EHR program would raise fraud and abuse concerns, exemptions under Stark Law and Anti-Kickback Safe Harbor were designed to encourage the widespread implementation of EHR and to let smaller providers accept gifts of EHR software without violating the law or statute.

The final rule for the EHR Anti-Kickback safe harbor and Stark exception, effective March 27, 2014

  1. updates the provision under which electronic health records software is deemed interoperable;
  2. removes the requirement related to electronic prescribing capability;
  3. extends the safe harbor’s sunset date to December 31, 2021;
  4. limits the scope of protected donors to exclude laboratory companies; and
  5. clarifies the condition that prohibits a donor from taking any action to limit or restrict the use, compatibility, or interoperability of the items or services.

The final rule modified an existing safe harbor, which once effective will allow the voluntary donation of EHR software until the sunset date of December 31, 2021. While the final rule extends the safe harbor until December 31, 2013, any donation of EHR items and services that occurs between January 1, 2014 and the effective date of the remaining provisions of the final rule (March 27, 2014) will need to comply with all the conditions of the existing safe harbor.

To read the final rule in full:

By Denise Bloch

Denise Bloch

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