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HHS extends Stark exception and safe harbor rule for EHR donations

January 10, 2014
Area(s) of Interest: Electronic Health Records Health Information Technology 


The U.S. Department of Health and Human Services Office of the Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) issued final rules revising and extending, through 2021, the Stark Law exception and fraud and abuse safe harbor permitting physicians to accept electronic health record (EHR) donations. The exceptions, originally scheduled to sunset on December 31, 2013, are intended to facilitate physicians' adoption of EHR technology. According to the agencies, the extension is necessary because EHRs have not yet been universally adopted nationwide, and continued adoption remains an important goal.


The new rules extend the ability of hospitals and certain other health care entities to subsidize the bulk of EHR costs (up to 85 percent) for physicians without violating federal self-referral and anti-kickback laws.


The extension brings welcome relief for physicians as they continue to adopt EHRs and struggle to with the high cost of implementation. The rules also made several other notable changes:



  • Excludes labs from the types of entities that may donate EHRs



  • Updates the definition of what type of software is considered interoperable for the purposes of subsidies/donations



  • Clarifies the requirement prohibiting any action that limits or restricts the use, compatibility or interoperability of donated items or services



  • Removes from the exception the requirement related to electronic prescribing capability


The CMS rule can be found here and the OIG rule can be found here.

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