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Health Law Alert: CMS and OIG Propose New Rules for Donated EHR Technology Safe Harbor and Exception

April 22, 2013

On April 10, 2013, the Office of Inspector General of the Department of Health and Human Services (OIG) and the Center for Medicare and Medicaid Services (CMS) issued similar proposed rules regarding the donated Electronic Health Records (EHR) technology Anti-Kickback Statute Safe Harbor and Stark Law exception.

The new rules propose extending the current sunset date (December 31, 2013) for the Safe Harbor and exception until at least December 31, 2016. 

The proposed rules would also modify requirements for donated EHR technology to be deemed interoperable.  Currently, EHR technology is deemed interoperable if “a certifying body recognized by the Secretary has certified the software no more than 12 months prior to the date it was provided to the physician.”  The proposed rules would modify this provision in two ways.  First, the proposed rules make the Office of the National Coordinator for Health Information Technology responsible for recognizing certifying bodies.  Second, the current 12 month timeframe for certification would be replaced by a requirement that, on the date provided, software “has been certified to any edition of the electronic health record certification criteria that is identified in the then applicable definition of Certified EHR Technology in 45 CFR part 170.” 

Finally, the proposed rules would remove electronic prescribing capability requirements for donated EHR technology.

OIG and CMS are additionally considering revising the definition of “protected donor” due to concerns over data and referral lock in.  One proposal under consideration would limit the scope of protected donors to include only hospitals, group practices, prescription drug plan sponsors, and Medicare Advantage organizations.  Another proposal would expand the definition to include entities such as safety net providers.   Alternatively, CMS and OIG are considering retaining the current definition of protected donor, but specifically excluding laboratory companies, durable medical equipment suppliers, and independent home health agencies. 

Comments on the proposed rules are due by June 10, 2013.    

Click here to view the CMS Proposed EHR Rules.

Click here to view the OIG Proposed EHR Rules.