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Proposed Rules Would Extend and Modify EHR Donation Stark Exception and Anti-kickback Safe Harbor

The Stark exception and the Anti-kickback safe harbor that protect electronic health record (EHR) donation to physicians are both set to expire on December 31, 2013. This week, in response to this looming deadline, the Centers for Medicare & Medicaid Services (CMS) introduced a rule that would extend the Stark exception to December 31, 2016. Also this week, the Department of Health and Human Services Office of Inspector General (OIG) introduced a proposed rule extending the Anti-kickback safe harbor to December 31, 2016.

The Stark exception requires that a donated EHR system meet interoperability standards as determined by a recognized certifying agency within 12 months prior to donation. The CMS proposed rule removes the 12 month timeframe and requires the Office of National Coordinator for Health Information Technology (ONC) determine which certifying agencies are qualified to deem whether an EHR system meets the required interoperability standard. Further, the CMS proposed rule would eliminate the requirement that the donated EHR system include electronic prescribing capability.

The OIG proposed rule mirrors the CMS rule. It eliminates the 12 month time frame, requires the ONC to recognize qualified certifying agencies and eliminates the electronic prescribing capability.

The potential for a three year extension of the Stark exception and Anti-kickback safe harbor provides a second opportunity for those who thought they had run out of time to pursue an EHR donation. Those already planning a donation should monitor the implementation timeline of both these proposed rules to ensure compliance with the proposed interoperability deeming requirements.