CMS, OIG Propose to Extend EHR Stark Exception and Anti-Kickback Safe Harbor


On April 10, 2013, CMS and the HHS Office of Inspector General (OIG) each published proposed rules to extend the sunset dates for the Stark exception and anti-kickback statute safe harbor permitting donations of EHR software and certain related items and services to physicians.  These provisions are set to expire on December 31, 2013; however, CMS’s and OIG’s proposals would extend the provisions to cover donations made until December 31, 2016 or, depending on commenter feedback, as late as December 31, 2021.

The proposed rules also include other potential modifications to the existing exception/safe harbor.  Under the existing provisions, the donated EHR software must have received certification as “interoperable” within twelve months prior to the donation.  The proposals will now consider EHR software interoperable if it has received EHR certification pursuant to the then-current definition of “certified EHR technology” as established by the Office of the National Coordinator for Health IT (ONC).  ONC’s standards and certification rules are not updated annually, so some donated EHR technology may not have complied with the prior exception/safe harbor if the technology was certified more than twelve months prior to donation.

In addition, CMS and OIG propose to eliminate the requirements in the exception/safe harbor that donated EHR software must include e-prescribing capability.  All EHR systems certified pursuant to ONC’s standards and certification rules must satisfy e-prescribing requirements, rendering the requirement redundant in the exception/safe harbor.

The proposed rules also seek comment on whether to limit the definition of “protected donors” to only hospitals, group practices, prescription drug plan sponsors and Medicare Advantage plans, or, alternatively, to specifically exclude from the definition of protected donors durable medical equipment suppliers, clinical laboratories, and home health agencies.  CMS and OIG also are seeking comment on whether to expand the definition of the “covered technology” that may be donated, and whether to add provisions limiting the requirements on data exchange that donors may impose on recipients.

The agencies are seeking comment from stakeholders by June 10, 2013.  CMS’s proposed rule is available here, and OIG’s proposed rule is available here.

Reporter, Christopher Kenny, Washington, D.C., + 1 202 626 9253,

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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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