CMS and OIG Proposed Rule for EHR Donations

On April 10, 2013, both the Centers for Medicare & Medicaid Services ("CMS") and the Office of Inspector General ("OIG") of the Department of Health and Human Services released Proposed Rules extending protections related to the donation of electronic health records ("EHRs"). In particular, the Proposed Rules extend the existing Anti-Kickback Safe Harbor (the "Safe Harbor") and the existing Stark Law Exception (the "Exception"). The Proposed Rules, if finalized, will amend the current exceptions in the following ways:
  • First, the interoperability requirement for the Exception and Safe Harbor must be "authorized by the National Coordinator for Health Information Technology" and interoperable as of the date of donation.  Previously, it only needed to be "recognized by the Secretary," whereas with this proposed amendment, the interoperability of donated EHRs must be recognized by a certifying body.
  • Second, under the Exception and Safe Harbor, proposed is the elimination of the electronic prescribing capability.  Currently, the donated software must include electronic prescribing capability.
  • Third, the Exception and Safe Harbor is scheduled to sunset on December 31, 2013; however, the Proposed Rule is soliciting comments for an extended sunset date of December 31, 2016.
  • Finally, the Proposed Rule is soliciting comments regarding the scope of protected donors.  In particular, the Proposed Rules are considering excluding specific donors from the protected donors list, such as durable medical equipment suppliers, independent home health agencies, and other "suppliers of ancillary services associated with a high risk of fraud and abuse."

If you have any questions or concerns related to these fraud and abuse exceptions, or would like to submit your comments, please contact Robert A. Wade at or 574.485.2002.The officials for the Proposed Rules will be accepting comments on the proposed rules for sixty (60) days.