The 2006 Stark exception for Certain Electronic Prescribing and Electronic Health Records Arrangements (EHR Donation Exception), and a 2006 Safe Harbor to the Federal Anti-Kickback Statute allow physicians to receive non-monetary remuneration in the form of electronic health records software (EHR) or information technology and associated training services.
CMS and the OIG (the Agencies) issued a Final Rule on December 27, 2013 amending the EHR Donation Exception and extending the sunset date of the EHR Donation Exception from December 31, 2013 to December 31, 2021 (Final Rule).
The Final Rule amends the EHR Donation Exception by:
- Excluding laboratory companies from the types of entities that may donate electronic health records (EHR) items and services to physicians
- Updating the provision under which EHR software is deemed interoperable (the “Deeming Provision”)
- Clarifying the requirements prohibiting any actions that limit or restrict the use, compatibility, or interoperability of donated items and services
- Removing the electronic prescribing capability requirement from the exception
Citing various complaints and the position that donations by ancillary suppliers may be associated with a high risk of fraud and abuse, the Agencies specifically excluded laboratories (both laboratories providing anatomic and clinical pathology services) from permissible donors under the EHR Donation Exception. The Agencies chose not to exclude hospitals with on-site laboratories from permissible donor status under the EHR Donation Exception.
The Deeming Provision, which used to define software that had been certified by the Office of the National Coordinator for Health Information Technology’s (ONC) in the 12 months prior to its donation as “interoperable”, will now deem software interoperable (and therefore subject to donations) if, on the date that it is provided to the physician, it has been certified by a certifying body authorized by ONC referenced in the then-applicable certification criteria. Software satisfying other interoperability definition requirements need not be certified in order to be to be donated. In addition, the Agencies eliminated the requirement that EHR software contain electronic prescribing capability in order to meet the interoperability requirements of the EHR Donation Exception.
The Agencies emphasize the provisions of the EHR Donation Exception ensuring that no donor take any action to limit or restrict the use, compatibility, or interoperability of donated items or services with other electronic prescribing or electronic health records systems. Expounding upon public comments, the Agencies note that any action taken by a donor to limit the use of the donated EHR items or services by charging fees to prevent non-recipient providers from interfacing with the donated items or services would pose legitimate concerns that parties were improperly locking in data and referrals.
