In the April 10 Federal Register, two agencies within the U.S. Department of Health and Human Services published proposed rules that many healthcare providers have been anxiously awaiting affecting donations of electronic health record (EHR) items and services. CMS and OIG each issued a proposed rule that would extend to at least December 31, 2016, the sunset provisions of the Stark exception and anti-kickback safe harbor for EHR donations. The exception and safe harbor currently mirror each other and are due to expire December 31, after which date many existing EHR subsidy agreements between healthcare providers and physicians no longer would be protected.

An extension of the sunset provision would recognize and alleviate the concerns that many providers have voiced regarding the upcoming expiration of the exception and safe harbor. The proposed rules also leave open the possibility of an even later sunset date that would protect EHR donation arrangements through December 31, 2021. The proposed rules also would eliminate the requirement that donated EHR software include electronic prescribing capability and make certain changes to recognize the role of the National Coordinator of Health Information Technology in certifying EHR software. Of particular note, CMS and OIG are each proposing to remove laboratories and other ancillary providers from the list of protected donors of EHR technology, noting that such provider types have raised significant concerns of fraud and abuse with respect to EHR donation.