CMS and the Office of Inspector General at HHS (OIG) have respectively 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. Both agencies have proposed almost identical changes in their proposed rules. Comments regarding these proposed changes are due by June 10, 2013 for these proposed rules.
The proposed changes include the following:
1. Previously, the donated EHR software must have been certified as interoperable within 12 months prior to the donation (a requirement which has been the subject of much discussion within the healthcare technology vertical). Now, the proposed rules provide that the EHR will be deemed interoperable if it has received EHR certification in accordance with the then current definition of certified EHR technology as established by ONC as of the date of donation to the recipient.
2. Previously, the donated EHR software had to have e-prescribing capability. However, CMS and OIG both are of the belief that e-prescribing has been well deployed and therefore their rules do not need to require this functionality. Accordingly, they propose to eliminate the e-prescribing capability requirement.
3. Currently, 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 are December 31, 2013. The proposed rules would extend these dates to December 31, 2016 or, depending on commenter feedback, as late as December 31, 2021. These specific dates are associated with specific Medicare and Medicaid electronic health record incentive programs.
4. Because of the potential for fraud and abuse, the agencies are considering restricting the class of “protected donors.” The proposed rules propose to restrict the “protected doctors” 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.
5. The agencies are also seeking comments on “new and modified conditions” that would prevent EHR donations from becoming a method for locking-in referrals, and that would encourage the free exchange of data.
6. The agencies are also seeking comment on whether to expand the definition of the “covered technology” that may be donated.
Link to CMS proposed rule (including instructions for comment by June 10th):
Link to OIG proposed rule (including instructions for comment by June 10th):