Under long-awaited final rules recently published by the federal government, hospitals and other “protected donors” may continue to “donate” interoperable electronic health record items and services without incurring liability under the federal physician self-referral law (Stark Law) and federal Anti-Kickback Statute for another eight years, subject to the specified requirements. The final rules extend the sunset dates, from Dec. 31, 2013, to Dec. 31, 2021, of both the EHR donation exception under the Stark Law and the safe harbor under the Anti-Kickback Statute for arrangements involving electronic health record (EHR) items and services. The final rules, which can be found here and here, were published on Dec. 27, 2013 by the Centers for Medicare & Medicaid Services (CMS) and the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS).

The new final rules not only extend the sunset date of the current regulations but contain several other important revisions to the EHR donation rules, including:

• Updated EHR software “interoperability” requirements. The final rules make two changes to the interoperability or “deeming” requirement to reflect the current HHS Office of the National Coordinator for Health Information Technology (ONC) program for certifying EHR technology for the Medicare and Medicaid EHR Incentive Programs. First, the final rules specify that the ONC solely is responsible for authorizing certifying bodies. Second, the new rules modify the current interoperability requirement to provide that EHR software may be deemed interoperable if, on the date that the software is provided to the recipient, it has been certified to any edition of the ONC’s EHR certification criteria that is then-current, based on the definition of Certified EHR Technology in the Medicare and Medicaid EHR Incentive Program regulations. For example, for a donation made in in 2013, the 2011 and 2014 editions of the ONC’s EHR certification criteria would be current.
• No e-prescribing capability requirement for donated EHR software. CMS and OIG have removed the electronic prescribing capability requirement for software and training services being eligible for donation. The agencies took into consideration the “meaningful use” standard promulgated under the HITECH Act and other technological advances in the industry and determined that the e-prescribing requirement no longer is necessary to achieve the goal of adopting e-prescribing capabilities for EHR.
• Laboratories no longer may be donors of EHR items and services. The final rules modify the EHR donation exception and safe harbor to exclude laboratories from the list of “protected donors.”
• Clarification of the requirement prohibiting action that limits or restricts the use, compatibility, or interoperability of donated EHR items and services. CMS and OIG also modified existing requirements of the EHR exception and safe harbor to (i) prevent the misuse of the exception and the safe harbor in a way that results in data and referral lock-in; and (ii) encourage the free exchange of data.

The sunset extensions take effect Dec. 31, 2013, while all other provisions will become effective on March 27, 2014.

Practical implications
The extension of the sunset provisions presents current donors the option of continuing to subsidize EHR items and services for physicians and other recipients without incurring liability under the Stark Law or Anti-Kickback Statute. It also grants other potential donors additional time to enter into EHR donation arrangements with physicians and others.

The last-minute publication of the final rules creates additional hoops to jump through for current EHR donors. If donors make the business decision to extend subsidy arrangements beyond 2013 as permitted by the rules, then those donors should review their EHR donation contracts immediately to determine whether the terms of the contract permit the donor to provide subsidized EHR items or services beyond Dec. 31, 2013, as some contracts may have been drafted to prohibit subsidies beyond the original sunset date. Donors should amend their existing EHR donation contracts as appropriate to address any subsidy extensions and modifications to the donation requirements. Furthermore, donors should review all policies and other documentation regarding EHR donation that may have been approved by the governing body and revise as necessary to comply with the new rules. Finally, all donors should verify that the EHR software they donate has been certified to current ONC edition criteria.