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Volume XII, Number 182

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Proposed Extension of Electronic Health Record (EHR) Waiver under Stark and Anti-kickback

Last week, the Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General (OIG) of the Department of Health Human Services (HHS) issued proposed rules to extend waivers that relaxed federal Stark and anti-kickback laws with regard to the donation of electronic health-record (EHR) items and services. The waiver was intended to promote the use of EHR systems.

Under the proposed rule, the Dec. 31, 2013 sunset provisions in the original rules would be extended until Dec. 31, 2016. CMS and OIG have indicated that they are considering a further extension, allowing the waiver to continue through Dec. 31, 2021. Additionally, the proposed rules make two other significant changes. Firstly, the rules update the provision under which EHR software is deemed interoperable.  Donated EHR technology must be “interoperable” as of the date it is donated.  EHR technology will be deemed to be interoperable if it has been certified through an authorization process established by the Office of the National Coordinator for Health Information Technology (ONC) to any edition of the electronic health record certification criteria under the then applicable definition of “Certified EHR.”  Secondly, CMS and OIG are considering the elimination of a requirement in the original rule that EHR is required to have electronic prescribing capabilities to qualify for the waiver.

CMS and OIG are soliciting public comments on other possible amendments to the exception, including limiting the scope of protected donors, and adding or modifying conditions to limit the risk of data and referral lock-in. CMS and OIG have indicated that they are contemplating specifically excluding the following from the list of permissible donors: laboratories, DME suppliers and independent home health agencies. Once the rules have been published in the Federal Register, there will be a 60-day comment period.

© 2022 BARNES & THORNBURG LLPNational Law Review, Volume III, Number 105
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About this Author

The Barnes & Thornburg Healthcare Department regularly represents physicians, medical groups, managed care organizations, hospitals, nursing homes, and national healthcare-related associations located around the country. Given our healthcare practice, we understand the unique commercial and regulatory environment in which healthcare organizations operate. Our attorneys bring their problem-solving and consensus-building skills to listen carefully to the goals of their clients and recommend practical solutions.

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