OIG and CMS Issue Proposals to Extend Safe Harbor and Exception for EHR Donations


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.

Written by:

Published In:


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© BakerHostetler | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »

All the intelligence you need, in one easy email:

Great! Your first step to building an email digest of JD Supra authors and topics. Log in with LinkedIn so we can start sending your digest...

Sign up for your custom alerts now, using LinkedIn ›

* With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name.