Laboratories Excluded from EMR Donations

Effective January 1, 2014 laboratories were excluded from the list of protected Electronic Health Record (EHR) donors. While the Stark exception and anti-kickback safe harbor established by the Office of Inspector General (OIG) and Centers for Medicare & Medicaid (CMS) have been extended through December 31, 2021, donations by laboratory companies have been specifically excluded.

On page 26 in the CMS final rule, CMS wrote

We carefully considered the comments that we received on this proposal and, based on the concerns articulated by commenters and the wide-ranging support from the entire spectrum of the laboratory industry (from small, pathologist-owned laboratory companies to a national laboratory trade association that represents the industry’s largest laboratory companies), we are finalizing our proposal to exclude laboratory companies from the types of entities that may donate electronic health records items and services under the exception. We believe this decision is consistent with and furthers our continued goal of promoting the adoption of interoperable electronic health records technology that benefits patient care while reducing the likelihood that the exception will be misused by donors to secure referrals. We also believe that our decision will address situations identified by some of the commenters involving physician recipients conditioning referrals for laboratory services on the receipt of, or redirecting referrals for laboratory services following, donations from laboratory companies.

Similar wording can also be found in the OIG final rule on page 37.

In the final rule CMS commented that excluding laboratory companies from the list of protected donors will address the fraud and abuse concerns made by commenters, state societies and national laboratory associations. CMS also noted that the safe harbor and Stark exception does not allow EHR donations to be based on account volume or value of referrals and encourages anyone with information about these non-compliant arrangements to contact the OIG fraud hotline.

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