Laboratories may no longer donate electronic health records

The OIG for the Department of Health and Human Services and CMS, have removed laboratories from the list of protected electronic health records donors under the Stark Law and the safe harbor exception to the Anti-Kickback Statute effective January 1, 2014. The finalization of this policy comes on page 26 of the CMS final rule and page 37 of the OIG final rule. Here is the wording from the CMS final rule, “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.”