College of American Pathologists




December 27, 2013
© 2013 College of American Pathologists
Special Report
In Significant Victory for Pathologists Laboratories Can No Longer Donate EHRs

December 27, 2013—On Dec. 23, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services and the Centers for Medicare and Medicaid Services (CMS) released their final rulings regarding electronic health record (EHR) donations under the anti-kickback statute safe harbor and Stark exception. The rules extend the safe harbor/exception until the end of 2021 but exclude “laboratory companies” from the types of entities that may donate EHR items and services, eliminating the abuses associated with these donations, and representing a significant victory for laboratories and pathologists.

OIG and CMS also clarified the existing prohibition on any action that limits or restricts the use, compatibility or interoperability of donated items or service. The rule is effective Jan. 1, 2014 without the usual 30-day delay.

Earlier this year, OIG and CMS issued largely identical proposed rules on EHR donations in hopes of extending the program with modifications, including possibly removing laboratories as protected donors.

The CAP has long been opposed to laboratories as donors of EHRs, calling attention to anti-competitive behavior and abuses associated with EHR donations sought by referring physicians from laboratories. CAP members have reported numerous cases of abusive business practices that have continued to escalate and run contrary to the intent of the safe harbor and the exception. When laboratories are included as protected donors, EHR donations have frequently become quid pro quo arrangements for referrals, not whether a laboratory offers the best service, satisfaction and turnaround time. Referral decisions in these arrangements are frequently premised on the richest EHR donation over quality, timely provision of test results and the best interests of patients.

In June, the CAP and 38 state pathology societies submitted comment letters to CMS and OIG in response to their proposed rules, urging the agencies to remove laboratories and pathology practices from the list of protected donors of EHR software and services. Prior to the final rules released earlier this week, in response to requests for clarification of EHR donations under existing law made by state pathology societies working in concert with the College beginning in 2010, nine states (Connecticut, Massachusetts, New York, New Jersey, Missouri, West Virginia, Pennsylvania, Tennessee and Washington) have exerted their authority under each state’s anti-kickback law to prohibit or limit EHR donations by clinical laboratories to referring physicians. For more information, visit


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