College of American Pathologists

  News Release


Published on December 27, 2013

Contact: Laura Diamond
Phone: 202-354-7102

Contact: Charles Fiegl
Phone: 202-354-7134

CAP Prevails: Laboratories Excluded from EHR Donation Anti-Kickback Statute Safe Harbor and Stark Exception

CAP Commends OIG and CMS

Washington, DC—Representing a significant victory for laboratories, pathologists and patients, the Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) released their final rulings on Dec. 23 regarding electronic health record (EHR) donations and the anti-kickback statute safe harbor and Stark exception. The rules, which are effective Jan. 1, 2014 and without the usual 30 day delay, 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. Additionally, they clarify the existing prohibition on any action that limits or restricts the use, compatibility, or interoperability of donated items or service.

“CAP is pleased that referral decisions can no longer be premised on the highest EHR donation offers and that patients will have access to laboratories referring physicians have chosen based on the quality and service rather than an EHR donation. While prohibited under the rules, these donations in practice were indeed quid pro quo arrangements for referrals. Recognition by OIG and CMS of these longstanding abuses and removal of ‘laboratory companies’ as protected donors are true victories for the laboratory community, pathologists and the patients they serve,” said George F. Kwass, MD, FCAP, chair of CAP’s Council on Government and Professional Affairs.

CAP has long been opposed to laboratories as donors of EHRs and has been active in lobbying against this at both the state and federal levels. CAP provided formal comments to OIG multiple times and in June 2013, the CAP, national pathology organizations 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 service.

In the final rules, policymakers recognized CAP’s advocacy efforts at the state level. In its comments CMS and OIG noted that “several States—including Missouri, New Jersey, New York, Pennsylvania, Tennessee, Washington, and West Virginia—have prohibited or restricted donations of electronic health record technology by laboratory companies to address fraud and abuse concerns.” CAP, working with state pathology societies, was instrumental in gaining clarification on the permissibility of such donations under existing laws in these states that now number nine.

CAP members have reported numerous cases of unfair and abusive business practices that had continued to escalate and run contrary to the intent of the safe harbor and the exception.

About the College of American Pathologists

As the leading organization for board-certified pathologists, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. With more than 18,000 physician members, the CAP has led laboratory accreditation for more than 50 years with more than 7,500 CAP-accredited laboratories in 50 countries. Find more information about the CAP at Follow CAP on Twitter at @pathologists.