“You get no bonus points for having a compliance program.”
– HHS Inspector General Daniel R. Levinson, remarks at the Health Care Compliance Association’s Annual Compliance Institute, April 18, 2016
This statement sums up Mr. Levinson’s announcement of the updated guidance explaining the criteria the Office of Inspector General (OIG) uses for exercising its permissive exclusion authority under Section 1128(b)(7) of the Social Security Act. Starting from the premise that everyone in health care has a compliance program, and if you do not you pose a higher risk, is an evolution from OIG’s original guidance published in 1997 that reflects the evolution of the health care industry. In 1997, OIG was attempting to encourage wide adoption of compliance programs. It used this guidance to advance that objective by giving a certain amount of credit to defendants settling False Claims Act (FCA) cases who had implemented a compliance program that followed the seven elements of the U.S. Sentencing Guidelines.
Almost 20 years later, OIG has largely achieved its original goal—virtually every health care provider and supplier has adopted some form of compliance program that, among other things, contains the seven elements and addresses federal health care program compliance. Now OIG is completing its pivot to its next goal that began with the 2008 Open Letter and 2013 updated Self-Disclosure Protocol—moving from encouraging the creation of compliance programs to operating effective compliance programs. Continue reading.