New OIG Guidance Signals Changed View of Compliance Programs

By on May 6, 2016

“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.

Tony Maida
Tony Maida counsels health care and life sciences clients on government investigations, regulatory compliance and compliance program development. Having served as a government official, Tony has extensive experience in health care fraud and abuse and compliance issues, including the federal and state Anti-Kickback and Stark Laws and Medicare and Medicaid coverage and payment rules. He represents clients in False Claims Act (FCA) qui tam matters, government audits, civil monetary penalty and exclusion investigations, and Centers for Medicare and Medicaid Services (CMS) suspension, and revocation actions, negotiating and implementing corporate integrity agreements, and making government self-disclosures. Read Tony Maida's full bio.