GAO Releases Report Analyzing HHS-OIG Integrity Agreements Since 2005

The U.S. Government Accountability Office (GAO) released a report on May 10th characterizing over 10 years of corporate integrity agreements and integrity agreements (collectively, "Agreements") entered into by the U.S. Department of Health and Human Services Office of Inspector General ("HHS-OIG") with entities subject to HHS-OIG's permissive exclusion authority. The report was requested by the Senate Committee of Finance due to concern that there was a lack of public information regarding HHS-OIG's use of Agreements in enforcement.

The GAO report reviewed over 652 Agreements entered into between July 2005 and July 2017, and describes, among other things: 1) the circumstances leading to the use of Agreements; 2) standard provisions included in Agreements; 3) HHS-OIG's methods for monitoring compliance with Agreements; and 4) enforcement by HHS-OIG in the case of noncompliance with the terms of Agreements.

Circumstances Leading to the Use of Agreements

When HHS-OIG is permitted to exercise its permissive exclusion authority, requiring the entity to enter an Agreement is one alternative to excluding the entity from participation in federal health care programs. In deciding what action to take, HHS-OIG considers the future risk posed by the entity to federal health care programs based on four broad criteria:

the nature and circumstances of the conduct; the entity's conduct during the government's investigation; whether the entity has made efforts to improve its conduct; and the entity's history of compliance. The GAO found four main initial allegations that resulted in an entity entering into an Agreement with HHS-OIG:

billing for services not rendered; provision of medically unnecessary services; acts prohibited by the federal Anti-Kickback Statute (42 U.S.C. 1320a-7b); and misrepresentation of services/products. The fourth category encompasses a wide range of conduct, such as one case that included allegations that the entity provided improper remuneration and falsified a physician's signature on laboratory requisition forms. Sixty-three percent of Agreements were based on only one initial allegation.

The GAO found that the number of new Agreements entered into each year decreased between July 2005 and July 2017, reflecting HHS-OIG's effort to focus its enforcement resources on entities that present the highest risk of fraud. Since 2014, HHS-OIG's monetary threshold for damages to federal health care programs that must be exceeded before it...

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