	Background

		HHS-OIG Exclusion Authority

HHS-OIG has the authority to exclude providers and other entities that  have committed certain acts from participation in federal health care  programs. Typically, such settlements resolve allegations  that the entity is liable under the False Claims Act for submitting false  claims to federal health care programs. The Office of Counsel to the Inspector General within HHS-OIG is  responsible for negotiating agreements and for monitoring them once  they take effect. From 2005 through 2017, HHS-OIG Entered into Dozens of New Agreements Each Year, the Majority of Which Applied to Three Types of Entities

From July 2005 through July 2017, HHS-OIG entered into 652 new  agreements—an average of about 50 agreements per year—ranging from  a high of 83 to a low of 37. The agreements were almost exclusively  CIAs, which apply to larger corporations, and IAs, which apply to  individual practitioners and entities such as small physician groups. HHS- OIG has used CIAs and IAs exclusively since 2010. From 2010 to July  2017, 74 percent of agreements have been CIAs and 26 percent of  agreements have been IAs. See figure 1 for more information on the  number and types of agreements since July 2005. 2). Specifically, HHS-OIG  entered into agreements with 30 different types of entities from July 2005  through July 2017, though slightly more than half of the agreements were  with 3 types—individual/small group practices, hospitals, and skilled  nursing facilities. 3.) Almost all of the agreements we reviewed were negotiated by HHS-OIG  at the same time DOJ was negotiating a legal settlement with the entity to  resolve related allegations under the False Claims Act. 4.) HHS-OIG Considers Risk Factors, Such As an Entity’s Conduct, When Evaluating Whether to Exercise its Exclusion Authority and in Negotiating Agreements

		HHS-OIG Has Criteria to Determine Whether to Pursue Exclusion or Enter into an Agreement; Certain Initial Allegations Were Common among Entities That Entered Into Agreements

HHS-OIG guidance includes the criteria that agency officials said they  follow to determine whether to exercise the agency’s permissive  exclusion authority, or take an alternate action, such as entering into an  agreement with an entity. Agreements Included Standard Provisions with Some Variation to Address Risks Specific to the Entities

We compared the provisions required in selected agreements to those  outlined in HHS-OIG’s current agreement templates and found that the  provisions were generally similar. HHS-OIG Uses Multiple Strategies to Ensure Compliance with Terms of Agreements and Imposes Certain Penalties When Noncompliance Is Identified

		HHS-OIG Reviews Required Reports, Communicates with Entities, and Conducts Site Visits to Monitor Entities’ Compliance with Agreements

According to HHS-OIG officials, the agency assigns a monitor to each  agreement—an HHS-OIG staff attorney or program analyst—who, for the  duration of the agreement, oversees the entity’s compliance with the  terms of its agreement. For agreements entered into from July 2005 through July 2017, our  review of HHS-OIG data found that HHS-OIG issued 41 letters  demanding stipulated penalties (between 0 and 7 letters per year) for  actions such as the failure to submit annual reports and employing  individuals excluded from participation in federal health care  programs. Penalty amounts demanded in  each letter ranged from $1,000 to over $3 million, with a median of  $18,000. Agency Comments

We provided a draft of this report to HHS and DOJ for review and  comment. These departments provided technical comments, which we  incorporated as appropriate.
Why GAO Did This Study

HHS-OIG has the authority to exclude providers and other entities that have committed certain acts, such as submitting false or fraudulent claims, from participation in federal health care programs. However, HHS-OIG can enter into agreements—CIAs and IAs—with providers and other entities as an alternative to exclusion. HHS-OIG is responsible for negotiating such agreements—which it typically does at the same time the Department of Justice (DOJ) is negotiating a legal settlement to resolve related allegations—and then monitoring the entities' compliance with them.
GAO was asked to review HHS-OIG's use of these agreements. This report describes (1) the number of agreements and their general characteristics; (2) the circumstances that may lead to an agreement and the standard provisions of agreements; and (3) monitoring efforts and actions taken, if any, in response to noncompliance with the agreements.
GAO examined agreements entered into from July 2005 (when HHS-OIG created its database) through July 2017 (most current at the time of GAO's analyses) and used HHS-OIG data to describe agreements' characteristics and actions to address noncompliance. GAO reviewed HHS-OIG documentation, including agreement templates and a selection of agreements to identify standard provisions. GAO also interviewed HHS-OIG and DOJ officials.
GAO provided a draft of this report to HHS and DOJ. The agencies provided technical comments, which were incorporated as appropriate.

What GAO Found

To help improve adherence to federal health care program requirements by entities that have allegedly engaged in certain acts, such as submitting false or fraudulent claims, the Department of Health and Human Services' Office of Inspector General (HHS-OIG) entered into 652 agreements with those entities from July 2005 to July 2017. Since 2010, two types of agreements have been used: Corporate Integrity Agreements (CIA) and Integrity Agreements (IA). The more commonly used CIAs apply to larger entities, compared to IAs, which apply to individual practitioners or small businesses. From July 2005 through July 2017, about half of all agreements were with 3 types of entities—individual or small group practices, hospitals, and skilled nursing facilities.
For new agreements since July 2005, the most common initial allegations that led to an entity entering into an agreement included billing for services not provided and providing medically unnecessary services. When negotiating agreements, HHS-OIG uses one of six templates that address the different types of entities or conduct involved. Across agreements the provisions are generally similar—for example, requirements to provide training on specified topics or to hire a compliance officer.
HHS-OIG uses multiple strategies to oversee agreements, such as requiring periodic reports from the entities that demonstrate compliance and assigning a monitor to review these reports and conduct site visits. HHS-OIG can also take certain actions to address noncompliance. For example, for new agreements from July 2005 through July 2017, HHS-OIG imposed monetary penalties 41 times, ranging from $1,000 to more than $3 million (median of $18,000), and excluded 4 entities from participation in federal health care programs.