Self-Disclosure of Provider Misconduct:
Assessment of CIA Modifications


As part of an ongoing self-assessment of our health care compliance initiatives, the Office of Inspector General (OIG) conducted an informal survey of the results of corporate integrity agreement (CIA) negotiations since the issuance of the "Open Letter to Health Care Providers" in March 2000. The purpose of the review was to determine the extent to which health care providers' existing compliance efforts and self-disclosure of misconduct influenced the decision to require a CIA or modify specific terms. An informal review of the results of recent CIA negotiations confirms that significant and appropriate modifications are being made to CIAs with health care providers that have established compliance programs and make disclosures of misconduct to the Government.


As part of the effort to reduce fraud and abuse in the Federal health care programs, the OIG and the Department of Justice use the False Claims Act (31 U.S.C. 3729-3733) and other authorities to sanction health care providers that have knowingly submitted false claims to Medicare. In addition to the imposition of monetary penalties, the OIG is authorized to exclude providers that violate the False Claims Act from participation in Medicare and other Federal health care programs. Absent a criminal conviction that triggers mandatory exclusion, the OIG may elect not to exclude a health care provider that has engaged in abusive conduct. Where the best interests of the programs are served by allowing continued participation by the provider, the OIG generally requires that the provider adopt specific measures to better ensure its integrity. These measures are set forth in a corporate, institutional or individual integrity agreement (collectively referred to as a CIA).

Consistent with the United States Sentencing Commission's "Federal Sentencing Guidelines Manual," the CIA contains the seven core elements of an effective compliance program. In addition, the OIG generally requires the submission of periodic reports concerning the provider's compliance efforts and reserves the right to impose sanctions for a material breach of the CIA. While CIAs almost always include these basic elements, the specific terms of a provider's CIA are subject to extensive negotiations. Among the relevant factors considered in crafting a specific CIA are the severity and extent of the underlying misconduct, the provider's existing compliance infrastructure and the resources available for such efforts. Perhaps the best measure of a provider's existing compliance efforts is the ability to identify and respond to potential misconduct. As Inspector General June Gibbs Brown observed in her March 9, 2000 "Open Letter to Health Care Providers":

open quote. . . the best evidence that a provider's compliance program is operating effectively occurs when the provider, through its compliance program, identifies problematic conduct, takes appropriate steps to remedy the conduct and prevent it from recurring, and makes a full and timely disclosure of the misconduct to appropriate authorities.close quote

The Open Letter went on to explain that the OIG would give more deference to the self-disclosing provider when negotiating a CIA and, under certain circumstances, might not even require a CIA as part of the resolution of the matter.

Report of Findings

In general, we found that when the OIG believed a CIA was necessary and where there was objective evidence of a comprehensive compliance program, the OIG often made two significant modifications in the CIA:

These two modifications alone represent a significant benefit to the provider. Other modifications generally focused on conforming the requirements of the CIA to the provider's existing compliance infrastructure. These modifications to the CIA were intended to promote continuity in the provider's ongoing compliance program, as well as reduce the overall costs of such efforts.


The following examples identify some of the factors considered in the process of negotiating a CIA in a self-disclosure case:1


An informal review of the results of recent CIA negotiations confirms that significant modifications are being made to agreements with health care providers that have established compliance programs and have self-disclosed misconduct to the Government. When negotiating a resolution to its administrative liability, a provider is often able to limit the scope and reduce the cost of a CIA or, in some instances, as a result of its self-disclosure and pre-existing compliance efforts, avoid the imposition of a CIA.


1. Since litigation risks and other case-specific facts may have influenced the resolution of the cases, the narratives do not represent an all-inclusive discussion of all factors that were considered in the CIA decision-making process. Understandably, the examples cannot be relied upon as precedents for future CIA resolutions.