The Office of Inspector General (OIG) announced on September 27, 2018, that it is increasing transparency of Federal actions against healthcare entities by publicly disclosing: (1) “closed corporate integrity agreements (CIAs) going back 10 years”; (2) OIG’s risk assessment of healthcare entities in False Claim Act (FCA) cases; and (3) starting in fiscal year 2019, the identities of healthcare entities who refuse to enter CIAs. The OIG’s September 27 letter announcing these actions can be found here.
A CIA is an agreement between OIG and a healthcare provider or other entity negotiated as part of a settlement of a Federal healthcare investigation. OIG’s risk assessment of healthcare entities in FCA cases is based on an April 2016 publication by OIG and looks at the following four factors to determine whether the healthcare entity poses a low or high risk of re-offending: (1) nature and circumstances of conduct; (2) conduct during investigation; (3) significant ameliorative efforts; and (4) history of compliance.
The announcement from OIG comes in response to a May 2018 request from U.S. Senators Claire McCaskill (D-MO) and Ron Wyden (D-OR) seeking greater transparency of enforcement actions against healthcare entities. As argued by Senators McCaskill and Wyden, “when these [Corporate Integrity] agreements expired, there was no public record of them—denying government agencies, State governments, or individuals access to enforcement histories for healthcare providers or vendors.” October 1, 2018 Press Release. Senators McCaskill and Wyden further State that “Taxpayers deserve to know when healthcare providers have essentially been repeat offenders or prior offenders, and this transparency will help achieve that goal.”
CIAs are typically in effect for five years and require a healthcare provider or other entity to agree to obligations intended to ensure compliance with healthcare laws. The requirements of a CIA vary depending on the facts of the case, but generally include, among other things:
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hiring or appointment of a compliance officer;
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development of written standards and policies;
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implementation of a comprehensive employee training program;
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retention of an independent review entity to conduct annual reviews;
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establishment of a confidential disclosure program;
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restriction on employment of ineligible persons; and
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various other reporting requirements.
In exchange for these agreements, the OIG will agree not to seek the entity’s exclusion from participation in Medicare, Medicaid, or other Federal health care programs.
