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General Information
The Office of Inspector General (OIG) often
negotiates compliance obligations with health
care providers and other entities as part
of the settlement of Federal health care
program investigations arising under a variety
of civil false claims statutes. A provider
or entity consents to these obligations
as part of the civil settlement and in exchange
for the OIG's agreement not to seek an exclusion
of that health care provider or entity from
participation in Medicare, Medicaid and
other Federal health care programs. False
claims submitted in violation of the False
Claims Act or Civil Monetary Penalties Law
give rise to the OIG’s permissive exclusion
authority under 42 U.S.C.1320a-7(b)(7).
Providers who settle these cases often deny
that they were liable or that they committed
the alleged conduct.
The typical term of a comprehensive corporate
integrity agreement (CIA) is five years.
These compliance measures seek to ensure
the integrity of Federal health care program
claims submitted by the provider. The more
comprehensive integrity agreements include
requirements to:
(1) Hire a compliance officer/appoint a
compliance committee;
(2) Develop written standards and policies;
(3) Implement a comprehensive employee
training program;
(4) Retain an Independent Review Organization to review claims submitted to Federal
health care programs;
(5) Establish a confidential disclosure
program;
(6) Restrict employment of ineligible persons;
(7) Report overpayments, reportable events and ongoing investigations/legal proceedings; and
(8) Provide an implementation report and annual reports to the OIG on the status of the entity's compliance activities.
While many CIAs have common elements, each
agreement addresses, in part, the specific
facts of the conduct at issue. CIAs
often attempt to accommodate and recognize
many of the elements of pre-existing voluntary
compliance programs.
In addition to CIAs, the OIG also may negotiate a Certification
of Compliance Agreement (CCA) with health care providers
and other entities, in lieu of a comprehensive CIA, under
appropriate circumstances. The relevant considerations
for whether an entity may be permitted to enter into
a CCA instead of a comprehensive CIA include those set
forth in the November 20, 2001 Open Letter to Health
Care Providers. The terms of a CCA include a requirement
that the entity maintain its existing compliance program,
as described in a Declaration that is attached to the
CCA. In addition, the entity is required to agree to
certain compliance obligations that mirror those found
in a comprehensive CIA, including reporting overpayments,
reportable events, and ongoing investigations and legal
proceedings to the OIG, and providing annual reports
regarding the entity’s compliance activities to
the OIG during the term of the CCA.
To view the list of health care providers
and entities who are currently subject to
CIAs, CCAs and settlement agreements with integrity
provisions, click here.
To view the full text of an
active CIA or CCA, simply double click on the name
of the entity listed in the CIA list.
Please note that settlement
agreements with integrity provisions are
not electronically available through this
web site. Rather, copies of such settlement
agreements may be obtained through a filing
a Freedom of Information Act (FOIA) request
with the United States Department of Justice.
Information on filing FOIA requests with
the Department of Justice may be obtained
through its web site, found at www.usdoj.gov
and selecting the FOIA section. This FOIA
request should be as specific as possible.
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