First Healthcare Compliance CONNECT May 2022

CIAs, Exclusions, and Your Practice
Rachel V. Rose, JD, MBA
Contracting with or employing an excluded
person can result in a government enforcement
action.
Before delving into a recent U.S. Department of Justice
(DOJ) settlement, which involved employing an “excluded”
individual, it’s important to appreciate some of the tools
that the U.S. Department of Health and Human Services
Office of the Inspector General (HHS-OIG) has at its
disposal – corporate integrity agreements (CIA) and
exclusion from all federal programs.
CIAs – are negotiated by HHS-OIG “with healthcare
providers and other entities as part of the settlement
of Federal health care program investigations arising
under a variety of civil false claims statutes. Providers
or entities agree to the obligations, and in exchange, OIG
agrees not to seek their exclusion from participation
in Medicare, Medicaid, or other Federal health care
programs.” Typically, a CIA lasts 5 years and the person
who enters into the CIA must make scheduled reports to
HHS-OIG. Importantly, CIAs are specific to the facts and
circumstances of a particular matter and include breach
and default provisions, which enable HHS-OIG to impose
additional monetary penalties (i.e., Stipulated Penalties).
A material breach of the CIA “constitutes an independent
basis for the provider’s exclusion from participating in
Federal healthcare programs.”
Exclusions – have been around since 1977 and are
imposed by HHS-OIG; however, they may arise because
of a False Claims Act case or other matter that was
initiated through or by DOJ. HHS-OIG’s authority to
impose exclusions is derived from the Social Security
Act §§ 1128, 1156.“The scope of an exclusion under
section 1128 of the Act is from all Federal health care
programs, as defined in 42 CFR 1001.2. … Exclusions
under section 1156 of the Act do not reach other Federal
programs (although HHS or another Federal agency
could separately initiate a suspension or debarment of
an excluded person from other Federal procurement
or nonprocurement programs).” The process begins
when a person receives a Notices of Intent to Exclude
(NOI). From there, the recipient of the NOI is given the
opportunity to respond. Once all the information is
considered, HHS-OIG renders its decision. If the findings
substantiate exclusion, the person is notified. From
there, they may appeal to an HHS Administrative Law
Judge and further appeal to the HHS Departmental
Appeals Board (DAB). After the DAB renders its decision,
judicial review in a U.S. District Court is also available.
Reinstatement of an individual or entity is not automatic;
rather, the person must apply for reinstatement. If
reinstated, the person receives written notice from
HHS-OIG that they have been reinstated. The excluded
individual may begin the process 90 days before their
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