Sponsors, contract research organizations, and academic research sites cannot rely on a single pre-employment background check to know whether a principal investigator, sub-investigator, or research coordinator is currently barred from federal health care programs. The U.S. Department of Health and Human Services Office of Inspector General (OIG) maintains a list of excluded individuals and entities that changes every month, and the consequences of missing an exclusion on an active trial reach far beyond the excluded person — they can attach to every claim the institution submits that traces back to that person’s involvement. This guide covers what OIG exclusion is, why it applies to clinical research staff specifically (not just clinical/billing staff generally), who on a research team needs to be screened, how to run the screening, and what to do when a match turns up.
What OIG exclusion actually is
Under Section 1128 of the Social Security Act (42 U.S.C. § 1320a-7), OIG has the authority to exclude individuals and entities from participation in all federal health care programs — Medicare, Medicaid, and other HHS-administered programs. Exclusions fall into two categories:
- Mandatory exclusions — OIG must exclude for convictions related to Medicare or Medicaid fraud, patient abuse or neglect, felony health care fraud, and felony controlled-substance offenses. The minimum exclusion period is five years, rising to ten years for a second offense and permanent exclusion for a third.
- Permissive exclusions — OIG has discretion to exclude for reasons including misdemeanor health care fraud, license revocation or suspension, submission of false claims, kickback arrangements, and default on health-education loan obligations.
The List of Excluded Individuals/Entities (LEIE) is OIG’s own record of everyone currently excluded. The operative legal consequence of exclusion is narrow but absolute: no federal health care program will pay for any item or service furnished, ordered, or prescribed by an excluded individual or entity, directly or indirectly. That indirect reach is doing real work in a research context — see the billing-risk section below.
Why this applies to a clinical research team specifically
Generic OIG-exclusion-screening guidance is written for hospital HR and revenue-cycle teams screening clinicians, coders, and billing staff against the LEIE before a routine claim goes out. That is a real and separate compliance obligation, but it is not the whole picture for a clinical trial. Research introduces two additional, research-specific reasons an institution has to screen its own trial staff, not just its general clinical workforce:
- Federal funding risk. Investigator salary, coordinator effort, and other personnel costs on a federally funded award (an NIH grant, for example) are themselves a claim against federal funds. An institution that continues to pay an excluded individual from federal award funds, or that lets an excluded individual direct federally funded research, creates exposure independent of any Medicare billing at all.
- Clinical trial billing risk. Many trials bill routine patient-care costs to Medicare or Medicaid alongside sponsor-funded research costs, governed by CMS’s qualifying-clinical-trial framework under National Coverage Determination (NCD) 310.1. If the item or service billed to Medicare was furnished, ordered, or supervised by an excluded principal investigator or sub-investigator — even where the trial itself is sponsor-funded — OIG’s no-payment rule can reach that claim. This is also the fact pattern that tends to surface in False Claims Act exposure once a compliance failure is discovered after the fact; see False Claims Act Liability in Clinical Trial Billing and Medicare Coverage Determinations: NCD and LCD for how that billing layer works.
In other words, a research office cannot outsource exclusion screening to the hospital’s general compliance program and assume it covers the research workforce. Investigators, coordinators, and other trial personnel who are not otherwise part of the clinical billing workforce still need to be screened, on the same cadence, for research-specific reasons.
Who on a research team needs to be screened
OIG’s own governing principle for scope is functional, not job-title-based: screen anyone whose role touches an item or service that is, directly or indirectly, in whole or in part, payable by a federal health care program, or who directs the use of federal award funds. In practice, a research compliance program should screen:
- Principal investigators and sub-investigators (including a sponsor’s own investigator staff on sponsor-funded trials)
- Clinical research coordinators and research nurses who administer study procedures or order study-related tests
- Pharmacists and pharmacy staff dispensing investigational or standard-of-care product under the protocol
- Any other staff member named on the trial’s delegation-of-authority log, particularly anyone with prescribing or ordering authority
- New hires before they are added to a delegation log or protocol staff roster, not only existing personnel at renewal time
Institutions that receive federal grant funding should also cross-reference the separate SAM.gov Exclusions list. LEIE and SAM.gov Exclusions are maintained by different agencies for different legal purposes — LEIE by HHS-OIG under Section 1128 for federal health care program participation, SAM.gov Exclusions by the General Services Administration under 2 CFR Part 180 for federal procurement and non-procurement transactions (which covers most federal grants and cooperative agreements). A name can appear on one list and not the other, so a research compliance program screening only LEIE is not fully covering its federal-funding exposure. See Debarment and Suspension Verification (SAM.gov) and SAM.gov for how that second list works.
How to run the screening
OIG makes the LEIE available two ways, both at exclusions.oig.hhs.gov:
- Online searchable database — for verifying a specific named individual or entity. OIG’s own guidance notes that because the Privacy Act prohibits distributing Social Security numbers in bulk, the online search is the way to confirm a specific individual’s exclusion status with certainty when a name alone is ambiguous.
- Downloadable database files — a full monthly database file plus monthly supplement files (new exclusions and reinstatements), intended for institutions that want to check a research-staff roster programmatically rather than name-by-name.
The LEIE is updated monthly, and the accepted practice across health care compliance programs — consistent with OIG’s own Special Advisory Bulletin on the effect of exclusion — is to screen on a monthly cycle: at onboarding, before adding anyone to a delegation-of-authority log or protocol staff roster, and monthly thereafter for as long as they remain active on federally funded or Medicare/Medicaid-billing research. A single check at hire is not sufficient, since exclusions are entered continuously and a staff member’s status can change mid-trial.
What to do if you get a match
A name match is not automatically a confirmed exclusion — common names produce false positives, which is why the online individual search (which allows narrowing by additional identifying detail) is the step that resolves ambiguity before anyone acts on a downloadable-file hit. Once a match is confirmed:
- Remove the individual from all clinical, prescribing, ordering, and study-conduct duties immediately; do not wait for a reassignment plan to be finalized before removing exclusion-affected responsibilities.
- Stop billing, or hold billing, for any item or service that individual furnished, ordered, or supervised going forward, and flag the period of overlap for review by research billing compliance and, where sponsor funds are involved, the sponsor.
- Assess retrospective exposure: claims and federally funded personnel costs already submitted during the period the individual was excluded but still active may need to be identified, and in some cases self-disclosed or refunded, which is where False Claims Act exposure becomes concrete rather than theoretical.
- Document the screening date, the match, the verification steps taken, and the remediation actions — this record is itself part of what an OIG audit of a research grant or a broader institutional compliance review will look for.
Reinstatement is not automatic even once an exclusion period ends — an excluded individual must apply for and be granted reinstatement by OIG before they may resume any activity that would otherwise trigger the exclusion, so the exclusion period being over on a downloaded file is not by itself sufficient without confirming reinstatement status.
Where this fits in a broader compliance program
Exclusion screening is one control among several that a research compliance program runs to keep federally funded and Medicare/Medicaid-billing research defensible. For the full structure those controls typically sit inside, see The Seven Elements of an Effective Compliance Program, Applied to Research Compliance. For what happens when a funder’s own oversight body reviews these controls directly, see How an OIG Audit of a Research Grant Works and Types of Audit Findings: The 2 CFR 200 Subpart F Taxonomy.
Frequently asked questions
Is LEIE screening the same as SAM.gov exclusion screening?
No. They are separate lists maintained by separate agencies for separate legal regimes — LEIE (HHS-OIG, Section 1128, federal health care program participation) and SAM.gov Exclusions (GSA, 2 CFR Part 180, federal procurement/non-procurement transactions, which includes most federal grants). A research compliance program with both Medicare/Medicaid billing exposure and federal grant funding needs to check both.
Do sponsor-employed clinical trial staff need to be screened, or only the site’s own employees?
Both. The exclusion rule attaches to the individual furnishing, ordering, or supervising the item or service, not to which organization employs them. A sponsor whose own field-based clinical staff interact with billable patient care, or a CRO providing site-facing personnel, carries the same exposure and the same screening obligation as the site itself.
How far back does a research office need to check when a match is confirmed?
There is no single fixed lookback period set by OIG; in practice this is assessed against how long the individual was active in the affected role and when the exclusion actually took effect, not when it was discovered. Institutions typically involve research billing compliance and legal counsel to scope the affected period once a confirmed match is identified, since the risk profile depends on both federal funding exposure and any Medicare/Medicaid claims submitted during that window.
Does IRB approval of a protocol substitute for exclusion screening of the investigator?
No. IRB review addresses the ethics and scientific qualifications of the protocol and investigator; it is not an OIG exclusion check and does not verify LEIE or SAM.gov status. Exclusion screening is a separate compliance function typically run by research administration, research billing compliance, or institutional compliance offices.
