Clarifying Sanction Screening: OIG LEIE Versus GSA SAM Exclusions
Failure to identify individuals or vendors featured on exclusion lists can be disastrous for healthcare organizations. From steep civil monetary penalties (CMPs) to lasting reputational damage, the fallout from working with excluded entities is severe—which is why total clarity around your sanction screening requirements is essential.
This article provides clear guidance to the OIG’s List of Excluded Individuals and Entities (LEIE) and the GSA’s System for Award Management (SAM) lists. We leverage over 30 years’ industry experience to answer questions like:
- Why are the LEIE and SAM lists so important?
- How often should I undertake sanction screening?
- What are the most common liabilities healthcare organizations face?
OIG Compliance Guidance: Why Sanction Screening Matters
While the OIG’s compliance guidance is not mandatory and does not appear in law or regulation, employing or doing business with sanctioned individuals or entities may result in liability for an organization, and any claims emanating from a sanctioned individual or entity may be viewed as a false claim. For example, a Medicare Part A cost report that includes sanctioned individuals can be viewed as containing false claims for those portions attributable to sanctioned individuals.
Therefore, OIG guidance advises organizations to conduct appropriate sanction screening to ensure they do not employ or do business with individuals or entities that are convicted of criminal violations or have been the subject of sanctioning, debarment, exclusion, or other adverse action that could impact their compliance with applicable laws and regulations.
The OIG LEIE and GSA SAM Lists: What You Need to Know
Every healthcare compliance leader should be highly familiar with the following exclusion lists:
- OIG LEIE: A comprehensive list of individuals and organizations currently excluded from participation in Medicare, Medicaid, and all other federal health care programs.
- GSA SAM: A large list of entities ineligible to receive federal contracts or other federal assistance, including contractors debarred, suspended, or otherwise restricted.
Each has its own specific criteria and implications for your compliance program, but there are a few key elements the lists share:
- Both lists are updated frequently, making regular sanction screening essential
- Working with entities featured on either list is a major compliance violation, with potential for either fines, lost patients, or lost contracts
- Each list is searchable using an online tool, but both create a heavy lift for compliance teams that could be ameliorated through automation
Now let’s explore each list in more detail.
Understanding the OIG List of Excluded Individuals and Entities (LEIE)
What is the LEIE?
The OIG maintains a list of all currently excluded parties on their LEIE. In order to avoid potential CMP liability, health care providers and entities have been advised by the OIG to access this web site, prior to hiring or contracting with individuals or entities, and thereafter periodically check it for the status of current employees and contractors.
Those on this list are barred from participation in government contracts or receiving government benefits or financial assistance (http://www.oig.nsf.gov/debarment). However, this advice does not carry the same weight and force as the call for screening against the LEIE as will be further discussed below.
All the OIG guidance calls for employee applications for all new employees and physicians include questions pertaining to any pending charge or conviction for violation of criminal law; and/or any sanction or disciplinary actions by any duly authorized regulatory or enforcement agency of government.
It should be the responsibility of any hiring authority to verify the accuracy and honesty of the responses provided by applicants. Similarly, credentialing committees should ensure that anyone given staff privileges are not excluded from the Medicare/Medicaid programs. All health care organizations should take that position and it is included in their compliance policies.
Why is OIG Guidance Necessary?
OIG guidance regarding sanction screening against the LEIE is necessary because Medicare and Medicaid do not make payments for any services furnished by excluded individuals or entities. The OIG has elaborated on the sanction screening process in a Special Advisory Bulletin issued in September 1999, entitled “The Effect of Exclusion From Participation in Federal Health Care Programs.” In that they stated the following:
- In accordance with the expanded sanction authority provided in HIPAA and BBA, and with limited exceptions, an exclusion from Federal health care programs effectively precludes an excluded individual or entity from being employed by, or under contract with, any practitioner, provider, or supplier to provide any items and services reimbursed by a Federal health care program.
- This broad prohibition applies whether the Federal reimbursement is based on itemized claims, cost reports, fee schedules or PPS.
- Exclusion remains in effect until the individual or entity has been reinstated to participate in Federal health care programs in accordance with the procedures set forth at 42 CFR 1001.3001 through 1001.3005.
- Reinstatement does not occur automatically at the end of a term of exclusion, but rather, an excluded party must apply for reinstatement.
The Prohibition Against Federal Program Payment
The prohibition against Federal program payment for items or services furnished by excluded individuals or entities also extends to payment for administrative and management services not directly related to patient care, but that are a necessary component of providing items and services to Federal program beneficiaries.
This prohibition continues to apply to an individual even if he or she changes from one health care profession to another while excluded. In addition, no Federal program payment may be made to cover an excluded individual’s salary, expenses or fringe benefits, regardless of whether they provide direct patient care.
An excluded party is in violation of its exclusion if it furnishes to Federal program beneficiaries items or services for which Federal health care program payment is sought. An excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a CMP of $10,000 for each item or service furnished during the period that the person or entity was excluded (section 1128A(a)(1)(D) of the Act).
The individual or entity may also be subject to treble damages for the amount claimed for each item or service. In addition, since reinstatement into the programs is not automatic, the excluded individual may jeopardize future reinstatement into Federal health care programs (42 CFR 1001.3002).
Contracting with an OIG-Excluded Entity
If a health care provider arranges or contracts (by employment or otherwise) with an individual or entity who is excluded by the OIG from program participation for the provision of items or services reimbursable under such a Federal program, the provider may be subject to CMP liability if they render services reimbursed, directly or indirectly, by such a program.
CMPs of up to $10,000 for each item or service furnished by the excluded individual or entity and listed on a claim submitted for Federal program reimbursement, as well as an assessment of up to three times the amount claimed and program exclusion may be imposed.
For liability to be imposed, the statute requires that the provider submitting the claims for health care items or services furnished by an excluded individual or entity “knows or should know” that the person was excluded from participation in the Federal health care programs (section 1128A(a)(6) of the Act; 42 CFR 1003.102(a)(2)).
Providers and contracting entities have an affirmative duty to check the program exclusion status of individuals and entities prior to entering into employment or contractual relationships, or run the risk of CMP liability if they fail to do so.
Avoiding OIG Sanction Screening Liability
In order to avoid potential CMP liability, the OIG urges health care providers and entities to conduct sanction screening against the OIG LEIE prior to hiring or contracting with individuals or entities. In addition, if they have not already done so, health care providers should periodically check the OIG website to determine the participation/exclusion status of current employees and contractors.
The website contains OIG compliance program exclusion information and is updated in both online searchable and downloadable formats. This information is updated on a regular basis.
The OIG website sorts the exclusion of individuals and entities by: (1) the legal basis for the exclusion, (2) the types of individuals and entities that have been excluded, and (3) the State where the excluded individual resided at the time they were excluded or the State where the entity was doing business.
In addition, the entire exclusion file may be downloaded for persons who wish to set up their own database. Monthly updates are posted to the downloadable information on the website.
GSA System for Award Management (SAM) Exclusion Screening: An Expert Overview
The System for Award Management (SAM.gov) is the federal government’s central platform for contracting and assistance awards. Within SAM is the Exclusions list, a government-wide database of individuals and entities that have been suspended, debarred, or otherwise excluded from participating in federal procurement and non-procurement programs.
The purpose of the SAM Exclusions list is to protect the federal government from doing business with parties that have demonstrated poor performance, misconduct, or fraud. It is not intended as punishment, but as a safeguard to ensure that taxpayer-funded business is conducted responsibly.
Why Does This Matter for Health Care Providers?
Health care providers often assume SAM.gov exclusions are irrelevant unless they are federal contractors. That isn’t always true. While most providers are not “government agencies” or “direct grantees,” their business activities often involve federal funding—for example, reimbursement through Medicare or Medicaid, participation in grant-funded research, or subcontracting under federal programs.
If a provider engages with an excluded party, they risk:
- Loss of federal program funding.
- Contract termination if involved in a covered transaction.
- Potential liability under the “knew or should have known” standard.
In short: if your organization touches federal dollars in any capacity, SAM screening should be part of your compliance program—right alongside the OIG’s List of Excluded Individuals and Entities (LEIE).
Government Debarment and Suspension in Practice
Federal debarment and suspension procedures exist to prevent waste, fraud, and abuse in federal programs. They apply to:
- Procurement contracts (federal agencies and contractors).
- Non-procurement programs (grants, cooperative agreements, and certain subawards).
Types of exclusions include:
- Administrative debarments: These are imposed by an agency to protect the government’s interest; generally last up to three years.
- Suspensions: There are temporary exclusions while investigations or proceedings are ongoing.
- Statutory debarments: These are mandated by law, often with fixed durations and limited agency discretion.
For example, the Department of Health and Human Services (HHS) can issue debarments, and in some cases, these actions may also appear on the OIG LEIE if they impact program payment eligibility.
Challenges in Screening the SAM.gov Exclusions List
Screening against SAM is not as straightforward as checking the OIG LEIE.
- Data quality: SAM records often include limited identifiers, which can lead to false positives and require additional validation.
- Scope: The majority of exclusions in SAM.gov are not health care-specific. Hospitals and providers contract with thousands of vendors—ranging from clinical suppliers to janitorial services—and many will not be relevant to patient care.
- Operational burden: Sorting through false hits, especially in large organizations, can become resource-intensive.
Who Should You Screen?
Given the scale of vendor relationships in health care, most organizations take a risk-based approach to SAM screening. Prioritize:
- Clinicians and staff.
- Direct care contractors and vendors (labs, registrars, coders, device suppliers).
- Business associates with access to patient data or involvement in billing.
It may be excessive to screen every commodity supplier (e.g., paper or landscaping vendors), but each organization should define and document its threshold.
What If You Find a “Hit”?
True matches in SAM are rare, but they cannot be ignored. If your organization confirms a legitimate exclusion:
- Investigate the reason and scope of the exclusion.
- Consult legal/compliance counsel on obligations.
- Determine the business impact—does the exclusion affect your federal reimbursements or program participation?
- Decide on continuation or termination of the relationship.
Important note: Even federal agencies are not automatically required to terminate existing contracts when a party is excluded. However, entering into new transactions with an excluded party is prohibited. For providers, knowingly continuing a relationship with an excluded party creates significant risk.
Conclusion: Monthly Scans Are Essential for Compliance
A detailed exploration of the LEIE and SAM list reveals one clear takeaway: regular screening is essential to protect your patients, reputation, and bottom line. Given that the SAM list is updated daily and the LEIE once per month, our experts suggest a monthly sanction screening cadence should be adequate for most organizations to flag and deal with excluded entities swiftly and effectively.
This can create a considerable challenge for compliance teams, though, demanding considerable manual effort. This is why our team offers expert consultations to help you evaluate your options and develop a sanction screening program that meets your needs without draining your resources.
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