OIG LEIE vs. GSA SAM: What to Check? [Explained] (42 CFR § 1001.1901)

Healthcare providers participating in federal healthcare programs must ensure that excluded individuals and entities do not participate in services tied to federal reimbursement. Under 42 CFR § 1001.1901, no payment may be made for items or services furnished, ordered, or prescribed by excluded individuals or entities. To meet this obligation, small practices often rely on two primary screening tools: the Office of Inspector General’s List of Excluded Individuals and Entities (LEIE) and the General Services Administration’s System for Award Management (SAM).

Although both databases identify individuals and entities barred from participation in federal programs, they serve different purposes. The LEIE is healthcare-specific and directly tied to Medicare and Medicaid payment eligibility, while SAM applies broadly to federal contracts, grants, and assistance programs. This article explains the differences between LEIE and SAM, clarifies what small practices must check, and provides practical tools to maintain defensible compliance.

Small healthcare practices frequently struggle to interpret overlapping federal screening requirements. Most are familiar with the OIG LEIE, but fewer understand whether and how the GSA SAM database applies to healthcare operations.

This lack of clarity creates compliance risk. Relying solely on one database may leave gaps, particularly when practices work with third-party vendors, billing companies, IT providers, or contractors who interact with federally funded programs. Understanding the distinct role of each database allows practices to design screening processes that are accurate, efficient, and defensible.

Regulatory Breakdown

42 CFR § 1001.1901 – Effect of Exclusion

42 CFR § 1001.1901 governs the payment effect of exclusion. The regulation provides that:

• No payment may be made under Medicare, Medicaid, or any other federal healthcare program for items or services furnished, ordered, or prescribed by an excluded individual or entity.

• This prohibition applies to both direct and indirect involvement in claim-related activities, including billing and administrative support.

• Claims associated with excluded individuals are considered non-payable and may result in repayment obligations.

The regulation establishes payment ineligibility, not screening mechanics. Responsibility rests with the provider to prevent excluded participation.

Scope and Purpose

• Healthcare-specific exclusion database

• Includes individuals and entities excluded from Medicare, Medicaid, and other federal healthcare programs

• Maintained by the Office of Inspector General

Update Frequency

• Updated monthly

Relevance to Small Practices

• Directly tied to healthcare reimbursement eligibility

• Providers are expected to screen employees, contractors, and vendors connected to claims

• Claims linked to LEIE-listed individuals are non-payable under 42 CFR § 1001.1901

The LEIE is the primary exclusion list for healthcare compliance.

Scope and Purpose

• Government-wide database covering exclusions from federal contracts, grants, loans, and assistance programs

• Consolidates multiple federal exclusion authorities

• Managed by the General Services Administration

Update Frequency

• Updated on a rolling basis

Relevance to Small Practices

• Applies primarily to vendors, contractors, and suppliers

• May include entities excluded for reasons unrelated to healthcare fraud

• Exclusions in SAM may not appear on the OIG LEIE

SAM does not replace the LEIE, but it may identify risks associated with federal contracting and assistance participation.

Although 42 CFR § 1001.1901 directly addresses OIG exclusions, federal oversight expectations increasingly recognize the importance of broader due diligence. Screening only the LEIE may leave practices exposed when working with:

• Billing companies

• IT service providers

• Medical equipment suppliers

• Staffing agencies

• Consultants or subcontractors

If a vendor is barred from federal contracting under SAM, continued engagement may create compliance vulnerabilities, even if the vendor does not appear on the LEIE.

Case Study: Vendor Screening Gap

A small internal medicine clinic outsourced billing operations to a third-party vendor. The clinic screened all internal staff against the OIG LEIE but did not screen vendors against the GSA SAM database.

During an audit, it was discovered that the billing vendor had been excluded from federal contracting under SAM due to fraudulent conduct unrelated to healthcare. Although the vendor did not appear on the LEIE, the clinic’s failure to conduct vendor due diligence resulted in enforcement scrutiny and repayment obligations tied to affected claims.

Key Lesson

LEIE screening alone is insufficient when vendors or contractors are involved in federally connected activities.

Relying Only on LEIE

Avoidance: Include SAM screening for vendors and contractors.

Screening Only at Hire

Avoidance: Perform recurring screenings aligned with updates.

Ignoring Vendors

Avoidance: Screen all entities connected to federal reimbursement.

Poor Documentation

Avoidance: Maintain dated, defensible logs with evidence.

Delayed Action on Matches

Avoidance: Suspend participation until exclusion status is resolved.

Best Practices for Small Practices

• Use free OIG LEIE and SAM search tools

• Integrate screenings into onboarding and vendor management workflows

• Centralize compliance documentation

• Assign clear responsibility for screening tasks

• Periodically audit screening completeness

These practices support reasonable diligence without excessive administrative burden.

Effective exclusion screening requires more than technical checks. Leadership engagement, staff awareness, and transparency ensure that screening responsibilities are treated as routine safeguards rather than reactive tasks.

When compliance is embedded into daily operations, both LEIE and SAM checks become standard practice.

Under 42 CFR § 1001.1901, excluded individuals and entities may not participate in federally reimbursed healthcare services. The OIG LEIE remains the primary screening tool for healthcare exclusions, but the GSA SAM database plays a critical complementary role, particularly for vendors and contractors.

Small practices that implement dual screening processes, document results, and respond promptly to matches are better positioned to demonstrate compliance, reduce enforcement risk, and protect financial stability.

Boosting compliance resilience requires more than policies alone. A compliance automation solution can streamline processes, simplify record-keeping, and deliver continuous risk assessments, helping you stay audit-ready and avoid compliance pitfalls.

• U.S. Department of Health & Human Services, Office of Inspector General. 42 CFR 1001.1901 – Effect of Exclusion

• General Services Administration. System for Award Management (SAM.gov)

• Centers for Medicare & Medicaid Services. Medicare Program Integrity Manua

• Federal Register. 42 CFR Part 1003 – Civil Monetary Penalties, Assessments, and Exclusions

• U.S. Department of Health & Human Services. HIPAA Documentation Retention Requirements (45 CFR 164.530(j)(2))