There are two federal exclusion lists: the Health and Human Services (HHS) Office of Inspector General (OIG) List of Excluded Individuals/Entities (LEIE) and the General Services Administration (GSA) System for Award Management (SAM.gov) Exclusion list, plus 43 State Medicaid/Medicare exclusion lists, but how do they differ, and why do they exist?
What is an exclusion, and how does it affect your organization?
Exclusions are administrative actions taken against an individual or entity by HHS OIG, a state agency or Medicaid Fraud Control Unit (MFCU), or one of the many agencies associated with SAM.gov.
Exclusions are levied against employees, vendors, suppliers, referring physicians, and providers for violating enumerated state and federal rules, regulations, or laws.
An exclusion or debarment results in an individual or entity’s inability to participate in federal healthcare reimbursement programs, regardless of the enforcing authority.
All exclusion prohibitions remain the same. State and federal agencies monitor both permissive and mandatory exclusions. However, the two types of exclusions differ in duration based on the severity of the excluded party’s action.
When it comes to comprehensive exclusion monitoring, two primary federal sources need to be screened for exclusions on an ongoing basis:
- Health and Human Services – Office of Inspector General (HHS-OIG) Exclusion Program, which maintains the List of Excluded Individuals and Entities (LEIE)
- General Services Administration System for Award Management (GSA-SAM.gov), formerly known as the EPLS
Additionally, varying, disparate State Medicaid exclusions sources require periodic screening. The Centers for Medicare & Medicaid Services (CMS) requires healthcare organizations to screen against all these sources at least monthly.
The HHS OIG List of Excluded Individuals and Entities (LEIE)
OIG has the authority to exclude individuals and entities from federally funded healthcare programs under section 1128 of the Social Security Act (and from Medicare and state healthcare programs under section 1156 of the Act) and maintains a list of all currently excluded individuals and entities called the List of Excluded Individuals/Entities (LEIE).
Anyone who hires an individual or entity on the LEIE may be subject to civil monetary penalties (CMP).
Healthcare entities should routinely check the list to avoid CMP liability and ensure that new hires and current employees are not on it.
The GSA SAM.gov
The SAM.gov database is called the System for Award Management (SAM). Formed under the Affordable Care Act mandate, SAM.gov created one broader dataset of individuals and entities that are debarred, sanctioned, or excluded from doing business under a federal contract.
SAM.gov, the most significant database for healthcare providers, includes several federal contracting databases such as USDA-FNS, TREAS-OFAC, OPM, and more.
If an individual or entity is listed on SAM.gov, a healthcare company should not contractually engage with such person or entity to avoid conducting business with a sanctioned, debarred, or excluded party. HHS OIG and CMS have both made it clear that federal program payment for (1) items or services furnished by excluded individuals or entities and (2) salaries, expenses, or fringe benefits of excluded individuals (regardless of whether they provide direct patient care) are prohibited.
SAM.gov datasets should be included in all exclusion screening processes for employed and contracted populations.
Important Operational Differences
The lists largely overlap regarding information, but because OIG’s LEIE and GSA’s SAM exclusion lists are owned and maintained by different agencies, there are naturally distinct administrative processes. For example, the LEIE contains license information and NPI records, while the SAM does not.
This can make searching for individuals in the SAM database more complicated. Additionally, the GSA does not have the authority to issue a financial penalty on an organization because it is a procurement repository – not an agency with jurisdiction.
The scope of exclusions included in OIG’s LEIE is subject to Sections 1128 and 1156 of the Social Security Act.
Section 1128 covers Medicare, Medicaid, and all other federal healthcare programs that provide benefits funded directly or indirectly by the United States.
Section 1156 extends this scope to include the state-level counterparts of Medicare and the health programs under Section 1128.
The SAM list includes debarment actions by a wider group of federal agencies.
Compliance programs must cross-reference each list to ensure they capture complete information.
State Medicaid Exclusion Lists
Each state has a department or agency dedicated to upholding the integrity of Medicaid programs and public health. Though each state enforcement authority can vary by name and function (Department of Medicaid, State OIG, Department of Health Care Services), each outlines the ineligibility rules for licensed providers who have been disciplined or lost certain license privileges.
Many states maintain and publish their exclusion list, which should be included in your monthly screening process.
However, state Medicaid exclusion sources are varied and present significant challenges to manual screening processes. They publish exclusion records in different formats and with varying amounts of data, making it complex and resource-intensive to identify a match within your population.
Forty-three states currently have exclusion lists publicly available. Less than five allow you to confirm a possible name match with a social security number like the OIG. This means that most states contain only a name, a possible address when the person or entity was excluded, and maybe a city.