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Exclusions FAQ

Answers to Questions Concerning Exclusions

What is the List of Excluded Individuals/Entities (LEIE)?

OIG’s List of Excluded Individuals/Entities (LEIE) provides information to the health care industry, patients and the public regarding individuals and entities currently excluded from participation in Medicare, Medicaid and all other Federal health care programs. Individuals and entities who have been reinstated are removed from the LEIE.

What authority does the OIG have to exclude individual or entities? Are there different types of exclusions?

The OIG imposes exclusions under the authority of sections 1128 and 1156 of the Social Security Act. A list of all OIG exclusions and their statutory authorities can be found on the Exclusion Authorities page.

What is OIG's Administrative Process for Imposing Exclusions?

Summary:

OIG's exclusions process is governed by regulations that implement sections of the Social Security Act. When an individual or entity gets a Notice of Intent to Exclude, it does not necessarily mean that they will be excluded. OIG will carefully consider all material provided by the person who received the Notice before making a decision. All exclusions implemented by OIG may be appealed to an HHS Administrative Law Judge (ALJ), and any adverse decision may be appealed to the HHS Departmental Appeals Board (DAB). Judicial review in Federal court is also available after a final decision by the DAB.

Details

When OIG is considering excluding an individual or entity under Section 1128 of the Social Security Act (Act), the administrative process is governed by regulations codified at 42 C.F.R. sections 1001.2001 through 1001.2007. The process varies somewhat, depending upon the basis for the proposed exclusion.

For all proposed mandatory exclusions (§§1128(a)(1)-(4) of the Act) and most proposed permissive exclusions (§§1128(b)(1)-(b)(5), (b)(8)-(b)(11), (b)(14), and (b)(15) of the Act), the administrative process is the same. OIG sends out a written Notice of Intent to Exclude to any individual that we are considering excluding. The Notice of Intent to Exclude includes the basis for the proposed exclusion and a statement about the potential effect of an exclusion.

The Notice of Intent to Exclude is pre-decisional and allows the individual 30 days to respond in writing with any information or evidence relevant to whether the exclusion is warranted and to raise any other related issues, such as mitigating circumstances. OIG considers all available information in making a final decision about whether to impose the exclusion.

If we decide to proceed with exclusion, we send the individual or entity a Notice of Exclusion along with information about the effect of the exclusion and appeal rights. The exclusion is effective 20 days after the Notice of Exclusion is mailed, and notice to the public is provided on OIG's website. The exclusion may be appealed to an HHS Administrative Law Judge (ALJ), and any adverse decision may be appealed to the HHS Departmental Appeals Board (DAB). Judicial review is also available after a final decision by the DAB.

When a permissive exclusion is being considered under §1128(b)(6) of the Act, the Notice of Intent to Exclude allows the individual or entity to request an opportunity to present oral argument to an OIG official before a decision about whether to exclude is reached. This is in addition to the right to submit documentary evidence and written argument.

If OIG decides to proceed with exclusion, we send the individual or entity a Notice of Exclusion and the subsequent administrative process is identical to the one described above. When a permissive exclusion is imposed under §§ 1128(b)(12) or (b)(13) of the Act, OIG is not required to send a Notice of Intent to Exclude. We send the individual or entity a Notice of Exclusion along with information about the effect of the exclusion and appeal rights. The exclusion is effective 20 days after the Notice of Exclusion is mailed, and notice to the public is provided on OIG's website. The subsequent administrative process is identical to the one described above.

When OIG is considering excluding an individual or entity under §1128(b)(7) of the Act, the administrative process differs more significantly from the one that is applicable to mandatory exclusions and most permissive exclusions. OIG will send the individual or entity a Notice of Proposal to Exclude. The written notice will include the basis for the proposed exclusion, the length of the exclusion, the factors we considered in setting the exclusion period, the effect of the exclusion, appeal rights and reinstatement information. Based upon this notice, the exclusion will be effective 60 days after the receipt of the notice unless, within that period, the individual or entity files a written request for a hearing. If the individual or entity makes a timely request for a hearing, an exclusion will not go into effect until and unless the ALJ upholds the OIG's decision to exclude. Any adverse decision may be appealed to the DAB, and judicial review is available after a final decision by the DAB.

What is the scope and effect of an exclusion?

The scope of an exclusion under Title 11 of the Social Security Act is from all Federal health care programs, as defined in 42 CFR 1001.2. Federal health care programs include Medicare, Medicaid, and all other plans and programs that provide health benefits funded directly or indirectly by the United States (other than the Federal Employees Health Benefits Plan). For exclusions implemented before August 4, 1997, the exclusion covers only the following Federal health care programs: Medicare, Medicaid, Maternal and Child Health Services Block Grant, Block Grants to States for Social Service, and State Children's Health Insurance programs. Federal health care program exclusions 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 effect of an exclusion is that no payment will be made by any Federal health care program for any items or services furnished, ordered or prescribed by an excluded individual or entity. No program payment will be made for anything that an excluded person furnishes, orders, or prescribes. This payment prohibition applies to the excluded person, anyone who employs or contracts with the excluded person, any hospital or other provider for which the excluded person provides services, and anyone else. The exclusion applies regardless of who submits the claims and applies to all administrative and management services furnished by the excluded person.

There is a limited exception to this payment prohibition for the provision of certain emergency items or services not provided in a hospital emergency room. See 42 CFR 1001.1901(c).

Additional information is available in the  Updated Special Advisory Bulletin on the Effect of Exclusions From Participation in Federal Health Programs.

Does the LEIE include exclusions from other agencies?

No, the List of Excluded Individuals/Entities includes only exclusion actions taken by the OIG

When were exclusions first implemented?

OIG has been implementing exclusions since about 1981, but the Department of Health & Human Services first began imposing them in 1977.

Does an exclusion affect a person's right to receive benefits under the Medicare, Medicaid and all Federal health care programs?

No. An exclusion affects only the ability to claim payment from these programs for items or services rendered; it does not affect the ability to receive benefits under the programs.

Does an OIG exclusion affect my ability to participate in a real estate transaction involving Department of Housing and Urban Development (HUD) financing?

No. The statutory authority for OIG's exclusion actions does not prohibit an individual who has been excluded by OIG from participating in any capacity (e.g., buyer, seller, real estate agent, loan processor) in real estate transactions that involve HUD financing. OIG has no authority to make determinations regarding an individual's eligibility to participate in a transaction that involves HUD financing; those determinations are made by HUD.

The effect of an OIG exclusion, and appearance on the General Services Administration's System for Award Management (SAM) website as a result of such exclusion, is that no payment will be made by any Federal health care program for items or services furnished, ordered, or prescribed by the excluded individual in any capacity.

Any questions regarding this issue should be directed to HUD via email at answers@hud.gov or by telephone at (800) CALL-FHA (5342).

What should I do if, when searching the LEIE, I receive a positive match?

Check the Special Advisory Bulletin on the Effect of an Exclusion for guidance. If you have already employed the individual, check the Self-Disclosure Protocol.

What is a waiver?

OIG has the authority to waive an individual or entity's exclusion from participating as a provider in Federal health programs. See Section 1128(c)(3)(B) of the Social Security Act (Act) and 42 C.F.R. 1001.1801(b). Waivers are only available for those excluded providers who are the sole community physician or the sole source of essential specialized services in a community. Waivers cannot be granted to anyone excluded based on a conviction related to patient neglect or abuse. See section 1128(a)(2) of the Act.

A waiver may only be requested by the administrator of a Federal or State health program. Excluded individuals or entities may not request a waiver from the OIG.

A list of current waivers in effect is available on our website.

What is the effect of an exclusion waiver on a payment?

When the OIG grants a waiver to an excluded individual or entity, it permits payment by Medicare, Medicaid, and all other Federal health care programs for items and services that they furnish, order, or prescribe, within the scope of the waiver (e.g., within a specified geographic location or institution, limited to a specific medical specialty, etc.). It is important to note that the waiver means that, within the scope identified in the waiver letter, Federal health care programs will pay for (1) covered services, such as office visits, home visits, and hospital visits, furnished by the physician or other health care provider, (2) hospital stays, medical tests, procedures, and/or equipment ordered by the physician or other health care provider, and (3) drugs, devices, and/or other items prescribed by the health care provider.

How does an excluded individual or entity get reinstated?

Reinstatement of excluded entities and individuals is not automatic once the specified period of exclusion ends. Those wishing to again participate in the Medicare, Medicaid and all Federal health care programs must apply for reinstatement and receive authorized notice from OIG that reinstatement has been granted.

To apply for reinstatement, send a written request to OIG at the address below. OIG will then provide Statement and Authorization forms that you must complete, have notarized, and return. The information contained in these forms will be evaluated and a written notification of OIG’s final decision on reinstatement will be sent to you. Generally, this process requires up to 120 days to complete, but can take longer.

Excluded providers may begin the process of reinstatement 90 days before the end of the period specified in the exclusion notice letter. Premature requests will not be considered.

If reinstatement is denied, the excluded party is eligible to reapply after 1 year.

To apply for reinstatement, send a written request to:

HHS, OIG, OI
Attn: Exclusions
P.O. Box 23871
Washington, DC 20026
(202) 691-2298 (Fax)

Obtaining a provider number from a Medicare contractor, a State agency or a Federal health care program does not reinstate eligibility to participate in those programs. Additional information in regulations can be found at 42 CFR 1001.3001-3005.

What is the difference between the LEIE and the General Services Administration's (GSA) Excluded Parties List System (EPLS) and System for Award Management (SAM) websites?

GSA administers EPLS and SAM, both of which contain debarment actions taken by various Federal agencies, including exclusion actions taken by the OIG. The List of Excluded Individuals/Entities contains only the exclusion actions taken by the OIG. You may access the EPLS at: http://www.epls.gov and SAM at https://www.sam.gov.

How can I report fraud or abuse related to the Medicare and Medicaid programs?

You may use the contact information on the OIG Hotline page.

How do I contact someone about exclusions?

HHS, OIG, OI
Attn: Exclusions
P.O. Box 23871
Washington, DC 20026
Telephone: (202) 691-2311
Fax: (202) 691-2298
Email: sanction@oig.hhs.gov

For purposes of the exclusion authority in section 1128(b)(8) of the Social Security Act (SSA), does an "immediate family member" include the lawfully married same-sex spouse of a person and family members that result from the lawful marriage of same-sex individuals?

Yes. Section 1128(j)(1) of the SSA and the regulations at 42 CFR 1001.1001(a)(2) define the term "immediate family member" to mean the person's:

  • Husband or wife;
  • Natural or adoptive parent, child, or sibling;
  • Stepparent, stepchild, stepbrother or stepsister;
  • Father-in-law, mother-in-law, daughter-in-law, son-in-law, brother-in-law, or sister- in-law;
  • Grandparent or grandchild; and
  • Spouse of a grandparent or grandchild.

In United States v. Windsor, 570 U.S. __, 113 S. Ct. 2675 (2013), the Supreme Court ruled that section 3 of the Defense of Marriage Act is unconstitutional. In light of this decision, the Department has instituted a policy of treating same-sex marriages on the same terms as opposite-sex marriages to the greatest extent reasonably possible. This FAQ clarifies Windsor's application to the exclusion authority under section 1128(b)(8) of the SSA. Effective June 26, 2013, the date of the Windsor decision, same-sex spouses and family members that result from same-sex marriages meet the definition of "immediate family member" if the state or other jurisdiction, whether foreign or domestic, where the couple was married recognizes the marriage under its laws, or if the state(s) or other jurisdiction(s) where the couple lives recognizes the marriage as a legally valid marriage. Any transfer of ownership or control interest in anticipation of or following a person's conviction, assessment, or exclusion (as described in section 1128(b)(8)(A)(iii) of the SSA) that is made on or after June 26, 2013 is subject to this policy.

Answers to Questions Concerning the LEIE

What is the data format for the LEIE?

The List of Excluded Individuals/Entities is available in two formats:

The Online Searchable Database enables users to enter the name of an individual or entitiy and determine whether they are currently excluded. If a match is made on an individual, the database can verify with an individual’s Social Security Number (SSN) that the match is unique. Employer Identification Numbers (EINs) are available for verification of excluded entities.

The LEIE Downloadable Database enables users to download the entire LEIE to a personal computer. Supplemental exclusion and reinstatement files are posted monthly to the OIG website, and these files can be merged with your previously downloaded data file to update your list.

If you do not wish to rely on the supplements to keep your information updated, download the Downloadable Data File each month.

Note: The Downloadable Database does not contain SSNs or EINs. Therefore, verification of specific individuals or entities through the use of the SSN or EIN must be done via the Online Searchable Database.

When is the LEIE updated with new information?

Both versions of the List of Excluded Individuals/Entities are generally updated by the middle of the month. The updates include all actions taken during the prior month.

Can you notify me when the LEIE is updated?

Sign up, located on the bottom right of every page, to receive email notifications when the List of Excluded Individuals/Entities is updated or sign up here to receive an RSS feed of updates.

Why is there a field to verify using SSNs on the Online Searchable Database, but the SSNs are not available in the Downloadable Data File?

The Privacy Act prohibits disclosing Social Security numbers (SSN), so they cannot be included in the Downloadable Database. However, the Online Searchable Database uses the SSN input by the user as one of the matching criteria. It does not supply SSNs to users. If you are a user of the Downloadable Database - and have a possible match on an individual and want to verify with a SSN - you should use the Online Searchable Database’s SSN feature to verify an identity.

What is the most efficient way to search the LEIE?

If you have only a few names to search, consider using the Online Searchable Database. It allows you to search up to five names at one time and to verify identities using a Social Security number or date of birth.

If you have a large group of individuals to search, consider downloading the entire list via the LEIE Downloadable Database to your computer and using a spreadsheet or database program to perform searches.

Note: The Downloadable Database does not contain SSNs or EINs. Therefore, verification of specific individuals or businesses through the use of the SSN or EIN must be done via the Online Searchable Database.

What is a UPIN?

The UPIN (unique physician identification number) was established by the Centers for Medicare & Medicaid Services as a unique provider identifier in lieu of the SSN. UPINs were assigned to physicians as well as certain nonphysician practitioners and medical group practices.

What is an NPI?

The NPI (national provider identifier) has replaced the UPIN (see question above) as the unique number used to identify health care providers. The Centers for Medicaid & Medicare Services first began assigning NPIs in 2006, and providers were required to use NPIs as of mid-2008.

Why do many LEIE records not contain NPIs, and which records include NPIs?

Many individuals and entities that are excluded by the OIG do not have National Provider Identifiers (NPI) to include in the LEIE. For those individuals and entities that have NPIs, OIG has added that information to records starting in 2008 and will include NPIs in LEIE records on a forward-going basis.

How do I obtain information on the DOB, UPIN, NPI, or the SSN if it isn't in the LEIE?

If a search result does not contain a DOB (date of birth), UPIN (unique physician identification number), NPI (national provider identifier), or SSN (Social Security number), it is not available from the OIG. Contact the Exclusions Staff to determine if there is any other information available.

Why are there providers in the LEIE that are not included in the National Practitioner Data Bank (NPDB) Public Use File?

The LEIE is a complete list of all currently excluded individuals and entities that have been excluded by the OIG pursuant to sections 1128, 1128A, and 1156 of the Social Security Act. The NPDB's Public Use File contains NPDB data specified under Titles IV of Public Law 99 660 and Section 1921 of the Social Security Act.

The criteria for inclusion in the NPDB are different than the criteria for inclusion in the LEIE. As a result, the records of many individuals and entities excluded by the OIG are not contained in the NPDB Public Use File. For example, a DME business owner that has been excluded by the OIG and included in the LEIE will not be found on the NPDB Public Use File.

Why are there providers in the NPDB who are not listed in the LEIE?

The LEIE contains all individuals and entities that are currently excluded. Once an individual or entity has been reinstated, they are removed from the LEIE. In contrast, the NPDB contains information on both exclusions and reinstatement actions taken by the OIG. Further, the NPDB contains records on additional providers who have not been excluded by OIG and therefore would not appear in the LEIE.

How can I obtain a copy of an individual's or entity's exclusion notice?

Submit a written request with a printout from the List of Excluded Individuals/Entities identifying the individual or entity. Requests without the printout will be returned. Generally, the only documentation available is the exclusion notice that informs the subject of the exclusion and its basis, its effect and the subject's appeal rights. If the subject has been reinstated, the notice informing the subject of that action is still available.

HHS, OIG, OI
Attn: Exclusions
P.O. Box 23871
Washington, DC 20026

Office of Inspector General, U.S. Department of Health and Human Services | 330 Independence Avenue, SW, Washington, DC 20201