Exclusions FAQ

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.

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

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 as we make our 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.

The scope of an exclusion under Title 11 of the Social Security Act is from 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 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 exclusions 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 Special Advisory Bulletin on the Effect of an Exclusion.

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

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

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.

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.

Reinstatement of excluded entities and individuals is not automatic once the 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. We 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 can begin the process of reinstatement within 120 days of the expiration of their exclusion. 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
Exclusions Staff
7175 Security Boulevard, Suite 210
Baltimore, MD 21244

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. There are no provisions for early or retroactive reinstatement. Additional information in regulations can be found at 42 CFR 1001.3001-3005.

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 just the exclusion actions taken by the OIG. You may access the EPLS at: http://www.epls.gov and SAM at https://www.sam.gov.

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

HHS, OIG, OI
Exclusions Staff
7175 Security Boulevard, Suite 210
Baltimore, MD 21244
Phone: (410) 281-3060
Fax: (410) 265-6780
Email: sanction@oig.hhs.gov

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 business 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 included for excluded entities.

The LEIE Downloadable Data File 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 Data File 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.

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.

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.

The Privacy Act prohibits disclosing Social Security numbers (SSN), so they cannot be included in the Downloadable Data File. 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 Data File - 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.

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 Datafile to your computer and using a spreadsheet or database program to perform searches.

Note: The Downloadable Datafile 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.

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.

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 it as of mid-2008.

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.

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 available.

HHS, OIG, OI
Exclusions Staff
7175 Security Boulevard, Suite 210
Baltimore, MD 21244