Andrew T. Wampler (awampler@wwmgs.com) is a Shareholder at Wilson Worley PC in Kingsport, TN.
Management, Legal, and Compliance review many issues when a healthcare provider plans to enter into an agreement. When the other party is another healthcare provider, one important consideration is whether the Department of Health and Human Services Office of Inspector General (OIG) has excluded that other party from federal programs. Such an exclusion is a penalty imposed by the government on those who have engaged in fraud, abuse, or other misconduct related to a federal healthcare program, not a voluntary decision by individuals who have decided not to enroll or to participate in federal programs.
The OIG has the authority to exclude individuals or entities under Title XI of the Social Security Act.[1] That exclusion applies to all federal healthcare programs, including Medicare, Medicaid, and other programs that provide health benefits that the United States funds either directly or indirectly.[2] If a healthcare provider enters into an agreement with or employs another who has been excluded from a federal healthcare program, the OIG may impose significant civil monetary penalties or even exclude that healthcare provider from future participation. The standard is whether the healthcare provider knew or should have known that the party it contracted with was excluded.
Under the exclusion power, the OIG can mandate that no payment will be made by any federal healthcare program for any items or services furnished, ordered, or prescribed by an excluded individual or entity. This prohibition covers the excluded party along with any entity that employs the excluded party, any hospital at which the excluded party provides services, or anyone else with whom the excluded party contracts. Further, the exclusion applies regardless of how the claim is submitted or who submits it, and it applies to all administrative and management services as well.
The exclusionary period is a minimum of five years, but can be longer. There is an administrative process in which a notice of intent to exclude is sent. The process includes an appeal to an Administrative Law Judge.
Checking the list
The OIG maintains a List of Excluded Individuals and Entities — the LEIE.[3] That list is available on the OIG’s website. The OIG also provides information regarding its exclusionary powers and their scope with frequently asked questions and instructional video. An exclusions staff is available to discuss any specific questions that users of the list may have.[4] The website offers email updates and allows requests for the OIG to render an advisory opinion.
Because of the significant risk of contracting with an excluded individual, healthcare providers should consult the LEIE to determine whether a potential employee or party to a contract has been excluded. Compliance should assist other stakeholders in ensuring that the list is reviewed prior to employing or contracting with any individuals who will provide any items or services payable by a federal healthcare program. It is also advisable that healthcare providers check the LEIE on a periodic schedule to review for existing contractors and employees to ensure that their status has not changed.
Users can search the LEIE database online. Up to five names may be searched at one time. The database is available at http://exclusions.OIG.HHS.gov/. For those who frequently review the LEIE and prefer to consult a spreadsheet, the OIG has a downloadable version of the database that is also accessible through its website and can be maintained offline. The Privacy Act prohibits Social Security numbers from being included on a downloadable date file. It updates both versions of the LEIE on a monthly basis, generally by the middle of the month. Those updates include all actions taken during the previous calendar month. The OIG uses the email notices referenced above to notify providers when the LEIE is updated.
Searchers should use care when searching for an entity or individual. Spelling and punctuation are important, but the database does not require capitalized letters. Checking multiple variations of a spelling is appropriate, because of errors that could happen in input or in maintenance of the database itself. The list may reference providers with hyphenated names under either name or the hyphenated name. Former names and married names may also require multiple searches. For entities, it is important to check all corporate names and ensure that the name of the entity is proper. Healthcare providers also use doing-business-as names and assumed names, particularly in this time of frequent acquisitions and mergers. At least for the first pass, a search should be as simple and as inclusive as possible to see how many results are provided.
Verifying the numbers
Verification of positive results is necessary. The online database has a field to verify Social Security numbers, but those numbers must be input. They are not available, because the HIPAA Privacy Act prohibits Social Security numbers from being included on a downloadable data file. Users can verify identity by checking an individual’s Social Security number or an entity’s Employer Identification number, which is a number provided by the Internal Revenue Service. Social Security numbers are a good way to confirm that the appropriate individual has been identified. Users input the Social Security numbers into the searchable database as one of the matching criteria, so those numbers are not provided by the OIG to the searcher.
Documenting the results is extremely important. The search results should be printed or saved electronically into the file that involves that contract. If there is a match, the page indicating whether the identity was verified should be printed as well. The database includes a unique physician identification number (UPIN) created by the Centers for Medicare and Medicaid Services (CMS) as a provider identifier in lieu of a Social Security number. The database also includes national provider identifiers (NPIs), which have replaced the UPIN as unique numbers used for providers. CMS began assigning NPIs in 2006, thus some of the individuals and entities that are excluded by the OIG do not have NPI numbers. If a search result does not contain a date of birth, UPIN, NPI, or Social Security number, it is not available from the OIG. If contacted, the exclusion staff can determine if there is other identifying information available. A copy of the individual’s or entity’s exclusion notice can be obtained by submitting a written request with a printout from the LEIE to the OIG Exclusions Department.
In the System for Award Management (SAM), various agencies, including the OIG, list debarment actions they have taken. SAM includes names of individuals or entities that have been debarred, suspended, or otherwise excluded from various federal programs. The SAM website is available at http://www.sam.gov. As with the OIG exclusion search, the website has user guidelines and resources available to assist with searches. The OIG recommends using its LEIE as the primary search engine for exclusions,[5] because the LEIE contains more specific details and is updated more regularly.
Conclusion
Exclusion searches are a necessary part of any contracting with healthcare providers. Compliance can assist the provider or organization with necessary steps to conduct the searches. For contact and support, the OIG has resources available to help providers avoid running afoul of federal requirements.
Takeaways
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Penalties for contracting with excluded parties can be severe.
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Excluded parties are identified in a database called the List of Excluded Individuals and Entities (LEIE).
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Searches for excluded parties are critical during contracting.
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Providers should verify the results of all LEIE searches.
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Providers should document and maintain all exclusion searches.
