By Rose Willis
Under the Federal “Exclusions Statute,” a health care provider that arranges or contracts with a person that the provider knows or should know is an excluded person, may be subject to Civil Money Penalties (“CMP”) liability, or exclusion, if the excluded person provides services that are payable, directly or indirectly, by a Federal health care program.
1999 Bulletin
In 1999, the Federal Department of Health and Human Services Office of Inspector General (OIG) issued a “Special Advisory Bulletin” which provided guidance to providers relating to (1) the scope of the Exclusions Statute prohibition on their employment or contracting activities; (2) when a violation of the prohibition will subject the provider to Civil Money Penalties; and (3) the determination of whether a potential employee or contractor is excluded.
2013 Bulletin
In May 2013, the OIG issued an updated Bulletin clarifying the effect of the Exclusions Statute on Healthcare Providers. The updated guidance from the OIG provides further detail regarding (1) how the Exclusions Statute can be violated; (2) administrative sanctions against those who have violated the Exclusions Statute; and (3) the scope and frequency of screening employees and contractors to determine whether they are excluded persons. The new guidance provided the following types of services as examples of services that may not be provided by an excluded person:
- Preparing surgical trays or reviews treatment plans, regardless of whether they are billable
- Inputting prescription information for pharmacy billing, regardless of whether they are billable
- Providing transportation services that are paid for by a Federal health care program
- Serving in a leadership role for a healthcare provider that provides items or services payable by Federal health care programs (for example, CEO, CFO, general counsel, director of health information management, director of human resources, physician office manager)
- Providing health information technology services and support, strategic planning, billing and accounting, staff training, and human resources for a healthcare provider that provides items or services payable by Federal health care programs.
Penalties for violating the Exclusions Statute may subject the healthcare provider to a CMP of $10,000 for each claimed item or service furnished during the period that the person was excluded, an assessment of up to three times the amount claimed for each item or service, and exclusion from Federal health care program.
The LEIE
The OIG’s List of Excluded Individuals and Entities (LEIE) database is available at: http://oig.hhs.gov/exclusions. This database is the healthcare provider’s primary tool in complying with the Exclusions Statute and confirming whether a person or entity is an “excluded person.”
While other databases exist that may incorporate the OIG’s exclusions (such as the NPDP and GSA’s SAM), the OIG recommends that providers rely only on the LEIE as the primary source of information about OIG exclusions because the LEIE is maintained by the OIG, updated monthly, and provides more details than other governmental databases.
Screening Tips and Frequency
The OIG has provided a list of 10 “tips” to providers in performing searches of the LEIE, which are located here: https://oig.hhs.gov/exclusions/tips.asp. Notably, OIG recommends that the provider maintain documentation of the initial name search performed (such as a printed screen-shot showing the results of the name search) and any additional searches conducted, in order to verify results of potential name matches.
Providers should check the LEIE prior to employing or contracting with persons and periodically check the LEIE to determine the exclusion status of current employees and contractors. Since the LEIE is updated monthly, the OIG recommends that employees and contractors (both prospective and current) should be screened each month to minimize potentially liability.
Contracting for Screening Services
If the health care provider contracts with another entity to perform their screening against the LEIE, the OIG recommends that the provider validate that the contractor is properly conducting the screening. For example, the provider should request and maintain screening documentation. Because it is the provider’s responsibility to make this determination, the provider will retain potential CMP liability if they employ or contract with an excluded person, even if the screening services are contracted out.
Self Disclosure
Providers who discover that they have contracted with or employed an excluded person and identified potential CMP liability may use the OIG’s Provider Self-Disclosure Protocol (“SDP”) to disclose and resolve the potential CMP liability. Self disclosure in some circumstances, for example where a provider contracted out its screening services, may reduce the amount of CMP liability. Information on the SDP can be found here: http://oig.hhs.gov/compliance/self-disclosure-info/index.asp.