On May 8, 2013, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) issued an updated Special Advisory Bulletin on the effect of exclusion from participating in federal health care programs. This Bulletin replaces and supersedes the 1999 Special Advisory Bulletin.

In the updated Bulletin, OIG recommends screening the List of Excluded Individuals and Entities (LEIE) on a monthly basis. OIG also provides additional guidance on the scope of the payment prohibition and potential civil monetary penalty (CMP) liability, including the obligation of providers that furnish items and services on the basis of orders or prescriptions to ensure at the point of service that the ordering or prescribing physician is not excluded.

Key takeaways from the updated Bulletin include:

Prohibited Payments. No federal health care program payment may be made for any items or services furnished (1) by an excluded person or (2) at the medical direction or on the prescription of an excluded person.

• The payment prohibition applies to all methods of federal health care program payment, including itemized claims, cost reports, fee schedules, capitated payments, a prospective payment system, or other payment system and applies when payment is made to a state agency or person that is not excluded.
• The prohibition of payment for items and services furnished by excluded persons includes items and services beyond direct patient care. Examples provided by the OIG include preparation of surgical trays or transportation services by ambulance drivers. Excluded persons are also prohibited from furnishing administrative and management services that are payable by federal health care programs, even if the services are not separately billable. For example, an excluded person may not serve in a leadership role for a provider that furnishes services payable by federal health care programs.
• Items and services provided at the medical direction or on the prescription of an excluded person are not payable when the person furnishing the items or services knows or should know of the exclusion. Providers that furnish items and services on the basis of orders or prescriptions (e.g. laboratories, imaging centers, DME suppliers, pharmacies) could be subject to non-payment and to CMP liability if they furnish items or services on the basis of an order or a prescription written by an excluded person. OIG recognizes that many such providers rely on managed care plans to screen, but recommends that such providers ensure at the point of service that the ordering or prescribing physician is not excluded.

Self-Disclosure. In this updated Bulletin, OIG advises that providers who identify potential civil monetary penalty (CMP) liability on the basis of employing, contracting with or arranging with an excluded person may use OIG's self- disclosure protocol (SDP) to disclose and resolve potential liability.

Screening. To avoid potential CMP liability, OIG recommends that providers check the LEIE prior to employing or contracting with persons and periodically thereafter.

• OIG does not formally require providers to check the LEIE (although, in practice, most providers will need to do so to ensure compliance), so it imposes no requirement as to the frequency of checks. It does, however, recommend monthly checks because (1) the LEIE is updated monthly and (2) monthly screening will best minimize overpayment and CMP liability.
• OIG recommends that other databases, such as the General Services Administration's System for Award Management or the National Practitioner Data Bank, not be used in lieu of the LEIE to screen for exclusions. OIG updates and maintains the LEIE and, accordingly, serves as the primary source of information about OIG exclusions.
• OIG recommends that providers maintain documentation of the search performed on the LEIE (such as printed screen shots of the results of a name search), or, if relying on the contracted party to perform the screening, request screening documentation from the contractor.