Your Pharmacy’s Legal Obligation to Ensure that It Does Not Associated with an Excluded Person
Your pharmacy has an affirmative legal obligation to ensure that it does not associate with (i.e., employ, transact business with, fill prescriptions for, etc.) an individual or entity that is currently excluded from participation in Medicare, Medicaid and all Federal health care programs. Many pharmacies are unaware of this legal obligation. Many pharmacies do not take the necessary steps to ensure that they have fulfilled this obligation. The results of inaction can be severe and may result in your pharmacy having to disgorge revenues received for any items or services furnished, ordered, or prescribed by an excluded individual or entity.
Under federal law, 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. 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). If payment has already been issued and your pharmacy is subsequently investigated, you will be required to return any monies you received as a result of your association with an excluded entity. For example, if a pharmacist that you employ is an excluded provider (unbeknownst to you, of course), your pharmacy will be legally obligated to return any monies it has received from any federal health program for prescriptions filled by that pharmacist. Similarly, if your pharmacy fills a prescription for a physician that is an excluded person, you are legally obligated to return any monies you received in connection with filling prescriptions issued by that physician.
The Office of Inspector General (OIG) maintains a List of Excluded Individuals/Entities (LEIE) database that all pharmacies should periodically check to ensure that they are not associating with an excluded person or entity.
As a new benefit to members of the Pharmacy Audit Intervention and Response Program (“PhAIR”), Frier & Levitt (“FL”), can assist your pharmacy in its efforts to ensure that it is not associating with an excluded person. FL will conduct an online search of the OIG’s List of Excluded Individuals/Entities (“LEIE”) database for up to five (5) individuals or entities of the PhAIR member’s choosing (e.g., employees, prescribing physician’s, etc.) to determine whether that person/entity is listed in the LEIE database. This service will be performed at no additional charge to the member and on a bi-monthly basis. If the person/entity is in the LEIE database, you will receive an e-mail alert advising you accordingly. In addition, in the event your pharmacy is investigated and asked to demonstrate what measures it has taken to determine whether it has associated with an excluded person/entity, Frier & Levitt shall provide a certification stating that it has performed a search of OIG’s LEIE online database, the dates on which the search was performed, and the results of the search. Frier & Levitt’s search is limited to an online review of the OIG’s LEIE database. We are not performing an exhaustive search of all databases that collect information regarding excluded persons/entities. We make no representations or warranties that a search of the LEIE database shall conclusively reveal whether a person or entity has been excluded from a federal health program.
In addition, for PhAIR members that would like Frier & Levitt to conduct a search for additional persons/ entities that may appear on the LEIE database, we will do so for a flat fee of $100.00 and monitor those persons/entities on a bi-monthly basis for one year. Furthermore, many States maintain their own online database of excluded persons/entities. If your State maintains an online database, Frier & Levitt shall, for a flat fee of $100, conduct a search your State’s online database for up to five (5) persons/entities of your choosing.





