Medicaid Exclusion File(s)

The Medicaid Exclusion File (MEF) lists covered entities that have chosen to use 340B drugs for their Medicaid patients and to bill Medicaid for those drugs (carve-in). When covered entities choose to carve-in for Medicaid, they must provide OPA with the Medicaid Provider Number/NPI used to bill Medicaid. These provider identifiers are listed in the MEF. Having this information in the MEF indicates to the states and manufacturers which drugs are not subject to Medicaid rebates, and helps ensure the prevention of duplicate discounts, as prohibited by statute.

The MEF also lists the Medicaid provider numbers and/or NPIs that the entities have identified as being used to bill for those drugs, to assist state Medicaid agencies in separating rebate-eligible claims from those that would result in duplicate discounts if rebates were requested. Entities must be consistent with their Medicaid billing carve-in/carve-out decisions. For entities that decide to carve-in, all drugs billed to Medicaid using the listed number/NPI must be purchased under the 340B program. Entities that DO NOT use 340B drugs for Medicaid patients (carve-out) must ensure that all drugs billed to Medicaid (under any provider number/NPI) were NOT purchased at 340B prices.

The 340B OPAIS The 340B Office of Pharmacy Affairs Information System (OPAIS) is a collection of information submitted by covered entities, contract pharmacies, and manufacturers maintained and verified by HRSA's Office of Pharmacy Affairs (OPA). takes a snapshot of carve-in decisions at 12:01 am ET on the 16th day of the month prior to the start of each quarter, regardless of weekends or holidays. At any time, covered entities may submit online change request forms to modify their Medicaid billing decisions, but changes only take effect the following quarterand only when received, approved, and processed by OPA before the time of the snapshot for that quarter. For example, a change submitted on June 1 and approved on June 2 will be reflected in the June 15 snapshot governing the July–September quarter. A change submitted on June 14 but not approved until June 16 will not be reflected in the June 15 snapshot, but will be included in the snapshot for the October quarterly MEF. The prior decision will remain in effect until the quarter beginning October 1.

Follow these steps to download and view the Medicaid Exclusion Files.

1. On the Reports page, click the Medicaid Exclusion Files button.

2. The Download Medicaid Exclusion File page displays a warning for covered entities that might claim duplicate drug price discounts, explains a requirement that entities must decide whether or not to use 340B pricing and bill Medicaid, and describes how drug manufacturers and wholesalers, and state Medicaid agencies can use the Medicaid Exclusion File to 340B participants.

   

3. Select the desired quarter from the drop-down list. This date range reflects the effective quarter of the covered entities' Medicaid billing carve-in decision.

4. Click the Download button. A dialog box will prompt you to open the file or save it for later. If you choose to open it, the Medicaid Exclusion File is displayed in an Excel spreadsheet.

   • The "start date" field represents the first date the covered entity began participating in the 340B Program The federal drug discount program authorized under section 340B of the Public Health Service Act and established by Congress under the Veterans Health Care Act of 1992 (Public Law 102-585, codified at 42 USC § 256b). The 340B program requires drug manufacturers to enter into pharmaceutical pricing agreements with the HHS Secretary, under which manufacturers agree not to sell covered outpatient drugs to covered entities above 340B ceiling prices.; the "term date" represents the effective date the entity no longer participates in the 340B Program, if applicable. These dates do not relate to the covered entities' MEF determination to carve-in Medicaid.
   • The “State” field identifies the state that is billed with the Medicaid Provider Number and/or the NPI Number. You can use commas to separate multiple Medicaid Numbers or NPI numbers. Blank value for State is displayed if there is no state associated with an NPI Number. The “St” field simply lists the state jurisdiction where the covered entity is located.