FAQs

As outlined in a HRSA Policy Release (“Clarification on Use of the Medicaid Exclusion File,” No. 2014-1), the MEF does not apply to 340B drugs that are billed under Medicaid managed care organizations (MCO). While HRSA has not established a policy for how to handle MCO drugs for purposes of prohibiting duplicate discounts, we are aware that some covered entities have already worked with MCOs and state partners to develop models for the prevention of duplicate discounts.

In addition, the Centers for Medicare & Medicaid Services (CMS) has developed an Information Bulletin (PDF - 171 KB) that describes best practices that states can use to avoid 340B duplicate discounts in Medicaid. HRSA encourages 340B covered entities to work with their state to develop strategies to prevent duplicate discounts on drugs reimbursed through MCOs.

The date in the “start date” column is the first date that the entity began participating in the 340B Program. The date in the “term date” column is the effective date the entity is no longer participating in the 340B Program. These dates DO NOT relate to the covered entity’s MEF determination as carve in or carve out for Medicaid fee-for-service. To download the MEF for a specific quarter, on the MEF homepage in the 340B OPAIS a quarterly date range must be selected and those dates reflect the effective dates of the selected MEF download. Please note that the MEF only applies to Medicaid fee-for-service.

Covered entities may request a change to the 340B MEF at any time, but changes do not take effect until the 1st day of the following quarter and only if approved by OPA before the time it takes a quarterly snapshot of carve in/carve out decisions. Covered entities should time their 340B Medicaid billing practice to coincide with the first day of the quarter that reflects the new billing status. The 340B OPAIS takes a snapshot of carve in/out decisions at 12:01 a.m. ET on the 16th day of the month prior to the start of each quarter, irrespective of weekends or holidays. HRSA therefore encourages covered entities to submit carve in/carve out decisions before HRSA takes its quarterly snapshot to provide sufficient time to process and approve the request. To access the current Medicaid Exclusion File, visit "Medicaid Exclusion File."

A covered entity site can remove its 340B ID from the MEF to reflect that it will carve out all state Medicaid for the quarter. A covered entity site can add its 340B ID to the MEF to reflect that it will carve in at least one state Medicaid for the quarter. A covered entity site that carves-in, may add or remove state(s) it will bill 340B drugs during the quarter. A covered entity site that carves-in, may add or remove the billing number(s) it will use to bill a specific state for 340B drugs during the quarter.

We generally do not make retroactive changes to the quarterly MEF once it is published. On rare occasion, a technical system issue may warrant an immediate modification. If retroactive changes are necessary, HRSA will communicate this to the 340B Program stakeholders.

If a covered entity site (340B ID) answers “yes” to the following question in 340B OPAIS, “At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices?” the site must also provide each Medicaid state it plans to bill, and the billing number(s) it will list on the bill to the state. This only applies to Medicaid fee-for-service. Billing number(s) may include the billing provider’s national provider identifier (NPI) only, state-assigned Medicaid number only, or both the NPI and state-assigned Medicaid number. This information listed for each covered entity site (340B ID) in 340B OPAIS is used to generate a quarterly Medicaid Exclusion File, which is an official data source used by stakeholders to determine which covered entity sites bill Medicaid fee-for-service for 340B drugs.

For more information, contact the 340B Prime Vendor at 1-888-340-2787 or via email at ApexusAnswers@340bpvp.com.

To carve out Medicaid, a covered entity chooses to forego the 340B discount drugs for Medicaid patients. In this arrangement, 340B drug inventory is dispensed only to non-Medicaid patients. The covered entity would not be included on HRSA’s 340B Medicaid Exclusion File.

Covered entity sites will be responsible for updating their response to the modified Medicaid billing question (At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices?) in 340B OPAIS by the end of their next annual recertification submission.

Covered entity sites will continue to be responsible for listing the billing number(s) used to bill 340B drugs to Medicaid fee-for-service on the HRSA Medicaid exclusion file (MEF). In addition, covered entity sites may continue to submit change requests to change their information listed on the HRSA MEF. Note that a covered entity site may request a change to its listing on the HRSA MEF at any time; however, changes only take effect the following quarter, and only if OPA receives, approves, and processes the change request before the 16th day of the month prior to the start of the quarter.