340B and Medicaid/Duplicate Discounts
Section 340B(a)(5)(A) of the Public Health Service Act prohibits duplicate discounts; that is, manufacturers are not required to provide a discounted 340B price and a Medicaid drug rebate for the same drug. Covered entities must have mechanisms in place to prevent duplicate discounts and should address prevention of duplicate discounts in their policies and procedures.
The 340B Medicaid Exclusion File is a mechanism created by HRSA which helps state Medicaid agencies comply with a specific 340B statutory provision: that drugs purchased at 340B prices must be excluded from Medicaid rebate requests to drug manufacturers. Covered entities must choose whether they will use 340B drugs for their Medicaid patients. If they choose to do so, they must provide the HRSA Office of Pharmacy Affairs (OPA) with their pharmacy Medicaid provider number or National Provider Identifier (NPI), which is placed in the 340B Medicaid Exclusion File. OPA makes the 340B Medicaid Exclusion File available to state Medicaid agencies and manufacturers so that the state does not request a Medicaid rebate from a manufacturer for the already discounted 340B drugs.
The 340B Medicaid Exclusion File is available on the HRSA 340B OPAIS website.