Eligible entities with pharmacies participating in the 340B Program must identify all outpatient pharmacy claims filled with 340B purchased drugs for 340B-eligible clients, including fee-for-service Medicaid and managed care, by submitting a value of "20" (340B / Disproportionate Share Pricing/Public Health Service) in the "Submission Clarification Code" field (420-DK). Submitting this value prevents duplicate discounts.
The 340B statute prohibits duplicate discounts, which occur when a covered entity obtains a 340B discount on medication and a Medicaid agency obtains a discount in the form of a rebate from the manufacturer for the same medication. Covered entities must have mechanisms in place to prevent such occurrences. Refer to the HRSA Duplicate Discount Prohibition page (hrsa.gov/opa/program-requirements/medicaid-exclusion/) for more information.
Pharmacy providers may not know at point-of-sale if a claim qualifies as a 340B claim. To qualify as a 340B claim, pharmacies must dispense 340B purchased drugs to a 340B eligible client. If the pharmacy submits the 340B claim without the Submission Clarification Code, the pharmacy must reverse and resubmit the claim once the pharmacy identifies the error. The manufacturer is invoiced if the pharmacy does not correct the claim. The pharmacy and the eligible entity may be held responsible for repaying any incorrectly invoiced amounts to the manufacturer. Manufacturers initially provide pharmacies with drugs at 340B prices, and pharmacies should not invoice the manufacturer after the sale for another rebate.