Establish a 340B purchasing account with a wholesale distributor (e.g., AmerisourceBergen's 340B program, McKesson's ClaritasMD, or Cardinal Health's 340B management platform); confirm the account is designated as a 340B account and not a GPO account in the wholesaler's system
Integrate the TPA's replenishment output with the wholesaler's ordering API or EDI order interface (typically EDI X12 850 Purchase Order or wholesaler-specific API); map replenishment-generated drug NDC, quantity, and ship-to location fields to the wholesaler's order format
Transmit 340B purchase orders to the wholesaler; receive EDI X12 855 Purchase Order Acknowledgment or API order confirmation; validate that the order was accepted as a 340B-priced order (not WAC or GPO pricing)
Receive the EDI X12 856 Advance Ship Notice (ASN) and 810 Invoice from the wholesaler; reconcile the invoice pricing against the HRSA-published 340B ceiling prices for the purchased NDCs (available at 340bpricing.hrsa.gov for covered entity users)
If any invoice price exceeds the 340B ceiling price, dispute the overcharge with the wholesaler and, if unresolved, submit a 340B pricing complaint to HRSA via the OPA complaint process
Maintain purchase records (NDC, quantity, 340B price paid, wholesaler invoice number) for a minimum of 3 years; these records are required for HRSA audits and internal 340B compliance audits
Known gotchas
A single drug can have multiple NDCs (different package sizes, generic vs. brand) with different 340B ceiling prices; ensure the purchasing system maps to the correct NDC-level ceiling price rather than a drug-name-level price
340B ceiling prices are updated quarterly by HRSA and are based on Average Manufacturer Price (AMP) minus a statutory discount; if the wholesaler's system is not updated with the current quarter's prices, the covered entity may be overcharged without realizing it
Drugs on the 340B program's orphan drug exclusion for certain eligible entity types (e.g., CAHs and free-standing cancer hospitals) may not be available at 340B pricing even if the entity is otherwise eligible; check HRSA exclusion lists before purchasing
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