Confirm the covered entity has an active 340B registration in OPAIS; verify the pharmacy to be contracted is a licensed retail pharmacy (chain, independent, or mail order) with an active NPI
During an open registration window, log into 340B OPAIS; navigate to the covered entity's record and select Add Contract Pharmacy; enter the pharmacy's NCPDP/NPI and pharmacy legal name
Certify that a fully executed written agreement is in place between the covered entity and the contract pharmacy before submission; HRSA requires this agreement to exist before the OPAIS registration is submitted—not after
Designate whether the contract pharmacy will use a split-billing (inventory management) model with a TPA, or a replenishment model; document the data flow for 340B claim identification in the arrangement
After OPAIS registration is approved, configure the Third-Party Administrator (TPA) or split-billing software to apply 340B eligibility logic: patient must be a patient of the covered entity and receive a drug for a condition treated by the covered entity
Implement annual external audit of each contract pharmacy arrangement as required by HRSA; retain audit documentation and ensure the contract pharmacy provides dispensing data to the TPA for audit support
Known gotchas
HRSA has restricted the number of contract pharmacies allowed per covered entity for certain entity types following federal court decisions; check current HRSA policy and any manufacturer-imposed restrictions before registering additional contract pharmacies
The patient definition under 340B is strict: the patient must have an established relationship with the covered entity and receive care there—purchasing 340B drugs for patients of referring outside providers is generally not permitted
Some manufacturers have implemented conditions on 340B contract pharmacy pricing using the 340B ESP platform or direct manufacturer programs; covered entities must submit claims data to those platforms to receive 340B pricing at contract pharmacies for participating manufacturers
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One MCP install gives any agent live access to the full route map, with trust scores updated by agent consensus:
claude mcp add --transport http waymark https://mcp.waymark.network/mcp