3.1 Pharmacy Claims
Pharmacies of eligible entities participating in the 340B Drug Pricing Program must identify all outpatient pharmacy claims filled with 340B stock for 340B-eligible people in all programs by submitting a value of "2Ø" ("34ØB / Disproportionate Share Pricing/Public Health Service") in the "Submission Clarification Code" field (42Ø-DK).
Many 340B covered entities elect to dispense 340B drugs to patients through contract pharmacy services, an arrangement in which the 340B covered entity signs a contract with a pharmacy to provide these prescription services. A covered entity that wishes to utilize contract pharmacy services to dispense section 340B outpatient drugs must have a written contract in place between itself and a specified pharmacy or pharmacies. A single covered entity that has more than one 340B eligible site at which it provides health care may have individual contracts for each such site or include multiple sites within a single pharmacy services contract. All contracted pharmacies must be listed in the HRSA’s Office of Pharmacy Affairs (OPA) Contracted Pharmacies Database, associated with the covered entity. The covered entity is responsible for compliance of their contract pharmacy arrangement(s) and must maintain ownership of the 340B drugs.
A “ship to, bill to” procedure can be used by which the covered entity purchases the drug; the manufacturer/wholesaler bills the covered entity for the drug that it purchased and ships the drug directly to the contract pharmacy.
3.2.1 Guidelines for Contract Pharmacy Services
Guidelines that govern the operation and compliance of contract pharmacies can be found at “Notice Regarding 340B Drug Pricing Program — Contract Pharmacy Services, Final Notice (PDF)." Federal Register 75 (March 5, 2010): 10272-10279.
Covered entities are responsible for ensuring compliance of their contract pharmacy arrangement(s) with all 340B Program requirements to prevent diversion and duplicate discounts.
3.2.3 HRSA Audit Requirements
All covered entities are required to maintain auditable records and are expected to conduct annual audits of contract pharmacies performed by an independent outside auditor to fulfill their ongoing obligation of compliance. To the extent that any compliance activity or audit performed by a covered entity indicates that there has been a violation of 340B Program requirements, such finding should be disclosed to HRSA along with the covered entity's plan to address the violation.
A pharmacy may not know at point-of-sale if a claim qualifies as a 340B claim. At the point the pharmacy is notified or discovers that the claim qualifies as a 340B claim, the original claim must be reversed and the claim resubmitted as a 340B claim with the correct “Submission Clarification Code” value (refer to Pharmacy Claim Submission, section 3 above). If the claim has not been corrected to include the correct "Submission Clarification Code" value, the pharmacy and the eligible entity are at risk for duplicate discounts.