Companies covered by 340B can choose to distribute 340 B drugs to patients through contract pharmacy services, an agreement by which the company covered by 340B signs a written contract with a pharmacy for the provision of pharmacy services. The use of an individual contract pharmacy or several contract pharmacies is optional and a company concerned should first determine its pharmacy needs and the appropriate distribution mechanism for these services when deciding whether or not to use a contracted pharmacy. The written contract should identify all pharmaceutical sites and covered company sites that will use the 340B drugs. HRSA recommends that the written agreement contain all essential elements of the contract pharmacy guidelines (75 Fed. Reg. 10272 (March 5, 2010). Contract pharmacies must register for the 340B program and be listed on 340B OPAIS before spending 340B drugs on behalf of an insured company. Insured companies are responsible for ensuring that all requirements of the 340B program are met. Contract pharmacies must develop Medicaid (i.e. no 340B drugs for Medicaid patients), unless the company concerned has reached an agreement with the state-run Medicaid agency to avoid double discounts. The covered company must notify HRSA of these agreements. The checklist of the carve-in requirement of the covered entity contains information on the determination of the carve-in authorization.
Carve-in Contractual Pharmacies Requests must be made to OPAexclusion@hrsa.gov. The answer to all elements of the checklist makes it easy to record smoothly. Carve-in applications will be reviewed by HRSA and, upon approval and on 340B OPAIS, will be listed as a carve-in, the company may begin setting up pharmacies early in the following quarter. Please contact the 340B Prime Vendor Program (PVP) for more information on contract pharmacies. If contract pharmacies are not properly listed in 340B OPAIS, this may result in pharmacies withdrawing from the 340B program. HRSA reserves the right to request clarification documents at any time or verify compliance. Section 340B (a) (1) of the Public Health Service Act (PHSA) stipulates that the Minister of Health and Human Services (the Secretary) enters into a pharmaceutical price agreement (AAE) with each manufacturer in which the manufacturer agrees to charge a price for covered outpatient drugs not exceeding a statutory amount (340 B). This requirement applies to all ENFs that receive federal bonuses – active grants, cooperation agreements and purchase contracts – of more than $10 million for any period during the execution period of an award/arbitration project. Grants Policy Bulletin: Legislative mandates in Grants Management for Fy 2020 (PDF – 398 KB) Legal provisions limiting the use of funds for grants and cooperation agreements for GJ 2020. In a contract pharmacy, the registered entity retains responsibility for preventing diversions and duplication, keeping verifiable records, and meeting all other requirements of the 340B Drug Pricing Program (340B Program).
Any covered company that chooses a contract pharmacy must ensure that such a contract fully meets these requirements; and that the covered company and the pharmacy of the contract comply with the terms of the contract. To the extent that the requirements of the 340B programme have been breached in a contracted pharmacy, the company concerned must inform the producers concerned and make good faith efforts to resolve problems directly with manufacturers and wholesalers. In addition, in the event of a substantial breach, HRSA can reasonably expect the covered company to pass this information on to HRSA at the same time as the company`s plan to remedy the breach. MRSA and manufacturers (in accordance with an approved audit plan) can inspect covered businesses and their pharmacies.