340B Pharmacy Services Agreement
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. 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).
340B Prime Vendor Program – The 340B Prime Vendor Program (PVP) is managed by Apexus through a contract with HRSA. Apexus is responsible for securing sub-ceilings for outpatient drug purchases and rebates on other pharmacy-related products and services for participating public hospitals, municipal health centres and other safety care providers. Covered companies can enter into agreements either through multiple contracts with individual pharmacies or through a single contract with a chain pharmacy that identifies specific pharmacy sites that support the insured unit`s 340B program. Based on the regulatory and regulatory requirements necessary to minimize fraud and abuse under the program, contract pharmacies can be compensated at a higher dosage rate in order to meet these standards and provide care in need. Today, approximately 17,000 health facilities are eligible for the 340B program, which allows them to increase resources, reach more eligible patients and provide more comprehensive services.