340B Pharmacy Services Agreement

Health Resources and Services Administration Office of Pharmacy Affairs – The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services, is the primary federal agency responsible for improving access to health services for the uninsured, isolated, or medically vulnerable. The Bureau of Pharmaceutical Affairs (OPA) is the arm of HRSA that administers the 340B drug discount program. The program allows 340B hospitals to use limited federal resources to provide more affordable and comprehensive health services to patients and the communities they serve. Hospitals are using $340 billion in savings to provide free care to uninsured patients, offer free vaccines, provide services in psychiatric hospitals, and implement medication management and community health programs, among other things. Companies covered by 340B may choose to provide 340B drugs to patients through contract pharmacy services, an agreement in which the company covered by 340B signs a written contract with a pharmacy to provide pharmacy services. The use of a single contract pharmacy or several contract pharmacies is voluntary and a covered entity should first determine its pharmacy service needs and the appropriate distribution mechanism for those services when deciding whether or not to use a contract pharmacy. The written contract should identify all pharmacy locations and all covered business locations that use 340B drugs. HRSA recommends that the written agreement include all essential elements of the Guidelines for ContractEd Pharmacies (75 Fed. Reg. 10272 (5 March 2010)). In order to comply with the ongoing obligation to comply, all covered entities are required to supervise the contract pharmacy, maintain verifiable records and conduct annual audits of their contract pharmacies by an independent accounting firm. Any compliance activity or audit performed by a registered entity that indicates a violation of the requirements of the 340B program must be disclosed to THE HRSA and include the company`s plan to remedy the violation.

Covered companies can enter into agreements either through multiple contracts with individual pharmacies or through a single contract with a pharmacy chain that identifies specific pharmacy locations that support the covered company`s 340B program. Depending on the regulatory and legal requirements necessary to minimize fraud and abuse under the program, contract pharmacies may be compensated with a higher delivery rate to meet these standards and provide care when needed. Today, there are approximately 17,000 health facilities eligible to participate in the 340B program, allowing them to leverage scarce resources, reach more appropriate patients, and provide more comprehensive services. Many of these facilities are located in rural America. Contract pharmacies must enroll in the 340B program and be enrolled in OPAIS 340B before dispensing 340B drugs on behalf of a covered company. The companies concerned are responsible for compliance with their pharmacy contract(s) with all the requirements of the 340B program. Contract pharmacies must outsource Medicaid (i.e., not use 340B drugs for Medicaid patients) unless the covered entity has an agreement with the state Medicaid agency to avoid double discounts. The covered company must notify hrsa of these agreements.

The Covered Entity Acquisition Application Checklist contains information on how to determine the right to hatch. Carve-in contract pharmacy requests should be sent to OPAexclusion@hrsa.gov. Answering all the points on the checklist makes it easy to sign up smoothly. Outbreak applications will be reviewed by HRSA and, once approved and registered as an authentication option on the OPAIS 340B, the Company may begin training in contract pharmacies early in the next quarter. Contact the 340B Prime Vendor Program (PVP) for more information on sculpture contract pharmacies. Failure to correctly register contract pharmacies in OPAIS 340B may be a reason for the withdrawal of contract pharmacies from the 340B program. HRSA reserves the right to request documents for clarification or to verify compliance at any time. Affected companies that decide to use pharmacy contracts must register each contract pharmacy. The companies concerned must register online pharmacy contracts during a registration period opened after a written contract. Contract pharmacies should be listed with the correct names and addresses to avoid delays in implementation. Contract pharmacies cannot participate in the 340B program until they have been approved by the Bureau of Pharmaceutical Affairs and the contract pharmacy is not listed on the 340B OPAIS. To expand the reach of the 340B program, the Health Resources and Services Administration (HRSA) has enabled 340 billion participants to contract with third-party pharmacies to deliver drugs to their eligible patients.

Contract pharmacies are an extension of the facilities covered by 340B to allow patients to access prescription drugs outside the four walls of the hospital or community clinic. For hospitals, these arrangements allow them to better serve their vulnerable communities by improving access to more affordable health services. A number of pharmaceutical companies have recently taken unprecedented steps that go beyond the scope of the law to limit the distribution of certain 340B drugs to hospitals and healthcare systems. These measures range from restricting the distribution of certain 340B drugs to demanding, superfluous and detailed reports on claims for 340B drugs dispensed by hospital contract pharmacies. The Department of Health and Human Services (HHS) is currently reviewing these questionable practices and has warned of potential litigation if drug manufacturers knowingly charge too high a fee for 340B drugs. 340B Prime Vendor Program – The 340B Prime Vendor Program (PVP) is managed by Apexus under contract with HRSA. Apexus is responsible for obtaining discounts below the cap on outpatient drug purchases and discounts on other pharmacy-related products and services for participating public hospitals, community health centers, and other safety net health care providers. National Rural Health Association – Approved in 1977 to improve access to care for Medicare and Medicaid recipients. Community pharmacies are encouraged to contact affected facilities in their community.

Eligible health organizations/covered facilities are defined by law and include HRSA-assisted health centers and doppelgängers, Ryan White Clinics and state AIDS drug assistance programs, Medicare/Medicaid Disproportionate Share hospitals, children`s hospitals, and other safety net providers. The full list of eligible organizations/companies covered can be found here. www.hrsa.gov/opa/eligibilityandregistration/index.html Notice regarding the 340B Drug Pricing Program — Contract Pharmacy Services (PDF – 72.6 KB) are the guidelines governing the operation and compliance of contract pharmacies for businesses covered by 340B. Section 340B of the Public Health Services Act requires pharmaceutical manufacturers participating in Medicaid to sell ambulatory drugs at discounted prices to health care organizations that care for patients in vulnerable communities, including low-income communities. These organizations include community health centres, children`s hospitals, hemophilia treatment centres, critical access hospitals, community hospitals alone, rural referral centres, and disproportionately large public and non-profit hospitals serving those in need. The 340B program provides eligible health care providers with a safety net of access to low-cost drugs that allow them to expand the type and scope of care they provide to the most vulnerable patient groups. The 340B Drug Pricing Program requires drug manufacturers to provide outpatient medications to eligible healthcare organizations/covered facilities at significantly discounted prices. .