340B Glossary
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A unique identification number assigned by OPA to each covered entity parent or child site (e.g., child site, subdivisions, or sub-grantees).
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The 340B Office of Pharmacy Affairs Information System (OPAIS) is a collection of information submitted by covered entities, contract pharmacies, and manufacturers maintained and verified by HRSA's Office of Pharmacy Affairs (OPA).
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Section 340B(a)(8) of the Public Health Service Act requires HHS to create a Prime Vendor Program (PVP) to develop, maintain and coordinate a program capable of distribution, facilitation, and other activities in support of the 340B Program. The PVP is a voluntary program for 340B covered entities and serves its participants by negotiating sub-340B pricing on pharmaceuticals, establishing distribution solutions and networks that improve access to affordable medications, and providing other value-added products and services. All covered entities may participate in the PVP, including hospitals that are prohibited from purchasing in a group purchasing arrangement.
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The federal drug discount program authorized under section 340B of the Public Health Service Act and established by Congress under the Veterans Health Care Act of 1992 (Public Law 102-585, codified at 42 USC § 256b). The 340B program requires drug manufacturers to enter into pharmaceutical pricing agreements with the HHS Secretary, under which manufacturers agree not to sell covered outpatient drugs to covered entities above 340B ceiling prices.
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An address verified as belonging to the covered entity that is used for billing purposes. A billing address is not required to be a physical address; it can be a P.O. box or other mailing address.
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One of the categories of non-hospital covered entities that are eligible to participate in the 340B Program. Black lung clinics receive funding from the HRSA Black Lung Clinic Program to seek out coal miners, whether they are currently involved in mining or not, and provide services to them and their families, regardless of their ability to pay. Services may be provided either directly by grantees or through formal arrangements with appropriate health care providers, such as Federally Qualified Health Centers, hospitals, state health departments, mobile vans and clinics. The Black Lung Clinic Program is authorized by Section 427(a) of the Black Lung Benefits Act (30 USCS§901).
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Acronym for "Completely Automated Public Turing test to tell Computers and Humans Apart," a type of challenge-response test used in computing to determine whether or not the user is human.
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A hospital clinic/department/offsite facility that is eligible to participate in the 340B Program because it is an integral part of a hospital that participates in the program, as evidenced by the fact that it is reimbursable on the hospital's Medicare cost report. OPA requires that a covered entity register as child sites all offsite clinics, departments, and services where 340B drugs are purchased or used, regardless of whether they are in the same building. Offsite generally means a location has a separate physical address than the hospital parent site and is not located within the main hospital. A hospital does not need to register outpatient clinics, departments, or services located within the entity's main hospital but may do so if they appear on a reimbursable line of a hospital's most recently filed cost report.
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One of the categories of hospitals that are eligible to participate in the 340B Program. Nonprofit hospitals that serve individuals through the age of 18 years of age and have a CMS-issued 3300 Series Medicare Provider Number to designate them as Medicare certified children's hospitals. Children's hospitals must meet certain requirements, including a DSH adjustment percentage greater than 11.75% and compliance with the GPO Prohibition, to be eligible to participate in the 340B program.
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Centers for Medicare and Medicaid Services, the federal agency within Health and Human Services (HHS) that administers the Medicare and Medicaid programs, including the Medicaid drug rebate program and the Medicare Part D prescription drug benefit.
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One of the categories of non-hospital covered entities that are eligible to participate in the 340B Program. Hemophilia Treatment Centers (HTC) that receive HRSA grant funding are expected to provide optimal care using a multi-disciplinary team approach that provides accessible, family-centered, continuous, comprehensive, coordinated, and culturally effective care for individuals with hemophilia and other bleeding disorders. The program is authorized under section 501(a)(2) of the Social Security Act. Non-hospital CEs of this type are identified by the prefix "HM" in the 340B ID.
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Combines Community Health Centers, School Based Programs, Health Care for the Homeless Programs, Migrant Health Programs, and Public Housing Primary Care Programs entity types.
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A pharmacy that enters into an agreement with a covered entity to provide services to the covered entity's patients, including dispensing entity-owned 340B drugs. Contract pharmacies must register for the 340B Program and be listed on the 340B OPAIS prior to dispensing 340B drugs on a covered entity's behalf. In addition, a contract pharmacy must have a written, signed contract pharmacy agreement in place with the covered entity prior to registering that pharmacy with the 340B Program. HRSA recommends that the written agreement include all essential elements of the contract pharmacy guidelines (75 Fed. Reg. 10272 (March 5, 2010). Failure to have the contract pharmacy correctly listed in the 340B OPAIS may be cause for removal of the contract pharmacy from the 340B Program.
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Section 340B(a)(4) of the Public Health Service Act specifies which covered entities are eligible to participate in the 340B Drug Program. These include qualifying hospitals, Federal grantees from HRSA, the Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services' Office of Population Affairs, and the Indian Health Service. Covered entities include six categories of hospitals and 11 categories of non-hospitals.
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Critical Access Hospitals are designated by the Centers for Medicare and Medicaid Services. The defining legislation is Section 1820(c)(2) of the Social Security Act. To be eligible to participate in the 340B Drug Pricing Program, Critical Access Hospitals must meet the requirements of section 340B(a)(4)(L)(i) of the Public Health Service Act.
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One of the categories of hospitals that are eligible to participate in the 340B Program. Disproportionate Share Hospitals serve a significantly disproportionate number of low-income patients and receive payments from the Centers for Medicaid and Medicare Services to cover the costs of providing care to uninsured patients. Disproportionate share hospitals are defined in Section 1886(d)(1)(B) of the Social Security Act. To be eligible to participate in the 340B Program, disproportionate share hospitals must meet the requirements of section 340B(a)(4)(L) of the Public Health Service Act.
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The 340B OPAIS uses the term "edit date" to denote the date that a 340B entity's information was edited. Edits can occur at any time.
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Non-HRSA user who has created an account. External users may or may not have any associations with a covered entity or a manufacturer. External users must follow a two-step authentication process to log into the system.
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One of the categories of non-hospitals that are eligible to participate in the 340B Program. Title X family planning clinics receive funding from the Title X Family Planning Program to provide contraceptive services, counseling, and reproductive health-related preventive services, with priority given to low-income people. Title X family planning clinics must apply for the 340B program through their grantee organization. Title V (state-funded) family planning clinics are not eligible for the 340B program.
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One of the categories of non-hospitals that are eligible to participate in the 340B Program. Federally Qualified Health Centers are community-based health care providers that receive funds from the HRSA Health Center Program to provide primary care services in underserved areas. They must meet a stringent set of requirements, including providing care on a sliding fee scale based on ability to pay and operating under a governing board that includes patients. Federally Qualified Health Centers may be Community Health Centers, Migrant Health Centers, Health Care for the Homeless, and Health Centers for Residents of Public Housing.
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One of the categories of non -hospital covered entities that participate in the 340B program. FQHC look-alikes are community-based health care providers that meet the requirements of the HRSA Health Center Program but do not receive Health Center Program funding.
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One of the categories of hospital covered entities that are eligible to participate in the 340B Program. Freestanding Cancer Hospitals are independent, non-profit hospitals that treat patients with cancer. For-profit hospitals are not eligible to participate in the 340B program. To be eligible to participate in the 340B Drug Pricing Program, Freestanding Cancer Hospitals must either: (1) have a disproportionate share adjustment percentage greater than 11.75% for the most-recently filed cost report; or (2) be eligible under a separate indigent care calculation that meets specific criteria including location in an urban area, 100 or more beds and net inpatient care revenues (excluding Medicare) for indigent care of more than 30% of net during the cost reporting period in which the discharges occur. This indigent care revenue must come from state and local government sources and Medicaid.
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Financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
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An agency of the U.S. Department of Health and Human Services, HRSA is the primary federal agency for improving access to health care services for people who are uninsured, isolated, or medically vulnerable.
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As defined in section 1927(k)(5) of the Social Security Act, manufacturers include all entities engaged in (1) the production, preparation, propagation, compounding, conversion, or processing of prescription drug products or (2) the packaging, repackaging, labeling, relabeling, or distribution of prescription drug products. A manufacturer must hold legal title to or possession of the NDC number for the covered outpatient drug. Such term does not include a wholesale distributor of drugs or a retail pharmacy licensed under state law. "Manufacturer" includes entities that sell outpatient drugs to covered entities, whether or not the manufacturer participates in the Medicaid rebate program.
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The Medicaid Exclusion File (MEF) lists covered entities that have decided to use 340B drugs for their Medicaid patients and to bill Medicaid for those drugs (carve-in). When covered entities choose to carve-in for Medicaid, they must provide the HRSA Office of Pharmacy Affairs with the Medicaid Provider Number/NPI used to bill Medicaid. These provider identifiers are listed in the MEF. Having this information in the MEF indicates to the states and manufacturers which drugs are not subject to Medicaid rebates, and helps ensure the prevention of duplicate discounts, as prohibited by the 340B statute. Covered entities are required to ensure that information in the MEF is accurate each quarter and at the time of annual recertification.
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The identification number of an institutional provider certified by the Centers for Medicare and Medicaid Services (CMS) to provide services to beneficiaries.
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Non-hospital covered entities that participate in the 340B program and receive Native Hawaiian Health Care Systems Program funding through the HRSA Health Center Program appropriation to provide medical and enabling services to Native Hawaiians.
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The HRSA office responsible for administering the 340B program.
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The main hospital facility of a covered entity that is eligible to use 340B drugs by virtue of enrollment in the 340B program. In contrast, hospital outpatient clinics/departments/services that have a different street address than the entity's main facility and are located outside the four walls of the main hospital, which are commonly called "child sites," must be separately registered with OPA before they can begin using 340B drugs.
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A registered entity or facility in the 340B program.
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Changing of a password due to an expired or forgotten password at login.
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A user who either does not have an account or is not logged in for a covered entity.
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One of the categories of hospital covered entities that are eligible to participate in the 340B Program. Rural Referral Centers are high-volume acute-care rural hospitals that treat a large number of complicated cases. Hospitals classified as Rural Referral Centers may be eligible to participate in the 340B Drug Pricing Program if they have a disproportionate share adjustment percentage equal to or greater than 8 percent for the most recently filed Medicare cost report and meet the requirements of section 340B(a)(4)(L)(i) of the Public Health Service Act.
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One of the categories of non-hospital covered entities that receive federal funding to provide HIV/AIDS treatment and related services to people living with HIV/AIDS who are uninsured or under-insured. In addition, the funding is used for technical assistance, clinical training, and the development of innovative models of care. The Ryan White HIV/AIDS Program is authorized by Title XXVI of the Public Health Service Act.
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One of the categories of non -hospital covered entities that diagnose and treat sexually transmitted diseases and receive funding from their state and local health departments through the Sexually Transmitted Disease Control Program administered by the Centers for Disease Control and Prevention. STD clinics must apply for the 340B program through their state program director.
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An address authorized to receive 340B drugs on behalf of a covered entity parent or child site and registered as such on the 340B OPAIS. Because pharmacies are not permitted to be registered as covered entity sites, they may be listed as shipping addresses of the parent entity or a registered outpatient child site, depending on the locations served by the pharmacy. When registering a new covered entity or a new outpatient facility online, the entity has a choice of listing shipping addresses under either the main entity's registration or the offsite facility's registration. Listing shipping addresses permits all parties to know where 340B drugs may be delivered by the manufacturer and wholesaler. Pharmacies that support multiple outpatient facilities should be listed as shipping addresses under the parent entity.
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One of the categories of hospital covered entities that are eligible to participate in the 340B Program. Sole Community Hospitals are designated by the Centers for Medicare and Medicaid Services. To be eligible to participate in the 340B Drug Pricing Program, Sole Community Hospitals must also have a disproportionate share adjustment percentage equal to or greater than 8 percent for the most-recently filed Medicare Cost Report and meet the requirements of Section 340B(a)(4)(L)(i) of the Public Health Service Act.
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Denotes an entity's start date in the 340B program. Entity start dates are updated quarterly.
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The date in the 340B OPAIS on which a provider's participation in the 340B program is terminated. After its termination date, a provider can no longer purchase 340B drugs. OPA updates termination dates on a quarterly basis.
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One of the categories of non-hospital covered entity groups that are eligible to participate in the 340B Program. Tribal Contract or Compact Health Centers (also called a 638 contract or compact) are operated by Tribes or Tribal organizations and Urban Indian Health Centers are outpatient health care programs and facilities that specialize in caring for American Indians and Alaska natives. They are operated under the Indian Self-Determination Act. To be eligible to participate in the 340B Drug Pricing Program, these health centers must be operated by programs funded under P.L. 93-638 or 25 USCS §1651.
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One of the categories of non-hospital covered entities that are eligible to participate in the 340B Program. These entities receive funding from their state tuberculosis control offices to prevent, diagnose and treat tuberculosis. The Centers for Disease Control and Prevention administers the program.
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One of the categories of non-hospital covered entities that are eligible to participate in the 340B Program. Urban Indian Health Centers are designated Federally Qualified Health Centers that provide comprehensive primary care and related services to American Indians and Alaska Natives. The facilities are owned or leased by Urban Indian organizations and receive grant and contract funding through Title V of the Indian Health Care Improvement Act. To be eligible to participate in the 340B Drug Pricing Program, these health centers must be operated by programs funded under P.L. 93-638 or 25 USCS §1651.
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