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 external user for a covered entity or manufacturer who is able to attest to any changes to an entity.
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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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Section 340b(a)(5)(A)(i) of the Public Health Service Act prohibits duplicate discounts; that is, manufacturers are not required to provide a discounted 340B price and a Medicaid drug rebate for the same drug. Covered entities must have mechanisms in place to prevent duplicate discounts. Carving-in describes a covered entity's decision to use 340B drugs for its Medicaid patients. Upon enrollment in the 340B Program, covered entities that decide to carve-in must provide their Medicaid provider number or National Provider Identifier (NPI) at the time they enroll. OPA lists this information in a Medicaid Exclusion File posted on its website. Having this information in the file 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 statute. Covered entities are required to ensure that information in the file is accurate each quarter and at the time of annual recertification.
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Section 340b(a)(5)(A)(i) of the Public Health Service Act prohibits duplicate discounts; that is, manufacturers are not required to provide a discounted 340B price and a Medicaid drug rebate for the same drug. Covered entities must have mechanisms in place to prevent duplicate discounts. Carving-out describes a covered entity's decision to not use 340B drugs for any of its Medicaid patients. For covered entities that opt to carve-out, ALL drugs billed under that Medicaid provider number/NPI must be purchased outside the 340B Program, and that Medicaid provider number/NPI should not be listed in the HRSA Medicaid Exclusion File.
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Manufacturers who participate in the Medicaid Drug Rebate Program (MDRP) enter into an agreement with the Secretary of Health and Human Services under which the manufacturer must agree to charge a price no greater than the statutory pricing formula (340B ceiling price) when selling covered outpatient drugs to 340B covered entities. In order to calculate the 340B ceiling price, the Unit Rebate Amount (URA) is subtracted from the Average Manufacturer Price (AMP) for the smallest unit of measure [340B Ceiling Price = (AMP – URA)]. Under section 340B(a) of the Public Health Service Act (PHSA), the 340B ceiling price is calculated by subtracting the unit rebate amount (URA) from the average manufacturer price (AMP) for the smallest unit of measure of each covered outpatient drug (as identified by the product's 11-digit National Drug Code (NDC). To ensure that the final price is operational in the marketplace, HRSA then multiplies this amount by drug's package size (PS), defined as the number of billing units in the labeled quantity from which the pharmacist dispenses, and the case pack size (CSP), defined as the number of salable units in the shipping container [340B Ceiling Price = (AMP-URA) x PS x CSP].
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An online process that allows covered entities and manufacturers to update their existing information in the 340B application.
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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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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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Indicates the nature of the organization that operates a provider of services. Proprietary operations (control types 3–6) are not eligible for participation in 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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Defines the size of the cases for an NDC (i.e., if a case of a dozen bottles of 100 pills, CSP = 12).
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A registration number assigned to health care providers by the U.S. Drug Enforcement Administration, allowing them to write prescriptions for controlled substances. Legally, the DEA number is solely to be used for tracking controlled substances. However, it is often used as a unique general "prescriber number" for anyone who can prescribe medication.
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An adjustment applied to hospitals that treat a high percentage of low-income patients, resulting in an additional payment to those hospitals. Factors included in this adjustment are the sum of the ratios of Medicare Part A Supplemental Security Income (SSI) patient days to total Medicare patient days and Medicaid patient days to total patient days in the hospital. 340B covered entity hospitals must meet a certain threshold for DSH percentage (greater than 11.75% for DSH, PED, and CAN; greater than or equal to 8% for RRC and SCH)
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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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Section 340B(a)(5)(A)(i) of the Public Health Service Act prohibits duplicate discounts; that is, manufacturers are not required to provide a discounted 340B price and a Medicaid drug rebate for the same drug. Covered entities must have mechanisms in place to prevent duplicate discounts. Upon enrollment in the 340B Program, covered entities must determine whether they will use 340B drugs for their Medicaid patients (carve-in) or whether they will purchase drugs for their Medicaid patients through other mechanisms (carve-out) in order to comply with the duplicate discount prohibition.
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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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A nine-digit number assigned by the U.S. Internal Revenue Service (also known as a Federal Tax Identification Number) used to identify a business entity for tax purposes.
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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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The date when the Cost Center report was filed (required field for all hospital registrations). This date must be (1) greater than the cost reporting period end date, (2) not older than a year, and (3) not a future date.
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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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Disproportionate share hospitals (DSH), children’s hospitals, and free-standing cancer hospitals participating in the 340B Program under 42 U.S.C. 256b(a)(4)(L) and (M) are subject to section 340B(a)(4)(L)(iii), which states that in order to participate in the 340B Program, these entities may not “obtain covered outpatient drugs through a group purchasing organization or other group purchasing arrangement.” Upon enrollment, the covered entity’s AO attests that the hospital will comply with the GPO Prohibition. This applies to the hospital as of the date of listing on the 340B OPAIS. The hospital AO attests to compliance with the GPO Prohibition during the annual recertification.
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Healthcare Cost Report Information System – HCRIS contains annual reports submitted by healthcare providers to Medicare. It provides information to CMS that assists with the annual settlement summary between CMS and healthcare providers.
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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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Eligible hospitals must be (1) owned or operated by a state or local government, (2) private, non-profit hospital with state/local government contract, or (3) public or private non-profit hospital granted governmental powers. For-profit organizations are ineligible for participation in the 340B Program.
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A pharmacy that is owned by and is a legal part of a 340B entity. Typically, in-house pharmacies are listed as shipping addresses of the entity and the entity owns the pharmacy license.
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For 340B purposes, the portion of the 10-digit NDC number assigned by the FDA to identify a specific manufacturer. A given corporate entity may own multiple labeler codes.
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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 Drug Rebate Program is a program that includes CMS, state Medicaid agencies, and participating drug manufacturers that helps to offset the federal and state costs of most outpatient prescription drugs dispensed to Medicaid patients.
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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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A unique 10-digit identification number for covered health care providers. Health care providers, all health plans, and health care clearinghouses must use the NPIs in the administrative and financial transactions adopted under HIPAA.
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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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A unique 11-digit, 3-segment code numeric identifier assigned to each medication listed under Section 510 of the US Federal Food, Drug, and Cosmetic Act. The segments identify the labeler or vendor, product (within the scope of the labeler), and trade package (of this product). The first segment (4 or 5 digits) is assigned by the Food and Drug Administration (FDA). The second segment (3 or 4 digits) identifies a specific strength, dosage form, and formulation for a particular firm. The third segment (1 or 2 digits) identifies package forms and sizes.
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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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External user who is designated as a Primary Contact for an entity. This user can enter registrations and update entity information. This user can enter registrations, and update entity information. Any changes to an entity performed by the PC user must be attested to by the AO for that entity.
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Defines the size of a single package for an NDC (i.e., if a case of a dozen bottles of 100 pills, PS = 100).
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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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340B covered entities must annually recertify their eligibility to remain in the 340B Program and continue purchasing covered outpatient drugs at discounted 340B prices. As part of this process, the Authorizing Official of each 340B covered entity certifies basic information about the entity and its 340B compliance. Covered entities with inaccurate information in the 340B OPAIS run a high risk of being removed from the program.
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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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The CMS Medicaid Drug Rebate (MDR) system performs the URA calculation using the drug manufacturer's pricing. The specific methodology used is determined by law and depends upon the drug's classification. Drug manufacturers remain responsible for correctly calculating the URA for their covered outpatient drugs.
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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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