340B Program Acronyms for Covered Entity Types and/or Grantees

Black Lung Clinics Program 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).

Critical Access Hospital (CAH) 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.

Free Standing Cancer Hospital (CAN) 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.

Covered Entity (CE) 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.

HRSA-Funded Health Center(CH) Combines Community Health Centers, School Based Programs, Health Care for the Homeless Programs, Migrant Health Programs, and Public Housing Primary Care Programs entity types.

Centers for Medicare & Medicaid ServicesCenters 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.

Contract Pharmacy (CP) 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.

Disproportionate Share Hospital (DSH) 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.

Disproportionate Share Adjustment Percentage

Employer Identification Number

Family Planning – Title X (FP) 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. (includes only Title X funded)

Health Center Program Look-AlikeOne 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.

Tribal Contract/Compact with IHS (P.L. 93-638) 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.

Healthcare Cost Report Information System 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.

Health Insurance Portability and Accountability Act (HIPAA) A U.S. law designed to provide privacy standards to protect patients' medical records and other health information provided to health plans, doctors, hospitals, and other health care providers.

Comprehensive Hemophilia Treatment Center (HTC) 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.

Ryan White Part C (formerly Title III) 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.

Health Resources and Services Administration (HRSA) 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.

Manufacturer (MFR) 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.

Medicare Provider Number (MPN)

Native Hawaiian Health Care Program 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.

National Provider Identifier (NPI)

Office of Pharmacy Affairs (OPA) The HRSA office responsible for administering the 340B program.

Children's Hospital 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.

Rural Referral Center (RRC) 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.

Ryan White Part A (formerly Title I) 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.

Ryan White Part B (formerly Title II) 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.

Ryan White Part B (formerly Title II) ADAP Rebate Option 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.

Ryan White Part B (formerly Title II) ADAP Direct Purchase 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.

Ryan White Part D (formerly Title IV) 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.

Sole Community Hospital (SCH) 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.

Ryan White Part F (formerly Special Projects of National Significance) 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.

Sexually Transmitted Diseases 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.

Tuberculosis 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.