1. Definitions and Acronyms
This chapter defines common HIV/AIDS terms and acronyms, including those used in reference to AIDS Drug Assistance Programs (ADAPs), which are marked with an asterisk (*).
These definitions are intended for informational purposes only; for legal definitions, please contact the Health Resources and Services Administration's (HRSA) HIV/AIDS Bureau's (HAB) Division of Service Systems' (DSS) ADAP Branch at (301) 443-6745.
AAR (Annual Administrative Report): TOP
Beginning in March 2003, all Titles began reporting in the CARE Act Data Report (CADR). Previously a component of the Uniform Reporting System (URS), the AAR was the primary national data collection system for Title I and Title II. The AAR was a provider-based report generating aggregate client, provider, and service data for each State and EMA. Information was reported on all clients who receive at least one service during the reporting period.
ACTG (AIDS Clinical Trials Group):
A network of medical centers around the country in which Federally-funded clinical trials are conducted to test the safety and efficacy of experimental treatments for AIDS and HIV infection. These studies are funded by the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID).
ADAP (AIDS Drug Assistance Program):
A State-administered program authorized under Title II of the CARE Act that provides FDA-approved medications to low-income individuals with HIV disease who have limited or no coverage from private insurance or Medicaid.
ADAP Flexibility Policy:*
HIV/AIDS Bureau's (HAB) Policy Notice 00-02 provides grantees greater flexibility in the use of ADAP funds and permits expenditures of ADAP funds for services that improve access to medications, increase adherence to medication regimens, and help clients monitor their progress in taking HIV-related medications. Grantees must request in writing the use of ADAP dollars for services other than medications.
The amount of Federal Title II dollars specifically designated to ADAP for that fiscal year.
ADAP Monthly Report (AMR):*
A monthly data reporting system for tracking trends in ADAPs. State ADAPs submit information to HRSA on client and funding information on a monthly basis and send pricing data to HRSA on a quarterly basis. As of March 2001, the AMR may be completed via the Internet.
Administrative or Fiscal Agent:
An organization, agent, or other entity (e.g., public health department, community-based organization) which assists a grantee in carrying out administrative activities (e.g., disbursing program funds, developing reimbursement and accounting systems, developing Requests For Proposals [RFPs], monitoring contracts). Not all grantees use a separate administrative or fiscal agent.
AETCs (HIV/AIDS Education and Training Centers):
Funded by the Ryan White CARE Act, the AETCs support training for health care providers to counsel, diagnose, treat, and manage individuals with HIV infection and to help prevent high-risk behaviors that cause infection.
AIDS (Acquired Immunodeficiency Syndrome):
A disease caused by the human immunodeficiency virus.
American Indian or Alaska Native:
A person having origins in any of the original peoples of North and South America (including Central America), and who maintain tribal affiliation or community attachment.
A substance that fights against a retrovirus, such as HIV. (See Retrovirus)
APA (AIDS Pharmaceutical Assistance):
A local pharmacy assistance program implemented by a Title I EMA or State. The Title II grantee, consortium, or Title I Planning Council contracts with one or more organizations to provide medications to clients. These organizations may or may not provide other services (e.g., primary care, case management) to patients or clients they serve through a Ryan White CARE Act (or other funding source) contract with their grantee.
A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent, including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.
ASO (AIDS service organization):
An organization which provides medical or support services primarily or exclusively to populations infected with and affected by HIV disease.
Average Manufacturers' Price (AMP):*
The average price paid to the manufacturer of a drug by a wholesaler for distribution of that drug to non-Federal (commercial) dispensing entities. The AMP is used by the Centers for Medicare and Medicaid Services (CMS) to calculate the Medicaid Rebate, and by HRSA's Office of Pharmacy Affairs to calculate the 340B Ceiling Price and the ADAP 340B Rebate.
Average Wholesale Price (AWP):*
The average price of a drug paid to a wholesaler by the dispensing entity. As of April 1, 1999, Medicaid determines the AWP of a drug by the following methodology: (1) For a single-source drug, the AWP equals the AWP of the single product; or (2) For a multi-source drug, the AWP is equal to the lesser of: (a) the median AWP of all generic forms of the drug or (b) the lowest brand name product's AWP. (A "brand name" product is a product that is marketed under a labeled name that is other than the generic chemical name for the drug.)
Best [Manufacturer] Price (BP):* TOP
Under the Section 340B Drug Discount Program, with respect to innovator, multiple source, and single source drugs, the lowest price available from the manufacturer during a rebate period to any wholesaler, retailer, provider, health maintenance organization, nonprofit entity, or government entity within the United States. Specifically excluded from the calculation of BP are prices to the Indian Health Service, Department of Veterans Affairs, Department of Defense, Federal Supply Schedule and Depot prices, and Public Health Service, and Section 340B covered entities. BP includes cash discounts, free goods that are contingent on any purchase requirements, volume discounts, and rebates.
Black or African American:
A person having origins in any of the black racial groups of Africa.
CARE Act (Ryan White Comprehensive AIDS Resources Emergency Act): TOP
The Federal legislation created to address the health care and service needs of people living with HIV/AIDS (PLWH) disease and their families in the United States and its Territories. The CARE Act was enacted in 1990, reauthorized in 1996 and again in 2000 as the Ryan White CARE Act Amendments of 2000.
CARE Act Data Report (CADR):
The annual data report form completed by CARE Act grantees and providers. This report provides aggregate provider, client, and services data for all CARE Act programs. The CADR is completed and submitted to HAB's Office of Science and Epidemiology (OSE).
CBO (community-based organization):
An organization which provides services to locally-defined populations, which may or may not include populations infected with or affected by HIV disease.
CDC (Centers for Disease Control and Prevention):
The Federal agency within the U.S. Department of Health and Human Services that administers HIV/AIDS prevention programs, including the HIV Prevention Community Planning process, among other programs. The CDC is responsible for monitoring and reporting infectious diseases, administers HIV/AIDS surveillance grants, and publishes epidemiologic reports such as the HIV/AIDS Surveillance Report.
CD4 or CD4+ Cells:
Also known as "helper" T-cells, these cells are responsible for coordinating much of the immune response. HIV's preferred targets are cells that have a docking molecule called "cluster designation 4" (CD4) on their surfaces. Cells with this molecule are known as CD4-positive (CD4+) cells. Destruction of CD4+ lymphocytes is the major cause of the immunodeficiency observed in AIDS, and decreasing CD4 levels appear to be the best indicator for developing opportunistic infections.
CD4 Cell Count:
The number of T-helper lymphocytes per cubic millimeter of blood. The CD4 count is a good predictor of immune health. As the CD4 cell count declines, the risk of developing opportunistic infections increases. The normal range for CD4 cell counts is 500 to 1500 per cubic millimeter of blood. CD4 counts should be rechecked at least every 6 to 12 months if CD4 counts are greater than 500/mm3. If the count is lower, testing every 3 months is advised. A CD4 count of 200 or less usually indicates AIDS.
Chief Elected Official (CEO):
The official recipient of Title I CARE Act funds within the EMA, usually a city mayor, county executive, or chair of the county board of supervisors. The CEO is ultimately responsible for administering all aspects of the CARE Act in the EMA and ensuring that all legal requirements are met. In EMAs with more than one political jurisdiction, the recipient of Title I CARE Act funds is the CEO of the city or urban county that administers the public health agency that provides outpatient and ambulatory services to the greatest number of people with AIDS in the EMA.
The provision of advice and assistance in obtaining medical, social, community, legal, financial and other needed services. Unlike case management, advocacy does not involve coordination and follow-up on medical treatments.
CMS (Centers for Medicare and Medicaid Services):
Formerly the Health Care Financing Administration (HCFA) CMS is the Federal agency in the Department of Health and Human Services (HHS) responsible for administering Medicaid, Medicare, and the State Children's Health Insurance Program.
Multiple drugs or treatments used together to achieve optimum results against HIV/AIDS infection. Information on treatment guidelines can be found at the following Internet address: http://www.aidsinfo.nih.gov/guidelines/.
A disease or condition indicating the coexistence of two or more unrelated disease processes (e.g., mental illness or substance abuse co-existing with HIV disease).
Compassionate Use Program:*
A method of providing experimental drugs by pharmaceutical manufacturers to very sick patients who have no other treatment options.
The process of determining the organization and delivery of HIV services. Planning bodies use this strategy to improve decision-making about services and maintain a continuum of care for PLWH.
Consortium/HIV Care Consortium:
A regional or Statewide planning body established by grantees under Title II of the CARE Act to plan and sometimes administer Title II services. This body consists of one or more public and one or more nonprofit private, healthcare and support services providers, people with HIV/AIDS, and community-based organizations operating within areas determined by the State to be most affected by HIV/AIDS. The consortium agrees to use Title II grant funds to plan, develop, and deliver (directly or through agreement with others) comprehensive outpatient healthcare and support services for individuals with HIV/AIDS. Agencies comprising the consortium are required to have a record of services provided to individuals with HIV/AIDS.
Continuum of Care:
An approach that helps communities plan for and provide a full range of emergency and long-term service resources to address the various needs of PLWH.
A pharmacy utilized by a covered entity to provide pharmacy services (e.g., dispensing, record keeping, drug utilization review, formulary maintenance, patient profile, counseling). Other services (e.g., home care, reimbursement services) may be provided, at the option of the covered entity.
DRP (Dental Reimbursement Program): TOP
Funded by the Ryan White CARE Act, the DRP provides support to dental schools, postdoctoral dental education programs, and dental hygiene programs for non-reimbursed care provided to persons with HIV disease.
Dispensing of pharmaceuticals:
Provision of prescription drugs to prolong life or prevent the deterioration of health.
DCBP (Division of Community Based Programs):
The division within HRSA's HIV/AIDS Bureau that is responsible for administering Title III, Title IV, and the HIV/AIDS Dental Reimbursement Program.
DSS (Division of Service Systems):
The division within HRSA's HIV/AIDS Bureau that is responsible for administering Title I and Title II (including the AIDS Drug Assistance Program, ADAP).
DTTA (Division of Training and Technical Assistance):
The division within HRSA's HIV/AIDS Bureau that is responsible for administering the AIDS Education and Training Centers (AETC) Program and technical assistance and training activities of the HIV/AIDS Bureau.
Early Intervention Services for Titles I and II: TOP
A combination of services that include outreach, HIV counseling and testing, referral, and other provisions of outpatient medical care and supportive services designed and coordinated to bring individuals with HIV disease into the local HIV continuum of care.
EIS (Early Intervention Services):
Encompasses care supported by Title III legislation made available by the grantee organization and its subcontractors. Subcontractors render care to clients referred by the grantee organization and are reimbursed for their services, or otherwise have a remunerative relationship with the grantee for the referred service. Applied in the outpatient setting, EIS assures a continuum of care that includes identifying persons at-risk for HIV infection, offering counseling and testing services and providing lifelong comprehensive primary care.
Eligible Metropolitan Area (EMA):
The geographic area eligible to receive Title I CARE Act funds. The Office of Management and Budget (OMB) defines metropolitan areas based on Census Bureau data. AIDS cases reported to the Centers for Disease Control and Prevention (CDC) determines eligibility. Some EMAs include just one city and others are composed of several cities and/or counties. Some EMAs extend over more than one State.
The standards set by a State or Territory ADAP, usually through an advisory committee, to determine who receives access to ADAP services. Financial eligibility is usually determined as a percentage of Federal Poverty Level (FPL), such as 200% FPL. Medical eligibility is most often a positive HIV diagnosis. Eligibility criteria vary among ADAPs.
ELISA (Enzyme-Linked Immunosorbent Assay):
The most common test used to detect the presence of HIV antibodies in the blood, which are indicative of ongoing HIV infection. A positive ELISA test result must be confirmed by another test called a Western Blot test.
A disease that occurs clearly in excess of normal expectation and spreads rapidly through a demographic segment of the human population, or geographic area. Epidemic diseases can be spread from person to person or from a contaminated source such as food or water.
The branch of medical science that studies the relationship between the various factors that determine the frequency and distribution of diseases, including the incidence, distribution, and control of disease in a population.
See Risk factor
Family Centered Care: TOP
A model in which systems of care under Ryan White CARE Act Title IV are designed to address the needs of PLWH/A and affected family members as a unit, providing or arranging for a full range of services. The family structures may range from the traditional, biological family unit to non-traditional family units with partners, significant others, and/or unrelated caregivers.
FDA (Food and Drug Administration):*
The HHS agency responsible for ensuring the safety and effectiveness of drugs, biologics, vaccines, and medical devices used (among others) in the diagnosis, treatment, and prevention of HIV infection, AIDS, and AIDS-related opportunistic infections. The FDA also works to safeguard the Nation's blood supply.
FSR 269 (Financial Status Report Form 269):
A report required within 90 days after the end of the budget period. It serves as documentation of the financial status of grants according to the official accounting records of the grantee organization.
The practice of projecting a range of future expenditures that a State ADAP may expect for drug purchases and dispensing.
FTE (Full Time Equivalent):
A standard measurement of full-time staff (either paid or volunteer) based on a 35-40 hour work-week. The FTE is calculated by taking the sum of hours worked by staff divided by 35-40, depending on how an organization defines full-time employment (e.g., 2 staff members who each work 20 hours per week equals 1 FTE).
Generic Drug (multiple source drug):* TOP
A covered outpatient drug for which there are two or more drug products which: (a) are rated as therapeutically equivalent (under the FDA's most recent publication of "Approved Drug Products with Therapeutic Equivalence Evaluations"), (b) are pharmaceutically equivalent and bioequivalent as determined by the FDA, and (c) are sold or marketed in the United States during a specified period.
A procedure in which a patient's blood is analyzed to determine antiretroviral resistance that identifies actual mutations in a patient's virus.
The recipient and responsible administrator of CARE Act funds. A full listing of definitions of grants management terms can be accessed at: http://www.nih.gov/grants/policy/gps/ under PHS Grants Policy Statement.
Grantee of Record:
The official Ryan White CARE Act grantee that received Federal funding directly from the Federal government (HRSA). This agency may be the same as the provider agency, or may be the agency through which the provider agency has subcontracted.
HAART (Highly Active Antiretroviral Therapy): TOP
An aggressive anti-HIV treatment usually including a combination of two or more drugs with activity against HIV whose purpose is to reduce the viral load to undetectable levels.
Health education/risk reduction:
The provision of services to educate clients with HIV/AIDS about HIV transmission and how to reduce the risk of transmission, including information on medical and psychosocial support services and counseling to help clients with HIV improve their health status.
HIP (Health Insurance Programs):
Programs authorized and primarily funded under Title II, including the ADAP, to make premium payments, co-payments, deductibles, or risk pool payments on behalf of a client to maintain his/her health insurance coverage. This includes the Health Insurance Continuation Program (HICP).
High-Risk Insurance Pool:*
A State health insurance program that provides coverage for high-risk individuals who are denied coverage due to a pre-existing condition or who have health conditions that would normally prevent them from purchasing coverage in the private market.
HIV/AIDS Bureau (HAB):
The bureau within the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (DHHS) that is responsible for administering the Ryan White CARE Act. Within HAB, the Division of Service Systems (DSS) administers Title I, Title II, and the AIDS Drug Assistance Program (ADAP); the Division of Community Based Programs administers Title III, Title IV, and the HIV/AIDS Dental Reimbursement Program; and the Division of Training and Technical Assistance administers the AIDS Education and Training Centers Program. The Bureau's Office of Science and Epidemiology administers the Special Projects of National Significance (SPNS) Program.
HIV counseling and testing:
The delivery of HIV counseling and testing to an individual. Counseling includes pretest and post-test counseling activities (i.e., offering the individual the HIV antibody test, as appropriate; services discussing the benefits of testing, including the medical benefits of diagnosing HIV disease in the early stages and the medical benefits of receiving early intervention primary care; reviewing the provisions of laws relating to confidentiality, including information regarding any disclosure that may be authorized under applicable law, and information regarding the availability of anonymous counseling and testing; and discussing the significance of the result, including the potential for developing HIV disease). Testing refers to antibody test administered by health professionals to ascertain and confirm the presence of HIV infection (e.g., ELISA and Western Blot). Counseling and testing does not include test to measure the extent of the deficiency in the immune system. These tests are considered to be fundamental components of comprehensive primary care. This service category excludes mental health counseling/therapy, substance abuse counseling/treatment, and psychosocial support services. These services are listed separately.
HIV/AIDS Dental Reimbursement Program:
The Ryan White CARE Act program within HRSA's HIV/AIDS Bureau's Division of Community Based Programs that assists accredited dental schools and post-doctoral dental programs with uncompensated costs incurred in providing oral health treatment to HIV-positive patients.
The entire spectrum of the natural history of the human immunodeficiency virus, from post infection through the clinical definition of AIDS.
The outcome of the client's HIV test result, including: HIV-positive/not AIDS, the client tested positive for being diagnosed with HIV but has not advanced to AIDS; HIV-positive/ AIDS status unknown, the client tested positive for HIV but it is unknown whether or not the client has advanced to AIDS; CDC-defined AIDS, the client has advanced to and has been diagnosed with AIDS; HIV-negative (affected), the client is HIV-negative and is an affected individual of an HIV-positive friend or family member; and unknown HIV/AIDS, the status of the client is unknown and not documented.
Home and Community Based Care:
A category of eligible services that States may fund under Title II of the CARE Act.
HOPWA (Housing Opportunities for People With AIDS):
A program administered by the U.S. Department of Housing and Urban Development (HUD) which provides funding to support housing for PLWH and their families.
HRSA (Health Resources and Services Administration):
The HHS agency responsible for directing national health programs that improve the Nation's health by expanding equitable access to comprehensive, quality, health care for all. HRSA works to improve and extend life for people living with HIV/AIDS, provide primary health care to medically underserved people, serve women and children through State programs, and train a health workforce that is both diverse and motivated to work in underserved communities. HRSA's HIV/AIDS Bureau (HAB) is responsible for administering the Ryan White CARE Act.
Hospital or Hospital-based clinic:
Clinics that include ambulatory/outpatient care departments or clinics, emergency rooms, rehabilitation facilities (physical, occupational, speech), hospice programs, substance abuse treatment programs, STD clinics, AIDS clinics, and inpatient case management service programs.
Injection Drug User
IGA (Intergovernmental Agreement):
A written agreement between a governmental agency and an outside agency that provides HIV services.
The number of new cases of a disease that occur during a specified time period.
The number of cases of a disease per population per specified time period, often expressed per 100,000 population. AIDS rates are often expressed this way.
Infected RWCA client:
An individual with HIV/AIDS who receives at least one Ryan White CARE Act eligible service during the reporting period.
Innovator Drug (single source drug):*
Under the Section 340B Drug Discount Program, a covered outpatient drug that is produced or distributed under an original new drug application approved by the Food and Drug Administration, including a drug product marketed by any cross-licensed producers or distributors operating under the new drug applications.
Innovator Multiple Source Drug:*
Under the Section 340B Drug Discount Program, a multiple source drug that was originally marketed under an original new drug application approved by the Food and Drug Administration.
Lead Agency: TOP
The agency responsible for contract administration; also called a fiscal agent. An incorporated consortium sometimes serves as the lead agency.
The provision of services to individuals with respect to powers of attorney, do not resuscitate orders, wills, trusts, bankruptcy proceedings, and interventions necessary to ensure access to eligible benefits, including discrimination or breach of confidentiality litigation as it relates to services eligible for funding under the CARE Act. It does not include any legal services that arrange for guardianship or adoption of children after death nor any services for the individual's caregiver.
Maintenance of Effort: TOP
The Title I and Title II requirement to maintain expenditures for HIV-related services/activities at a level equal to or exceeding that of the preceding year.
A rebate supplied by a pharmaceutical manufacture to an entity (including ADAPs) that equals a percentage of the cost of the drug.
A process whereby an individual who meets the Medicaid medical eligibility criteria, but has income that exceeds the financial eligibility ceiling, may "spend down" to the eligibility level. Most State Medicaid programs offer an optional category of eligibility, referred to as the "medically needy" eligibility category for these individuals. The individual accomplishes spenddown by deducting accrued medically related expenses from his/her countable income.
Mental Health Services:
Psychological and psychiatric treatment and counseling services to individuals with a diagnosed mental illness, conducted in a group or individual setting, and provided by a mental health professional licensed or authorized within the State to render such services. This typically includes psychiatrists, psychologists, and licensed clinical social workers.
More than one race:
A racial category where an individual identifies with more than one race.
Native Hawaiian or Other Pacific Islander: TOP
An individual with origins from any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.
National Drug Code (NDC):*
The identifying drug number maintained by the FDA. For purposes of the Section 340B Drug Discount Program, the NDC number includes the labeler code (which is assigned by the FDA and identifies the establishment), the product code (which identifies the specified product or formation), and the package size code when reporting requested information.
A systematic process to determine the service needs of a defined population. Defined as the extent of need, available services, and service gaps by population and geographic area.
Also called Nucleoside Reverse Transcriptase Inhibitor (NRTI). The first effective class of antiviral drugs (e.g., AZT, ddI, ddC, d4T). NRTIs act by incorporating themselves into the HIV DNA, thereby stopping the building process. The resulting HIV DNA is incomplete and unable to create new virus.
Also called Nucleotide Reverse Transctiptase Inhibitor (NtRTI), block reverse transcriptase, an enzyme crucial to viral production in HIV-infected people (e.g., tenofovir).
Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI):
A class of antiretroviral agents (e.g., delavirdine, nevirapine). NNRTIs stop HIV production by binding directly onto an enzyme (reverse transcriptase) in a CD4+ cell and preventing the conversion of the HIV virus' RNA to DNA. NNRTIs have suffered from HIV's ability to rapidly mutate and become resistant to their effects.
Office of Management and Budget (OMB): TOP
The office within the executive branch of the Federal government which prepares the President's annual budget, develops the Federal government's fiscal program, oversees administration of the budget, and reviews government regulations.
Office of Pharmacy Affairs (OPA):*
Formerly the Office of Drug Pricing (OPA), is within HRSA's Bureau of Primary Health Care (BPHC) and is responsible for administering the Section 340B Drug Discount Program.
Opportunistic Infection (OI):
An infection or cancer that occurs in persons with weak immune systems due to AIDS, cancer, or immunosuppressive drugs such as corticosteroids or chemotherapy. Kaposi's Sarcoma (KS), pneumocystis pneumonia (PCP), toxoplasmosis, and cytomegalovirus are all examples of opportunistic conditions. Also more loosely termed "Opportunistic Condition."
Office of Science and Epidemiology (OSE):
The office within HRSA's HIV/AIDS Bureau that administers the SPNS Program, HIV/AIDS evaluation studies and the Ryan White CARE Act Data Report (CADR).
Services that identify individuals with HIV/AIDS, and make them aware of and enroll them in care and treatment service programs (i.e., case management). These services do not include HIV counseling and testing or HIV prevention education. Outreach programs must be planned and delivered in coordination with local HIV prevention outreach programs to avoid duplication of effort; be targeted to populations known through local epidemiologic data to be at disproportionate risk for HIV infection; be conducted at times and in places where there is a high probability that HIV-infected individuals will be reached; and be designed with quantified program reporting that will accommodate local effectiveness evaluation.
Over the Counter Drug:*
A drug that may be sold without a written prescription. Section 340B of the drug discount program stipulates that over the counter drugs must be prescribed by a physician, or another person authorized to prescribe under State law, to receive a drug discount or rebate.
Part F: TOP
Under the CARE Act, Part F provides funding for the AETC, SPNS, and the HIV/AIDS Dental Reimbursement Program.
Patient Assistance Program (PAP):*
A program where a pharmaceutical manufacturer provides emergency therapeutics to ensure a continuum of care for individuals unable to obtain medications through any other source (i.e., clients on waiting lists for ADAP).
Pay and Chase:*
A phrase used to describe the process where an ADAP pays for a prescription and then "chases" an insurance company or other third party payer to retrieve the cost of the prescription.
Pharmacy Benefits Managers (PBMs):*
Companies or organizations that provide a range of services related to prescription drug services, including (but not limited to) mail order services, claims processing, maintaining a pharmacy network, and drug utilization reviews.
A procedure in which blood platelets are analyzed to document antiretroviral resistance by determining whether a specific antiretroviral agent inhibits HIV replication. If it does not, the patient may be resistant to the antiretroviral medication.
PHS (Public Health Service):
An administrative entity of the U.S. Department of Health and Human Services. HRSA is a PHS agency and became a DHHS operating division (OPDIV) that reported directly to the Secretary in October 1995.
Public Health Service Act
A planning body appointed or established by the Chief Elected Official (CEO) of an EMA. The primary responsibilities of a planning council are to establish a delivery plan for HIV care services in the EMA and set priorities for the use of Title I CARE Act funds.
Person[s] Living with HIV Disease
Point of Purchase Discount:*
A method of accessing the Section 340B Drug Discount Program which allows covered entities (including ADAPs) to receive a specified up-front discounted price on pharmaceuticals purchased from wholesalers and manufacturers.
The total number of persons living with a specific disease or condition at a given time.
The proportion of a population living at a given time with a condition or disease (compared to the incidence rate, which refers to new cases).
Primary Health Care Service:
Any preventive, diagnostic, or therapeutic health service received on an outpatient basis by a patient who is HIV positive. Examples include medical, sub-specialty care, dental, nutrition, mental health or substance abuse treatment, and pharmacy services; radiology, laboratory, and other test used for diagnosis and treatment planning; counseling and testing.
The process used by a planning council or consortium to rank priorities among service categories. These rankings are to ensure consistency with locally identified needs. The process should also address how best to meet each priority.
Primary prophylaxis is treatment to prevent the onset of a particular disease. Secondary prophylaxis or maintenance therapy is treatment to prevent the recurrence of symptoms in an existing infection that has been brought under control.
An enzyme that triggers the breakdown of proteins. HIV's protease enzyme breaks apart long strands of viral protein into separate proteins constituting the viral core and the enzymes it contains. HIV protease acts as new virus particles are budding off a cell membrane.
Protease inhibitors (PI) prevent maturation of virus protein by competitively inhibiting HIV protease, an enzyme essential for viral protein cleavage. When HIV protease is blocked, immature virus particles are produced.
The degree to which a health or social service meets or exceeds established professional standards and user expectations. Evaluation of the quality of care should consider (1) the quality of the inputs, (2) the quality of the service delivery process, and (3) the quality of outcomes, in order to continuously improve systems of care for individuals and populations.
Quality Assurance (QA):
The formal and systematic process of identifying problems in service delivery, designing activities for overcoming these problems and following up to ensure that no new problems have developed and that corrective actions have been effective. The emphasis is on meeting minimum standards of care.
Quality Improvement (QI):
An ongoing process that involves organizational members in monitoring and evaluating inputs, processes, outputs, and outcomes in order to continuously improve service delivery. In contrast to QA which focuses on identifying and solving problems, QI seeks to prevent problems and to maximize the quality of care.
Rebate Option:* TOP
An alternative method of accessing the Section 340B Drug Discount Program, available only to ADAPs, that allows ADAPs to receive rebates on pharmaceuticals equal to the State Medicaid rebate amount from manufacturers participating in the Section 340B Program. These rebates allow States that are not centrally administered to achieve savings closer to those received from accessing the Section 340B point of purchase option.
Under the Section 340B drug discount program, an amount (expressed as a percentage) equal to the average total rebate required under section 1927(c) of the Social Security Act with respect to each dosage, form, and strength of a single source or innovator multiple source drug during the preceding calendar quarter, divided by the average manufacturer price (AMP) for such a unit of the drug during such quarter.
The legislatively mandated responsibility of planning councils to assign CARE Act amounts or percentages to established priorities across specific service categories, geographic areas, populations, or subpopulations.
A type of virus that, when not infecting a cell, stores its genetic information on a single-strand RNA molecule instead of the more usual double-strand DNA. HIV is an example of a retrovirus. After a retrovirus penetrates a cell, it constructs a DNA version of its genes using a special enzyme, reverse transcriptase. This DNA then becomes part of the cell's genetic material.
Reverse Transcriptase (RT):
A unique viral enzyme that constructs DNA from an RNA template, which is an essential step in the life-cycle of a retrovirus such as HIV. The RNA-based genes of HIV and other retroviruses must be converted to DNA if they are to integrate into the cellular genome.
RFP (Request for Proposal):
An open and competitive process for selecting providers of services (sometimes called an RFA or Request for Application).
Behaviors or other factors that place a person at risk for a disease. For HIV/AIDS, these factors include male-to-male sexual contact, injection drug use, and commercial sex work.
Salvage Therapy: TOP
An alternative antiretroviral treatment regimen that replaces a failing treatment regimen.
SAMHSA (Substance Abuse and Mental Health Services Administration):
The agency within the U.S. Department of Health and Human Services that administers programs related to alcohol abuse, substance abuse, and mental health.
SCSN (Statewide Coordinated Statement of Need):
A written statement of need for the entire State developed through a process designed to collaboratively identify significant HIV issues and maximize CARE Act program coordination. The SCSN process is convened by the Title II grantee, with equal responsibility and input by all programs. Representatives must include all CARE Act titles and Part F managers, providers, PLWH, and public health agency(s).
Section 340B Drug Discount Program:*
A program administered by HRSA's Office of Pharmacy Affairs (formerly the Office of Drug Pricing [ODP]) and established by the passage of Section 340B of Public Law 102-585, the Veteran's Health Care Act of 1992, which limits the cost of drugs to Federal purchasers and to certain grantees of Federal agencies. ADAPs have two methods of accessing the Section 340B program-either through a point of purchase discount or the ADAP 340B rebate option.
The development of detectable antibodies to HIV in the blood as a result of infection. It normally takes several weeks to several months for antibodies to the virus to develop after HIV transmission. When antibodies to HIV appear in the blood, a person will test positive to the standard ELISA test for HIV.
The number of persons in a population who test HIV-positive based on serology (blood serum) specimens. Seroprevalence is often presented as a percent of the total specimens tested or as a rate per 100,000 persons tested.
A report that provides information about the percent or rate of people in specific testing groups and populations who have tested positive for HIV.
SPNS (Special Projects of National Significance):
Supports the development of innovative HIV/AIDS service delivery models that have the potential for replication in other areas, locally and nationally.
Sexually Transmitted Disease
An ongoing, systematic process of collecting, analyzing, and using data on specific health conditions and diseases (e.g., Centers for Disease Control and Prevention surveillance system for HIV/AIDS cases).
A report providing information on the number of reported cases of a disease such as HIV/AIDS, nationally and for specific sub-populations.
Provides emergency relief to metropolitan areas that are disproportionately affected by HIV/AIDS.
Assists States and Territories in improving the quality, availability, and organization of health care and support services for individuals and families with HIV disease, and provides access to needed pharmaceuticals through the AIDS Drug Assistance Program (ADAP).
Title II Base Funds:*
The amount of Title II funds not allocated to the ADAP.
Provides support for early intervention and primary care services for people with HIV/AIDS.
Enhances access to comprehensive care for children, youth, women, and their families at-risk for HIV, and access to research of potential clinical benefit.
A population identified to be reached through some action or intervention. Targeted populations may be groups with specific demographic or geographic characteristics.
A grouping of disease exposure and infection routes. In relation to HIV/AIDS, transmission categories may include injection drug use, men who have sex with men, heterosexual contact, and perinatal transmission.
Treatment adherence services:
Provision of counseling or special programs to ensure readiness for and adherence to complex treatments (i.e., adherence to HIV/AIDS drug regimens).
Unduplicated client count: TOP
An accounting of clients in which a single individual is counted only once. For providers with multiple sites, a client is only counted once, even if he or she receives services at more than one of the provider's sites.
Unique record number (URN):
A nine-digit encrypted record number following HRSA's URN specifications that distinguishes the client from all other clients and that is the same for the client across all provider settings. The URN is constructed using the first letter of the first name, the third letter of the first name (if blank, use middle initial, if no middle initial use '9'), the first letter of the last name, third letter of the last name (if blank, use '9'), month of birth, day of birth, and gender code. This string is then encrypted using a HRSA-supplied algorithm that can be incorporated into the provider's data collection system.
A need that is not currently being addressed through existing services, either because no services are currently available or because available services are inappropriate for or inaccessible to the target population.
VA facility: TOP
A facility funded through the Department of Veterans Affairs.
Viral Load Test:
In relation to HIV, a test that measures the quantity of HIV RNA per unit of blood plasma. Results are expressed as a number of copies per milliliter of blood plasma and are an indicator of virus concentration and reproduction rate. This test is used as a predictor of HIV disease progression.
The presence of virus in blood or blood plasma. Plasma viremia is a quantitative measurement of HIV levels similar to viral load but is accomplished by seeing how much of a patient's plasma is required to spark an HIV infection in a laboratory cell culture.
Voluntary Manufacturer Rebate:*
A rebate supplied by a pharmaceutical manufacturer to an entity (including ADAPs) at an amount and schedule arranged by both parties, ranging from a verbal agreement to written contracts.
Western Blot: TOP
A test for detecting the specific antibodies to HIV in a person's blood. It is commonly used to verify positive ELISA tests. A Western Blot test is more reliable than the ELISA, but it is harder and more costly to perform. All positive HIV antibody tests should be confirmed with a Western Blot test.
A person having origins in any of the original peoples of Europe, the Middle East or North Africa.
Under the Section 340B Drug Discount Program, any entity having a wholesale distributor's license, to which a manufacturer sells the covered outpatient drug, but which does not re-label or repackage the covered outpatient drug.
Wild Type Virus:
Naturally occurring HIV with an optimal genetic makeup and no lab-induced mutational defects. This term also refers to HIV that has not been exposed to antiviral drugs and therefore has not accumulated mutations conferring drug resistance.
Sources Used for This Chapter
Congressional Black Caucus Initiative: Frequently Asked Questions and Answers. April 2001.
Gilden, David (ed.). Gay Men's Health Crisis Treatment Issues: Glossary.
Glaxo Wellcome, Inc. Patient Assistance Program.
HRSA, HAB, Division of Service Systems. Needs Assessment Guide. Rockville, MD: U.S. Department of Health and Human Services, 2003.
HRSA, HAB, Division of Service Systems. Title II Manual. Rockville, MD: U.S. Department of Health and Human Services, 2003.
HRSA, HAB, Office of Science and Epidemiology. Instructions for Completing The Ryan White CARE Act Data Report (CARE Act Data Report), (Cross-Title Data Report). Rockville, MD: U.S. Department of Health and Human Services, 2001.
Levi, Jeffrey, et. al. "Can Access to the Private Individual Insurance Market be Increased for People Living with HIV?" Washington, DC: The Center for Health Policy Research, The George Washington University School of Public Health and Health Services, February 1999.
U.S. Department of Health and Human Services, HCFA. Program Memordum No. AB-97-25, dated January 1998.
U.S. Department of Housing and Urban Development (HUD). Glossary: Form HUD-40076-COC. Washington, DC: United States Government Printing Office, February 1999.