Glossary
Plain-English definitions of the drug pricing, FDA, provider, payer, coding and health IT terms behind U.S. healthcare data. Written for the people who analyze it, sell into it and build on it.
The 21st Century Cures Act is a broad federal law enacted in December 2016 that funded biomedical research, changed how the FDA develops and reviews drugs and devices, and set national rules for health IT interoperability and information blocking.
A 340B contract pharmacy is an outside pharmacy, such as a retail chain, independent or specialty pharmacy, that dispenses 340B-priced drugs to patients of a covered entity under a written agreement with that entity.
A 340B covered entity is a hospital, health center or clinic that meets the eligibility criteria in Section 340B of the Public Health Service Act and is registered with HRSA to buy outpatient drugs at 340B ceiling prices.
The 340B Drug Pricing Program is a federal program that requires drug manufacturers participating in Medicaid to sell covered outpatient drugs at or below a statutory ceiling price to eligible safety-net providers called covered entities.
The 505(b)(2) pathway is a type of New Drug Application in which the applicant relies, at least in part, on safety and effectiveness data it did not generate and has no right to reference, such as published literature or the FDA's findings for an approved drug.
A 510(k) Premarket Notification is a submission to FDA showing that a new medical device is substantially equivalent to a legally marketed predicate device. It is the most common premarket route for moderate-risk devices.
An Abbreviated New Drug Application (ANDA) is the FDA application used to approve a generic drug. It relies on the FDA's earlier finding that a reference drug is safe and effective instead of repeating clinical trials, provided the generic is shown to be bioequivalent.
The ACA Marketplace, or Health Insurance Marketplace, is the government-run platform created by the Affordable Care Act where individuals, families and small employers compare and buy private health plans, with income-based subsidies.
Accelerated approval is an FDA pathway that lets a drug or biologic for a serious condition with unmet medical need be approved based on a surrogate or intermediate clinical endpoint, on condition that confirmatory trials verify the expected clinical benefit.
An accountable care organization (ACO) is a group of physicians, hospitals and other providers that agree to be jointly accountable for the quality and total cost of care for a defined patient population, sharing in the savings they generate.
The ACO REACH Model (ACO Realizing Equity, Access, and Community Health) is a voluntary CMS Innovation Center model in which accountable care organizations take high levels of financial risk, including capitation, for Original Medicare patients.
An active pharmaceutical ingredient (API) is the substance in a medicine that produces its intended pharmacological effect, as opposed to the inactive ingredients (excipients) that help form, preserve or deliver the finished dose.
Advanced practice provider (APP) is an umbrella term for licensed clinicians other than physicians who diagnose, treat and often prescribe, most commonly nurse practitioners and physician assistants. It is a workforce label, not a license.
An adverse drug event (ADE) is an injury or undesirable experience associated with the use of a medication, including known side effects, allergic reactions, harm from medication errors, overdoses and drug interactions.
An all-payer claims database (APCD) is a state-run database that collects medical and pharmacy claims, eligibility and provider files from public and private payers, giving a multi-payer view of health care use and spending in that state.
The allowed amount is the maximum a health plan will pay for a covered service, counting both the plan payment and patient cost sharing, set by a fee schedule or negotiated contract rather than by what the provider charges.
An alternative payment model (APM) is any payment approach that adds accountability for quality and total cost to fee-for-service or replaces it. In Medicare, Advanced APMs give qualifying clinicians a path outside MIPS.
An ambulatory surgery center (ASC) is a facility that operates exclusively to perform outpatient surgical procedures for patients who do not need hospital admission. Medicare, which calls it an ambulatory surgical center, expects patients to leave within 24 hours.
The Area Deprivation Index (ADI) is a composite measure that ranks U.S. neighborhoods by socioeconomic disadvantage using census data on income, education, employment and housing quality, published at the census block group level.
An attending physician is the fully trained physician with primary responsibility for a patient's care during an episode such as a hospital stay, who supervises any residents involved and is named as the attending provider on the claim.
Average Manufacturer Price (AMP) is the average price wholesalers and retail community pharmacies pay a manufacturer for a covered outpatient drug, reported confidentially to CMS and used to calculate Medicaid rebates and 340B ceiling prices.
Average Sales Price (ASP) is a manufacturer's average price for a drug across U.S. sales to all purchasers, net of most discounts and rebates, reported quarterly to CMS and used to set Medicare Part B payment for physician-administered drugs.
Average Wholesale Price (AWP) is a benchmark drug price published by drug pricing compendia, usually calculated as a markup on Wholesale Acquisition Cost, that serves as a reference point in pharmacy reimbursement contracts.
A beneficiary is a person entitled to receive benefits under a health program or plan. The term is used most often for people enrolled in Medicare or Medicaid, while commercial plans usually say member or enrollee.
Best Price is the lowest price a manufacturer makes available for a brand-name covered outpatient drug to almost any U.S. purchaser during a rebate period, after discounts, and it helps set the rebate the manufacturer owes Medicaid.
A biologic is a medical product made from or containing components of living organisms, such as a therapeutic protein, vaccine, blood product or cell or gene therapy, and licensed by the FDA under Section 351 of the Public Health Service Act.
A Biologics License Application (BLA) is the request to the FDA for a license to market a biological product, such as a vaccine, blood product, monoclonal antibody or gene therapy, in U.S. interstate commerce under the Public Health Service Act.
The Biologics Price Competition and Innovation Act (BPCIA) is the 2010 federal law that created an abbreviated FDA licensure pathway for biosimilar and interchangeable biological products and set exclusivity periods for the reference biologics they copy.
A biomarker is a defined characteristic measured as an indicator of normal biological processes, disease processes, or responses to an exposure or intervention, such as a blood protein level, a gene variant or an imaging finding.
A biosimilar is a biologic that is highly similar to an FDA-licensed reference product and has no clinically meaningful differences from it in safety, purity or potency, approved through the abbreviated Section 351(k) pathway.
Board certification is a voluntary credential, separate from a state medical license, showing that a physician completed accredited training in a specialty and passed the certifying board's examinations. Most boards require ongoing continuing certification to keep it.
A Boxed Warning is the most prominent safety warning FDA can require in prescription drug labeling: a bordered statement at the top of the Prescribing Information that describes a serious or life-threatening risk of the product.
A brand-name drug is a medicine sold under a proprietary trade name by the company that holds its FDA approval, usually the original innovator product approved through a New Drug Application or Biologics License Application.
Breakthrough therapy designation is an FDA status for a drug or biologic intended to treat a serious condition when preliminary clinical evidence shows it may substantially improve on available therapy, giving the sponsor intensive FDA guidance during development.
A bundled payment is a single payment amount, or a spending target, that covers all services in a defined episode of care, such as a joint replacement from surgery through recovery, across the providers involved.
A business associate agreement (BAA) is the contract HIPAA requires between a covered entity and a vendor that handles protected health information on its behalf, setting how the vendor may use, protect and report on that information.
Capitation is a payment model in which a payer pays a provider or health plan a fixed amount per enrolled person for a defined period, usually per member per month (PMPM), regardless of how many services that person uses.
CAQH ProView is an online platform where clinicians enter and maintain their professional, practice and credentialing information once and authorize health plans, hospitals and other organizations to access it, instead of completing separate applications.
Cell therapy is a treatment in which living cells are transferred into a patient to repair tissue, replace missing function or fight disease. The cells may come from the patient (autologous) or a donor (allogeneic) and may be genetically modified.
A certificate of need (CON) is a state regulatory approval that health care providers must obtain before building or expanding facilities, adding beds, offering certain new services or buying major medical equipment. Program scope varies widely by state.
Certified EHR Technology (CEHRT) is the CMS regulatory term for health IT that meets a defined set of ONC certification criteria, which hospitals, clinicians and Advanced Alternative Payment Models must use to meet Medicare program requirements.
The Certified Health IT Product List (CHPL) is the official public database of health IT products certified under the ONC Health IT Certification Program, showing each product's developer, version, certified criteria, status and compliance history.
A chargemaster, or charge description master (CDM), is the master list a hospital keeps of every billable item and service, with internal charge codes, billing codes and a gross list price used to build claims.
The Children's Health Insurance Program (CHIP) is a joint federal and state program that covers uninsured children in families whose incomes are too high for Medicaid but too low to easily afford private coverage.
Claims adjudication is the process a health plan uses to check a submitted claim against eligibility, coverage, coding and pricing rules and decide whether to pay it in full, pay part of it, or deny it.
Claims data is the record of bills that providers and pharmacies submit to health insurers for payment, capturing who received care, who provided it, what was done or dispensed, the diagnoses reported and what was charged and paid.
A CLIA certificate is the federal certificate a laboratory must hold to test human specimens for health purposes in the United States. CMS issues it under the Clinical Laboratory Improvement Amendments in five types matched to the complexity of testing.
Clinical decision support (CDS) is technology that gives clinicians, staff or patients knowledge and person-specific information at the right time to improve health care decisions, such as drug interaction alerts, order sets and risk scores.
A clinical laboratory is a facility that examines specimens from the human body, such as blood, urine or tissue, to provide information for diagnosing, preventing or treating disease or assessing health. U.S. clinical laboratories must be certified under CLIA.
A clinical trial is a research study that prospectively assigns human participants to one or more interventions, such as a drug, device, procedure or behavioral program, to evaluate the effects on health outcomes.
A clinical trial site is a location, such as a hospital, academic medical center, physician practice or dedicated research clinic, where participants are enrolled and study visits and procedures take place under a principal investigator.
ClinicalTrials.gov is the public U.S. registry and results database of clinical studies, run by the National Library of Medicine at NIH, where sponsors and investigators post study designs, locations, status and results.
ClinVar is a free public archive run by the National Center for Biotechnology Information (NCBI) that collects submitted classifications of human genetic variants and their relationship to diseases and drug responses, along with supporting evidence.
A CMS Certification Number (CCN) is the identifier CMS assigns to a provider certified to participate in Medicare or Medicaid, such as a hospital, nursing home or home health agency. The standard six-character format encodes the state and facility type.
Commercial health insurance is health coverage provided through private insurers and employer plans rather than government programs, mainly employer group coverage and individual policies, including plans sold on the ACA Marketplace.
A Community Health Needs Assessment (CHNA) is the assessment of local health needs that each tax-exempt hospital facility must conduct at least every three years under Internal Revenue Code Section 501(r)(3), paired with an implementation strategy.
A companion diagnostic (CDx) is a medical device, usually an in vitro diagnostic test, that provides information essential for the safe and effective use of a corresponding drug or biological product, such as whether a patient carries a target biomarker.
Competitive intelligence (CI) is the ethical, systematic collection and analysis of public and lawfully obtained information about competitors, their products, pipelines and strategies, used to inform business decisions.
A compounded drug is a medication prepared by a licensed pharmacist, physician or FDA-registered outsourcing facility by combining, mixing or altering ingredients to meet a need that an approved product does not. Compounded drugs are not FDA-approved.
The Conrad 30 Waiver Program lets each state health agency request waivers of the two-year home residence requirement for up to 30 foreign medical graduates on J-1 visas per year who agree to practice in underserved areas.
Consolidated Clinical Document Architecture (C-CDA) is an HL7 implementation guide that defines XML templates for common clinical documents, such as continuity of care documents and discharge summaries, exchanged between U.S. health IT systems.
A contract research organization (CRO) is a company a sponsor hires to take over some or all of its clinical trial obligations, such as protocol design, site selection, monitoring, data management and regulatory submissions.
A controlled substance is a drug or chemical whose manufacture, possession, prescribing and distribution are regulated under the federal Controlled Substances Act because of its potential for abuse or dependence, and placed in one of five schedules.
Cost sharing is the part of the cost of covered health care that an insured person pays out of pocket, through deductibles, copayments and coinsurance. Premiums and the cost of non-covered services are not cost sharing.
Covered lives is the number of individual people, including dependents, covered by a health plan, pharmacy benefit or formulary. It is the standard measure of a payer's size and reach in market access and network analysis.
Credentialing is the process hospitals, health plans and other organizations use to verify a clinician's qualifications, such as license, education, training, board certification and professional history, before granting privileges or network participation.
A Critical Access Hospital (CAH) is a small rural hospital designated under a Medicare program that limits it to 25 inpatient beds and pays it based on reasonable costs rather than fixed prospective rates, to keep essential services open in remote areas.
Current Good Manufacturing Practice (CGMP) is the set of FDA requirements for the methods, facilities and controls used to manufacture, process, pack and hold drugs and other regulated products so that they consistently meet quality standards.
Current Procedural Terminology (CPT) is the code set, owned and maintained by the American Medical Association, that describes medical, surgical and diagnostic services performed by physicians and other clinicians for claims and reporting.
Data enrichment is the process of adding missing or more detailed attributes to existing records by matching them to trusted external or reference data, such as adding NPI numbers, specialties and practice addresses to a list of physician names.
De-identification is the process of removing or transforming identifiers in health data so that it no longer identifies individuals. Data that meets the HIPAA de-identification standard is no longer protected health information.
A DEA registration number is the identifier the Drug Enforcement Administration assigns to a practitioner or business registered to handle controlled substances, such as a clinician who prescribes drugs in Schedules II through V.
A decentralized clinical trial (DCT) is a study in which some or all trial activities, such as consent, visits, drug delivery and data collection, take place away from traditional trial sites, often at home or at local clinics.
A dialysis facility is a Medicare-certified clinic that provides dialysis to patients with end-stage renal disease (ESRD), whose kidneys can no longer sustain life. It delivers in-center hemodialysis and often trains and supports patients who dialyze at home.
A digital opinion leader (DOL) is a healthcare professional or other expert whose influence on medical opinion comes mainly from online channels such as professional social networks, podcasts, blogs and video, rather than from publications or podium talks alone.
A dispensing fee is the amount a payer pays a pharmacy on top of a drug's ingredient cost to cover the cost of filling a prescription, such as pharmacist time, packaging and overhead.
A dosage form is the physical form in which a drug is manufactured and delivered, such as a tablet, capsule, oral solution, injection, cream or inhaler, combining the active ingredient with excipients into a usable dose.
Drug establishment registration is the legal requirement that domestic and foreign facilities that manufacture, repack, relabel or otherwise process drugs for U.S. commercial distribution register with FDA and renew each year.
A drug indication is a disease, condition or clinical use for which a drug is approved, stated in the Indications and Usage section of its FDA labeling. Approved indications define the uses a manufacturer may promote.
A drug launch is the commercial introduction of a newly approved prescription drug or biologic, or of an existing product for a newly approved indication, including the pricing, distribution, payer access, medical and promotional work around it.
A drug rebate is a payment a manufacturer makes after a drug is sold, usually to a payer, pharmacy benefit manager or government program, that lowers the net cost of the drug without changing its list price.
A drug recall is the removal or correction of a marketed drug product that FDA considers to be in violation of the laws it administers, for example because it is contaminated, mislabeled, subpotent or made under deficient manufacturing controls.
A drug shortage, as defined in federal law, is a period of time when the demand or projected demand for a drug within the United States exceeds its supply. FDA and ASHP each publish shortage lists using different criteria.
A dual eligible beneficiary is a person enrolled in both Medicare and Medicaid, either with full Medicaid benefits or with partial help from Medicaid that pays Medicare premiums and, in some cases, Medicare cost sharing.
An electronic health record (EHR) is a digital record of a patient's health information, such as diagnoses, medications, allergies, lab results and clinical notes, built to be shared securely across the providers and organizations involved in that patient's care.
An electronic medical record (EMR) is a digital version of the paper chart kept by a single practice or organization, holding the medical and treatment history of patients seen there, and not originally designed to share data with outside providers.
Electronic prescribing (eRx) is the computer-based creation, transmission and management of prescriptions between prescribers, pharmacies and payers, replacing paper, fax and phone orders with standardized electronic messages.
Eligibility criteria are the inclusion and exclusion rules in a clinical trial protocol that define who may enroll, based on factors such as age, sex, diagnosis, disease stage, prior treatment, laboratory values and other conditions.
Entity resolution is the process of determining which records, within one dataset or across several, refer to the same real-world person, organization, location or product, and linking them under a single identity.
An Established Pharmacologic Class (EPC) is the FDA-recognized class name, such as Kinase Inhibitor or HMG-CoA Reductase Inhibitor, stated in the Highlights of a prescription drug's labeling and based on mechanism, physiologic effect or chemical structure.
Expanded access, often called compassionate use, is the FDA pathway that lets a patient with a serious or immediately life-threatening condition receive an investigational drug or biologic outside a clinical trial when no comparable or satisfactory alternative exists.
Fast Healthcare Interoperability Resources (FHIR) is an HL7 standard for exchanging health data through web APIs, representing information such as patients, medications and claims as modular resources in JSON or XML.
Fast track designation is an FDA program that speeds development and review of drugs and biologics that treat serious conditions and could address an unmet medical need, through more frequent FDA communication and rolling submission of the application.
The FDA Adverse Event Reporting System (FAERS) is the FDA database of adverse event reports, medication error reports and product quality complaints involving drugs and therapeutic biologics, used for postmarketing safety surveillance.
The FDA Enforcement Report is a weekly FDA publication that lists product recalls once the agency has classified them, with the recalling firm, product description, reason for recall, lot codes, distribution and recall class.
FDA Form 483, titled Inspectional Observations, is the document FDA investigators give a firm at the end of an inspection to list conditions or practices that, in their judgment, may violate the Federal Food, Drug, and Cosmetic Act.
A Federal Upper Limit (FUL) is a CMS-calculated cap on the aggregate amount state Medicaid programs can spend on the ingredient cost of certain multiple source drugs, set using the average manufacturer prices of equivalent products.
A Federally Qualified Health Center (FQHC) is a Medicare and Medicaid provider type, defined in Section 1861(aa) of the Social Security Act, for safety-net primary care organizations that are paid under a dedicated FQHC prospective payment system.
Fee-for-service (FFS) is a payment model in which a payer reimburses a provider separately for each billable service, such as a visit, test or procedure, so total payment rises with the volume of services delivered.
The Food and Drug Administration (FDA) is the federal agency within the U.S. Department of Health and Human Services that regulates drugs, biologics, medical devices, food, cosmetics and tobacco products under the Federal Food, Drug, and Cosmetic Act.
A formulary is the list of prescription drugs a health plan or pharmacy benefit manager covers, often organized into cost-sharing tiers and paired with rules such as prior authorization, step therapy and quantity limits.
A formulary tier is a level within a drug plan formulary that sets how much the patient pays for a covered drug, with lower tiers usually holding preferred generics at low cost sharing and higher tiers holding non-preferred or specialty drugs.
An FQHC Look-Alike is a health center that HRSA has designated as meeting all Health Center Program requirements without receiving Section 330 grant funding, which qualifies it for FQHC payment rates and 340B drug pricing.
Gene therapy is a treatment that modifies a person's genes, by adding, inactivating, replacing or editing genetic material, to treat or prevent disease. In the United States, gene therapies are regulated as biologics by the FDA Center for Biologics Evaluation and Research.
A generic drug is a copy of an approved brand-name drug with the same active ingredient, strength, dosage form, route of administration and conditions of use, shown to be bioequivalent to it through an Abbreviated New Drug Application.
Genetic testing is laboratory analysis of DNA, RNA, chromosomes or gene products to identify variants linked to disease, disease risk, carrier status, drug response or tumor characteristics.
A genetic variant is any difference in a DNA sequence compared with a reference sequence, ranging from a single changed base to large deletions, duplications or rearrangements of chromosome segments.
A germline variant is present in egg or sperm, is found in virtually every cell of the body and can be passed to children. A somatic variant arises after conception in some cells only, such as a tumor, and is not inherited.
A GLP-1 receptor agonist is a drug that mimics glucagon-like peptide-1, a gut hormone, to raise glucose-dependent insulin release, suppress glucagon, slow stomach emptying and reduce appetite. The class is approved for type 2 diabetes, weight management and related uses.
Good Clinical Practice (GCP) is the international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials, meant to protect participants and ensure that trial results are reliable.
Graduate medical education (GME) is the supervised residency and fellowship training physicians complete after medical school to qualify for independent practice and board certification in a specialty. Medicare is its largest public funder.
Gross-to-net is the difference between a drug's gross sales at list price and the net revenue the manufacturer keeps after rebates, discounts, chargebacks, fees and other price concessions.
A group practice is an organization of two or more physicians or other clinicians who share a legal entity, facilities, staff and billing, typically billing payers under the group's taxpayer identification number and organizational NPI.
A group purchasing organization (GPO) is an entity that negotiates contracts with drug, device and supply manufacturers and distributors on behalf of member hospitals and other providers, using combined purchasing volume to obtain lower prices.
The Hatch-Waxman Act is the Drug Price Competition and Patent Term Restoration Act of 1984, the federal law that created the modern generic drug approval pathway while giving brand manufacturers patent term restoration and new periods of exclusivity.
HCP segmentation is the grouping of healthcare professionals (HCPs) into segments that share traits such as prescribing potential, treatment behavior, practice setting or channel preference, so each group can receive a tailored engagement strategy.
HCP targeting is the process drug, device and diagnostics companies use to decide which healthcare professionals (HCPs) to engage, through which channel and how often, based on patient population, prescribing or procedure volume, specialty and access.
The Health Center Program is the federal program, authorized by Section 330 of the Public Health Service Act and run by HRSA, that funds community-based primary care organizations serving medically underserved areas and populations.
Health equity is the state in which every person has a fair and just opportunity to attain their highest level of health, which requires removing avoidable, unjust differences in health and access to care between population groups.
Health information exchange (HIE) is the electronic sharing of patient health information among doctors, hospitals, labs, pharmacies and other organizations. The term also names the organizations, often state or regional, that operate this exchange.
The Health Insurance Portability and Accountability Act (HIPAA) is a 1996 federal law whose regulations set national standards for protecting health information and for electronic health care transactions, code sets and identifiers.
Health IT surveillance is the ongoing oversight of certified health IT by ONC-Authorized Certification Bodies and through ASTP/ONC direct review, to confirm that products keep meeting certification requirements after certification and in real use.
Health Level Seven (HL7) refers both to HL7 International, a nonprofit standards development organization, and to the family of standards it publishes for exchanging clinical and administrative health data, including HL7 Version 2, CDA and FHIR.
A Health Professional Shortage Area (HPSA) is a geographic area, population group or health care facility that HRSA has designated as having too few primary care, dental or mental health providers for the people it serves.
The Health Resources and Services Administration (HRSA) is the agency of the U.S. Department of Health and Human Services that funds and oversees programs improving access to care for people who are uninsured, isolated or medically vulnerable.
A health system is an organization that owns or manages multiple care delivery sites, typically one or more hospitals plus physician groups, under common ownership or joint management. It is the parent organization above individual hospitals, clinics and practices.
A healthcare API (application programming interface) is a defined way for software to request, send or update health data in another system, such as an EHR, payer platform or public database, usually through standards such as HL7 FHIR.
A healthcare claim is the bill a provider or pharmacy submits to a health plan to request payment for care, listing the patient, the treating and billing providers, diagnoses, services delivered and charges.
The Healthcare Common Procedure Coding System (HCPCS) is the standardized code set used on U.S. health insurance claims to report services, procedures, supplies, drugs and equipment, organized into Level I (CPT) and Level II codes.
A healthcare CRM is customer relationship management software adapted for healthcare, used by life sciences companies to manage engagement with clinicians and accounts, and by providers to manage patient, referral and physician relationships.
Healthcare lead generation is the process of identifying and qualifying potential buyers, such as physicians, practices, hospitals, pharmacies or payers, for products and services sold into healthcare, and passing them to sales teams for outreach.
A healthcare professional (HCP) is a trained, usually licensed individual who delivers or directs patient care, such as a physician, nurse, pharmacist or dentist. In life sciences, the term also covers people who prescribe, recommend or influence the use of products.
A Healthcare Provider Taxonomy Code is a 10-character code from the code set maintained by the National Uniform Claim Committee (NUCC) that classifies a health care provider by type, classification and area of specialization.
HGVS nomenclature is the international standard for describing DNA, RNA and protein sequence variants, written as a reference sequence followed by a prefix and the change, such as a coding DNA substitution c.1799T>A.
A Hierarchical Condition Category (HCC) is a group of related diagnosis codes used in risk adjustment models, such as the CMS-HCC model for Medicare Advantage, to predict expected health care costs for a person and adjust payments.
The HITECH Act is the 2009 federal law, enacted as part of the American Recovery and Reinvestment Act, that funded EHR adoption through Medicare and Medicaid incentive payments and strengthened HIPAA privacy, security and breach notification rules.
A home health agency (HHA) is an organization certified to provide skilled nursing and therapy services in patients' homes. Medicare covers these services for homebound patients who need intermittent skilled care under a plan of care from a physician or allowed practitioner.
Hospice is a program of palliative care for people with a terminal illness who choose comfort-focused care instead of curative treatment. Medicare covers hospice when a physician certifies a life expectancy of six months or less if the illness runs its normal course.
A hospital is a state-licensed institution that provides inpatient diagnostic, therapeutic and rehabilitation services under physician supervision, with 24-hour nursing care. Medicare defines a hospital in Section 1861(e) of the Social Security Act.
A hospital outpatient department (HOPD) is part of a hospital that serves patients who are not admitted, providing services such as clinic visits, imaging, infusions and same-day surgery. Medicare pays its facility services under the Outpatient Prospective Payment System.
Hospital price transparency is the federal requirement that hospitals operating in the United States publish their standard charges, including payer-specific negotiated rates and cash prices, in a machine-readable file and a consumer-friendly format.
Hospital privileges are the permission a hospital grants a clinician to practice there and perform a defined list of services, such as admitting patients or doing specific procedures, based on verified credentials and demonstrated competence.
The hospital star rating is the CMS Overall Hospital Quality Star Rating, a one-to-five-star summary of a hospital's performance on publicly reported measures of mortality, safety, readmissions, patient experience and timely care, published on Medicare Care Compare.
A hospitalist is a physician, or sometimes an NP or PA, whose practice focuses on caring for patients while they are in the hospital, taking over from the patient's outpatient clinicians during the stay and handing care back at discharge.
A HPSA score is the priority number HRSA assigns to each Health Professional Shortage Area, from 0 to 25 for primary care and mental health and 0 to 26 for dental health, with higher scores indicating greater need.
ICD-10-CM is the U.S. clinical modification of the World Health Organization ICD-10 classification, used to code diagnoses, symptoms, injuries and reasons for encounters on claims and health records in every care setting.
ICD-10-PCS (International Classification of Diseases, Tenth Revision, Procedure Coding System) is the U.S. code set for procedures performed during hospital inpatient stays, built from seven-character alphanumeric codes.
An independent diagnostic testing facility (IDTF) is a Medicare supplier that performs diagnostic tests, such as MRI, CT, ultrasound, sleep studies or cardiac monitoring, independently of a hospital or physician office, under specific federal performance standards.
Information blocking is a practice by a health care provider, health IT developer or health information network that is likely to interfere with access, exchange or use of electronic health information, unless required by law or covered by an exception.
Informed consent is the process by which a prospective participant learns the purpose, procedures, risks, benefits and alternatives of a study and voluntarily agrees to take part, usually documented with a signed consent form.
The Inpatient Prospective Payment System (IPPS) is how Medicare pays most acute care hospitals for inpatient stays: a predetermined amount per discharge based on the diagnosis-related group (DRG) of the case, adjusted for local wages and hospital factors.
An inpatient rehabilitation facility (IRF) is a rehabilitation hospital or a rehabilitation unit of an acute care hospital that provides intensive, physician-supervised therapy to patients recovering from conditions such as stroke, spinal cord injury or major trauma.
An Institutional Review Board (IRB) is a committee that reviews and monitors research involving human participants to protect their rights and welfare, with authority to approve, require changes to or disapprove a study.
An integrated delivery network (IDN) is a health system that owns or coordinates care across the continuum, typically hospitals, physician groups, outpatient and post-acute services and sometimes a health plan, and manages contracting and purchasing centrally.
An interchangeable biosimilar is a biosimilar that meets an additional FDA standard allowing a pharmacist to substitute it for its reference product without asking the prescriber, where state pharmacy law permits.
Interoperability is the ability of different health IT systems and organizations to securely exchange electronic health information and use it without special effort, so data created in one system can be understood and acted on in another.
An Investigational New Drug Application (IND) is the submission a sponsor files with FDA to obtain an exemption from the ban on shipping unapproved drugs across state lines, so the drug can be tested in human clinical trials.
A J-code is a HCPCS Level II code beginning with the letter J, used mainly to bill drugs that are injected, infused or otherwise administered by a clinician, such as chemotherapy and biologic infusions.
Joint Commission accreditation is a quality and safety evaluation of a health care organization by The Joint Commission, an independent nonprofit. For hospitals it can also stand in for a government survey when CMS grants deemed status for Medicare.
A key opinion leader (KOL) is a physician, researcher or other clinical expert whose research, guideline work or teaching shapes how peers diagnose and treat a disease, and whom drug and device companies engage for scientific advice.
Locum tenens, Latin for "holding the place," describes temporary clinicians who fill in for absent providers or cover vacant positions for days to many months, usually through a staffing agency or a direct contract.
LOINC (Logical Observation Identifiers Names and Codes) is the standard code set for identifying laboratory tests, clinical measurements, survey instruments and clinical document types, maintained by the Regenstrief Institute.
A long-term care hospital (LTCH) is an acute care hospital that treats medically complex patients needing extended hospital-level care, such as prolonged ventilator support. Medicare requires an average inpatient length of stay greater than 25 days.
Loss of exclusivity (LOE) is the point at which a branded drug or biologic no longer has patent or FDA regulatory exclusivity protection that blocks competitors, opening its market to generic or biosimilar versions.
A managed care organization (MCO) is a health plan that receives a fixed premium or capitation payment per member to arrange and pay for covered care through a contracted provider network, using tools such as prior authorization to manage cost.
Market access is the work of securing coverage, reimbursement and appropriate pricing for a drug or medical device so that the patients it is approved for can obtain it, spanning payer strategy, pricing, contracting and evidence of value.
Maximum Allowable Cost (MAC) is an upper limit that a pharmacy benefit manager, health plan or state Medicaid program sets on the ingredient cost it will pay a pharmacy for a generic or multiple source drug, regardless of which manufacturer made it.
Mechanism of action (MOA) is the specific biochemical interaction through which a drug produces its effect, such as blocking a receptor, inhibiting an enzyme or binding a protein, described in drug labeling where it is known.
Medicaid is the joint federal and state health coverage program for eligible people with low incomes, including children, pregnant women, parents, older adults and people with disabilities, run by each state within federal rules.
The Medicaid Drug Rebate Program (MDRP) is the federal program under which drug manufacturers pay quarterly rebates to state Medicaid programs in exchange for Medicaid coverage of their covered outpatient drugs.
Medical affairs is the function in a drug, biologic or device company that generates and communicates scientific evidence about its products and the diseases they treat in a non-promotional way, bridging research and development and commercial teams.
A medical science liaison (MSL) is a field-based scientific expert in the medical affairs function of a drug, biologic or device company who holds peer-to-peer scientific exchange with clinicians and researchers, separate from sales.
A medical specialty is a defined branch of medical practice, such as cardiology, dermatology or pediatrics, in which physicians complete dedicated residency training and can seek board certification. Subspecialties are narrower fields within a specialty.
Medical Subject Headings (MeSH) is the National Library of Medicine controlled, hierarchical vocabulary used to index and search biomedical literature in MEDLINE and PubMed, and to catalog books and other resources.
A Medically Underserved Area (MUA) is a county, group of counties, group of census tracts or civil division that HRSA has designated as lacking access to primary care, based on an Index of Medical Underservice score of 62.0 or less.
A Medically Underserved Population (MUP) is a HRSA designation for a specific group within an area, such as low-income residents, that faces economic, cultural or linguistic barriers to primary care even if the area as a whole is not underserved.
Medicare is the federal health insurance program for people 65 and older, certain younger people with disabilities, and people with end-stage renal disease or ALS, administered by the Centers for Medicare & Medicaid Services.
A Medicare Administrative Contractor (MAC) is a private company that CMS contracts with to process Original Medicare fee-for-service claims, enroll providers and handle first-level appeals within a defined geographic jurisdiction.
Medicare Advantage (MA), also called Medicare Part C, is the option to receive Medicare benefits through a private health plan that contracts with CMS and is paid a monthly amount per enrollee to cover Part A and Part B services.
Medicare assignment is a provider's agreement to accept the Medicare-approved amount as full payment for a covered service in Original Medicare, billing Medicare directly and charging the patient no more than the deductible and coinsurance.
A Medicare cost report is the annual financial and statistical filing that Medicare-certified institutional providers submit to CMS. It details costs, charges, patient days, beds, staffing and payer mix, and it is used to settle certain Medicare payments.
A Medicare coverage determination is a formal decision on whether Medicare covers an item or service: a National Coverage Determination (NCD) is made by CMS nationwide, and a Local Coverage Determination (LCD) by a Medicare Administrative Contractor.
The Medicare Drug Price Negotiation Program, created by the Inflation Reduction Act of 2022, lets CMS negotiate maximum fair prices with manufacturers for selected high-spending Medicare drugs that lack generic or biosimilar competition.
Medicare Part A is the hospital insurance part of Original Medicare. It covers inpatient hospital stays, skilled nursing facility care after a qualifying hospital stay, hospice care and some home health services.
Medicare Part B is the medical insurance part of Original Medicare, covering physician services, outpatient hospital care, preventive services, durable medical equipment and many drugs administered in a clinic or physician office.
Medicare Part D is the voluntary Medicare outpatient prescription drug benefit, delivered through private stand-alone drug plans and Medicare Advantage plans that contract with CMS and set their own formularies within federal rules.
Medicare Part D Prescriber data is a set of public use files from the Centers for Medicare and Medicaid Services (CMS) reporting the prescriptions and drug costs paid under Medicare Part D for each prescriber, by brand and generic drug name.
Medicare Physician and Other Practitioners data is a set of public use files from the Centers for Medicare and Medicaid Services (CMS) reporting services, charges and payments billed under Medicare fee-for-service Part B, by provider and procedure code.
The Medicare Physician Fee Schedule (MPFS) sets national payment rates for professional services billed to Medicare Part B, calculated from relative value units, geographic cost adjustments and an annual conversion factor.
The Medicare Promoting Interoperability Program is the CMS program that requires eligible hospitals and critical access hospitals to use Certified EHR Technology and report interoperability measures each year or receive reduced Medicare payments.
A Medicare Severity Diagnosis Related Group (MS-DRG) is one of the categories Medicare uses to classify acute care inpatient hospital stays with similar diagnoses, procedures and resource use, each paid a predetermined amount.
Medicare Star Ratings are the CMS 1-to-5 star quality scores for Medicare Advantage and Part D prescription drug plans, based on clinical quality, member experience, complaints and plan operations, and published each fall.
MedWatch is the FDA Safety Information and Adverse Event Reporting Program, which collects reports of adverse events, medication errors and product problems for FDA-regulated medical products and distributes safety alerts to the public.
The Merit-based Incentive Payment System (MIPS) is the Medicare Quality Payment Program track that adjusts Part B payments to eligible clinicians up or down based on a yearly score across quality, cost, improvement activities and interoperability.
A monoclonal antibody (mAb) is a laboratory-made protein, produced from a single cloned cell line, that binds one specific target (antigen) and is used as a biologic drug for cancer, autoimmune, infectious and other diseases.
National Average Drug Acquisition Cost (NADAC) is a CMS pricing benchmark that estimates the average invoice price retail community pharmacies pay for a covered outpatient drug, published per unit at the NDC level and updated weekly.
The National Drug Code (NDC) is the unique 10-digit, three-segment number that identifies a drug product in the United States by its labeler, its specific formulation and its package size.
The National Health Service Corps (NHSC) is a HRSA program that offers scholarships and student loan repayment to primary care medical, dental and behavioral health clinicians in exchange for service at approved sites in shortage areas.
The National Plan and Provider Enumeration System (NPPES) is the CMS system that assigns National Provider Identifiers, stores the information providers report about themselves, and publishes that data through the NPI Registry and downloadable files.
The National Provider Identifier (NPI) is the unique 10-digit number that HIPAA requires health care providers to use in standard electronic transactions, issued once per individual or organization by the Centers for Medicare & Medicaid Services.
An NCT number is the unique identifier ClinicalTrials.gov assigns to each registered study, written as the letters NCT followed by eight digits, such as NCT01234567. It stays with the study for the life of the record.
A New Drug Application (NDA) is the formal request a sponsor submits to the FDA for permission to market a new drug in the United States, containing the clinical, nonclinical, manufacturing and labeling data needed to show the drug is safe and effective.
New prescriptions (NRx) are prescriptions dispensed for the first time under a new prescription, excluding refills. NRx includes renewals for continuing patients, so it does not measure new patients.
New-to-brand prescriptions (NBRx) count prescriptions for patients who have not taken a specific brand during a lookback period, including patients new to therapy, patients switching from another product and patients adding the brand.
Next-generation sequencing (NGS) is a family of massively parallel DNA and RNA sequencing technologies that read millions to billions of fragments at once, making it practical to sequence gene panels, exomes or whole genomes in a single run.
A nurse practitioner (NP) is a registered nurse with graduate-level education and national certification who diagnoses and treats patients, orders tests and prescribes medications within a scope of practice set by state law.
Off-label use is the prescribing of an FDA-approved drug for a use not included in its approved labeling, such as a different disease, patient population, dose or route. It is generally legal for clinicians but limits what manufacturers may promote.
The ONC Health IT Certification Program is the voluntary federal program that tests and certifies health IT, such as EHRs, against standards and criteria set by HHS in 45 CFR Part 170, so buyers and CMS programs can rely on consistent functions.
Open Payments is the CMS transparency program that publishes payments and other transfers of value from drug, device, biologic and medical supply manufacturers to physicians, certain other practitioners and teaching hospitals.
The Orange Book is the FDA publication "Approved Drug Products with Therapeutic Equivalence Evaluations," which lists drugs approved under the FD&C Act along with their therapeutic equivalence codes, listed patents and regulatory exclusivities.
An orphan drug is a drug or biologic the FDA has designated as intended for a rare disease or condition, generally one affecting fewer than 200,000 people in the United States, making its sponsor eligible for Orphan Drug Act incentives.
Orphan drug designation is an FDA status granted to a drug or biologic intended to treat, diagnose or prevent a rare disease or condition, generally one affecting fewer than 200,000 people in the United States, that qualifies the sponsor for development incentives.
The Outpatient Prospective Payment System (OPPS) is how Medicare pays hospitals for most outpatient services, such as clinic visits, imaging and outpatient surgery, using predetermined rates for Ambulatory Payment Classifications (APCs).
An over-the-counter (OTC) drug is a medicine that consumers can buy and use without a prescription because the FDA considers it safe and effective when used as directed on its Drug Facts label.
A Paragraph IV certification is a statement in a generic or 505(b)(2) drug application asserting that a patent listed in the Orange Book for the reference drug is invalid, unenforceable or will not be infringed by the proposed product.
A patent cliff is a steep, concentrated drop in revenue that occurs when one or more high-selling drugs lose patent and regulatory exclusivity within a short period, allowing lower-priced generic or biosimilar competitors to take share.
A patient assistance program (PAP) is a program, usually run by a drug manufacturer or its foundation, that provides free or deeply discounted medication to eligible patients who are uninsured, underinsured or otherwise unable to afford it.
The patient journey is the sequence of steps a patient goes through for a condition, from first symptoms and diagnosis through treatment decisions, access hurdles, therapy start, adherence and switching or stopping treatment.
Patient leakage is care that a health system or physician network could provide but that its patients receive from outside providers instead, usually measured as the share of referrals, procedures or spending that goes out of network.
Payer mix is the breakdown of the patients, visits or revenue of a hospital, practice or other provider by source of payment, such as Medicare, Medicaid, commercial insurance and self-pay, usually expressed as percentages.
Pharmacogenomics (PGx) is the study of how inherited genetic variation affects a person's response to drugs, including how quickly a drug is metabolized, how well it works and the risk of serious adverse reactions.
A pharmacy benefit manager (PBM) is a company that administers prescription drug benefits for health plans, employers and government programs by processing pharmacy claims, building pharmacy networks, managing formularies and negotiating manufacturer rebates.
A Phase 1 clinical trial is the first stage of testing an investigational drug in humans, designed mainly to assess safety, tolerability and dosing, and how the body absorbs, distributes, metabolizes and excretes the drug.
A Phase 2 clinical trial tests an investigational drug in patients who have the target disease or condition, to gather early evidence of effectiveness, identify common short-term side effects and choose doses for Phase 3.
A Phase 3 clinical trial is a large study, usually randomized and controlled, that tests an investigational drug in patients to confirm effectiveness, monitor side effects and provide the evidence FDA reviews for approval.
A Phase 4 clinical trial is a study conducted after FDA approves a drug or biologic, to gather more information about its safety, effectiveness or optimal use in broader populations and over longer periods of time.
A physician is a clinician with a Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (DO) degree who is licensed by a state to practice medicine, which includes diagnosing illness, performing procedures and prescribing drugs.
A physician assistant (PA) is a licensed clinician trained in a graduate-level medical program who examines, diagnoses and treats patients and prescribes medications, working with physicians under rules that each state sets.
A physician liaison is a relationship manager employed by a hospital, health system or specialty practice who builds and maintains ties with referring physicians and their offices to grow and retain patient referrals.
The Physician Payments Sunshine Act is the 2010 federal law, Section 6002 of the Affordable Care Act, requiring drug, device, biologic and medical supply manufacturers to publicly report payments to physicians, teaching hospitals and, from 2021 data, other clinicians such as NPs and PAs.
Physician recruitment is the process hospitals, medical groups and other employers use to identify, attract, contract and relocate physicians to fill clinical needs, often guided by data on physician supply, demand and shortage areas.
A pipeline drug is an investigational product still in development and not yet approved by the FDA for the use being studied, tracked by stage from preclinical research through clinical trials and regulatory review.
A Place of Service (POS) code is a two-digit code on a professional claim that identifies the setting where a service was delivered, such as a physician office, an inpatient hospital, a patient home or a telehealth visit.
Precision medicine is an approach to disease prevention and treatment that accounts for individual differences in genes, environment and lifestyle, so that therapies and tests are matched to defined subgroups of patients rather than to an average patient.
Premarket Approval (PMA) is the FDA review process for most Class III medical devices, the highest-risk category, requiring valid scientific evidence, usually including clinical data, that the device is safe and effective for its intended use.
A prescriber is a clinician legally authorized to order prescription drugs for patients. Prescribing authority comes from state law, and prescribing controlled substances also requires a registration with the Drug Enforcement Administration (DEA).
Prescribing Information (PI) is the FDA-approved labeling for a prescription drug or biologic that tells health care professionals how to use it, covering approved indications, dosing, contraindications, warnings, adverse reactions and clinical study results.
A prescription drug (Rx) is a medicine that federal law allows to be dispensed only on the order of a licensed practitioner, because it is not safe to use without professional supervision. Its label must carry the statement Rx only.
A primary care provider (PCP) is the clinician who serves as a patient's first point of contact and provides continuing, comprehensive care, coordinating referrals to specialists. PCPs are usually family medicine, internal medicine or pediatric physicians, NPs or PAs.
A primary endpoint is the main outcome a clinical trial is designed to measure. It is chosen before the trial starts, determines whether the intervention met its goal and sets the sample size needed to detect an effect.
A principal investigator (PI) is the qualified individual who leads a clinical study at a site and is responsible for conducting it according to the protocol and federal regulations while protecting the safety of enrolled participants.
Priority review is an FDA designation that sets a six-month goal for acting on a marketing application, instead of the standard ten months, for drugs and biologics that would significantly improve the treatment, diagnosis or prevention of a serious condition.
A procedure code modifier is a two-character code added to a CPT or HCPCS code on a claim to show that a service was changed by a specific circumstance, such as body side, a split component or a distinct procedure, without changing the code itself.
Procedure volume is the number of times a specific procedure is performed by a provider, facility or market over a set period, typically counted from billing claims using standard procedure codes.
Protected health information (PHI) is individually identifiable health information, in any form, that a HIPAA covered entity or business associate creates, receives, maintains or transmits about a person's health, care or payment for care.
Provider data management (PDM) is the set of processes and systems that health plans, health systems and other organizations use to collect, verify, maintain and distribute accurate information about clinicians and facilities.
A provider directory is a health plan's list of the doctors, hospitals, pharmacies and other providers in its network, showing names, specialties, locations, contact details and, for many listings, whether a provider is accepting new patients.
The Provider Enrollment, Chain and Ownership System (PECOS) is the CMS database and online system through which physicians, practitioners, suppliers and institutional providers enroll in Medicare, update their information and revalidate their billing privileges.
A psychiatric hospital is a hospital primarily engaged in the inpatient diagnosis and treatment of mental illness under physician supervision. Medicare pays it, and psychiatric units of general hospitals, under the Inpatient Psychiatric Facility PPS.
A public use file (PUF) is a dataset that a government agency releases for free download without a data use agreement, after aggregating or de-identifying the records and suppressing small counts so individuals cannot be identified.
The Purple Book is the FDA's searchable database of licensed biological products, listing reference products, biosimilars and interchangeable products with their licensure dates, exclusivity information and, for some products, patent lists.
A Qualified Health Information Network (QHIN) is a health information network designated under TEFCA to connect directly with other QHINs and route nationwide health data exchange for the organizations that join it.
A randomized controlled trial (RCT) is a study in which participants are assigned by chance to receive either the intervention being tested or a control, so that differences in outcomes can be attributed to the intervention itself.
Real-world data (RWD) are data on patient health status or the delivery of health care that are routinely collected outside traditional clinical trials, from sources such as electronic health records, insurance claims, registries and wearable devices.
Real-world evidence (RWE) is clinical evidence about the use and potential benefits or risks of a medical product, derived from analysis of real-world data such as insurance claims, electronic health records and registries.
Recall classification is the FDA ranking of a product recall as Class I, II or III according to the relative health hazard of the recalled product, from a reasonable probability of serious harm or death down to unlikely to cause harm.
A Reference Listed Drug (RLD) is the approved drug product that the FDA identifies as the one a generic applicant relies on when seeking approval through an Abbreviated New Drug Application (ANDA), usually the original brand product.
A reference product is the single FDA-licensed biologic, approved through a full Biologics License Application, against which a proposed biosimilar or interchangeable biosimilar is compared and evaluated.
A referral network is the set of relationships through which providers send patients to one another for specialist care, tests, procedures or post-acute services, usually measured from claims as links between referring and receiving providers.
A referring physician is the physician or other practitioner who sends a patient to another provider, or orders a service such as imaging, laboratory tests, medical equipment or home health care, and is named on the resulting claim.
Regulatory exclusivity is a period of marketing protection that the FDA grants by statute when it approves certain drugs or biologics, during which it cannot accept or approve some competing applications, whether or not any patent is in force.
A relative value unit (RVU) is the measure Medicare uses to rank the resources needed to provide a professional service against other services. RVUs for work, practice expense and malpractice drive Physician Fee Schedule payment.
Remote patient monitoring (RPM) is the collection of physiologic data, such as blood pressure, weight, blood glucose or oxygen saturation, from patients outside a clinical setting using connected devices, with data sent to clinicians who review it and manage care.
Risk adjustment is the statistical method payers and regulators use to account for differences in the expected health care costs of the people a plan or provider covers, so payments and comparisons reflect patient health, not just efficiency.
A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that FDA can require for a medication with serious safety concerns, to help ensure its benefits outweigh its risks when labeling alone is not enough.
The route of administration is the path by which a drug enters the body, such as oral, intravenous, subcutaneous, intramuscular, topical or inhaled. It shapes how fast and how completely the drug reaches its site of action.
A Rural Emergency Hospital (REH) is a Medicare provider type, effective January 1, 2023, for critical access hospitals and small rural hospitals that convert to providing emergency and outpatient services without acute inpatient care.
A Rural Health Clinic (RHC) is a Medicare and Medicaid certified outpatient primary care clinic located in a non-urbanized shortage area, created by the Rural Health Clinic Services Act of 1977 and paid a special per-visit rate.
Rural-Urban Commuting Area (RUCA) codes are a USDA classification that labels each U.S. census tract from 1 (metropolitan core) to 10 (rural) using measures of urbanization, population density and daily commuting.
RxNorm is the National Library of Medicine normalized naming system for clinical drugs in the United States. It gives each drug concept an identifier (RxCUI) and links it to NDCs and to drug names used in other vocabularies.
A safety-net provider is a hospital, clinic or other organization that, by legal mandate or explicit mission, offers care regardless of ability to pay and serves a substantial share of uninsured, Medicaid and other vulnerable patients.
A self-funded health plan is an employer-sponsored health plan in which the employer pays covered claims from its own funds instead of buying an insurance policy, usually hiring an insurer or third-party administrator to run it.
A short-term acute care hospital treats patients with serious illness, injury or surgical needs during relatively brief inpatient stays. In Medicare terms it is a hospital paid under the Inpatient Prospective Payment System (IPPS).
Site of care is the setting where a health service is delivered, such as an inpatient hospital, hospital outpatient department, ambulatory surgery center, physician office or the patient's home. The same service can be paid very differently depending on the site.
Site-neutral payment is the policy of paying the same Medicare rate for the same service regardless of where it is performed, such as a hospital outpatient department, a physician office or an ambulatory surgical center.
A skilled nursing facility (SNF) is an institution certified by Medicare to provide daily skilled nursing or rehabilitation services, usually for a short stay after a hospital admission. Most SNFs are also Medicaid-certified nursing facilities for long-term residents.
A sliding fee discount program is the set of policies, required of federally funded health centers, that reduces patient charges on a scale tied to household income and family size, with the largest discount at or below the federal poverty guidelines.
A small-molecule drug is a medicine whose active ingredient is a low-molecular-weight chemical compound, usually made by chemical synthesis, with a defined structure that can be copied exactly. Most tablets and capsules are small-molecule drugs.
SNOMED CT (Systematized Nomenclature of Medicine Clinical Terms) is a comprehensive clinical terminology of coded concepts, used in electronic health records to record problems, findings, procedures and other clinical information.
A specialty drug is a high-cost medicine, often for a complex or chronic condition, that typically needs special handling, administration, monitoring or distribution. There is no single legal definition; payers, PBMs and Medicare Part D each apply their own criteria.
A specialty pharmacy is a pharmacy that dispenses high-cost or complex medications, such as drugs for cancer, multiple sclerosis or rare diseases, and provides services like prior authorization support, patient monitoring and special handling.
A staffed bed is a hospital inpatient bed that is set up, equipped and supported by enough staff to admit a patient. It measures working capacity, which is often lower than the number of beds a hospital is licensed to operate.
A state medical license is the legal authorization, issued by a state medical board, that allows a physician to practice medicine in that state. Physicians generally need a license in each state where their patients are located, including for telehealth.
Step therapy is a health plan rule requiring a patient to try one or more preferred treatments, usually lower-cost drugs, before the plan will cover a different treatment prescribed by the clinician.
Structured Product Labeling (SPL) is the Health Level Seven (HL7) XML document standard that FDA uses to receive and publish the content of drug labels together with coded product data such as NDCs, ingredients, dosage forms and packaging.
A Taxpayer Identification Number (TIN) is the number the Internal Revenue Service uses to identify a taxpayer. In healthcare it identifies the business entity paid for claims, usually an Employer Identification Number (EIN) or, for some sole proprietors, a Social Security Number.
A teaching hospital is a hospital that trains medical residents and fellows in graduate medical education programs. Medicare recognizes teaching status through payments that cover residency costs and the higher patient care costs of teaching settings.
Telehealth is the use of electronic information and telecommunications technology, such as live video, audio-only calls, store-and-forward images and remote monitoring, to deliver health care, health education and related services at a distance.
Territory planning is the design of sales territories and field coverage: grouping geographies and accounts into balanced territories, sizing the field force and setting call plans so representatives can reach target customers efficiently.
A Therapeutic Equivalence Code (TE code) is the rating the FDA assigns in the Orange Book to show whether a drug product is therapeutically equivalent to other pharmaceutically equivalent products, meaning it is expected to have the same clinical effect and safety profile.
Total addressable market (TAM) is the total annual revenue a product or service could earn if it captured every potential customer in its defined market, before accounting for competition, access limits or realistic adoption.
Total prescriptions (TRx) is the count of prescriptions dispensed for a product over a period, combining new prescriptions (NRx) and refills. It is the standard volume measure for drugs dispensed through retail and mail pharmacies.
A trial sponsor is the person or organization that takes responsibility for and initiates a clinical investigation, such as a drug company, academic institution, government agency or individual physician, while investigators conduct it.
The Trusted Exchange Framework and Common Agreement (TEFCA) is the voluntary nationwide framework, required by the 21st Century Cures Act, that lets health information networks share records with one another under common legal terms and technical rules.
Uncompensated care is the cost of health care services for which a hospital or clinic receives no payment, usually measured as the sum of charity care given under a financial assistance policy and bad debt from unpaid patient bills.
The Unified Medical Language System (UMLS) is a set of files and software from the National Library of Medicine that brings together many health and biomedical vocabularies, linking their terms for the same concept so systems can translate between them.
The Uniform Data System (UDS) is the standardized annual report that every Health Center Program awardee and look-alike submits to HRSA, covering patients, services, staffing, clinical quality, costs and revenue.
A Unique Device Identifier (UDI) is a code FDA requires on the labels of most medical devices, made up of a device identifier for the labeler and model plus a production identifier such as lot, serial number or expiration date.
A Unique Ingredient Identifier (UNII) is a free, non-proprietary 10-character alphanumeric code that the FDA assigns to a substance, such as an active or inactive drug ingredient, based on its scientific identity.
The United States Core Data for Interoperability (USCDI) is a federal standard from the Office of the National Coordinator for Health IT that defines a set of health data classes and elements for nationwide, interoperable exchange.
An urgent care center is a walk-in facility that treats illnesses and injuries needing prompt attention but not an emergency department, such as sprains, minor cuts and respiratory infections. It is not a distinct federal certification category.
Value-based care is an approach to paying for health care that ties provider revenue to the quality, outcomes and total cost of the care delivered, rather than only to the number of services billed under fee-for-service.
Variant classification is the evidence-based process of assigning a genetic variant to a category of clinical significance, most commonly the five-tier ACMG/AMP scale from pathogenic through uncertain significance to benign.
A variant of uncertain significance (VUS) is a genetic variant for which the available evidence is insufficient or conflicting, so it cannot be classified as pathogenic, likely pathogenic, likely benign or benign.
A Warning Letter is a formal FDA notice telling a company or individual that it has committed violations of regulatory significance that must be corrected promptly, or it may face enforcement action such as seizure or injunction.
White space analysis is a market research method that finds segments, geographies or customer groups where demand exists but current products, services or providers do not meet it, marking them as openings for growth.
Wholesale Acquisition Cost (WAC) is the list price a drug manufacturer sets for sales to wholesalers or direct purchasers in the United States, before rebates, prompt pay discounts or other price reductions.