Glossary

340B compliance depends on precise definitions.

This glossary explains key 340B program terms, especially the ones that trigger HRSA audit risk, repayment exposure, and missed savings.

Virtue 340B's Terms

Use the categories below to find the exact definition you need, then follow related links to see how terms connect

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Compliance & Audits
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Drug Pricing & Pharmacy Operations
Program Fundamentals

340B Ceiling Price

The maximum price a drug manufacturer may charge a covered entity for a covered outpatient drug purchased under the 340B program, calculated as the Average Manufacturer Price (AMP) minus the Unit Rebate Amount (URA).

340B Drug Pricing Program

A federal program requiring drug manufacturers to sell covered outpatient drugs at discounted prices to eligible healthcare organizations (covered entities) that serve underserved and vulnerable patient populations.

340B ID

A unique identification number assigned by HRSA to each covered entity site registered in OPAIS, used to identify the entity for 340B drug purchasing and compliance purposes.

340B Prime Vendor Program (PVP)

A voluntary program managed by Apexus under a HRSA agreement that negotiates sub-340B pricing and other value-added contracts on behalf of 340B covered entities, providing access to discounts below the statutory ceiling price.

340B Program Manager

The individual within a covered entity responsible for day-to-day administration of the 340B program, including compliance oversight, vendor coordination, OPAIS maintenance, and staff training.

340B Savings Utilization (Use of Savings)

How a covered entity uses the financial savings generated through 340B drug purchases to support its mission, expand patient services, and benefit the communities it serves.

340B-Eligible Patient

An individual who meets the HRSA-defined criteria to receive 340B-priced drugs from a covered entity, based on an established care relationship with that entity.

5i Drugs

Drugs that are inhaled, infused, instilled, implanted, or injectable—a commonly used shorthand in the 340B program to describe a category of drug administration routes relevant to covered outpatient drug determinations.

ACA / PPACA (Affordable Care Act)

Federal legislation enacted in 2010 that significantly expanded the 340B program by adding new eligible covered entity types and strengthening program integrity provisions.

Accumulation Model (340B)

A 340B inventory model in which eligible drug purchases are tracked and accumulated over time before a replenishment order is placed, used in certain split-billing and contract pharmacy arrangements.

ACO (Accountable Care Organization)

Groups of doctors, hospitals, and other health care providers that voluntarily coordinate care for Medicare patients; HRSA has issued guidance on the intersection of ACOs and 340B eligibility.

Actual Acquisition Cost (AAC)

The actual price a pharmacy or covered entity pays to acquire a drug, as determined by CMS or state Medicaid programs, used as a basis for Medicaid pharmacy reimbursement in some states.

ADAP (AIDS Drug Assistance Program)

A state-operated program funded under Ryan White Part B that provides HIV/AIDS medications to low-income, uninsured, and underinsured individuals, with a specific patient eligibility provision in the 340B program.

Administrative Dispute Resolution (ADR)

The formal HRSA process for resolving disputes between covered entities and manufacturers under the 340B program, including claims of overcharging by manufacturers and claims of diversion or duplicate discounts by manufacturers against covered entities.

AMP True-Up

A retroactive adjustment that occurs when a manufacturer restates its reported Average Manufacturer Price (AMP) for a prior period, potentially resulting in refunds to covered entities that paid above the corrected 340B ceiling price.

Apexus

The company that manages the 340B Prime Vendor Program under a contract with HRSA, providing sub-340B pricing, distribution solutions, and educational resources to 340B covered entities.

Apexus Generics Program (AGP) Price

A contracted price available to PVP participants on certain multi-sourced generic products, negotiated by Apexus with distributor partners to provide additional savings on generic drugs.

Associated Site (OPAIS)

HRSA's OPAIS terminology for sites that share grant numbers (FQHCs) or designation numbers (FQHC look-alikes), replacing the prior parent-child relationship terminology for these entity types.

Audit Readiness (340B)

The state of having the documentation, controls, policies, and data infrastructure in place to respond effectively to an HRSA audit with minimal disruption and maximum confidence.

Auditable Records (340B)

The organized, retrievable records a covered entity must maintain to demonstrate compliance with 340B program requirements, including purchasing, dispensing, patient eligibility, and billing documentation.

Automation (340B)

The use of technology systems to automate data collection, eligibility determination, inventory management, and reporting processes in a 340B program, reducing manual effort and improving data accuracy.

Average Manufacturer Price (AMP)

The average price paid to a drug manufacturer by wholesalers for drugs distributed to retail community pharmacies, used as the basis for calculating the 340B ceiling price and Medicaid rebates.

Average Sales Price (ASP)

The weighted average of all non-federal sales to wholesalers for a drug, net of chargebacks, discounts, and rebates, used as a basis for Medicare Part B reimbursement for certain drugs administered in outpatient settings.

Average Wholesale Price (AWP)

A publicly available benchmark representing the national average of list prices charged by wholesalers to pharmacies, historically used as a basis for pharmacy reimbursement but not reflective of actual transaction prices.

BAA (Business Associate Agreement)

A HIPAA-required written contract between a covered entity and a vendor (business associate) who handles protected health information on the entity's behalf, establishing the vendor's obligations to protect that data.

Best Price / Medicaid Best Price (BP)

The lowest price a manufacturer charges any purchaser for a covered outpatient drug, reported to CMS and used to calculate Medicaid rebates. 340B prices are excluded from the best price calculation.

Big 4 Federal Purchasers

The four largest federal government purchasers of pharmaceuticals: the Department of Veterans Affairs (VA), Department of Defense (DoD), Public Health Service (PHS), and Coast Guard, which receive the lowest federal drug prices through the Federal Ceiling Price mechanism.

Billing Address (OPAIS)

The address field in OPAIS used to denote the verified address belonging to the covered entity, which may be a P.O. box or mailing address and is not required to be a physical location.

Billing Workflows (340B)

The processes and systems a covered entity uses to bill payers—including Medicaid, Medicare, and commercial insurers—for drugs dispensed through its 340B program, which must be configured to prevent duplicate discounts and support accurate claims submission.

BIN (Bank Identification Number)

A six-digit number used in pharmacy claims processing to identify the pharmacy benefit manager or processor that should receive and process a prescription drug claim.

Black Lung Clinic (BL)

A clinic receiving HRSA Black Lung Clinic Program funding to provide services to coal miners and their families regardless of ability to pay, eligible for 340B participation.

CDM (Charge Description Master)

A comprehensive list of all services, procedures, and drugs that a hospital or health system can bill to payers, used in 340B programs to ensure that drugs purchased at 340B prices are billed correctly.

Chargeback

The mechanism wholesalers use to request reimbursement from drug manufacturers for the 340B discounts they provide to covered entities, compensating wholesalers for the difference between their purchase price and the lower 340B price they charge covered entities.

Child Site (340B)

An offsite outpatient facility of a 340B-eligible hospital that is registered in OPAIS as a separate site under the parent hospital's 340B program, enabling 340B drug purchasing for patients served at that location.

CHIP (Children’s Health Insurance Program)

A federal-state partnership program providing health insurance coverage to children in families with incomes too high for Medicaid but who cannot afford private insurance, relevant to 340B as a payer for some covered entity patients.

CIA (Corporate Integrity Agreement)

See Corporate Integrity Agreement (CIA). A formal compliance agreement between a healthcare organization and the HHS OIG.

Civil Monetary Penalty (CMP)

A financial penalty that can be imposed on drug manufacturers who knowingly and intentionally charge covered entities above the 340B ceiling price, administered by the HHS Office of Inspector General.

Claims Data (340B)

Prescription drug claims data generated when 340B drugs are dispensed to eligible patients, used for eligibility determination, duplicate discount prevention, compliance reporting, and program performance analysis.

Claims Reconciliation (340B)

The process of comparing 340B drug purchasing records against dispensing and billing records to verify accuracy, identify discrepancies, and ensure that all 340B transactions are properly documented and accounted for.

CMP (Civil Monetary Penalty)

See Civil Monetary Penalty (CMP). A financial penalty imposed by the HHS OIG on manufacturers who knowingly overcharge covered entities above the 340B ceiling price.

Community Benefit Report (340B)

A structured document that demonstrates how a covered entity has used its 340B program savings to benefit patients, expand services, and support the communities it serves.

Compliance Documentation

The organized collection of records, policies, agreements, data, and evidence a covered entity maintains to demonstrate that its 340B program is operating in accordance with program requirements.

Consumer Price Index-Urban (CPI-U)

A measure of inflation for urban consumers used in the Medicaid Drug Rebate Program to calculate inflation-based penalties on drug price increases, which affects the 340B ceiling price for certain drugs.

Continuous Improvement (340B Program)

An operational philosophy and practice of regularly evaluating and improving 340B program processes, controls, and documentation to strengthen compliance and optimize performance over time.

Continuous Monitoring (340B)

An ongoing compliance oversight service that regularly reviews 340B program data, operations, and controls to detect issues in real time rather than waiting for an annual audit to surface problems.

Contract Pharmacy (340B)

An independent or chain pharmacy that has a written agreement with a 340B covered entity to dispense 340B-priced drugs to the covered entity's eligible patients on its behalf.

Contract Pharmacy Network Optimization

The strategic process of evaluating and improving a covered entity's contract pharmacy network to maximize patient access, 340B drug capture rates, and program savings while maintaining compliance.

Corporate Integrity Agreement (CIA)

A formal agreement between a healthcare organization and the HHS Office of Inspector General (OIG) requiring specific compliance program improvements and monitoring obligations, typically as an alternative to exclusion from federal health care programs.

Corrective Action Plan (CAP)

A formal written plan submitted to HRSA by a covered entity in response to audit findings, documenting the specific steps the entity will take to correct identified compliance deficiencies and prevent recurrence.

Covered Entity (CE)

A healthcare organization that meets federal eligibility requirements to participate in the 340B Drug Pricing Program and purchase qualifying outpatient drugs at discounted prices.

Covered Outpatient Drug (COD)

A drug or biological product covered under the Medicaid Drug Rebate Program that manufacturers must provide to 340B covered entities at or below the 340B ceiling price.

Critical Access Hospital (CAH)

A hospital certified to receive cost-based Medicare reimbursement, designed to improve financial performance of rural hospitals and reduce closures, eligible for 340B participation with a DSH adjustment percentage of at least 8%.

CRM (Customer Relationship Management)

Software and systems used to manage interactions with clients and prospects, referenced in Virtue 340B's operational context as a tool for managing client relationships and tracking business development activity.

CSOS (Controlled Substance Ordering System)

An electronic system authorized by the DEA that allows pharmacies and other registrants to order Schedule I and II controlled substances electronically, relevant to 340B programs that include controlled substance dispensing.

Data Integrity (340B)

The accuracy, completeness, consistency, and reliability of the data used to administer and document a covered entity's 340B program, including patient eligibility, purchasing, dispensing, and billing records.

Data Mapping (340B)

The process of linking data elements across multiple systems—such as EHR, pharmacy, and split-billing software—to ensure that patient eligibility, prescriber, and drug information flow correctly to support accurate 340B eligibility determinations.

Dispensing Fee

A fee paid to a pharmacy for the professional services associated with dispensing a prescription drug, separate from the drug cost component of reimbursement.

Disproportionate Share Hospital (DSH)

A hospital that serves a significantly disproportionate number of low-income patients and receives Medicare DSH adjustment payments, eligible for 340B participation with a DSH adjustment percentage greater than 11.75% and subject to the GPO Prohibition.

Diversion (340B)

A statutory violation that occurs when a covered entity dispenses or otherwise uses 340B-purchased drugs for patients who do not meet the 340B patient eligibility criteria.

DRL (Data Request List)

A formal list of documents and data that HRSA requests from a covered entity at the start of a 340B audit, defining the scope of documentation the entity must produce for the audit review.

Duplicate Discount (340B)

A statutory violation that occurs when a covered entity receives a 340B price reduction on a drug and a Medicaid rebate is also collected on the same drug transaction.

EHB (Electronic Handbook)

HRSA's Bureau of Primary Health Care's Electronic Handbook, a database containing grant information for HRSA grantees that HRSA uses to determine eligibility for certain covered entity types.

EHR / EMR (340B Context)

Electronic Health Record and Electronic Medical Record systems used by covered entities to maintain patient health information, which serve as the primary source of patient eligibility data for 340B program operations.

EMA (Eligible Metropolitan Area)

A metropolitan area designated by the federal government as having a high HIV/AIDS case count, qualifying organizations in that area for Ryan White Part A funding and 340B participation.

Estimated Acquisition Cost (EAC)

A Medicaid pricing benchmark used by some states that estimates the typical price paid by pharmacies for a specific drug, used as a basis for Medicaid reimbursement in states that have not transitioned to AAC-based methodologies.

Federal Ceiling Price (FCP)

The maximum price a drug manufacturer may charge the four largest federal health care purchasers (VA, DoD, PHS, and Coast Guard) for covered drugs, calculated as a discount from non-FAMP.

Federal Register Notice (FRN)

A formal publication in the Federal Register announcing regulatory guidance, proposed rules, final rules, or other official notices from federal agencies that affect the 340B program.

Federal Supply Schedule (FSS)

A contracting vehicle through which federal government agencies can purchase pharmaceuticals and other products directly from commercial suppliers at pre-negotiated prices, used primarily by VA, DoD, and other federal health care providers.

Federally Qualified Health Center (FQHC)

A community-based health care provider receiving HRSA Health Center Program funding to provide primary care in underserved areas on a sliding fee scale, eligible for 340B participation and not subject to the GPO Prohibition.

FFS (Fee-for-Service Medicaid)

The traditional Medicaid payment model in which providers are paid for each individual service rendered, as opposed to Medicaid managed care arrangements where providers receive capitated payments.

GCA (Guardian Compliance Advisors)

One of the largest clients supported by Virtue 340B, referenced in internal documentation as a key client relationship.

Government Accountability Office (GAO)

An independent, nonpartisan federal agency that conducts research and investigations for Congress, including multiple studies of the 340B Drug Pricing Program that have influenced legislative and regulatory activity.

GPO (Group Purchasing Organization)

An organization that leverages the collective purchasing power of its member healthcare entities to negotiate discounted prices from drug manufacturers and distributors, which certain 340B hospital-type entities are prohibited from using for covered outpatient drugs.

GPO Prohibition

A statutory requirement that prohibits certain hospital-type 340B covered entities (DSHs, children's hospitals, and free-standing cancer hospitals) from purchasing covered outpatient drugs through group purchasing organization (GPO) arrangements.

Hemophilia Treatment Center (HM)

A comprehensive hemophilia treatment center that receives HRSA grant funding to provide multidisciplinary care for individuals with hemophilia and other bleeding disorders, eligible for 340B participation.

HFMA (Healthcare Financial Management Association)

A professional membership organization that helps healthcare finance executives navigate the complexities of the healthcare industry, including the financial implications of 340B program participation.

HIN (Health Industry Number)

A unique, universal identification number used by trading partners in the health care supply chain to identify entities, commonly used by drug wholesalers and manufacturers to identify covered entities for 340B purchasing.

HIPAA (340B Data Handling)

The federal law governing the privacy and security of protected health information (PHI), which applies to 340B program data handling including patient eligibility records, claims data, and information shared with vendors and contract pharmacies.

Hospital Outpatient Facility (340B)

An offsite outpatient facility of a hospital that may be eligible to register as a child site in the 340B program if it meets specific Medicare cost report requirements.

HRSA (Health Resources and Services Administration)

The U.S. federal agency responsible for administering the 340B Drug Pricing Program through its Office of Pharmacy Affairs, overseeing covered entity registration, recertification, guidance, and audit activity.

HRSA Audit (340B)

A formal compliance review conducted by HRSA to assess whether a covered entity is administering the 340B program in accordance with program requirements, including patient eligibility, diversion prevention, and duplicate discount controls.

In-House Pharmacy (Entity-Owned Pharmacy)

A pharmacy that is owned by and is a legal part of the 340B covered entity, typically listed as a shipping address in OPAIS and used to directly dispense 340B drugs to the entity's eligible patients.

Independent 340B Audit

A third-party compliance review of a covered entity's 340B program conducted by an independent expert to assess program integrity, identify compliance gaps, and evaluate audit readiness before an HRSA review.

Innovator Multiple Source Drug

A drug originally approved under a new drug application (NDA) for which therapeutically equivalent generic versions are also available—a brand-name drug that has gone off-patent and has generic competition.

Integrated Delivery Network (IDN)

A network of hospitals, physician practices, and other health care providers that are organizationally affiliated and may share administrative and clinical services, relevant to 340B in the context of GPO Prohibition compliance for member entities.

Internal Controls (340B)

The systematic processes, checks, and safeguards a covered entity puts in place to prevent compliance violations, detect errors, and ensure the 340B program operates as intended.

LARC (Long-Acting Reversible Contraception)

A category of contraceptive methods (including IUDs and implants) that provide long-term pregnancy prevention without requiring daily action, relevant to 340B programs at Title X and FQHC covered entities.

LDD (Limited Distribution Drug)

A drug that is only available through a restricted distribution network designated by the manufacturer, often due to safety requirements or specialty distribution needs, which can limit a covered entity's ability to access 340B pricing through standard channels.

Manufacturer Restrictions (340B)

Unilateral policies implemented by some drug manufacturers that limit or condition covered entities' access to 340B pricing for drugs dispensed through contract pharmacies, creating significant compliance and operational challenges.

Medicaid Carve-In / Carve-Out

A covered entity's election in OPAIS regarding whether it will (carve-in) or will not (carve-out) bill Medicaid fee-for-service for drugs purchased at 340B prices, which determines duplicate discount prevention obligations.

Medicaid Drug Rebate Program (MDRP)

The federal program requiring drug manufacturers to pay rebates to state Medicaid programs in exchange for coverage of their drugs, which is the mechanism that also obligates manufacturers to offer 340B pricing to covered entities.

Medicaid Exclusion File (MEF)

A quarterly file generated by HRSA from OPAIS data that identifies which covered entity sites are billing Medicaid fee-for-service for 340B drugs, used by state Medicaid agencies to exclude those claims from manufacturer rebate requests.

Medicaid Managed Care (MMC) and 340B

The intersection of Medicaid managed care organization (MCO) arrangements with 340B program operations, representing a growing area of duplicate discount compliance risk that is not addressed by the Medicaid Exclusion File.

Medicaid Rebate Net Price

The effective price paid by state Medicaid programs for covered outpatient drugs after accounting for manufacturer rebates, representing the actual cost to Medicaid after rebate collection.

Medicare Cost Reports (MCR)

Annual financial reports filed by Medicare-participating hospitals that document costs, charges, and patient statistics, used to calculate DSH adjustment percentages that determine 340B eligibility for hospital-type covered entities.

Medicare DSH Adjustment Percentage (DSH %)

A percentage calculated from a hospital's Medicare and Medicaid patient day ratios that determines eligibility for DSH adjustment payments and, for 340B purposes, whether a hospital meets the minimum DSH threshold required for program participation.

Mixed-Use Setting (340B)

A hospital area or department that serves both inpatient and outpatient patients, creating compliance complexity for 340B programs because only outpatient drug use is eligible for 340B pricing.

Mock Audit (340B)

A simulated HRSA audit conducted by an independent expert to test a covered entity's audit readiness, identify documentation and control gaps, and prepare staff for the real audit process.

MTM (Medication Therapy Management)

A service provided by pharmacists to optimize drug therapy and improve patient outcomes, which may be offered as part of a covered entity's 340B program services.

NABP (National Association of Boards of Pharmacy)

An independent organization that supports state boards of pharmacy in protecting public health by developing pharmacy licensing standards and accreditation programs, relevant to 340B as a source of pharmacy regulatory standards.

NACHC (National Association of Community Health Centers)

A national advocacy and support organization representing federally qualified health centers and look-alikes, which plays an active role in 340B policy advocacy and provides resources for FQHC 340B program management.

National Drug Code (NDC)

A unique 10- or 11-digit, three-segment number that serves as the universal product identifier for human drugs in the United States, used throughout the 340B program for drug purchasing, eligibility determination, and compliance tracking.

National Provider Identifier (NPI)

A unique 10-digit identification number assigned to health care providers and used in administrative and financial transactions, including 340B Medicaid billing and OPAIS registrations.

Native Hawaiian Health Center (NH)

A health center receiving HRSA Native Hawaiian Health Care Systems Program funding to provide medical and enabling services to Native Hawaiians, eligible for 340B participation.

NCPDP (National Council for Prescription Drug Programs)

A nonprofit standards development organization that develops data standards for pharmacy claims and transactions, including the electronic transaction standards used in 340B contract pharmacy claims processing.

NFPRHA (National Family Planning and Reproductive Health Association)

A national advocacy organization representing Title X family planning providers, which advocates for policies supporting family planning programs including 340B access for Title X clinics.

NOA (Notice of Grant Award)

An official document issued by a federal funding agency that formally awards grant funding to an organization, serving as documentation of federal grant status that supports 340B eligibility for grant-funded covered entity types.

Non-Federal Average Manufacturer Price (Non-FAMP)

The average price paid to a manufacturer by wholesalers for drugs distributed to non-federal purchasers, used as the basis for calculating the Federal Ceiling Price for the Big 4 federal purchasers.

Non-Innovator Multiple Source Drug

A generic drug that is not originally marketed under an original NDA and for which therapeutically equivalent versions are available from multiple manufacturers, subject to the generic URA formula in the Medicaid rebate and 340B programs.

Notice of Proposed Rulemaking (NPRM)

A formal notice published in the Federal Register announcing that a federal agency is proposing a new rule or regulation and inviting public comment before the rule is finalized.

Office of Inspector General (OIG)

An independent oversight unit within HHS that investigates fraud, waste, and abuse in HHS programs—including the 340B program—and has authority to impose civil monetary penalties and conduct audits and investigations.

Office of Pharmacy Affairs (OPA)

The HRSA office responsible for administering the 340B Drug Pricing Program, including covered entity registration, manufacturer oversight, program guidance, and audit activity.

OPAIS (340B Office of Pharmacy Affairs Information System)

The HRSA-managed online system that serves as the official registry for 340B covered entities, manufacturers, and contract pharmacies, and is used for registration, recertification, and program administration.

Orphan Drug Act (ODA)

Federal legislation that provides incentives for the development of drugs to treat rare diseases, establishing the orphan drug designation process that is relevant to the 340B orphan drug exclusion for certain covered entity types.

Orphan Drug Designation

A special status granted by the FDA to a drug intended to treat a rare disease or condition, qualifying the drug for certain regulatory incentives and making it potentially subject to the 340B orphan drug exclusion for certain covered entity types.

Orphan Drug Exclusion (340B)

A statutory provision that excludes drugs designated by the FDA as orphan drugs for rare diseases from 340B pricing requirements for certain hospital-type covered entities, including rural referral centers, sole community hospitals, critical access hospitals, and free-standing cancer hospitals.

Own Use (340B)

The principle that 340B drugs purchased by a covered entity must be used as part of and in furtherance of the entity's core institutional mission of patient care—not resold or distributed outside the entity's patient population.

Patient Assistance Program (PAP)

A manufacturer-sponsored program that provides free or heavily subsidized medications to patients who cannot afford them, which can interact with 340B program operations and must be carefully managed to avoid compliance issues.

Patient Definition Policy (Documentation)

A written policy that defines how a covered entity determines whether an individual qualifies as a 340B-eligible patient, including criteria for establishing the care relationship required by HRSA.

PCN (Processor Control Number)

A unique identifier assigned to a specific pharmacy benefit manager or third-party administrator that processes prescription drug claims for a particular health plan, used in pharmacy claims routing.

Penny Pricing

A 340B program policy establishing that when the ceiling price calculation results in a value of less than one cent, the manufacturer must charge exactly $0.01 per unit for that covered outpatient drug.

Pharmaceutical Pricing Agreement (PPA)

A signed agreement between a drug manufacturer and the Secretary of HHS in which the manufacturer agrees to provide covered outpatient drugs to 340B covered entities at or below the 340B ceiling price.

Pharmacy Benefit Manager (PBM)

An administrator of prescription drug benefit programs that processes and pays prescription claims, maintains drug formularies, and negotiates rebates with manufacturers—interacting with 340B programs through contract pharmacy reimbursement and claims processing.

PHI (Protected Health Information)

Individually identifiable health information that is protected under HIPAA, including patient data used in 340B program operations such as prescription records, eligibility information, and claims data.

Policies & Procedures Review (340B)

A structured assessment of a covered entity's 340B policies and procedures to verify they are current, comprehensive, and aligned with HRSA program requirements and the entity's actual operational practices.

Policies and Procedures (P&P)

Written documents that define how a covered entity administers its 340B program, specifying processes for patient eligibility determination, diversion prevention, duplicate discount prevention, contract pharmacy management, and other compliance-critical activities.

Program Optimization (340B)

The process of evaluating and improving a covered entity's 340B program operations to maximize savings, capture missed opportunities, and ensure the program is functioning at its full potential within compliance boundaries.

Provider-Based Status (340B)

A Medicare designation that allows hospital outpatient departments to bill a facility fee in addition to a professional fee, which is relevant to 340B child site eligibility for offsite hospital outpatient facilities.

PSAO (Pharmacy Services Administrative Organization)

An organization that provides administrative, contracting, and operational services to independent pharmacies, potentially including support for participating in 340B contract pharmacy arrangements.

Public Health Service Act (PHSA)

The federal statute that established the 340B program under Section 340B, providing the legal authority for HRSA to administer the program and defining its requirements for manufacturers and covered entities.

PVP Orphan Drug Price

A contracted price negotiated by the Prime Vendor Program with manufacturers for orphan-designated drugs, available to covered entity types subject to the orphan drug exclusion, providing an alternative to the statutory 340B price for these products.

PVP Sub-WAC Price

A contracted price negotiated by the Prime Vendor Program that is below the wholesale acquisition cost (WAC), available to covered entities subject to the GPO Prohibition as an alternative to GPO pricing for non-covered outpatient drugs.

PVP Value-Added Contracts

Contracts negotiated by the Prime Vendor Program for non-covered outpatient drug products and services needed in the pharmacy environment, including vaccines, blood glucose monitoring supplies, and pharmacy automation hardware and software.

Recertification (340B)

The annual process through which covered entities verify and update their information in OPAIS and attest to their continued eligibility and compliance with 340B program requirements.

Referral Claims (340B)

Prescription drug claims generated when a covered entity's patient receives a referral from a covered entity provider to an outside provider, where the covered entity maintains responsibility for the patient's care.

Repayment Obligation (340B)

The financial obligation a covered entity incurs when HRSA determines that 340B pricing was obtained on drugs that were diverted, subject to duplicate discounts, or otherwise non-compliant, requiring the entity to repay the improperly obtained savings.