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340B ESP Glossary of Terms

A quick reference for understanding common terms across 340B ESP

This glossary defines terms commonly used throughout 340B ESP. It is intended as a quick reference and does not provide comprehensive explanations of platform modules, workflows, or functionality.


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340B ESP Registration Date – Indicates the date that the entity registered with 340B ESP.

340B ID – A unique covered entity identification number provided by HRSA upon 340B program enrollment.


A

Aberrant Quantity – Total units of the drug is outside an acceptable range, as listed in the 340B ESP Medical NDCs Units of Measure.

Access Token – Partners share with covered entities so covered entities can grant them permissions to access data through API.

Account – An account is a group of one or more pharmacies or dispensing locations whose purchases, submitted claims, and eligibility are evaluated together under a manufacturer's claims policy. Each account is associated with a specific covered entity and manufacturer network, and its included locations are identified through Pharmacy IDs and identifier mappings. Validated claims are used to support purchases assigned to the same account, and the account receives an Eligible, At Risk, or Suspended/Ineligible status based on the relationship between those purchases and claims.

Account Identifier Mappings – Helps 340B ESP associate purchases and submitted claims with the correct account based on pharmacy and identifier relationships. These mappings determine which purchases and claims are evaluated together for purchase validation.

Admin – Provides full access to manage and invite users to registered covered entities. Admins can view all data, invite partners, and perform all actions available to Users.

Associated Identifiers – In Account Identifier Mappings, identifiers are values, such as HIN, DEA, and NPI, that help identify 340B pharmacies or dispensing locations. These identifiers are mapped to in-house and contract pharmacy locations, which subsequently link purchases and claims to identifiers assigned to their respective pharmacies.

At Risk – An account with an At Risk status is approaching the manufacturer’s threshold for suspension/ineligibility. This status occurs when validated purchases begin to outpace submitted claims and the account nears the manufacturer’s allowable imbalance threshold. Access to the manufacturer’s pricing offer remains available, but corrective action may be required to prevent suspension/ineligibility.

Authorizing Official – An external user for a covered entity who is able to attest to any changes to an entity within the HRSA OPAIS system.


B

Back-End Validations – Back-end validations are the set of checks 340B ESP performs after a 340B pharmacy or medical claims has been successfully ingested into the platform. These validations evaluate data consistency, program eligibility, and compliance with manufacturer policies before claims are approved.


C

Claim Units – The number of drug units represented by submitted claims for a product in Purchase Validation.

Column Mapping – The configuration used to match columns in a claims file with the corresponding 340B ESP submission fields, so the system can correctly interpret and process the submitted data.

Conforming – A claim that successfully passes both front-end and back-end validations in 340B ESP. The claim contains the required data in the correct format, has no identified validation issues, and meets the applicable manufacturer’s submission and policy requirements.

% Conforming – Percentage of conforming claims by total claims submitted.

Contract Pharmacy – A pharmacy that has a contractual relationship with a 340B covered entity to dispense 340B-eligible drugs on the covered entity’s behalf. In 340B ESP, contract pharmacy eligibility and access to manufacturer pricing may vary based on the applicable manufacturer policy.

Contract Pharmacy Policy – A manufacturer policy that evaluates 340B eligibility based on claims and purchases associated with individual contract pharmacies.

Contract Pharmacy Group – A pharmacy group represents a set of related pharmacies that are part of the same chain or pharmacy network. In 340B ESP, the Pharmacy Groups section shows the pharmacy groups associated with the selected covered entity. Each pharmacy group card summarizes the number of pharmacies in the group and the types of identifiers associated with those pharmacies, such as DEA, HIN, or NPI identifiers. Pharmacy groups may include active 340B contract pharmacies or in-house pharmacies.

Covered Entity – A hospital or clinic enrolled in the 340B program.


D

DEA (Drug Enforcement Administration Number) – Registration number provided by the DEA to identify individuals or entities authorized to prescribe, dispense, manufacture, or distribute controlled substances.

Designations – Designations are submitted by covered entities to 340B ESP to recognize specified contract pharmacies as eligible to receive 340B pricing under manufacturer policies.

Dispensing Location – A pharmacy, facility, or other location where a covered entity’s drugs are dispensed or administered.

Duplicate – A claim identified as a duplicate of a previously submitted claim based on a matching combination of fields. For pharmacy claims, the matching fields are the prescription number, date of service, prescription date, and NDC. For medical claims, the matching fields are the claim number, date of service, NDC, and service provider ID.


E

Eligible – A contract pharmacy that complies with all manufacturer policy requirements and whose eligibility is confirmed through 340B ESP.

Entity Type – The HRSA-designated classification of the covered entity. The entity types helps determine the operational structure and regulatory characteristics of the covered entity.

Exceptions – Indicates that the contract pharmacy receives 340B price for one or more products because of a Designation or an Exemption from specific manufacturer policy requirements.

Exemptions – Covered Entity and Pharmacy that meet specific qualifications exempting them from a policy.


F

Front-End Validations – Occur before ingestion and focus on data structure, formatting, required fields, and manufacturer requirements for submission.


H

HIN (Health Industry Number) – Identifier used to represent a pharmacy with manufacturer and supply chain systems.


I

Ineligible – A contract pharmacy that has not completed all manufacturer policy requirements.

In-House Pharmacy – A pharmacy or dispensing location owned or operated by the covered entity, rather than an external contract pharmacy.

In-House Pharmacy Group – Entity-owned pharmacies and facilities from HRSA are grouped together under In-House. This grouping helps distinguish in-house locations from contract pharmacies.

Invalid 340B ID – The 340B ID does not match a covered entity listed in HRSA OPAIS.

Invalid Service Provider ID – The service provider ID cannot be linked to an in-house pharmacy or contract pharmacy for the associated 340B ID.

Invalid Unit of Measure – HCPCS code is populated on claim, but is not associated with that NDC or the incorrect NCPDP unit of measure is provided.


M

Manufacturer – The pharmaceutical company associated with the applicable 340B pricing offer and policy requirements in 340B ESP. Manufacturers may establish claim submission, eligibility, validation, and enforcement requirements that determine how covered entities and contract pharmacies maintain access to 340B pricing.

Manufacturer Policy – The requirements established by a pharmaceutical manufacturer that determine how covered entities, contract pharmacies, accounts, or products qualify for and maintain access to the manufacturer’s 340B pricing offer.


N

NPI (National Provider Identifier) – A unique identifier assigned to healthcare providers and organizations.

Non-Conforming – A claim that does not successfully pass one or more back-end validations in 340B ESP. The claim may contain missing, invalid, or incorrectly formatted data, or it may not meet the applicable manufacturer’s submission or policy requirements. One or more issue types are listed in 340B ESP Non-Conforming Claim Issue Summary to explain why the claim is classified as non-conforming.


P

Pending Identifiers – Pending Identifiers are identifiers that are currently awaiting transfer or reassignment from one group to another. This may be a DEA, HIN, or NPI used to associate purchases and submitted claims with an account.

Pharmacy Group – A pharmacy group represents a set of related pharmacies that are part of the same chain or pharmacy network. In 340B ESP, the Pharmacy Groups section shows the pharmacy groups associated with the selected covered entity.

Primary Contact – The individual designed in HRSA as the main point of contact for the covered entity.

Private Token – A secure credential Partners use to authenticate their API request to 340B ESP, which should not be shared.

Processing (Status) – The processing status indicates that the claims file is undergoing back-end validation checks.

Product / NDC-11 – The product listed on the purchases and claims.

Purchase Units – The number of purchased units for the product.

Purchases – The number of purchases associated with the product that do not require validation.

Purchases by Identifier – The Purchases by Identifier table shows the identifiers associated with unvalidated purchases in the account.

Purchases by Product – The Purchases by Product table categorizes purchases by their product name and their NDC-11. Each row lists the purchases associated to the requisite product and/or NDC-11.

Purchases by Product – No Validation Needed – The Purchases by Product – No Validation Needed table shows products that do not require validation based on the combination of covered entity, manufacturer and retail network listed at the top.


R

Request Date – The date the identifier transfer or reassignment request was submitted.

Role – Displays the user’s assigned access level, such as Admin or User.


S

Status (Claim Submission) – Indicates the current processing state of a claim submission in 340B ESP.

Status (Contract Pharmacy) – Indicates the number of products Eligible, At Risk, or Ineligible for 340B pricing, per manufacturer guidelines.

Status (User) – Indicates the user's account status for the selected covered entity.

Submitted Units – The number of units from validated, conforming claim submissions displayed as positive units in Submission Balances.

Suspended – An account with a Suspended status no longer has access to the manufacturer’s 340B pricing offer. This status occurs when validated purchases exceed submitted claims beyond the threshold established by the manufacturer. The account remains suspended until enough claims are submitted to reduce the imbalance and satisfy the manufacturer’s policy requirements.


U

Unassigned Identifiers Group – The Unassigned group contains identifiers that appear on purchases or submitted claims but are not assigned to a single pharmacy or dispensing location. This may include identifiers that are:

  • Associated with both a contract pharmacy and an in-house pharmacy location.

  • Not currently mapped to a contract pharmacy or in-house pharmacy location.

Covered entities must review these identifiers and reassign them to the appropriate contract pharmacy or in-house location to ensure purchases link to respective claims.

Universal Claims Policy – A manufacturer policy that evaluates purchases against applicable submitted claims across an account, rather than evaluating only the claims associated with an individual contract pharmacy. Universal claims policies are reviewed in Purchase Validation, where purchase and claim activity from one or more pharmacies or dispensing locations may be grouped and evaluated together.

Unvalidated Purchase Units – The number of purchased units for the product that remain unvalidated.

Unvalidated Purchases – The number of purchases that have not yet been validated by corresponding claim submissions.

Unvalidated WAC – The total wholesale acquisition cost value associated with the account’s unvalidated purchases.

User – Grants standard access needed for day-to-day activities, such as viewing data, submitting data, and navigating between multiple covered entities, to which they have been invited.


W

WAC (Wholesale Acquisition Cost) – The manufacturer’s listed price for a drug sold to wholesalers, excluding discounts, rebates, and other price reductions.


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