So You Think You Know 340B?
The agency that oversees the 340B Program.
What is HRSA (Health Resources and Services Administration)?
This 340B term refers to the situation where a manufacturer gives both a discounted drug and a Medicaid rebate.
What is a duplicate discount?
This file from a drug distributor lists available NDCs, item numbers, and pricing information.
What is the wholesaler catalog (or item catalog)?
4-characters which refer to a federal drug discount program that helps safety-net providers improve access to care.
What is 340B?
This is the term for a retail or specialty pharmacy used by a covered entity to dispense 340B drugs off-site.
What is a contract pharmacy?
This term describes drugs that are costly, require special handling, and patient monitoring.
What are specialty drugs?
Covered Entities must be listed in this public database to participate in 340B.
What is 340B OPAIS (Office of Pharmacy Affairs Information System)?
To prevent duplicate discounts, covered entities must update this quarterly to remain complaint with Medicaid billing.
What is the Medicaid Exclusion File (MEF)?
This file shows prescriptions sent electronically by providers
What is the ePrescribe data file?
This acronym refers to the unique drug identifier used in purchasing and billing.
What is NDC (National Drug Code)?
These are used by Covered Entities to track 340B-eligible dispenses across contract pharmacies.
What are accumulators?
Specialty pharmacies often help patients enroll in these to reduce out-of-pocket costs.
What are copay assistance programs?
This document is used to determine which outpatient sites are eligible to participate in the 340B Program
What is the Medicare Cost Report?
HRSA requires covered entities to keep these for at least 5 years to support program compliance.
What are auditable records?
This data file shows what drugs were bought, in what quantity, at what price, and from which account.
What is the purchasing data (or invoice file)?
This platform is used by manufacturers to monitor 340B contract pharmacy claims and limit duplicate discounts.
What is ESP (340B ESP or Electronic Submission Platform)?
The “bill-to/ship-to” relationship must be documented and maintained by this entity.
What is the covered entity?
This payer-imposed review must be completed before a specialty medication is approved for coverage.
What is prior authorization?
Covered entities must recertify their 340B eligibility this often.
What is annually (once a year)?
If HRSA identifies noncompliance during an audit, the CE must take this action.
What is a corrective action plan (CAP) and possibly repay manufacturers?
This file tracks when a patient is admitted, transferred, or discharged from a facility.
What is the ADT file (Admission, Discharge, Transfer)?
The acronym for the software or vendor who manages your contract pharmacy data.
What is TPA (Third Party Administrator)?
These are two common audit risks when using contract pharmacy networks.
What are diversion and duplicate discounts?
This type of accreditation is often required for specialty pharmacies to access limited distribution drugs.
What is URAC (or ACHC)?
Before participating in 340B, an entity must have this type of number assigned by CMS.
What is a Medicare Provider Number?
This modifier is often used on claims to identify 340B drugs in outpatient settings
What is the UD modifier?
This file tracks which dispenses are eligible to be replenished at 340B pricing.
What is the accumulator file?
This acronym refers to an entity that negotiates drug pricing, but its use is restricted under 340B rules.
What is GPO (Group Purchasing Organization)?
Some TPAs allow covered entities to use this type of model to overcome manufacturer restrictions.
What is an alternative distribution model (ADM)?
These stakeholders often negotiate reimbursement and access terms for specialty drugs.
Who are Pharmacy Benefit Managers (PBMs)?