What is 340B audit?

What is 340B audit?

Audit Scope HRSA’s 340B Program audits review manufacturer compliance with respect to eligibility status, including compliance with 340B Program requirements and the determination that the manufacturer provided 340B drugs at or below the 340B ceiling price to participating covered entities.

What is a TPA in 340B?

Overview. Health centers participating in the 340B drug pricing program often rely on contract pharmacies and 340B administrators (sometimes called third-party administrators, or “TPAs”) to carry out their mission, deliver discounted drugs to their patients, and ensure compliance with 340B program requirements.

What is 340B GPO prohibition?

There is a statutory prohibition against obtaining covered outpatient drugs through a group purchasing organization (GPO) or other group purchasing arrangement for disproportionate share hospitals (DSH), children’s hospitals (PED), and free-standing cancer hospitals (CAN).

What is 340B WAC?

Many 340B hospitals have worked to control their drug expenses through optimization of procurement practices, including examining purchases on wholesale acquisition cost (WAC) accounts to identify unnecessary spending.

What is Apexus 340B?

What is the 340B Prime Vendor Program? The 340B Prime Vendor Program (PVP), managed by Apexus™, is a contract awarded by the Health Resources and Services Administration (HRSA), which is responsible for administering the 340B Drug Pricing Program.

How do distributors validate their customers 340B eligibility?

A: Entities should register all sites with the 340B Program prior to participating in the 340B Program. The Office of Pharmacy Affairs will verify eligibility by conferring with the appropriate granting agency.

How does 340B split billing work?

Split billing is the process of separating the inpatient (IP) and OP hospital charges from 340B-eligible areas. Effectively, this method identifies all of a CE’s OP charge codes and uses them to identify drug replenishment opportunities at 340B pricing.

Is DSH the same as 340B?

Disproportionate share hospitals (DSH) are eligible to participate in 340B if their DSH adjustment–a measure that identifies hospitals that treat a disproportionate share of low income Medicare or Medicaid patients–is above 11.75%.

What does WAC mean in pharma?

Wholesale Acquisition Cost
 Pharmacy Discount Price: The price paid to the Pharmacy by a. program (i.e., ADAP, Medicaid) for drugs.  Wholesale Acquisition Cost (WAC): WAC is the price set by. manufacturers.

What does WAC stand for pharma?

Wholesale Acquisition Cost (WAC) is defined in the U.S. Code as “…the manufacturer’s list price for [a] drug or biological to wholesalers or direct purchasers in the United States, not including prompt pay or other discounts, rebates or reductions in price…”

What is 340B PVP?

The 340B Prime Vendor Program (PVP) is a contract awarded by HRSA, which is responsible for administering the 340B Drug Pricing Program.

What is the role of PVP in 340B?

A: The Apexus PVP is an outpatient pharmacy program that secures sub-340B contract pricing on medications that by law have a 340B statutory price. The PVP also contracts for other value-added products and services that an outpatient ambulatory pharmacy would use and/or dispense.

What do you know about 340B and contract pharmacy compliance?

Contract Pharmacy Compliance- Duplicate discount Do you know your state policies surrounding 340b and contract pharmacies? Fee-for-service Medicaid claims must not be filled with 340b drugs at the contract pharmacy unless the entity and the state have arranged a method to avoid a duplicate discount.

How do you manage 340B compliance?

Include 340b items on monthly meeting agendas. Inform the providers on the benefits of the program and why they must comply with regulations. Have a reporting tool/process that can be used by all staff to report 340b violations/incidents. Incorporate 340b knowledge requirements in position descriptions for each group.

What is the HRSA 340B guide?

The Guide is a dynamic document intended to be used in conjunction with materials developed by the HRSA 340B Peer-to-Peer Program and other resources available from the HRSA Office of Pharmacy Affairs and the 340B Prime Vendor Program managed by Apexus. If you have a comment or question about this Guide, please send an e-mail to

What is 340B auditor/consultant-cheek consulting?

340b Auditor/Consultant-Cheek Consulting Objectives Review 340b program history Demonstrate knowledge of the advantages and disadvantages of the contract pharmacy model Discuss the implementation of a successful 340b contract pharmacy program Discuss compliance and self-auditing practices for contract pharmacy 340b PROGRAM

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