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340B Manufacturer Change Form - HRSA - hrsa

340B Manufacturer Change Form - HRSA - hrsa 2025

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The document is a 340B Manufacturer Change Form issued by the Department of Health and Human Services, specifically the Health Resources and Services Administration. It outlines the process for manufacturers to update their information related to the Pharmaceutical Pricing Agreement, including changes to contact details and addresses. The form must be submitted via email by an authorized individual, and it emphasizes that the original authorizing signatory cannot be changed. Additionally, it includes a public burden statement regarding information collection.

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What is the 340B Opais pricing component?

The 340B OPAIS pricing component is the official federal source for 340B ceiling prices, and it calculates those prices based on information supplied by manufacturers, the Centers for Medicare Medicaid Services (CMS), and First Data Bank (FDB).

What is the modifier 20 for 340B?

20 Modifier: The NCPDP D. 0 standard for retail pharmacy claims submission allows a pharmacy to indicate that a drug that is the subject of the claim was purchased through the 340B program.

Who is permitted to submit electronic change requests on behalf of the covered entity?

Updates to Covered Entities are made by submitting a Change Request. You must be the logged-in AO or PC to submit change requests.

Can changes to the 340B Medicaid exclusion file be submitted?

At any time, covered entities may submit online change request forms to modify their Medicaid billing decisions, but changes only take effect the following quarterand only when received, approved, and processed by OPA before the time of the snapshot for that quarter.

How to calculate 340B pricing?

The 340B ceiling price for a covered outpatient drug is equal to the Average Manufacturer Price (AMP) from the preceding calendar quarter for the smallest unit of measure minus the Unit Rebate Amount (URA) and will be calculated using six decimal places.

What does opais stand for?

340B OPAIS The 340B Office of Pharmacy Affairs Information System (OPAIS) is a collection of information submitted by covered entities, contract pharmacies, and manufacturers maintained and verified by HRSAs Office of Pharmacy Affairs (OPA).) has been created to meet these requirements.

What is the 340B pricing program?

The 340B Drug Pricing Program is an essential source of support for Community Health Centers, allowing them to stretch increasingly scarce federal resources and reinvest in patient care. The program allows health centers to purchase outpatient drugs at significantly reduced costs.

340B Manufacturer Change Form - HRSA - hrsa 2025

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