340B Pricing | 340B Covered Outpatient Drugs

FAQ ID: 1549

Last Modified: 08/12/2022

Q: Can a manufacturer place special conditions or restrictions on selling covered drugs to an entity at the 340B price that do not apply to non-340B purchasers?

A: Consistent with section 340B(a)(1) of the PHSA, manufacturers are expected to provide the same opportunity for 340B covered entities and non-340B purchasers to purchase covered outpatient drugs when such drugs are sold through limited distribution or specialty pharmacies. As outlined in the January ...
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FAQ ID: 1337

Last Modified: 08/02/2022

Q: If a manufacturer determines that it charged in excess of the ceiling price to a covered entity, what is the manufacturer required to do?

A: All manufacturers are required to comply with the statute and all terms of the Pharmaceutical Pricing Agreement, including the obligation to charge covered entities no more than the ceiling price for covered outpatient drugs. HRSA recommends that manufacturers notify the Office of Pharmacy Affairs o...
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FAQ ID: 1357

Last Modified: 08/02/2022

Q: How should a covered entity resolve an incorrect ceiling price?

A: Covered entities should work directly with manufacturers and wholesalers to validate whether the price paid was at or below the 340B ceiling price. Prime Vendor participants can verify pricing accuracy by visiting the password-protected Prime Vendor Program website. HRSA can validate whether the pri...
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FAQ ID: 1239

Last Modified: 09/01/2021

Q: If I notice an incorrect price loaded in OPAIS, how do I correct this?

A: Suggested steps include:

1. Check the labeler code on 340B OPAIS (https://340bopais.hrsa.gov/manufacturersearch ), and check the Medicaid Drug Rebate Program labeler code (...
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FAQ ID: 1367

Last Modified: 09/01/2021

Q: Is there a specific formulary for the 340B drugs? What drugs are included under the 340B Drug Pricing Program?

A: There is no designated formulary for the 340B Program. A manufacturer must offer all covered outpatient drugs at or below the 340B ceiling price. The term covered outpatient drug is defined in section 1927(k) of the Social Security Act. The Centers for Medicare & Medicaid Services provides a list ...
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FAQ ID: 2381

Last Modified: 04/08/2021

Q: What was the effective date of the 340B Ceiling Price and CMP Regulation?

A: The effective date for the 340B Ceiling Price/CMP regulation was January 1, 2019.

FAQ ID: 1366

Last Modified: 09/14/2020

Q: What is the procedure used by manufacturers to refund payment to covered entities who are overcharged for 340B drugs?

A: Manufacturers should notify HRSA in writing of their intention to issue a refund. This letter should address which drugs are affected and for what time period. This letter may be made public on the HRSA website. Apexus, the 340B Prime Vendor, has a voluntary program to help manufacturers refund mone...
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FAQ ID: 1420

Last Modified: 03/26/2020

Q: May a manufacturer require only 340B entities to purchase covered outpatient drugs through specialty distribution channels?

A: Consistent with section 340B(a)(1) of the PHSA, manufacturers are expected to provide the same opportunity for 340B covered entities and non-340B purchasers to purchase covered outpatient drugs when such drugs are sold through limited distributors or specialty pharmacies. This extends to the manner ...
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FAQ ID: 2686

Last Modified: 03/25/2020

Q: What is the difference between the ceiling price and the package adjusted price?

A: The 340B ceiling price is defined in statute (section 340B(a)(1) of the Public Health Service Act) and implementing regulations (42 CFR §10.3 and §10.10(a)). The 340B ceiling price is the maximum statutory price a manufacturer can charge a covered entity for the purchase of a covered outpatient drug...
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FAQ ID: 1229

Last Modified: 01/24/2020

Q: What is HRSA’s “penny-pricing” policy regarding 340B ceiling prices?

A: When the 340B ceiling price calculation results in an amount less than $0.01, the 340B ceiling price will be $0.01. For more information, please visit the 340B Ceiling Price and Civil Monetary Penalties final rule (82 FR 1210, January 5, 2017) at: ...
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FAQ ID: 1265

Last Modified: 01/24/2020

Q: Which manufacturers and drugs are subject to 340B pricing, and can participating manufacturers offer only a subset of the drugs they manufacturer at 340B prices?

A: Manufacturers who participate in Medicaid are required to participate in the 340B Program and provide a 340B ceiling price for all covered outpatients drugs. To view which manufacturers participate in the 340B Program, please visit: ...
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FAQ ID: 1310

Last Modified: 01/24/2020

Q: How is the 340B ceiling price calculated?

A: Pursuant to section 340B(a)(1) of the Public Health Service Act and the 340B Ceiling Price and Civil Monetary Penalty final rule (82 FR 1210, January 5, 2017), the 340B ceiling price for a covered outpatient drug is equal to the Average Manufacturer Price (AMP) from the preceding calendar quarter fo...
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FAQ ID: 1657

Last Modified: 01/24/2020

Q: Are 340B prices available when purchasing inpatient drugs?

A: No. 340B pricing applies to covered outpatient drugs only.

FAQ ID: 2382

Last Modified: 01/24/2020

Q: Which policies does the 340B Ceiling Price and CMP Regulation replace?

A: The 340B Ceiling Price and CMP Regulation replaces former "Clarification of Penny Pricing" policy release (2011-2 (November 21, 2011)) and the final guidelines in 1995 describing ceiling price calculations for new drugs [60 FR, 51488 (October 2, 1995)].

FAQ ID: 2385

Last Modified: 01/24/2020

Q: Who is tasked with imposing civil monetary penalties against manufacturers who knowingly and intentionally overcharge a covered entity?

A: Pursuant to a delegation of authority, the HHS Office of the Inspector General (OIG) has the authority to impose CMPs utilizing the definitions, standards, and procedures under 42 CFR Parts 1003 and 1005, as applicable. For additional information, see the delegation of authority Federal Register Not...
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FAQ ID: 2537

Last Modified: 01/24/2020

Q: What is the effective date of the 340B Ceiling Price and CMP Regulation?

A: The effective date for the 340B Ceiling Price/CMP regulation (82 FR 1210, January 5, 2017) is January 1, 2019. The rule will be applied prospectively. Manufacturers that offer 340B ceiling prices as of the quarter beginning January 1, 2019 must comply with the requirements of the final regulation.

FAQ ID: 2558

Last Modified: 01/24/2020

Q: If a manufacturer determines it overcharged a covered entity for a covered outpatient drug, how soon must the manufacturer refund the affected covered entity?

A: HRSA requires manufacturers to refund covered entities on all drug overcharges and should work with the covered entities in good faith to make repayments. Specifically for new drugs and as outlined in the CMP final rule, manufacturers are required to calculate the actual 340B ceiling price and offe...
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FAQ ID: 1188

Last Modified: 11/01/2019

Q: How soon after a drug is approved by the FDA is 340B pricing available?

A: The 340B price is available for a new covered outpatient drug as of the date the drug is first available for sale. For the purposes of the 340B Program, manufacturers must estimate the ceiling price using the methodology described in the 340B Ceiling Price and Civil Monetary Penalties (CMP) final ru...
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FAQ ID: 1206

Last Modified: 11/01/2019

Q: Does HRSA allow an exemption for de minimis refund amounts when a manufacturer calculates 340B entity refunds following a new drug pricing estimation?

A: To the extent that a manufacturer and a covered entity agree that a de minimis threshold for refunds should be established, such a threshold can be established.

FAQ ID: 1255

Last Modified: 11/01/2019

Q: Does HRSA provide a list of the prices for 340B drugs?

A: Section 340B(d)(1)(B) of the Public Health Service Act requires HRSA to collect information from manufacturers in order to verify the accuracy of 340B ceiling prices, and then make ceiling prices available only to covered entities. The pricing component of the 340B OPAIS is a secure, web-based appl...
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340B Pricing/Covered Outpatient Drugs

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