340B Eligibility Requirements/Registration

FAQ ID: 1356

Last Modified: 04/12/2024

Q: We are a 340B covered entity hospital that qualifies as more than one covered entity type. We have decided to change the status of our registration to be a different entity type, what process should we follow to change our status and ensure no interruption in our 340B services?

A: In order to change the status of the covered entity type registered in 340B OPAIS, please contact the HRSA 340B Program Operations Branch at 340bcompliance@hrsa.gov as soon as possible. It is important to remember that the hospital must meet all program ...
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FAQ ID: 1190

Last Modified: 05/12/2023

Q: Do clinics/departments/services located within the four walls of a registered 340B hospital have to be registered in 340B OPAIS?

A: Outpatient clinics/departments/services within the four walls (i.e. same physical mailing address) of the registered parent 340B hospital do not need to separately register/enroll into the 340B Program. However, the covered entity remains responsible for demonstrating that those outpatient clinics/d...
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FAQ ID: 1295

Last Modified: 09/28/2022

Q: How should a hospital covered entity determine if an offsite outpatient facility is eligible for the 340B Program as a child site and should be registered on 340B OPAIS?

A: An offsite hospital outpatient facility is eligible to be registered as a child site if it is listed as a reimbursable facility on the parent hospital’s most recently filed Medicare cost report and has associated outpatient costs and charges. If the facility is a free-standing clinic of the hospital...
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FAQ ID: 2436

Last Modified: 09/28/2022

Q: What are HRSA’s expectations regarding hospital eligibility and a contract with State or local government?

A: A hospital that is private, non-profit with a contract with a state or local government to provide health care services to low income individuals who are not entitled to benefits under Medicare or eligible for State Medicaid is eligible for the 340B Program. The hospital must be able to demonstrate ...
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FAQ ID: 1193

Last Modified: 08/02/2022

Q: May an outpatient facility that is reimbursed by CMS as a provider based facility, but not included on the most recently filed Medicare cost report, participate in the 340B Program?

A: A facility must be both reimbursable and included in the hospital’s most recently filed Medicare cost report with associated outpatient costs and charges to access the 340B Program and register in 340B OPAIS. HRSA’s outpatient facility guidelines can be found at ...
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FAQ ID: 1319

Last Modified: 08/02/2022

Q: Our hospital has a clinic (within the four walls of the parent) that does not appear on the hospital's most recently filed Medicare cost report. Is this an eligible 340B area?

A: Only hospital outpatient facilities that appear as reimbursable outpatient cost centers on the hospital’s most recently filed Medicare cost report are eligible to be listed and participate in the 340B Program. For additional information, please review: ...
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FAQ ID: 1687

Last Modified: 08/02/2022

Q: Must an entity remove a child site as soon as it knows it will not be on the next filed cost report, or should an entity remove a child site upon the date that the next cost report will be filed?

A: HRSA guidance states that an outpatient facility is eligible for the 340B Program if it is a reimbursable facility on the hospital’s most recently filed Medicare cost report. If the child site will no longer be a reimbursable facility with associated outpatient costs and charges on the next filed Me...
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FAQ ID: 1364

Last Modified: 08/31/2021

Q: When does a pharmacy qualify as an entity-owned pharmacy?

A: An entity-owned pharmacy is owned by, and is a legal part of, the 340B entity. Typically, entity-owned pharmacies are listed as shipping addresses of the entity.

FAQ ID: 1230

Last Modified: 09/30/2020

Q: If an entity is funded under more than one grant program that is eligible to participate in the 340B program, must the entity register all programs with the OPA (e.g., the entity is eligible as a Title X Family Planning Clinic and Federally Qualified Health Center)?

A: Eligible entities should consider all program requirements when deciding how to register for the 340B Program and may register more than one grantee type. Entities may only provide 340B drugs to individuals receiving a service consistent with the scope of the grant program for which the entity is re...
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FAQ ID: 1220

Last Modified: 09/14/2020

Q: A clinic is located within the four walls of the parent but has a separate physical address. What is meant by "within the four walls?" Is the same physical address the only limiting condition?

A: A clinic that shares the parent's physical address is considered within the four walls, even if it has a different suite address. For further clarification, please contact Apexus Answers https://www.340bpvp.com/apexus-answers

FAQ ID: 4308

Last Modified: 07/23/2020

Q: What are HRSA’s expectations for providing hospital classification documentation to support eligibility of hospitals in the 340B Program?

A: HRSA is now requesting documentation to support the hospital classification selected at the time of registration to further verify eligibility of parent hospital registrations.
The 340B OPAIS will prompt Authorizing Officials and Primary Contacts (AOs and PCs) to upload supporting documentation...
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FAQ ID: 1184

Last Modified: 05/29/2020

Q: How must we register our in-house pharmacy that is a separate legal entity under our 340B covered entity?

A: An in-house pharmacy is not eligible to register as a child site. The in-house pharmacy could be listed as a shipping address. If the covered entity has a contract with the in-house pharmacy because it is a separate legal entity, then it must be registered as a contract pharmacy and may not dispense...
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FAQ ID: 1213

Last Modified: 05/29/2020

Q: As a grantee, if I need to add a new site to our existing 340B entity, what actions should I take?

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.

FAQ ID: 1240

Last Modified: 05/29/2020

Q: If a covered entity has physician clinics, do they need to be registered as child sites?

A: Only hospital outpatient facilities that appear as reimbursable outpatient cost centers on the hospital’s most recently filed Medicare cost report are eligible to be listed and participate in the 340B Program. HRSA requires each hospital to register all of its offsite outpatient facilities where 340...
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FAQ ID: 1241

Last Modified: 05/29/2020

Q: Can wholesalers / manufacturers refuse to ship to addresses listed in 340B OPAIS?

A: 340B OPAIS is the official source for 340B covered entity information. Billing and shipping addresses listed in 340B OPAIS provide manufacturers and wholesalers positive assurance that the purchasing/receiving site is eligible to obtain 340B drugs. Covered entities are responsible for ensuring that ...
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FAQ ID: 1303

Last Modified: 05/29/2020

Q: Can a covered entity list an in-house pharmacy as a child site?

A: Pharmacies are not eligible 340B covered entities and therefore should not be listed as child sites within 340B OPAIS. Covered entities should determine whether it is appropriate for the pharmacy to be added as a shipping address for the covered entity in 340B OPAIS.

FAQ ID: 1373

Last Modified: 05/28/2020

Q: What actions does HRSA expect an entity to take if it loses 340B Program eligibility?

A: Covered entities should stop purchasing 340B drugs immediately upon losing eligibility. The entity must complete a termination request on 340B OPAIS and answer the following three questions:
1) The date the entity became ineligible;
2) The circumstances surrounding the loss of eligibilit...
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FAQ ID: 1431

Last Modified: 05/27/2020

Q: Can the 340B OPAIS registration accommodate simultaneous online covered entity and contract pharmacy registrations?

A: Yes. For further guidance on how to register, the logged-in user can refer to the user guide located in the "Help" section of 340B OPAIS.

FAQ ID: 1577

Last Modified: 05/27/2020

Q: Is a covered entity required to list a pharmacy that is part of the covered entity (i.e. entity-owned pharmacy) on 340B OPAIS?

A: If a covered entity wants to ship 340B drugs directly to an entity-owned pharmacy, the pharmacy address would need to be listed on 340B OPAIS. This is commonly achieved by listing the pharmacy address as a shipping address of the entity. However, if the pharmacy address matches the address of the pa...
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FAQ ID: 1637

Last Modified: 05/27/2020

Q: When does a pharmacy qualify as a contract pharmacy?

A: 340B covered entities may contract with a pharmacy to provide services to the covered entity’s patients, including the service of dispensing entity-owned 340B drugs. To engage in a contract pharmacy arrangement, the entity and pharmacy must have a written agreement in place and register each contrac...
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340B Eligibility Requirements/Registration

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