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Section 340B(a)(4) of the Public Health Service Act (PHS) Act (42 U.S.C. 256b) lists the various types of organizations eligible to participate in and purchase discounted drugs under the 340B Program.
See the complete list of eligible entities.
We require registration and approval for covered entities to participate in the 340B Program.
We limit the registration period for 340B Program registration of new covered entities and the addition of outpatient facilities to the following:
- January 1-January 15 for an effective start date of April 1;
- April 1-April 15 for an effective start date of July 1;
- July 1-July 15 for an effective start date of October 1; and
- October 1-October 15 for an effective start date of January 1.
If the 15th falls on a Saturday, Sunday, or federal holiday, the deadline will be the next business day.
Covered entities will not be able to submit registrations outside of the dates we list above except when the Secretary declares a Public Health Emergency.
During Initial Registration:
It is the Covered entity’s responsibility to pay close attention to all alerts during the registration process and upload necessary supporting documentation on the same day that the registration is submitted. Registrations may be rejected if supporting documentation is not submitted.
NOTE: A covered entity cannot register a contract pharmacy as a covered entity.
During OPA Review of Registration:
PLEASE NOTE: It is the entity’s responsibility to review the OPA reviewer comments each time a registration is sent back in OPAIS to determine if there are any items that require action for that particular registration.
If the entity is unable to act on the registration for any reason, please make a note in the review box and return it to OPA and explain the issue. Registrations returned without action will be rejected. OPA will not approve any registration if it is returned without a response from the entity.
Covered Entities must register for the 340B Program first, so we can verify that the entity meets all statutory requirements prior to participation. The entity may register as more than one entity type—but, only if it meets the eligibility requirements for both.
What should you do before you register for the 340B Program?
Review the following:
- Set up your account.
To register, you must have a 340B Office of Pharmacy Affairs (340B OPAIS) user account. Visit the 340B OPAIS site and select “help” in the upper right hand corner of the page.
To ensure that the Authorizing Official (AO) and Primary Contact (PC) receive 340B OPAIS email notifications, add noreply@hrsa.gov to your email program’s spam filter.
- Identify your Authorizing Official and Primary Contact.
The AO must be an individual who can bind the organization to a contract, such as a CEO, COO, CFO, clinic administrator, or program manager.
The PC should be an employee of the organization. They may not be the same as the AO, and cannot be a consultant or contractor.
- Check if your site is already registered.
Search 340B OPAIS for registered sites. This will prevent you from registering duplicates or identify terminated registrations you may want back in the 340B Program.
If you aren't sure if your sites are already registered, contact the 340B Prime Vendor Program (PVP) for assistance.
- Be aware of the latest registration dates and deadlines.
The quarterly registration periods take place from the first through the fifteenth of January, April, July, and October. This is the only time you will be able to submit a new registration.
Upon approval, the covered entity's start date will be the first day of the next quarter.
- Contact your grant Program Director or Program Manager.
Contact the state grantee. Let them know you are applying to the 340B Drug Pricing Program and they will receive an email from HRSA asking them to verify the receipt of grant funds.
To verify eligibility, we will send an email to the appropriate Project Director (PD) or Program Manager (PM) to confirm the entity receives eligible grant funding for all grantee types (e.g. Ryan White (RW), Family Planning (FP), Hemophilia Treatment Centers (HTC), STD/318, and TB/317) registrations.
The PD or PM has five business days to confirm the entity receives eligible grant funding. If they don't respond to the email by the deadline, we will reject the registration(s).
- Prepare to complete registration in one session.
You must complete the online registration in one session.
If you do not finish the registration process, the registration will close and you will need to start at the beginning of the process. Registrations must be approved and submitted by the AO by the end of the open registration period.
- Gather needed information.
The entity will need to provide a federal grant number when registering for the 340B Program.
If the entity plans to use 340B drugs for your Medicaid patients, you will need to provide your Medicaid billing number or National Provider Identifier.
The entity can also find the federal grant number at the agency that receives the grant from the Federal Grant Program.
Have all the information on hand to efficiently complete the registration process. OPA may ask for more information and ask clarifying questions regarding eligibility during the review process.
HRSA is requiring Ryan White clinics to submit the following:
- Notice of Funding Opportunity (NOFO) number at the time of registration (please note Ryan White (A, B, C, D, F) NOFO format) HRSA-XX-XXX
- Date range of their NOFO funding
Contact your state or local Ryan White program manager or your HAB Project Officer if the entity is unsure of the Federal Grant Number or the NOFO. NOTE: Entities must be receiving the appropriate Federal funding at the time of 340B registration-not prospectively.
Use the table below as a guide for determining the federal grant number. Contact the PVP for help.
| Entity Type | Federal Grant Number Format | Additional Information |
|---|---|---|
| Health Center Program Award Recipients (CH) | H80CS----- | Site ID=BPS-H80----- |
| Health Center Program Look-Alikes (LAL) | LALCS----- | Site ID=BPS-LAL------ |
| Hemophilia Treatment Centers (HTC) | H30MC----- | |
|
Ryan White A (RWI) and RW B (RWII): Ending the HIV Epidemic (EHE): A Plan for America – Ryan White HIV/AIDS Program Parts A and B-Direct Grantees ONLY) NOTE: If an entity is already active in 340B OPAIS as a Ryan White (A, B, C, D, F) with the same entity name/address/city/zip-code, the entity does not need to register under the EHE grant# 6UT8HAXXXXX-XX-XX, the entity however must ensure the policies and procedures reflect the EHE grant# and that the entity meets patient definition. |
6UT8HAXXXXX-XX-XX | |
| Ryan White A (RWI) | H89HA----- | |
| Ryan White B (RWII, RWIIR, RWIID) | X07HA-----, X08HA-----, X09HA----- | |
| Ryan White C (HV) | H76HA----- | |
| Ryan White D (RW4) | H12HA----- | |
| Family Planning (FP) | FPHPA------ | |
| Tuberculosis Prevention Clinics (TB) | 1U52PS------- | This is not the same as the funding opportunity number |
| Sexually Transmitted Disease Prevention Clinics (STD) | 1H25PS------- | This is not the same as the funding opportunity number |
| Black Lung Clinics | H37RH----- | |
| Tribal compacts/contracts | N/A | |
| Urban Indian | N/A | |
| Native Hawaiian | H1CCS----- |
- Prepare your contract pharmacy agreements.
Be prepared to register all contract pharmacies at the time of registration.
The entity may register contract pharmacies only after having a written contract with a contract pharmacy prior to the registration period. (NOTE: The written contract pharmacy contract must match exactly the contract pharmacy name and address registered in OPAIS.)
Visit Contract Pharmacy Services for more information.
Have your pharmacy’s Drug Enforcement Agency (DEA) number and pharmacy address ready when registering.
- Continue to check 340B OPAIS.
If OPA has questions regarding your registration, the AO will receive a task notification email. This will indicate an action to take on the registration or to answer questions.
It is the entity’s responsibility to review the OPA reviewer comments each time a registration is sent back in OPAIS to determine if there are any items that require action for that particular registration.
If the entity is unable to act on the registration for any reason, please make a note in the review box and return it to OPA and explain the issue. Registrations returned without action will be rejected. OPA will not approve any registration if it is returned without a response from the entity.
- Seek technical assistance.
Use the Help section in 340B OPAIS to access the user guides. The entity can also contact the 340B Prime Vendor Program for technical assistance before and during the registration period.
What happens after you register?
It is the entity’s responsibility to review the OPA reviewer comments each time a registration is sent back in OPAIS to determine if there are any items that require action for that particular registration.
If the entity is unable to act on the registration for any reason, please make a note in the review box and return it to OPA and explain the issue. Registrations returned without action will be rejected. OPA will not approve any registration if it is returned without a response from the entity. Monitor your email and your 340B OPAIS dashboard for task notifications.
Once approved, the AO and PC will receive an email confirming successful enrollment in the 340B Program. This email will include the date on which you may begin purchasing 340B drugs and your covered entity’s 340B identification number.
The 340B identification number is your covered entity’s unique number that manufacturers, wholesalers, and others will use to verify your participation in the 340B Program.
You should also use this number to regularly verify that your covered entity’s information is up-to-date in the 340B OPAIS. It is your responsibility to ensure your information is correct. Notify OPA immediately if there are changes to your eligibility.
NOTE: Always have your 340B identification number handy when you contact PVP for technical assistance.
Hospitals must first register for the 340B Program so we can verify the hospital meets all statutory requirements prior to participation. The entity can only be registered and participate as one hospital type.
What should you do before you register for the 340B Program?
Review detailed 340B Program hospital registration instructions, including how to convert from one hospital type to another.
- Setup your account.
To register, you must have a 340B Office of Pharmacy Affairs Information System (340B OPAIS) user account. Visit the 340B OPAIS and choose “help” in the upper right hand corner of the page.
To ensure that the Authorizing Official (AO) and Primary Contact (PC) receive 340B OPAIS email notifications, add noreply@hrsa.gov to your email program’s spam filter.
- Identify your Authorizing Official and Primary Contact.
The AO must be an individual who can bind the organization to a contract, such as a CEO, COO, CFO, or program manager.
The PC should be an employee of the organization. They may not be the same as the AO, and cannot be a consultant or contractor.
- Know your hospital classification.
Section 340B(L)(i) of the Public Health Service Act (PDF - 39 KB) defines the hospital classifications that are eligible for the 340B Program.
Your hospital must meet one of these classifications:
- Owned or operated by a state or local government,
- Private, non-profit with a contract with a unit of state or local government,
- Public or private non-profit corporation, which is formally granted governmental powers by a unit of state or local government.
Note: Determine which classification you will choose during the registration process, before you begin.
You will also need supporting documentation when you register. Documentation must be available upon request and should be a part of the hospital’s auditable records.
The 340B Program hospital registration instructions describe the required documentation.
- Know what clinics/services are registered.
Search the 340B OPAIS to verify registered clinics/services. This will prevent you from registering duplicates or identify terminated registrations you may want back in the 340B Program.
If you are unsure if your sites are already registered, contact the 340B Prime Vendor Program (PVP) for assistance.
- Be aware of the registration dates and deadlines.
The quarterly registration periods take place from the first through the fifteenth of January, April, July, and October. This is the only time you will be able to submit a new registration.
Upon approval, the covered entity’s start date will be the first day of the next quarter.
- Prepare to complete registration in one session.
You must complete the online registration in one session. If you do not finish the registration process, it will close and you will need to start at the beginning of the process.
Registrations must be approved and submitted by the AO by the end of the open registration period.
- Gather required information.
You will need your hospital’s latest filed Medicare cost report to complete the registration. If you plan to use 340B drugs for your Medicaid patients, you will need to provide your Medicaid billing number or National Provider Identifier.
Have all the necessary information on hand to efficiently complete the registration process. We may ask for more information or documentation, or ask clarifying questions regarding hospital eligibility during the review process.
- Prepare your contract pharmacy agreements.
Be prepared to register all contract pharmacies at the time of registration. You may register contract pharmacies only after having a written contract with a contract pharmacy prior to the registration period.
Visit Contract Pharmacy Services for more information.
Note: Have your pharmacy’s Drug Enforcement Agency (DEA) number and pharmacy address ready when registering.
- Be aware of alerts.
It is the covered entity’s responsibility to pay close to all alerts during the registration process and upload necessary supporting documentation on the same day that the registration is submitted. Registrations may be rejected if supporting documentation is not submitted.
- Continue to check 340B OPAIS.
It is the entity’s responsibility to review the OPA reviewer comments each time a registration is sent back in OPAIS to determine if there are any items that require action for that particular registration.
If the entity is unable to act on the registration for any reason, please make a note in the review box and return it to OPA and explain the issue. Registrations returned without action will be rejected. OPA will not approve any registration if it is returned without a response from the entity.
- Seek technical assistance.
Use the Help section in 340B OPAIS to access the user guides. The entity can also contact the 340B Prime Vendor Program for technical assistance before and during the registration period.
What happens after you register?
It is the entity’s responsibility to review the OPA reviewer comments each time a registration is sent back in OPAIS to determine if there are any items that require action for that particular registration.
If the entity is unable to act on the registration for any reason, please make a note in the review box and return it to OPA and explain the issue. Registrations returned without action will be rejected. OPA will not approve any registration if it is returned without a response from the entity. Monitor your email and your 340B OPAIS dashboard for task notifications.
Once approved, the AO and PC will receive and email confirming successful enrollment in the 340B Program. This email will include the date on which you may begin purchasing 340B drugs and your covered entity’s 340B identification number.
The 340B identification number is your covered entity’s unique number that manufacturers, wholesalers, and others will use to verify your participation in the 340B Program.
You should also use this number to regularly verify that your covered entity’s information is up-to-date in the 340B OPAIS. It is your responsibility to ensure that covered entity database information is current at all times. Please notify us immediately if there are changes to your eligibility.
Note: Have your 340B identification number handy when you contact PVP for technical assistance.
Additional Resources
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