Form 1 340BRegistration-Covered Entities All Other-Revised

Dept. of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau

OMB No. 0915-0327; Expiration Date: XX/XX/20XX

INSTRUCTIONS FOR COMPLETING THE 340B REGISTRATION FORM

For use by any site registering as a non-hospital covered entity type (other than Consolidated Health Center, Federally Qualified Health Center Lookalike and STD/TB clinics). Specific eligibility requirements are posted on the OPA website.

An organization eligible to participate in the 340B Program must complete the registration process in order to purchase and use 340B drugs for its eligible patients. This registration must be completed and submitted according to the established deadlines that are published on the OPA website. The registration process is not complete unless all necessary supporting documentation is submitted on the same day to OPA. Once the Office of Pharmacy Affairs (OPA) receives an entity’s registration and verifies that the organization is eligible, the entity may purchase 340B drugs beginning on the entity’s participating start date listed on the 340B database.

The entity should ensure that all information is current and accurate on the 340B database record. It is the covered entity’s responsibility to notify OPA of any changes by submitting an official 340B Program change request.

NOTE ON SHIPPING ADDRESSES – complete this section ONLY if your covered entity’s 340B drugs will be shipped to an address that is different from the covered entity address. Covered entities should be aware that listing a location as a shipping address does not make that location eligible to use 340B drugs for any individuals treated there. However, do NOT use this section to provide information for a contract pharmacy arrangement. Please refer to the OPA website for instructions on registering a contract pharmacy.

Once your registration has been processed, OPA will notify you (at the e-mail address that you provide) of your covered entity’s 340B Program participation start date and provide you with your 340B identification number, a unique number that OPA assigns to each covered entity. Please use this number in all correspondence to OPA. 340B identification numbers will be used by manufacturers, wholesalers, and others to search the OPA database to verify your participation in the 340B Program. It is the entity's responsibility to notify its wholesaler or manufacturer that it is registered for 340B prices when it places an order.

This registration form must be completed and submitted according to the established deadlines that are published on the OPA website (www.hrsa.gov/opa).

Public Burden Statement:  An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.  The OMB control number for this project is 0915-0327.  Public reporting burden for this collection of information is estimated to average 1.0 hour per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 10C-03I, Rockville, Maryland, 20857.

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OFFICE OF PHARMACY AFFAIRS

340B PROGRAM REGISTRATION FORM FOR COVERED ENTITIES

Acknowledgement of Covered Entity Participation in Outpatient Discount Drug Pricing under Section 340B of the Public Health Service Act.

1. Covered Entity Information:

Covered Entity Name:

Covered Entity Sub-Division Name (if applicable):

Employer Identification Number:

Street Address (PO Boxes are not allowed):

City: _ State: ZIP:

Billing Address (if different):

City: _ State: ZIP:

Shipping Address (if different; PO Boxes are not allowed)

City: _ State: ZIP:

Entity Type (see next page for list of codes):

Are you attempting to reinstate under a previous 340B ID number?

• Yes 340B ID Number: ________________________

• No

UDS or Grant Number (if known):

2. Medicaid Billing Information: You must answer the following question regarding Medicaid billing.

Will the covered entity dispense 340B purchased drugs to Medicaid patients AND subsequently bill Medicaid for those dispensed 340B drugs? Yes  No 

If “Yes”, please provide the entity’s Medicaid Provider Number(s) (MPN) and/or National Provider Identifier(s) (NPI) for each applicable entity location that bills Medicaid for 340B drugs. If you are unsure of the entity’s MPN and/or NPI, please check with your State Medicaid agency. It is important that your Medicaid billing status and appropriate provider identifier number(s) are accurate in the OPA database and align with your billing practices in order to prevent Medicaid rebates on drugs that were purchased at the 340B discounted price.

Medicaid Provider Number(s) and/or _

National Provider Identifier(s) and/or

All covered entities should notify OPA prior to any change in Medicaid billing status. For more information, please visit the HRSA website.

3. 340B Primary Contact and Authorizing Official Information:

Covered Entity Primary Contact Name

(Must be someone employed by the Covered Entity):

Title:

Phone: Ext. _ Fax:

Email Address:

Covered Entity Authorizing Official

The Authorizing Official must be someone who can bind the organization into a contract, such as the President, Vice President, Chief Executive Officer, Chief Operating Officer, Chief Financial Officer, or Executive Director. Forms that are signed by an individual that OPA determines is not an acceptable representative will not be processed. If you are in doubt regarding the acceptability of a signature, please contact please contact the 340B Prime Vendor Program at 1-888-340-2787 or via email at [email protected] prior to submission of your registration.

Authorizing Official Name:

Title:

Phone: Ext. _ Fax:

Email Address:

4. Signed Agreement:

The undersigned represents and confirms that he/she is fully authorized to legally bind the covered entity and certifies that the contents of any statement made or reflected in this document are truthful and accurate. The undersigned further acknowledges the 340B covered entity’s responsibility to abide by the following:

As an Authorized Official, I certify on behalf of the covered entity that:

1. all information listed on the 340B Program database for the covered entity will be complete, accurate, and correct;

2. the covered entity will meet all 340B Program eligibility requirements;

3. the covered entity will comply with all requirements of Section 340B of the Public Health Service Act and any accompanying regulations including, but not limited to, the prohibition against duplicate discounts and diversion (section 340B(a)(5)(A) and (B) of the Public Health Service Act;

4. the covered entity will maintain auditable records pertaining to compliance with the requirements described in paragraph (3) above, pursuant to section 340B(a)(5)(C) of the Public Health Service Act;

5. if the covered entity uses contract pharmacy services, that the contract pharmacy arrangement will be performed in accordance with OPA requirements and guidelines;

6. the covered entity acknowledges its responsibility to contact OPA as soon as possible if there is any change in 340B eligibility and/or breach by the covered entity of any of the foregoing; and

7. the covered entity acknowledges that if there is a breach of the requirements described in paragraph (3) that the covered entity may be liable to the manufacturer of the covered outpatient drug that is the subject of the violation, and, depending upon the circumstances, may be subject to removal from the list of eligible 340B entities.

In addition, I have read all applicable registration instructions and I am aware that my registration will not be reviewed if the required supporting documents are not submitted today.

Please provide any additional information or clarification that may be helpful in reviewing this registration for 340B program eligibility: _________________________________________________________________________________________

_________________________________________________________________________________________________

_________________________________________________________________________________________________

Signature of Authorizing Official: Date:

_

List of Covered Entity Type Codes

Please select from the list below and enter the appropriate code(s) for your entity on the Registration Form under “Entity Type.” You should enter all codes for which your organization is eligible as the scope of your grant may determine the eligibility of pharmaceuticals purchased under 340B.

Code	Program
BL	Black Lung Clinics Program
CH	Consolidated Community Health Center Cluster Program (includes Community Health Centers, Migrant Health Centers, Healthcare for the Homeless Programs, Public Housing Primary Care Programs, and School- Based Health Center (Healthy Schools, Healthy Communities) Programs
FP	Family Planning
FQHC638	Tribal Contract/Compact with IHS (P.L. 93-638)
FQHCLA	Federally Qualified Health Center Lookalike NOTE: if your organization is an FQHCLA, you MUST notify OPA if you are successful in receiving a Section 330 grant at a later date.
HM	Comprehensive Hemophilia Treatment Center
HV	Ryan White Part C
NH	Native Hawaiian Health Care Program
RWI	Ryan White Part A
RWII	Ryan White Part B
RWIID	Ryan White ADAP Rebate Option
RWIIR	Ryan White ADAP Direct Purchase
RW4	Ryan White Part D
SPNS	Special Projects of National Significance
STD	Sexually Transmitted Diseases
TB	Tuberculosis
UI	Urban Indian

This registration form must be completed and submitted according to the established deadlines that are published on the OPA website (www.hrsa.gov/opa).

Public Burden Statement:  An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.  The OMB control number for this project is 0915-0327.  Public reporting burden for this collection of information is estimated to average 1.0 hours per response for registrations and 0.5 hours per response for recertifications, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 10C-03I, Rockville, Maryland, 20857.