2.6 340B Recertification Covered Entities All Other Non-Hosp

Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau
OMB No. 0915-0327

OFFICE OF PHARMACY AFFAIRS (OPA)
340B PROGRAM RECERTIFICATION FOR NON-HOSPIAL (other than Federally Qualified Health
Center, HEALTH CENTER PROGRAM LOOK-ALIKES and STD/TB clinics) ENTITIES
A completed recertification must include the following information:

I. 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): ____________________________________________________
Grant Number: ___________________________________________________________________________

Time period the assistance was received (applicable to RW entities): From___________to______________

II. Medicaid Billing Information:
At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices?
Yes 
No 
If the answer is yes, please provide the state(s) and associated billing number(s) listed on the claims to bill Medicaid feefor-service for particular states that you plan to bill for 340B drugs in the space(s) below (this could include numbers for
the state your hospital is located in and any out-of-state Medicaid agencies your hospital plans to bill for 340B drugs). All
numbers you plan to use to bill Medicaid fee-for-service should be provided and may include the billing provider’s national
provider identifier (NPI) only, state assigned Medicaid number only, or both the NPI and state assigned Medicaid number.
Do not list a state for which the covered entity will not bill Medicaid fee-for-service for drugs purchased at 340B prices.
HRSA exports the Medicaid billing information listed in this site’s 340B OPAIS record to generate the quarterly Medicaid
exclusion file (MEF). HRSA requires the information on the MEF be accurate and complete for every registered site in the
340B OPAIS, and that covered entities follow any additional state Medicaid requirements in order to prevent duplicate
discounts.
While this site may request a change to its 340B OPAIS record at any time, the Medicaid fee-for service billing practice

Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau
OMB No. 0915-0327

at this site, must match the quarterly MEF.

State

State Assigned
Medicaid Number

NPI

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

III. 340B Primary Contact and Authorizing Official Information:
Covered Entity Primary Contact Name
(Must be someone employed by the Covered Entity):
Title:
Phone:

Ext.

_

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.

_

Email Address:

IV. Signed Agreement:
The undersigned represents and confirms that he/she is fully authorized to legally bind the covered entity into a
contract 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 OPAIS for the covered entity will be complete, accurate, and correct;
(2) the covered entity will meet all 340B Program eligibility requirements of Section 340B of the Public Health Service
Act;
(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/rebates
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) the covered entity acknowledges its responsibility to contact OPA as soon as possible if there is any

Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau
OMB No. 0915-0327

change in 340B eligibility and/or breach by the covered entity of any of the foregoing; and
(6) 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.
Please provide any additional information or clarification that may be helpful in reviewing this recertification for
340B program eligibility:
_________________________________________________________________________________________
___________________________________________________________________________________________
______
___________________________________________________________________________________________
______
Signature of Authorizing Official:

Date:
_

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 .25 hours 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 14N136B, Rockville, Maryland, 20857.