1.9 340B Recertification Childrens Hospital

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 REGISTRATION FOR CHILDREN’S HOSPITALS
To meet the eligibility requirements for a children’s hospital to participate in the 340B Program and be listed
as a covered entity on the 340B Office of Pharmacy Affairs Information System (OPAIS) pursuant to section
340B(a)(4)(M) of the Public Health Service Act, this registration form must be completed and submitted
according to the established deadlines published on the OPA website (www.hrsa.gov/opa).
A complete registration package must include the information noted in sections I-VI below. In addition, the
hospital may be required to provide additional supporting documentation including:
1.
A copy of the latest filed Medicare cost report Worksheet S that includes a digital encrypted signature
stamp*;
2. A copy of Worksheet S-3 from the most recently filed Medicare Cost report. Children’s hospitals that do
not file a Medicare cost report must provide a statement from a qualified independent auditor (see 74
Fed. Reg. 45206 (Sept. 9, 2009));
3.
A copy of Worksheet S-2 to demonstrate ownership type, and depending upon the hospital type the
additional documentation described in II, C, below.
* The date and time prepared listed in the upper right corner of all worksheets must match the date and time of the
digital encrypted signature stamp.
The entire registration package must be submitted on the same day to be considered complete. A registration that
is submitted without any of the required documentation will be rejected.

I. Hospital Information:

Hospital Name:

Medicare Provider Number:
Employer Identification Number:

_
_

Hospital Street Address (PO Boxes are not allowed):
City:

_ State:

ZIP:

_

_ State:

ZIP:

_

ZIP:

_

Hospital Billing Address (if different):

City:

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

_ State:

II. Eligibility Criteria


Entity is a Children's hospital defined by section 1886(d)(1)(B)(iii) of the Social Security Act, and this
status is recognized by CMS.

A. Disproportionate Share Adjustment Percentage:
% based on
Medicare Cost Reporting Period: __ / __ / ____ – __ / __ / ____
Filing Date: __ / __ / ____

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

B. Type of Control per HCRIS (as filed on cost report Worksheet S-2, Line 21)








1 – Voluntary Nonprofit, Church
2 – Voluntary Nonprofit, Other
3 – Proprietary, Individual
4 – Proprietary, Corporation
5 – Proprietary, Partnership
6 – Proprietary, Other
7 – Government, Federal








8 – Governmental, City-County
9 – Governmental, County
10 – Governmental, State
11 – Governmental, Hospital District
12 – Governmental, City
13 – Governmental, Other

C. Hospital Classification
 Owned or Operated by State or Local Government

Official documentation must indicate that the hospital is owned or operated by a unit of State or Local
government. More than one document may be necessary to demonstrate eligibility. Any documentation provided
should clearly state the hospital’s ownership, the date the ownership was established, and the name of the
hospital. Please refer to the hospital registration instructions on the Office of Pharmacy Affairs website for a
description of acceptable documentation.

 Private, Non-Profit Hospital with State/Local Government Contract
Hospitals must be able to demonstrate through official documentation that it is both private nonprofit
and that it has a contract as set forth in the statute. Please refer to the hospital registration instructions on
the Office of Pharmacy Affairs website for a description of acceptable documentation.
Contract start date: __ / __ / ____

Contract end date: __ / __ / ____

 Check here if the entity’s contract is valid until cancelled.
Public or Private Non-Profit Hospital Formally Granted Governmental Powers, submit the following:
Please submit the following documentation:

1. Documents that clearly state the hospital’s ownership, the date the ownership was established, and
the name of the hospital. More than one document may be necessary to demonstrate eligibility;
2. Identity of the government entity granting the governmental powers;
3. A description of the governmental power that has been granted to the hospital and a brief
explanation as to why the power is considered to be governmental; and
4. A copy of an official document issued by the government to the hospital that reflects the formal
granting of governmental power.
Please refer to the hospital registration instructions on the Office of Pharmacy Affairs website for a
description of acceptable documentation.
 Ineligible for-profit institution – for-profit institutions are ineligible for registration

III. Statutory Prohibition on Group Purchasing Organization (GPO) Participation
Section 340B(a)(4)(L)(iii) of the Public Health Service Act, which is reiterated in the Statutory Prohibition on Group
Purchasing Organization Participation Policy Release (2013-1), requires that the hospital not obtain covered
outpatient drugs through a group purchasing organization or other group purchasing arrangement. This is an

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

eligibility requirement for Disproportionate Share Hospitals, Children’s Hospitals, and Free Standing Cancer
Hospitals.
The Authorizing Official must certify that this hospital will not obtain covered outpatient drugs through a group
purchasing organization or group purchasing arrangement for covered outpatient drugs as of the participating start
date listed on the 340B OPAIS. If covered outpatient drugs are purchased using a GPO while participating in the
340B Program, the covered entity understands that this violates program eligibility requirements and that the
covered entity is obligated to inform OPA and may be required to repay manufacturers for the 340B discount
received.
 Yes, I Confirm

IV. Medicaid Billing
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 fee-for-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 feefor-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 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.

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

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

Phone:

Ext.: ______________

Email Address:
Covered Entity Authorizing Official
The Authorizing Official must be someone who can legally bind the organization into a contract, such as the
President, Chief Executive Officer, Chief Operating Officer, Chief Financial Officer, or Program Director.
Forms that are signed by an individual that OPA determines is not an acceptable representative will not be
processed. If you have questions regarding the appropriate Authorizing Official, please contact the 340B
Prime Vendor Program at 1-888-340-2787 or via email at ApexusAnswers@340bpvp.com prior to submission
of your registration.
Covered Entity Authorizing Official Name:
Title:
Phone: _________________________ Ext.: ______________
Email Address:

VI.

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 and its outpatient facilities 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, including section 340B(a)(4)(L)(iii) of the
Public Health Service Act when applicable, regarding the group purchasing organization prohibition - which
states that the covered entity hospital does not obtain covered outpatient drugs through a group purchasing
organization or other group purchasing arrangement;
(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 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.
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 that may be helpful in reviewing this registration for 340B eligibility:
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________

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

Authorizing Official signature:

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 2 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.