340B Participant Change Request Redline

Department of Health and Human Services, Health Resources and Services Administration, Office of Pharmacy Affairs
OMB No. 0915-0327

OFFICE OF PHARMACY AFFAIRS (OPA)
340B PROGRAM COVERED ENTITY CHANGE REQUEST FORM
Note: The Authorizing Official represents the covered entity and must be fully authorized to legally bind the covered
entity. The Authorizing Official is usually the CEO/CFO/COO/President/Vice President or equivalent.

I. Covered Entity Details
Entity Name:
Hospitals:
1) Has there been a change in the Medicare Provider Number (MPN)?CMS Certification Number (CCN)?
a) If “Yes”, “You have indicated that the MPN CCN has changed. The hospital must terminate from the 340B
program and submit a new registration using the new CCNMPN.”
b) If “No” following question:
2) Has there been a change in the hospital’s classification?
a) If “Yes”, “The hospital must provide documentation to support the change as specified on the 340B Drug
Pricing Program – Registration webpage.”
a)
Entity Sub-Division Name:
Employer Identification Number (EIN): (Enter the registrant’s EIN if a sub-grantee/sub-recipient)
As assigned by the IRS

Grant Number:

For Urban Indian (UI) and FQHC638 add field:
Tribal Agreement #:
Select: Title I or Title V

Formatted: Font: (Default) Arial, 10 pt

Site ID:
Nature Of Support (for STD/TB only)
 Direct Funding (dollars received from CDC or an intermediate organization)
 In-Kind products or services (see note below; must have been purchased with section 318
funds)
 None
Time period section 318 funding or in-kind support was received
From Date

To

Date

 Valid until no longer receiving
Note: In-kind contributions may be in the form of real property, equipment, supplies and other
expendable property, and goods and services directly benefiting and specifically identifiable to the
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project or program.

Department of Health and Human Services, Health Resources and Services Administration, Office of Pharmacy Affairs
OMB No. 0915-0327

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

Please submit the following documentation:
(1) A copy of the Notice of Award from CDC that identifies the recipient (i.e., primary grantee), Federal
award, and financial information, including the grant number and budget period; and
(2) For subrecipients (i.e., subgrantees), a copy of the executed written agreement (e.g., notice of
subaward, or contract, MOU, MOA, etc.) with the recipient that includes the name and address of the
recipient, subrecipient, subrecipient service delivery site, the grant and NOFO numbers, and the terms
and conditions of support.

Street Address
Address Line 1: ______________________________________________________________________
Address Line 2 (Optional):_____________________________Suite (Optional): ___________________
City: __________________________________

State: _________________

Zip: _____________

If address is changing:
1.

Is the service remaining open at the old address?
Yes  No 

2.

Will this entity continue to receive federal funding that makes them eligible for the 340B Program? (for all
grantees except Federally Qualified Health Centers and Health Center Program Look-Alikes)
Yes  No 

**PO Boxes Not Allowed

Billing Address
 Billing Address is same as Street Address
Address Line 1: _____________________________________________________________________
Address Line 2 (Optional):_____________________________Suite (Optional): ___________________
City: _________________________________

State: _________________

Zip: _____________

Shipping Addresses
 Shipping Address is same as Street Address
Address Line 1: _____________________________________________________________________
Address Line 2 (Optional):_____________________________Suite (Optional): ___________________
City: _________________________________

State: _________________

Zip: _____________

Is the requested shipping address location a pharmacy (a pharmacy prepares and dispenses drugs to patients); a
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Department of Health and Human Services, Health Resources and Services Administration, Office of Pharmacy Affairs
OMB No. 0915-0327

healthcare service delivery site (a healthcare service delivery site administers/dispenses drugs to patients as
part of medical encounters); or an “other” receiving location (an “other” receiving location does NOT
administer/dispense drugs directly to patients (e.g., warehouse, loading dock, re-packager, compounding center,
central fill facility, centralized distribution center, or lab/facility that prepares and ships drugs to a healthcare service
delivery site))?
1) If PHARMACY is selected, then “Is the pharmacy owned by the covered entity (documentation to
demonstrate entity ownership may include a pharmacy license and listing of the pharmacy on the covered
entity’s grant or Medicare Cost Report)?”
a. If “No” is selected, then: “The pharmacy must be registered as a contract pharmacy.”
b. If “Yes” is selected, then: “List the pharmacy as a shipping address under the 340B ID that purchases
the drugs.”
2) If HEALTH CARE SERVICE DELIVERY SITE is selected, then “Is the health care service delivery site
registered in OPAIS”?
a. If “No” is selected, then: “An unregistered healthcare service delivery site may NOT be listed as a
shipping address.”
b. If “Yes” is selected for any hospital or CH/FQHCLA grantee, then: “List the parent hospital, hospital
child site, or grant associated site as a shipping address under the 340B ID that purchases the
drugs.”
c. If “Yes” is selected for any non-CH/FQHCLA grantee, then: “Is the healthcare delivery site listed as a
receiver in an OPA- approved Central Purchasing Distribution Model (CPDM)?”
i. If “Yes” is selected, then: “List the healthcare delivery site as a shipping address under the
340B ID that purchases the drugs.”
ii. If “No” is selected, then: “The healthcare delivery site must be listed as a receiver in an OPAapproved CPDM before it can be listed as a shipping address.”
3) If “OTHER’ RECEIVING LOCATION is selected, then: “Select the type of receiving location from the list
below and list the location as a shipping address under the 340B ID that purchases the drugs.”
a. Select type of “other” receiving location:
i. Warehouse
ii. Loading dock
iii. Re-packager
iv. Central fill facility
v. Centralized distribution center
vi. Lab/facility that prepares drugs and ships them to a healthcare service delivery site
vii. Other (please describe):

II. Contact Information
Authorizing Official
Email: __________________________________ Name: _________________________________
Title:

_________________________________________________________________________

Organization: ____________________________________________________________________
Phone: __________________________________ Ext.: ___________________________________
E-mail: _________________________________________________________________________

Primary Contact
Email: __________________________________ Name: _________________________________
Title:

_________________________________________________________________________

Organization: ____________________________________________________________________
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Department of Health and Human Services, Health Resources and Services Administration, Office of Pharmacy Affairs
OMB No. 0915-0327

Phone: __________________________________ Ext.: ___________________________________
E-mail: _________________________________________________________________________

II.III.

Eligibility Criteria (Hospitals Only)

 Entity is a Disproportionate Share Hospital defined by section 1886(d)(1)(B) of the Social Security Act,
and this status is recognized by CMS.
Select One:
 Entity is a Rural Referral Center defined by section 1886(d)(5)(C)(i) of the Social Security Act, and this
status is recognized by CMS.
o

Is this facility classified as a referral center (Worksheet S-2, Line 116)


Y



N


If No: “Please attach CMS Rural Referral Center (RRC) approval
letter.”

 Entity is a Sole Community Hospital defined by section 1886(d)(5)(C)(iii) of the Social Security Act, and
this status is recognized by CMS.
o If this is a sole community hospital (SCH), enter the number of periods SCH status
in effect in the cost reporting period (Worksheet S-2, Line 35)
 [Enter number]
 If “0”: “Please attach CMS Sole Community Hospital (SCH)
approval letter”

A. Disproportionate Share Adjustment Percentage:
% based on
Medicare Cost Reporting Period: MM / DD / YYYY – MM / DD / YYYY
Filing Date: Date/Time Prepared: MM / DD / YYYY
B. Control Type per HCRIS (as filed on cost report Worksheet S-2, Line 21)









0 – Undetermined
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
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Department of Health and Human Services, Health Resources and Services Administration, Office of Pharmacy Affairs
OMB No. 0915-0327

on the Office of Pharmacy Affairs website for a description of acceptable documentation.

Contract start date: MM / DD / YYYY

Contract end date: MM / DD / YYYY

 Check here if the entity’s contract is valid until cancelled.
 A public corporation which is formally granted governmental powers by a unit of State or local government
or Private Non-Profit Hospital Formally Granted Governmental Powers
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.IV. 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 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
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 at this site, must match the quarterly MEF.

State

Medicaid Number

NPI

Authorizing Official Signature
By signing, I represent and confirm that I am fully authorized to bind the covered entity and certify that
the contents of any statement made or reflected in this document are truthful and accurate. The covered
entity will comply with all of the requirements and restrictions of section 340B of the Public Health
Service Act, including, but not limited to, the prohibitions on duplicate discounts and drug diversion.
Submission Comment
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Department of Health and Human Services, Health Resources and Services Administration, Office of Pharmacy Affairs
OMB No. 0915-0327

Please provide any additional information that may be helpful in reviewing this change request:

_________________________________________________________________________________________

 By checking this box, I confirm that I have read the above statements and fully understand my obligations.

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 0.25 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.

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