1.8 340B Recertification SCH and RRC

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 RECERTIFICATION FOR RURAL REFERRAL CENTERS AND SOLE
COMMUNITY HOSPITALS
A complete recertification package must include the information noted in sections I-V below. In addition, the
hospital may be required to provide additional supporting documentation including:
(1) A copy of the signed, dated, and electronically encrypted Worksheet S from the latest filed Medicare cost
report;
(2) A copy of Worksheet E, Part A from the latest filed Medicare cost report (for the DSH adjustment
percentage in II, A, below.);
(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.

I. Hospital Information:
Hospital Name:
1) Has there been a change in the CMS Certification Number (CCN)?
a) If “Yes”, “You have indicated that the CCN has changed. The hospital must terminate from the 340B
program and submit a new registration using the new CCN.”
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.”
CMS Certification Number (CCN):

_

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

_
_ State:

ZIP:

_

_ State:

ZIP:

_

ZIP:

_

If address is changing:
1.

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

Hospital Billing Address (if different):
City:

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

_ State:

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

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. Eligibility Criteria
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.
 Is this facility classified as a referral center (Worksheet S-2, Line 116)
o

Y

o

N


If No: “Please attach CMS Rural Referral Center (RRC) designation 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.
 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)
o [Enter number]
 If “0”: “Please attach CMS Sole Community Hospital (SCH) designation
letter”
A. Disproportionate Share Adjustment Percentage:
% based on
Medicare Cost Reporting Period: __ / __ / ____ – __ / __ / ____
Date/Time Prepared: __ / __ / ____
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Department of Health and Human Services, Health Resources and Services Administration, Office of Pharmacy Affairs
OMB No. 0915-0327

B. Type of Control (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: 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. 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
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Department of Health and Human Services, Health Resources and Services Administration, Office of Pharmacy Affairs
OMB No. 0915-0327

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

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.

IV. 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, 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 are in doubt regarding the acceptability of a signature, 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: _______________________________________________________________________

V. Signed Agreement:

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

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;
(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), and the exclusion of orphan drugs
for critical access hospitals, free- standing cancer hospitals, sole community hospitals and rural referral
centers.
(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.
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
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.

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