Form 2 Recert-Critical Access; Sole-community; Rural-Referral c

OPA 340B Registration Database
Recert-Critical Access; Sole-community; Rural-Referral centers
(Orphan Drug)-Revised
Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau
OMB No. 0915-0327; Expiration Date: XX/XX/20XX

Covered Entity Details
340B ID:
Entity Type:

Entity Name:

Employer Identification Number:

Entity Sub-Division Name:

Grant Number:

Medicare Provider
Number:

Covered Entity Address
Street Address (PO Box Not Allowed)

Continue

*Address Line 1:

Undo

*

Address Line 2:
*City:
*State:

*

Select a State

*Zip:







*
-

*

Billing Address Same as Street Address

Billing Address

Continue

*Organization
Name:

*

*Address Line 1:

*

Undo

Address Line 2:
*City:

*

*State:
*Zip:

-

*

Shipping Address Same as Street Address





Shipping Address (PO Box Not Allowed)

Add

Covered Entity Date Information
Registration Date:

Participating Start Date:

Participating Approval Date:

Termination Reason:
Termination Date:
The date the entity became ineligible:
Last date that 340B drugs were or will be
purchased under this 340B ID:

Termination Comments:

Qualification Information

OPA 340B Registration Database

Qualifying information for outpatient facilities (child sites) will be automatically carried over from the main hospital record; please email us at [email protected] if you need
to report an independent DSH adjustment percentage, cost reporting period or ownership classification for a particular site. Organizations with DSH percentages below applicable thresholds must
decertify the parent hospital and ALL associated outpatient facilities.

Entity is a Critical Access Hospital defined by section 1820(c)(2) of the Social Security Act, and this status is recognized by CMS.





Hospital Classification:

Medicaid Billing
Medicaid Billing Information
You must answer the following question regarding Medicaid Billing:
Will you bill Medicaid for drugs purchased at 340B drug price?

 Yes









 No
Yes 

Orphan Drug Exclusion
340B hospitals subject to the orphan drug exclusion (i.e., critical access hospitals, free-standing cancer hospitals, sole community hospitals and rural referral centers) are responsible for
ensuring that any orphan drugs purchased through the 340B Program are not transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the orphan drugs
are designated under section 526 of the Federal Food, Drug, and Cosmetic Act. Please choose one of the following:

 The





The hospital will
will purchase
purchase orphan drugs under the 340B Program and maintain auditable records
records to demonstrate compliance
compliance with the orphan drug
drug exclusion.
The hospital cannot
cannot or
or does
does not
not wish
wish to maintain auditable
auditable records regarding
regarding compliance with
with the
the orphan drugs exclusion and will
will purchase all
all orphan
orphan drugs
drugs outside of the 340B
340B
 The





Program
Program regardless
regardless of
of the indication
indication for
for which
which the
the drug
drug is
is used
used and
and will
will not
not use
use aa Group
Group Purchasing Organization
Organization (GPO) to purchase
purchase those drugs if the hospital is a free-standing cancer
cancer
hospital.
hospital.
Note: Any change to your selection will be effective on the first day of the quarter following approval by OPA.

Contact Information
Authorizing Official

Name:
Title:
Phone:
Email:

Ext:

Make





Make Primary Contact Information same as
as Authorizing
Authorizing Official
Primary Contact

Name:
Title:
Phone:

Ext:

Email:

Update

February 19, 2015

2:49 PM ET

Terminate

[email protected] | 1-888-340-2787

Cancel

OMB Number: 0915-0327, Expiration: XX/XX/20XX

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OPA 340B Registration Database

Black Lung Clinics Program Grantee/ Program Manager
Batch Certification 2015

NOTE: Recertification is not complete until you check the certification statement below and
click the "Attest and Recertify" button.
Covered Entities
The number of rows returned: 1

340B ID

Batch
Name

Rows/Page:

Subdivision
Name

Entity Name

Address

200

Set
City

State Zip

Status

1

Program Manager/Authorizing Official
Name:
Title:
Phone:

Ext:

Email:

Authorized Signature







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. Failure to recertify may be grounds for removal from the 340B Program.
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 meets 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, freestanding cancer hospitals, sole community hospitals and rural referral centers.
(4) the covered entity maintains 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.

Attest and Recertify

February 19, 2015

1:33 PM ET

[email protected] | 1-888-340-2787

OMB Number: 0915-0327, Expiration: XX/XX/20XX

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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
0.5 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 10C-03I, Rockville, Maryland, 20857.