REDLINE Registration CAH

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 CRITICAL ACCESS HOSPITALS

To meet the eligibility requirements for a Critical Access Hospital to participate and be listed as an eligible covered entity under Section 340B(a)(4)(L) of the Public Health Service Act, this registration form must be completed and submitted according to the established deadlines that are published on the OPA website (www.hrsa.gov/opa).

A completed registration package must include:

1. The following registration information and compliance certification, and the following documents if the hospital is alerted;

2. A copy of Worksheet S that is signed and dated from the latest filed Medicare cost report;

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.

All documentation described in 1-3 above is required to constitute a complete registration package. The entire package must be submitted on the same day to be considered complete. Incomplete packages will not be processed.

1. Hospital Information:

Hospital Name:

Medicare Provider Number: _ Employer Identification Number: _

Hospital Street Address (PO Boxes are not allowed): _ City: _ State: ZIP: _ Hospital Billing Address (if different):

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

City: _ State: ZIP: _

2. Eligibility Criteria

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

1. Medicare Cost Reporting Period: __ / __ / ____ – __ / __ / ____

Filing Date: __ / __ / ____

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

	1 – Voluntary Nonprofit, Church		8 – Governmental, City-County
	2 – Voluntary Nonprofit, Other		9 – Governmental, County
	3 – Proprietary, Individual		10 – Governmental, State
	4 – Proprietary, Corporation		11 – Governmental, Hospital District
	5 – Proprietary, Partnership		12 – Governmental, City
	6 – Proprietary, Other		13 – Governmental, Other
	7 – Government, Federal

3. 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

D. Government Official who can certify the hospital’s classification

Name: Title:

Government Organization:

Phone: Ext.:

E-mail:

3. 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 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.

4. 340B Primary Contact and Authorizing Official Information:

Covered Entity Primary Contact Name

(Must be someone employed by the Covered Entity):

Title:

Phone: Ext. _ Fax:

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 [email protected] prior to submission of your registration.

Covered Entity Authorizing Official Name: _

Title:

Phone: Ext. _ Fax:

Email Address:

5. 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 Program database 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. 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.

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: _______________________________________________________________________________________

_______________________________________________________________________________________

_______________________________________________________________________________________

_______________________________________________________________________________________

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 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 14N-39, Rockville, Maryland, 20857.

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