Registration Outpatient

Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau

OMB No. 0915-0327

OFFICE OF PHARMACY AFFAIRS (OPA)

340B REGISTRATION FORM FOR OUTPATIENT FACILITIES USING MEDICARE COST REPORT

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 A, Worksheet C, Worksheet S-2 and Worksheet E Part A from the latest filed Medicare cost report (for the DSH adjustment percentage in II, A, below).

4. A trial balance.

All documentation described in 1-4 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 (Main Provider) Name:

Hospital (Main Provider) Medicare Provider Number:

Hospital (Main Provider) Employer Identification Number:

Hospital (Main Provider) Street Address:

2. Hospital Outpatient Facility Information:

Please complete the following section and include all requested information. This registration form and supporting documentation must be completed and submitted according to the established deadlines that are published on the OPA website (www.hrsa.gov/opa). The registration process is not complete unless the registration form has been completed in its entirety (all requested information is filled in on the form) and all required supporting documentation is submitted on the same day to OPA. Incomplete packages will not be processed.

Indicate the following regarding the outpatient facility to be registered:

Name of Facility:

Outpatient Employer Identification Number (if different from parent):

Facility Medicare Provider Number (if different):

Facility Street Address (P.O Boxes are not allowed):

Facility Billing Address (if different):

Facility Shipping Address (PO Boxes are not allowed):

3. Cost Center Information:

Hospitals registering outpatient facilities must identify one or more specific cost center lines that the facility being registered falls under on the organization's most recently filed Medicare cost report. In the following fields, enter the Net Expenses for Allocation for the entire line (Worksheet A, Column 7) followed by the total outpatient charges for the entire line (Worksheet C, Column 7).

Next, enter expenses associated with the specific clinic, service or facility being registered – if more than one clinic, service or facility is rolled up to a single cost center (e.g., Line 90/Clinic), these figures will come from the corresponding working trial balance. (For cost centers/lines that reflect only a single outpatient clinic, service or facility, these figures will come directly from Worksheet A, Column 7 and will be the same as those provided for the entire line -- e.g., Line 90.xx subscripts). Finally, enter the outpatient revenue associated with the specific clinic or service being registered (also from the trial balance).

Line Number/Description	Net Expenses (Worksheet A)	Outpatient Charges (Worksheet C)	Specific Service/Clinic Cost (Trial Balance)	Specific Service/Clinic Outpatient Revenue (Trial Balance)

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 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.

5. Statutory Prohibition on Group Purchasing Organization 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 a requirement for Disproportionate Share Hospitals, Children’s Hospitals, and Free Standing Cancer Hospitals.

The authorizing official must certify that this hospital will not participate in a group purchasing organization or group purchasing arrangement for covered outpatient drugs as of the date of this listing on the OPA database. If drugs are purchased using a GPO for covered outpatient drugs 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

 Not applicable

5. Authorized Signature

I acknowledge that I am familiar with the most recent Centers for Medicare & Medicaid Services’ guidelines concerning Medicare certification of hospital components as one cost center and HRSA’s guidelines for hospital outpatient facilities. Pursuant to those guidelines, I request that the attached list of qualifying outpatient facilities be added to the database of 340B covered entities. I have examined the list and certify that each outpatient facility is reimbursable on the covered entity’s most recently filed Medicare cost report and is an integral part of the aforementioned hospital under the Medicare provider number listed above. I further acknowledge that the main provider hospital is in compliance with 340B published guidelines and regulations.

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, 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. 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

Name & Title of Authorizing Official and Title Phone Email

(please print or type)(e.g.CEO,CFO,COO)

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 .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 14N-39, Rockville, Maryland, 20857.