Outpatient Facility Registration

You must be the logged-in AO or PC to register outpatient facilities.

All outpatient clinics and services that are located outside of the four walls of the hospital and that intend to use or purchase 340B drugs for its patients must register with the 340B program. They must appear on the hospital's most recently filed cost report in order to register.

If an off-site location is actually a separate hospital or medical center, or even a small office with several services being provided, each clinic, department, or service must be registered separately in the 340B program database. For example, if there is a single off-site location that provides radiology services, physical therapy services, and pediatric services, the covered entity should register each service individually to establish its eligibility for 340B drugs.

Be Prepared to Upload Cost Report Documentation. As part of the registration process, the system will require you to upload worksheets from the most-recently filed Cost Report to support the registration Qualification Information. Failure to upload the required documentation before submitting the registration will result in rejection of the registration for the quarter.

The required attachments vary by hospital type:

Cost Report Worksheets for Outpatient Facilities

Hospital Type

Cost Report Worksheets

S

S-2

S-3

E (Part A)

A

C

Trial Balance

ClosedDisproportionate Share Hospital (DSH) One of the categories of hospitals that are eligible to participate in the 340B Program. Disproportionate Share Hospitals serve a significantly disproportionate number of low-income patients and receive payments from the Centers for Medicaid and Medicare Services to cover the costs of providing care to uninsured patients. Disproportionate share hospitals are defined in Section 1886(d)(1)(B) of the Social Security Act. To be eligible to participate in the 340B Program, disproportionate share hospitals must meet the requirements of section 340B(a)(4)(L) of the Public Health Service Act.

Yes

Yes

No

Yes

Yes

Yes

Yes

ClosedCritical Access Hospital (CAH) Critical Access Hospitals are designated by the Centers for Medicare and Medicaid Services. The defining legislation is Section 1820(c)(2) of the Social Security Act. To be eligible to participate in the 340B Drug Pricing Program, Critical Access Hospitals must meet the requirements of section 340B(a)(4)(L)(i) of the Public Health Service Act.

Yes

Yes

No

No

Yes

Yes

Yes

Freestanding Cancer Hospital (CAN)

Yes

Yes

No

Yes

Yes

Yes

Yes

ClosedChildren's Hospital (PED) One of the categories of hospitals that are eligible to participate in the 340B Program. Nonprofit hospitals that serve individuals through the age of 18 years of age and have a CMS-issued 3300 Series Medicare Provider Number to designate them as Medicare certified children's hospitals. Children's hospitals must meet certain requirements, including a DSH adjustment percentage greater than 11.75% and compliance with the GPO Prohibition, to be eligible to participate in the 340B program.

Yes

Yes

Yes

No

Yes

Yes

Yes

ClosedRural Referral Center (RRC) One of the categories of hospital covered entities that are eligible to participate in the 340B Program. Rural Referral Centers are high-volume acute-care rural hospitals that treat a large number of complicated cases. Hospitals classified as Rural Referral Centers may be eligible to participate in the 340B Drug Pricing Program if they have a disproportionate share adjustment percentage equal to or greater than 8 percent for the most recently filed Medicare cost report and meet the requirements of section 340B(a)(4)(L)(i) of the Public Health Service Act.

Yes

Yes

No

Yes

Yes

Yes

Yes

ClosedSole Community Hospital (SCH) One of the categories of hospital covered entities that are eligible to participate in the 340B Program. Sole Community Hospitals are designated by the Centers for Medicare and Medicaid Services. To be eligible to participate in the 340B Drug Pricing Program, Sole Community Hospitals must also have a disproportionate share adjustment percentage equal to or greater than 8 percent for the most-recently filed Medicare Cost Report and meet the requirements of Section 340B(a)(4)(L)(i) of the Public Health Service Act.

Yes

Yes

No

Yes

Yes

Yes

Yes

Follow these file attachment rules to prevent rejection during uploading:

  • Only Microsoft Excel (xlsx) and Adobe PDF formats are allowed. Excel files must not be macro-enabled.
  • File size is limited to 50MB.
  • Files must not be password protected.
  • Files must pass virus scan.
  • Number of uploaded files must not exceed 10 files per submission.
  1. From the 340B home page, select Register > Register Covered Entity and/or Outpatient Facility from the top menu or click the Register Covered Entity icon.

    screen shot of Covered Entity Registration selection from the 340B OPAIS home page

  2. On the Covered Entity Registration page, click the "A Hospital" button.

    screen shot of selection of "A Hospital" from the Covered Entity Registration page

  3. On the Search for Hospital page, enter the MPN for the new hospital and click the Search button.

    screen shot of Search for Hospital page

  4. On the Register Hospital page, confirm the hospital name, street address, entity type, and current 340B status.

    screent shot of Register Hospital page, showing selection of "Register Outpatient Facilities"

    Outpatient facilities may be registered while the parent hospital is still pending OPA approval. If the parent hospital registration is pending OPA review, it will be indicated by an "Alert" message.

  5. Select the Register Outpatient Facilities option and click the Continue button. The system will display the Covered Entity Outpatient Facility Search Results page.

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