Requesting Changes to a Covered Entity

Updates to Covered Entities are made by submitting a Change Request.

You must be the logged-in AO or PC to submit change requests.

1. From the Covered Entity Details page for an active entity for which you are responsible as AO or PC External user who is designated as a Primary Contact for an entity. This user can enter registrations and update entity information. This user can enter registrations, and update entity information. Any changes to an entity performed by the PC user must be attested to by the AO for that entity., click the Change Request button.

   Hospitals

   

   Outpatient Facilities

   For outpatient facilities, the Outpatient Facility Provider Number and Outpatient EIN are also shown if they are different from the parent hospital.

   

   Non-Hospitals

   For non-hospital entities, the Grant Financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Number is shown instead of the Medicare Provider Number.

   

2. The Change Request page will display the entity's entire registration for your review. Click the Edit… link to edit the information for a particular section.

   Hospitals

   

   If the entity is under recertification, only the AO may be changed.

   Outpatient Facilities

   For outpatient facilities, the page will show the Entity Subdivision Name, Outpatient Facility Provider, and Outpatient EIN.

   

   Non-Hospitals

   For non-hospital entities, the page will show the Entity Subdivision Name and Grant Number.

   

3. Update the data that needs to be changed.

   Edit Main Details / Edit Addresses

   If you select the Edit Main Details link or the Edit Addresses link, the system displays the entity's details and address information.

   Hospitals

   

   • Entity Name may be changed if necessary.

     • When there is a hospital name change, there are two questions the participant will need to answer. Answer Yes or No to "Has there been a change in the Medicare Provider Number (MPN) The identification number of an institutional provider certified by the Centers for Medicare and Medicaid Services (CMS) to provide services to beneficiaries.?"

     • If your answer is "Yes", then the message, "You have indicated that the MPN has changed. The hospital must terminate from the 340B program and submit a new registration using the new MPN. Please discard this Change Request." is displayed.

     • If your answer is "No", then the following question is displayed:

       • "Has there been a change in the hospital's classification?"

         • If your answer is "Yes", then the message, "The hospital must provide documentation to support the change as specified on the 340B Drug Pricing Program - Registration webpage." is displayed.

   • Employer Identification Number (EIN) A nine-digit number assigned by the U.S. Internal Revenue Service (also known as a Federal Tax Identification Number) used to identify a business entity for tax purposes. may be changed if a new one has been assigned by the IRS.
   • Street Address may be changed if necessary.

   • Billing Address An address verified as belonging to the covered entity that is used for billing purposes. A billing address is not required to be a physical address; it can be a P.O. box or other mailing address. and Shipping Address An address authorized to receive 340B drugs on behalf of a covered entity parent or child site and registered as such on the 340B OPAIS. Because pharmacies are not permitted to be registered as covered entity sites, they may be listed as shipping addresses of the parent entity or a registered outpatient child site, depending on the locations served by the pharmacy. When registering a new covered entity or a new outpatient facility online, the entity has a choice of listing shipping addresses under either the main entity's registration or the offsite facility's registration. Listing shipping addresses permits all parties to know where 340B drugs may be delivered by the manufacturer and wholesaler. Pharmacies that support multiple outpatient facilities should be listed as shipping addresses under the parent entity. – all fields may be changed if either "… same as Street Address" box is unchecked.

   Details/Address Controls

   Control	Description
   Add Shipping Address	Reveal the address fields to add a new shipping address.
   Cancel	Cancel any changes and return to the Change Request page.
   Continue	Accept any changes and return to the Change Request page.

   Outpatient Facilities

   For outpatient facilities, the page will also show the Entity Subdivision Name, Outpatient Facility Provider Number, and Outpatient EIN.

   

   • Entity Subdivision Name may be changed, if necessary.

   • Outpatient EIN may be changed if a new one has been assigned by the IRS.

   • Outpatient Facility Provider Number may be changed if it is different from the parent hospital.

   • Street Address may be changed if necessary.

   • Billing Address and Shipping Address – all fields may be changed if either "… same as Street Address" box is unchecked.

   Details/Address Controls

   Control	Description
   Add Shipping Address	Reveal the address fields to add a new shipping address.
   Cancel	Cancel any changes and return to the Change Request page.
   Continue	Accept any changes and return to the Change Request page.

   Non-Hospitals

   For non-hospital entities, the page will also show the Entity Name, Entity Subdivision Name, Employer Identification Number (EIN), and Grant Number.

   

   • Entity Name may be changed, if necessary.

   • Entity Subdivision Name may be changed if necessary.

   • Employer Identification Number (EIN) for the sub-grantee/recipient may be changed if a new one has been assigned by the IRS.

   • Grant Number add or update as necessary. A grant number guidance message is displayed for the entity types as specified below:

     Entity Type	Entity Type Name	Message
     STD	Sexually Transmitted Diseases	Grant Number should be in the following example format: "NH25PS######"
     TB	Tuberculosis	Grant Number should be in the following example format: "NU52PS######"
     FP	Family Planning (Title X only)	Grant Number should be in the following example format: "FPHPA######"
     RWI	Ryan White Part A	Grant Number should be in the following example format: "H89HA#####"
     RWII RWIID RWIIR	Ryan White Part B Ryan White Part B ADAP Direct Purchase Ryan White Part B ADAP Rebate Option	Grant Number should be in the following example format: "X07HA#####"
     HV	Ryan White Part C	Grant Number should be in the following example format: "H76HA#####"
     RW4	Ryan White Part D	Grant Number should be in the following example format: "H12HA#####"
     HM	Comprehensive Hemophilia Treatment Center	Grant Number should be in the following example format: "H30MC#####"

     Grant Number is not displayed for Urban Indian and Tribal Contract/Compact with IHS (P.L. 93-638) entities. It is required for all other non-hospital entity types. Contact the federal grantee or project officer if you don't know the Grant Number.

   • Site ID may be added or changed for CH and FQCHLA entities.
     • OPAIS will check to see if the Site ID is already used on another covered entity site in OPAIS. If it is, you will get a warning to verify that the new Site ID is correct. If you think it is correct, you may submit the change request with that Site ID and the OPA reviewer will determine if the Site ID is acceptable.
   • Nature of Support may be added or changed for STD and TB entities.
   • Street Address may be changed if necessary.

   • Billing Address and Shipping Address – all fields may be changed if either "… same as Street Address" box is unchecked.

   Details/Address Controls

   Control	Description
   Add Shipping Address	Reveal the address fields to add a new shipping address.
   Cancel	Cancel any changes and return to the Change Request page.
   Continue	Accept any changes and return to the Change Request page.

   Edit Contacts

   If you select the Edit Contacts link, the system displays the entity's current AO and PC contact information.

   

   • The Organization name is required. You will not be able to save any changes if it is missing for either the AO or the PC.

   • To change the AO or PC for the entity, click the Please Select Contact drop-down list to search the system for their email address.

     • If they have a 340B account, their name, title, organization, and phone number will be filled automatically.

     • If they do not have a 340B account, type their name, title, organization, and phone number in the spaces provided. They will receive a New User Account Invitation email asking them to create an account.

   Edit Contacts Controls

   Control	Description
   Reset	Clear any existing contact information for the AO or PC.
   Cancel	Cancel any changes and return to the Change Request page.
   Continue	Accept any changes and return to the Change Request page.

    

   Update Qualification Information

   Select the Edit Qualification Information link to edit the QI information for Hospitals.

   For making a change to the QI for Hospitals, submit a change request on the Parent Hospital.

    

   Click Continue after making the changes to submit the change request. Review the changes you have made on the Covered Entity and the differences between the submitted data to the CMS Centers for Medicare and Medicaid Services, the federal agency within Health and Human Services (HHS) that administers the Medicare and Medicaid programs, including the Medicaid drug rebate program and the Medicare Part D prescription drug benefit. data displayed in the Comparison with CMS Data section

   Attachments

   When the attachments upload selection page displays, click the Select button, navigate to the file to be uploaded, and click on it.

   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.

     

   • The file name of the attachment will appear in the Document Name box. It may be changed to better describe the attachment if desired.

   • Under Attachment Types, click the Other checkbox..

   • Type any additional notes in the Attachment Comments text box.

   • Repeat these steps to select and identify any additional attachments.
   • Click the Submit button to proceed.

   The system will display a list of the selected attachments.

   

   • Click the link in the FileName column to open the attachment with the application that created it (e.g., Excel).
   • Click the Edit link to return to the attachments upload selection page to edit the document name, attachment type or comment.
   • Click the Remove link to delete the associated attachment from the entity
   Edit Medicaid Billing

   If you select the Edit Medicaid Billing link, the system displays the entity's Medicaid billing information. If Yes is selected for the Will you bill Medicaid for drugs purchased at 340B prices? question, the system allows the entity's Medicaid billing information to be changed or Medicaid and NPI numbers to be added or deleted.

   

   Edit Medicaid Billing Controls

   Control	Description
   Add New Record	Expand the page for entry of a Medicaid Provider Number and state or a 10-digit NPI Number.
   Insert	Accept the new Medicaid Provider Number or NPI Number.
   Edit	Opens the Medicaid Provider Number or NPI Number for editing.
   Delete	Deletes the Medicaid Provider Number or NPI Number.
   Cancel	Cancel any changes and return to the Change Request page.
   Continue	Accept any changes and return to the Change Request page.

4. Review pending changes.

   Pending Changes

   As you make changes to the registration, they will be summarized at the bottom of the Change Request page for review before submission.

   

   Pending Changes Controls

   Control	Description
   Textbox	"Please provide any additional information that may be helpful in reviewing this registration for 340B eligibility." Type any comments that will help OPA in approving the registration. This comment will be displayed in the attestation task submitted to the AO for approval.
   Cancel	Cancel any changes and return to the Change Request page.
   Continue	Accept any changes and return to the Change Request page.

   If you are the AO…

   The Authorizing Official Signature section is appended below the Pending Changes section to allow you to attest to the registration.

   

   AO Approval Controls

   Textbox	"Please provide any additional information that may be helpful in reviewing this registration for 340B eligibility:" Type any comments that will help OPA in approving the registration or reinstatement.
   Checkbox	"By checking this box, I confirm that I have read the above statements and fully understand my obligations." Select this box to submit the change request for OPA approval.
   Cancel	Exit from the attestation page without taking action.
   Submit	After selecting the checkbox to authorize the submission, click this button to submit the registration or reinstatement for OPA approval. The submission confirmation page will be displayed. The change request will be removed from the My Tasks section of the AO's My Dashboard. All change requests must be approved by OPA. Upon OPA approval of a change request, both the AO and the PC will receive an Approval of online 340B Change Request email. If OPA rejects a change request, both the AO and the PC will receive a Rejection of online 340B Change Request email.

5. Confirm the changes and submit to OPA for their review an approval.

   Confirmation and Submission

   The system will display a confirmation message. Click the OK button to complete the change request and return to your My Dashboard.