Recertifying a Covered Entity

Covered entities must annually recertify their eligibility to remain in the 340B Drug Pricing Program and continue to purchase covered outpatient drugs at discounted 340B prices. Advanced email notification with preliminary information about the recertification process are sent to the ClosedAuthorizing Official (AO) An external user for a covered entity or manufacturer who is able to attest to any changes to an entity. and Primary Contact (ClosedPC 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.).

Recertification Initiative Starting email message content

If the PC submits the recertification, the AO must review and attest to the recertification before the submission is sent to OPA for review. OPA will contact the AO internally through Closed340B OPAIS The 340B Office of Pharmacy Affairs Information System (OPAIS) is a collection of information submitted by covered entities, contract pharmacies, and manufacturers maintained and verified by HRSA's Office of Pharmacy Affairs (OPA). via a pending task (which will also generate an email to the AO) if any additional clarification is needed.

On the recertification start date, entities that need to be recertified will appear as ClosedRecertification 340B covered entities must annually recertify their eligibility to remain in the 340B Program and continue purchasing covered outpatient drugs at discounted 340B prices. As part of this process, the Authorizing Official of each 340B covered entity certifies basic information about the entity and its 340B compliance. Covered entities with inaccurate information in the 340B OPAIS run a high risk of being removed from the program. tasks in My Dashboard under My Tasks for both the AO and the PC.

My Tasks tab on My Dashboard showing Recertification task

Selecting a Recertification task hyperlink will display the Recertification Information page.

Recertification Information Page Showing Required Updates

This page will display the updates needed for specific sections for a successful recertification.

Clicking the Continue button will display the Recertification Covered Entity Details page.

If you are recertifying a parent hospital, where either the “Cost Reporting End Date” and/or the “Gov Contract End Date” field will expire prior to the end of the recertification end date, there will be a warning displayed on the Recertification Summary with the actions that need to be taken to update the information.

If you are recertifying any Ryan White entity, where the “Time period the Assistance was received” field has expired or will expire by the recertification end date, there will be a warning displayed on the Recertification Summary with the actions that need to be taken to update the information.

If you are recertifying a TB or STD entity type, the “Time period the Assistance was received” field has expired or will expire by the recertification end date, there will be a warning displayed on the Recertification Summary with the actions that need to be taken to update the information.

If you are recertifying a CH or FQHCLA entity, where the entity is no longer “active” in EHBs, which is a requirement for 340B participation, there will be a warning displayed on the Recertification Summary with the actions that need to be taken to update the information.

The Recertification Covered Entity Details page will display "Please update…" messages to indicate where required information must be updated.

Recertification Covered Entity Details Please Update Message for Covered Entity Details

and "Please review..." to indicate the fields that are recommended for updates.

Recertification Covered Entity Details Please Review message for Covered Entity Details

Click an Edit… link (to the right side of the page) to access the details where updates are required.

Recertification Covered Entity Details Please Update Message for Medicaid Billing Information

Select the Continue button to see what fields need to be updated.

Update the information identified as requiring updates, you may also update other CE information during recertification, and click the Continue button.

Repeat this activity for any information where updates are required.

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.

  1. If you change the entity's Qualification Information during recertification or if the most recent cost report is out of date, the system will prompt you to upload updated supporting documentation from the latest Medicare cost report.

    screen shot of message displayed if Hospital Classification is changed

    See Uploading Attachments during Recertification.

  2. If you change the entity’s ClosedFiling Date The date when the Cost Center report was filed (required field for all hospital registrations). This date must be (1) greater than the cost reporting period end date, (2) not older than a year, and (3) not a future date., and if the Filing Date is more than 5 months and 5 days after the Cost Reporting Period end date then the system will display a warning message and require you to upload the signed/dated Worksheet S from your latest filed Medicare Cost Report.

    Recertification Qualification Information hightlighting the filing date message

    The Warning message and system will not stop you from submitting the recertification if there are no other recertification task errors or updates required. The warning message will also appear on the review page and will disappear when the relevant documentation is uploaded.

340B OPAIS policy requires that all Medicaid Numbers and NPI Numbers be associated with a State and that there are no duplicates. In the past this policy was not in place so there may be NPI numbers not associated with a State and there my be duplicate Medicaid Numbers and NPI Numbers, but during Recertification the policy will be enforced.

After selecting Edit Medicaid Billing, a Medicaid Billing details page will be displayed that will provide the ability to perform updates.

Recertification Edit Medicaid Billing page

To update the Medicaid Number(s) or the NPI Number(s) select the Edit/Delete hyperlink in right most column of a row in the table. This will display the Edit Medicaid and NPI Info by State pop-up window.

Recertification Edit Medicaid and NPI Info by State popup window

On the Edit Medicaid and NPI Info by State pop-up window you can:

Change the State

Select a State from the State drop-down list.

Add Medicaid Number(s) and/or NPI Number(s)

Enter new numbers into either box with a comma or space between entries.

Remove Medicaid Number(s) and/or NPI Number(s)

Highlight and delete numbers in either box.
Delete all Select the Delete button. This will delete all the Medicaid Numbers and NPI Numbers associated with this State.

To return to the previous page saving all updates, select the Save button.

To return to the previous page without saving any updates, select the Cancel button.

 

Duplicates cannot be created because upon the save in the Edit Medicaid and NPI Info by State pop-up window, the duplicates will be ignored. However, if duplicates already exist, it is up to the AO and PC to correct them either by associating each duplicated number with a different State or removing the duplicates from the current State.

Recertification Select to Edit Duplicate Medicaid Numbers

Select Edit/Delete in the row with the duplicate Medicaid Numbers.

The Edit Medicaid and NPI Info by State pop-up window will be displayed.

Recertification Edit Medicaid Info By State with Duplicate Medicaid Numbers

To delete duplicates

  1. Remove all but one of the duplicates from the Medicaid Numbers box.

    Recertification Edit Medicaid Info By State with Duplicate Medicaid Number Removed

  2. Select the Save button.

    Recertification Medicaid Info By State with Duplicate Medicaid Number Removed

To associate one of the duplicates with another State

  1. Select a different State and clear out all the Medicaid Numbers and NPI Numbers that are not to be associated with the new State.

    Recertification Edit Medicaid Info By State with Duplicate Medicaid Number to new State

  2. Select the Save button.

    Recertification Medicaid Info By State with Duplicate Medicaid Number to new State
Recertification Select to Edit Duplicate NPI Numbers

Select Edit/Delete in the row with the duplicate NPI Numbers.

The Edit Medicaid and NPI Info by State pop-up window will be displayed.

Recertification Edit Medicaid Info By State with Duplicate NPI Numbers

To associate duplicates with different States

  1. Select a State
  2. Clear out all of the NPI Numbers that are not to be associated with the selected State. Duplicate NPI Numbers do not need to be removed.

  3. Select the Save button.

    Recertification Edit Medicaid Info By State with Duplicate NPI Number Separated

    Because duplicates cannot be created, only one of the NPI Number duplicates will be associated with the selected State. The rest of the duplicates will remain NOT associated with a State.

To delete any NPI Numbers not associated with a State

Do not do this until all the NPI Numbers that are to be associated with a State have been associated with a State.

  1. DO NOT select a State

  2. Make no changes to the NPI Numbers or Medicaid Numbers as that will be ignored anyway.

    The Delete button will delete the entire record regardless of any changes to NPI Numbers or Medicaid Numbers.

  3. Select the Delete button.

When all updates are complete, review the information displayed on the Covered Entity Details page and select the action of Cancel, Submit, or Terminate you which to perform.

screen shot of Covered Entity Summary page for recertification
Covered Entity Recertification Submission Controls for PC
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

Click this button to cancel the recertification and return to the home page.

Submit

Click this button to submit the recertification.

Terminate

Click this button to terminate the entity (AO approval required).

Upon clicking the Submit button, the confirmation page is displayed. Click the OK button to return to My Dashboard. If you are submitting the recertification as the PC for the entity, your submission must be reviewed and attested to by the AO for your organization before submission to OPA.

screen shot of Recertification Submission confirmation

The Authorizing Official Signature section is appended to the bottom of the summary page to allow you to attest to the registration.

screen shot of "Authorizing Official Signature" area of the recertification summary page

Failure to upload required documentation will delay approval of the recertification and result in the entity's termination if not provided by the recertification deadline.

Covered Entity Recertification Attestation Controls for AO
Control Description
Additional Information Comment Box The AO can provide any additional information that they feel will assist OPA in determining their Covered Entities eligibility and recertification.

Checkbox

"By checking this box, I confirm that I have read the above statements and fully understand my obligations."

Select this box if you intend to submit the recertification to OPA for approval.

Cancel

Exit from the attestation page without taking action.

Submit

Click this button to submit the recertification for OPA approval.

  • Recertifications that have no changes or that only contain updates to low-risk fields will be approved automatically by the system.

  • Upon attestation, the task will be removed from the My Tasks tab of your My Dashboard.

Terminate

Click this button to terminate the entity. The Termination Information page will be displayed for entry of the termination reason, dates, and comments.

Upon clicking the Submit button, the confirmation page is displayed. Click the OK button to return to My Dashboard. If you are submitting the recertification as the PC for the entity, your submission must be reviewed and attested to by the AO for your organization before submission to OPA.

screen shot of Recertification Submission confirmation