Applies to: All Users

Description: This article provides a comprehensive breakdown of the data request located within the HRSA/ Mock audit workflow in SectyrHub 340B. The data request tab is broken into the various elements of a HRSA data request. Please note that your covered entity's data request will not include all the sections listed below, as they are entity specific.

To save your work at any time, click the "Save and Continue" or “Save and Exit” button located at the bottom of the screen.   

  • Clicking the “Save and Continue” button will save your work while remaining on the same workscreen.  
  • Clicking the “Save and Exit” button will save your work then redirect you to the listing page. 

To upload a copy of the original data request received from HRSA (or your auditor), click the Upload New File button located in the top right corner of the page. 

You may also choose to leave additional notes about that data request in the Notes box found at the top of the data request tab.

While each sub-section of the data request is unique, they share many of the same features:

  • Click the blue down/ up arrow icon located by the section name to expand/collapse a given section.
  • Click the blue Download Files hyperlink in the section header to download the previously uploaded files from a given section. This will pull the available documents into a zip file onto your computer. 
  • Utilize the information in the blue text boxes to guide your review process. The information icons will reveal additional information.
  • Click the Create Task button to create a task. Enter a description, select the primary assignee, enter the due date and click the Create Task button.
  • Enter the contact information into the appropriate fields and click the Save Contact Info button. This is particularly helpful during the on-site visit if the auditor has a specific question related to the given documents. 
  • Once a section is complete(fully reviewed and documents provided to the auditor), check the Complete checkbox located in the section header.

The sections are as follows: Policies and Procedures, Eligibility Documentation (Locations List), Eligibility Documentation (Medicare Cost Report), Eligibility Documentation (Trial Balance), Eligibility Documentation (Indigent Care Agreement and Proof of Non-Profit Status), Eligibility Documentation (Proof of Ownership), Eligibility (Notice of Grant Award), 340B Universe, Provider List, Drug Purchasing Documentation, Contract Pharmacy Documentation, Self-Disclosure Documentation, and Medicaid Billing Documentation. 

The following information will provide instruction pertaining to each section specifically. 

 

Policies & Procedures:

Applies to all covered entities. 

This section pulls over all documents that have been uploaded within the policies & procedures workscreens and displays the Record Name, Available Documents, Included Coverage, and Active Issues. Clicking the Record name will direct you to the given workscreen, clicking the document name will download the document, and clicking the issue count will direct you to the issues listing. 

Because the linked documents reflect what is available within the associated policies & procedures workscreens, you may choose to re-upload them into this section to memorialize what will be given to the auditor. 

To upload documents, click the Upload New File button and select the file(s). Once added, documents can be given a description and a status (In Review and Ready to Upload). These documents will pull into a zip file if the Download Files text in the gray section header is selected. 

 

Eligibility Documentation (Locations List):

Applies to all covered entities. 

This section pulls over all locations (parent site and child-sites when applicable) from the OPAIS sync. Confirm that no outstanding discrepancies impact the site locations. Once confirmed, click the Add To Documents button to create an Excel document that includes the 340B IDs, names, and addresses for each site.  

To download the Locations List Excel, click the Download Files text in the gray section header. You may choose to upload additional documents into this section to memorialize what will be given to the auditor.

To upload documents, click the Upload New File button and select the file(s). Once added, documents can be given a description and a status (In Review and Ready to Upload). These documents will also pull a the zip file if the Download Files text in the gray section header is selected. 

 

Eligibility Documentation (Medicare Cost Report):

Applies to hospital covered entities. 

This section pulls over all documents that have been uploaded within the Medicare Cost Report workscreens and displays the Cost Report period, Available Documents, and Active Issues. Clicking the period timeframe will direct you to the given workscreen, clicking the document name will download the document, and clicking the issue count will direct you to the issues listing. When selecting which documents to provide to the auditor, select the cost report(s) relevant to the sample period. 

Because the linked documents reflect what is available within the associated Cost Reports, you may choose to re-upload them into this section to memorialize what will be given to the auditor. 

To upload documents, click the Upload New File button and select the file(s). Once added, documents can be given a description and a status (In Review and Ready to Upload). These documents wil pull into a zip file if the Download Files text in the gray section header is selected. 

 

Eligibility Documentation (Trial Balance):

Applies to hospitals with child-sites. 

This section pulls over the Child-Site Crosswalks associated with each Medicare Cost Report workscreens. To download a copy of the Child-Site Crosswalk spreadsheet, click the Download Excel button. 

Once reviewed and any additional changes made, you may choose to upload the crosswalk and trial balance into this section to memorialize what will be given to the auditor. 

To upload documents, click the Upload New File button and select the file(s). Once added, documents can be given a description and a status (In Review and Ready to Upload). These documents will pull into the zip file if the Download Files text in the gray section header is selected.

 

Eligibility Documentation (Indigent Care Agreement and Proof of Non-Profit Status):

Applies to non-governmental hospitals only. 

This section pulls over all documents that have been uploaded within the Indigent Care Agreement workscreens and displays the Record Name, Available Documents, and Active Issues. Clicking the Record name will direct you to the given workscreen, clicking the document name will download the document, and clicking the issue count will direct you to the issues listing. 

Because the linked documents reflect what is available within the associated Indigent Care Agreement workscreens, you may choose to re-upload them into this section to memorialize what will be given to the auditor.

To upload documents, click the Upload New File button and select the file(s). Once added, documents can be given a description and a status (In Review and Ready to Upload). These documents will pull into a zip file if the Download Files text in the gray section header is selected.

 

Eligibility Documentation (Proof of Ownership):

Applies to governmental hospitals only. 

There is not an associated workscreen to which it links; however, it can be uploaded into this section, as a working document as well as a final once completed, to maintain organization during and after the data collection process. 

To upload documents, click the Upload New File button and select the file(s). Once added, documents can be given a description and a status (In Review and Ready to Upload). These documents will pull into the zip file if the Download Files text in the gray section header is selected.

 

Eligibility (Notice of Grant Award):

Applies to grantees only. 

This section pulls over all documents that have been uploaded within the Grants workscreens and displays the Grant Number, Available Documents, Budget Period, Sub-Grant, and Active Issues. Clicking the grant number will direct you to the given workscreen, clicking the document name will download the document, and clicking the issue count will direct you to the issues listing. 

Because the linked documents reflect what is available within the associated policies and procedures workscreens, you may choose to re-upload them into this section to memorialize what will be given to the auditor.

To upload documents, click the Upload New File button and select the file(s). Once added, documents can be given a description and a status (In Review and Ready to Upload). These documents will pull into a zip file if the Download Files text in the gray section header is selected.

 

340B Universe:

Applies to all covered entities. 

The included table provides an overview of the elements that should be included within the 340B Universe. 

Because the 340B Universe changes constantly, there is not an associated workscreen to which it links. However, it can be uploaded into this section, as a working document as well as a final once completed, to maintain organization during and after the data collection process. 

To upload documents, click the Upload New File button and select the file(s). Once added, documents can be given a description and a status (In Review and Ready to Upload). These documents will pull into a zip file if the Download Files text in the gray section header is selected.

 

Provider List:

Applies to all covered entities. 

Because the Provider list changes regularly, there is not an associated workscreen to which it links. However, it can be uploaded into this section to maintain organization during and after the data collection process. 

To upload documents, click the Upload New File button and select the file(s). Once added, documents can be given a description and a status (In Review and Ready to Upload). These documents will pull into a zip file if the Download Files text in the gray section header is selected.

 

Drug Purchasing Documentation:

Applies to all covered entities. 

There is not an associated workscreen to which it links. However, it can be uploaded into this section to maintain organization during and after the data collection process. 

To upload documents, click the Upload New File button and select the file(s). Once added, documents can be given a description and a status (In Review and Ready to Upload). These documents will pull into a zip file if the Download Files text in the gray section header is selected.

 

Contract Pharmacy Documentation:

Applies to all covered entities with contract pharmacies. 

This section pulls over all documents that have been uploaded within the Pharmacy Services Agreements (PSA) workscreens and displays the Record Name, Available Documents, number of included pharmacies and child-sites and Active Issues. Clicking the Record name will direct you to the given workscreen, clicking the document name will download the document, and clicking the issue count will direct you to the issues listing. 

Because the linked documents reflect what is available within the associated PSA workscreens (and will likely require highlighting), you may choose to re-upload them into this section to memorialize what will be given to the auditor.

To upload documents, click the Upload New File button and select the file(s). Once added, documents can be given a description and a status (In Review and Ready to Upload). These documents will pull into a zip file if the Download Files text in the gray section header is selected.

 

Self-Disclosure Documentation:

Applies to all covered entities. 

There is not an associated workscreen to which it links. However, it can be uploaded into this section to maintain organization during and after the data collection process. 

To upload documents, click the Upload New File button and select the file(s). Once added, documents can be given a description and a status (In Review and Ready to Upload). These documents will pull into the zip file if the Download Files text in the gray section header is selected.

 

Medicaid Billing Documentation:

Applies to all covered entities. 

This section pulls over all sites and their associated NPIs from the OPAIS Sync. Confirm that no outstanding discrepancies impact the Medicaid information. Once confirmed, click the Add To Documents button to create an Excel document that includes the 340B IDs and their NPIs. 

To upload documents, click the Upload New File button and select the file(s). Once added, documents can be given a description and a status (In Review and Ready to Upload). These documents will pull into the zip file if the Download Files text in the gray section header is selected.

 

Re-Audit Documentation:

Applies to all covered entities who have previously been audited by HRSA. 

This section is for documentation related to all previous HRSA audits. The CE should provide a description and supporting documentation of how it determined the full scope of the non-compliance as well as a list of all affected manufacturers, letters sent to the manufacturers offering repayment and the list of settlements.  The supporting documentation for Areas for Improvement, Notices of Disagreement and Corrective Action Plans must also be included.

To upload documents, click the Upload New File button and select the file(s). Once added, documents can be given a description and a status (In Review and Ready to Upload). These documents will pull into the zip file if the Download Files text in the gray section header is selected. 

 

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