ADR Petitions

The system displays the fields to enter the petition details.

Petition Details section – Fields

Item	Description
Filing Status	Indicate if the Filing Status is “Individual” or “Joint”
Covered Entity 340B IDs	List the 340B ID A unique identification number assigned by OPA to each covered entity parent or child site (e.g., child site, subdivisions, or sub-grantees).(s) from the submitted petition
Manufacturer Name and Labeler Codes	List the Labeler Code(s) from the submitted petition
Date of Alleged Violation	Enter the date of alleged violation from the petition
HRSA Summary of the Petition	Type a summary of the issue
Estimate of Monetary Damages	Enter the amount of monetary damages. Only numeric values are allowed.

You can view and update the Petitioner organization and contact information in the Contacts section.

For entering a new Petitioner Contact, click Reset and enter the contact email. If it is a new contact then enter the Name, Phone, Title, and Organization of the petitioner.

In this section, you can enter narrative description of the issue and upload relevant documentation, summary of good faith efforts, and information on estimate of monetary damages.

Petitioner Narrative Details section – Fields

Item	Description
Petitioner Narrative	Upload the document containing the Petitioner Narrative
Petitioner Narrative Notes	Add optional comment relevant to the Petitioner Narrative
Good Faith Summary	Upload the document containing the Good Faith Summary
Good Faith Summary Notes	Add optional comment relevant to the Good Faith Summary
Estimate of Monetary Damages Document	Upload the document containing information about the monetary damages
Estimate of Monetary Damages Notes	Add optional comment relevant to the Monetary Damages document

Once you have uploaded a document to any one of the fields, the document will also show up as an attachment for selection under the other two fields. If you have a single document that contains information on all three items, then you can upload the document once and select the uploaded attachment for the other fields.

In this section, you can upload the supporting documents to the ADR petition. Only the following document folders are available to the Petitioner for uploading additional documentation:

• Petition

• Invoices

• Incorrect 340B Correspondence

• 340B Prices

• Communications with Wholesalers & Manufacturers

• Communications with HRSA OPA

• Additional Information – Petitioner

You can only view documents uploaded by the Opposing to the following document folders:

• Opposing Supporting Documentation

• Additional Information – Opposing

Document section – Fields

Item	Description
Folder Name	Displays the Name of the Folder
Last Updated On	Displays the date when the folder was last updated
Document Count	Displays number of attachments in the folder
Upload	Click on this button to upload a document to the folder. Access to upload documents to each folder depends on the role by which you are editing the petition.
View Folder	Click on this button to view the folder contents

Select the Upload button on the appropriate folder to add the relevant attachments. In the upload Document dialog box, select the document(s) to be uploaded. You can add an optional comment.

The maximum file size allowed for upload is 100 MB and the allowed file types are .doc,.docx,.pdf,.csv,.wpd,.ppt,.pptx,.txt,.xls,.xlsx,.jpg,.png,.tif,.msg,.eml,.ics". (Word documents, Excel spreadsheets, PowerPoint presentations, PDF, image files, email messages, etc.)

The selected documents are uploaded temporarily and shown in the Documents Pending Upload section. You can select the Remove button, if you need to remove the uploaded file before saving the petition.

After reviewing the uploaded document information, click on Save at the bottom of the page to save the information updated in the Petition. The document count on the appropriate folder will be updated to reflect the uploaded documents.

You can select View Folder to view the individual documents in a folder.

View Folder – Fields

Item	Description
Uploaded On	Displays the date when the document was uploaded. The documents are sorted in descending order by this field.
Uploaded By	Displays the user or the user on whose behalf the document was uploaded
Comment	Displays an optional comment that was added when the document was uploaded
Document Name	Displays the name of the document
Actions	The Download action will allow you to download the document

You can add comments to the Petition using the Add Comment function from the Comments section.

Enter the text you want to add as Comment and Click on Add.

The text gets saved to the Petition as a Comment. You will be able to Remove or Edit the comment before you click on the petition Save button.

Comments section – Fields

Item	Description
Created On	Displays the date when the document was uploaded. The documents are sorted in descending order by this field.
Uploaded By	Displays the user or the user on whose behalf the document was uploaded
Comment	Displays an optional comment that was added when the document was uploaded
Document Name	Displays the name of the document
Remove	Click on Remove to delete the comment. Remove is not available after saving the comment.
Edit	Click on Edit to edit the comment. Edit is not available after saving the comment.

In the NDC A unique 11-digit, 3-segment code numeric identifier assigned to each medication listed under Section 510 of the US Federal Food, Drug, and Cosmetic Act. The segments identify the labeler or vendor, product (within the scope of the labeler), and trade package (of this product). The first segment (4 or 5 digits) is assigned by the Food and Drug Administration (FDA). The second segment (3 or 4 digits) identifies a specific strength, dosage form, and formulation for a particular firm. The third segment (1 or 2 digits) identifies package forms and sizes. Details section, you can enter the NDCs in question which belong to the labeler codes specified in the petition. You can enter one or more NDCs separated by commas or each one on a new line. The system validates if the entered NDC is not in the correct format; specifically, NDCs should be entered as 11 digits with no hyphens that includes leading zeros, e.g., 00777310502.

You can view and update the Opposing organization and contact information in the Contacts section.

For entering a new Opposing Contact, click Reset and enter the contact email. If it is a new contact then enter the Name, Phone, Title, and Organization of the Opposing.

In this section, you can upload the response to the petition from the Opposing and optional comment relevant to the document containing the Opposing response.

Opposing Narrative Details section – Fields

Item	Description
Petition Response	Upload the document containing the opposing party response to the petition
Petition Response Notes	Enter optional comment relevant to the petition response

In this section, you can upload the documents supporting the response to the ADR petition. Only the following document folders are available to the Opposing for uploading additional documentation:

• Opposing Supporting Documentation

• Additional Information – Opposing

You can only view documents uploaded by the Petitioner to the following document folders:

• Petition

• Invoices

• Incorrect 340B Correspondence

• 340B Prices

• Communications with Wholesalers & Manufacturers

• Communications with HRSA OPA

• Additional Information – Petitioner

The documents section shows the following information:

Document section – Fields

Item	Description
Folder Name	Displays the Name of the Folder
Last Updated On	Displays the date when the folder was last updated
Document Count	Displays number of attachments in the folder
Upload	Click on this button to upload a document to the folder. Access to upload documents to each folder depends on the role by which you are editing the petition.
View Folder	Click on this button to view the folder contents

Select the Upload button on the appropriate folder to add the relevant attachments. In the upload Document dialog box, select the document(s) to be uploaded. You can add an optional comment.

The maximum file size allowed for upload is 100 MB and the allowed file types are .doc,.docx,.pdf,.csv,.wpd,.ppt,.pptx,.txt,.xls,.xlsx,.jpg,.png,.tif,.msg,.eml,.ics". (Word documents, Excel spreadsheets, PowerPoint presentations, PDF, image files, email messages, etc.)

The selected documents are uploaded temporarily and shown in the Documents Pending Upload section. You can select the Remove button, if you need to remove the uploaded file before saving the petition.

After reviewing the uploaded document information, click on Save at the bottom of the page to save the information updated in the Petition. The document count on the appropriate folder will be updated to reflect the uploaded documents.

You can select View Folder to view the individual documents in a folder. The following table shows the fields displayed on View Folder section.

View Folder – Fields

Item	Description
Uploaded On	Displays the date when the document was uploaded. The documents are sorted in descending order by this field.
Uploaded By	Displays the user or the user on whose behalf the document was uploaded
Comment	Displays an optional comment that was added when the document was uploaded
Document Name	Displays the name of the document
Actions	The Download action will allow you to download the document

You can add comments to the Petition using the Add Comment function from the Comments section.

Enter the text you want to add as Comment and Click on Add.

The text gets saved to the Petition as a Comment. You will be able to Remove or Edit the comment before you click on the petition Save button.

Comments section – Fields

Item	Description
Created On	Displays the date when the document was uploaded. The documents are sorted in descending order by this field.
Uploaded By	Displays the user or the user on whose behalf the document was uploaded
Comment	Displays an optional comment that was added when the document was uploaded
Document Name	Displays the name of the document
Remove	Click on Remove to delete the comment. Remove is not available after saving the comment.
Edit	Click on Edit to edit the comment. Edit is not available after saving the comment.

The system displays the fields to enter the petition details.

MFR Petition Details section – Fields

Item	Description
Initiated Date	Enter the date the petitioner submitted the petition.
Filing Status	Indicate if the Filing Status is “Individual” or “Joint”
Manufacturer Name and Labeler Codes	List the Labeler Code(s) from the submitted petition
Covered Entity 340B IDs	List the 340B ID(s) from the submitted petition
Date of Alleged Violation	Enter the date of alleged violation from the petition
HRSA Summary of the Petition	Type a summary of the issue
Estimate of Monetary Damages	Enter the amount of monetary damages. Only numeric values are allowed.

You can view and update the Petitioner organization and contact information in the Contacts section.

For entering a new Petitioner Contact, click Reset and enter the contact email. If it is a new contact then enter the Name, Phone, Title, and Organization of the petitioner.

In this section, you can enter narrative description of the issue and upload relevant documentation, summary of good faith efforts and information on estimate of monetary damages.

Petitioner Narrative Details section – Fields

Item	Description
Petitioner Narrative	Upload the document containing the Petitioner Narrative
Petitioner Narrative Notes	Add optional comment relevant to the Petitioner Narrative
Good Faith Summary	Upload the document containing the Good Faith Summary
Good Faith Summary Notes	Add optional comment relevant to the Good Faith Summary
Estimate of Monetary Damages Document	Upload the document containing information about the monetary damages
Estimate of Monetary Damages Notes	Add optional comment relevant to the Monetary Damages document

Once you have uploaded a document to any one of the fields, the document will also show up as an attachment for selection under the other two fields. If you have a single document that contains information on all three items, then you can upload the document once and select the uploaded attachment for the other fields.

In this section, you can upload the supporting documents to the ADR petition. Only the following document folders are available to the Petitioner for uploading additional documentation:

• Petition

• Audit Work Plan Attachment

• Audit Findings Summary

• Final Audit Report

• Communications with Medicaid Agency and MCOs

• Additional Information – Petitioner

You can only view documents uploaded by the Opposing to the following document folders:

• Opposing Supporting Documentation

• Additional Information – Opposing

The documents section shows the following information:

MFR Document section – Fields

Item	Description
Folder Name	Displays the Name of the Folder
Last Updated On	Displays the date when the folder was last updated
Document Count	Displays number of attachments in the folder
Upload	Click on this button to upload a document to the folder. Access to upload documents to each folder depends on the role by which you are editing the petition.
View Folder	Click on this button to view the folder contents

Select the Upload button on the appropriate folder to add the relevant attachments. In the upload Document dialog box, select the document(s) to be uploaded. You can add an optional comment.

The maximum file size allowed for upload is 100 MB and the allowed file types are .doc,.docx,.pdf,.csv,.wpd,.ppt,.pptx,.txt,.xls,.xlsx,.jpg,.png,.tif,.msg,.eml,.ics". (Word documents, Excel spreadsheets, PowerPoint presentations, PDF, image files, email messages, etc.)

The selected documents are uploaded temporarily and shown in the Documents Pending Upload section. You can select the Remove button, if you need to remove the uploaded file before saving the petition.

After reviewing the uploaded document information, click on Save at the bottom of the page to save the information updated in the Petition. The document count on the appropriate folder will be updated to reflect the uploaded documents.

You can select View Folder to view the individual documents in a folder.

MFR View Folder section – Fields

Item	Description
Uploaded On	Displays the date when the document was uploaded. The documents are sorted in descending order by this field.
Uploaded By	Displays the user or the user on whose behalf the document was uploaded
Comment	Displays an optional comment that was added when the document was uploaded
Document Name	Displays the name of the document
Actions	The Download action will allow you to download the document

In the Audit Details section, enter the Audit Date and the Audit ID of the Manufacturer Audit that should have been conducted on the Opposing entity.

Click on Add Audit Finding to select the finding and enter the other details about the audit finding such as Summary of Finding Details, MFR Proposed Solution and Covered Entity Response Summary.

Audit Details section – Fields

Item	Description
Audit Date	Enter the audit date
Audit ID	Enter the Audit ID for the Manufacturer Audit from Compliance
Finding	Select from “Diversion” or “Duplicate Discount Section 340B(a)(5)(A)(i) of the Public Health Service Act prohibits duplicate discounts; that is, manufacturers are not required to provide a discounted 340B price and a Medicaid drug rebate for the same drug. Covered entities must have mechanisms in place to prevent duplicate discounts. Upon enrollment in the 340B Program, covered entities must determine whether they will use 340B drugs for their Medicaid patients (carve-in) or whether they will purchase drugs for their Medicaid patients through other mechanisms (carve-out) in order to comply with the duplicate discount prohibition.”
Summary of Finding Details	Enter the summary of the finding details
MFR Proposed Solution	Enter the MFR Proposed Solution
Covered Entity Response	Enter the Covered Entity Response
Remove	Click Remove to delete the finding
Edit	Click Edit to update the finding details

You can view and update the Opposing organization and contact information in the Contacts section.

For entering a new Opposing Contact, click Reset and enter the contact email. If it is a new contact then enter the Name, Phone, Title, and Organization of the Opposing.

In this section, you can upload the response to the petition from the Opposing and optional comment relevant to the document containing the Opposing response.

Opposing Narrative Details section – Fields

Item	Description
Petition Response	Upload the document containing the opposing party response to the petition
Petition Response Notes	Enter optional comment relevant to the petition response

In this section, you can upload the documents supporting the response to the ADR petition. Only the following document folders are available to the Opposing for uploading additional documentation:

• Opposing Supporting Documentation

• Additional Information – Opposing

You can only view documents uploaded by the Petitioner to the following document folders:

• Petition

• Audit Work Plan Attachment

• Audit Findings Summary

• Final Audit Report

• Communications with Medicaid Agency and MCOs

• Additional Information – Petitioner

The documents section shows the following information:

Document section – Fields

Item	Description
Folder Name	Displays the Name of the Folder
Last Updated On	Displays the date when the folder was last updated
Document Count	Displays number of attachments in the folder
Upload	Click on this button to upload a document to the folder. Access to upload documents to each folder depends on the role by which you are editing the petition.
View Folder	Click on this button to view the folder contents

Select the Upload button on the appropriate folder to add the relevant attachments. In the upload Document dialog box, select the document(s) to be uploaded. You can add an optional comment.

The maximum file size allowed for upload is 100 MB and the allowed file types are .doc,.docx,.pdf,.csv,.wpd,.ppt,.pptx,.txt,.xls,.xlsx,.jpg,.png,.tif,.msg,.eml,.ics". (Word documents, Excel spreadsheets, PowerPoint presentations, PDF, image files, email messages, etc.)

The selected documents are uploaded temporarily and shown in the Documents Pending Upload section. You can select the Remove button if you need to remove the uploaded file before saving the petition.

After reviewing the uploaded document information, click on Save at the bottom of the page to save the information updated in the Petition. The document count on the appropriate folder will be updated to reflect the uploaded documents.

You can select View Folder to view the individual documents in a folder.

View Folder section – Fields

Item	Description
Uploaded On	Displays the date when the document was uploaded. The documents are sorted in descending order by this field.
Uploaded By	Displays the user or the user on whose behalf the document was uploaded
Comment	Displays an optional comment that was added when the document was uploaded
Document Name	Displays the name of the document
Actions	The Download action will allow you to download the document

You can add comments to the Petition using the Add Comment function from the Comments section.

Enter the text you want to add as Comment and Click on Add.

The text gets saved to the Petition as a Comment. You will be able to Remove or Edit the comment before you click on the petition Save button.

Comments section – Fields

Item	Description
Created On	Displays the date when the document was uploaded. The documents are sorted in descending order by this field.
Uploaded By	Displays the user or the user on whose behalf the document was uploaded
Comment	Displays an optional comment that was added when the document was uploaded
Document Name	Displays the name of the document
Actions	The Download action will allow you to download the document

The Activity tab contains a table that provides a chronological record of activities that occurred on the Petition. The activities are ordered in descending order.

Activity section – Fields

Item	Description
Date Time	Indicates the date and time when the activity occurred
User	Displays the user who performed the activity
Description	Displays a description of the activity. The activity can be adding or updating petition details, uploading attachments, sending email notifications to any of the parties related to the petition, adding, or updating contacts, updating any of the Statuses, adding comments, and adding or updating decision details.

The Petitioner Narrative section displays the documents uploaded to the petition under Petitioner Narrative, Good Faith Summary and Monetary Damages.

The Opposing Narrative tab displays the response attached to the petition from the Opposing Party along with any notes or comments.

The Documents tab displays the document folders with the petition supporting documents.

Document section – Fields

Item	Description
Folder Name	Petition Document folder name
Last Updated On	Date when an attachment was last uploaded in the folder
Last Updated By	Email address of the user who last uploaded to the folder
Document Count	Number of individual documents in the folder
Actions	View Folder – displays the individual documents in the folder

The comments tab contains a table that provides a chronological record of comments attached to the petition.

The NDC Details tab shows the NDCs in question that have been specified in the petition.

The Documents tab displays the document folders that contain the supporting documents submitted in the petition.

Document section – Fields

Item	Description
Folder Name	Petition Document folder name
Last Updated On	Date when an attachment was last uploaded in the folder
Last Updated By	Email address of the user who last uploaded to the folder
Document Count	Number of individual documents in the folder
Actions	View Folder – displays the individual documents in the folder

The Audit Details section displays the Audit Date and Audit ID of the Manufacturer Audit conducted on the Covered Entity.