Submissions-Fall 2023 and Spring 2024

Working with Submissions

A utilization file contains prescription (Rx) utilization data. Prescription utilization data is submitted by a Contract entity (Pharmacy Benefit Managers (PBMs), States) to a Manufacturer to verify that it has met the defined Contract terms; therefore, the entity must receive the required rebate amount per the Contract term. The Utilization data typically includes information such as the number of prescriptions filled, the quantity of medication dispensed, and the total amount of drug costs incurred by patients. 

The Validata can process the following three types of utilization files:

• Non-Coverage Gap files
  A Non-Coverage Gap utilization file is a file in .txt, .ncpdp, .csv format, containing the prescription utilization data. Each file can vary in scope and format. For example, one file may contain information about the provider of the data and the prescription-level data, and a second file may contain only the prescription-level data. Utilization files can also vary in what data is contained in and the order in which it is given. Standard utilization files can include commercial, Medicaid, and commercial-medical benefit transactions.
• Coverage Gap data files
  A Coverage Gap data file is a flat file, a text document with no formatting structure, containing prescription data, service provider data, and gap discount amounts for Coverage Gap transactions. Due to Health Care Reform, manufacturers are required to pay 50% of the Medicare Part D Coverage Gap, but they also have the option to dispute payments that may be invalid. The data file is used for the dispute process.  
• Coverage Gap invoice files
  A Coverage Gap invoice file is a flat file, a text document with no formatting structure, containing invoice data, manufacturer data, and total gap discount amounts for Coverage Gap transactions. Due to Health Care Reform, manufacturers must pay 50% of the Medicare Part D Coverage Gap. Payments are made based on the invoice file.

Model N Validata application allows the Manufacturer to load the Utilization file to the application as a Submission using the Standard NCPDP (National Council for Prescription Drug Programs) Mapping Set or the custom format using the custom Mapping set, validate the utilization data, and proceed with further downstream processing. 

This section covers the complete end-to-end details about Submission to provide a broad context for this new feature. As a starting point, a visual depiction of the process is provided here:

This section provides the details and linked user documentation pages for every associated functionality. 

The PBMs and States submit the prescription-level utilization with the Manufacturer to be processed for rebate processing. After receiving  Utilization data from the submitters, the Manufacturer must save it to a file folder in their local system or in the Disk File System accessible by the Validata application.

Model N Validata application allows the Manufacturer to import the Utilization files to the application as a Submission. A Validation Analyst can create a Submission including one or more than one utilization files. When creating a new Submission in the system, the Validation Analyst can choose whether it is a Coverage Gap Submission or a Non-Coverage Gap Submission by using the Is this submission Coverage Gap? user input. Further, for a Coverage Gap Submission, the Analyst can choose the type of files included in the Submission: Data or Invoice. For detailed documentation about creating a Submission, Adding a New Non-Coverage Gap Submission and Adding a New Coverage Gap Submission.

The utilization files are imported into the Validata application using a standard NCPDP (National Council for Prescription Drug Programs) or custom Mapping Set. The Mapping set tells the Validata application what data is contained in the Utilization line and where to store the data. Once the Utilization data has been imported, it can be validated. For detailed documentation about Mapping Set, see the Mapping Sets documentation.

By opening the newly created Submission from the Submissions list table, the Validation Analyst can view the file uploading progress and status. The count of files successfully loaded to the application, the file details, the count of lines in the Submission, and the line level details. The Analyst can also perform actions like adding new files to the Submission, changing the medical benefit, mapping sets, and 340B settings for the uploaded files. For detailed documentation about imported files, see Viewing Files Included in the Submission. The Analyst can view the imported utilization lines to the Submission before proceeding with Submission validation. See Viewing the Line Level Details For Non-Coverage Gap Submission and Viewing Data Lines for Coverage Gap Submission.

When the file upload is completed, the Utilization lines are ready to be validated against a Validation Set. When creating the Submission, the Analyst can either opt-in to auto-run validation when the line upload is completed or else the Analyst can manually run Validation later on. On the Submission details page, the Run Validation is shown, which allows the Validation to start the validation. The lines are validated using a Validation Set. The Validation Set tells the Validata application, using which Rule Set, the accuracy of the submitted data in the Utilization lines will be validated and how the errors should be handled for the encountered Utilization lines. You can choose from the three severity levels for each possible error: Warning, Major and Critical. For detailed documentation about Validation Sets, see Validation Sets. For detailed documentation about Submission validation, see Validating a Submission.

When Submission is validated using a Validation Set, and the submitted utilization line is not stamped with an Error Code of severity level Critical or Major, the line is assigned an Included status. When the submitted utilization line is stamped with an Error Code of severity level Critical or Major, the line is assigned an Excluded status. On the Line Level Details page, the Analyst can override the status of a line from excluded to included/included to excluded and override one or more records to a lower severity by selecting the lines. For detailed documentation, see Overriding Submission Line's Validation Result.

When all validations have been run and the utilization lines are validated and summarized, publish the utilization lines using the export Mapping Set in Validata. Using the Publish option, the Validation Analyst can create a Submission in the downstream processing Payer application for the validated lines. A Submission is auto-created in the Payer application.Using the Export option, the Analyst can export the validated submission lines. The exported .txt file containing the exported lines will be displayed on the Exports tab in the Publish window. The Analyst can later download the .txt file and use it for processing in the Payer application. For detailed documentation about Publishing Submission, see Publishing a Submission.

Now that we learned about the Submission process flow let's see what features and functionalities are available on the Submissions module and what actions users can perform on the Submission module. ​​​​​​

Navigate to the articles in the below tabs to view the detailed documentation about every feature.