Billing codes (expansion/compression only)
Where the application is an expansion of an existing Billing code (Tier 1 or 2 only), enter the Billing code to be expanded.
Where the application is a compression of an existing Billing code (Tier 1 or 2 only), enter the Billing code to be compressed.
Billing codes (new/amendment)
You will need to enter one or more proposed, resultant Billing codes for your application.
Select the ‘Add row’ button to add a product to the list.
The Edit pop-up will be displayed. The sections and fields on this screen will differ based on the application pathway. The guidance for each pathway is in a separate section below.
You can use the following links to jump to the relevant pathway:
In this section:
Billing code (amendments only)
For an amendment, provide the Billing code to be amended. The selection of a Billing code will pre-fill information in the product details page.
Product name
The product name is the name the product is sold under in Australia. If the product is a system or kit, provide the name of the system or kit and the component within the product name.
The information you provide for Product Name will be available on the Prescribed List should your application be successful.
Description
The information you provide for Description will be available on the Prescribed List should your application be successful.
Provide information that is specific to the product including: model number, descriptor for the product and components of the product, composition and any special features.
Size/Size range
Provide the size or size range for the proposed Billing code.
This section asks about the regulatory status of your medical device through the Therapeutic Goods Administration (TGA).
Australian Register of Therapeutic Goods (ARTG) ID refers to:
- An ARTG ID is a number given to products entered and current on the ARTG.
- You can find your ARTG entry on the Therapeutic Goods Administration Certificate of Inclusion on the Register
- Only products entered on the ARTG can be listed on the Prescribed List, but applications can be lodged if an ARTG inclusion application is in progress (parallel processing).
For an amendment application, you will be asked if you are modifying regulatory information. If you select No then you will not be required to complete the remainder of this section.
Does your device have ARTG ID/’s? (new item only)
Select ‘Yes’ if your device already has an ARTG ID.
Please enter relevant ARTG IDs
If you selected ‘Yes’ above, you will need to enter the relevant ARTG IDs, Product name, GMDN code/term and Manufacturer.
Please enter relevant Application IDs
If you selected ‘No’ above, you will need to enter the relevant ARTG Application IDs, Product name GMDN code/term and Manufacturer to confirm that your ARTG inclusion application is in progress.
For an amendment application, you will be asked if you are modifying catalogue numbers. If you select No then you will not be required to complete the remainder of this section.
Catalogue numbers will be added via a spreadsheet upload.
To add catalogue numbers for your proposed Billing code, select download catalogue items to download the spreadsheet template (it will be pre-filled with catalogue numbers if there are already rows in this section).
Enter information in the blue fields/rows. To add more rows, select insert rows above within Excel.
Save the Excel file locally. Once you have finished entering the catalogue numbers, select the upload catalogue items button, and select your locally saved file.
The catalogue numbers will be uploaded. This will take a few minutes, but you can continue to fill out the form. You will need to wait for the catalogue numbers to be uploaded before you can move to the comparators section.
Please note that this section will only accept a single document upload.
For an amendment application, you will be asked if you are modifying grouping information. If you select No then you will not be required to complete the remainder of this section.
Category
Select the relevant category in which the product should be listed. If the product fits into more than one category, list the category that will represent the greatest use of the product as only one Billing code can be allocated to the product.
Subcategory
Select the relevant subcategory in which the product should be listed, from the subcategories pre-populated from the selected category.
Group
Indicate in which group the product should be listed.
Subgroup
Indicate in which sub-group the product should be listed, if there are sub-groups available within the selected group.
Suffix
Indicate in which suffix the product should be listed, if there are suffixes available within the selected subgroup.
Benefit amount
Selection of an existing grouping will pre-populate the Benefit amount as read only.
For a Tier 1 application, a new benefit amount cannot be specified.
A comparative product may be similar in form or function to your product. For tier 1 applications, comparators must be selected from the Prescribed List.
For each comparator, you will need to compile the evidence of how the comparator differs to your product, across all components including description, size, material.
This replaces the need for you to complete and lodge a separate comparator comparison table as a document or spreadsheet.
Add a comparator by selecting the relevant PL item from the pop-up. Once you have selected the PL billing code, select ‘Edit’ from the drop-down menu against the row and open the comparator pop-up. Here you will be able to compare your product to the comparator product, against all attributes.
Note that if you do not have comparator information for adverse events or contraindications, you can mark this as unavailable within these attributes.
MBS contains a listing of all the Medicare professional services subsidised by the Australian Government.
- To be eligible for the Prescribed List, your product must have an MBS listed service for either the implantation or application of the product.
At least 1 MBS item must be added, and no more than 4 can be added to your product. If there are more than 4 relevant MBS items, please enter the most relevant items.
MBS items can be selected from the MBS by selecting the Add MBS item button and searching for the relevant MBS item. You will also be required to add a reason against each MBS item.
Documentation can be entered here or at the Application level.
Supporting documentation required includes:
- Instructions for use
- Product information including a product brochure including references to all catalogue numbers related to the device
- Surgical technique
Please refer to the PL Guide for guidance on the required evidence for a tier 1 application.
In this section:
Billing code (amendments only)
For an amendment, provide the Billing code to be amended. The selection of a Billing code will pre-fill information in the product details page.
Product name
The product name is the name the product is sold under in Australia. If the product is a system or kit, provide the name of the system or kit and the component within the product name.
The information you provide for Product Name will be available on the Prescribed List should your application be successful.
Description
The information you provide for Description will be available on the Prescribed List should your application be successful.
Provide information that is specific to the product including: model number, descriptor for the product and components of the product, composition and any special features.
Size/Size range
Provide the size or size range for the proposed Billing code.
This section asks about the regulatory status of your medical device through the Therapeutic Goods Administration (TGA).
Australian Register of Therapeutic Goods (ARTG) ID refers to:
- An ARTG ID is a number given to products entered and current on the ARTG.
- You can find your ARTG entry on the Therapeutic Goods Administration Certificate of Inclusion on the Register
- Only products entered on the ARTG can be listed on the Prescribed List, but applications can be lodged if an ARTG inclusion application is in progress (parallel processing).
For an amendment application, you will be asked if you are modifying regulatory information. If you select No then you will not be required to complete the remainder of this section.
Does your device have ARTG ID/’s? (new item only)
Select ‘Yes’ if your device already has an ARTG ID.
Please enter relevant ARTG IDs
If you selected ‘Yes’ above, you will need to enter the relevant ARTG IDs, Product name, GMDN code/term and Manufacturer.
Please enter relevant Application IDs
If you selected ‘No’ above, you will need to enter the relevant ARTG Application IDs, Product name GMDN code/term and Manufacturer to confirm that your ARTG inclusion application is in progress.
For an amendment application, you will be asked if you are modifying catalogue numbers. If you select No then you will not be required to complete the remainder of this section.
Catalogue numbers will be added via a spreadsheet upload.
To add catalogue numbers for your proposed Billing code, select download catalogue items to download the spreadsheet template (it will be pre-filled with catalogue numbers if there are already rows in this section).
Enter information in the blue fields/rows. To add more rows, select insert rows above within Excel.
Save the Excel file locally. Once you have finished entering the catalogue numbers, select the upload catalogue items button, and select your locally saved file.
The catalogue numbers will be uploaded. This will take a few minutes, but you can continue to fill out the form. You will need to wait for the catalogue numbers to be uploaded before you can move to the comparators section.
Please note that this section will only accept a single document upload.
For an amendment application, you will be asked if you are modifying grouping information. If you select No then you will not be required to complete the remainder of this section.
Category
Select the relevant category in which the product should be listed. If the product fits into more than one category, list the category that will represent the greatest use of the product as only one Billing code can be allocated to the product.
Subcategory
Select the relevant subcategory in which the product should be listed, from the subcategories pre-populated from the selected category.
Are you a proposing a new Group for this device?
If you answer ‘Yes’ above, you will need to enter the proposed new group name and proposed new subgroup name.
If you answer ‘No’ above, you will need to indicate in which existing group the product should be listed.
Are you a proposing a new Subgroup for this device?
If you answer ‘Yes’ above, you will need to enter the proposed new group name and proposed new subgroup name.
If you answer ‘No’ above, you will need to indicate in which existing sub-group the product should be listed, if there are sub-groups available within the selected group.
Suffix (not required if new grouping has been proposed)
Indicate in which suffix the product should be listed, if there are suffixes available within the selected subgroup.
Benefit amount
Selection of an existing grouping will pre-populate the Benefit amount as read only.
If you have selected an existing grouping but wish to propose a new benefit amount, or you have proposed a new grouping, you will need to enter the proposed benefit amount.
If you have proposed a new grouping, you will need to answer the following:
Is the device sold to public hospitals?
If yes, provide details of the cost to public hospitals.
If no, you will be asked:
Is your device sold in Canada, France, New Zealand, Singapore or the United Kingdom?
If yes, you will be required to provide detail of the devices use and cost in one or more of these countries.
Does your device result in different clinical outcomes compared to the comparator?
If ‘Yes’ enter any measured evidence of different clinical outcomes which would occur from use of this product
Does your device result in different cost effectiveness compared to the comparator?
If ‘Yes’ enter any measured evidence of different cost efficiency outcomes which would occur from use of this product
A comparative product may be similar in form or function to your product. For tier 2 and 3 applications, comparators can be selected from the Prescribed List, from the MBS, or be a non-PL and non-MBS comparator.
For each comparator, you will need to compile the evidence of how the comparator differs to your product, across all components including description, size, material.
This replaces the need for you to complete and lodge a separate comparator comparison table as a document or spreadsheet.
Add a PL comparator by selecting the relevant PL item from the pop-up. Once you have selected the PL billing code, select ‘Edit’ from the drop-down menu against the row and open the comparator pop-up. Here you will be able to compare your product to the comparator product, against all attributes.
Note that if you do not have comparator information for adverse events or contraindications, you can mark this as unavailable within these attributes.
MBS contains a listing of all the Medicare professional services subsidised by the Australian Government.
- To be eligible for the Prescribed List, your product must have an MBS listed service for either the implantation or application of the product.
At least 1 MBS item must be added, and no more than 4 can be added to your product. If there are more than 4 relevant MBS items, please enter the most relevant items.
MBS items can be selected from the MBS by selecting the Add MBS item button and searching for the relevant MBS item. You will also be required to add a reason against each MBS item.
Documentation can be entered here or at the Application level.
Supporting documentation required includes:
- Instructions for use
- Product information including a product brochure including references to all catalogue numbers related to the device
- Surgical technique
Please refer to the PL Guide for guidance on the required evidence for a tier 2 or 3 application.