Welcome to the Prescribed List mini clips with practical tips on submitting applications.
This is the first mini clip and we plan to continue with a few of these presentations aiming to assist sponsors with their applications and submissions.
In this first mini clip, we start with an introduction on applications for medical devices, how to choose the tier for the application assessment pathway under which you need to submit your prescribed list or in short, PL application, and a couple of other challenges the sponsors and the department face when we deal with PL applications.
This is not intended to be a comprehensive guidance on all possible questions, but rather a light touch on the commonly asked questions.
If you have human tissue products and you plan to apply to list them on the PL Part B, you still may wish to watch this introductory miniclip as the basic principles for submitting applications are similar across the PL.
Although the tiered application assessment pathways do not apply to the Part B applications, please refer to the draught of the Prescribed List Guide and Prescribed List Application Training Presentation for the links to these documents.
Please refer to the last slide for any devices or human tissue products.
If the sponsor wishes to list their device or human tissue product on the PL, the sponsor must prepare an application ensuring they have all required information.
They need to submit their application via the Health Products Portal HPP by the cut off date, pay an application fee and if prompted, respond to the Department and provide any information requested by the Department in respect to their application within the time stipulated by the department.
The Department does not accept applications sent or provided in any way other than the VIA HPP.
Sponsors are expected to submit complete applications with the correct information that allows and informs proper assessment at the time of lodgement.
Consistently with the above, Tier 1 applies to medical devices classified by the Therapeutic Goods Administration TGA as Class 2B.
They're well established and with well understood, stable designs and limited variations.
Applications for listing of the interchangeable very similar with comparable compare devices listed in the same PL grouping, IE have similar characteristics and are intended to be used in the established patient portal with the same indications and unlikely will cause any increase in the PO expenditure within the grouping.
Applications for the well known and well understood groups and subgroups.
For example, standard simple specialist orthopaedic plates acceptable for Tier one versus plates with the suffix COM or perieticular plates are required to be submitted under Tier 2 spinal non expandable non integral fixation fusion spaces Tier one versus spinal integral fixation cages or spinal expandable cages.
Tier 2 but Flamex devices with high number of variations.
Tier 2 Tier 1 is not applicable for PO applications for Class 3 or Part C applications, or for any applications for the devices, billing codes for which or comparators which are currently listed on the PL with a condition.
Sponsors may only apply for listing the device in one of the existing PL groupings.
The PL Guide provides example of devices from the PL categories according to the existing PL grouping structure that are considered as eligible for Tier 1 assessment pathways.
There may be some exceptions to the rules in certain circumstances.
However, it is the sponsor's responsibility to provide sufficient justification and convincing explanation to the Department on the rationale.
Where certain applications may be assessed under Tier One, while usually those devices or applications are expected to be submitted under Tier 2, the Department may agree or disagree with the reasoning provided.
After the department has completely transitioned to the new 3 tiered assessments, incorrectly submitted Tier One applications will usually be rejected.
The Tier 2 assessment pathway is intended for devices that are not suitable as far for assessment via the Tier 1 pathway and require assessment by the respective ECAG and in some error cases, HDA Consultant sponsors apply for Tier 2 pathway.
There are no separate application forms in HPP for 2A or 2B.
However, assessments will be conducted according to the information provided in the application, meaning the applications where sponsors apply for new groupings will require assessments under Tier 2B pathway.
The Tier 3 pathway is for devices requiring assessment by the MSAC in order to establish the comparative clinical effectiveness and cost effectiveness, and in some cases, assessment of the device is conducted as part of the assessment of the related Medicare service.
The PO application may be submitted prior to or concurrently with or subsequent to the MSAC application.
We aim to provide clear direction for each pathway in the PL Guide.
Where, after consideration of the guide, the appropriate pathway is still unclear, sponsors may contact the department seeking further advice.
Sponsors may consolidate applications for the related devices and submit multiple applications.
May be referred to as billing code applications under one application submission.
The aim of having this functionality in the HPP is to streamline the application and assessment process.
It is expected that there is a common source of information available and required to be assessed, For example, product brochure or surgical technique that covers all related devices.
If each device only has its own brochure or surgical technique and there are no common documents, such devices are not taken as related devices and accordingly, applications for such devices should not be consolidated in one submission.
Do not duplicate documents in your application.
HPP allows to attach documents at the application submission level.
This is for the common materials and at the billing code level.
If there are additional documents specific to a particular device, the Department and ECAD do not need the same documents attached with the application submission multiple times.
If you are not sure, please add a list of the documents into the executive summary with an explanation as to which document relates to what billing code application.
Please use common sense in the naming convention for your attachments so the Department and ECO can easily understand the nature of the attached documents.
There are a range of documents that you're required to submit for all of your applications.
The documents include A2 page executive summary.
This document is not promotional material.
Please use it as an opportunity to provide the mapping and references for your application.
Please include clear references where the required information can be found.
Manufacturer's product material must cover all devices in your application and or listed under the billing code as applicable.
If you cannot find some of your devices in the brochure attached, it is highly likely the Department and ECAG will not find these devices either.
If you do not have the required information for some of the devices, please remove the respective catalogue numbers from your application.
Please state the page numbers in the brochures where the information can be found.
We require the information to establish that the category, subcategory, group, subgroup, suffix stated in the application or billing code are correct for all devices and that all devices are acceptable to be listed under the same billing code.
We also will require that the billing codes, product name, description, and size are informative and correct.
When you provide images for the devices, they must be representative and easily identifiable and connected to all catalogue numbers required to be considered.
Please do not send us images for which no source of information is provided and which do not have reference to the catalogue numbers.
For Tier 2 applications, you are required to provide clinical data.
You are also required to provide economic evidence for applications under Tier 2B and Tier 3.
When assessing applications, the Department often receives files of large size that create difficulties when opening them.
Please ensure you only provide relevant information and clearly label your files.
Use common sense in the naming convention.
Please label clearly which brochure is for your subject device and which is for the comparator.
Please do not attach multiple brochures for the comparator.
Provide references to the relevant page number and sections in the document.
Do not attach any irrelevant documents.
For example, we do not need to see your certificates for the overseas regulatory approvals.
These documents are for the TGA, not for PL assessments.
Additionally, the department often receives files that cannot be accessed or considered.
Please make sure that documents are not password protected.
All documents must be provided in English.
To sum up, before submitting your application, Please ensure all devices in your application and or are listed under the billing code are grouped correctly and the billing codes, product name, description, size and ARTG entry also must be correct.
Thank you for watching this Miniclip.
Don't forget to visit the Draught Prescribed List guide on our website and look at the training presentation.
We will continue with other Miniclips in the series and we will invite you to watch them when they are ready.
If you have any questions after watching the Miniclip and reading the Draught Prescribed List guide, or you have any feedback on this video, send us an e-mail at prescribedlist at health.gov dot AU.