Key points
- The Prostheses List is now updated 3 times a year
- The process has recently changed and there is a lack of clarity
- An ongoing reform process is underway
[Note the following only describes applying for listing on Part A on the Prostheses List]
The Minister for Health is responsible under the Private Health Insurance Act 2007 for deciding whether to list a prostheses on the Prostheses List. The process is outlined in the Prostheses Guide but this is due for an update and some parts of the process have already changed.
At present, the process can be difficult to understand or plan for, and it is sometimes not clear why decisions have been made. Industry Working Groups established by the Minister for Health under the Agreement with MTAA are currently assessing ways to improve transparency and timeliness of the process.
Under Prostheses Reform the Minister for Health agreed to increase listing frequency for the List to three times a year (1 March, 1 July, and 1 November) from the previous two, to enable faster listing. As described below, this has been a ‘mixed blessing’ for speed to listing.
The company that manufactures or distributes the prosthesis (the sponsor) must make an application through the Prostheses List Management System (PLMS) and pay the accompanying fee of $600.
The sponsor must elect whether to request inclusion in an existing prostheses group, usually at the same benefit, or to apply to create a new group or suffix with potentially with a higher benefit.
Applications are then routed to the relevant Clinical Advisory Committee (CAG) (or the Panel of Clinical Experts (PoCE) if there is no specific CAG) which have clinical experts along with consumer and industry representatives. The CAG makes a recommendation on the clinical benefit of the device compared to available products, and whether the grouping requested by the company is appropriate.
The former Health Economic Sub-Committee (HESC), set up to examine the relative benefits and costs, has now been abolished and the Department has begun to commission external groups where the sponsor has requested a higher benefit, unless it is referred to MSAC (see below).
Recommendations by the CAGs and HESC are provided to the Prostheses List Advisory Committee (PLAC) for final recommendations to the Minister. The Minister is not bound by the recommendations, but generally follows them.
The submission process is changing and timelines are announced on a rolling basis but cut-off dates for applications are being set approximately:
- 9-11 weeks ahead of the CAG meetings
- 18 weeks ahead of the PLAC meeting
- 24 weeks ahead of the publication of the Prostheses List
While the change to three listings per year is generally welcome, timelines between application and listing are now longer in many cases and the process has become more rigid. Prior to the change there were two CAG meetings for every listing cycle. Now there is just one per cycle, which provides fewer opportunities to make applications.
There is an opportunity to speed up processing time for applications where the same grouping and benefit is being requested by a company. Proposals are currently under discussion as part of the Prostheses Reform Industry Working Group on Quality of Information and Guidance.
In addition to improvements to transparency and speed already mentioned, MTAA also considers the following to be issues with the current application process:
- The Department of Health sometimes refers applications for listing to the Medical Services Advisory Committee, which has much more complicated requirements than the PLAC process. This creates substantive and unanticipated hurdles for companies and can delay listing significantly
- Different types of value and innovation are sometimes not recognised, for example:
- physical attributes that lead to greater functionality and make healthcare delivery models more efficient;
- less invasive and improved patient experience because of device innovation
These points are also under discussion as part of the Prostheses Reform Industry Working Group on Revised Benefit Setting and Review Framework.
