Printable version of PLAC Bulletin 17 (PDF 286 KB)
At its meeting on 14 May 2014, the PLAC endorsed a protocol for a process to remove items from the Prostheses List, where items have been incorrectly listed. The protocol is attached to this Bulletin.
The PLAC indicated that the process was logical and addressed procedural fairness appropriately. The PLAC would like to review the process in 12 months’ time.
The Department intends to implement this process from 1 July 2014.
If stakeholders have comments or concerns they should contact Megan Parrish, whose contact details are below.
Email: Megan Parrish
Phone: (02)6289 8512
Protocol for removal of items from the Prostheses ListFrom time to time, devices are listed on the Prostheses List in an incorrect grouping or are listed in error.
In order to address this, the Prostheses List Advisory Committee (PLAC) has approved the following process which will be followed when these matters come to light.
When a device has been identified as being incorrectly grouped or incorrectly listed, the Department of Health (the Department) will:
- Seek expert opinion from the relevant Clinical Advisory Group (CAG) or Panel of Clinical Experts (PoCE);
- If the CAG/POCE agree that the device is correctly listed, there will be no further action;
- If the CAG/PoCE agree that the device is incorrectly listed, the Department will ensure that the reasoning is appropriately recorded;
- The Department will then contact the relevant sponsor and provide the CAG/PoCE advice;
- If the sponsor agrees with the CAG/PoCE advice, the Department will prepare a brief for the PLAC to enable a decision to be made and taken into consideration when a new List is prepared for the Minister for Health’s approval;
- If the sponsor does not agree with the CAG/PoCE advice, an opportunity will be provided for the sponsor to present information for the CAG/PoCE to consider;
- If the CAG/PoCE agree that the information provided by the sponsor supports the continuation of the status quo, the sponsor will be informed, and no further action will be taken;
- If the information provided by the sponsor does not change the decision of the CAG/PoCE, then the sponsor will be informed that a brief will be prepared for PLAC in order that a formal recommendation to the Minister for Health be made;
- A brief will be prepared for PLAC. If PLAC agrees that a device should be in a different group, or should be removed from the List, then advice will be provided to the Minister for Health for consideration for the making of the next Prostheses List.
- The sponsor will be advised of the PLAC decision.