The role of the Prostheses List Advisory Committee (PLAC) is to provide recommendations to the Minister for Health and Ageing on the listing of products on Part A of the Prostheses List and the benefits payable for them.
The purpose of the PLAC bulletin is to provide stakeholders to the prostheses arrangements with information relevant to current and future Prostheses Lists. The Bulletin is posted on the Prostheses page of the Department of Health and Ageing’s website and can be found at the following address: http://www.health.gov.au/internet/main/publishing.nsf/Content/privatehealth-pdc-bulletin.htm
Conflicts of Interest
PurposeTo provide an update on the approach that the Prostheses List Advisory Committee (PLAC) has recently agreed for future consideration of potential conflicts of interest arising in respect of Clinical Advisory Group (CAG), Panel of Clinical Experts (PoCE), or PLAC members.
IssuesThe PLAC has noted that there is an increasing trend for medical device sponsors to engage clinicians to assist in horizon scanning, design of clinical trials, identification of gaps in the market place, and review of existing product lines to identify cost effective enhancements.
The Prostheses Secretariat and PLAC greatly value the expertise of experienced clinicians, and consequently we are developing guidelines that will allow us to assess risks and actively manage potential conflicts of interest.
The aim is to ensure that the depth of expertise available to consider new CAG and PoCE prostheses applications, and provide expert advice on issues at Prostheses meetings, is maintained, without actual or perceived conflicts of interest compromising the results.
The PLAC has agreed to implement some risk management based procedures to assess risks, and actively manage potential conflicts.
|Examples||Travel grants to attend training or present at conferences||Sponsor Advisory Board|
Direct financial interest
(held by member or their spouse/partner)
|Assess risk |
Develop mgt plan
|PLAC to assess impact on CAG/PoCE work. |
In event direct conflict agreed by PLAC, member invited to divest shares or withdraw
BackgroundOn 20 December 2010, the PLAC Chair wrote to all PoCE and CAG clinicians seeking an updated Disclosure of Interest form, with a higher level of detail than previously sought.
The Prostheses Secretariat is continuing to review these disclosures as they are received, and they will undertake a preliminary risk evaluation against the matrix above.
The PLAC has requested that the Secretariat present this assessment at the PLAC meeting on 12 May 2011 to facilitate discussion and agreement on the level of risk associated with potential conflicts; and agree an intervention strategy where it is warranted. As new members are appointed and current members are re-appointed, updated declarations will be reviewed in the same manner.
Any enquiries from members or stakeholders about these interim arrangements should be directed to the Chair of the PLAC for consideration.
Restructure of the Prostheses SectionThe Prostheses Section, Private Health Insurance Branch, has been restructured. Roles and responsibilities are as follows:
Prostheses List Management Team – Director: Samantha Harris (02) 6289 4998
- PLAC secretariat
- Consultative Committee secretariat
- Database management and development
- CAG secretariat: Vascular, Ophthalmic, Cardiac, Urogenital, Vascular
- Panel of Clinical Experts Secretariat: Neurosurgical, General and Miscellaneous, Plastic and Reconstructive and ENT
- HTA Review implementation
- CAG secretariat: Hip, Knee, Specialist Orthopaedic, Cardiothoracic, Spinal
- Part B – Human Tissue
- HTA Review implementation
Implementation of Recommendation 12 b – e of the Health Technology Assessment Review will be completed by the Clinical Assessment Teams.
Application Assessment Process TimelineThe attached application timeline (Diagram 1) has been developed to improve the transparency of the Prostheses Listing arrangements and to assist stakeholders with their understanding and management of the continuous application process.
The key dates provided (Table 1) relate to new applications for the February 2012 Prostheses List.
The timeline and key dates will also be included on the Department’s website.
- Diagram 1: Clinical Advisory Groups (CAG) and Panel of Clinical Advisory Experts (PoCE) Clinical Evaluation (PDF 66 KB)
- Table 1: Cut-off dates for clinical assessment for the February 2012 Prostheses List (PDF 152 KB)