Prostheses List Advisory Committee (PLAC) Bulletin 2

Bulletin number 2, January 2011

Page last updated: 13 January 2011

Printable version of Prostheses List Advisory Committee (PLAC) Bulletin 2 (PDF 38 KB)

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

Key Dates for August 2011 Prostheses List



9 February 2011Prostheses List Advisory Committee Meeting
End of FebruaryApplication Workshops (dates and venues to be advised)
10 March 2011Prostheses List Advisory Committee Meeting
15 March 2011Ongoing listing fees invoices to be sent
March/AprilCAG meetings
13 April 2011Prostheses List Advisory Committee Meeting
12 May 2011Prostheses List Advisory Committee Meeting
May/JuneCAG meetings
8 June 2011Prostheses List Advisory Committee Meeting
27 June 2011ARTG and MBS item numbers required for recommended new applications for the August 2011 Prostheses List
Early July 2011Letter to sponsors re: payment of initial listing fees/gaps
22 July 2011Deadlines for payment of initial listing fees
1 August 2011August 2011 Prostheses List scheduled to be released
11 August 2011Prostheses List Advisory Committee Meeting
15 August 2011August 2011 Prostheses List scheduled to commence

Prostheses List Guide and Application Forms

Stakeholders are advised to use the Guide and forms that are available on the Department of Health and Ageing website at
http://www.health.gov.au/internet/main/publishing.nsf/Content/health-privatehealth-prostheseslistforms

The Prostheses List Guide and/or Application Forms will be updated as required and stakeholders will be notified of any updates via a Private Health Insurance circular or a PLAC Bulletin.

Protocol for Feedback to TGA

Recommendation 10b of the Review of Health Technology Assessment in Australia December 2009 called for the formalisation of communication between the Prostheses and Devices Committee (now the Prostheses List Advisory Committee, PLAC) and the TGA – this will ensure safety concerns are brought to the attention of the regulator.

A protocol for PLAC feedback to the TGA has been developed that establishes a formal process for providing information (including concerns about the intrinsic safety of a prosthesis) to the TGA and for the TGA to respond to this information.
(Attachment A - Prostheses List Advisory Committee - Protocol for Reporting Concerns with Prostheses to the Therapeutic Goods Administration (PDF 9 KB)).

Under the protocol, the PLAC will be required to report intrinsic safety concerns immediately to the TGA and individual clinicians participating in the prostheses listing process will also be encouraged to report concerns immediately to the TGA.

Concurrent Applications

The Government agreed to the implementation of the Review of Health Technology Assessment in Australia December 2009 recommendation 7 that applicants have the option of applying to different Health Technology Assessment processes concurrently.

Stakeholders were advised via Private Health Insurance Circular 45/10 on 22 July 2010 that applications for the Prostheses List will be accepted for products without an ARTG listing or associated MBS item number however the product will not be listed on the Prostheses List until these numbers have been provided.
If an application is submitted and applications for ARTG listing and MBS items are not progressing due to the actions of the sponsors within two Prostheses Lists, then the application will be terminated.

Status of New Applications

A table advising the status of new applications received since 2 August 2010 is being developed and will be circulated to stakeholders in the near future.

The table will include the number of applications received within a particular month and how far applications have progressed.

It should be noted that regardless of when an application is received, if the application completes the CAG/PoCE clinical assessment process and the PLAC recommends the application be listed and time does not permit the normal negotiation process to occur, a truncated benefit will be offered for the next available Prostheses List.