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Prostheses List Advisory Committee (PLAC) Bulletin 7

Bulletin number 7, December 2011

Printable version of Prostheses List Advisory Committee (PLAC) Bulletin 7 (PDF 122 KB)

HTA Recommendation 12b-e Implementation Update

Recommendations 12b-e of the HTA Review have been implemented as outlined below:
August 2011 Prostheses List
– Phase 1
• Hip
• Knee
• Bone Cement/Substitute (SOCAG)
• Ophthalmic
• Arthroplasty (SOCAG)

February 2012 Prostheses List
– Phase 1
• Neurosurgical
– Phase 2
• Vascular
• Cardiac
• Plates & Screws
• External Fixateurs
– Phase 3
• Cardiothoracic
• Urogenital
• General & Miscellaneous
• ENT

The implementation of Phase 3 (remaining SOCAG products) will not be completed until the August 2012 Prostheses List.

February 2012 Prostheses List

It is anticipated that sponsors will be sent the following documentation in early January 2012:

2-6 January 2012	Granting Letters
9-13 January 2012	Draft February 2012 Prostheses List

Please contact the Prostheses Section on (02) 6289 9463 if you have any queries.

MBS/ARTG Number Assessment Process

As advised in PLAC Bulletin #5, the process for assessing applications pending MBS/ARTG numbers was that applications were to be held over to be reviewed by the PLAC once MBS/ARTG numbers were received.

Following feedback from stakeholders, the PLAC has agreed to assess applications without MBS/ARTG numbers. The process is as follows:

• All applications will be assessed by the CAG/PoCE clinicians.
• All applications will then be assessed by the PLAC.
• Cut off dates will then apply to applications recommended for listing pending MBS and/or ARTG numbers.

The cut off dates are listed below:

8 February 2012	Prostheses List Advisory Committee Meeting
Mid February	Prostheses List Information Sessions
March – April 2012	CAG meetings
8 March 2012	Prostheses List Advisory Committee Meeting
15 March 2012	Ongoing listing fee invoices for February 2012 Prostheses List to be sent (invoice payable within 28 days)
11 April 2012	Prostheses List Advisory Committee Meeting
April – May 2012	CAG meetings
10 May 2012	Prostheses List Advisory Committee Meeting
14 June 2012	Prostheses List Advisory Committee Meeting
29 June 2012	ARTG and MBS item numbers required for recommended new applications for the August 2012 Prostheses List
Late July 2012 (TBC)	Letter to sponsors re: payment of initial listing fees/gaps (invoice payable within 14 days)
Early August 2012 (TBC)	August 2012 Prostheses List scheduled to be released
Mid August 2012 (TBC)	August 2012 Prostheses List scheduled to commence

August 2012 Prostheses List – Cut off dates for Clinical Assessment

The key dates table below has been developed to improve the transparency of the Prostheses Listing arrangements and to assist stakeholders with preparation of new applications for the August 2012 Prostheses List. It provides a summary of proposed cut off dates for new applications to be reviewed by the Clinical Advisory Groups (CAGs) and Panel of Clinical Experts (PoCE).

The timeline and key dates will also be included on the Department’s website.

Clinical Advisory Groups (CAG)	1st meeting date	Cut-off for first meeting	2nd meeting date	Cut-off for 2nd meeting (*CAG final cut-off date for the August 2012 Prostheses List)
Cardiac	14 April 2012	24 February 2012	26 May 2012	5 April 2012*
Cardiothoracic	16 March 2012	27 January 2012	18 May 2012	30 March 2012*
Hip	16 March 2012	27 January 2012	11 May 2012	23 March 2012*
Knee	3 March 2012	13 January 2012	5 May 2012	16 March 2012*
Opthalmic	16 April 2012	27 February 2012	21 May 2012	2 April 2012*
Special Orthopaedic	9 March 2012	20 January 2012	4 May 2012	16 March 2012*
Spinal	2 March 2012	13 January 2012	26 April 2012	8 March 2012*
Urogenital	9 March 2012	20 January 2012	25 May 2012	5 April 2012*
Vascular	23 April 2012	2 March 2012	28 May 2012	10 April 2012*

Panel of Clinical Experts (PoCE)
PLAC Meeting Date	Cut-off date
14 June 2012	19 April 2012*

(* PoCE final cut-off date for the August 2012 Prostheses List).

Note:
• Cut-off dates for CAG applications are seven weeks prior to the next CAG meeting.
• For PoCE applications we advise that the standard evaluation period is a minimum of eight weeks. Therefore it is advisable to send applications to the Prostheses Section eight weeks prior to each PLAC meeting, but preferably at the beginning of the August 2012 Prostheses List period, as other issues may arise that could extend the evaluation time frame.
• The CAG Secretariat will advise sponsors of the meeting date that their application(s) will be tabled. This will occur when applications are acknowledged.
• In the event of meeting date changes or clinician unavailability in a specialty area, affected sponsors will be advised as soon as possible, of any variation to these timelines.
• A pre-lodgement meeting can be arranged upon request.
• All new applications are checked upon receipt by the department for administrative completeness, for example, correct fees, forms etc.
• There is no guarantee that applications received by the proposed cut off dates will be finalised for the August 2012 Prostheses List.