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Prostheses List Advisory Committee (PLAC) Bulletin 1

Bulletin number 1, December 2010.

Printable version of PLAC Bulletin 1 (PDF 49KB)

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 the creation of future Prostheses Lists. The Bulletin is posted on the Prostheses page of the Department of Health and Ageing’s website.

Prostheses List Advisory Committee

The Prostheses List Advisory Committee (PLAC) had its inaugural meeting on Wednesday 10 November 2010. The PLAC recognised the sound foundation set by the Prostheses and Devices Committee and looks forward to progressing reforms from the Review of Health Technology Assessment in Australia December 2009 (the HTA Review).
Two more meetings are scheduled this year:

• Tuesday 23 November 2010; and
• Tuesday 14 December 2010.

The primary focus of the PLAC is currently to progress new applications for the February 2011 Prostheses List.

The PLAC will also assist with the progression of initiatives from the HTA Review including:

• continuous applications;
• concurrent assessment;
• a protocol for feedback to TGA;
• reviewing terms of reference for the PLAC subcommittees (based on the terms of reference and business rules for the PLAC); and
• further developing clinical evidence requirements for new applications for inclusion on the Prostheses List, and beginning to develop procedures for assessing cost effectiveness in a more rigorous and transparent way.

Updates on these initiatives will be provided to stakeholders in future PLAC bulletins.

Continuous Applications

The Government agreed to the implementation of the Review of Health Technology Assessment in Australia December 2009 recommendation 12a to accept applications on a continuous basis, but still make the Prostheses List every six months. Sponsors were advised via Private Health Insurance Circular 33/10 on 20 May 2010 that continuous applications for the Prostheses List would be accepted from 2 August 2010. The Circular also advised that applications received by 23 August 2010 will have the best prospect of being considered in time for the February 2011 Prostheses List.

Sponsors are advised that poor quality applications will be returned to the sponsor for correction.

Sponsors are also advised that once an application has been submitted additional information to support that application can not be provided at a later date. If a sponsor wishes to include additional information they must submit a new application.

Sponsors are encouraged to contact the Prostheses Section (02 6289 9463 or Prostheses) if they have any questions in relation to preparing their application.

Summary of the August 2010 Prostheses List Cycle

The August 2010 Prostheses List cycle:

• resulted in 9,505 billing codes on the August 2010 Prostheses List – 9,229 in Part A Prostheses and 276 in Part B Human Tissue;
• became effective 14 August 2010 and an amendment was required that became effective 5 October 2010;
• 467 new applications were processed and 2,616 amendments to existing items were made; and
• conflict of interest issues impacted on orthopaedic applications and reviews. Note these conflict of interest issues have now been resolved and there are no members of the PLAC or its subcommittees affected by this potential conflict of interest.

More detailed information is provided at Attachment A.

Printable version of Attachment A (PDF 22 KB).

Attachment A- August 2010 Prostheses List Cycle

Prostheses and Devices Committee

The Prostheses and Devices Committee (PDC) met seven times – in March 2010 (x1), April 2010 (x2), May 2010 (x1) and June 2010 (x3) – to consider:

• applications to list new products;
• recommendations from the Panel of Clinical Expert (PoCE) clinicians on grouping schemes forneurosurgical prostheses and PoCE prostheses not previously grouped;
• benefit reviews for partial ossicular replacement prostheses (PORP) and total ossicular replacement prostheses (TORP);
• infusion pump review; and
• recommendations from the following CAGs resulting from grouping and/ or benefit reviews: UPCAG, OPCAG, VPCAG (group 9a and 9b), SPCAG (for bone cement and bone graft substitute products) and SOCAG.

Applications for New Products

Applications received (including deferrals from previous cycles and an internal review)

467

Terminated (either a valid ARTG number was not supplied by the cut-off date or the sponsor withdrew the application)	41
Listed*	297
Deferred	24
Not Listed	105

* Only 288 billing codes were created: six (6) new applications to be listed were included in existing billing codes and three (3) new applications were compressed into one (1) billing code.

Due to timing issues near the end of the cycle and the Prostheses and Devices Negotiating Group (PDNG) conflicts of interest, there were a large number of truncated benefits offered for the August 2010 Prostheses List cycle including all new orthopaedic products.

Amendments to Existing Items

The PDC recommended many changes to existing listings - including 1,694 changes to details and 263 changes to benefits affecting a total of 1,805 billing codes and 659 deletions. The 659 listings deleted included:

• eight (8) as recommended by the PDC as they do not meet the criteria for listing;
• 23 as the sponsor failed to pay ongoing listing fees;
• 404 at the request of the sponsor;
• 25 as a result of compressions;
• 189 as a result of transfers; and
• 10 as a result of expansions.

In addition to the 288 billing codes created for new products, a further 225 billing codes were created:

• 21 as a result of expansions;
• Seven (7) as a result of compressions;
• Seven (7) as a result of duplications; and
• 189 as a result of transfers; and
• One (1) reinstatement.

Product Reviews

Product reviews contribute to a large number of amendments to the Prostheses List each cycle. Product reviews for the August 2010 cycle included:

• For the PoCE assessment bodies:

Neurosurgical prostheses - grouping scheme
PoCE prostheses not previously grouped - groups and benefits reviews
Partial ossicular replacement prostheses and total ossicular replacement prostheses -
benefits review

• For the CAG assessment bodies:

SPCAG – grouping scheme for bone cement and bone graft prostheses (note the grouping scheme
is to be included in SOCAG);
SOCAG – grouping scheme;
OPCAG – groups and benefits reviewed;
UPCAG – groups reviewed; and
VPCAG – groups 9a and 9b.

The SOCAG, SPCAG, UPCAG and VPCAG reviews were not completed in the cycle and are not
reflected in the August 2010 Prostheses List.

Amendment List

An amendment to the Rules was required and commenced 5 October 2010.
The amendment included:

• changing the ‘size’ of billing code CZ020.
• deleting twelve (12) billing codes GL007, SK046, SK120, SK121, SK122, SK123, SK124, SK125, SK186, SR047, SR048 and SR049. All of these billing code deletions were at the request of the sponsor.
• transferring four (4) billing codes from Orthotech Pty Ltd to Biomet Australia Pty Ltd. These changes were affected by deleting Billing Codes OH240, OH241, OH123 and OH347 and replacing them with Billing Codes BH103, BH104, BH105 and BH106.
• changing three (3) billing codes from PU057, PU058 and ST988 to PU059, PU060 and SK510. Three new products for the August 2010 Prostheses List were inadvertently given billing codes that had been used before for other products that were subsequently deleted.
• reinstating three (3) items, billing codes SY060, SY071 and SY270. These deletions were to occur in conjunction with the implementation of the new grouping scheme for Specialist Orthopaedic products. The new grouping scheme did not go ahead for the August 2010 Prostheses List and hence these deletions should not have occurred for the August 2010 Prostheses List.
• duplicating five (5) Billing Codes under an additional sponsor with the addition of BH100, BH101, BH102, BH107 and BH108.

Gap permitted prostheses

There are 2,205 (23.9%) gap permitted products on Part A of the Prostheses List.