EXPLANATORY STATEMENT
Issued by Authority of the Minister for Health and Ageing
National Health Act 1953
Determination under subsections 73AAG (6) and (7)
(HIB 19/2006)
Subsection 73AAG(6) of the National Health Act 1953 (the Act) provides that the Minister may determine in writing the prostheses that are no gap prostheses and the benefit amount for each no gap prosthesis.
Subsection 73AAG(7) provides that the Minister may determine in writing the prostheses that are gap permitted prostheses, and the minimum and maximum benefit amounts for each gap permitted prosthesis.
The Schedule to this determination has two parts:
- Part A – Prostheses; and
- Part B – Human Tissue List.
The Schedule to this determination is known as the “Prostheses List”.
This determination commences on 14 September 2006. It replaces, in its entirety, the determination dated 21 March 2006 (HIB13/2006).
This determination updates the previous Prostheses List by:
- adding 368 new products to parts A and B as no gap prostheses or gap permitted prostheses;
- changing several existing products in part A and B including:
amending the descriptions of products;
allocating new billing codes in respect of new sizes or models of products;
compressing billing codes to cover a range of products offered at the same cost;
changing supplier names to reflect new supplier arrangements; and
changing the minimum benefit amount and/or maximum benefit amount; and
- deleting 382 products in part A.
The determination is consistent with the recommendations of the Prostheses and Devices Committee.
In Part A of the Prostheses List, some products are grouped according to their clinical effectiveness, as assessed by Clinical Advisory Groups. The purpose of the groupings is to identify products of similar clinical effectiveness or clinical design, in order to assist in determining the benefits payable for the products and to assist with clinical choice.
Four new Clinical Advisory Groups have been formed for:
- cardiothoracic prostheses;
- spinal prostheses;
- urogenital prostheses; and
- vascular prostheses.
Clinical Advisory Groups already exist for:
- hip prostheses;
- knee prostheses;
- cardiac prostheses; and
- lens prostheses.
Other products that do not fit into clinical advisory groups have been grouped according to their product type, as determined by the Emergency Care Research Institute (ECRI) or Global Medical Devices Nomenclature System (GMDNS) descriptor allocated by the Therapeutic Goods Administration. Products in this category that were on the first Prostheses List (August 2005) were termed ‘grandfathered’ products and originally had benefit amounts agreed based on a formula. Benefits payable in respect of these ‘grandfathered’ products have now been negotiated with sponsors and have been incorporated into the new Determination.
Benefits payable in respect of the products that have been assessed and grouped by the four new Clinical Advisory Groups and new products, have also been negotiated with the sponsors and have been incorporated into the new Determination.
Products that have not had benefit amounts reviewed within the first twelve months of the current prostheses arrangements have had minimum benefit amounts indexed by four percent, consistent with the June 2006 all groups CPI that was released in July 2006. The following groups of prostheses have had the CPI increase:
- cardiac, knee, hip and lens products that were grouped by the Clinical Advisory Groups for the first Prostheses List; and
- new products on the October 2005 Prostheses List that have not since been re-negotiated.
The following endoscopic band ligators and haemostatic patches have been removed from the Prostheses List as they do not meet the criteria for listing:
- BS083, Boston Scientific Pty Ltd, Speedband Superview Super 7, Multiple Band Ligator, non latex;
- ME027, Medtel Australia Pty Ltd, Syvek Patch, Closure Device;
- ME028, Medtel Australia Pty Ltd, SyvekNT Patch, Closure Device; and
- MC311, Medtronic Australasia Pty Ltd, Clo-sur PAD, Polyprolate.
Cervical artificial intervertebral discs have also been removed from the Prostheses List following the Minister for Health and Ageing’s endorsement of a recent Medical Services Advisory Committee’s recommendation that states “In the absence of evidence of effectiveness, MSAC recommends that public funding for AIDR in the cervical spine should not be supported.” Cervical intervertebral discs removed from the Prostheses List include:
- MC541, Medtronic Australasia, Brian Cervical Disc System;
- MC588, Medtronic Australasia, Prestige Artificial Cervical Disc; and
- SY330, Synthes Australia Pty Ltd, Prodisc L Artificial Cervical Disc.
CONSULTATION
This Determination has been made having regard to advice provided by the Prostheses and Devices Committee (PDC), a ministerially appointed committee comprised of nominees from health funds, hospitals, clinicians, prostheses and devices suppliers, the Commonwealth, and consumer representatives. In making their recommendations, the PDC were advised by Clinical Advisory Groups, other clinical experts, and benefits negotiators, all appointed by the PDC.
This determination and this Explanatory Statement have been registered on the Federal Register of Legislative Instruments.
PRIVATE HEALTH INSURANCE BRANCH
DEPARTMENT OF HEALTH AND AGEING
AUGUST 2006