Health Insurance

Prostheses List

Formerly known as Schedule 5 - Benefits payable in respect of surgically implanted prostheses, human tissue items and other medical devices list.

Under the Private Health Insurance Act 2007, private health insurers are required to pay benefits for a range of prostheses that are provided as part of an episode of hospital treatment or hospital substitute treatment for which a patient has cover and for which a Medicare benefit is payable for the associated professional service.

The type of products on the Prostheses List include cardiac pacemakers and defibrillators, cardiac stents, hip and knee replacements and intraocular lenses, as well as human tissues such as human heart valves, corneas, bones (part and whole) and muscle tissue. The list does not include external legs, external breast prostheses, wigs and other such devices.

The Prostheses List contains prostheses and human tissue prostheses and the benefit to be paid by the private health insurers. There are more than 9,500 products on the Prostheses List. With respect to the benefits, there are two categories of prostheses:

No-gap prostheses

No-gap prostheses are listed with a single benefit, and patients will have no out-of-pocket expenses for theses prostheses. For each Medicare Benefit Schedule (MBS) item, it is aimed to have at least one no-gap prosthesis available.

Gap-permitted prostheses

Gap-permitted prostheses have both a minimum and maximum benefit listed. For these prostheses private health insurers are required to pay at least the minimum benefit.

Patients may incur an out-of-pocket expense for these prostheses, which, at a maximum, will be the difference between the minimum and the maximum benefit.

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Human Tissue Review

The Commonwealth Department of Health and Ageing is inviting submissions from interested parties to the review of Part B Human Tissue of the Prostheses List.

In October 2007, Robert Doyle completed his Review of the Prostheses Listing Arrangements (Doyle Report). Recommendation 15 of this report, which the Government agreed to, is as follows:
In relation to human tissue:

• The Department of Health and Ageing should carry out a comprehensive review of existing benefits for human tissue items, informed by cost-accounting data provided by tissue banks, by June 2010.
• The Department should ensure it has appropriate clinical expertise available to provide advice to the Minister on the listing of human tissue items.
• In providing advice on items for inclusion on the List and benefit levels, the Department should have regard to the principles that no profit should be derived from trade in human tissue and items involving autologous tissue should not be listed.

This review is the first step in addressing recommendation 15 of the Doyle Report.

A discussion paper has been developed to assist in informing submissions.
Human Tissue Review Discussion Paper (Word 150 KB)
To make a submission, or for further information, please contact:

Human Tissue Review
Private Health Insurance Branch
Acute Care Division
MDP 86
GPO Box 9848
CANBERRA ACT 2606

Email: human.tissue.review@health.gov.au
Telephone: 02 6289 1712
Fax: 02 6289 9444

The closing date for submissions is Tuesday 16 June 2009. Please note the closing date has been extended to close of business Friday 26 June 2009.
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Informed Financial Consent

Clinical choice remains a matter between the doctor and the patient. If a doctor considers that a gap-permitted prosthesis is the most clinically suitable for a patient, the doctor should provide appropriate clinical and financial information so that the patient may give informed financial consent before the procedure proceeds.

Private Health Industry Agreed Guidelines

Informed Financial Consent (IFC) - Prostheses and Devices (PDF 55 KB)

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Arrangements for listing and setting benefits for prostheses

A ministerially appointed committee called the Prostheses and Devices Committee (PDC) makes recommendations to the Minister for Health and Ageing on the prostheses that should be listed and the benefits payable for them. In making recommendations, the PDC considers advice from Clinical Advisory Groups, members of the Panel of Clinical Experts and the Prostheses and Devices Negotiating Group. Members of these groups are appointed by the PDC.
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The February 2009 Prostheses List

The Prostheses List, which lists the no-gap and gap-permitted prostheses and the benefits payable for them is released twice per year. The most current version of the List is known as the February 2009 Prostheses List. The February 2009 Prostheses List has a commencement date of 23 February 2009.

The Prostheses List is provided as a Microsoft Access database (for users of Access 97 and 2003 respectively). It is also provided as a Microsoft Word document, a pdf and an Excel spreadsheet.

To access any of the files, right click on the link and select "Save Target As..." to save the compressed file (.zip) to your local drive. You will need a file decompression program such as Winzip to unzip the files.

For further information, please refer to Private Health Insurance circular 7/09

PDF Versions (effective as at 03/03/2009)

Download the ZIPPED PDF Version of the Prostheses List - Part A (Other 3109 KB)
Download the UNZIPPED PDF Version of the Prostheses List - Part A (PDF 4159 KB)

Download the PDF Version of the Prostheses List Part B (Human Tissue) (PDF 65 KB)

Access Versions

Link to Access Versions

Word Versions

Link to Word Versions

Excel Versions

Link to Excel Versions
Note: Due to limitations with Excel - cell height cannot be greater than 256 pixels - some cells in the spreadsheet may contain incomplete information. You are advised to reference another version of the Prostheses List if you find incomplete information.

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The August 2009 Prostheses List

The next list to be published after the February 2009 List will be the August 2009 Prostheses List. The following are the key dates for the August 2009 Prostheses List cycle:

2 February 2009	Applications accepted, Amendment applications and applications for Duplication, Expansion, Compression and Transfer (requiring clinical assessment and/or benefit negotiation) accepted
20 February 2009	Applications close – including amendment applications and applications for Duplication, Expansion, Compression and Transfer requiring clinical assessment and/or benefit negotiation
3 April 2009	ARTG cut-off date
26 June 2009	Close date for duplications/deletions/transfers
Early July 2009	Invoices for initial listing fees sent to sponsors
31 July 2009	February 2009 Prostheses List scheduled to be published
15 August 2009	February 2010 Prostheses List scheduled to commence

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The Prostheses List Guide and Application Forms

The Prostheses List guide to listing and setting benefits for prostheses (the Guide) consists of two parts:

• Part 1 – Understanding the Prostheses Arrangements; and
• Part 2 – Making an application for inclusion in the Prostheses List.

Part 1 provides information on the prostheses arrangements including references to the new legislation, mandatory fees, the application cycle processes, explains the clinical assessment of products and the evidence required to demonstrate their clinical effectiveness.

Part 2 provides a detailed explanation of how to assemble and present an application to list a product on the Prostheses List, the information it should include and the evidence required to support it.

All sponsors are encouraged to use the Guide, and should be aware that it may be updated prior to the commencement of a cycle to ensure that the information it contains is current.

Note:
1. The Guide does not address the requirements for Human Tissue items. Please contact the Prostheses Section for further information on Human Tissue items - contact details below.

The Prostheses List Guide

current as 24 December 2008
Prostheses List Guide Part 1 (PDF 603 KB)

Prostheses List Guide Part 2 (PDF 581 KB)
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Application Forms for the Prostheses List

current as 24 December 2008
Application Part A1 - application form (PDF 59 KB)
Application Part A1 - application form (Word 211 KB)

Application Part A2 - Statement in Support (PDF 111 KB)
Application Part A2 - Statement in Support (Word 257 KB)

Application Part B - Cardiac (PDF 374 KB)
Application Part B - Cardiac (Word 378 KB)

Application Part B - Cardiothoracic (PDF 219 KB)
Application Part B - Cardiothoracic (Word 182 KB)

Application Part B - Hip (PDF 262 KB)
Application Part B - Hip (Word 313 KB)

Application Part B - Knee (PDF 280 KB)
Application Part B - Knee (Word 386 KB)

Application Part B - Ophthalmic (PDF 207 KB)
Application Part B - Ophthalmic (Word 254 KB)

Application Part B - Spinal (PDF 446 KB)
Application Part B - Spinal (Word 423 KB)

Application Part B - Urogenital (PDF 265 KB)
Application Part B - Urogenital (Word 292 KB)

Application Part B - Vascular (PDF 79 KB)
Application Part B - Vascular (Word 426 KB)

Application to amend listing (PDF 192 KB)
Application to amend listing (Word 246 KB)

Application to duplicate, compress, expand or transfer billing codes (PDF 201 KB)
Application to duplicate, compress, expand or transfer billing codes (Word 230 KB)

Human Tissue application (PDF 54 KB)
Human Tissue application (Word 171 KB)

Application to amend human tissue listings (PDF 48 KB)
Application to amend human tissue listings (Word 247 KB)

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Presentation July 2008 (PDF 765 KB)

Prostheses Cost Recovery

The Private Health Insurance (Prostheses) Rules 2007 and the Private Health Insurance (Prostheses Application and Listing Fee) Rules 2007 supporting the Private Health Insurance Act 2007 became effective 1 April 2007.

These Acts and Rules incorporate all of the prostheses reforms that were announced in April 2003 and include the implementation of mandatory cost recovery for the administration of the prostheses arrangements.

Application Fees

An Application Fee of $600 must accompany each Application to list a new product on Part A of the List. Failure to provide the correct fee with the application will result in the application being returned without further processing.

Initial Listing Fees

An Initial Listing Fee of $200 is payable for each new listing to Part A of the Prostheses List. Sponsors will be invoiced for these once the Minister has granted their application. This fee is applicable for New Applications, Duplications, Expanded items and Transfers. The initial listing fees are payable within 14 calendar days of being invoiced. Failure to pay the initial listing fee will result in the new application not being included in the Prostheses List.

Ongoing Listing Fees

An Ongoing Listing Fee of $200 is payable for all items that are continuing from the previous list excluding those that were newly listed on the most recent Protheses List to the imposition date. This fee is invoiced twice a calendar year on two imposition dates - 15 March and 15 September. Sponsors have 28 days in which to pay the ongoing listing fees. Failure to pay the ongoing listing fees will mean that the affected product(s) will become eligible for removal from the following Prostheses List.

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Contact details

Director Prostheses Section
PDC and Prostheses List

David O'Neill
Email: david.o'neill@health.gov.au
Phone: 02 6289 9850

Director Prostheses Section
Clinical Assessment and Benefit Negotiation

Kathy Hill
Email: kathy.hill@health.gov.au
Phone: 02 6289 1270
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Other relevant information

Circulars

Other relevant websites

Therapeutic Goods Administration (TGA)
Medical Services Advisory Committee (MSAC)

Consumer information

Industry links

Australian Health Insurance Association (AHIA)

Australian Private Hospitals Association (APHA)

Catholic Health Australia (CHA)

Medical Technology Association of Australia (MTAA)

Australian Medical Association (AMA)

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