Prostheses List
Application to List a New Prosthesis
Product System
Important Information about this application
Assistance to complete this application
The Prostheses List – Guide to listing and setting benefits for prostheses (the Guide) provides important
information and guidance on how to make an application to list a prosthesis, including definitions for
terminology used in this form. Refer to the Guide as you complete this application to ensure the
information and documentation you provide complies with the application requirements.
Contact the Prostheses Secretariat:
Phone: (02) 6289 9463
Email: Prostheses@health.gov.au
Application Fee
Under the Private Health Insurance Act 2007 (the Act), an application to list a prosthesis must be
accompanied by an application fee. The application fee is currently $600AUD per prosthesis.
Further information about the application fee can be found in the Guide.
The application fee/s can be paid:
By cheque:
Payable to: Attention: Accounts, Department of Health, GPO Box 9848, CANBERRA ACT 2601
Enter Bank Name and Cheque No:
By credit card:
Please call (02) 6289 1095 (Max: $15,000)
Please quote:
 Cost Centre: 308025
 GL: 4100004000
 Internal Order code: DPROSAPPLIC
Enter Date Paid:
By EFT:
BSB No: 092 009
Account No: 115031
Please quote “GL4100004000” and as much of your sponsor name as possible, in the “To account”
information field.
Enter Date Paid:
Approved December 2015 (TRIM E15-11269)
Approved Form
An application to list a kind of prosthesis on the Prostheses List should be submitted via the Prostheses
List Management System (PLMS) portal whenever possible and practical. The PLMS portal is at
www.prostheses.health.gov.au.
If PLMS is not accessible, an application to list a kind of prosthesis can be submitted on this form.
This form has been approved by the Secretary or Delegate in accordance with section 333-10 of the Act
for the purposes of section 72-10 of the Act.
Information in the form will be used by the Prostheses List Advisory Committee (PLAC) and its subcommittees to make a recommendation on listing the product/s on the Prostheses List.
Information in the form will be used by the Department of Health to process the application and list the
product/s on the Prostheses List if the application is successful.
Where to send applications
Please email applications and attachments to:
Prostheses Secretariat
Private Health Insurance Branch
Department of Health
Prostheses@health.gov.au
Approved December 2015 (TRIM E15-11269)
Application to list a new prosthesis – product system
Secretariat use ONLY:
APPLICATION NUMBER/S:
Date Received :
Entered on Administration Database:
Date:
Initials:
Application checked:
Date:
Initials:
NOTE: Mandatory fields in the application are denoted with an asterisks (*) symbol.
Sponsor’s contact information for this application
Sponsor name: *
Sponsor ABN: *
Primary Contact
Full name and position: *
Phone number - Office: *
Phone number - Mobile:
Email: *
Secondary Contact (optional)
Full name and position:
Phone number - Office:
Phone number - Mobile:
Email:
Approved December 2015 (TRIM E15-11269)
Application to list a new prosthesis – product system
Product System
Product system name: *
Product System Components
Please list the individual components below: *
Product #
Product Name
1
2
Please complete the following sections for each component (individual product listing):
-
New Prosthesis Device
Comparator(s)
Benefit and economic information for the new grouping (if applicable)
Please complete the following sections for the product system as a whole:
-
Product Setting and Product Purpose
Medicare Benefits Schedule (MBS) Item(s) and Descriptor(s)
Overseas Status and Comparative Clinical Effectiveness
Attachments
Submission Declaration
Approved December 2015 (TRIM E15-11269)
Application to list a new prosthesis – product system
Product #1 - New Prosthesis Device
Product Details
Product name: *
Description: *
Size(s): *
Catalogue Number(s): *
Proposed benefit: *
ARTG ID Number
ARTG ID
Sponsor Name
ARTG Entry Name
Class
OR
☐
Alternatively, tick here if you have applied to include your device on the ARTG (ARTG ID
Number is pending)
Grouping
Category: *
Subcategory: *
Group: *
SubGroup:
Suffix(es):
Approved December 2015 (TRIM E15-11269)
Application to list a new prosthesis – product system
Product #1 - Comparator(s)
Comparator Details
(a)
Please list the comparator(s) (maximum of 5) for your product. If the comparator(s) exists
on the Prostheses List, enter details in part i). If the comparator is not on the Prostheses List (other
treatment/therapy), enter details in part ii): *
i)
a product/s on the Prostheses List
Billing code
ii)
Product name
other treatment/s or therapy/ies for the clinical indication/s your product is designed to treat:
Treatment/Therapy Name
(b)
Prostheses List Grouping
Description
Benefit amount/Cost
If you have entered more than one comparator for your product, please identify the main
comparator (billing code or name):
Approved December 2015 (TRIM E15-11269)
Application to list a new prosthesis – product system
Product #1 - Benefit and Economic Information for the New
Grouping
NOTE: Only complete this section (Benefit and economic information for the new grouping)
if you are applying to list your product in a grouping that is not currently included in the
Prostheses List (i.e. a new subcategory, group, subgroup, suffix or combination of suffixes)
Clinical Outcomes
Please identify the quantifiable or measurable clinical outcomes delivered by your product,
compared with the comparator(s). Refer to measurable and/or quantifiable factors relating to
patient outcomes, such as recovery time, failure rates, complications, and life expectancy. *
Outcome
Description
Outcome 1
Outcome 2
Outcome 3
Cost Savings
Please provide details of measurable evidence of any cost savings to insurers/Commonwealth
achieved through the use of the product. Cost savings around improved patient outcomes may
include reductions in the theatre time/hospital stay, reductions in post-surgical care costs, fewer
complications, reduced revision surgery: *
Benefit Rationale
Please provide a clear rationale for how monetary value of any clinical advantages afforded by use
if the product were calculated in the proposed benefit: *
Approved December 2015 (TRIM E15-11269)
Application to list a new prosthesis – product system
Product Utilisation
If your product is sold in Australia and/or another country, please provide utilisation and price
details below: *
Country
Utilisation per year
Cost (in local currency)
What is the projected utilisation of the product over the first two years of listing on the Prostheses
List? *
What is the basis for the projection? *
Will the use of this product replace the use of another product? *
☐
No
☐
Yes - Please advise which product will be replaced by the use of this product:
Other Information
Is there any other information you can provide to support the proposed benefit for your product?
Approved December 2015 (TRIM E15-11269)
Application to list a new prosthesis – product system
Product #2 - New Prosthesis Device
Product Details
Product name: *
Description: *
Size(s): *
Catalogue Number(s): *
Proposed benefit: *
ARTG ID Number
ARTG ID
Sponsor Name
ARTG Entry Name
Class
OR
☐
Alternatively, tick here if you have applied to include your device on the ARTG (ARTG ID
Number is pending)
Grouping
Category: *
Subcategory: *
Group: *
SubGroup:
Suffix(es):
Approved December 2015 (TRIM E15-11269)
Application to list a new prosthesis – product system
Product #2 - Comparator(s)
Comparator Details
(a)
Please list the comparator(s) (maximum of 5) for your product. If the comparator(s) exists
on the Prostheses List, enter details in part i). If the comparator is not on the Prostheses List (other
treatment/therapy), enter details in part ii): *
i)
a product/s on the Prostheses List
Billing code
ii)
Product name
other treatment/s or therapy/ies for the clinical indication/s your product is designed to treat:
Treatment/Therapy Name
(b)
Prostheses List Grouping
Description
Benefit amount/Cost
If you have entered more than one comparator for your product, please identify the main
comparator (billing code or name):
Approved December 2015 (TRIM E15-11269)
Application to list a new prosthesis – product system
Product #2 - Benefit and Economic Information for the New
Grouping
NOTE: Only complete this section (Benefit and economic information for the new grouping)
if you are applying to list your product in a grouping that is not currently included in the
Prostheses List (i.e. a new subcategory, group, subgroup, suffix or combination of suffixes)
Clinical Outcomes
Please identify the quantifiable or measurable clinical outcomes delivered by your product,
compared with the comparator(s). Refer to measurable and/or quantifiable factors relating to
patient outcomes, such as recovery time, failure rates, complications, and life expectancy. *
Outcome
Description
Outcome 1
Outcome 2
Outcome 3
Cost Savings
Please provide details of measurable evidence of any cost savings to insurers/Commonwealth
achieved through the use of the product. Cost savings around improved patient outcomes may
include reductions in the theatre time/hospital stay, reductions in post-surgical care costs, fewer
complications, reduced revision surgery: *
Benefit Rationale
Please provide a clear rationale for how monetary value of any clinical advantages afforded by use
if the product were calculated in the proposed benefit: *
Approved December 2015 (TRIM E15-11269)
Application to list a new prosthesis – product system
Product Utilisation
If your product is sold in Australia and/or another country, please provide utilisation and price
details below: *
Country
Utilisation per year
Cost (in local currency)
What is the projected utilisation of the product over the first two years of listing on the Prostheses
List? *
What is the basis for the projection? *
Will the use of this product replace the use of another product? *
☐
No
☐
Yes - Please advise which product will be replaced by the use of this product:
Other Information
Is there any other information you can provide to support the proposed benefit for your product?
Approved December 2015 (TRIM E15-11269)
Application to list a new prosthesis – product system
Product Setting and Product Purpose
Product Setting
Please select the setting in which the product/product system is provided (‘a’, ‘b’ or ‘c’): *
☐
(a)
patient is receiving treatment in hospital
☐
(b)
patient is receiving hospital substitute treatment
Hospital substitute treatment is defined in Section 69-10 of the Private Health Insurance Act 2007. Briefly, it is
treatment that substitutes for hospital treatment and is any combination of nursing, medical, surgical, podiatric
surgical, diagnostic, therapeutic, prosthetic, pharmacological, pathology or other services intended to manage a
disease, injury or condition.
☐
(c)
patient is receiving treatment outside of hospital.
Please describe:
Approved December 2015 (TRIM E15-11269)
Application to list a new prosthesis – product system
Product Purpose
Please select the purpose of the product/product system (‘a’, ‘b’ or ‘c’): *
☐
☐
(a)
Is the product surgically implanted in the patient and purposely designed in order to:
(i)
Replace an anatomical body part; or
(ii)
Combat a pathological process; or
(iii)
Modulate a physiological process?
(b)
Is the product essential to and specifically designed as an integral single-use aid for
implanting a product described in (a) (i), (ii) or (iii) above, which is only suitable for use in
the patient in whom that product is implanted:
Please advise what the surgically implanted product is that this product is integral to
implanting.
☐
(c)
Is the product critical to the continuing function of the surgically implanted product to
achieve the outcomes described in (a) (i), (ii), or (iii) above, and which is only suitable for
use by the patient in whom that product is implanted?
Please advise what the surgically implanted prosthesis is that this product is critical to the
continuing function of
Please briefly explain the function of the product: *
Approved December 2015 (TRIM E15-11269)
Application to list a new prosthesis – product system
Medicare Benefits Schedule (MBS) Item(s) and Descriptor(s)
Please list up to ten (10) MBS item numbers for professional services in which the product is
intended to be implanted or applied. *
(Note: An application will be processed without an MBS Number however it will not be listed until a
valid MBS Number is provided by the sponsor).
MBS Item No
MBS Item descriptor
Please provide a reason for selecting the above MBS item(s):
OR
☐
Alternatively, tick here if you have applied for an MBS Item number (MBS Item(s) number is
pending).
Approved December 2015 (TRIM E15-11269)
Application to list a new prosthesis – product system
Overseas Status and Comparative Clinical Effectiveness
Overseas Status
(a)
(b)
Has authority been given to sell this product/product system in any other country? *
☐
No
☐
Yes – Please provide information about the approvals:
Has the product/product system been sold or being sold under any other name in any
country? *
☐
No
☐
Yes – Please provide the name(s):
Comparative Clinical Effectiveness
Please explain how the clinical effectiveness and cost effectiveness of your product/product
system compares with the comparator(s). Please refer to the clinical evidence you have provided
to support your application: *
Approved December 2015 (TRIM E15-11269)
Application to list a new prosthesis – product system
Attachments
Listed below are attachments related to your application. Please include all relevant files when
submitting your application.
Required attachments:
-
An exploded image of the product with labelled components
-
Supporting literature (full studies/reports)
Optional attachments:
-
Overseas approval certificates (e.g. CE mark and FDA approval)
-
Documentation describing; product features, indications, contraindications, technical
specifications, instructions for use, surgical technique etc.
-
Images of the individual components
-
Economic and cost analysis studies/reports (for each component where a new grouping
has been proposed)
Approved December 2015 (TRIM E15-11269)
Application to list a new prosthesis – product system
Submission Declaration
☐
I declare that all information provided in this application is true and correct. I agree to pay
the application fee.*
Approved December 2015 (TRIM E15-11269)