Application to List a New Prosthesis

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:

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 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 sub-committees 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

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:

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

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 /

☐ 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):

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 / Product name / Prostheses List Grouping /

ii) other treatment/s or therapy/ies for the clinical indication/s your product is designed to treat:

Treatment/Therapy Name / Description / Benefit amount/Cost /

(b) If you have entered more than one comparator for your product, please identify the main comparator (billing code or name):

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: *

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?

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 /

☐ 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):

Product #2 - Comparator(s)

Comparator Details

i) a product/s on the Prostheses List

Billing code / Product name / Prostheses List Grouping /

ii) other treatment/s or therapy/ies for the clinical indication/s your product is designed to treat:

Treatment/Therapy Name / Description / Benefit amount/Cost /

(b) If you have entered more than one comparator for your product, please identify the main comparator (billing code or name):

Product #2 - Benefit and Economic Information for the New Grouping

Clinical Outcomes

Outcome / Description /
Outcome 1
Outcome 2
Outcome 3

Cost Savings

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: *

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?

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:

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: *

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):

☐ Alternatively, tick here if you have applied for an MBS Item number (MBS Item(s) number is pending).

Overseas Status and Comparative Clinical Effectiveness

Overseas Status

(a) Has authority been given to sell this product/product system in any other country? *

☐ No

☐ Yes – Please provide information about the approvals:

(b) 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: *

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)

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)