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How to list on the MBS

Application processes for MSAC assessments

The December 2009 Review of the Health Technology Assessment in Australia (HTA Review), recommended that MSAC strengthen and streamline its operations and improve the flexibility of its regulatory processes.
Work has been undertaken to address this recommendation.
An MSAC public discussion document was released in December 2010 which allowed for stakeholder input into the proposed new processes in early 2011.

• MSAC public discussion document (PDF 228 KB)
• MSAC public discussion document - Accessible (Word 5275 KB)

Input from stakeholders has informed changes to the new MSAC application process which are illustrated in the process map which is attached below.
Further mapping and analysis is being undertaken to ascertain where further streamlining of applications can occur.

Information to assist applicants with co-dependent technologies is available through the Health Technology Assessment Access Point

Overview of the process

Below is a short fact sheet providing a description of the major stages of an application assessment.
Fact Sheet on the MSAC Process - How to get something on the MBS (Accessible Word 296 KB)
Fact Sheet on the MSAC Process - How to get something on the MBS (PDF 99 KB)

Process map to guide an applicant's understanding of the consideration of a new medical service or change to an existing medical service (Powerpoint 187 KB)
Process map to guide an applicant's understanding of the consideration of a new medical service or change to an existing medical service (PDF 20 KB)

Who can apply?

Applications can be made by the medical profession, medical industry and others with an interest in seeking Australian government funding for a new medical service or change to an existing service.

When can you apply

The meeting dates for MSAC and its subcommittees in 2013 are available on the Committees - calendar, deadlines and agendas page.

Including PASC and ESC cut off for lodgement of submissions and applicant responses.

These have been aligned with PBAC meeting dates for 2013.

What you need to provide us in order to apply

This pre-assessment documentation covers information needed for the Initial Meeting, Suitability consideration, PASC submission and proposed MBS benefit.

Pre-assesment documentation to initiate an application to MSAC for public funding of a proposed medical service - Includes Part A, Ai, B, C, Di (Accessible Word 665 KB)
Pre-assessment documentation to initiate an application to MSAC for public funding of a proposed medical service - Includes Part A, Ai, B, C, Di (PDF 157 KB)

Applicants are encouraged to provide feedback on these documents to hta@health.gov.au.
This feedback will be used to further refine the documentation.

How to apply

Step 1: Confirm Lobbyist status

Step 2: Organise an Initial Meeting (not compulsory).

In the first instance, we ask that potential applicants complete two forms (Part Ai and Part Aii) when submitting an application to the MSAC that provides information to the Department on the proposed service or change to an existing MBS item. Please note, initial meetings are no longer compulsory. If an applicant would prefer not to have an initial meeting, then we ask that the Part B application form is also completed. If an applicant does require an initial meeting, we will need to consult with various areas of the Department to prepare for an initial meeting. Therefore, we do prefer to have at least two weeks notice for an initial meeting. However, once we have received Parts Ai and Aii, we will be able to provide you with more accurate timeframes.

Step 3: Confirm Suitability for Assessment of the proposed medical service
Supply Part B of the Pre-assessment documentation to initiate an application to MSAC for public funding of a proposed medical service and relevant supporting documentation
Draft letter for professional body support (Word 31 KB)
Draft letter for professional body support (RTF 53 KB)

Step 4: Complete a proposed Decision Analytic Protocol to PASC for consideration
Deadlines for a proposed decision analytic protocol for 2013
Supply Part C and Di and where necessary Dii of the Pre-assessment documentation to initiate an application to MSAC for public funding of a proposed medical service

Step 5: Complete a submission of evidence to MSAC for assessment
Deadlines for a submission-based assessment for 2013
Draft Guidelines for the submission of evidence to MSAC for assessment
Please contact hta@health.gov.au if you have any queries relating to this stage

Before submitting evidence for MSAC's approval, all therapeutic goods used in the relevant medical service should have been:
listed on the Australian Register of Therapeutic Goods ;
or an application for listing should have been lodged with the Therapeutic Goods Administration.

For further inquiries, contact the HTAAP Hotline on (02) 6289 7550 or email hta@health.gov.au.

Further advice to applicants

It is accepted that documents submitted throughout the MSAC process may contain information the applicant believes is confidential.
However these claims will be agreed by the department on a case by case basis, in line with current government policies (these include, but are not limited to, statistical data and positions of trust classifications).

In any claim for confidentiality the applicant will be asked to state the basis on which the claim for confidentiality is being made. Further information on the relevant government policies is available at www.ags.gov.au/publications/agspubs/legalbriefings/br64.htm

How to apply for listing on the Pharmaceutical Benefits Scheme (PBS)

How to apply for listing on the Prostheses List

How to apply for listing where you think you may have a co-dependent technologies

Page currency, Latest update: 23 April, 2013