September 2012
An Overview of the New Arrangements
for Listing on the Medicare Benefits
Schedule
Recent changes to processes for the Medical Services Advisory Committee (MSAC) have resulted in
the establishment of a new governance structure and procedures for the assessment of applications
for public funding. This paper provides an overview of these recent changes and identifies the need
for improved stakeholder engagement.
Some initiatives being introduced include the introduction of application managers, information
sessions, the development of fit‐for‐purpose assessment pathways and the re‐development of
supporting documents. The supporting documents will include MSAC guidelines, revised application
forms, MSAC economic guidelines and MSAC diagnostic guidelines. Additionally, the changes aim to
simplify the process for determining suitability for assessment.
The Department invites comment on these documents and feedback on the new processes.
Background
MSAC was established in 1998 to improve health outcomes for patients. Its role was to advise the
Australian Minister for Health and Ageing on evidence relating to the safety, effectiveness and cost‐
effectiveness of new medical technologies and procedures.
A number of reviews and reforms have explored ways to improve the processes for assessing
medical services. The key aim of the Review of Health Technology Assessment in Australia (HTA
Review) which reported to government in December 2009 was to address the regulatory burden
that results from HTA processes, to ensure that those processes are efficient, measured and
proportionate. The Review focussed on HTA processes performed by the Therapeutic Goods
Administration (TGA), the Prostheses List Advisory Committee (PLAC), Pharmaceutical Benefits
Advisory Committee (PBAC) and the MSAC – including co‐dependent technologies that may go
through more than one of these processes. Applications involving co‐dependent technologies may
raise additional issues during the assessment process; however these are not addressed in this
paper.
Since 2009, in response to stakeholder concerns about lengthy, cumbersome health technology
processes identified through the HTA Review, the Australian Government has undertaken a
comprehensive overhaul of the management and governance processes relating to the Medicare
Benefits Schedule (MBS). This was done to improve not only the quality of MSAC’s advice to
government, but also the transparency, timeliness, efficiency and effectiveness of the processes that
inform MSAC’s advice.
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September 2012
Following a public call for comment in 2010 on proposed changes (including those recommended in
the HTA Review) key reforms to the MSAC assessment process were introduced on 1 January 2011.
These included new terms of reference for MSAC and the establishment of two sub‐committees; the
Protocol Advisory Sub‐Committee (PASC) and the Evaluation Sub‐Committee (ESC). The
government’s dedication to the broader role of MSAC was reinforced in the 2011 Budget through
the announcement of the Comprehensive Management Framework for the MBS (CMFM). Under the
CMFM, MSAC will not only provide advice on new medical services involving technologies and
procedures, but on all proposed changes to the MBS. Details of the new assessment process are
under the heading Summary of the New Process.
Ongoing stakeholder engagement
Many of the changes are as a result of feedback requesting increased transparency and consultation
during the assessment of medical services. The Department is committed to ongoing stakeholder
engagement, and has built‐in stakeholder consultation at several points in the new process. In
addition, stakeholder engagement on key areas of the process is planned as implementation
continues. Individuals or groups with an interest in commenting on issues proposed for MSAC’s
consideration may register to receive email alerts notifying them of all opportunities for consultation.
The increase in publicly available information about applications and opportunities for comment are a
considerable step towards increased transparency.
Where it is appropriate/helpful, stakeholders will be provided with support on how to lodge their
application and will have opportunities to be walked through the MSAC process. The Department will
hold information sessions on the MSAC reforms where stakeholders will have the opportunity to
discuss any issues and provide feedback on the MSAC process. Applications will be managed by a
specific application manager throughout the process.
The reforms to MSAC processes require both the revision of current documentation and
development of some new documentation. The Department will seek comment from stakeholders
on revised application forms, MSAC guidelines, MSAC economic guidelines and MSAC diagnostic
guidelines.
Next Steps
The process described in Summary of the New Process is appropriate for full health technology
assessments. The next steps include developing fit‐for‐purpose pathways for assessment, consistent
with MSAC’s new terms of reference.
The expanded role of MSAC has resulted in a range of different applications being subject to MSAC
processes:

new technologies/services;

reviews of existing MBS items; and

amendments to existing items.
It has become evident that not all applications will require the high level of scrutiny involved in a full
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September 2012
MSAC process. It is intended that the processes to support a proposal will correspond with the clinical
and financial risk of the proposal. Fit‐for‐purpose approaches to the assessment of applications can be
applied, where appropriate.
Such fit‐for‐purpose approaches will allow the MSAC process to offer applicants the flexibility to
request an expedited approach. It should be noted that there is a risk that the evidence submitted
may be deemed inadequate. In such a case, the application would need to be resubmitted.
The Department will continue to develop a range of fit‐for‐purpose assessment pathways and will
seek feedback from stakeholders as this development progresses. The Department is also working on
improvements to co‐dependent technology assessment, with the aim that a common application
form be used for applications that are considered by both MSAC and the PBAC.
Improved communications and closer stakeholder engagement is a major priority for the
Department. The Medical Benefits Division has been restructured and the Medicare Financing and
Listing Branch has been created. This Branch is responsible for the administration of MSAC,
Medicare data, analysis and costings. A section has also been created with a specific focus on
stakeholder engagement. A dedicated team of staff from this section will be responsible for the case
Management of each application and will provide a single contact for applicants throughout the
MSAC process.
Summary of the New Process
The new assessment process is focussed on increasing consultation and transparency and ensuring
the MBS supports cost‐effective, evidence‐based best practice care. The new process allows for
stakeholder consultation during the assessment of items for listing on the MBS. The process occurs
in four broad stages: determination of suitability for assessment, development of the research
question/s, assessment of evidence, and MSAC appraisal. These stages are detailed below:
1. Determination of suitability for assessment
The steps that occur during this stage are explained below and are designed to limit the burden on
the applicant.
i. Potential applicants may request an initial meeting or attend an information session with
Departmental representatives. Initial meetings allow potential applicants to ask questions
about the process and discuss the proposed service with relevant representatives from the
Department.
ii. The applicant is asked to submit preliminary information to ensure the proposal meets the
requirements for consideration for public funding. This includes the provision of evidence
from relevant peak bodies that this is a necessary and appropriate part of practice. At this
step, the Department also assigns an ‘application manager’ to support the applicant through
the process. The Department also commences identification (or recruitment) of particular
clinical or other expertise to the MSAC Expert Standing Panel (MESP) to provide subject matter
advice on the proposal, and to the Protocol Advisory Sub‐Committee (PASC).
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2. Development of research question/s
This stage allows the applicant and the wider community to have input into the scope of the
assessment for applications.
i. Once the proposed application is deemed suitable for assessment it is listed on the MSAC
website and the applicant is requested to submit further information to enable PASC to
determine the research question for public funding by proposing a Decision Analytic Protocol
(DAP). The DAP sets out the clinical management algorithm that specifies both the clinical and
economic evidence required to inform MSAC’s appraisal. A draft DAP is developed by an
external evaluation group for consideration by PASC. The applicant is provided the
opportunity to comment on the draft DAP before PASC’s consideration.
ii. The draft DAP is considered and amended (where necessary) by PASC and published on the
MSAC website for public consultation providing an opportunity for all interested parties to
comment on the proposed assessment approach. The MSAC secretariat will also approach
relevant professional bodies for comment during public consultation.
iii. The final step in this stage is for PASC to review the outcomes of the public consultation and
determine the final DAP.
3. Assessment of evidence
There are two assessment pathways an applicant can choose once the DAP has been finalised, either
a contracted assessment (CA) or a submission based assessment (SBA).
A CA is when an applicant agrees to the Department contracting an assessment group with expertise
in health technology assessment to gather the evidence which addresses and supports the research
questions for public funding.
An SBA is when an applicant gathers the evidence which addresses and supports the questions for
public funding as outlined in the final DAP. The Department will then undertake a contracted
ritique of the SBA. An applicant may choose to go down the path of an SBA as it is likely to expedite
the process.
An assessment of the evidence is undertaken, by either the assessment group for a CA or the
applicant for an SBA. An assessment report, which provides evidence and analysis to address the
issues identified in the final DAP, is provided to the Department for the consideration of the
Evaluation Sub‐Committee (ESC). The form of the assessment report is specified in the MSAC
Guidelines to ensure that all elements that need to be considered by MSAC and its sub‐committees
are addressed.
The ESC considers the assessment report and identifies the main issues and uncertainties that MSAC
may need to specifically appraise. ESC produces a written report summarising these issues, which is
made available to the applicant for comment. Both the ESC report (and applicant comments) and the
assessment report are provided to MSAC.
4. MSAC appraisal
The final stage in the process is MSAC’s appraisal of the evidence presented in the assessment and
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ESC reports to inform its advice to government. MSAC prepares a detailed rationale for its
conclusions in the form of a ‘public summary document’ (PSD).
After the Minister has noted MSAC’s advice and agreed to its public release, MSAC’s advice, the PSD,
and the assessment report will be made available on the MSAC website. Where specific material is
agreed to be confidential, the report will be published with the confidential material redacted. The
Department offers debrief meetings to applicants following the public release of MSAC’s advice.
Following MSAC’s consideration, the Department of Health and Ageing is required to consider the
financial impact to government, consult with the Department of Finance and Deregulation, seek
Cabinet agreement and draft and implement legislative change before an item can be amended or
added to the MBS.
The introduction of new opportunities for public comment and increased public release of
assessment documentation provides a significant increase in the transparency of listing processes
for the MBS, and greater opportunity for input and feedback from interested parties.
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