AMA submission on the Proposal for Changes to the Medical Services Advisory Committee (MSAC) Processes for Applications for Public Funding

Discussion Paper: Proposal for Changes to the Medical Services Advisory Committee (MSAC) Processes for Applications for Public Funding

The current processes for assessing new health technologies have served Australians well.  Australians have access to safe, quality health care and technologies at a reasonable cost.

It is important to ensure that the assessment of new medical services and technologies for public funding is sufficiently rigorous to ensure they are safe and clinically effective, but also that the assessment process is timely.

As a principle, health technology assessment processes need to support high quality clinician decision-making at the point of health care delivery to achieve better health outcomes for patients and higher levels of patient satisfaction.  Clinician advice to patients about the optimal treatment for their condition and circumstances needs to be based on the best available clinical data on outcomes, which can be gathered from pre-market assessment and post-market surveillance.  The AMA supports post-market monitoring and evaluation through to collection of evidence to monitor patient safety and clinical outcomes in the Australian setting.

The objective of the MSAC assessment processes should be to provide Australians with timely access to new medical services, devices and technologies that are safe, clinically effective and affordable.

The AMA supports efficiencies in MSAC assessment processes that have the effect of:

• keeping any regulatory costs for individuals and organisations who seek to provide new services and technologies as low as possible; and
• minimising the time it takes for a new medical service, device or technology to be assessed.

If the proposals in the MSAC discussion paper:

• improve the timeliness of MSAC assessments;
• ensure that the assessment is informed by the relevant craft groups; and
• provide transparency of all administrative decisions that are made during the assessment,

the AMA has no particular comment to make on the broader proposals.

However, the AMA makes the following specific comments in relation to a few matters:

Eligibility for assessment and the appropriate assessment pathway

It is not clear from this discussion paper when the MSAC pathway will be used, and when applicants might instead be subject to the MBS Quality Framework.  Further, given that Departmental officers will be making decisions about whether applications are accepted or rejected for assessment, and if accepted, which pathway the applicant must apply to, there should be clear, publicly available criteria against which applications will be judged for acceptance for assessment either by MSAC or under the MBS Quality Framework.

We raised this eligibility issue in our June 2010 Submission on the MBS Quality Framework Discussion Paper and the Department has still not addressed this issue.  In the meantime, craft groups who have made initial application have been summarily rejected without a transparent criteria and reasons for the rejection.

The Department must make the criteria for eligibility assessment available.  These criteria will provide applicants with greater certainty about the pathway that will be used to assess their service and why, and ensure that Departmental decisions about eligibility for assessment and the appropriate assessment pathway are consistent and transparent.

There should be strict timelines for when applicants first seek a pre-lodgment meeting with the Department till when they are rejected or accepted as eligible for assessment.

Data collection and analysis

The discussion paper proposes a more rigours approach to data collection requirements and a new approach to definitive evidence collection protocols.

The AMA supports the collection and evaluation of data for new medical services provided in the Australian setting.  The proposal for definitive evidence collection protocols is to systematically collect information on the individuals who are treated with the medical service to monitor the service and its impact on improving healthcare outcomes.

If the Government is to achieve its objective of ensuring an evidence base to support ongoing Medicare funding of medical services it needs to understand that the gathering and analysis of evidence requires administrative and financial resources.  The documentation is silent on how data collection will be supported and resourced and who will be responsible for them.  As past experience has shown, data collection will not occur if these key elements are not addressed.

Protocol Advisory Subcommittee (PASC)

The AMA notes that the requirement that members will be appointed to the PASC “only for their expertise and not as representatives of a particular organisation” is discordant with the additional requirement that members “must be able to effectively represent the views of a particular area of expertise”.

Recommended fees

The Department has chosen to define schedule fee in the discussion paper to mean “the amount the Government considers appropriate as a recommended fee for an MBS item” (page 25, 2nd paragraph).  The AMA strongly opposes the use of this definition and insists on immediate correction to be consistent with current legislative definitions.

Schedule fee is already defined in section 8 of the Health Insurance Act 1973 as "the fee specified in the table in respect of the service".

The MBS schedule fees are the amount of fees against which the Government pays Medicare benefits.  Section 4, 4AA and 4A of the Health Insurance Act 1973 provide for the General Medical Service Table, the Diagnostic Imaging Services Table and the Pathology Services Table, respectively, to contain the amount of fees applicable in respect of each item in those tables.  Those fees are there only for the purpose of calculating the amount of the Medicare benefit payable for a medical service, as provided for in section 9 of the Health Insurance Act 1973. 

The Health Insurance Act does not contemplate or authorise the Government to "recommend" fees for those medical services.  Therefore it is inappropriate for the Department to give the MBS Schedule Fee a new construct as part of the implementation of the new MSAC assessment process.

Government initiated services

The AMA would expect that where the Government intends to fund a new service, that service would undergo the same assessment process that would have applied had the relevant craft group made an application for public funding for that service.