Australian Labor Party
The Government decision to amend the Medicare Benefits Schedule
(MBS) so that it no longer covers Hyperbaric Oxygen Treatment (HBOT) for non-diabetic
wounds was not taken lightly. The decision is based on advice from the Medical
Services Advisory Committee (MSAC) following a rigorous assessment of the
evidence for the effectiveness of HBOT for non-diabetic wounds. MSAC stated to
the committee that the available evidence indicates that HBOT for non-diabetic
wounds has failed the 'effectiveness test', that it failed to provide
sufficient evidence that this was effective treatment.
As Professor Robyn Ward, Chair, MSAC, informed the committee that in the only
available Randomised Controlled Test (RCT) of HBOT for the treatment of
non-diabetic wounds published in 1994:
...data shows you there is no statistical difference in the
proportion of patients who achieve resolution of their wounds, or in the wound
size, at 18 weeks.
The MSAC assessment of 2011 of HBOT for non-diabetic wounds, follows
earlier assessments in 2001 and 2004 in which the same 1994 RCT data was
assessed. It was the only RCT available at the time of all three assessments.
Following the 2001 and 2004 assessments, interim funding was provided for HBOT
for non-diabetic wounds, thereby allowing the applicants more time to gather
further evidence, including a significant extension to the three year timeframe
set after the 2004 assessment.
The Department of Health and Ageing (the department) noted that the applicants
were now seeking 'a continuation of interim funding, to more than fifteen
years, on the basis of evidence which was insufficient at MSAC's first
consideration in 2001'. The department stated that throughout the consideration
by MSAC, the HBOT industry had many opportunities to provide additional
information. The HBOT industry also had over a decade of interim MBS funding to
conduct an RCT to demonstrate the long-term effectiveness of HBOT 'but have not
The department concluded:
If the HBOT industry believes it has new or additional
evidence another application can be submitted to MSAC at any time.
The department also noted that in October 2012, in response to further
issues raised by the applicants in discussions with the department following
the release of the MSAC assessment, the Government commissioned a further
review from the National Health and Medical Research Council (NHMRC) of MSAC's
Following the outcome of the August consideration by MSAC,
the applicants were offered the opportunity to highlight any errors of fact
that they believed were present in the MSAC analysis.
Meetings were held with Hyperbaric Health and other
interested parties on 5, 10 and 13 September. Dr Hawkins of Hyperbaric Health
made a submission on 17 September which outlined the concerns of the affected
parties. These continued to focus on the Assessment Report, rather than the
MSAC documents. The material, together with the various MSAC documents was
forwarded to NHMRC with a request to review the material and provide advice
about the approach and the issues raised.
The NHMRC endorsed the approach taken by the MSAC.
Mr Richard Bartlett, Department of Health and Ageing, explained the reasons
for the NHMRC review:
...I said that if there were any errors of fact that [the
applicants] could identify in what MSAC had done that we would get them
independently reviewed. Dr Hawkins subsequently provided a document which did
not identify errors of fact; it identified differences in interpretation. I
asked NHMRC to go through that, and to have a look at the MSAC documents, and
to comment on the process that was followed. The NHMRC feedback was that MSAC
had given appropriate weight to the evidence before it. 
The department also clarified for the committee that in addition to
special consideration given to HBOT for non-diabetic wounds by the NHMRC, the
department taken every step to have the concerns of the applicants addressed:
Since then, there has been some ongoing discussion with the
applicants...Since the public summary document was made available, we have taken
extensive steps to ensure that the applicants were given every opportunity to
raise concerns that they had with the process and to have these explored.
Labor Senators also note that the department also informed the committee
that the MSAC processes have recently been enhanced, following the 2009 Health
Technology Assessment Review (HTA Review) which 'aimed to address the
regulatory burden on businesses that results from HTA processes, to ensure that
those processes are efficient, measured and proportionate.
The submission further indicated that:
The importance of MSAC's assessment of evidence was
reinforced in the 2011 Budget through the announcement of the Comprehensive
Management Framework for the MBS (CMFM). Under the CMFM, MSAC not only provides
advice on new medical services involving technologies and procedures, but on
all proposed changes to the MBS. The MSAC process ensures that applicants,
stakeholders and the general public have ample opportunity to provide input
into the assessment.
Professor Ward, Chair of MSAC, set out for the committee how MSAC
conducts its work and prepares advice to the Minister, in a rigorous,
systematic and transparent way:
When preparing its advice to the minister, MSAC's terms of
reference require the committee to appraise the strength of the evidence on
safety, effectiveness and cost-effectiveness of a medical service compared to
its likely alternatives. To do this, MSAC's deliberations rely on a series of
sources, including a large assessment report prepared by external contractors
and the inputs from its subcommittees, as well as dissenting reports from
applicants. MSAC publishes the rationale for its advice in the form of a public
summary document. In all its work, MSAC uses processes which provide
transparency and accountability, procedural fairness, to affect its
stakeholders, which minimise conflicts of interest by separating advocacy from
While there were concerns raised about the handling of the dissenting
report by David Smart and Mike Bennett, the department clarified for the
committee that Dr Smart was a member of an assessment panel providing
information to MSAC and was not a member of MSAC itself.
Labor Senators also note that the Consumers Health Forum (CHF) of
Australia was supportive of the independent process for assessing whether
treatments are publicly funded, so that the decisions are not driven by media
profile or political know-how:
In all our consultations with health consumers there is very
strong support for basing health decisions on independent, validated evidence
about what is effective ... This approach has constantly been reinforced in all
of CHF's consumer consultations over the years.
CHF's view is that MSAC's role as an impartial adviser is
fundamental in ensuring consumers receive the best possible care. If there were
no independent, evidence based process it would mean that those with the
loudest voice, the highest media profile or the political know-how would be
able to influence whether to spend public funds, and that is not a situation
that would serve health consumers well. It is not a system that the public
could have confidence in.
An issue that received a lot of attention during the inquiry was the
suggestion by some witnesses that MSAC had not treated HBOT as a second line
treatment in its calculations and that by doing so the cost-effectiveness
estimates were flawed.
MSAC clarified that HBOT for non-diabetic wounds had failed the effectiveness
test and that it had examined HBOT as a second line treatment.
A further issue raised by some witnesses to the inquiry was the nature
of the evidence required by MSAC and whether or not MSAC had made it
sufficiently clear, what was required.
The Chair of MSAC, Professor Ward, explained that required level of evidence from
a RCT should have been well known:
Medical practitioners and scientists nowadays are skilled and
trained in the sorts of evidence that they need to collect which is most
influential in informing their own practice and is obviously now of use in
health technology assessments like this. It is true to say that the practice of
evidence based medicine has been going for about 20 years. Probably in more
recent times the medical profession has actually understood what it means and
the sort of data they needed to collect in order to comply with evidence based
practice. The short answer to your question is, yes, I would expect it was
reasonable that the applicants would understand the sort of evidence that would
need to be collected in this context. I am pleased to see that they are doing
The committee was also informed that an RCT is currently being conducted
by the Wesley Centre for Hyperbaric Medicine.
Following the completion of that trial a new application may be made to MSAC if
the study provides new evidence in favour of HBOT for non-diabetic wounds.
Professor Ward, Chair of MSAC, noted that:
MSAC very much look forward to receiving the randomised
control study when it is completed. We hope that the applicants take onboard
some of our suggestions—they are not obliged to—around that study, particularly
issues related to the endpoint of that study, so that we are in a good place to
make a decision or recommendations about HBOT down the track.
The applicants for HBOT services for non-diabetic wounds have now been
given opportunities, spread over a decade, to meet the criteria for ongoing
Medicare funding and have been unsuccessful on all three occasions. It was
identified over a decade ago that a more substantial Randomised Control Trial
was needed, but such a trial has not been provided to MSAC to date. When the
current trial is completed a new application to MSAC can be made. The 2011 MSAC
assessment of HBOT for non-diabetic wounds has also been scrutinised by the
National Health and Medical Research Council and this inquiry.
Government Senators support the decision to withdraw Medicare funding
for HBOT for non-diabetic wounds as:
- the decision is consistent with its commitment to evidence based
- the department has gone out its way to assist the applicants,
including the special review by the NHMRC and other follow-up activities;
- interim funding has been provided for around a decade to enable
new evidence to be obtained to determine if HBOT for non-diabetic wounds can
meet the effectiveness test, but such evidence still has not been produced; and
- even though a new trial is underway, it does not appear to
provide a reasonable prospect of better evidence for some years.
As indicated in the Department of Health and Ageing submission,
it is important to note that funding under the MBS is continuing for HBOT
services for a range of other indications including diabetic gangrene and
diabetic foot ulcers, soft tissue radionecrosis, osteoradionecrosis,
necrotising soft tissue infections including necrotising fasciitis or
Fournier’s gangrene, air or gas embolism, gas gangrene, and decompression
Senator for Tasmania
Senator Anne McEwen
for South Australia
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