Concerns Over Rushed Prostheses List Changes

[vc_row][vc_column][vc_column_text]This week the Department of Health issues a consultation paper discussing options for reforms and improvements to the Prostheses List.

The Department said it was seeking the input from stakeholders to support an evidence base for future Prostheses List reforms and improvements. The consultation paper contains a number of questions for consideration by stakeholders.

The consultation process announcement follows the recent release of two reports: Options for a Revised Framework for Setting and Reviewing Benefits for the Prostheses List and the Review of the General Miscellaneous Category of the Prostheses List.

The reports acknowledged the significant risk of unintended consequences that could arise because of poorly planned Prostheses List reform including limits to patient access and choice, and the increased risk of cost shifting onto patients. Neither report was able to reach a definitive conclusion about the future direction of the Prostheses List.

The chance to engage in constructive Prostheses List reforms were welcomed by a range of industry groups including the Australian Private Hospitals Association (APHA), Catholic Health Australia (CHA) and the Medical Technology Association of Australia (MTAA).

APHA CEO, Michael Roff, said APHA welcomed the opportunity to be part of the discussions, which to-date have not fully involved private hospitals, consumer, or the medical profession.

“Considering doctors determine which prostheses they use in surgery, particularly in the private setting, it is important this anomaly is corrected,” Mr Roff said.

The message from stakeholders is clear: any reforms need to ensure they do not lead to a ‘managed care’ system where the ability to pick a doctor, medical device, or the procedure that’s best for the patient is compromised.

Concerns have been raised over the weight being given to the Private Health Insurance lobby’s position to transition Australians’ health to a system where insurers can refuse to allow patients access to devices they deem unnecessary for them to have to pay for.

MTAA CEO, Ian Burgess, said the consultation process was an important first step in the process to carefully consider positive reforms to the Prostheses List that genuinely reflect the considered feedback of all stakeholders, and the timeliest way to implement them.

“It’s vital that any reforms put forward by the Government do not remove the protections the Prostheses List provides for surgeon choice and patients access, or result in further out-of-pocket costs,” Mr Burgess said.

The Department set the submission close date for 15 February, meaning doctors, hospitals and MedTech innovators will be forced to work through the Christmas and New Year period (on top of managing the COVID pandemic) in order to ensure their voices are heard.

The decision by the Department to rush the consultation period over the holiday break has raised questions about whether Health bureaucrats have already decided on the reforms they want to implement.[/vc_column_text][/vc_column][/vc_row]


[vc_row][vc_column][vc_column_text]A new publication in Science Magazine, sponsored by Abbott, shows how Australia can create more value from its enviable biomedical R & D effort by promoting partnerships across industry, research and health services to address our healthcare priorities.  

The COVID-19 pandemic has been a high point in the recent history of Australian medtech. The urgency of confronting a novel virus put a major premium on agile collaboration.  Arms of the Australian healthcare system that typically operate in competition found themselves working alongside each other to get the most important job in the world done quickly, and right.  We can be proud of the fact that, in Australia, we delivered on the task.  Our testing rates are among the world’s highest; our hospital bed and ventilator capacity scaled up in record time; and normal elective surgery schedules were quickly re-established. 

The important lesson is that healthcare works best when its stakeholders have aligned interests. The urgency of the COVID challenge broke down institutional barriers to collaboration – between the Commonwealth and states, between private and public hospitals, between competitors in industry, and between government and the private sector.  

After the pandemic, there is no need to reinstitute those barriers.  

That is the motivation that inspired Abbott to sponsor a major new publication in the prestigious journal Science, focused on how Australia can, and should, take a partnership approach to the innovation challenges necessary to address our 21st century healthcare needs.  

Australia’s public and privately funded medical research effort is impressive by world standards, at well over $A6 billion.  Yet less than 2% of our R & D spend ends up focused on translating insights from basic science into new therapies, new services or updated clinical guidelines. A key deficiency contributing to that gap is the lack of emphasis on bringing commercial and clinical expertise together with research skills in a coherent way. This insight is not new; it was a key focus of the McKeon Review of Health and Medical Research back in 2013. Not enough has changed since, despite some initiatives from governments and research institutions. 

The Science supplement draws together the major peer reviewed studies conducted over the last decade on what differentiates successful translation efforts. Some of the major findings include: 

  • The role of time. Responsive regulatory and path-to-market systems attract translational investment 
  • Incentives for localisation: where the intellectual property is registered is a complex decision, based not just on market size but other factors including expected returns from reinvestment, relative taxation of IP, and successful examples of win-win outcomes from IP collaborations 
  • Recognition that translation is a specialist skill: integrating it into research institutional structures and incentivising direct funding of translation initiatives. The Medical Research Future Fund does some of this, but added scale will create better results. 

We also highlight two examples of “self-starter” collaborations in Australia with great promise: the Australian Cardiovascular Alliance (ACVA) and Australia’s National Digital Health Initiative, ANDHealth. 

The post-COVID environment is an ideal time to revive the impetus for change in our health innovation effort. We can already see what happens when we all pull together.  [/vc_column_text][/vc_column][/vc_row]


Medtronic recently announced statistically significant 12-month results from a large, multi-centre randomised controlled trial (RCT) that demonstrated the importance of DTM Spinal Cord Stimulation (SCS) in providing backpain relief, compared with conventional SCS therapy, using the Medtronic Intellis platform.

At 12 months, 84% of patients with chronic back pain treated with DTM SCS reported at least 50% pain relief, compared to 51% of patients treated with conventional SCS(p=0.0005).

There was also a difference in the proportion of patients who reported profound back pain relief (>80% reduction in VAS score) favouring DTM SCS (69%) compared with conventional SCS (35.1%). The study met its primary endpoint at three months, and in pre-specified secondary analysis showed the importance of DTM SCS compared to conventional SCS and has sustained these results at 12 months.

Pain relief was measured by the Visual Analog Scale (VAS), a widely used and accepted measure for pain intensity that records patient-reported pain levels on a scale of 0-10. Fifty-percent pain relief, as measured by VAS, is a recognised industry standard to define therapy success. The majority of DTMS SCS patients in the study exceeded the threshold, with seven out of ten experiencing profound back pain relief at 12 months.

Patients treated with DTM SCS also reported an average VAS score reduction of 75% in back pain, compared with 50% treated with conventional SCS. Average VAS scores for patients treated with DTM SCS at 12 months were 1.74 for back pain and 1.45 for leg pain.1 The term remitter has previously been used to classify patients with a pain score of 2.5 or less. 1 As a group, patients in the DTM SCS group clearly fell below this level with a mean VAS score of 1.74 for back pain and 1.4 for leg pain.

Richard Sullivan at Precision Brain, Spine and Pain and the Director at Large for the International Neuromodulation Society was among the first Australian physicians to gain experience with this programming paradigm.

“The 12 month data from Medtronic’s DTM SCS study puts this therapy ahead of other treatments in managing post-surgery back pain,” said Dr Richard Sullivan. “As such spinal cord stimulation should now become the standard therapy in this condition once spinal stability is confirmed. My personal experience in using DTM SCS therapy for patients in this situation is consistent with these outstanding study results.”

“DTM SCS is based on a novel understanding of how neurons and glial cells contribute to chronic pain,” said Charlie Covert, vice president and general manager of the Pain Therapies business, part of the Restorative Therapies Group at Medtronic. “The 12 month data reported demonstrate the value of Medtronic’s continued focus on pursuing science-based approaches to improving human health and underscore our ability to integrate existing technologies with novel therapies like DTM SCS to improve the outcomes of people suffering from chronic pain.”[/vc_column_text][/vc_column][/vc_row]

MTAA endorses the Prime Minister’s Modern Manufacturing Strategy

[vc_row][vc_column][vc_column_text]This week’s announcement was widely welcomed by many in the MedTech industry, with leaders signalling that the almost $1.5 billion in new investment to be a clear indication of the Morrison Government’s commitment to ensuring Aussie Manufacturing, particularly MedTech, can continue to be a global leader.

Medical Technology Association of Australia (MTAA) CEO, Ian Burgess, has congratulated the Morrison Government on its policy and called upon the industry to take it up in full.

“More than half of Australian medical device companies have grown from local start-ups, so today’s announcement will make an important impact where it is needed most, shoring up Australia’s MedTech innovators now and into the future,” Mr Burgess said.

The Australian MedTech sector has been steadily growing, and now has over 19,000 people directly employed by the industry – many of these in manufacturing. The MedTech industry is an employer of choice; 78% of employees in the industry have a degree, 25% have a postgraduate degree. Today’s announcement will ensure that employment in the sector continues to grow.

The $107.2 million allocated to the Supply Chain Resilience Initiative will mean industries such as MedTech can continue to ensure all Australians have access to medical devices when they are needed.

“During COVID-19 the Government asked MedTech to supply 7,500 ventilators, the MedTech supply chain worked, and the ventilators and other essential medical equipment were delivered,” Mr Burgess said.

MTAA and its MedTech members have thrown their support behind the measures the Prime Minister has today outlined, which, we believe, will improve Australians access to the best and latest medical technologies they need, and can distribute these to the world.[/vc_column_text][/vc_column][/vc_row]


Importantly, conclusions from the study data enabled the development of the PRODIGY Risk Score, an easy-to-use risk prediction tool to identify patients at high risk of respiratory depression who would benefit from continuous monitoring with capnography and pulse oximetry.

The study, which analyzed 1,335 patients across 16 sites in the United States, Europe and Asia, found that respiratory depression, as defined by changes in pulse oximetry and capnography monitoring parameters, occurred in 46% of medical and surgical patients evaluated who were receiving IV opioids for pain. This incidence rate is significantly higher than previously reported in clinical literature.1 The complete study results are published online in Anesthesia and Analgesia1, the official journal of the International Anesthesia Research Society (IARS).

“PRODIGY data confirms that respiratory depression in patients receiving parenteral opioids occur frequently and are potentially unknown to hospital healthcare providers,” said Ashish K. Khanna, M.D., primary study investigator and an associate professor of Anesthesiology, section head for Research and intensivist at the Wake Forest School of Medicine. “Together with risk assessment using the PRODIGY Risk Score, the use of capnography and oximetry for continuous monitoring of patients identified as high risk for respiratory depression may increase safety when parenteral opioid analgesia cannot be avoided.”

Currently, there are no universally accepted guidelines to direct effective and safe assessment and monitoring practices for patients receiving in-hospital opioid analgesia. In addition to providing insight into the rate of respiratory depression, a key objective of PRODIGY was to develop and validate an accurate and easy-to-use risk assessment scoring tool. The PRODIGY Risk Score uses risk factors including: age > 60 years, male gender, opioid naïvety, sleep disorders and chronic heart disease for respiratory depression events risk prediction.

“The PRODIGY Risk Score has acceptable accuracy for risk stratification using several robust methods of internal validation, addressing significant gaps in preventing this common and potentially deadly condition,” said Frank Chan, vice president and general manager of the Patient Monitoring business, which is part of the Minimally Invasive Therapies Group at Medtronic. “Patients with respiratory depression were more likely to experience an adverse event that prolonged hospitalization and more likely to require rescue action, including rapid response team activation.”

The PRODIGY study is the largest known study using continuous capnography and pulse oximetry data on surgical and medical patients collected by Medtronic Microstream and

Nellcor monitoring technology. The study design used an innovative mechanism of data collection whereby bedside providers were blinded to continuous monitoring systems and all alarms were also silenced. All patients experiencing respiratory depression were reviewed and confirmed by an independent clinical event committee of physicians with expertise in perioperative respiratory medicine.


About Respiratory Compromise

Respiratory compromise is a potentially life-threatening, progressive condition negatively impacting a person’s ability to breathe adequately to maintain oxygenation and carbon dioxide removal. Patients with respiratory depression may experience shallow, slow or no breathing after opioid administration which undetected can lead to cardiopulmonary arrest and death.3 This condition is rapidly becoming the third-most costly hospital inpatient expense in the U.S., and dramatically increases the likelihood of adverse patient outcomes and cost of patient care.4 Not only is respiratory compromise common and dangerous, it has been very difficult to predict.[/vc_column_text][/vc_column][/vc_row]


[vc_row][vc_column][vc_column_text]At the height of the pandemic, NSW Premier, Gladys Berejiklian, appealed to businesses to pivot their focus to producing critical medical supplies in the fight against COVID-19.

The Premier said that global supply chains were disrupted, but thanks to local universities and manufacturers stepping up, they were able to join forces to develop prototype ventilators.

“Two ventilators are on track to receive regulatory approval within weeks and, if needed, can be produced for hospitals here and potentially overseas, saving lives and boosting jobs,” Ms Berejiklian said.

The Ventilator Innovation Project was part of the NSW Government’s $800 million investment to help increase services and equipment to combat COVID-19.

The NSW Government knows that having access to a ventilator can be the difference between life and death for severe COVID cases, which have become all too apparent in situations overseas.

In some of the worst-hit nations, health staff were forced to limit who could access ventilators – a situation the Government says is why NSW needs reliable local supply chains to safeguard patients.

Minister for jobs, Investment, Tourism and Western Sydney, Stuart Ayres, said the pandemic had inspired a wave of innovation and rapid development across the globe, and local manufacturers and universities had risen to the challenge.

“One thing history has shown us is that crises stimulate innovation and this pandemic has provided an environment for launching and testing new ideas,” Mr Ayres said.

“We congratulate the successful teams behind the CoVida Ventilator, led by the University of Sydney, with clinicians at Westmead and Royal North Shore Hospitals, and Ventasys, developed by AmpControl with clinicians at the John Hunter Hospital.”[/vc_column_text][/vc_column][/vc_row]


[vc_row][vc_column][vc_column_text]The Select Committee on Financial Technology and Regulatory Technology has made the recommendations in its interim report.

“The AMA has long advocated for Medicare-subsidised telehealth consultations, and temporary Medicare COVID-19 arrangements have shown the value of telehealth,” AMA President, Dr Omar Khorshid, said today.

“The telehealth items have supported the provision of care during these very difficult times, and have been embraced by patients and doctors.

“The AMA is in discussions with the Commonwealth Government about the long-term future of Medicare-funded telehealth for patients who need to see their GP or non-GP specialist.

“This is an ongoing piece of work. In the meantime, the AMA has called for the extension until March next year of the temporary telehealth items, which are due to expire at the end of this month.

“While work on e-prescribing is progressing very quickly, it is still in a limited testing phase. We welcome the Government’s commitment to its roll-out and want to see the extension of temporary COVID-19 arrangements that have allowed pharmacists to dispense medication using a digital image of a prescription.

“With Australia still in the midst of a global pandemic, these temporary arrangements must continue. They are essential to efforts to contain the spread of the virus.

“The AMA is keen to see the Government make a decision on the extension of these temporary arrangements as soon as possible. Practices are already taking appointments for October and beyond.

“Practices and patients alike need certainty about the availability of telehealth, particularly for vulnerable patients.”[/vc_column_text][/vc_column][/vc_row]


[vc_row][vc_column][vc_column_text]The program of large scale, major scientific and collaborative research initiatives, will be aimed at solving some of Australia’s greatest challenges, focused on outcomes that lead to positive impacts, new jobs and economic growth.

 CSIRO Chief Executive Dr Larry Marshall said the collaboration and goodwill stimulated by the response to COVID-19 can be harnessed and used to accelerate our recovery, create new jobs and stimulate the economy.

“While COVID-19 will undoubtedly continue to disrupt, Australia will come together through this crisis and build a strong future in the process. We are calling for partners to join this Team Australia approach to solving what seem like unsolvable problems,” Dr Marshall said.

On the centenary of CSIRO’s first mission, to eliminate Prickly Pear, it will direct $100 million annually to the co-creation of missions, working with the brightest minds across the research sector and industry, to help Australia achieve these outcomes:

  • Increase our resilience & preparedness against pandemics
  • Mitigate the impact of disasters: drought, bushfires and floods
  • Create a hydrogen industry to generate a new clean energy export industry
  • Accelerate the transition to agile manufacturing for higher revenue and sovereign supply
  • Overcome our growing resistance to antibiotics, so they keep saving lives
  • Create a national climate capability to navigate climate change uncertainty
  • Help our farmers overcome drought, mitigate climate impacts, increase yield and profitability, create a sustainable Future Protein Industry and leverage the world’s love of Australian-grown food to collectively drive our trusted agriculture and food exports to $100 billion
  • Use technology to navigate Australia’s transition to net zero emissions, without derailing our economy
  • Safeguard the health of our waterways by monitoring the quality of our water resources from space
  • Create new industries that transform raw mineral commodities into unique higher-value products like critical energy metals that build Australia’s value added offering, jobs, and sovereign supply
  • End plastic waste by reinventing the way plastic is made, processed and recycled
  • Double the number of small and medium businesses (SMEs) benefitting from Australian science to become a collaboration nation.

Minister for Industry, Science and Technology Karen Andrews welcomed CSIRO’s continued commitment to solving real-world problems.

“Science and technology are our greatest tools when it comes to maximising opportunities and addressing the challenges that face Australia at this time of great upheaval,” Minister Andrews said.

“We need to make sure that our scientists and researchers are working collaboratively with industry to solve real world challenges for the benefit of everyday Australians.”

David Thodey AO, Chair of CSIRO said, “The CSIRO Board fully endorses this Mission-led strategy and is committed to supporting the talented scientists and researchers at CSIRO, our universities and business partners to work together on these challenges for the good of our Nation in these challenging times.”

Dr Marshall said CSIRO was drawing on its 100-year history to develop the missions with its partners across science and industry, to support the nation at a tough time.

“For over a century we have worked with scientists around the country to solve our greatest challenges, and find the opportunities that give Australia her competitive advantage. From our first mission to save our agricultural land from prickly pear, to discovering breakthroughs like fast WiFi, Australia’s first digital computer, our 70-year history in battling bushfires, and our latest vaccine, virus and surgical mask work for COVID-19, CSIRO has always made Australia’s success our mission.”

Dr Alan Finkel, Australia’s Chief Scientist said, “Great science starts with a vision, but vision alone is insufficient. The vision has to be backed by real commitment. That’s what the CSIRO missions are all about, and I hope their rallying call is heard far and wide.”

Dr Brian Schmidt, Vice Chancellor of the Australian National University said, “ANU looks forward to working with CSIRO and its partners to co-design and deliver a national effort to help address some of the globe’s greatest challenges. At this moment, collaborative effort has never been more needed, and ANU will happily answer the call.”

Nick Hazell, v2food Founder and CEO said, “Missions set out a vision for Australia in a future we all can believe in – sustainable and science-led. The Missions are about coming together and using CSIRO science to make the most of Australia’s potential and having a positive impact on the world in light of the challenges we all face.”[/vc_column_text][/vc_column][/vc_row]

First of 2,000 NOTUS emergency ventilators delivered to national medical stockpile

[vc_row][vc_column][vc_column_text]Executive Chairman, Jefferson Harcourt said the $31.3 million federal government supply contract sees us now manufacturing at speed. “Assembly lines are up and running at Planet Innovation in Box Hill and Medmont International in Nunawading, as part of our expert network of manufacturers and suppliers.”

“We’ve seen ingenuity, resilience and extraordinary collaboration from our myriad of partners in meeting the challenges of our COVID-19 response… And we couldn’t have done it without the incredible support of the Australian government, the Victorian Government and the Advanced Manufacturing Growth Centre.” he said.

“Grey Innovation is very proud to have a led this amazing consortium of local companies to produce the NOTUS emergency ventilator to ensure every Australian who might need a ventilator, will have one.”

“Delivery of the first ventilators from the NOTUS project is a testament to the hard work and resilience of the Australian MedTech industry,” said Ian Burgess, MTAA CEO today.

“The impacts of COVID-19 have been felt across the entire healthcare sector and will continue well into the future, but despite these impacts, the Australian MedTech industry has pulled together in an unprecedented effort to support the Morrison Government’s pandemic response,” Mr Burgess said.

Federal Industry, Science and Technology Minister, Karen Andrews, said the agreement had helped Grey Innovation employ 22 new engineers with another 250 jobs created or retained across the suppliers.

“The local production of these ventilators is an outstanding example of what can be achieved when industry and government work together and draw on our highly advanced manufacturing capability”, she said.

“These ventilators are available to be sent anywhere they are needed in Australia and give us an impressive reserve capacity.

“Hopefully they won’t all be needed, but these machines will ensure that our hospitals are well equipped to withstand future surges in intensive care cases.”

The NOTUS Emergency Invasive Ventilator Program is a Grey Innovation-led initiative, supported by the Australian Government, the Victorian Government and AMGC.[/vc_column_text][/vc_column][/vc_row]