DISRUPTION IN HEALTHCARE: WHAT IS CHANGING

[vc_row][vc_column][vc_column_text]Although disruption has not yet reached healthcare there are signs that that is beginning to change. The increasing focus on technology particularly wearables, entry of innovative giants into the healthcare space and renewed government investment and interest in fixing a public hospital crisis mean that disruption is coming. The clear warning to healthcare companies is adapt or die. Meanwhile for consumers this disruption could lead to healthcare as a whole shifting to the service driven model adopted by the likes of Uber. This model could dramatically improve consumers’ experiences and healthcare outcomes.

Medical technology has taken off in recent years drawing increasing investment and public attention. Of particular importance is the growth in health ‘wearables’ such as Fitbits. This sector has exploded in recent years with experts predicting wearables to be worth US$12.1 billion by 2021. Wearables are important as they are a consumer rather than expert driven product and allow users to track and monitor their own health.

In combination with developing diagnostic tools and the potential for AI health assistants such as Amazon’s ‘Alexa’, wearables could fundamentally change the way that we approach healthcare. This new focus on technology for individual users is a far cry from healthcare delivery even a few years ago. This new focus on individual users’ health outcomes (rather than the time spent treating them) could help companies disrupt the current fee-for-service model.

In addition to empowering individual consumers and shifting the healthcare delivery model wearables have allowed companies to gather health data on an unprecedented scale. These companies are beginning to enter the healthcare space with past disruptors Amazon and Apple both developing healthcare solutions. Amazon in particular with its focus on disrupting brick-and-mortar stores could pivot into providing online pharmacy services and through cutting out the pharmacist provide significant savings to consumers.

Similar services are already available in the UK where companies are allowing consumers to order repeat scripts online significantly improving compliance with medication directions. Meanwhile Apple is leveraging health data from the Apple Watch and its own employees through developing an in-house medical service to test future med-tech products and service delivery methods.

The Australian Government is also taking steps to encourage innovation in the healthcare space. Recent budgets have focussed on health spending and through programs like the Medical Research Future Fund the government is investing in Australia’s future healthcare needs. The government is also taking steps to assist innovators, through R&D tax incentives smaller start-ups get access to refundable credits while larger companies receive a tax offset.

Despite the changes following the 2018 budget, R&D tax incentives will still assist start-ups, especially in the area of healthcare where clinical trials have been exempted from the $4 million cap on cash refunds for companies with a turnover less than $20 million. These tax incentives have allowed Australian companies to focus on research and development and create innovative solutions to healthcare problems. For example, CancerAid has credited the scheme with providing them with the funding they needed to develop an app to allow cancer patients to connect with each other.

In addition to specific programs, the national focus on the failings of public hospitals could serve as a flashpoint that could encourage greater innovation and in turn disruption. In the last article we discussed how the fee-for-service model inherently disincentivises innovation and addressing this could disrupt the industry as a whole.

The current public hospital crisis has led to high costs and poor health outcomes and repeated attempts to fix it through increasing funding or pushing for efficiency the system continues to fall short. This suggests that innovation and disruption may be the only solution to ‘fix’ public hospitals in Australia, and as such will continue to receive both government and industry attention and support.

The final article in this series will discuss how disruption can be measured and what conclusions can be drawn from this in an Australian context.

Health Horizon is a start-up that empowers health consumers by allowing them to find and track health innovations that interest or affect them so that they can gain control over their health future.

*Regina E. Herzlinger, original article here.[/vc_column_text][/vc_column][/vc_row]

Public Hospital Admissions Rising Fast

[vc_row][vc_column][vc_column_text]Admissions to public hospitals are growing faster than admissions to private hospitals, according to a new report from the Australian Institute of Health and Welfare (AIHW). The report, shows that of the 11 million admissions to hospitals in 2016–17, 6.6 million were in public hospitals and 4.4 million were in private hospitals.

“Admissions rose by 4.3% on average each year for public hospitals and 3.6% for private hospitals between 2012– 13 and 2016–17, and these were greater than the average growth in population of 1.6% over the same period” said AIHW spokesperson Jenny Hargreaves.

In 2016–17, the majority of admissions to public hospitals (83% or 5.5 million) were for public patients – however, about 1 in 7 (14% or 912,000 admissions) were for patients who used private health insurance to fund all or part of their admission.

There were 2.2 million admissions involving elective surgery in total. In terms of the safety and quality of care delivered, the report shows that in 2016-17 there were more than 186,000 hospital-acquired complications or 2.2% of 8.6 million in-scope admissions. Overall, the average length of stay in 2016-17 was 3.2 days in public hospitals and 2.2 days in private hospitals.

Australian Private Hospitals Association (APHA) CEO Mr Michael Roff said the report reveals public hospitals have not shied away from taking privately insured patients, while forcing those on public waiting lists to wait longer for treatment.

“The latest data shows privately insured patients continue to jump the queue in public hospitals. The median wait time for elective surgery for a public patient is 42 days. That’s twice as long as the privately insured who wait a median of 21 days,” Mr Roff said.

“The AIHW data show one in seven public admissions were for privately insured patients – that’s 14 percent of all admissions to public hospitals,” he said.

Meanwhile the peak body for the Private Health Insurance industry said: “The harvesting of patients from public emergency departments and pressuring them to go private, risks undermining Medicare and the Australian health system,” Dr Rachel David, CEO of Private Healthcare Australia.

“As a result of this cash grab, public patients are waiting longer for their surgery in public hospitals and the practice adds more than $1 billion to the cost of health fund premiums per year.

CEO of the Medical Technology Association of Australia (MTAA), Ian Burgess, said under MTAA’s Agreement with the Government to reform the Prostheses List, the MedTech industry is incurring revenue cuts of $1.1 billion which goes directly to the private health insurance companies to improve the affordability of private health insurance.

“We’re the major reason this year’s average private health insurance premium increase was the lowest in 17 years,”

“MTAA strongly supports the need for a healthy and viable private health insurance sector in Australia, however private insurance needs to provide consumers value and that value needs to be better communicated. This includes the choice of medical technology that a patient’s treating doctor considers to be the most clinically appropriate, generally with no gap payment applying to that technology,” Mr Burgess said.

And don’t miss ABC 4 Corners this Monday as it looks at what’s driving up your out of pocket costs. This will air just before Senate Estimates providing another opportunity to put healthcare costs front and centre. PulseLine will continue to look at the fierce debate and asked the question, is Private Health Insurance worth it? [/vc_column_text][/vc_column][/vc_row]

PRIVATE HEALTH INSURERS NEED TO FOCUS ON VALUE

[vc_row][vc_column][vc_column_text]As Sydney Morning Herald reporter, Esther Han said earlier this week “it appears the federal government’s private health insurance reforms – including cutting the cost of devices on the prostheses list and allowing insurers to offer discounts to young adults – have done little to stem the flow of members heading to the exits.”

CEO of the Medical Technology Association of Australia (MTAA), Ian Burgess, said under MTAA’s Agreement with the Government to reform the Prostheses List, the MedTech industry is incurring revenue cuts of $1.1 billion which goes directly to the private health insurance companies to improve the affordability of private health insurance.

“APRA quarterly figures show that private health insurance benefits paid for prostheses decreased by 13%, saving the private health insurance industry $72 million in the March quarter alone.

“We’re the major reason this year’s average private health insurance premium increase was the lowest in 17 years,”

“MTAA strongly supports the need for a healthy and viable private health insurance sector in Australia, however private insurance needs to provide consumers value and that value needs to be better communicated. This value currently includes the choice of medical technology that a patient’s treating doctor considers to be the most clinically appropriate, generally with no gap payment applying to that technology,” Mr Burgess said.

The latest APRA data shows that in the 12 months ending March 2018, private health insurers increased premium revenue by 4% and retained more of that revenue, with total benefit payments increasing by just 3%. As a result, gross margin increased from 13.6% to 14.41% and profit before tax increased by 3.9% to $1.8 billion.

Private health insurers have managed to consistently increase margins and profit levels, compared to three years ago profit before tax has increased by 20%.

Referring to Roy Morgan research that in the year to March 2018, an estimated 256,000 people decided not to renew their private health insurance, Norman Morris, Industry Communications Director, Roy Morgan said “there is major doubt among many members regarding the current value to them of retaining their private health insurance. It is up to the health funds to communicate the value of having private health insurance”.  

“Our research on member satisfaction with private health funds has shown major differences in satisfaction across funds and as a result the poorer performers could learn from the top ones and so improve their chances of member retention,” Mr Morris said.

While the latest APRA data for the year to March shows a decline of 36,742 in the number of people with hospital insurance and an increase of 52,977 in those with general insurance (extras), these represent net movements (exits and new). The Roy Morgan data represents an exit rate in the order of 1.9%, which is broadly in line with industry modelling published by the Department of Health.

The APRA figures show the number of people with hospital cover as a proportion of the population is continuing to decline – down another 0.1 per cent in just three months to 45.5%.

Private Healthcare Australia CEO Dr Rachel David said: “In fact more Australians than ever currently hold PHI. What people say they might do and what they actually do can be quite different and our research has repeatedly shown than 80% of people with PHI value it and want to keep it.

“Of course, members are concerned about rising premiums and out-of-pocket medical costs but they also understand that premiums are rising because the funds are paying for more healthcare,” said Dr David.

“We are working with the government and stakeholders to improve affordability by addressing issues such as cost-shifting from the public sector, low-value and wasteful care, fraud and compliance issues with the MBS”, Dr David said .

Meanwhile the Australian Private Hospital Association (APHA) pointed out the statistics released this week showed a 4% increase in privately insured patients treated in public hospitals this quarter.

CEO of APHA Michael Roff said this means more than 800,000 public hospital episodes of care were funded through private health insurance in the past 12 months, resulting in health insurers unnecessarily paying out $1.1 billion to public hospitals and forcing premiums up.

The increase of private patients in public hospitals is costing the private health system $1 billion, further evidence of real “fat in the system”.

“It means more people without the ability to pay for private health care will be left waiting for their surgery. We know that public hospitals let private patients jump the queue, with public patients waiting twice as long for treatment compared to insured patients. So the more private patients they treat, the longer public patients have to wait,” Mr Roff said.

Earlier in the week PulseLine was present when Shadow Minister Catherine King MP delivered her Post-Budget Briefing speech at the Australian Institute of Policy Studies to a full room in Sydney. She made it clear that for Labor the priorities are threefold – Medicare, public hospitals and private health insurance.

Labor has already announced our policy to task the Productivity Commission with an inquiry into the private health system, and to cap premium increases at 2% for two years.

“This policy was driven by two messages that we heard over and over in recent years.

“The first was from consumers, who told us that private health insurance premiums have become unaffordable. And they’re right – premiums have increased by 27 per cent since 2014 – costing families an average $1,000 more. Health insurance is now a leading cost-of-living concern – right up there with energy bills. Hospital cover has dropped to its lowest level since 2011. This is a worrying portent for the future viability of this industry. But private health insurance is still a product that Australians want – and rightly so.

“The second message we heard loud and clear was from the private health insurance industry itself. It told us that governments and regulators needed to step in urgently to turn the tide. We agree. And so while Labor’s policy prescription is different than the insurers’, we have the same aim: to maintain private health insurance coverage and the unique balance between our public and private systems, said Ms King.

Ms King pointed out that it has been 20 years since the Productivity Commission has reviewed the private health system in and despite recent reviews, reforms and Senate inquiries it has barely scratched the surface of the complex private health system.

The APRA publications provide industry aggregate summaries of key financial and membership statistics for the private health insurance industry. Key performance statistics for the private health insurance industry in the year ended 31 March 2018:[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_single_image image=”1989″ img_size=”full”][vc_column_text]Reform in healthcare is clearly a hot issue and will continue to be as we hurtle towards the next Federal election.[/vc_column_text][/vc_column][/vc_row]

2018 BUDGET REVIEW

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OVERVIEW

Treasurer Scott Morrison has handed down this third, and likely last budget before the next federal election. The theme of this year’s budget was focused on governments living within their means, keeping spending and taxes under control, and providing essential services.

In the weeks leading up to the budget, the Turnbull Government had begun announcing its commitments, giving the public a sneak-peek into what to expect when the budget was officially handed down.

The government used the budget head-start to differentiate itself from what it describes as the ‘high-taxing’ Shorten Opposition. As speculated, the government reaffirmed its commitment to cutting the corporate tax rate, and to the introduction of phased income tax relief, spread across seven years. As a result, low and middle-income earners will see immediate tax relief from 1 July 2018, with the Low-Income Tax Offset to almost double to $1,000 a year.

During his budget speech to the House of Representatives, the Treasurer announced the 37 per cent marginal rate will be abolished from 2024-25 and replaced with a simplified tax scale that includes a new rate of 32.5 per cent – making bracket creep a thing of the past for most working-class Australians. It’s also worth noting that the top marginal tax rate won’t see a threshold rise until, at least, 2024, increasing to $200,000.

The Treasurer’s pledge of $140 billion in personal income tax relief over the decade is optimistic as that seven years will run over two electoral cycles, meaning it could be susceptible to revision if there is a change of government.

Treasury modelling shows an optimistic return to wage growth of 3.25 per cent, which currently sits at approximately 2 per cent.

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Health portfolio

The 2018-19 budget builds on the government’s investment in health, which is expected to increase from $78.8 billion in 2018-19 to $85 billion in 2021-22. The Health portfolio now accounts for 16.13% of overall government expenditure.

As the nation’s fiscal situation continues to improve, the government is being encouraged to prioritise health expenditure for Australians. The current service delivery system in Australia provides fragmented care. If Australia seeks to become the “healthiest nation on earth” it will need to transform its healthcare system to be fit for the 21st century. While the healthcare industry will continue to advocated for reforms that shift away from volume and towards value-based healthcare (VBHC), this year’s budget made no commitments to aligning reform to VBHC.

The government has pledged to deliver $6 billion in record funding for Australia’s health and medical research sector, including $3.5 billion for the National Health and Medical Research Council, $2 billion in disbursements from the Medical Research Future Fund and $500 million from the Biomedical Translation Funding. The government will also invest an additional $10 million towards the BioMedtech Horizons program for which the Medical Technology Association of Australia (MTAA), through its Agreement, has ensured an additional $30 million.

Overall, stakeholders are positive about the budget’s health commitments. It is believed the Minister for Health, Greg Hunt, is taking a much more proactive approach with the sector, countering past negatives such as the ‘medicare’ campaign. One example of this is the government’s commitment to improving rural health services through the Stronger Rural Health Strategy, underpinned by this year’s budget commitments.

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Other insights from the health budget include:

  • $1.3 billion over 10 years to establish a National Health and Medical Industry Growth Plan.
  • $2.2 million in 2018-19 for the operational costs of the Australian Breast Device Registry and the Cardiac Devices Registry. The registries contribute to the long-term sustainability of the health system by supporting improved clinical care and better patient outcomes. This measure further extends the 2017-18 Budget measure titled Operational Costs for Cardiac and Breast Device Registries — extension.
  • $2.4 billion for the Pharmaceutical Benefits Scheme (PBS) and Repatriation PBS over five years from 2017-18 to fund more medicine listings, including $241 million for SPINRAZA, a medicine to treat Spinal Muscular Atrophy (SMA), and $703.6 million for breast cancer treatment Kisqali.
  • $338.1 million for mental health funding, focusing on suicide prevention, research and older Australians.
  • Additional $10 million for the BioMedTech Horizons program.
  • $40 million for whooping cough immunization.
  • $25.4 million over four years for new and amended Medicare Benefits Schedule and Veterans’ Benefits items.
  • $83.3 million for mental health nurses in rural areas.
  • $106.8 million over four years to modernise health and aged care payments systems.
  • $30 million over four years to the Australian Institute of Health and Welfare to improve accessibility to health information and statistics, including better data sharing capability and information and communications technology upgrades.
  • help women take advantage of opportunities in the health care and social assistance industry by providing $64.3 million to establish a Jobs and Market Fund to grow the National Disability Insurance Scheme’s workforce.
  • $37.6 million over four years from 2018-19 to improve follow-up care for people discharged from hospital following a suicide attempt — the highest at risk group in Australia — including:
    • $10.5 million for beyondblue to provide national support and oversee the implementation of the Way Back Support Service (WBSS) in Primary Health Networks.
    • $27.1 million for Primary Health Networks to commission services to be accessed by WBSS clients (contingent on co-contributions from States and Territories).
    • $33.8 million funding boost for Lifeline will enable the mental health helpline to continue to save lives every day.
    • $12.4 million over four years from 2018-19 to strengthen the National Mental Health Commission.
  • As expected no announcement related to the Prostheses List or private health insurance.

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Budget Reply

The opposition used their budget reply speech to promise voters that, if elected, Labor would be able to deliver a larger tax break for low and middle-income earners than a coalition government. The opposition’s Working Australians Tax Refund, delivered at a cost of nearly $6 billion over four years, equates to $928 per year, which the opposition says would represent a tax refund of $400 more than offered in the budget.

The opposition is trying to position itself as the party of health and education by outlining a number of key policy announcements including a promise to reverse the government’s policies on hospitals by creating a $2.8 billion Better Hospitals Fund.

Opposition Leader Bill Shorten has said the funding would mean more beds to reduce emergency room wait times, a reduction in waiting lists for elective surgery, and upgrades to emergency departments in the suburbs and regions.

Stakeholders welcomed the opposition’s promise to provide new MRI machines to 20 hospitals and imaging centres in the regions and outer suburbs, giving Australians with cancer a better level of care. Worth noting is that while 40 per cent of cancer cures involve radiation therapy, only nine cents in every dollar for cancer treatment is spent on radiation therapy. Promising $80 million to pay for the machines if Labor won the next election, MR Shorten said Medicare would cover the costs of 500,000 more scans for cancer sufferers.[/vc_column_text][/vc_column][/vc_row]

ACCESS TO MEDICAL TECHNOLOGY: MRI LICENCES IN THE SPOTLIGHT

[vc_row][vc_column][vc_column_text]One of the biggest advancements in medical technology is in the diagnostic assessment of patients through Magnetic Resonance Imaging technology or the MRI scan as it is more commonly known.

The history of MRI can be traced all the way back to 1971 when physician and experimenter Raymond Damadian discovered that the hydrogen signal in cancerous tissue is different to that of healthy tissue because tumours contain more water.

Jump forward a few years and in 1977 Raymond Damadian built the first MRI scanner and achieved the first MRI scan of a human body. A truly amazing technological achievement.

As with most medical technology, questions of cost and access are always at the forefront of public debate and a constant challenge for policy makers to be able to meet public expectations.

Recently, the Senate Community Affairs References grappled with this very issue through its’ inquiry into access to diagnostic imaging equipment around Australia.

A key focus of the inquiry was how are MRI licences granted and who gets them. What is the process and how does it work?

Unlike with pharmaceuticals which is subject to a rigorous process of independent assessment via the pharmaceutical benefits advisory committee (PBAC) no such process exists for a sponsor wanting to apply for a full Medicare rebate able MRI licence.

MRI licences are granted solely by the Minister for Health of the day. Consequently, successive Governments have been left open to the accusation that MRI licences are granted to meet political objectives as opposed to patient need based on such key criteria as population growth and changing demographics.

To emphasise the importance of this point the Senate Committees first recommendation was that:

“…. the Commonwealth Government immediately implement an application process with clear, objective and transparent assessment criteria to permit hospitals and radiology practices to apply for licences for Magnetic Resonance Imaging machines”.

With Australia facing an increasing ageing demographic and the welcome fact that we are all living longer, community expectations will always be a constant challenge for policy makers when it comes to access to medical technology.

Access to diagnostic imaging services like MRI scans is but one example of this constant challenge.

Financial resources are always limited and finite, yet Government will always face the constant demand to fund more health services, more pharmaceuticals and new medical technology.

For any Government allocating scarce resources, particularly in health then transparency should be welcome and more help than hinderance.

While there are regular complaints with the speed at which some new and innovative drugs get listed on the PBS, the independence of the PBAC is never called into question, for the simple fact that it is an independent process.

For diagnostic imaging services and in this case access to MRI licences, the lack of an independent process for allocating those licences, will leave the Government of the day open to criticism as to the allocation of those licences.

With the Senate Report now handed down, the ball is now in the Governments court as to how they respond to the recommendations.

The community should know in the next few months what the Government response will be to this challenging issue.[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_zigzag][/vc_column][/vc_row][vc_row][vc_column width=”1/4″][vc_single_image image=”1915″ img_size=”full”][/vc_column][vc_column width=”3/4″][vc_column_text]

ABOUT THE AUTHOR

Jody Fassina is the Managing Director of Insight Strategy and has been an strategic adviser to MedTech and pharmaceutical stakeholders.[/vc_column_text][/vc_column][/vc_row]

THE BATTLE OF PRIVATE PATIENTS IN PUBLIC HOSPITALS ROLLS ON

[vc_row][vc_column][vc_column_text]Last year the medical device industry signed an agreement with the Commonwealth Government to deliver $1.1 billion in benefit reductions for private health insurers in exchange for various reforms intended to provide patients better access to life-changing and life-saving technology.

The Australian’s story has highlighted evidence that private patients in public hospitals is costing the private health system $1 billion. This is further evidence of real “fat in the system” including the more than $1.6 billion a year in uncovered gap payments.

The revelations support an earlier report from Catholic Health Australia which showed public hospitals were encouraging patients to ‘go private’, allowing the hospital to bill the patient’s health insurance and Medicare, at a cost of $1.1 billion per year.

Australian Private Hospitals Association CEO, Michael Roff, raised concerns about the increasing number of private patients in public hospitals as a result of active recruitment of the privately insured patients by the public system.

“Around Australia people are being left languishing on waiting lists while those with private health insurance are cajoled into using their insurance in the public system and jumping the public queue. It’s time for states to be held to account and for Australians to get the health system they deserve,” Mr Roff said.

“If this practice did not occur it is estimated health insurance premiums would be at least six percent lower.”

Queensland Minister for Health and Minister for Ambulance Services, Steven Miles said profit driven rent-seeking was nowhere more obvious than in the private hospital industry.

“Its [the private hospitals industry] latest attempt to secure monopoly billing rights for private patients demonstrates it is unwilling to compete with public hospitals and has no concern for the ongoing viability of private health insurance Privately insured patients pay a lot for their insurance, and they should be able to choose the hospital they want to use,” Mr Miles said.

“The entire premise of taxpayer subsidised private health insurance is to take pressure off the public system.

“Increasingly, private patients want to be treated in public hospitals. They should be able to use their insurance — which they pay thousands of dollars for.

“If the private hospitals succeed in their campaign they will drive even more Australians to desert private health insurance.”

The recent Heads of Agreement put forward by the Commonwealth seeks to tackle this issue directly by ensuring “the information and process for patients electing to use private health insurance in public hospital emergency departments is appropriate, robust and best supports consumer choice.” This week Tasmania and the Northern Territory signed up to the Heads of Agreement, leaving only Queensland and Victoria to commit.

The medical technology industry has always maintained – given it represents 10% of private health insurers overall costs – real savings would come from other areas of the health system including private hospitals and medical services.

CEO of the Medical Technology Association of Australia (MTAA), Ian Burgess, said the MedTech industry is incurring a $1.1 billion cut which is going directly to the private health insurance companies to improve the affordability of their insurance products.

“We’re the major reason this year’s average private health insurance premium increase was the lowest in 17 years,” Mr Burgess said.

“MTAA strongly supports the need for a healthy and viable private health insurance sector in Australia.

“Our dual public and private healthcare system means reform is complex and challenging but to ensure it’s sustainable all stakeholders need to be held to a level of transparency.”

Reform in healthcare is clearly a hot issue and will continue to be as we hurtle towards the next Federal election.[/vc_column_text][/vc_column][/vc_row]

THE BEATING HEART OF THE MEDICAL TECHNOLOGY AGREEMENT COMES LIFE

[vc_row][vc_column][vc_column_text]Some of the key issues the Agreement Workplan seeks to address includes:

  • Support sector stability and sustainability
  • Reduce the time to market for medical devices
  • Ensure Australian patients have access to safe, effective, and cost effective innovative medical devices in the private sector
  • Improve the transparency and efficiency of the Prostheses List arrangements
  • Recognise superior clinical performance
  • Support Australian medical technology innovation

“The release of the Agreement workplan and industry working groups terms of reference is important to ensure transparency around this process and the delivery of reforms that are in the Agreement,” said Ian Burgess, Chief Executive Officer of the Medical Technology Association of Australia.

“Under this Agreement, the MedTech industry is incurring revenue cuts of $1.1 billion which goes directly to the private health insurance companies to improve the affordability of their insurance products.

“We are the major reason that this year’s average private health insurance premium increase was the lowest in 17 years.

“Full implementation of the reforms contained in the Agreement is essential to ensure that patients benefit from improved access to medical technology.”

Under the Agreement, three Industry Working Groups (IWGs) have been established each with a specific focus.

The most challenging of the three includes developing a revised framework for benefit setting and benefit review reflecting the use of health technology assessment (HTA) including evaluation of the value, cost-effectiveness and innovation of medical technology.

The second involving reducing red tape to improve the transparency and efficiency of the Prostheses List (PL) arrangements through the quality and content of the information contained in the Guidelines and the Prostheses List Management System (PLMS).

Lastly, the Cardiac Technical Support Services has been tasked to make recommendations and provide advice on how technical support services for active implantable cardiac devices should be funded to ensure the Australian healthcare system and privately insured patients receive maximum benefit from this technology.

“The Prostheses List (PL) ensures privately insured patients continue to access safe and clinically effective prostheses however this Agreement will provide the PL with much needed reform,” said Mr Burgess.

“For example, the removal of two-year follow-up clinical data as an unnecessary and standard requirement for assessment of some devices will greatly improve access to market.

“Sufficient clinical evidence, appropriate to the device, will still need to be submitted to enable a comparative assessment of clinical performance for the purposes of setting benefits on the PL.

“This will ensure the PL remains robust but recognises the quantum of follow-up data required will vary with the type of prosthesis, its intended use and the quantity of other relevant clinical evidence available or previously assessed.”

The Workplan makes it clear the Agreement will review ways to list new targeted devices on the PL that do not meet the current criteria for listing by 30 June 2020.

“Further, as reiterated by Hearts4Heart – Time to Change the Beat report non-implantable devices such as catheter ablation need to be included on the PL to relieve pressure on public waiting lists for patients with atrial fibrillation, said Mr Burgess.

“Inequity of treatment is not in the best interest of private health insurance policy holders.

“We believe access to a full range of medical technology is the most valuable component of a private health insurance policy and we’re committed to doing what we do best – assist patients lead healthier and more productive lives.”[/vc_column_text][/vc_column][/vc_row]

MEDICAL TECHNOLOGY WITH THE POTENTIAL TO TRANSFORM LIVES GETS CASH INJECTION

[vc_row][vc_column][vc_column_text]The Minister for Health, the Hon Greg Hunt MP, the Medical Technology, Biotechnology, and Pharmaceutical (MTP) Industry Growth Centre and the Medical Technology Association of Australia (MTAA) announced earlier this week the first 11 recipients of a $10 million investment from the Australian Government’s $35 million BioMedTech Horizons program.

The program aims to help Australia move more cutting-edge ideas and breakthrough discoveries towards proof-of-concept and commercialisation, and stimulate collaboration across disciplines and between the research, industry and technology sectors to maximize entrepreneurship and idea potential.

Investments from the program are focused on precision medicine and 3D anatomical printing. Successful projects in this first round include a fully synthetic 3D printed spinal cage, a genome profiling platform to enable precision cancer medicine, a wireless Brain-Machine Interface suitable for treating neurological disorders, and microwearables for precision medicine.

Minister Hunt said  the Government is committed to improving the health services for all Australians and will continue to invest in better treatment, care and medical research.

“Our researchers are innovators, and this investment will speed up the journey from idea to reality. These technologies have the potential to create better health outcomes for Australians, while driving investment and strengthening our economy. All Australians benefit from investment in health and medical research,” Mr Hunt said.

Ian Burgess, CEO of MTAA, said the industry was proud to be part of the BioMedTech Horizons program and supporting Australian innovation.

“Our Agreement with the Government to reform the Prostheses List has provided an additional $30 million towards the BioMedTech Horizons program and has doubled the funding available for these first recipients,” Mr Burgess said.

“Global advances in medical technology have resulted in a 56 per cent reduction in hospital stays and a 16 per cent drop in annual mortality rates over the past 20 years.

“If we want to see further advances on these figures we need to address the inequity of treatment options in our health system by removing the barrier for non-implantable devices such as catheter ablation in the private health system.

“This shows the significant value that medical technology can provide – saving and improving the lives of patients, and saving costs to our health system. These exciting technologies  being supported by the BioMedTech Horizons program can similarly lead to saving and improving lives, and contributing enormous value to the Australian health system.”

Sue MacLeman, Managing Director and CEO of MTPConnect, said the delivery of the BioMedTech Horizons program is providing the necessary support to boost investment, commercialisation and success of health innovations in Australia.

“These first investments from the BioMedTech Horizons program are set to fuel ongoing innovation in Australia, in line with MTPConnect’s priorities for growth of the medical technology, biotechnology and pharmaceutical sector,” Ms MacLeman said.

“These 11 outstanding projects address identified global megatrends including precision healthcare and the digital evolution, as well as forecast areas of unmet clinical need, such as immunology, advanced prosthetics and infectious diseases including sepsis.

“MTPConnect is dedicated to working with the sector to ensure growth in collaboration between research and industry, to drive greater commercialisation. The BioMedTech Horizons program is set to address barriers of funding to support viable, new health biological and medical technologies to reach proof-of-concept, clinical trials and beyond, in line with our vision to advance the vibrant sector.”[/vc_column_text][vc_single_image image=”1875″ img_size=”full”][vc_separator][vc_column_text]The Gennaris Neural Systems project led by Director of Monash Vision Group, Professor Arthur Lowery, said the Federal Government’s support for this project would enable them to bring manufacturing back to Australian shores, allowing Australia to become a leading provider of advanced medical prosthetics that place sophisticated electronics within the human body.

“This funding is key to translating the First in Human trials of our cortical visual prosthesis to a successful commercial product,” Mr Lowery said.

“Bringing together advances in electronics and implantable devices open up a huge range of potential applications and potential treatments for neurodegeneration.”

Partner to the Gennaris Neural Systems project and Grey Innovation Group Chairman, Jefferson Harcourt, said the BioMedTech Horizons program is very well targeted and plays an important role in translating research.

“It is very encouraging to see us working together and playing to our strengths as a sector”, said Mr Harcourt.

“Delivering real collaboration takes time and trust from all sides, and in the past frankly there has been a lot of hype. Times are clearly changing, and I applaud the Government and MTPConnect for having the conviction to allocate meaningful funds to targeted and well-constructed consortia. This will significantly increase the chances of success.”

The medical technology industry currently employs more than 17,700 people and adds $1.9 billion to the Australian economy. This is a high skilled, high net worth industry with over 52 per cent of employees having a tertiary qualification, and 25 per cent having a postgraduate qualification.

MTPConnect will continue its work with the sector to support initiatives addressing identified barriers to growth in the sector, increasing the number of innovations to reach proof of concept and clinical trials in key knowledge priority areas.

The 11 projects selected for the initial $10 million BioMedTech Horizons program investment are listed below:[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_tta_accordion color=”turquoise” active_section=”1″][vc_tta_section title=”3D printed graft for surgical repair of the wrist ligament” tab_id=”1524111574159-3ca495cd-2645″][vc_column_text]Griffith University, Orthocell, University of Western Australia, Queensland University of Technology


Development of a 3D printed, personalised graft for surgical repair of the Scapholunate interosseous wrist ligament (SLIL) is set to produce the first SLIL repair product on the market. SLIL injuries are common and can severely impair wrist function for the 69 cases of wrist trauma per 10,000 individuals. SLIL injuries are most common in young individuals, causing long-term chronic difficulties. Therefore, a product that offers better health outcomes is likely to significantly reduce economic burden on healthcare systems over the life time of such patients. This project will support pre-clinical research and development to enable Orthocell to start human clinical trials, seek regulatory approval and commercialise.[/vc_column_text][/vc_tta_section][vc_tta_section title=”B3D Cervical Interbody Fusion Device ” tab_id=”1524111549409-5fdd9e13-a87f”][vc_column_text]Allegra Orthopaedics, University of Sydney, University of Wollongong, Boron Molecular, Sabre Medical

The Allegra Orthopaedics fully synthetic spinal cage works to regenerate bone under spinal load conditions and be completely resorbed by the body, leaving it and the intervertebral space free of foreign materials – making it a one-of-a-kind innovation. The device is 3D-printed from a synthetic bone bioceramic (Sr-HT-Gahnite) invented at The University of Sydney. The synthetic bone possesses the mechanical strength required for load-bearing conditions, bioactivity needed for outstanding bone regeneration, and resorbability that reduces the risk of rejection and infection – all in a customisable structure. No bone graft is required as the device material induces bone graft. This project will provide the necessary funding for device production for preclinical testing.[/vc_column_text][/vc_tta_section][vc_tta_section title=”BioPen” tab_id=”1524111512736-be45f446-cc84″][vc_column_text]The University of Melbourne, St Vincent’s Hospital Melbourne, University of Wollongong, Swinburne University of Technology

The BioPen is set to provide the first in-situ bioprinting treatment for cartilage injuries, developed at the St Vincent’s Hospital Melbourne biofabrication facility, BioFab3D@ACMD. Cartilage injuries occur in two thirds of all joint trauma, with many leading to osteoarthritis that cannot be adequately prevented or treated using current complex surgery interventions. The BioPen project is working to accurately repair the joint injury, by rapidly isolating stem cells from a patient, loading these into a gel scaffold then printing new cartilage using a hand-held device directly into the defect. The combination of stem cell technology, engineering and surgical innovation promises to simplify surgery through a one-off surgical procedure with the capacity to bank cells for future use if repeat surgery is required. The BioMedTech Horizons funding will enable this project to advance a prototype device, methodologies and bio-ink formulations towards a commercialisable therapy.[/vc_column_text][/vc_tta_section][vc_tta_section title=”CAR-T immunotherapies for solid cancers” tab_id=”1524111469305-4815abcc-1e35″][vc_column_text]Carina Biotech, Seattle Children’s Research Institute, The University of Adelaide, Women’s and Children’s Hospital Adelaide, CTM@CRC

Chimeric Antigen Receptor T-cell (CAR-T) therapy is an individually customised approach to cancer treatment that genetically engineers a patient’s own immune cells to react to a specific molecular marker on their cancer. CAR-T therapy has shown extraordinary efficacy against blood cancers, however solid cancers have been less responsive to CAR-T therapy to date. Carina Biotech has produced CAR-T cells targeted to a solid cancer molecular marker, which has been published as present in many solid cancers, while having no expression on healthy cells. BioMedTech Horizons investment will allow Carina to work to achieve in-vivo proof of concept for its CAR-T cells across multiple animal models of human solid cancer.[/vc_column_text][/vc_tta_section][vc_tta_section title=”A clinically-accredited and commercial-ready genome profiling platform to enable precision cancer medicine” tab_id=”1524111421463-67e12ef9-3bab”][vc_column_text]Garvan Institute of Medical Research, Genome.One, Illumina

Precision cancer medicine is set to transform the clinical trial industry, with international trials attracting heavy investment. This next generation of clinical trials requires fast, comprehensive and cost-effective genomic profiling of patient tumours. The FDA recently approved two US cancer genomic tests, however, their cost (AU$5,500) is prohibitive for routine use in Australia and their matching to US-approved drugs and trials are of limited utility to Australians. Offshore testing also fails to develop necessary domestic infrastructure for precision cancer clinical trials.  The genome-profiling platform for precision cancer medicine is set to include a clinically-accredited tumour profiling test and a cancer genomics data platform that incorporates a national patient matching system for precision cancer clinical trial access. It aims to provide competitively priced and rapid local testing. These solutions work to ensure that, in the face of increasing global capabilities and investment in precision cancer clinical trials, Australia will remain an attractive trial site and leader in precision medicine.[/vc_column_text][/vc_tta_section][vc_tta_section title=”EarGenie: Personalised management of hearing impairment for infants” tab_id=”1524111262689-0113ff94-a030″][vc_column_text]Bionics Institute, Hydrix, Taralye Early intervention Centre, Plunkett Consulting Group, Australian Hearing

EarGenie is an innovative system for personalised management of hearing impairment, aiming to enable life-long benefits using a novel combination of electrophysiology and functional near-infrared spectroscopy (fNIRS) to perform a diagnostic hearing evaluation. Deaf infants face delayed and inadequate language development, affecting education, social participation, and even employment later in life. Major contributing factors are the delay between diagnosis and the selection and accurate adjustment of hearing devices, delayed individualised optimisation of device features, and difficulty choosing a specific therapy to optimise language development. EarGenie is set to transform the precision of diagnosis and optimisation of hearing instrument function, to deliver major benefit to language development in deaf children. This project will allow for the development of a clinical prototype as well as plans for regulatory approval and clinical trials.[/vc_column_text][/vc_tta_section][vc_tta_section title=”Gennaris Neural Systems (GNS)” tab_id=”1524111262606-419c966c-a95e”][vc_column_text]Monash University, Alfred Health, MiniFAB, Grey Innovation

Monash Vision Group (MVG) has developed a wireless Brain-Machine Interface (BMI, offering the potential to bypass damage to nerves and neural pathways, restoring function to affected areas of the brain. MVG’s Brain-Machine Interface has been implemented in a cortical vision prosthesis that is designed to bypass damage to the visual pathway and restore basic vision. This funding will assist the transition between preclinical and clinical programs, allowing the utility of the visual prosthesis to be demonstrated. A company will be established to manufacture MVG’s Brain-Machine Interface and commercialise the visual prosthesis. The aim of this company is to bring the product to market by 2021 to address the unmet need of a treatment for complete blindness. MVG’s cortical vision prosthesis has been designed to treat a range of blindness causes, such as glaucoma and optic nerve damage, which are not suitable for retinal implants. The successful commercialisation of this technology will establish Australia as an exporter of implantable medical devices, and global market leader in BMI manufacturing.[/vc_column_text][/vc_tta_section][vc_tta_section title=”Leaping towards precision medicine: Microwearables” tab_id=”1524111599138-bf1ca2f8-1b66″][vc_column_text]WearOptimo, The Australian National University, Queensland Government, Johnson & Johnson Innovation, Australia National Fabrication Facility

Microwearables (simple, wearable devices) have the opportunity to be a cornerstone of precision medicine by offering personalised diagnostics across a range of diseases. These devices are minimally-invasive, pain-free sensors applied to the skin to access biomarkers and biosignals. Microwearables transduce electrical, optical or biochemical biomarkers from a hair’s width depth within the skin for both episodic and continuous monitoring. In doing so, it aims to leapfrog traditional diagnostics: based on lab-based assays of blood samples and histopathology – with the costs, risks and time-delays. WearOptimo will be developed as a fit-for-purpose enterprise to rapidly compete at scale – meeting the unique opportunity at the nexus of three growing markets: IoT for medicine; personalised medicine; and wearable electronics for healthcare. This project will take the next critical step in working to advance Microwearables into an enterprise – to commercial, proof-of-concept, and investor ready.[/vc_column_text][/vc_tta_section][vc_tta_section title=”‘PoreStar’ – Porous Polyethylene Implant Material ” tab_id=”1524111692209-71cba53e-1736″][vc_column_text]Anatomics

In 2014, Anatomics, in conjunction with CSIRO and Australian universities, developed a breakthrough pHDPE implant material, PoreStar. PoreStar’s material advantages include its superior tensile and flexural strength avoiding cracks when bent, the ability to adhere with screws very close to the implant margins without material breakage, and a unique scaffold architecture that facilitates tissue ingrowth. This project aims to advance the state-of-the-art in craniomaxillofacial (CMF) implant manufacturing, leveraging 3D printing to reduce process complexity, product turnaround time and cost of goods. Moreover, the project seeks to improve surgical practice by extending the use of temporary implants to patient-specific CMF surgeries, and develop improved software solutions for surgical planning and preoperative estimation of cosmesis, aiming to reduce complications and reoperation rates for CMF surgeries.[/vc_column_text][/vc_tta_section][vc_tta_section title=”Rapid diagnostic for the pathogens that cause sepsis” tab_id=”1524111727437-fcd722ee-5f3b”][vc_column_text]Biotech Resources, Monash University Centre for Biospectroscopy, The Alfred Hospital, Monash Health, Hydrix

Biotech Resources (BTR) is working to develop the world’s first rapid diagnostic test ‘Aimalux’ for the direct detection of the bacteria and fungi that cause sepsis from whole blood. The technology and platform has been developed by the Monash University Centre for Biospectroscopy in Melbourne Australia. Sepsis is a life-threatening disease that results in the deaths of over 6 million people every year around the world, and more than 5,000 Australians. It is time critical medical emergency. Every hour without treatment increases a patient’s chance of dying by 7.6%. And yet there is no definitive test for sepsis with more than 30% of cases going misdiagnosed. If the symptoms of Sepsis are missed and treatment is not administered, then this can result in patient death. This also means that many patients are treated unnecessarily as a precaution, which has its own detrimental consequences as well as adding to the rise of antibiotic resistance super bugs. Aimalux aims to provide a diagnostic result within 35 minutes, to revolutionise the way sepsis is currently diagnosed, reduce healthcare costs, and save lives.[/vc_column_text][/vc_tta_section][vc_tta_section title=”Towards bedside gene therapies: Development of a microfluidic gene delivery device for immune cell modification and optimisation for clinical use” tab_id=”1524111767698-bd213694-22ad”][vc_column_text]Indee, University of South Australia Future Industries Institute, Main Sequence Ventures, Defence Science Technologies Group, University of Sydney, Becton Dickinson

Pioneering cures for terminally ill patients, with conditions including many forms of cancer, are now available thanks to a new generation of treatments called gene-modified cell therapies (GMCTs). Indee Labs plans to make GMCTs accessible to the masses by solving manufacturing issues responsible for their high price tags. It also aims to reduce the lead times for a treatment from months to weeks, saving the lives of patients with aggressive conditions. Gene delivery to cells is the most critical and problematic step in manufacturing GMCTs. This project aims to will develop the only practical gene delivery technology, microfluidic vortex shedding (µVS), into a product that will be trailed by pharmaceutical companies. µVS will offer revolutionary improvements over existing gene delivery methods including high yield, negligible immune cell perturbation along with rapid processing of research-, clinical- and commercial-scale samples with a simple workflow and a small footprint.[/vc_column_text][/vc_tta_section][/vc_tta_accordion][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]For more information on the BioMedTech Horizons program and first round recipients, visit www.mtpconnect.org.au/biomedtechhorizons.[/vc_column_text][/vc_column][/vc_row]

SURVEY REVEALS PATIENTS FACING OUT-OF-POCKET BILL OF $10,000 OR MORE

[vc_row][vc_column][vc_column_text]It seems like a week doesn’t go by when healthcare costs aren’t the front of the news.  Late last week the Consumer Health Forum of Australia released its national survey of out-of-pocket costs from some 1,200 patients. It highlights that specialist fees and critical services are becoming unaffordable to Australians raising further pressure on the private health insurance and the private health system more broadly.

 The survey report Out of Pocket Pain and a companion report Hear Our Pain containing scores of personal stories of people’s experience with treatment costs.

“The responses to the survey give a disturbing insight into the high costs of medical care and challenge the notion that everyone can access the care they need in Australia,” the CEO of the Consumers Health Forum Leanne Wells, said

“We have heard from pensioners and single mothers who have foregone recommended care because of cost, from many people exasperated to find that the insurance they have held for many years will not cover gaps of thousands of dollars, from patients who learn belatedly of unexpected extra costs for junior surgeons, anaesthetists and MRI scans, and from people who have had to call for special access to their superannuation funds to cover the bill.” Leanne Wells, said

Among key results of the survey are:

  • More than a quarter of respondents treated for breast cancer incurred out of pocket costs of more than $10,000;
  • More than a third of respondents with chronic conditions like multiple sclerosis reported out of pocket costs of more than $10,000;
  • One in six respondents said that out of pocket costs had a significant impact on their lives;
  • A frequently-expressed view that using private health insurance would expose people to more costs; and
  • A third of respondents said the out of pocket costs were not explained to them before treatment.

This comes as the second meeting of the Ministerial Advisory Committee on Out-of-Pocket Costs, chaired by Australia’s Chief Medical Officer, Professor Brendan Murphy recently took place.

The meeting was attended by the Minister for Health, the Hon Greg Hunt MP who reinforced that a healthy and stable private health insurance system is essential for the stability of Australia’s overall health care system.

Minister Hunt spoke about the Government’s commitment to work with the stakeholders to address community concerns around large unexpected out-of-pocket costs and the need for a transparent model to ensure consumers have the ability to make an informed decision on their medical treatment.

Breast Cancer Network Australia CEO Kirsten Pilatti said: “BCNA has been outraged by a number of our members reporting extreme variations in out of pocket costs. Only full disclosure will ensure consumers can make the right choice for themselves.”

The CEO of CHOICE, Alan Kirkland said: “It can be completely perplexing and sometimes impossible for patients in need of surgery to work out how much they will be out of pocket. What’s worse, this often occurs when you are at your most vulnerable and least able to bargain over costs.”

“It’s not surprising that so many patients have reported significant out-of-pocket medical costs, even when they have private health insurance, Australian Healthcare and Hospitals Association (AHHA) Chief Executive Alison Verhoeven said.

“As the private healthcare system, its out-of-pocket costs and increasing confusion continue to run away from us, we reiterate our own call for a Productivity Commission review of the health system, including an appropriate and affordable balance between private and public healthcare that is patient-centred rather than provider-centred.”

Rachel David from Private Healthcare Australia said: “While we can’t discount the very real concerns reported to the CHF, we need to be very careful about drawing conclusions about the extent of the problem from a survey that essentially solicits complaints.”

PulseLine will be interested to see if the Government’s forthcoming private health reforms deliver the much-needed transparency for consumers and puts downwards pressure on healthcare costs. Reform in healthcare is clearly a hot issue and will continue to be as we hurtle towards the next Federal election in the first half of 2019.[/vc_column_text][/vc_column][/vc_row]

PELVIC MESH SENATE INQUIRY REPORT RELEASED

[vc_row][vc_column][vc_column_text]Since February 2017, the Senate Community Affairs References Committee has considered more than 550 submissions from patients, surgeons, medical device companies, regulators and other stakeholders. The Committee also held five public hearings across Australia, hearing testimony from a number of stakeholders, including from women who bravely shared their stories of experiencing complications from their treatments.

The Committee recognised both the complexity of the conditions – stress urinary incontinence and pelvic organ prolapse – and treatment options available to clinicians and acknowledging the many Australian women whom have benefited from procedures involving transvaginal mesh products.

The Medical Technology Association of Australia (MTAA) and some of its member companies also testified before the committee, acknowledging the pain and suffering experienced by the women who had testified before the Committee, but also reiterated its agreement with groups representing medical professionals, that the products remain important treatment options.

Urogynaecological Society of Australasia (UGSA) Chair, Dr Jenny King, said the Committee’s recommendation that all mesh devices should be used as a last resort would affects women’s options for care by limiting access to the safest and most effective surgical treatment for urinary incontinence, the mid-urethral slings.

“This decision is one of the most retrograde steps in the history of modern surgery. It simply disregards sound scientific data,” Dr King said.

Australian Medical Association President, Dr Michael Gannon, added that not all women had problems with the devices.

“It [the report] fails to recognise the massive number of women who have benefited from mid-urethral sling operations,” he said.

The MTAA’s CEO, Ian Burgess, said the industry body is committed to working with the Government as it considers its response to the Committee’s report.

“Registries can be invaluable but they are complex and expensive. We need to ensure that when we set up a registry we’re very clear around what data is being collected and the extent of that data,” Mr Burgess said.

“Further, in terms of the cost of registries, we need to ensure all those that benefit pay for it – including regulators, healthcare professionals, insurers, hospitals and policy makers.

“The Committee also recommends the Department of Health work with MTAA and the Medical Board to review systems in place to support consistent, high ethical standards. The report notes the evidence of MTAA and member companies that no financial or other incentives have been provided to medical practitioners to use or promote transvaginal mesh implants, and that members of MTAA are bound by a Code of Practice that sets high standards for ethical interactions with healthcare providers.

“Should the Government accept this recommendation, we look forward to working with the Department. A key reform would be the implementation of a harmonised industry code of practice which all device manufacturers and suppliers are required to adhere to by law or regulation. The MTAA Code of Practice would be an appropriate basis for such a harmonised code.”

PulseLine understands the Government will be looking to complete its response by the end of November.[/vc_column_text][/vc_column][/vc_row]