Government Accepts Stillbirth Recommendations

[vc_row][vc_column][vc_column_text]In Australia, about 6 babies are stillborn every day, and two die in the neonatal period within 28 days of birth, due to congenital anomalies which account for almost a third of all perinatal deaths.

Rates of perinatal death have remained relatively constant since 1997. Rates of stillbirths among Indigenous women, while decreasing, are still at an alarming rate compared to other demographics.

Last year Labor Senator for NSW, Kristina Keneally, was moved to tears when discussing the Stillbirth Research and Education Report, which she said would be “part of the legacy” of those children who had been lost and their brave parents who had to endure that loss.

Australian Institute of Health and Welfare (AIHW) spokesperson, Dr Fadwa Al-Yaman, said ongoing monitoring of perinatal deaths could help build the evidence-base to drive better outcomes.

“The report provides valuable information to enable effective policy, practice and services for mothers and babies,” Dr Al-Yaman said.

The AIHW said it was also working to improve the quality of data around the contributing factors to stillbirths.

Minister for Health, Greg Hunt, said reducing the rate of stillbirth in Australia, including providing the best possible support services for families living with the tragedy of stillbirth, is a priority for the Morrison Government.

“We understand the importance of this issues not only for the women affected, but for their partners, families and the broader community,” Mr Hunt said.

Red Nose Australia CEO, Keren Ludski, welcomed the Government’s funding announcement and commended the Government for accepting all recommendations in the Senate Select Committee on Stillbirth Research and Education Report.

“The stillbirth rate in Australia is six a day – that’s one baby every four hours. Enough is enough – it’s time we made reducing stillbirth a national priority,” Ms Ludski said.

“Red Nose Day on Friday 9 August will have a significant focus on raising awareness and funds for stillbirth research, with a goal of reducing stillbirth by 20 per cent over the next three years – equalling 500 little lives saved, and I urge all Australians to get involved by buying a red nose or making a donation,” she said.

The recommendations accepted by the Federal Government include:

  • Developing a National Stillbirth Action and Implementation Plan
  • Investing in stillbirth research
  • Developing best practice and culturally appropriate resources, and
  • Working with States and Territories to make improvements in key areas including improving national perinatal mortality data collections, improving access to publicly funded stillbirth autopsies, building the perinatal pathology workforce, developing more culturally and linguistically appropriate models of care, bereavement support and protocols for public hospitals and community health services.

You can download the Federal Government’s response to the Stillbirth Research and Education Report here.[/vc_column_text][/vc_column][/vc_row]

Government Releases New Charter for Aged Care Rights and Quality Standards

Ask the expert:

Maree McCabe, Dementia Australia CEO:

“The Charter of Aged Care Rights states that people receiving Australian Government funded aged care have the right to safe and high-quality care and services, to be treated with dignity and respect, and to have their identity, culture, and diversity valued and supported.”
 
“The new standards place consumers at the centre of their care and focuses on giving people greater choice and flexibility, as well as making it easier for consumers, their families and carers to understand the regulation and what can be expected from a service.”

The details:

More information on the new Charter and Standards can be found at www.agedcare.govcms.gov.au/ensuring-quality

Victorian Government to Change Discriminatory IVF Policy and Practice

How it works:

  • Change legislation to ensure same-sex female couples are recognised as one family. Allowing same-sex couples to use donated sperm and eggs or embryo, removing discrimination and increasing the chances of being able to have biologically-related siblings by using the one donor.
  • Undertake further consultation on removing the discriminatory requirement that Victorians hoping to grow their family with IVF must first undergo police and child protection checks, which can cause long delays.
  • Ensure more Victorians can become a parent through IVF, without the high costs, with public IVF services – bulk billed and subsidised for low-income Victorians.
  • Improve quality and safety by investigating reports of rogue practitioners who put patients at risk or peddle false hope about their chances of conception.

Ask the Minister:

Jenny Mikakos Victorian Minister for Health

“We know that while IVF can be a life-changing experience for many families, it can also be an emotional and financial rollercoaster. That’s why this once-in-a-generation review was so important.”

“We’re removing unfair hurdles faced by too many families and making IVF easier and more affordable to access – it will mean the world to thousands of Victorian families.”

Ask the expert:

Dr Sue Matthews Chief Executive of the Royal Women’s Hospital, Victoria

“We welcome the report’s recognition that current regulation is not fit-for-purpose and are pleased to be playing our role in creating equitable access to IVF.”

“An important factor will be getting the structures and mechanisms right, including setting up appropriate governance and funding arrangements.”

The details:

The changes are in response to the findings of the landmark report commissioned in 2018.

The full report can be viewed at https://www2.health.vic.gov.au/hospitals-and-health-services/patient-care/perinatal-reproductive/assisted-reproduction/regulatory-review

The EU’s New Regulatory Framework for Medical Devices

ABOUT THE SPEAKER

Diana Kanecka
Manager, International Affairs – MedTech Europe

Diana Kanecka works with the International Affairs team at MedTech Europe. Previously, Diana’s focus within MedTech Europe concerned medical devices and chemicals legislation. She holds a Postgraduate Diploma in European Union Law from the King’s College of London and a Master’s degree in Interdisciplinary European Studies/European Single Market from the College of Europe. Diana has a strong interest in trade policy and regulatory topics. She was also an active member of the European Health Parliament project where she worked with the ‘economic dimension of healthcare’ committee on development of recommendations on the future of healthcare systems.

MTANZ WARNS OF IMPACT OF MEDICAL DEVICE REGULATION CHANGES ON PATIENTS

[vc_row][vc_column][vc_column_text]MTANZ CEO, Faye Sumner, said the “proposed Therapeutic Products Bill and the ongoing centralised procurement process by PHARMAC could have the joint effect of increasing the costs of medical devices and procedures while potentially reducing choice for the clinician and delaying access to life-saving, innovative medical technology.”

MTANZ has assured patients that medical devices used in New Zealand currently meet the highest quality standards both in New Zealand and internationally.

Currently, all devices entering New Zealand must be notified to the Government’s regulator, Medsafe. However, MTANZ argues that this will become a more complex registration process with associated costs, under the proposed NZ Therapeutic Products legislation replacing the Medicines Act 1981.

At the same time, PHARMAC is taking control of the procurement of medical devices supplied to the District Health Boards.

Ms Sumner says the New Zealand MedTech industry believes the proposed PHARMAC cost-based procurement system is not best suited to the procurement of medical devices.

“We propose a value-based procurement system that ensures clinicians have the autonomy and authority to acquire the right device for the right procedure. It is about treating a patient with the best possible device rather than the cheapest possible device.

“Our industry is very concerned at the multiplying effect of both significant changes being introduced in parallel and the potential disruption to the supply chain which could lead to the reduced availability of medical device products in the New Zealand market,” Ms Sumner said.

Ultimately the impact of both these changes will be felt by New Zealand patients.

These changes will no doubt be watched very closely by both the Australian MedTech companies and Private Health Insurers.

The Australian Private Health Insurance industry has been advocating for the introduction of a similar national procurement system here in Australia.[/vc_column_text][/vc_column][/vc_row]

Insurers caught out fudging facts again

Mr Koce used data for 2016-1­­7 from the Private Hospital Data Bureau and the National Hospital Cost Data Collection published by Independent Hospital Pricing Authority (IHPA) in an attempt to compare prices for prostheses in the public and private sector. The information on costs for both these data sets is based on analysis of Australian Refined – Diagnosis Related Groups (AR-DRGs). One dataset is for private hospitals and one is for public hospitals and each are compiled by different agencies.

The 2016-17 data does not fully reflect the cuts imposed on prostheses across four main categories in February 2017, and also precedes the cuts implemented as part of the MTAA-Government Agreement signed in October 2017.

The latter cuts are estimated to be worth $1.1 billion over the life of the Agreement and resulted in the lowest premium increase in 19 years in 2019. This is even before a further round of Prostheses List benefit reductions under the Agreement, which will take place in February 2020. MTAA estimates that the February 2017 and Agreement cuts have delivered $450 million in savings already in the 2017-18 premium years, higher than forecast under the Agreement.

It is, therefore, inappropriate and completely disingenuous for Mr Koce to quote three-year-old statistics to make his case.

Furthermore, DRGs are not an appropriate tool to compare prostheses costs. DRGs are used to determine hospital funding in Australia. A DRG will not explain which prostheses was the best for the patient, including whether a more expensive one makes more sense based on the many factors that could impact treatment under that DRG. They describe averages, not specifics, and will not take into account legitimate differences in volume mix between prostheses use between public and private patients.

The numbers floated by Mr Koce are similar to those used time and again by the PHI industry in their attempts to get the device industry to temporarily rescue it from difficulties. MTAA has demonstrated that they are not correct, and by the time the last cuts under the Agreement are implemented in February 2020, there will be very little continuing justification for the comparison.

Private health insurers should rather pay heed to APRA’s recent warnings that “often [their] strategies are vague, fail to address the material risk or rely heavily on actions by others”, that “waiting for a third party to ‘serve-up’ a solution is not a defensible strategy” and that “APRA would expect that better prepared insurers are taking actions to improve the value of services for members”.

Insurers must focus on providing value – access to a comprehensive range of life-saving and life-changing medical devices, with generally no out-of-pocket costs for those devices, is a key contributor to the value proposition of private health.

RECORD BREAKING $26.7 BILLION HEALTH BUDGET

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What to know:

The Government’s health investment includes a $2.7 billion dollar spend on top of $24 billion in recurrent spending over the coming year – taking the total 2019-20 health budget to $26.7 billion.

The recurrent funding investment will focus on families with additional funding to provide an extra 8,000 paediatric operations and 10,000 cataract surgeries, over four years.

What Minister Hazzard had to say:

“This record Budget will see the first stage of an unprecedented boost to the frontline workforce with an extra 8,300 staff over the next four years under a $2.8 billion commitment – 45 per cent to staff to go to the regions.

“This record Budget will ensure patients, their families and those in regional communities already doing it tough in drought-affected areas continue to get timely, world-class care, no matter where they live.”

The health highlights:

  • $2.8 billion to recruit a total of 8,300 frontline health staff over four years;
  • $10.1 billion over four years to invest in NSW’s health infrastructure to continue current works and commence upgrading and building a further 29 hospital and health facility projects, as well as ensure compliance with new leasing standards;
  • $70 million over four years to provide 35 new free mobile dental clinics allowing access to dental checks and basic dental care for up to 136,000 primary school children in Western Sydney, Mid North Coast and the Central Coast each year;
  • $42 million over four years to provide women with greater choice around IVF services and a partnership with the University of NSW for the first state-wide fertility preservation service for young cancer patients at The Royal Hospital for Women;
  • $76 million over four years to boost elective surgery, focusing on children and cataract patients, with delivery of an additional 8,000 paediatric operations and 10,000 cataract surgeries in addition to the investment in frontline staff;
  • $27.1 million to employ 221 paramedics and call centre staff (second tranche of record 750 workforce announced last year) to improve response times, reduce paramedic fatigue and support safety;
  • $23.5 million for mental health to expand the capacity of Lifeline and Kids Helpline over four years;
  • $45 million over four years in palliative care for 100 palliative care nurses, Aboriginal health workers, digital health solutions and the refurbishment of existing facilities. This is in addition to a $100 million package for palliative care that was announced as part of the 2017-18 Budget; and
  • In 2019-20, the Government will invest $2.9 billion in the Health capital program, which includes $148 million from the Ministry of Health’s recurrent expense budget and $78 million for lease acquisitions.

Health infrastructure investment:

One of the largest health projects in NSW is on track to deliver world-class care to local communities for decades to come. This includes a $2.7 billion spend on health infrastructure in 2019-20, up 27 per cent on last year.

The record $2.7 billion health infrastructure investment in 2019-20 will enable the following works:

  • Commencement of new works John Hunter Hospital ($780 million), the Children’s Hospital at Westmead ($619 million) and Tumut Hospital ($50 million);
  • Continuing works at Griffith Hospital, Goulburn Hospital, Hornsby Hospital and Mona Vale Hospital;
  • New hospital car parks at Liverpool, Shellharbour and Wagga Wagga; and
  • Planning for major projects including Sutherland Hospital, Sydney Children’s Hospitals Network at Randwick and the Comprehensive Children’s Cancer Centre, and Royal Prince Alfred Hospital.

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National Plan For Better Pain Management

The list:

The plan has listed eight key goals for a better outcome.

  1. People living with pain are recognised as a national and public health priority
  2. Consumers, their carers and the wider community are more empowered knowledgeable and supported to understand and manage pain
  3. Health practitioners are well-informed andskilled on best practice evidence-based care and are supported to deliver this care
  4. People living with pain have timely access to consumer-centred best practice pain management including self-management, early intervention strategies and interdisciplinary care and support
  5. Outcomes in pain management are improved and evaluated on an ongoing basis to ensure consumer-centred pain services are provided that are best practice and keep pace with innovation
  6. Knowledge of pain flourishes and is communicated to health practitioners and consumers through a national research strategy
  7. Chronic pain is minimised through prevention and early intervention strategies
  8. People living with pain are supported to participate in work and community

Facts and figures:

The number of Australians living with chronic pain is set to rise from 3.24 million to 5.23 million by 2050.

Last year alone, Australians paid $2.7 billion in out of pocket expenses to manage their pain.

As a nation, the annual cost will rise from $139.3 billion to an estimated $215.6 billion by 2050.

Ask the expert:

Painaustralia CEO, Carol Bennett

“The Australian Government and Minister Greg Hunt funded and supported the development of the first-ever National Strategic Action Plan for Pain Management (NSAPPM) in May 2018. The year of exhaustive consultation and development that followed have now culminated with the final release of the NSAPPM that sets out the key priority actions to improve access to, and knowledge of best practice pain management, in the next three years,”

The details:

The full report can be found at www.painaustralia.org.au/static/uploads/files/national-action-plan-11-06-2019-wfflaefbxbdy.pdf

Health insurers called out by APRA

[vc_row][vc_column][vc_column_text]In an unprecedented move for the prudential regulator, APRA has called out the industry for being too reliant on lobbying government to provide solutions and underprepared for the challenges that lie ahead.

According to APRA Senior Manager Peter Kohlhagen in a speech to the Health Insurance Summit in Sydney last week, “we aren’t convinced that any insurer yet has a robust strategy for managing the risks”, and that “the current environment is likely to lead to consolidation if it continues for an extended period.”

Mr Kohlhagen emphasized that insurers will need to have a “Plan B” in the event of failure, and that for many that “Plan B” would most likely be a merger.

He also said that “APRA will not hesitate to act to protect the interests of policyholders should it become necessary due to viability concerns with an insurer.”

“That can take the form of an orderly merger or other exit from the market. Importantly, an insurer that has a plan and executes it when it becomes necessary can control its own destiny. An insurer that fails to plan will find that it loses that opportunity.”

With 82 per cent of Australian households concerned about the cost of private health insurance, the rising costs of healthcare and the confusion brought on by the Government’s recent gold/silver/bronze/basic reforms, the risks facing the industry are very real.

APRA’s letters points to active measures that could be taken by health funds to improve industry practices and boost sustainability, such as facilitating substitutes for in-hospital treatment, revising health supplier contracts and developing preventative health and well-being offerings for their members.[/vc_column_text][/vc_column][/vc_row]

New Zealand MedTech To Be Impacted

[vc_row][vc_column][vc_column_text]The Government is introducing a new regulatory scheme for therapeutic products, and in addition, PHARMAC, the medicines purchasing agency, is extending its authority over medical devices in public (District Health Board – DHB) hospitals.

A draft bill setting out the framework for the new regulatory regime was released for consultation earlier in the year.  The purpose of the proposed Bill is to:

1. a) ensure acceptable safety, quality, and efficacy or performance of therapeutic products across their lifecycle; and

(b) regulate the manufacture, import, promotion, supply, and administration or use of therapeutic products.

Following the consultation process, a Bill is proposed for introduction into Parliament by the end of 2019 and scheduled for commencement from late 2022.

In addition to these regulatory changes, funding arrangements for devices are also changing -presenting a number of challenges to those operating in New Zealand.

PHARMAC was created in 1993 to manage government spending on medicines. Whilst there is a lot of debate around its impact on the health budget and patient access to innovative medicines, it is undeniable that it has delivered lower spending growth on pharmaceuticals.

New Zealand now has one of the lowest public spends on pharmaceuticals in the OECD. But New Zealand also ranked lowest in the OECD for the proportion of new medicines that are subsidised (2010-2015) – 12% compared with 48% for Australia, and 58% for the OECD on average.  And in 2013, generics accounted for more than three-quarters of the volume of pharmaceuticals in New Zealand.

Since 2012, PHARMAC has been working on the procurement of hospital medical devices including introducing the first national contracts for devices in 2014 and implementing the first market share procurement for wound care in 2017/18.  They now have $200 million under contract.

PHARMAC wants to commence the next phase of its work on medical devices as early as 2020. This would see PHARMAC deciding which medical devices are funded and also making decisions about introducing new technology that DHB hospitals can use.

The conflation of these two changes have significant implications for the 240 companies operating in the medical devices sector in New Zealand. The PHARMAC approach will potentially erode patient and clinician choice, training and education for medical professionals, long term competition and viability of the sector, timely access to innovative therapies, value in healthcare and overall patient outcomes.

The PHARMAC proposal is open for consultation until 28 June 2019.[/vc_column_text][/vc_column][/vc_row]