With 10,000 people turning 65 every day in the U.S., Americans aged 65 and older now hold more than 27% of all U.S. wealth. It’s no wonder seniors are prime targets for scammers and swindlers. An expert at the University of Michigan estimates that “about 20% to 25% have mild cognitive impairment while about 10% have dementia.” For these seniors — nearly 20 million — the chore of accurately and promptly paying bills may be stressful and difficult to execute properly. Medicare Advantage (MA) plans, accountable care organizations, long-term care insurers, Medicaid home and community-based providers, and others with a financial interest in preserving the independence of seniors can benefit from assisting seniors in their financial tasks.

Effective personal financial management is necessary for preserving assets and maintaining independence. This is increasingly important as the cost of health care continues to increase. Even with Medicare, 20% of seniors pay more than $2,000 a year in out-of-pocket health care costs. As the nation’s senior population continues to grow, those who care for seniors can address fraud and cognitive impairment by investing in financial management services that extend independence for seniors by reliably paying their bills.

Studies show that financial management services can also lower health-related costs. In just one example, the Brookdale Center for Healthy Aging & Longevity analyzed the value and costs of daily money management programs (DMM). The research found DMM programs to be cost-effective in extending independent living and staving off expensive custodial care alternatives, such as nursing home placement. DMM/case management programs save an estimated $60,000 per individual compared with nursing home placement throughout the Medicare beneficiary’s lifetime. This is because individuals with DMM services remain in their homes and communities longer and maintain a higher quality of life.

Approximately 80% of people with Alzheimer’s disease and related dementias receive care in their homes from family or friend-of-family caregivers. In 2020, the financial management service, SilverBills, was selected to partner with AARP to conduct research studies that explored the mindset of caregivers for older adults with regard to financial management. Caregivers often experience extreme stress associated with managing the lives of their loved ones — 40-70% suffer from caregiver stress syndrome, according to one source. Caregiver stress syndrome is a condition characterized by physical, mental and emotional exhaustion, and it has a significant impact on the lives of those who take care of their loved ones. It can impact not only the long-term health and wellness of the caregiver but also the health and wellness of the patient. Financial management services can help address caregivers’ frustration with the overwhelming needs of their loved ones by providing an overlooked yet necessary benefit for the patients.

Helping seniors with their personal finances by paying their bills according to their wishes is a relatively new service. Evidence shows that these financial management services directly improve the health and well-being of seniors and their caregivers. Some financial management service companies have earned the patronage of local governments and prestigious funders, including the National Institutes of Health and AARP. It is time for health plans, particularly MA plans, to pay attention as well.

Photo: Olga Shumitskaya, Getty Images

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A recent Minderoo Foundation report found that Aboriginal and Torres Strait Islander people hold less than one per cent of all executive and senior positions within Australia.

Indeed, this lack of representation and inclusion of Indigenous viewpoints at senior levels in the decision-making process probably contributed to the executive failure displayed by Rio Tinto with the destruction of Juukan Gorge in May 2020.

However, the Melbourne Business School calculated the Indigenous business sector at $4.88 Billion (AUD), which means that it is larger than Australia’s beer industry at $4.3 Billion. Given the size of the Indigenous economy, the underrepresentation of Indigenous Australians at senior levels is noteworthy.

However, in Australia, there are no legal requirements to enforce diversity at senior levels, rather, the Australian Stock Exchange has a guideline to “set measurable objectives for achieving gender diversity in the composition of its board, senior executives and workforce generally.”

It is important to note that this guideline does not include other minorities, which compares unfavourably with the United States which possesses a NASDAQ Board, Diversity Rule.

Three professions make up most of all board appointments and senior executives in Australia: lawyers, accountants, and engineers. While many boards are broadening the range of professional backgrounds considered for vacant roles, there is still a bias demonstrated by hiring panels towards engaging those with existing executive experience.

This tends to preclude the emergence of socially diverse directors and is another factor that impedes diversity of thought. Something that the Harvard Business School found to be critical in performing well in a volatile, uncertain, complex, and ambiguous business environment.   

If you are outside the three listed professions above and are a minority then you will need two things. Firstly, what I call social credibility, or an endorsement of your skill set and secondly, access to networks so that you are made aware of the unlisted vacancies. Certainly, this was the situation I found myself in a few years ago, with the disclaimer that I was also a qualified Chartered Accountant.  

Now I set myself a goal of joining a Board and in becoming a senior executive. One of the factors that I discovered from researching the background of senior executives and Board Directors was that most had completed a Master of Business Administration (MBA). With that in mind I looked at the domestic MBA rankings and their respective costs. 

Seeing the tuition cost I started comparing potential scholarship options to reduce my fees and, was successful in receiving the UQ MBA Student Scholarship – Indigenous. Juggling full-time work with part-time study and raising a young family was incredibly challenging.

However, completing my MBA at the University of Queensland Business School led me to securing a non-executive Director role with a Not-for-Profit Board, Aboriginal Community Housing Limited. An opportunity that my MBA network alerted me to and, encouraged me to apply for it. Subsequently, working on an NFP board aiming to provide better housing options for Aboriginal and Torres Strait Islander communities and families has been incredibly rewarding. 

The social credibility from attaining an MBA led me to my first executive role and the opportunity to work with retired professional Australian Rules football player and prominent Indigenous business leader Adam Goodes.

Which then expanded my professional networks that enabled me to successfully launch my own management consulting business Malu. A wholly owned Indigenous and veteran-owned company that provides business consulting and coaching services across Australia.

In summation, if you are outside of the three preferred professions within Australia that comprise senior executive or Board Roles, and a minority, then completing an MBA can help in finding and securing your first board or executive appointment.

While for companies looking outside traditional recruitment pipelines can allow you to identify and nurture talent, which could enable your business to thrive in a VUCA environment.

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Almost every day, there is another headline touting the latest advancement in artificial intelligence (AI).

And almost every time, the subject of the story isn’t actually AI.

While we have made huge advancements in automation and natural language processing (which is usually what those articles are about), neither of these are really AI.

Both are crucial steps on the journey towards AI, but a home speaker that turns the lights on when I ask it to isn’t exactly intelligent – artificially or otherwise.

That’s not for want of trying. With Australia’s AI spending heading for $3.6 billion, and $44 million in Government grants being made available to develop AI and digital capability centres, it’s a destination we’re determined to reach, but we have not moved as far over the past decade, as many would believe.

The challenge lies in how we define AI. In its simplest form, it should be a program that is able to draw on its own past experiences, think for itself, and come up with new answers, creations, or processes on its own.

Some call this level of advancement ‘singularity’ or ‘General AI’, but can anything less really be called artificial intelligence?   

Today’s breed of ‘AI’ are algorithms with a finite and defined purpose – these are also known as ‘weak’ or ‘narrow’ AI. They are constrained by how they have been programmed and essentially boil down to a series of ‘if x, then y’ commands.

The machine learning and automation we have today definitely make our lives easier, but it is reactionary – it needs to be told what to do and how to do it before acting.

Take shopping centre parking lots as an example.

What is currently being described as ‘AI’ are programs that monitor how many parking spaces are occupied and how many are free. Perhaps it does this through sensors in each spot; maybe this is achieved through object recognition via smart CCTV. Either way, the end result is something like the occupied spots displaying a red light above them, those that are still available showing a green light, and an LED screen tallying up the remaining free spots to display them at the car park’s entrance.

While this is an impressive feat of automation and convenient for shoppers, it is far from AI.

It still relies on an algorithm that essentially tells the program that if there is a car in a spot, show a red light; if there is not, show a green light, then count the free spots and display that number (if x, then y).

True AI in the shopping centre car park would make far more intelligent decisions without necessarily being told what it should be looking for. What might this look like?

By analysing the makes and models of each car entering the car park, it could make an estimation of the average purchasing power of shoppers, discover the trends for when different cohorts are at the shopping centre, and advise each store on optimum staffing levels.

To make this more accurate, it might track the brands on the shopping bags patrons are leaving with, drawing on that experience over time to uncover when specific stores are likely to be busier. 

On the loss prevention front, it might identify that a recently found shoplifting patron entered the car park and could notify stores to be vigilant. Perhaps it could identify when a stolen car, or a car with stolen license plates, enters the facility.

If it identifies that more parents take their children to the centre at particular times and days, this insight could be shared with centre management to make sure the big fluffy mascot makes an appearance or children’s entertainers are prioritised at that time.

With a true AI, the point is that we wouldn’t necessarily know what insights it would discover or what connections it would make between seemingly disparate data points.

A big hurdle between where we are today and where we think we are is the bottleneck of computing and storage.

For an AI to be able to take in all its past experiences and all the necessary data points and create its own thought processes, it needs truly massive amounts of data it can analyse immediately.

Until we figure out how to overcome this bottleneck, we’ll continue making better mouse traps – but they won’t be telling us anything new about mice.  

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You wouldn’t believe it to listen to most of the narrative surrounding the recent Commonwealth Budget, but Australia’s government is in a very strong position to make the investments the country needs to make to build a resilient and sustainable economy. 

While the Treasurer will have wanted to avoid doing anything which might be seen to add to inflationary pressures, at a time when the cost of living is rising faster than at any time since the 1980s, comments about the ‘hard yards of budget repair’ were unnecessary, and risk biasing future budgets towards austerity, underemployment and a failure to make essential strategic investments.

There is overwhelming evidence that our current global inflation has its roots in continuing Covid disruptions to fragile supply chains, in the (major) European war, and in what are early harbingers of the unprecedented changes to the global climate, which almost certainly lie ahead of us.

Those who blame inflation mainly on the financial support package during the pandemic ignore the lack of a wage-price spiral in Australia. Despite low unemployment, real wages have been falling and not rising. They also ignore the fact that the size of the economy has just returned to its long-run trend and that the fall in unemployment and labour force shortages are a reflection of the collapse of net immigration in March 2020. If you blame low-interest rates and quantitative easing, remember that the cash rate had already been cut to 0.75% before the pandemic without creating enough inflation to match the RBA’s target since 2014 and that large-scale QE over many years had failed to create inflation in Japan, the USA, the UK or the Eurozone – for a good reason, as it is just an asset swap between the public and private sectors and not ‘free money’.

Commonwealth government net debt and gross debts are only 23% and 37% of GDP, respectively; however, you define the debt as well below the average level for OECD countries and a small fraction of that of the USA or Japan. Even the conventional narrative of what constitutes a sustainable fiscal policy would imply that Australia is far from having an unsustainable fiscal policy, looking many years into the future. 

But the conventional ‘government as household’ narrative is misleading. In a monetary system like ours, every dollar the government spends is a new dollar; the role of federal taxes is not to pay for government spending in advance but to delete dollars from the monetary system to create a room within the productive capacity of the economy for the government to spend and invest without creating inflationary pressure; the role of treasury bonds is not to allow the government to borrow, but to drain excess reserves from the banking system, in support of the RBA’s interest rate target.

The government’s net debt is better thought of as the net supply of dollars to the private sector than as a debt in the conventional sense. Our government does not need to borrow back the currency it issues at all, in the conventional sense of the word. It does not need to balance the books, and that is not an appropriate objective.

So what would this economist recommend Jim Chalmers to do in future budgets? By all means, be careful not to add to inflationary pressures when the economy absorbs the consequences of what feels like the four horsemen of the apocalypse. But when the global economy slows, and if peace returns to Europe, as the impact of COVID in China and elsewhere across supply chains ebbs, as net migration adds to labour supply, and as energy and food prices start falling, global inflationary pressures will fall too, and additional excess capacity will open up in the Australian economy.

If we want a modern, sustainable economy, with an accelerated shift to renewables, other investments in a more rapid move to a net zero economy and in defending our remaining biodiversity, in improved aged care, healthcare, education and training and public services generally, and in the scientific research needed to address the major challenges of the decades to come, then it will be a mistake to leave workers and other real resources which could have contributed towards this mission underemployed because of a mistaken view of fiscal strategy.

The Commonwealth government can spend too much, relative to the taxes it collects, and contribute towards inflation. But it can never run out of the currency it issues. The barrier to spending is always current and expected future productive capacity. The challenge is to maintain and enhance that capacity to build a well-being economy without damaging the natural environment on which we all depend. 

The priority should not be ‘budget repair’ in future budgets – there is nothing in the budget which needs repairing – but the maintenance of low, stable inflation while planning for technological development, social well-being and ecological sustainability.

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The Covid-19 pandemic challenged the U.S. healthcare system like never before—particularly the segment of the industry that cares for seniors and people with disabilities. Facing a massive disruption to the status quo, providers had to quickly pivot to new models of care, such as hospital-at-home programs, which helped reduce hospitalizations and freed up hospital beds for higher acuity patients.

Accelerated by the pandemic’s quarantines and lockdowns, home-based healthcare emerged as a solution with unlimited potential and rising popularity due to its proven ability to lower costs and reduce hospitalizations. Patients, providers, and payers all support this shift to home-based care. In fact, 94 percent of Medicare beneficiaries say they would prefer to recover at home following a hospital stay and 97 percent of health plan leaders believe that more care should be delivered at home.

Unfortunately, just as need and demand for home healthcare are at their peak, the Centers for Medicare & Medicaid Services (CMS) is proposing to cut rates for Medicare home health by up to $4 billion, devastating access to these critical services.

CMS’s 2023 Home Health Prospective Payment System Rate Update Proposed Rule includes billions of dollars in Medicare payment cuts to home health agencies. In 2023 alone, Medicare proposes a permanent 7.69% rate reduction, which equates to a $1.33 billion cut from home healthcare.

Proposed payment cuts to home health providers are contrary to increased demand, patients with more complex needs, equitable access to care, and substantial cost increases across the industry. While CMS increased payment reimbursement rates by 20 percent for hospitals and skilled nursing facilities during the pandemic – in addition to provider relief funds – home health agencies received no additional reimbursement and are still facing significant financial challenges attributed to Covid-19. CMS’s unprecedented proposed cuts, coupled with inflationary pressures and increased labor costs, will make it increasingly difficult for home health providers.

Home healthcare providers have unique challenges, including gas expenses which are trending nearly 30% higher compared to June 2021. Based on 7.8 billion miles of travel to and from patients’ homes at 24 miles per gallon, gas prices alone have in the aggregate cost agencies an extra $384 million per year.

Additionally, we should consider that home health agencies are facing a severe workforce shortage that makes meeting current demand for care extremely difficult. WellSky’s home health clients have stated that their referral volumes are the highest they have ever been—but they have been forced to turn patients away because they simply don’t have the staff or resources in place to care for them. Our own data show that in January of this year referral rejections across the industry reached 58 percent in home health.

Long before Covid-19, home health providers began developing innovative ways to allow patients with advancing need for healthcare services to receive care in their homes and age in place. The needs of this population and the complexities of their conditions have grown. If the proposed rule becomes effective, the cuts will force many of these higher acuity patients into higher cost settings, which will lead to higher costs for CMS. On the other hand, if cuts are not made, more care and higher acuity care will continue to be provided in the home, which is the most cost-effective and desired setting for care advancement.


The Preserving Access to Home Health Act (S. 4605/H.R. 8581), introduced by Sens. Debbie Stabenow and Susan Collins in the Senate and Reps. Terri Sewell and Vern Buchanan in the House, would require any cuts to home health payment rates to be put on hold until 2026. By delaying the proposed cuts, CMS and the home health industry would have the opportunity to more thoroughly develop a payment model that preserves access to care and refines the approach to determining budget neutrality in home health as required by Congress.

By 2040, the senior population (those 65 and older) will grow to 80 million people. With this “silver tsunami” ahead, our healthcare system must be ready to innovate to create lower cost options that improve quality, access, and outcomes. Healthcare at home is here to stay. That’s why it is so crucial to stop detrimental cuts to Medicare and preserve access to vitally important healthcare at home services.

We stand with the home health industry and will continue to do everything we can to support the Preserving Access to Home Health Act and fight for the success of the home healthcare system.

Photo: Mbve7642, Getty Images

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The recent Jobs & Skills Summit highlighted an urgent need for Australia to act fast to resolve our ongoing labour shortages. Positively, the Albanese Government agreed to take immediate action on a variety of labour initiatives as a result of the Summit. 

One such initiative included increasing the ceiling for permanent migration and working towards resolving the current visa backlog. This is an excellent long-term approach, and we applaud the government for taking a stand on what is often a political hot potato.

But with the second most severe labour shortages in the developed world, Australia cannot afford to only apply long-term solutions like migration to the problems we face today.

Luckily, we don’t have to reinvent the wheel when there are lessons that can be learnt from comparable markets that are further in their post-pandemic recovery, such as the UK.

A tale of two cities  

The Australian and UK markets have similar employment markets in a number of ways. 

Both markets are highly diverse and reliant on both domestic and migrant workers. They are also both fuelled by SMEs, totalling 99.8 percent of all businesses in Australia and 99.9 percent in the UK. 

Hiring in both countries can be a long and arduous process, with employees increasingly demanding more flexibility and employers are scrambling to fill vacancies.

Unemployment is also sitting historically low for both countries, at 3.4 per cent and 3.8 per cent for Australia and the UK, respectively. This amounts to a 48-year low for Australia, far lower than pre-pandemic levels for both countries, and means that the power is very much in employees’ and candidates’ favours.

Additionally, both countries also continue to grapple with underemployment, with at least 6.0 per cent of Australia’s working population and 6.7 per cent of the UK’s working population currently underemployed. This suggests some dissatisfaction when it comes to work, whether stemming from working too few hours or occupying a role that is beneath an employee’s experience and qualifications.

The lessons are in the differences

But there are also some notable differences between the two job markets. The UK market is further along in its post-pandemic recovery than Australia because it re-opened its borders to migrant workers earlier than Australia.

This issue is now being addressed, but with the sheer scale of the current visa backlog, it will take time to return to pre-pandemic levels of migration. Crucially, the UK is also far more advanced than Australia when it comes to identifying creative employee benefits that an employee actually needs to build out organisations’ employee value propositions.

One excellent example relevant to our work at Wagestream is the proliferation of employer-delivered financial wellbeing tools utilised by UK human resources departments and hiring managers to attract and retain staff. 

It’s no secret that we are facing a global cost-of-living crisis, so employers who are able to address the resulting financial stress of their employees will have the edge over those who don’t.

Yet, in Australia, the uptake of employer-delivered financial well-being tools is still in its relative infancy. This is compared to the UK, where dozens of large and mature financial well-being organisations help hundreds of thousands of employees manage their finances better.

Tools like this could give the UK an edge now that Australia has also opened its borders and is playing catch up to attract its share of migrant workers in our “global war for talent”.

Employee financial well-being must be front of mind

There is not much we can do now about the fact that the UK came out of lockdown far earlier than Australia, aside from ploughing ahead with our plans to boost immigration.

But Australian employers can act immediately to follow in the UK’s steps in focusing on the financial well-being of their workforce in this incredibly tight labour market.

As an example, Wagestream analysis of over 10,000 Indeed.com job postings found that offering ‘earned wage access’ as an employee benefit resulted in roles being filled 27 per cent faster than those that didn’t. Thirty-three per cent of respondents in a survey of 1,250 new employees also said that knowing Wagestream was available was a driving factor in them choosing to take the job. 

That’s a pretty powerful employee attraction tool!

It’s time we acknowledge that, in the current economic landscape, employee financial well-being not only helps to attract talent but also increases employee satisfaction and retention.  

This is a fact our labour market would ignore at its own peril.

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Money pile and medicine pills representing medical expenses

The latest–and perhaps final–blow to the once-promising Alzheimer’s Disease medication Aduhelm came when its maker, Biogen, said it will stop collecting data on patients who are using it. Biogen said this was a result of Medicare and Medicaid restricting coverage so severely that there would not be a substantial number of patients to follow. Even after Biogen cut its original price of $56,000 per year in half, there were very few takers for the medication, which aims to attack proteins some scientists have linked to cognitive decline, in both the public and commercial payer spaces.

Unless something changes, we will never know if this drug–or the more promising beta amyloid-directed monoclonal antibodies that are currently in late stages of development–   could help the thousands of Americans who suffer from Alzheimers. Many who did qualify for Aduhelm can also no longer get it, as Medicare and Medicaid will only cover it if patient data is collected–which is exactly what Biogen says it will quit doing.

Zooming out, there is a lot more at stake than Aduhelm: as more novel pharmaceuticals, including life-saving gene-therapies come to fruition, the danger is increasing that these medications will never actually reach those who need them, due to Medicaid, Medicare and others not covering their high costs.

But the door is opening to change; recently, a rule that restricted Medicare and Medicaid to setting just one price per drug, is supposed to go away; allowing the agencies to set a price range. This means that they could start more easily entering into value-based purchasing agreements for medications, where there is a linkage between pay and performance.

While it may be too late for Ahuhelm, such an arrangement could still be used for other more promising beta amyloid-directed monoclonal antibodies that are currently in late stages of development. This may be the only way to make sure these medications–and the patients they could help–are given a chance.

Currently, the Centers for Medicaid and Medicare Services, the federal program that runs Medicare and works with states to operate Medicaid programs, has stated that if approved by the FDA, the entire class of beta amyloid-directed monoclonal antibodies will be subject to restricted reimbursement like Aduhelm. For example, all accelerated approvals must undergo post-marketing clinical trials, analogous to the stringent requirements imposed on Aduhelm. And even beta amyloid-directed Alzheimer’s Disease drugs that go through the regular approval process must enter a “coverage with evidence development” protocol, which implies that post-approval collection of data in patient registries will be mandatory.

But all this does is place more obstacles in front of patients, and it doesn’t actually do anything productive with the data that would be collected.

On the other hand, value-based pricing would measure the cognitive decline or progress in Alzheimer’s Disease patients on the medication, and, accordingly, adjustments could be made to the acceptable price range of the product. Payers like Medicaid and Medicare could also receive reimbursement from pharma companies if the patients’ lives are not improved.

This differs substantially from the approach of the Boston-based nonprofit Institute for Clinical and Economic Review and others who claim to embrace value-based pricing. Last year, ICER conducted a preliminary analysis of Aduhelm, extrapolating from clinical trial data. ICER concluded that a cost-effective price benchmark range would be between $3,000 and $8,400 per year for early-stage Alzheimer’s Disease patients, which is much lower than the current price of $28,000. But ICER’s assessment was not based on real world evidence beyond the clinical trials, as any true value-based pricing agreement would be.

Aduhelm’s ship has perhaps sailed, with the baggage of the FDA approval controversy, the recent departure of Biogen’s CEO and now the end of following patient data. Nevertheless, value-based arrangements could very much be in play for other beta amyloid-directed monoclonal antibodies, including Biogen/Eisai’s Lecanemab, Roche’s donanemab, and Roche’s gantenerumab–all currently in human trials.

Undoubtedly this would be a major undertaking, particularly logistically. And, getting Medicare and Medicaid to buy in won’t be easy. But, there’s precedent for the agencies wanting to pursue value-based agreements. The Center for Medicare and Medicaid Innovation has the authority to test models which modify Medicare payments for certain high-priced drugs.

And, to illustrate further, at the time of FDA’s approval of the CAR-T therapy Kymriah (tisagenlecleucel) in 2017 – indicated for acute lymphoblastic leukemia – it was accompanied by the announcement of a novel outcomes-based agreement with Medicare and Medicaid, in which those agencies would pay for Kymriah only if patients had responded to it by the end of the first month. Without disclosing why, Medicare and Medicaid quietly backed away from that agreement.

Maybe the substantial unmet need in Alzheimer’s Disease will trigger Medicaid and Medicare to consider alternative approaches to reimbursement. No one should pay for something that doesn’t work, including taxpayers—and those taking these medications. Value-based pricing prevents this.

Value-based pricing could have shown us with more certainty the real level of effectiveness of Aduhelm. Maybe it is worth paying something for; and value-based contracts are the only way to figure that out.

We are just at the beginning of a huge pipeline of drugs, including gene-therapies and other life-changing medications, for conditions long seen as incurable. Having a contract model where price is based on outcome data is the only way to make sure the people who really need these drugs get them–and only continue to take them if they work.

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The outsized impact of type 2 diabetes on the health system in the United States is well established – millions of Americans experience declining health and higher healthcare costs each year because of this epidemic and chronic condition. According to the CDC, diabetes costs $327 billion each year and the total cost rose 60% from 2007 to 2017. Most of these are direct medical fees from either pharmaceutical treatments or care for symptoms of the disease.

What is frustrating to those who focus on diabetes care is that this is not a mysterious, misunderstood disease. The risk factors behind diabetes, the link between the disease and diet and activity level, and ways to mitigate its progression through lifestyle choices are well known and backed by decades of research. But despite this, the way we treat diabetes does not match up with what we know about what causes it.

More often than not, the primary form of therapy offered to diabetes patients is pharmacological. And while we have incredibly innovative and effective drugs that can mitigate the symptoms of diabetes, they end there, failing to address the underlying causes of the disease. This means that, without those accompanying life-style changes, patients are inevitably on the path of their disease progressing, causing more adverse events, increased medication usage and higher healthcare costs.

This pattern is at odds with what we know about how best to treat type 2 diabetes and is failing patients and leaving providers without the tools needed. In fact, the issue is so critical that the American Diabetes Association has recommended new standards of care, calling for the use of mobile apps and digital solutions for therapies like behavioral counseling and lifestyle changes as the first line of treatment. So why is this not the experience for so many of the millions of people with this condition?

In short, it’s been a challenge of scale. Lifestyle changes are hard under the best circumstances, much less while dealing with a chronic illness. People need support to change long-standing diet and exercise habits and, with so many patients suffering from diabetes and a host of other cardiometabolic conditions, it’s no shock that providing one-on-one support has not often been possible, especially in a model where primary care physicians are the most likely to oversee diabetes care.

But the good news is that there may be another option – tapping into technology to scale up the delivery of behavioral therapies to type 2 diabetes patients. Prescription digital therapeutics can and should be considered as part of type 2 diabetes therapies because they can help provide that first line of defense that the current standard of care calls for. Backed by clinical research and regulated by the FDA, these can be prescribed by a physician as easily as any pharmaceutical treatment and require only the smartphones that so many of us use daily to deliver always-on, tailored support rooted in proven therapies like Cognitive Behavioral Therapy (CBT).

CBT has been used in psychological practice for decades to treat conditions ranging from anxiety and depression to addiction – as well as helping with nutritional and activity changes. Based around the concept of helping patients interrogate and understand the subconscious underpinnings of habitual behaviors, CBT has been shown to be an effective way to help people make healthier eating choices, achieve glycemic control and minimize the progression of cardiometabolic diseases.

A growing number of prescription digital therapeutics for a host of conditions – including cardiometabolic diseases – will soon hit the market and clinical trial data has shown that they are truly effective. Organizations like the American Diabetes Association have made moves to update guidelines to include the use of these validated digital tools. While pharmaceuticals are a critical piece of the treatment landscape for type 2 diabetes, they have been the exclusive and de-facto first-line treatment for too long. And while they provide relief to patients, when used alone they are also part of a cycle of increasing costs and lower health outcomes. Patients, doctors, payers and the health system at large deserve better and prescription digital therapeutics that can help patients take control of their own cardiometabolic health may be part of the solution.

Photo: MURAT GOCMEN, Getty Images

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The FDA’s recent complete response letter (CRL) for vadadustat — an oral therapy evaluated for the treatment of anemia in patients with chronic kidney disease (CKD) — was a big surprise and disappointment for our community. The trials had quite convincingly demonstrated efficacy as measured by raising hemoglobin levels and safety as measured by major adverse cardiovascular events (MACE) for the dialysis-dependent population—findings that should have sealed the approval, but did not.

It was perplexing that the FDA decided against seeking insight from the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) for vadadustat, which is an orally administered hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). Did the FDA’s experience with the roxadustat advisory committee meeting, in which they overwhelmingly voted against approving the drug for the treatment of anemia associated with CKD in the dialysis-dependent and non-dialysis-dependent patient populations, sound the death knell for vadadustat and the entire HIF-PHI class of drugs?

Roxadustat has already been approved in Japan, South Korea, Chile, and the EU. Vadadustat is approved in Japan and is currently pending approval in the EU. The FDA seems to be an outlier as a regulatory agency by failing to see the positive benefit/risk assessment of this drug class. Any potential safety concerns with HIF-PHIs that the FDA may have can easily be resolved with a long-term pharmacovigilance plan.

The FDA was primarily concerned with venous thromboembolism and vascular access thrombosis events with roxadustat; yet there was no indication that vadadustat had that safety issue. Data presented at the American Society of Nephrology’s annual meeting in 2021 specifically addressed thromboembolic complications and vascular access thrombosis in dialysis and non-dialysis patients and clearly showed that vadadustat was non-inferior to the study comparator, darbepoetin. This should have allayed the concerns that the CRDAC had with roxadustat, while distinguishing that vadadustat had a better safety record both in terms of MACE and of venous thromboembolism and vascular access thrombosis.

The fact that the FDA did not even request a CRDAC for vadadustat suggests that the regulators may have already made up their minds about this entire class of drugs. This is disappointing and unfortunate for America’s vulnerable kidney patients.

One of the greatest unmet needs in treating anemia is in the non-dialysis patient population, which lacks convenient treatment options. Erythropoietin stimulating agents (ESAs) are difficult to administer. These parenteral drugs may require patients to visit a healthcare facility for administration, which can be burdensome for patients and their caregivers, especially considering the frequency of administration. In contrast, HIF-PHIs are oral agents that improve both iron absorption and mobilization, thereby reducing the need for iron administration in anemic CKD patients. Considering all these factors, HIF-PHIs could be effective and more convenient for non-dialysis CKD patients who are receiving inadequate treatment today.

Medicare data indicate disconcerting findings: those 65 and older are more likely to have received a transfusion to treat their anemia than iron or ESAs during the two years prior to dialysis initiation. Transfusions are undesirable because they lead to allosensitization, potentially reducing the patient’s donor pool for a future transplant. This is counterproductive to the mission of the federal government’s Advancing American Kidney Health (AAKH) initiative, which aims to improve kidney transplantation rates. Moving forward, it will be critical for stakeholders to evaluate ways to align these incentives and the ability to administer an oral agent at home to treat anemia, avoid transfusions, and help fulfill the goals of improved transplantation rates. However, if the FDA has already made up its mind about the safety of this class of drugs, sadly, we will not see any significant improvements in the treatment of anemia for the non-dialysis patient population.

Dialysis-dependent patients are different from the non-dialysis patient population: 80% of individuals in the former group achieve their target hemoglobin levels with moderate doses of ESAs. However, the remaining 10-20% are hyporesponders for a variety of reasons usually related to inflammation.  With a novel mechanism of action, HIF-PHIs would likely be more effective in reducing hepcidin levels, thereby mobilizing iron, helping patients avoid transfusions, and improving quality of life related to higher hemoglobin levels. Another important point is that one of the AAKH initiative’s goals is to increase home dialysis rates to 40-50% of patients. Considering the burden associated with administering parenteral ESAs, HIF-PHIs would add value to the treatment plan of patients who do not require regular visits to a dialysis facility.

Impact of the FDA’s decision on the HIF-PHI drug class

Reflecting on how the FDA’s decision would impact other agents in the class that are currently under development, one has to wonder about daprodustat, another HIF-PHI currently under review by the FDA. Results published in the New England Journal of Medicine (NEJM), which were presented in November 2021 at the American Society of Nephrology annual meeting, showed non-inferiority for MACE in both dialysis and non-dialysis populations based on an intention to treat analysis—the gold standard for analyzing drug safety. MACE non-inferiority of daprodustat was demonstrated among the dialysis population in both intention-to-treat and the on-treatment analysis.

With the CRL for vadadustat, the FDA has made the puzzling decision to extrapolate the safety findings of vadadustat in the non-dialysis population to the dialysis-dependent population, despite non-inferiority data for the latter. According to Akebia, the developer of vadadustat, the FDA has cited hepatocellular injury and thromboembolic events, specifically vascular access thrombosis, as the basis for its rejection. However, the results published in NEJM clearly show these adverse events were no different than the active comparator—hepatocellular injury wasn’t an issue in either population. Table S7 of the supplemental information, which lists the emergent adverse events in the safety population, does show an increase in transaminases in the ESA-untreated non-dialysis patients treated with vadadustat (1.8% of patients) compared to darbepoetin (1.0% of patients). The difference, however, is negligible in the ESA-treated non-dialysis subgroups who received either vadadustat (1.2%) or darbepoetin (1.3%).

In my opinion, this is not a valid reason for rejecting the drug in the non-dialysis population that was studied, and most certainly not in the dialysis population.

The non-dialysis population treated with daprodustat demonstrated an increased incidence of esophageal and gastric erosions, as well as increased cancer risk compared to those treated with darbepoetin. While this was not observed in the dialysis patients treated with daprodustat, if the FDA takes a similar stand to vadadustat and extrapolates the safety results to both groups, it could jeopardize the approval of daprodustat in both populations.

I strongly urge the FDA to conduct a CRDAC for daprodustat so that we do not see a repeat of the non-transparent decision on vadadustat, where it appears to many that the FDA had unilaterally decided on the HIF-PHI class of drugs based on the findings with roxadustat. The FDA has apparently conflated concerns with one drug to concerns about the entire class. We would like to hear directly from experts on a CRDAC as they query the sponsor about a specific drug prior to an approval decision being made.  The FDA should consider each drug on its own merit instead of looking at these drugs as an entire class—both from an efficacy and safety perspective.

Another potentially valuable drug in the nephrology space, tenapanor, was rejected last year by the FDA citing less than robust efficacy, but there were no safety concerns.  However, the benefits of this drug still exist given that it could reduce the number of pills a patient needs to take to decrease serum phosphorus levels. Such treatment options are important in the patient-centered culture we are trying to achieve.  Nephrology has one of the lowest rates of new drug applications, despite the fact that nearly 40 million Americans are living with some form of kidney disease.

It is ironic that the AAKH and the Kidney Innovation Accelerator (KidneyX) -— both federal programs that were conceptualized to improve nephrology care, slow the rate of progression of CKD, and decrease the costs associated with treating end-stage renal disease care — are not able to realize their goals due to barriers to innovation in treatments for kidney disease resulting from the FDA’s track record of rejecting new drug applications for less-than-compelling reasons.

I have no doubt about the efficacy of the HIF-PHIs, and neither does the FDA, in my opinion. While the FDA reviewers are concerned with drug safety, they have left the door open for drug developers to conduct some additional safety studies, perhaps in smaller groups of patients who may be at higher risk for theoretical adverse outcomes. I am hopeful that the companies developing these drugs — often small startups — will find the resources or right partners to conduct these additional studies, although the challenges are great due to cost and the time involved in such trials.

Kidney disease patients need access to innovative therapies to expand treatment choices and improve quality of life. The FDA should closely examine whether it is applying the appropriate benefit/risk assessment for new drugs intended for this population. The FDA’s non-transparent rejection of vadadustat in the dialysis population, where efficacy is well established and there is no clear safety signal, represents a failure by the FDA to act in the best interests of the patients it was created to serve.

Editor’s Note: The author is on the advisory board of Akebia, which received the FDA rejection of vadadustat — an oral therapy evaluated for the treatment of anemia in patients with chronic kidney disease.

Credit: sarawuth702, Getty Images

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Individuals are using more and more devices and digital platforms to store personal and private information given more than 60 per cent of the world’s population is now online.

Yet, users are often not ‘digitally literate’ enough to fully understand the risks that come with these online environments. 

While this is often addressed as an IT issue with pressure on companies to implement the latest and most secure technologies, the ‘human’ factor should not be forgotten as an element to build a strong defence against cyber threats. However, with users expanding in the online environment, the challenge remains on how digital literacy and cyber security can be promoted at this growing scale.

In a digital environment full of risks, everyone needs to be taken care of

One of the most inherent difficulties for businesses in the hybrid environment is maintaining visibility across devices and the employees that use them. The Australian workforce now sees 36 per cent of workers using personal devices to access corporate data and a greater 49 per cent connecting IoT devices to their home networks. 

Such an array of unmanaged systems has created a void of proper cybersecurity practices and a basic understanding of it. This has left both businesses and individuals exposed to unnecessary risks by giving hackers the easy fodder to enter a database – statistics suggest that 46 per cent of all data breaches are a result of human error. 

Even at the most basic level of password management, individuals show little literacy in proper password hygiene habits. The latest DBIR report showed that 82per cent of breaches is still involving human error. These poor password hygiene habits also extend beyond the value of protection as many are still unaware of what to do when an attack does occur. The latest IDC report by LastPass reveals that 45per cent of individuals did not change their passwords even after a breach had occurred. 

Your security is as good as your weakest link. It doesn’t matter how robust everything else is, if one person leaves the door open, anyone can walk in. With this in mind, businesses need to make cybersecurity easy enough that both technical and non-technical people can implement it. Any given customer base consists of a range of digital capabilities and if digital assets are not user-friendly, these individuals will take shortcuts to gain access to a business’ services.

Businesses must offer solutions that ensure continuity for their employees and customers to save valuable time and effort, which, can also maintain points of sales. Nobody wants to spend hours a day learning about security, it instead needs to be ingrained into everything they do, so it becomes second nature.

How to get started on education

Even though a company may have the best cybersecurity standards and practices in place for their employees, the true challenge is ensuring that this is maintained and implemented across a wide scale. 

First and foremost, businesses need to look at their employees as the first line of defence through a zero-trust approach towards digital entities. Not only is this a robust framework that is simple and cost-effective for businesses, but it can ensure greater security and integrity of personal and corporate assets. Basic security practices can also be amended through this approach of continuously validating each digital interaction, specifically mitigating the risk of compromised credentials.

While a strong password is a basic premise to protecting identity in the digital realm, passwordless solutions are the future that will have all users, digitally proficient or not, covered. Using technology such as LastPass authenticator, SSO, or federated identity enables users to login into devices and applications without the need to type in a password.

This streamlines the user experience for employees and customers, while still maintaining a high level of security and complete control for IT and security teams. This improves overall cybersecurity within the business and streamlines the user experience to maintain the point of sales – a win-win. 

The proliferation and expansion of online environments are not showing signs of slowing down. Implementing highly sophisticated technologies is not enough to address the human factor in the face of cyber threats. Education of good password hygiene practices and making sure that education filters through to all users are good starting points to promote cybersecurity from individual to organisational level. These strategies are not simply solutions to existing security risks, but should also be integrated into an ongoing promotion of proficiency that echoes with an ever-evolving digital environment.

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