37 million people. That’s roughly the entire population of the state of California. It’s also the estimated number of people in the US living in poverty. And it’s the number of people in the US who are affected by chronic kidney disease (CKD).
The scope and scale of such a widespread and costly health condition seems overwhelming. According to the National Kidney Foundation, chronic kidney disease affects nearly 15% of the adult population in the United States. It’s a problem that is picking up speed quickly – the United States is expected to have nearly 17% of all Americans afflicted with CKD by 2030.[1] The projected 17% only accounts for those who are aware of their condition, and The National Institutes of Health (NIH) estimates that 9 out of 10 people in the US who have chronic kidney disease don’t realize it. While the prevalence of CKD grows, it’s also a disease that quickly evolves and worsens. According to the US Renal Data System and University of Pennsylvania Medicine, at least 21,000 people transition from CKD to the final stage of the disease, End Stage Kidney Disease (ESKD), every year.[2],[3] And the challenge only continues to expand in scope - almost 150,000 new patients start dialysis each year in the US and arguably more need dialysis but do not realize it.
It’s a disease that’s exploding in terms of prevalence, and with that comes equally alarming upward trends in cost associated with the mismanagement of the condition. Throughout this article we will dive deeper into exactly why kidney disease is so costly, look at what has prevented greater innovation and better management of the disease, note some promising shifts toward a new era of disease management and identify what’s required to maintain progress toward for better care for all.
Costly Mismanagement of End Stage Kidney Disease
Living with ESKD is enormously challenging for patients. For many, life revolves around their dialysis sessions—which means three times a week at a dialysis clinic, for four hours each appointment. There is the misconception that because dialysis patients spend so much time in the clinical setting, their condition is sufficiently monitored. However, as is true with most chronic conditions, adverse health events often happen outside of the clinical setting. Hospitalization rates among those living with the disease are needlessly high and are the result of preventable known complications. Nationally, 40% of dialysis patients are hospitalized for fluid overload[4], leading to 10 ICU days per year on average for every ESRD patient.[5] Furthermore, mortality rates are appalling. Each year, roughly 20% of patients die from a sudden cardiac event[6], and half don’t live more than five years after they have been diagnosed.
Due to lack of awareness, timely interventions and the deployment of innovative technology, $14 billion is spent every year on dialysis-related hospitalizations, 65% of which is due to preventable vascular access and fluid management issues. And while ESRD patients represent only 1% of the Medicare population, they account for nearly 8% of the total costs. These facts only further reinforce that our healthcare system, which was architected with acute episodic care in mind, is not set up to best serve the growing number of adults managing multiple chronic conditions outside the clinical setting.
The stakes and the costs are high, so what’s holding back innovation?
There has been some recent progress in how we approach ESKD—but it pales in comparison to how rapidly innovation has transformed the management of other diseases and chronic conditions. For example, in cancer treatment, diagnosis used to require “exploratory surgery”—now doctors can use miniature video cameras to look inside the body—and can even place radio waves in a tumor to kill cancer cells by heating them.[7] While diagnosing and managing a condition like cancer differs greatly from ESRD, the fact remains that innovation springs where funding flows. In 2021, the NIH dedicated just over $7.4 billion to cancer research, whereas allocations for research in kidney disease just barely passed $660 million.[8]
Given that we know the costs are high, it’s puzzling that an equally substantial investment hasn’t been made to drive costs down. It begins with an awareness problem, and it’s compounded by a lack of compelling incentives. Just in the first half of 2021, global venture capital funding for digital health companies hit $15 billion – a 138% increase from the first half of the prior year.[9] Naturally, a substantial portion (30%) of those funds went to telehealth solutions but not nearly enough went toward companies in the kidney health space. Lack of attention and investment in this segment of healthcare makes the opportunity for innovation significantly less appealing to entrepreneurs. It begs the question, how to we draw the right attention and funding to CKD and ESRD? The answer – declare it a priority then create pathways for systemic change.
Developments in public policy and chronic kidney disease
While progress in CKD and ESRD innovation and investment has been slower than desired, there have been promising recent improvements which create the kind of momentum necessary for scalable systemic change. For example, CMS expanded its reimbursement for remote patient monitoring technologies, and the CURES act mandated that dialysis patients are required to be given access to Medicare Advantage plans.
Another promising advancement in 2018 was the formation of the Kidney Innovation Accelerator (KidneyX) a public-private partnership between HHS and the American Society of Nephrology (ASN). Since its inception, the partnership has encouraged innovation by trying to create an artificial kidney, as well as redesign dialysis and improve the patient experience. In addition to fostering and facilitating these advancements, KidneyX has also contributed to advancements by giving grant money to innovators, including Alio.[10] KidneyX brought attention and new innovators into a space that otherwise may not have attracted the disruption and innovation needed to help patients.
Lastly, in 2019, the White House and the Department of Health and Human Services (HHS) unveiled the Advancing American Kidney Health (AAKH) initiative. Shortly thereafter, the initiative was launched by presidential executive order. Finally, kidney health was being recognized at the same level that diseases like cancer had been through the 2016 Cancer Moonshot. The AAKH initiative set out to do three things:
- Prevent kidney failure through better diagnosis, treatment, and preventative care.
- Increase affordable alternative treatment options, educate patients on treatment alternatives, and encourage the development of artificial kidneys.
- Increase access to kidney transplants by modernizing the transplant system and updating counterproductive regulations.[11]
Collectively, these shifts in the public policy landscape drew a new level of attention and investment to serve as a catalyst for change. But delivering innovation and new solutions doesn’t happen with the flip of a switch. Innovative solutions still take time to conceptualize, test, refine and pass through regulatory bodies.
Where do we go from here?
Conversations at a national policy level aren’t enough to create meaningful change at the patient level. To do so, we must capitalize on the influx of attention and investment and nurture the momentum the last few years provided. Here are three meaningful shifts we can make to not only advance the conversation but also catalyze the type of change we want and need to see for the sake of our public health system and patients alike.
- Reshaping the reimbursement landscape - This means continuing to build, open and expand on pathways to incentivize the adoption of remote patient monitoring (RPM) and remote therapeutic monitoring (RTM) technologies. These tools will ultimately save money for the healthcare system because of their ability to prevent and detect conditions that result in hospitalizations and deaths.
- Eliminate barriers slowing down innovation – Increase patient access to and awareness of potentially life-saving technology and solutions. This also means reassessing the efficiency of costly regulatory processes slowing the commercial availability of technological solutions. For example – consider the surge of innovation we saw when the Secretary of HHS declared that emergency use authorization (EUA) was appropriate during the pandemic.
- Continue to foster partnerships between the public and private sector - Build upon the success of public-private partnerships (PPP’s) like KidneyX. When done correctly, PPP’s can leverage the unique strengths of both the private and public sectors to combat complex healthcare issues. These partnerships bring further attention to advocacy and policy efforts, increase visibility and awareness at a national level, and draw additional funding and venture capital support.
For far too long, patients and families have needed better, and we and the rest of the kidney innovation community are doing our best to make this new world a reality. A reality where managing a chronic condition is not as all-consuming, where clinicians and caregivers have actionable clinical-grade data to best serve their patient population, and ultimately, those with chronic conditions can avoid adverse health events and enjoy peace of mind made possible by the latest innovations that technology has to offer. Until then, we must continue to demand better for these patients and their families.
Eric D. Hargan: Eric is the CEO of The Hargan Group and was most recently deputy secretary of the Department of Health and Human Services (HHS) after having served as acting secretary. He also served at HHS under the George W. Bush administration. In addition to serving on the Board of Operation Warp Speed, Eric oversaw the set-up and launch of the Provider Relief Fund, the Kidney Health Initiative and other parts of the U.S. pandemic response. Since leaving his post at HHS, Hargan has joined the boards of Alio Medical, University Hospitals in Cleveland, Tomorrow Health, and HealthTrackRx. Follow him on Twitter at @EricDHargan
Dave Kuraguntla, Alio Co-founder and CEO. Dave received his master’s degree from Boston University and was a researcher at the National Institutes of Health. He then went to medical school on an Air Force scholarship. He was preparing for a surgical residency when he experienced firsthand the need for better technological solutions for those with chronic conditions. Drawing on his experience, he began to explore the potential of noninvasive wearables for conditions like End Stage Kidney Disease (ESKD) and started Alio. Since then, Alio has secured $35 million in funding to-date and formed key strategic partnerships with organizations including the NHS in the UK, Intermountain, Lifeline and US Renal Care. For more information visit www.alio.ai or follow us on Twitter at @WeAreAlio.
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