Technology offers one ‘moonshot’ closer to optimal kidney care
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I first heard the expression “moonshot” describing the goals of the Advancing American Kidney Health executive order, which was signed in 2019 by then-President Donald J. Trump.
The initiative created unprecedented excitement about the possibilities for the future of kidney care. Since then, CMS has launched the Kidney Care Choices model, the End-Stage Renal Disease Treatment Choices (ETC) program and private-public partnerships like KidneyX — all aimed at charting new paths for innovation. The race to achieve optimal kidney care had finally arrived.
Like many nephrologists, I was weary of the status quo in kidney care and stigma associated with dialysis as “life-saving care” that was provided at great risk and cost. The notion of reducing the risk of end-stage kidney disease, improving access to home dialysis and preemptive kidney transplant and expanding the organ pool was reinvigorating. Under the Advancing American Kidney Health (AAKH) initiative and value-based payment reform, we could reverse the perverse incentives that made sickness profitable and instead reward efforts to improve kidney health and prevention of ESKD.
The term moonshot originated from the once-fanciful idea of landing astronauts on the moon.
Throughout the course of history, we have seen that when people set their minds to wildly ambitious goals — a moonshot — the seemingly impossible starts to become possible.
I embraced what the moonshot of AAKH promised: “to transform and promote optimal kidney care.” But what innovations would be necessary to help realize these lofty ambitions?
Lessons from failure
Fifty-five years after the Apollo 11 moon landing, the world has been propelled exponentially ahead by advances in technology. Five years after AAKH, kidney care has seen dizzying progress in research and science. We have new options to provide renal replacement therapy, expand kidney transplant availability and make the patient and provider experience more user-friendly and accessible. Portable and implantable artificial kidneys, vascular access technology, salvaging kidneys with advanced chronic kidney disease, improved perfusion methods for donated organs and xenotransplantation present possibilities for kidney care that existed only as concepts a short time ago.
Currently, user interface and functional improvements driven by human factors design and miniaturization of components have simplified and increased portability of dialysis systems. New companies have arisen to challenge traditional dialysis manufacturers.
In this light, the demise of Aksys Ltd. and its personal hemodialysis system (PHD) provides a cautionary tale. The Aksys platform was designed with at-home therapy in mind. After gathering considerable attention and FDA approval, forward-thinking providers and investors eagerly pursued the innovative PHD. The company went public, but Aksys experienced financial challenges and was abruptly and unceremoniously folded by its majority owner — a private equity fund.
My personal observation is that this debacle forced providers to scramble to replace their home hemodialysis machines and retrain entire patient programs.
High-stakes innovation
The preceding story is not meant to dissuade the adoption of innovative technologies or bemoan the role of private equity funding. But, as the Apollo space program experienced, failure is an inherent hazard associated with high-stakes innovation. Similarly, competition is necessary to spur improvements in dialysis care. We now have multiple home hemodialysis options in the market, in part due to pioneering companies like Aksys. However, the risk of a new device failing due to an unforeseen loss of investor backing, manufacturing problem or major safety recall is enough to inhibit enthusiasm by capital constrained providers leery of risk if something big fails.
Moreover, investors are fickle and have no obligation to fund unprofitable ventures. Thus, advances in dialysis technology to improve ease of use, safety and reliability are only viable if they generate enough earnings to keep investors happy and assuage concerns about risk.
With dialysis reimbursement lagging, labor costs increasing and price controls eroding for dialysis organizations, patients will only have access to innovative technologies if these can create margin. This requires new technology to significantly reduce cost per treatment, lessen avoidable expenditures under at-risk payer contracts, or prevent patient loss (eg, death) or drop out, particularly for home dialysis.
The limited upside for bundled reimbursement is compounded by a transitional drug payment policy that makes it nearly impossible for dialysis providers to sustain innovative pharmacologic treatments after the transition period. Implementing innovations with no long-term return on investment is a barrier for adopting new innovations and discourages companies from funding research and development in ESKD.
Labor
Perhaps the greatest need technology can meet is augmenting or replacing the technical functions performed by expensive, hard to recruit and hard to retain human labor. Staff shortages and attrition of our most dedicated and experienced dialysis nurses and staff predated the pandemic and have no indications of lessening. New devices that could reduce staff training and experience requirements while maintaining or improving safety would be highly attractive and cost-saving.
Nephrology, with its shrinking workforce, subpar fellowship recruitment and inadequacy of fellowship dialysis training poses a quality and leadership conundrum for dialysis facilities. Technology-powered solutions to reduce intradialytic complications, better individualize dialysis prescriptions and minimize inter-provider practice variation could help bridge this gap.
Access cannulation and infection prevention remain dual Achilles’ heels in dialysis. Robotically assisted access cannulation could help overcome reliance on scarce expert cannulators and reduce use of catheters. Remote dialysis machine operation to lessen the number of tasks performed at chairside could reduce deviation from infection control policies, sometimes bypassed or ignored by busy workers.
Xenotransplantation
Xenotransplantation and artificial kidneys exemplify moonshot ideas to address the major shortage of organs available for transplant. The quest to replace the complex cellular functions of the kidneys with wearable or implantable devices involves the latest in genomics and bioengineering applications. However, these approaches are still highly experimental and require more time and investment via rigorous clinical trials, so safety and cost-benefits are fully understood.
In the meantime, neither appears to be a realistic, scalable solution for the hundreds of thousands of patients living with ESKD and the many thousands more who will still develop kidney failure despite best efforts. A far more impactful solution would be decisive health policy reform to implement universal opt-out kidney donation. Other near-term options to expand the organ pool would be permitting fair-market compensation for living kidney donation and providing lifetime health coverage for living donors.
AI, treating CKD
The most wonderful progress since AAKH is the emergence of a new armamentarium of therapies to prevent kidney failure and its associated cardiovascular mortality and complications. The enlarging body of clinical trials and compelling scientific evidence showing benefit of sodium glucose transporter-2 inhibitors, glucagon-like receptor-1 antagonists and non-steroidal mineralocorticoid receptor antagonists herald a monumental shift in the paradigm for treating both diabetic and non-diabetic CKD. The potential cost-effectiveness of these highly effective therapies to alter the trajectory of chronic kidney and cardiovascular diseases at a population-level represents a golden public policy and public health opportunity to reallocate resources to preventative care.
The rapid evolution of AI and machine learning has found applicability to nephrology. AI and machine learning algorithms can differentiate patients at risk for developing CKD and/or predict the rate of CKD progression more reliably than usual clinical observation. Utilizing a variety of methods, including in-vitro biomarkers, routine laboratory tests and electronic health records, AI and machine learning can accurately detect those at highest risk for CKD progression and kidney failure. Because of differences in the onset and speed of CKD progression in different individuals, using AI to detect and treat patients with the highest risk and likelihood of benefit is groundbreaking. Detection of pre-clinical CKD and preemptive intervention to completely avoid CKD using AI-fueled technology could revolutionize kidney health in the United States.
Even without AI and machine learning, there is a pragmatic opportunity to align current health care capabilities with value-based care and payer incentives. Simple technological interventions, like standardizing blood and urine testing, can have powerful effects on CKD detection and risk stratification at a system level when payer alignment is present. Adopting ordering of automated primary care testing resulted in a 38% increase in detection of patients at high risk for CKD within the Cleveland Clinic ACO in 2021. Intermountain Health, a leading value-based health system and regional payer, implemented an enterprise laboratory bundle of eGFR and urine albumin ordering. This resulted in more than 1,400 new primary care patients per month being systematically risk stratified using the kidney failure risk equation, with scores calculated in the EHR to trigger nephrology referrals, eConsult and other interventions in Intermountain’s primary care networks.
Optimal kidney care
How do we move to optimal kidney care and realize the moonshot of AAKH? Narrow dialysis operating margins do not enable financial risk-taking, creating a barrier to innovation and cause of de facto commoditization of dialysis care. Consolidation of nephrologists by third-party aggregators, influence of private equity and payers employing physicians have expanded the corporatization of kidney care far beyond large dialysis organizations.
Commercial insurers do not have the same societal obligation to fund longitudinal kidney therapies as federal and state governments. For all the technological marvels within reach, the free market operates without sufficient morality or conscience to ensure there is a path to pay for these innovations. Paradoxically, a consequence of better therapeutics may be an increased need for renal replacement therapy as more patients with CKD survive to reach ESKD. It is within this unpredictable climate that kidney technologies will either blossom or wilt.
But we should remember the race for the moon was only completed because NASA ignored pessimistic risk projections and decided to push on despite multiple failures. As we iterate and innovate to achieve optimal kidney care, there will be losers. But for the potential winners, our patients and communities, our willingness to double down and aim for the moon seems a justifiable, albeit calculated risk.
- References:
- AKF urges changes to Medicare proposal that would impact quality of care and access to innovative products for people on dialysis. https://www.kidneyfund.org/article/akf-urges-changes-medicare-proposal-would-impact-quality-care-and-access-innovative-products-people. Accessed Sept. 8, 2024.
- Chan L, et al. Diabetologia. 2021;doi:10.1007/s00125-021-05444-0.
- Dialysis machine firm Aksys shuts down. https://www.chicagobusiness.com/topic/aksys-ltd. Accessed Sept. 8, 2024.
- Huang B, et al. Front Cell Dev Biol. 2022;doi:10.3389/fcell.2022.953408.
- Huml AM, et al. Am J Transplant. 2021;doi:10.1111/ajt.16129.
- In dialysis, life-saving care at great risk and cost. https://www.propublica.org/article/in-dialysis-life-saving-care-at-great-risk-and-cost. ProPublica. Accessed Sept. 9, 2024.
- Jones HW. NASA’s understanding of risk in Apollo and Shuttle. https://ntrs.nasa.gov/api/citations/20190002249/downloads/20190002249.pdf. NASA Ames Research Center. Accessed Sept. 7, 2024.
- Kjellstrand CK, et al. Semin Dial. 2004;doi:10.1111/j.0894-0959.2004.17214.x.
- Tangri N, et al. Diabetes Obes Metab. 2024;doi:10.1111/dom.15678.
- Tuttle KR, et al. Clin J Am Soc Nephrol. 2022;doi:10.2215/CJN.02980322.
- For more information:
- Leslie P. Wong, MD, MBA, FACP, FASN, is the system executive medical director of medicine at Rochester Regional Health, Rochester, New York. He can be reached at leslie.wong@rochesterregional.org.
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