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According to Dr. Bruce Culleton, Vice President and Chief Medical Officer, Kidney Care at CVS Health, 93% of Americans who have kidney disease don't know they have it. And he tells Daniel some of the ways physicians and nurses can address this health literacy issue. Dr. Culleton also explains some of the health equity and disparity challenges that exist in this space. For instance, African Americans are three-to-four times more likely to develop kidney failure than white Americans.
Healthy Conversations brings together leaders and innovators in health care to talk about the biggest issues facing patients and providers today. Every month, we explore new topics to help uncover the clinical insights and emerging technologies transforming health care in real time.
Bruce Culleton, MD:
93% of Americans who have kidney disease don't know they have it. So I think there's an education component directed towards physicians and nurses, but also a health literacy issue that needs to be directed towards patients and underserved communities and how do we actually get the right information to those patients and empower them to have the discussions with their physicians.
Daniel Kraft, MD:
Welcome to Healthy Conversations. I'm Dr. Daniel Kraft and today I'm in Healthy Conversation with Dr. Bruce Culleton. He's the vice President and Chief Medical Officer for Kidney Care at CVS Health.
I've always thought particularly through my medical training, that the renal docs, the Kidney Care folks are the smartest clinicians in the room and often the patients are the most complicated. You certainly had a really interesting career path as a clinical technologist, as a clinician and as a nephrologist in research at University of Calgary, then on to Baxter, Becton Dickinson, now CVS Health.
What initially drew you into the realm of nephrology, kidney care and now onto the health care side of the industry?
Bruce Culleton, MD:
No one laid this path out for me, but honestly I was surrounded by just great people and very fortunate and those people gave me opportunities to really move my career in a direction that I hadn't envisioned, and it all started here just outside Boston, where I worked at the Framingham Heart Study. I think as many of us know, it is a pretty famous study for identifying hypertension, dyslipidemia, smoking, all those risk factors.
I set out there initially to explore the relationship between kidney disease and cardiovascular disease and then used that population-based learning back in Canada when I moved back to Calgary. That led to being recruited to Baxter Healthcare where I spent nearly 10 years in a global role to better understand the medical products and the device space and met some amazing people while I was there. One person that I think you might know is Dean Kamen, pretty famous for devices that he's brought to market to improve patients' lives.
Daniel Kraft, MD:
In fact, I just saw Dean Kamen in person last week and I've been to Manchester to DEKA. He's been the sort of the engineering side of a lot of the home dialysis and making it much more connected. There's a project KidneyX, even with wearable dialysis that's emerging. We are familiar with inpatient or clinic-based dialysis, but what's the arc of that?
Bruce Culleton, MD:
At least from a device side, we need better technology to grow home dialysis, but I do think home dialysis leads to better outcomes and better quality of life for patients.
In the work I've been doing with Dean, it's really around developing a device, a machine, and the system that goes around that machine to help get more patients treated in their homes with hemodialysis. Really with changes in payment models, I could easily see a space where instead of the 12-13% of patients who are treated in home today who have kidney failure, that growing to 25% and all the way to 40% probably in this country. But I think more long term, even though we do get a little obsessed with wearable kidneys, I think the exciting pieces around xenotransplantation. That moves it to a completely different level where patients don't have to worry about actually doing dialysis, whether it's wearable or not, whether it's in center or home. I know it's really early, but pretty exciting advancements over the last 12 or 24 months.
Daniel Kraft, MD:
This field is moving slow, slow, then fast. 20 years ago when I was a resident at Mass General, I worked with Megan Sykes and David Sachs on some of the elements related to Xenotransplantation and the news as of late 2021 was the first basically human transplant of a xenograft from a humanized pig into a human. Since then, there's been a first heart transplanted, and if you're on that list, it might not be kosher, but you'll take that organ. What do you think that might be in the next decade?
Bruce Culleton, MD:
I think it's a little bit early to predict where we're going to be in 10 years, but it feels like we've made some more substantial advancements in the last 12 months, 15 to 20 years ago, the whole concept of xenotransplantation was pretty exciting, but then came to an end when you couldn't get around some of the concerns around organ viability and viral transfer to humans.
Daniel Kraft, MD:
Let's maybe zoom back.
What are you seeing on the technology stack that's most exciting to you? I've even looked at a company recently that might even have the equivalent of a continuous glucose monitor type patch that can do real-time potassium.
Bruce Culleton, MD:
Recently, we looked at a company as well that had continuous ECG monitor. You could look at the T waves and use algorithms to identify changes in T waves to predict hyperkalemia as well. We're moving in that direction, certainly lots of data. I think what's missing at this point in time is being able to take that data and make smart clinical decisions with the data.
Daniel Kraft, MD:
All those sort of digital biomarkers from a patient, whether that's their heart rate variability, even the EKG and seeing with AI even before their peaked T waves, behavior challenges, changes in voice, which might change your fluid status. I think it's going to be a really interesting sort of way to help manage patients and be much more proactive rather than reactive.
Maybe just zoom out a little bit further. What does the Chief Medical Officer of Kidney Care at CVS Health do? What's top of mind for you and your team right now?
Bruce Culleton, MD:
On a day-to-day basis, I'm mainly involved in the clinical performance, the clinical quality and safety of our overall programs. I think bringing this home hemodialysis machine to the market within the next year or two. And then we've got a real focus on how we support some of the new payment models from CMS. And finally, Daniel, we have a focus, a really important focus on how we can solve for some of the health equity challenges and health disparity challenges that exist within kidney disease.
Daniel Kraft, MD:
Maybe share a few highlights of those disparities. What are some of the big gaps and how are you looking to narrow them?
Bruce Culleton, MD:
Kidney disease, I think, is a disease that really exemplifies a lot of the healthcare disparities. African Americans are three to four times more likely to develop kidney failure than white Americans. Hispanics are 30% more likely to develop kidney failure than white Americans. There's also disparities in access to home dialysis, access to transplantations. Those are the big ones.
Underlying a lot of those problems are issues related to social determinants of health. We've hired some leaders to be focused solely on health equity and kidney disease. This is an important thing to solve moving forward in how do we make clear equitable within the kidney disease space.
Daniel Kraft, MD:
And part of that care is actually being proactive and picking up folks early.
Bruce Culleton, MD:
93% of Americans who have kidney disease don't know they have it, so I would say we're not doing a good job at all. So I think there's an education component directed towards physicians and nurses, but also a health literacy issue that needs to be directed towards patients and underserved communities, and how do we actually get the right information to those patients and empower them to have the discussions with the physicians?
Daniel Kraft, MD:
What helps move the needle there?
Bruce Culleton, MD:
Sometimes what we see even within the kidney space is just having someone talk to a patient who looks like them and has a similar background to them. An example, Jesse Roach, who's the medical lead for our health equity activities within kidney Care. Jesse's African American and Jesse published a piece showing that 5% of all nephrologists are African American in this country and over 30% of dialysis patients are African American. So clearly there's even more to do from the perspective of how do we track the right people to come into nephrology, the right physicians, and the right nurses for that matter, so that they're able to actually have those conversations that are appropriate with African American patients.
Daniel Kraft, MD:
Any sort of top of line advice you'd have for reaching folks who often have disparities and also helping be on the more preventative side of the equation given that it is growing with our obesity, probably exacerbated by the pandemic.
Bruce Culleton, MD:
Well, I think knowledge is power and passing that knowledge onto your patients is very powerful and it helps them to become more activated in their own health. I also think we just do a bad job at getting family members involved. That's a challenging scheduling issue at times, but it really does help ensure that those patients actually hear what you're saying.
Daniel Kraft, MD:
Health is social. I have a family member with stage three renal disease and it's all about lowering the protein and salts, and if the whole family's having french fries and beef for dinner, it might make it more challenging.
That kind of ties to your early role as an educator. How do we do a better job of teaching kidney care and is the current curriculum for both patients and providers sufficient?
Bruce Culleton, MD:
Well, I think there's a lot to do on the education side, Daniel. I think we all learn about kidney disease in medical school and we're motivated to learn because we need to pass our exams, and then when we become more specialized or less specialized, we become more focused on other things that we know we need to be an expert in.
Really to solve the awareness issue in kidney disease is not necessarily an approach directed towards clinicians. I think it's really public policy. I really think it's public awareness and patient awareness, and some of this, again circles back to health literacy.
On the other extreme, we do see today within the kidney space, nephrologists that simply aren't comfortable with home dialysis and that's a training issue. There are a lot of nephrologists who finish their fellowship who have never seen home dialysis patients in their training. When I trained in Canada, on the first day, I was given a cohort of home dialysis patients and I had to look after them for the two years of my training, and unfortunately there's still some programs where really that exposure is lacking in the US.
Daniel Kraft, MD:
And given that kidney care and CKD crosses so many different specialties and impacts, is that also a matter of teaching not just the nephrologist, but the pharmacist, the cardiologist, the primary care docs more about CKD and how they help manage that in collaboration with their nephrology teams?
Bruce Culleton, MD:
Yeah, that's a great point.
Today, about 50% of patients start dialysis in an unplanned way, meaning that they often start in the emergency room or they start in a hospital. So we need to go upstream and we need to educate those other caregivers that are looking after these patients around the need for a planned approach to dialysis. We also need to use data because for most of these patients, if you look back at their data, they've had blood work done, they've seen specialists, some of them have even seen nephrologists, but either they decline rapidly in an unpredictable way or they're just lost in the system. There's gaps in care.
Daniel Kraft, MD:
Speaking of data, how does that sort of come together to be more highlighted? Someone's creatinine changing a little bit or new protein in their urine, as you mentioned, and the CDC estimates nine out of 10 adults who have CKD don't even know they have it, and that's the point when you can maybe fend off the need for dialysis as well. Where are we with bringing the data together?
Bruce Culleton, MD:
I think we've made some real advances in this space over the last three to five years. We have luckily access to 22 million patients as part of our partnership with Aetna within CVS. So we've been able to use that data and look at those claims and better predict which patients are more likely going to progress and which patients are stable, which patients need immediate attention versus attention that may not be so immediate. There are other companies doing this in this space and pulling in data directly from LabCorp or Quest, for example. Pulling that together with social determinants of health. We do need to refine it and I think other companies can do better in sort of translating that data into knowledge and then translating that knowledge into clinical action.
Daniel Kraft, MD:
Exactly. My favorite chart is all the exponential data needs to turn into actual insights and knowledge and then that knowledge can't be stuck in a paper on a publication that needs to be translated to the bedside or more increasingly the website. And speaking of website, what are some of the challenges and learnings and maybe advancements that were catalyzed by the pandemic for the patients with CKD and even dialysis inside the CVS and Aetna system?
Bruce Culleton, MD:
A lot of that was driven by the pandemic and an increase in mortality above what was expected. What we've learned is that patients who are treated primarily in facility dialysis are at risk, especially in a pandemic. They have to commute back and forth to a clinic three times per week. They're exposed to other patients, they're exposed to health care providers. Everyone is trying to do their best, but they're put at risk. That opened a lot of people's eyes really around the safety of home dialysis versus in-center dialysis. The waivers that were created by CMS were also really important to allow us to better take care of patients virtually, and we're hoping that those waivers obviously get translated into law to allow us to continue to look after patients remotely while they're in their own home.
Daniel Kraft, MD:
What would you say has changed in the arc of a patient with early to late stage renal failure? Where would you predict things might be in the next decade? How can the clinicians listening play a role in sort of advancing kidney care?
Bruce Culleton, MD:
I think what's really going to make a difference, I do think technology's going to advance care undoubtedly. I also think that moving from volume-based care to value-based care will also really help deliver better care to patients in a holistic way, and that really gets down to the point. If you are a physician and you are responsible for the outcomes and cost of this patient's care, you will use technology to help you if it helps you. You will use your partners to help you if it helps you deliver better quality of care and lower costs. I really think some of the newer payment models, especially in kidney disease, but I know elsewhere in other disease states as well, where you're shifting more to outcome-based care. For me, I think that's going to be a big change and deliver better care for patients in the next five to 10 years.
Daniel Kraft, MD:
Yep. You got to follow the incentives and hopefully those will move in the right direction.
Do you see the advent of new approaches and tools, whether it's apps or data or wearables, that would sort of help synergize with that virtualized care model for home dialysis or follow up from inpatient?
Bruce Culleton, MD:
Well, I know you do this too, but I use my smartwatch every day and I use that data to help inform me around healthy lifestyle, around exercise, around what I eat, and that's just the beginning, I believe, and there's no doubt in my mind that the information that we're going to be collecting can lead to better overall outcome for patients.
Daniel Kraft, MD:
We already have an overwhelming amount of data and apps and sensors. The trick is how do you create that sort of your kidney health coach, which ties into your mental health and your diet? Polychronic diseases are often overlaid with kidney disease, and so I think the ability of layers of not just data, but the insights and the action ability, both for a clinician and patient have a long way to go, but lots of potential.
For patients living with CKD today, things are evolving. What are the best options you're seeing for treatment right now?
Bruce Culleton, MD:
The big advances that have been made on the pharmacological side have been the GLP1 inhibitors as well as the SGL2 inhibitors. The data behind those are pretty substantial, especially the SGL2 inhibitors for patients with more advanced disease and with proteinuria. Those advancements are the first, I think in this space, probably going back to ACE inhibitors and angiotensin receptor blockers, which is 15 to 20 years ago. Now, again, they're indicated for patients who already have disease. I do think for us to really make large strides within this space as we need to move further upstream, identify those patients who have early disease that can be halted or reversed and even further upstream to identify patients who are at risk of developing kidney disease. We do know that kidney disease has, it's not just the diabetes, it's not just hypertension, it's also a lot of patients that develop kidney failure, unfortunately because of genetics and some of those diseases may be open to gene therapy in the future.
Daniel Kraft, MD:
So would you see a world where everyone's sequenced maybe at their corner CVS or before they're even born, where we'll have on the risk profile for the primary care doc or specialist, their sort of renal risk element, and we tune their prevention screening in different ways as well as picking the right drug based on pharmacogenomics, et cetera. We're still often in a one size fits all therapy mode. How do we move it to more precision prevention and treatment?
Bruce Culleton, MD:
The technology in this space has advanced so much even in the last five years. I think we will get to a point where you can actually be more precise and personalized with the care that's delivered to a patient based upon their genetic profile.
Daniel Kraft, MD:
Genetics, proteome, microbiome, all those might play a role in what, what's most appropriate. And that brings us down maybe back to the pharmacy or specialty pharmacy level. Are we seeing the role or the pharmacist and the specialty pharmacy change in relation to CKD and what happens to patients who might need to travel a lot for work and can't be tied to one facility or pharmacy?
Bruce Culleton, MD:
Let me just talk about the pharmacist for a second. Do you know the most trusted health care provider is the pharmacist and at that point of engagement with the pharmacist, the patient is actually engaged in their health. So we are actually running a pilot on patients who have kidney disease in the Austin market where we've got our pharmacist more engaged in patients who come in to pick up their kidney medicines. And that pharmacist has been trained to actually provide more in-depth education to the patient around their kidney disease. I think that's just one example. We're a national provider from a pharmacy perspective, so there are ways for patients to get their medications when they travel again using the CVS equipment.
Daniel Kraft, MD:
Given that CVS and Aetna and beyond, you have such a level of deep data and longitudinal wise. We also know that some CKD can be caused from nephrotoxicity. Are you seeing some new signals from the noise that are going to help identify and prevent problems? Because in many cases you end up with CKD from non-genetic causes or not from classic diabetes or hypertension.
Bruce Culleton, MD:
There is an opportunity, we've been working with ActiveHealth, a company inside of Aetna on a kidney disease care management program to identify gaps in care in those CKD patients. Some of those gaps in care are related to pharmacy claims and some of it's related to what drugs they're on and some of it's related to what drugs they're not on. And we communicate those gaps back to providers. But an example would be a patient who's got advanced kidney disease, who's still on metformin. Metformin has a black box warning for use in patients with advanced kidney disease. We still see that and we communicate that out to the provider to ensure that the patient comes off metformin. We do the same for nephrotoxic patients.
Daniel Kraft, MD:
In terms of picking up CKD earlier or managing it, what about the other modalities that might support a patient with CKD, whether it's home potassium or other labs? Are you seeing any exciting shifts or elements that might help the continuum of care in different locations?
Bruce Culleton, MD:
Maybe I'll talk about what I think is a gap in care in diagnostics. I do know we've made some advancements in detecting albumin in patients urine, using smartphones to scan dipsticks at home and makes it easier for patients, but we still don't have a really accurate measure of kidney function. The current measurement is largely based upon someone's serum creatinine measurement, which is converted into an estimation of glomerular filtration using other variables in demographic variables or other lab variables. There's still a lot of within patient variability within EGFR measurements, and that often creates some confusion around, is a patient in stage three? How come they're in stage three today and they're in stage four now, and now they're back in the stage three? There's, I think, a real need for us to get to a better place where there's a lower cost, a better measure of kidney function. I'm not aware of anything that's coming soon, but just highlighting that as a gap from a diagnostic perspective.
Daniel Kraft, MD:
Thank you for joining us in Healthy Conversations, lots of activity in the kidney space, particularly with CKD, and thanks for the work that you and your team are doing to keep improving that for all our patients and across the healthcare paradigm.