Transcript:

Welcome to Kidney Health Connections, a podcast exploring the future of kidney health and the rapid shift to value-based care, where you can learn about the latest innovations that are helping patients live healthier, more fulfilling lives. Here's your host, Dr. George Hart.

Dr. George Hart: Hello everyone. In 2019, the U.S. federal government introduced a bold model to reform kidney care in the U.S. The Advancing American Kidney Health Initiative not only restored nephrologist as the cornerstone of kidney care, but it launched the latest value-based payment model for kidney care. The Kidney Care Choices, or KCC, model aims to reduce the cost of kidney care and improve patient outcomes.

We're honored today to have Ellen Lukens, Deputy Director of the Center for Medicare and Medicaid Innovation, who joins us today to discuss why CMS introduced the KCC model and the future of the program. Ellen leads the policy development at CMS Innovation Center and has been instrumental in developing new payment and specialty care models that serve as the foundation of value-based specialty healthcare today.

Ellen, thank you very much for joining us and happy to have you today. I think it would be helpful for this audience if you could just take a minute and maybe really kind of describe the mission of CMMI and what the goals are with these new programs.

Ellen Lukens: Yeah, I'd be happy to. So, as many of you probably know, the CMS Innovation Center, or CMMI, was established as part of the Affordable Care Act. And it was established to test, or essentially pilot, new ways to provide care for Medicare beneficiaries, and there's sort of three statutory requirements that would either improve quality, and maintain costs, improve quality and reduce costs, or reduce costs and maintain quality. So, there's sort of these three outcomes that the Innovation Center was focused on.

Since the inception, we've tested over 50 of these models, and actually in 2021, we sort of hit a reset of what is it that we're doing, where is it that we want to go, and really reset our vision to a health system that achieves equitable outcomes through high quality, affordable, person-centered care. And then we have sort of pillars that support that strategy, one of which is accountable care, which is one of the pillars these kidney care models are nested under. They also help support health equity.

So when we redid that strategy, we ended up talking to a lot of providers, beneficiaries, as well as other stakeholders like states, to really understand where they thought the Innovation Center was doing well and where they were not. So, I think we've really tried to make some changes and improve the models in response to that input.

Dr. George Hart: That's very helpful. Thank you very much. I had an opportunity when I was still in practice to participate in some of the earlier renal focused value-based care models. And I have to say, I appreciate the direction and the expansion of how the clinical care models are going. I mean, value-based care is not a new concept, but how you're applying it now in subspecialty care is a little bit newer. Maybe help us understand what was attractive about the kidney care space and, you know, the focus that you now have on improving care for our patients.

Ellen Lukens: Yeah, that's a great question. I think from our perspective, and in talking with clinicians for particular areas of specialty care, so like kidney care, or for beneficiaries undergoing active chemotherapy, in that case oncologists, specialists often in those cases are really serving, it's what we think of as the quarterback for the patient's care, rather than the primary care physician. So that really presents an opportunity for us to focus on that provider to increase the care coordination and management. So, if you think about value-based care, one of the tenets of value-based care is really to decrease fragmentation and increase coordination. And so we really see the nephrologist as key in being able to do that.

Kidney care also has a unique set of easily identifiable providers. And another characteristic, as you all know, is the Medicare program has a special role for patients with kidney disease, given the eligibility of ESRD beneficiaries under 65 for Medicare. So, you know, in terms of thinking through the lens of what we're trying to solve in these models, and specifically in the kidney space, for KCC, we collaborated with nephrologists, dialysis providers, and the patient community to really think about how is it that we can improve care and where we thought there were current gaps. And so one was really to improve the care for beneficiaries receiving dialysis, another key sort of goal was really to move further upstream in the care continuum to prevent CKD patients from experiencing kidney failure, and another one was to increase transplants.

So I think you've seen a few different models emerging to address these different issues. I will also say, just in closing that I think the nephrology community and the kidney community has been really innovative and really open to partnering with CMS to improve care for its beneficiaries.

Dr. George Hart: I love the concept of the nephrologist being the quarterback, you know, kind of dear to my heart because I do think we have an opportunity in this population to close that fragmented care. So again, really appreciate the direction and the expansion of how the model's going.

We get to talk to a lot of nephrology practices across the country who are participating in the KCC model. Most of the feedback we get is really positive, but it's a little too early maybe to determine if this is really a homerun yet. I think it's at least a double, or a single or a double. What are you hearing from physicians and the value-based care companies?

Ellen Lukens: I'll say most of the feedback we hear from physicians and other organizations participating in these models is that we're headed in the right direction. Practices are generally supportive, and they agree with what we're measuring. There seems to be consensus that going upstream to capture CKD beneficiaries is prudent, and that focusing on the nephrologist is the right thing to do. As you may have seen, we released our first evaluation report on September 19, and that's available on our website for anyone who's interested. And that evaluation report showed positive quality results from this model. The report found statistically significant increases in rates of optimal starts and home dialysis, which are two key outcomes from the model.

But in terms of some highlights, the KCF model option increased the proportion of patients with ESRD dialyzing at home by 20 percent. Both model options increased peritoneal dialysis; KCF was by 26 percent, and CKCC was by 8 percent. The CKCC model option increased optimal ESRD starts by 16 percent, and the KCC model option increased the proportion of patients with an active waitlist status by 15 percent. So as you can hear, there were some really nice quality outcomes that emerged from the evaluation. This was for one year. It was performance year 2022.

In terms of overall impacts on Medicare payments, though, we did not see any effects. So these results, again, are only for one year, but we're hopeful that we'll continue to see these positive quality results in future years.

At the CMS Innovation Center, when we test models, as part of our statutory requirement, as we think about certifying and expanding them nationally, which means that we would actually be able to offer this model nationally — it would be a permanent model — in order to be able to do that, there are three criteria. So one is that the model saves money and improves quality, so it reduces Medicare payments and it improves quality. The second scenario is that it increases quality and is cost neutral. And the third is that it increases both quality and savings.

And so, as you can see in this model, part of the reason we're so encouraged by the evaluation results is that you can see we did improve quality. I've done a few site visits to KCC practices, and something that I find really exciting is when I visited those different practices, there was so much enthusiasm and real belief in how much they were changing quality and improving care for their patients.

And I think one thing that's exciting that they both talked about was optimal ESRD starts. And I think what we've seen is that the data is really showing that. So I think what we were hearing anecdotally on some of those site visits, and my colleagues also did some ones at different locations, is really sort of playing out in the evaluation data.

As you know, when we do our evaluations, generally we have an intervention group that's doing the model and a control group. So sometimes we are surprised to see changes in the control group and the intervention group, in which case maybe there's not as much of a delta or difference. But in this case, it's really exciting to see what some of the practices were telling us is actually being born out in the data.

I think there has been also some concern and frustration with certain model parameters, like the retrospective trend adjustment, I that's been problematic for a lot of folks. So I would say generally the feedback we've had is very, very positive.

Dr. George Hart: I think that's consistent with a lot of what we're finding in our conversations, certainly optimism and hope with the direction of the clinical model, you've brought up the retrospective trend adjustment, obviously some headwinds that nobody was expecting. We've seen one value-based company actually exit the program in part over this. How are you guys viewing this sort of change and was it expected, is it concerning, disappointing?

Ellen Lukens: Yeah, I mean, I think we are always disappointed when we lose a participant because, you know, this is a partnership fundamentally. We have to partner with the providers in order to test these models and really, you know, explore these pilots and understand whether these care management interventions or care models improve care and reduce or maintain spending. So, I think it's not something that we're ever happy about.

I think the other thing that sort of, you know, if you think about the CMS Innovation Center, we have our statutory mandate, and then we have the models, and sometimes marrying those two things can be hard. But one thing is that we are, as you heard, held to a standard in terms of our model performance. And so, in terms of the kidney models, I think that means two things. One is, you know, when we think about our evaluation, we do need sufficient participation to be able to achieve statistical significance so that we have enough participants that if there's a reasonable change, we can actually observe that statistically, because that's how our evaluations are structured.

So I think that, you know, we don't want to lose folks, but we do still have enough to test the model and potentially achieve statistical significance. I think the other thing, though, which is really, if you think about operating in this environment with sort of multiple pressures, we want a permanent pathway for kidney care in the regular Medicare program. And to do that, to achieve what we would call certification for expansion, meaning offering it nationally, this model, we would have to show that it's at least budget neutral.

Dr. George Hart: That totally makes sense. And, you know, I think you can probably empathize with where nephrologists are now. They're playing really four different hands of chess, if you will. We have a mandatory model in play. We have the voluntary model. We have another mandatory model about to roll out that doesn't primarily impact nephrologists, but certainly impacts the patient we care for. Plus, the entire shift of patients from Medicare fee-for-service into Medicare Advantage programs.

CMS has a huge impact on, you know, how all of this rolls out. Any comments or thoughts on the mandatory models? And then, I'm also going to be interested in how you view the role that CMS has and how the private payer side is responding in the MA world.

Ellen Lukens: Yeah, those are two really good questions. So I'm going to talk about the mandatory model first, and then a little bit about the sort of multi-payer aspect of this.

So in terms of thinking of the IOTA model, I know we always have these acronyms, but the IOTA model really came about, and that's the model focused on kidney transplantation. The kidney transplant centers would actually be the participants. We have a proposed rule that was out, and then it'll move to a final rule.

But in terms of the context for that, that was, I would say it came from two different areas. One was that Health and Human Services, as you all are aware, There's the Organ Transplant Affinity Group, or OTAG, and there's really been a strategy to ensure equitable access to organ transplants and improving the accountability for U.S. organ transplantation through payment quality and regulatory efforts. There's really been a huge effort around improving the process, improving outcomes, and really enhancing the number of transplants that take place.

So the IOTA model sort of came partly out of that and also partly out of broad discussions around the kidney care community. So if you think about it, as you were referring to, we had a model, the KCC model, which is where the nephrologist is really taking responsibility for that patient over longitudinally, really, and thinking about how to best manage that patient, and in many cases, really doing a lot of care coordination and care management. And then there was also the ETC model, which is another mandatory model that focused on home dialysis.

And so I think the feeling was, the IOTA model was really filling that gap where it was really focused on the transplant piece and the transplant hospitals rather than the nephrologist. I think, you know, we are still working through the comments and drafting the final rule, so there's not a ton I can say about that now. Just to say that, you know, we believe that covering the entire life cycle of kidney care is really important, so I think that is part of the reason that the IOTA model came out.

The ETC model, the other mandatory model, is around home dialysis. And one thing that's kind of interesting about that model is, as you've probably observed, that does have public evaluation reports out. And as we were just talking about, there's the model participants and then the controls. And what's been interesting is both groups have increased home dialysis pretty dramatically over this time period. So that model, again, is really much more focused on that one piece rather than the sort of broader longitudinal KCC model.

I think your final piece of your question was around multi-payer alignment, like how do we engage with other payers, and, you know, also with Medicare Advantage? And so I think, from our perspective, when we talk to nephrologists, when we talk to folks participating in our models, one thing they are often concerned about is the investment required to participate in the model and also any potential burden with reporting or other things.

And so part of what we try to do is minimize that burden to the extent possible, but they also often work with private payers to try to mimic some of the model design, so that they're not sort of managing against multiple parameters. Now, I know that that is very difficult. We, too, work on our end. I think you've probably seen some of our models coming out as more of a multi-payer approach. That's particularly true where you have a high concentration, like, if you think about our behavioral health model that we're working on with states, that's Medicare and Medicaid. Just to make sure we really have both of those populations, because Medicaid does play such a critical role for that population. So we are working on that, and we are working on thinking about how do we directionally align with other payers, like how do we think about those core elements, not everything being exactly the same, but really trying to align on broad parameters to make it easier for the clinician.

Dr. George Hart: Well, one thing for sure, all of these models coming at the same time are working to create more traction with nephrologists for understanding that they need to shift in how they think, a change in culture, in this movement away from fee-for-service into a more value-based care approach and holistic approach to care. The more traction we get, it's obviously more effective. Easier for nephrologists to kind of operationalize change and culture change and again, you know, take care of patients, because nephrologists want to treat every patient the same way regardless of the payer source. So that's really, I think, important.

Ellen Lukens: what you said is very consistent with what we hear from nephrology practices. So, for example, if they participate in our model, what they're saying is they then sort of enhance the wraparound services for a lot of the patients. So they'll have, maybe for the most complex patients, an assigned care manager or a patient navigator. And then they feel that, you know, they really want this for all their patients — it's like it becomes their care model in the practice..

So I definitely, um, think what you're hearing is very consistent with what we are hearing is that sometimes they're just sort of providing all of these services to all the patients in their practice, even though they're not necessarily getting the revenue from each payer..

Dr. George Hart: Absolutely, I do think there's a halo effect, so we're moving the needle in a positive direction. You briefly mentioned earlier the interest in, you know, kind of level setting access to care for all patients and, you know, addressing and even overcoming some of the inequities that we know are out there. We're seeing social determinative health quality measures now in the CKCC model. Can you help us, you know, or talk to us a little bit more about where CMMI is regarding these initiatives?.

Ellen Lukens: Yeah, absolutely. So we talked a little bit earlier about how we took a step back in 2021 and really did a strategy refresh and thinking about, you know, what is it we want CMMI to look like in the future. And as part of that, as I talked about, we did a lot of interviews and some qualitative work, but we also actually looked at our data, and one thing we looked at was participants in our models, and what we realized is that the participants in our models were predominantly or much more likely to be white and higher income than a typical Medicare beneficiary..

That's problematic for multiple reasons, but I think what we, you know, as we looked at these data, we realized we can't keep offering the exact same things and expect this to change. We really have to be much more thoughtful about how we implement models. So we really took a step back and said, okay, when we design them, when we think about the participants, when we send out requests for applications, all along that continuum, how do we think about engaging a much broader set of providers?.

So an example would be, prior to that time we really had almost no participation from federally qualified health centers, and part of that is because they're paid on a different payment system, so it was a little bit complex to include them. But we realized that that was critical to helping us achieve our health equity goals..

So our newer models that have come out have really incorporated entities like federally qualified health centers into the model design to allow them to participate. And then if you think about sort of the progression of that and how that's moved along, in addition to sort of being the fabric of how we think about the model, we are also asking folks to do health equity plans and collect SDOH data..

And you may know that we actually had a very successful model that ended a little bit ago, the Accountable Health Communities model. And we had, it was a voluntary model where some organizations did health related social needs screening and referral. And I think, you know, at the time when we tested that, people were very skeptical. They said, no one's going to want to be screened. And we found out that people did, were willing to be screened.

And so I think that that was a really helpful model in terms of like establishing a collection mechanism. And then also really thinking about, is this something that can be done? So once we've proved that in concept, we've then added that to many of our models, including KCC, so that we do collect these data. And I think in the future, that will really help us do more robust evaluation and really understand our models better.

One plug, not necessarily related to health equity, is, I don't know if you're aware, but we're actually making our model data now available to researchers. So we're also hoping that academics and, you know, researchers will really start to dig in to the CMMI data because we think there's so much to learn. And we do our evaluation reports, but, you know, we really think we encourage other folks to look at our data because we think really these models do provide so much information. And the more folks that really dig into them, the more we're all going to learn.

Dr. George Hart: I couldn't agree more. For me, at this stage of my career, you know, this is a great time to still be a nephrologist and involved. I think this is one of those periods where we're going to look back 10 and 20 years later and see this as really a period of change that, you know, led to the future and what things can look like.

I love the direction of improving access to care. Certainly, we were struggling in a fee-for-service environment to do some of these things, and I think value-based care applied broadly gives us flexibilities that we didn't currently or previously had.

Put you on the spot: you're in the room where it happens, you're in the seat next to the people that are making these decisions and are part of it all…where's this going? The genie seems to be out of the bottle, and I don't see us putting it back in. What does your crystal ball tell you?

Ellen Lukens: Well, I mean, I know where we want this to go, and I hope that that's clear to the participants that this is a model that we are testing because we want to make something more permanent in the kidney space. And so, we have folks that have come in to help us test it and really understand, like, can we make this work? Can we meet one of those statutory requirements within this model so that we can make this type of more coordinated kidney care available more broadly.

So I think that is our North Star. I think it'll be a couple years before we know if we can do that or not, but that is where we're headed. We really do want to make sure, you know, the kidney space and the nephrologists have really done an incredible job partnering with us, and so now that we're at this KCC part of our journey, I think we're really ready to say, like, how do we make this permanent? How do we make this model work, and how do we make more folks be interested in participating?

Dr. George Hart: We recently asked one of our provider partners about her experience in the KCC model, and her response really stuck with me. She said, “We're in the middle of a major change in our healthcare system.” And she could imagine telling her grandkids, “I was there when it started. I was in the room when it happened.”

Helen, you're in the middle of driving that change, and we so appreciate you taking the time to join us and discuss the shift to value-based kidney care. For those of you listening in, you can find additional resources on the Kidney Care Choices model on our website where we've posted the recording in the transcript of this interview.

For more episodes, subscribe to Kidney Health Connections on the listing app of your choice, or please visit our website at interwellhealth.com.

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