Mahesh Krishnan on ESRD policy reform, funding innovation, and the evolution of kidney care delivery

"Ultimately, this journey shaped my belief that to drive real change in care delivery, you need to work on the system level, influencing policy, clinical protocols, and innovation."

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Oct 08, 2024

Dear fellow explorers,

Welcome to our second Q&A in a series of collaborations with Dr. Janis Naeve, a scientist-turned-venture capitalist who has backed companies across the lifecycle in life sciences and kidney disease. Having served in leadership roles at Amgen Ventures, Cota Capital, and KidneyX, and on the Board at companies like Algen Bio, Mission Bio, Excision Bio, Probius, and CellFE, we’re lucky to have Janis as our guide into the fascinating and groundbreaking world of biopharma, biotech, and life sciences.

As always, thank you for being here and for being part of this conversation. If this interview, topic, or format resonates with you, we’d love to hear from you in the comments below. Keep exploring.

— Tim

Meet Mahesh Krishnan

Mahesh Krishnan is Group VP at DaVita. He co-leads the DaVita Venture Group, DaVita’s external innovation arm. He also oversees the clinical aspects of DaVita’s pharma strategy and implementation function, and oversees parts of public policy in DC. Most recently, he served as DaVita’s first international chief medical officer where he oversaw DaVita’s growth to 250 clinics in 10 countries. Prior to that, he served as the medical head of DaVita Clinical Research. He has a passion for service design to improve the quality, efficiency and effectiveness of healthcare delivery at scale.

Before joining DaVita, Dr. Krishnan served as medical director for Epogen® at Amgen, the head of global health economics and outcomes research for nephrology and the medical policy lead for all Amgen US products. Prior to that, he was in practice of nephrology in Northern Virginia for nearly five years. He has served on editorial boards, has written three books and has more than 70 peer-reviewed publications. Dr. Krishnan earned his medical degree from The Jefferson Medical College at Thomas Jefferson University. He also holds a master's degree in public health from Johns Hopkins University and an MBA in medical services management at the Johns Hopkins Carey School of Business.

Today, Mahesh chairs Kidney Care Partners (KCP), where he advocates for policy reform and innovation in kidney care delivery. His journey — from clinical practice to global leadership, and his focus on aligning policy, funding, and innovation in nephrology — is the core of our conversation today.

What you’ll learn today

Can you tell us about your career journey and how it has shaped your approach to care delivery in nephrology?

MK: For me, kidney care is quite personal. My grandmother was on dialysis, so when I think of a patient, it’s not an abstract concept. I picture her in the chair, and that personal connection influences everything I do. Every patient is somebody’s grandmother, grandfather, sibling, spouse or child. That’s a responsibility I take very seriously.

I went into nephrology because I valued the patient relationship, and it was the perfect blend of primary care familiarity with the technical skill needed to manage transplant or dialysis patients. I spent five years in practice before experiencing burnout. I had this passion to improve care for every patient as if they were my own family, but I realized my sphere of influence was limited. I tried taking on Herculean projects, like implementing an EMR system—literally wiring the cables myself—and I found that I couldn’t fix the healthcare system alone.

That realization led me to shift my focus. After spending five years at Amgen as the Epogen medical director, where I also served as the Global Health Economics director for all nephrology products and the global medical policy lead for Amgen’s domestic portfolio, I gained extensive experience in retrospective research, public policy, and large-scale nephrology programs. During that time, I worked on several initiatives like DOPPS and other projects aimed at improving the care of ESRD patients.

However, I missed the direct patient services side of care, which led me to transition to DaVita, a comprehensive kidney care provider. At DaVita, I spent five years as the clinical head of DaVita Clinical Research, which is a site management organization involved in pharmaceutical, device, and diagnostics trials. One of the initiatives I’m proud of during this time was our effort to establish a biorepository for personalized medicine in end-stage renal disease (ESRD) patients.

I then had the opportunity to serve as the founding International Chief Medical Officer at DaVita. During this period, we built over 240 clinics in 13 countries, from Saudi Arabia to Malaysia. My focus was on improving the quality of care at the national level, which required adapting care models to each country’s unique challenges and opportunities to best serve the individual needs of each population. I’m proud of the significant improvements we achieved in patient care and clinician support across these countries.

More recently, I’ve shifted my focus to innovation. I helped launch the DaVita Venture Group, DaVita’s growth and innovation arm focused on improving the holistic care experience beyond the kidneys. There, I’ve been proud to be part of any number of innovations that have helped patients, which include new approaches to home dialysis, digital patient engagement, xenotransplantation and new pharmaceuticals. Public policy has always been a central focus of my career, from my time at Amgen to now, and I currently serve as chair of Kidney Care Partners. Additionally, I continue to work on implementing clinical protocols and new drugs within DaVita’s system, ensuring that changes align with patient needs and that innovation is effectively integrated into the care model.

Ultimately, this journey shaped my belief that to drive real change in care delivery, you need to work on the system level, influencing policy, clinical protocols, and innovation.

You’ve had leadership roles at Amgen and DaVita. What motivated your move from Amgen, and how did it influence your path forward?

MK: I had a fantastic experience at Amgen. The leadership there, particularly my general manager at the time, also a physician, was deeply committed to patient care. When hurricanes hit New Orleans, in addition to financial contributions to organizations like the Red Cross, we mobilized resources—Epogen blankets, Neupogen hand sanitizers and got them to patients—far beyond what was expected. That dedication to patient care was central to everything we did.

But as the company grew and I transitioned from Thousand Oaks to Washington, D.C., I started to feel disconnected from the direct impact on patients. My whole goal in life is to improve care for patients, and I was too far removed from that. I began to miss that hands-on involvement and the ability to directly influence care delivery. That’s why the opportunity at DaVita was so appealing. They were aligned with my mission to improve patient care, and it brought me back closer to the delivery of services, where I felt I could have a more immediate and meaningful impact.

The move from pharma to care services was a big shift, but it allowed me to tackle care delivery challenges at scale, both in the U.S. and internationally. It also introduced me to the policy side of healthcare, which has been central to my work ever since. In hindsight, leaving Amgen helped me refocus on the direct relationship between innovation, policy, and patient care.

How does your role as chair of Kidney Care Partners (KCP) align with your priorities around innovation?

MK: At KCP, we’re all about improving the quality of care for kidney patients. Innovation plays a huge role in that. It’s not just about technology; it’s about rethinking how we deliver care, how we engage patients, and how we address systemic issues like payment models.

One of the key priorities is reforming the way we approach kidney care from a reimbursement perspective. The bundled payment system, for example, was revolutionary when it was introduced, but it needs to evolve. We need payment models that ensure dialysis services are paid reasonably, incentivize better outcomes and encourage the adoption of new therapies and technologies that can help patients. In that context, innovation can’t happen in a vacuum; it needs to be supported by policies and incentives that drive progress.

KCP also advocates for policies that make it easier for innovations to be integrated into the care continuum. Whether it’s home dialysis technology, better diagnostics, or advances in transplantation, we need a healthcare system that’s ready to embrace and scale these innovations.1

Find the full press release at kidneycarepartners.org

For many, policy can seem like a ‘black box.’ Can you walk us through the process of affecting change in healthcare policy, particularly in nephrology?

MK: Policy can definitely feel like a black box, but it’s actually quite systematic once you understand the players and the timelines. The first thing to understand is that change takes time, and it requires coordination between multiple stakeholders—Congress, regulatory bodies like CMS, patient advocacy groups, and healthcare providers.

For example, if you want to influence Medicare policy, you need to work closely with the Centers for Medicare & Medicaid Services (CMS). CMS has a defined process for reviewing and updating policies, which typically involves rulemaking, public comments, and consultations with experts. It’s a long process—sometimes years—but it’s necessary to ensure that any policy change is thoughtful and takes into account the perspectives of all stakeholders.

On the legislative side, working with Congress can also be slow but effective if done strategically. KCP has worked hard to build relationships on Capitol Hill and advocate for kidney care reform. Sometimes it’s about pushing for incremental changes, like adjusting payment models or increasing funding for research. Other times, it’s about making a case for more transformative changes, such as creating new policies that support innovation in care delivery.

The key is persistence. Policy changes don’t happen overnight, but with the right coalition of advocates, including patients, you can make meaningful progress.

Example of policy changes with timeline of CMS incentivizes for the use of home therapies. Credit: Baxter

What advice would you give to policymakers or industry leaders to accelerate progress in kidney care?

MK: My advice is to focus on aligning incentives with outcomes. Right now, the system is focused on the rigidly defined confines of the bundle payment system, and that expense is capped legislatively to 98% of 2008 expenses. Essentially a cost containment model. We need to shift toward a model that rewards keeping patients healthy and out of the hospital. The world is moving toward value based, larger outcomes focused care delivery. So we in Kidney care need to move in that direction as well. I think that is very doable. If we focus on doing that for patients, then that naturally aligns with all sectors— healthcare providers, pharma, tech companies, and patient advocacy groups. Together, we can create a more patient-centered, innovative approach to kidney care.2

What do you think are the most urgent unmet needs in nephrology right now?

MK: The most urgent need is early detection and intervention. Far too many patients are diagnosed with kidney disease when it's already at an advanced stage. That results in missed opportunities to slow down the progression of kidney disease and patients crashing into dialysis. We need better screening tools, more awareness, and a stronger emphasis on preventive care. One way we are working to address this need at DaVita is through seamless care integration across the care continuum, from slowing progression of kidney disease through helping support transplantation and with an emphasis on optimal dialysis starts.

Additionally, there’s a huge need for more research and development into therapies that can slow or stop the progression of chronic kidney disease, as well as therapies that could successfully address the large number of comorbidities that result in hospitalization for later stage patients.

What are the current funding gaps in nephrology innovation, and how can we address them?

MK: One of the biggest challenges in nephrology is the lack of sufficient funding for innovation, especially for early-stage research. While there is a lot of insurance expense for dialysis treatments and basic care—the upstream investment in breakthrough therapies is disproportionately difficult in late stage kidney disease. As a result, our patients are unable to access new diagnostic tools, and technologies that can fundamentally change the patient experience.

The current payment models don’t incentivize investment in innovation. And that’s unique to late stage kidney disease patients. For example, it’s hard for companies to develop new drugs or devices for kidney disease when the reimbursement structure isn’t set up to reward their adoption. As a result, investors and innovators would rather look at other sectors of healthcare that reward innovation such as oncology or cardiovascular disease. Which means that our patients fall further and further behind their non-renal peers. There’s also a gap in funding for preventive care. As a society, we spend so much on dialysis and end-stage renal disease, but very little on interventions to detect and slow early kidney disease or even prevent it altogether.

To address these gaps, we need a multi-pronged approach. First, we need more public-private partnerships to fund early-stage innovation. Second, we need to reform payment models to ensure that innovations—whether they’re drugs, devices, diagnostics or digital tools—are not only reimbursed on parity with other disease states but also incentivized. And finally, we need to involve more patients in the conversation, ensuring that the innovations being developed actually meet their needs and improve their quality of life.

Where do patients fit into the conversation when making the case for innovation in kidney care?

MK: Patients are central to everything we do at KCP and at DaVita. It’s easy to get caught up in technology or policy discussions, but at the end of the day, innovation should be about improving patient outcomes and their quality of life. We often say in nephrology that the patients are the ones who bear the real burden—whether it's multiple dialysis sessions per week, the limited treatment options, or the complex transplant process.

Involving patients in these conversations is critical, especially when we’re advocating for policy changes or new innovations. Patient advocacy groups play a major role here. At KCP, we work closely with organizations that represent patients because they bring the real-world perspective that’s often missing from the technical discussions.

Innovation in kidney care must be patient-centered. Whether it’s designing a new device or developing a digital health tool, we need to ask, “How does this improve the patient’s experience? How does it make their life easier, healthier, or more manageable?” When patients are at the table, they can help guide the direction of that innovation, ensuring it aligns with their needs.

What types of innovation do you foresee for patients with kidney disease, and what barriers need to be addressed to achieve them?

MK: There are several exciting innovations on the horizon for kidney care. Digital health, in particular, has enormous potential. Remote monitoring, telehealth, and wearable devices could help patients manage their conditions from home, reducing the need for frequent hospital visits. Imagine a future where dialysis could be managed remotely, or even from a patient’s home, with real-time data shared with their care team.

Another area is personalized medicine. We’re getting closer to a world where treatments are tailored to an individual’s needs. In nephrology, this could mean more precise interventions that slow the progression of kidney disease or prevent it altogether or renal replacement therapies that are tailored to each individual patient. Advances in artificial intelligence could help us better predict which patients need what now, and then allow us to deploy customized treatment options.

However, there are barriers to achieving these innovations. The biggest challenge is the current ESRD payment model, which isn’t set up to incentivize the adoption of new technologies. Another barrier is regulatory. It’s a long and expensive process to bring new therapies and technologies to market, and the hurdles seem much higher for kidney patients than say oncology patients. Lastly, there’s patient and physician awareness and trust. If those groups don’t feel confident in new technologies or therapies, adoption will be slow. We need to ensure that innovation is introduced in a way that builds trust and is accessible to everyone, not just a select few.34

Attempted depiction of the ESRD value chain. The Post Op

What role does personalized care play in the future of kidney care, and how can systems be improved to support it?

MK: Personalized care is the future, not just in nephrology but across healthcare. Every patient is different, and we’re moving toward an era where treatments can be tailored specifically to their biology, lifestyle, and needs. In kidney care, this means moving away from focusing on interventions that are designed for the individual.

For example, we could tailor dialysis prescriptions based on a patient’s real-time health data, or adjust medication regimens according to their genetic profile. We’re already seeing the impact of personalized medicine in oncology, and I believe nephrology is the next frontier.

To support this shift, we need better diagnostic tools, more comprehensive patient data, and a healthcare infrastructure that allows for flexible, patient-specific care. Right now, our payment and care models are built around standardized costs, which makes it difficult to implement personalized approaches. We also need to train clinicians to think differently about care—encouraging them to use data and new technologies to offer more individualized treatments.

But the potential here is huge. Personalized care could not only improve outcomes but also make kidney disease management more efficient and less burdensome for patients. It’s about making care fit the patient, rather than forcing the patient to fit the care.

What final thoughts or takeaways would you like our audience to leave with?

MK: At the end of the day, everything we do should come back to improving the lives of patients. Whether it's innovation in technology, policy reform, or the way care is delivered, the patient experience has to be at the center of it all. And that’s the type of care we’d want if it was our loved one receiving that treatment. We have an opportunity right now to rethink how we approach kidney care—through earlier interventions, personalized treatments, and policies that incentivize better outcomes.

It’s a complex system, but if we understand how healthcare is financed, we can predict how it will be organized and delivered. We have to align those financial incentives with the best possible patient care. That’s how we’ll make real, lasting change in nephrology.

Keep Exploring

We put together a few resources based on topics covered in our Q&A, then asked Mahesh to include a few of his recommendations as well. Enjoy!

Mind the gap in kidney care: translating what we know into what we do. Historically, it takes an average of 17 years to move new treatments from clinical evidence to daily practice. Given the highly effective treatments now available to prevent or delay kidney disease onset and progression, this is far too long. The time is now to narrow the gap between what we know and what we do. A paper published for the World Kidney Day joint steering committee discusses how systemic barriers must be acknowledged so that sustainable solutions are developed and implemented without further delay.
Medtronic, DaVita launch Mozarc Medical, aimed at introducing new solutions for patients with kidney failure: Central to the creation of Mozarc Medical is its global workforce, which includes the former Medtronic Renal Care Solutions (RCS) business (now part of Mozarc Medical) and other industry-leading talent hired to advance the new company's strategic mission. “Mozarc Medical's focus will be on meaningful and innovative kidney health technologies that improve the overall patient experience and increase access to care globally," said Ven Manda, CEO of Mozarc Medical. "At a time when patient preferences are evolving and in-home kidney care is on the rise, Mozarc Medical is uniquely positioned to better serve patients with kidney disease around the world."
Kidney Care Partners (KCP): Through its work with policymakers, Kidney Care Partners (KCP) advocates for policies that improve the coordination of care and the understanding of chronic kidney disease (CKD), lower the barriers that block patients from accessing and choosing treatments, expand and enhance research efforts, and that reform the economics underlying the kidney care landscape so that financial incentives are aligned with patient goals.
New chair of Kidney Care Partners discusses goals for 2024: In an interview from March of 2024, Mahesh outlined KCP’s priorities for the year, which included restoring patient choice under the Medicare Secondary Payer Act; securing appropriate reimbursement for innovative products; ensuring appropriate coverage and reimbursement under Medicare Advantage (MA); and addressing inclusion of oral-only drugs in the ESRD Prospective Payment System (PPS) bundle.
The Dialysis Outcomes and Practice Patterns Study (DOPPS) Program: The mission of the DOPPS Program is to improve the experience of patients with kidney disease by identifying links between international variations in clinical practices and outcomes. The studies within the DOPPS Program are designed to identify best practices for treating patients. Started as a hemodialysis study in 1996, the DOPPS has tracked over 120,000 patients on hemodialysis, peritoneal dialysis, and with chronic kidney disease, in over 20 countries.
End Stage Renal Disease (ESRD) Prospective Payment System (PPS): The Social Security Act requires a bundled PPS for renal dialysis services furnished to Medicare beneficiaries for the treatment of ESRD effective January 1, 2011. The ESRD PPS provides a patient-level and facility-level adjusted per treatment (dialysis) payment to ESRD facilities for renal dialysis services provided in an ESRD facility or in a beneficiary’s home. The bundled per treatment payment includes drugs, laboratory services, supplies and capital-related costs related to furnishing maintenance dialysis. The ESRD PPS provides a training add-on for home and self-dialysis modalities and additional payment for high cost outliers when there are unusual variations in the type or amount of specific medically necessary care, when applicable.
ESRD PPS Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES): The intent of the TPNIES is to facilitate beneficiary access to certain qualifying, new and innovative renal dialysis equipment and supplies by providing an add-on payment adjustment to support ESRD facilities in the uptake of new and innovative equipment and supplies under the ESRD PPS (see above). Only one company, Outset Medical, has received TPNIES approval from CMS.
ESRD PPS Transitional Drug Add-on Payment Adjustment: The TDAPA is a payment adjustment under the ESRD PPS for certain new renal dialysis drugs and biological products. For new renal dialysis drugs and biological products that fall into an existing ESRD PPS functional category, the TDAPA helps ESRD facilities to incorporate new drugs and biological products and make appropriate changes in their businesses to adopt such products. For new renal dialysis drugs and biological products that do not fall within an existing ESRD PPS functional category, the TDAPA is a pathway toward a potential base rate modification.
Signals Brief: Protecting Patient Choice—The Ardelyx Lawsuit Against CMS and the Fight For Innovation Beyond The Bundle. To better understand how Mahesh’s comments fit into the broader, current landscape of kidney care, read our recent article on the Ardelyx lawsuit against CMS. Researching and writing this piece was one of my key drivers for reconnecting with Mahesh and better understanding the role of organizations like KCP and DaVita in this equation. For me, this story captures Mahesh’s realization about working at the system level to bring about real, lasting change.
The Future is Curvy: Using 5-Year S Curves To Grow and Succeed (TEDx): Have you ever felt the weight of burnout and questioned the impact you could truly make? In his talk, Dr. Mahesh Krishnan addresses this pivotal moment, unveiling a transformative 5-year plan that propelled him from physician burnout to an actionable journey. He believes that a new form of the clinician triple threat, expert in individual patient care, population health and the business of medicine, is the exact specialist needed to treat our ailing healthcare system.