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March 11, 2024
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New chair of Kidney Care Partners discusses goals for 2024

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Healio | Nephrology News & Issues recently interviewed Mahesh Krishnan, MD, MPH, MBA, the new chair of Kidney Care Partners, about goals for the advocacy group in the coming year.

Healio | Nephrology News & Issues: What do you bring to the table as the new chair of Kidney Care Partners (KCP)?

Mahesh Krishnan

Mahesh Krishnan, MD, MPH, MBA: During the years, I have developed a deep understanding of legislative and regulatory processes. I believe that, through thoughtful and consensus-driven policies, we can achieve transformational improvements for the nation’s kidney care delivery system and the patients it serves. That is my goal as chair of KCP.

My work is personal to me, as my grandmother had chronic kidney disease and she went on dialysis when her disease progressed to kidney failure. Her difficult experience drives my passion for improving care, helping people avoid CKD or slow its progression and creating the best care system possible for end-stage kidney disease patients, including transplantation and choice of dialysis care.

Healio | Nephrology News & Issues: What were important accomplishments for KCP under past chair John P. Butler?

Mahesh Krishnan, MD, MPH, MBA: John took the helm of KCP in January 2020, right when COVID-19 began to spread, and was a tireless champion and leader for the renal community as we navigated the pandemic. This included meetings with federal policymakers to ensure patients could access vaccines, therapies and essential services. His priority was to minimize and prevent, when possible, disruptions in care.

From the beginning, it was clear that the patients receiving dialysis were particularly vulnerable to COVID-19. John helped the community coalesce and reprioritize as new challenges and barriers arose throughout the pandemic.

John also remains a steadfast advocate for policy changes that expand access to innovation. KCP continues to prioritize reform of the relatively static bundle, which is based on treatment standards from, essentially, the early 1990s. Doing so would provide a sustainable pathway to reimbursement for innovation and consequently, would incentivize research in an area that has seen little support.

Patients on dialysis have not had the same access to innovative treatment options as those living with other chronic conditions. That must change. There is an enormous inequity in the delivery of health care in America, particularly in the treatment of kidney disease, that disproportionately impacts Black and Hispanic people, as the U.S. Renal Data System annual data report continues to document.

A critical part of this effort is to address the lack of meaningful funding in the kidney space. Under John’s leadership, KCP achieved important steps forward through the transitional drug add-on payment adjustment (TDAPA) and transitional add-on payment adjustment for new and innovative equipment (TPNIES). However, the final step in this intermediate solution to the problem has not been achieved. Specifically, KCP continues to advocate for reforms to the post-TDAPA, which has left dialysis facilities without sufficient resources to adopt newer therapies that improve patients’ life quality and outcomes. This is not only unfair to patients with kidney disease but also threatens research and development investment in nephrology by limiting market potential.

Here are some of the priorities you have set for the upcoming year. Share some specifics on some of these goals:

  • restore patient choice under the Medicare Secondary Payer Act;
  • secure appropriate reimbursement for innovative products;
  • ensure appropriate coverage and reimbursement under Medicare Advantage (MA); and
  • address inclusion of oral-only drugs in the ESRD Prospective Payment System (PPS) bundle.

Mahesh Krishnan, MD, MPH, MBA: The Medicare Secondary Payer Act (MSPA) is a great place to start because the Supreme Court’s recent decision in Marietta v. DaVita upended this critical patient protection law that has been on the books for 40 years and served to protect patient and family health coverage. Ensuring all patients with ESKD can access safe, effective care with the coverage of their choice is a priority for our community.

KCP strongly supports H.R. 6860, the Restore Protections for Dialysis Patients Act. This legislation would prevent discrimination against patients with kidney failure by restoring the protections Congress originally intended under the MSPA. It would ensure patients, and, importantly, their families can access dialysis and other preventive and acute care services via their private insurance throughout the statutory 30-month coordination period. We are seeing more Congressional support for H.R. 6860 each week, and I look forward to continuing to collaborate with policymakers and patients to advance this bill.

I alluded earlier to reforms needed to expand access to innovations, but the sad truth is that, under our current payment system, this is not happening. While there have been modest adjustments to the cost of the per-treatment payment bundle since its inception in 2011, it has become obvious that the costs of providing that care have increased faster than those adjustments. And what is included reflects an outdated standard of treatment.

While the Transitional Add-on Payment Adjustment (TDAPA) may have been created to adjust for new products and therapies, as the real-world “rubber meets the road” once TDAPA or the Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES) end, CMS essentially returns reimbursement to the pre-TDAPA/TPNIES amount. This policy creates a barrier to innovation for this group of providers, for whom MedPAC projects a zero margin in 2024. That is problematic for today’s patients on ESKD and has long-term consequences for investment in the kidney space.

We already see that the United States spends significantly less on nephrology research than in areas like oncology or chronic pain because there is essentially no market pathway under current policy. And we see that this reimbursement system has had a chilling impact on the number of new drugs being developed for patients with ESKD. Investors and innovators cite the lack of payment for innovation as the predominant reason for not investing in our space.

Not only are we seeing that payment is often insufficient, but the policy itself can create additional challenges for providers and patients rather than incentivizing improvements in care. The proposal to include oral-only phosphate-lowering drugs in the bundle beginning in January 2025 is just one example. The variation from patient to patient and the method of administration of these drugs, which are taken with meals, makes adequately reimbursing these medications through the bundle process particularly challenging. In addition, because patients who require these therapies must have ready access to multiple pills per day inside and outside the dialysis clinic, there are significant medication adherence burdens, operational hurdles and costs for facilities. While KCP is advocating, at minimum, for a delay in the implementation of this policy, these challenges also speak to the broader need for payment reform.

When thinking about the future of kidney care, you cannot leave out MA. Since 2021, when Congress allowed patients with ESKD the same access rights to MA as their peers without kidney failure, the number of beneficiaries with ESKD electing an MA plan has grown dramatically. While many see additional benefits or lower cost-sharing, there can be some downsides for those with ESKD that may not be immediately apparent when considering enrollment. We are focused on network adequacy to ensure ESKD patients have access to the dialysis care they need, regardless of where they live or which plan they choose.

Outpatient dialysis care has succeeded in the United States because it has consistently met patients where they are, in convenient outpatient settings instead of hospitals or in their own homes with proper training and support. We are concerned that insufficient provider networks offered by some MA plans may erode this important convenience for dialysis services, which require patients to undergo physically draining treatments multiple hours a day, at least three times per week.

Further, access to innovations can also be an issue with MA, which is often an unreliable partner to dialysis facilities concerning the timely provision of payment for new drugs or technologies in the TDAPA and TPNIES periods. We believe access to care should be addressed regardless of a patient’s Medicare coverage choice and, of course, we need to ensure that regardless of payer, we continue robust data collection and surveillance under the U.S. Renal Data System.

For MA and fee-for-service (FFS) Medicare, so much is determined by the PPS. Right now, that system will remain aged, underfunded and unsustainable as long as we fail to account for mounting labor costs and the actual cost of delivering care. This community, including policymakers, need to start thinking about where and what reforms can ensure solvency, equity and quality of care to help in the fight against kidney disease.

Healio | Nephrology News & Issues: What are the key factors in improving quality measures for evaluating kidney care?

Mahesh Krishnan, MD, MPH, MBA: In a word, harmonization. We have many different quality measurement systems today – the Quality Incentive Program (QIP), 5-star, Dialysis Facility Compare and individual ESKD Network programs – along with physician measures. Other elements of the kidney ecosystem, like transplant, have their own measures.

Believe it or not, many of these are not harmonized across settings. Harmonization is key to reducing burden, fatigue and waste in health care settings. One promising first step to achieving this goal is to implement digital quality measures, which can accurately capture real-world data.

We also need an aligned program that focuses on measures that matter. There are so many measures in the ESRD QIP today that critical metrics, like reducing the use of catheters, are reduced to a level that makes the entire program almost meaningless. We have sought to work with CMS during the last several years to refocus the various quality programs so that they are patient-centric and actionable.

Healio | Nephrology News & Issues: One of your goals for this coming year is to increase the use of “patient centric” care. How do you define that process?

Mahesh Krishnan, MD, MPH, MBA: Patient centric, in this case, is quite literal. We need to evaluate everything we are trying to do through the experience of the patient. That means ensuring that patient-reported outcomes align with shared decision-making and that patients can access quality care under whatever coverage they determine is best for them – whether that is private coverage, MA, Medicare FFS or the new integrated care models.

It means that patients have access to innovative new products and services that allow them to improve or maintain their quality of life while receiving treatments.

Healio | Nephrology News & Issues: What can KCP do to help remove barriers for those living with ESKD seeking a kidney transplant? What is the role of CMS and Medicare here as well?

Mahesh Krishnan, MD, MPH, MBA: Transplant is the ideal treatment for someone with ESKD and is the only cure for kidney failure. Unfortunately, several barriers – not the least of which is organ availability – often make it difficult for a patient to receive one. The government has rightly focused much attention on these issues in recent years through efforts to address federal organ procurement contracts, logistics and the need for quality metrics. Members of the kidney community are already asking policy questions about future transplant innovations, such as greater financial and social support to encourage living donors and xenotransplantation. KCP has created a transplant workgroup to help us evolve existing KCP positions and develop new ones. It is the first time we have done that, so I am excited to see that effort underway.

Healio | Nephrology News & Issues: With KCP’s diverse membership, how do you achieve consensus on an agenda aimed at improving kidney care?

Mahesh Krishnan, MD, MPH, MBA: KCP is not known as a single-issue coalition by Congress or the administration. We also ground our thinking in what is right for the patient. Our four priority areas reflect that overarching goal. Plain and simple, we are a consensus-based organization that strives to support efficient and effective policy changes that improve patient lives. If healthy differences of opinion emerge, as can often occur in coalitions, we welcome the debate and ultimately settle the issue, in every case, in the best interest of the patient.