Kidney failure is a life-altering condition affecting approximately 800,000 Americans, forcing over 550,000 of them to depend on dialysis for survival by replacing the role of the kidney and removing many of the toxins from their body. As part of this vital treatment, patients typically spend three to four hours at a dialysis center, three times a week. These sessions are incredibly taxing for patients and caregivers, both physically and mentally. Unfortunately, dialysis doesn’t remove enough phosphorus from the blood for most patients. As a result, approximately 80% of patients develop a condition called hyperphosphatemia (HP), which increases the risk of heart disease, stroke, and even death. Managing phosphorus levels is one of the hardest challenges kidney patients face every day.
Kidney patients manage their phosphorus levels with a mix of diet, dialysis, and medications called phosphate-lowering therapies (PLTs), which are essential to lowering phosphorus levels. However, managing phosphorus can be complicated and requires persistent monitoring and evaluation to provide the best possible outcomes. Now, a Medicare policy change could make it harder for patients to get the medications they need.
I have spent decades of my career working to develop the most effective and innovative treatments for patients with many diseases, including chronic kidney disease. Along with many of my colleagues who work with kidney patients, I am seriously concerned about the Centers for Medicare and Medicaid Services (CMS) current course of action pertaining to coverage for PLTs.
The issue started with Medicare’s decision in 2011 to include oral-only medications, including PLTs, in the End State Renal Disease bundled payment system, also known as the “ESRD bundle.” This bundled system aims to help CMS manage the costs associated with dialysis services, efficiently and effectively, by covering dialysis services, staffing, tests, equipment, and injectable medications in a single per patient, per session payment directly to dialysis providers. However, evidence from past novel therapies entering the ESRD bundle demonstrate that if oral-only PLTs are in the ESRD bundle, patient access to these critically important medications will severely restricted and patients’ health may be at risk. Phosphate lowering therapies should not be included in the ESRD bundle payment system, and Congress has recognized the need to protect patient access to these important medications three times in the past by blocking CMS’s plan to include oral-only PLTs in the ESRD bundle. Unfortunately for patients, the current law will expire on December 31, 2024. If Congress doesn’t act again, oral-only PLTs will be included in the ESRD bundle starting January 1, 2025 and patient access to important medicines will be at risk.
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The upcoming Medicare changes could jeopardize access to these essential medications, putting millions of patients on maintenance dialysis with HP at risk. Starting January 1, 2025, providers may be forced to exclude certain PLTs from their treatment options, leading to protocolized care that ignores individual needs and removes the shared patient-provider decision making often required to address complex medical issues. Patients would also face hurdles in obtaining medication, having to go through dialysis centers instead of their local pharmacies, who will face significant challenges to facilitate the delivery of oral medications that patients take at home.
Black and Hispanic communities are already hit hardest by kidney disease, and they are likely to suffer the most from this Medicare change. Black patients are 4.2 times more likely, and Hispanic patients are 1.3 times more likely to develop kidney failure than white patients. Around 60% of people on dialysis are from Black and Hispanic communities, where factors like access to healthcare and healthy food make managing kidney disease even harder. Many of these patients live in food deserts, where access to fresh, healthy food is limited. The affordable, prepackaged foods they can find are often high in phosphorus, making it much harder to manage their phosphorus levels through diet alone.
We’ve seen the potential negative effects of similar changes in the past. When CMS added other medications to the ESRD payment system, patients faced significant challenges accessing newer, more effective treatments. In 2021, CMS included calcimimetics, a medication for treating secondary hyperparathyroidism in patients with kidney disease, in the ESRD bundle. Both during and particularly at the end of the initial rollout period (also known as the transitional drug add-on payment adjustment or TDAPA period), patients struggled to access a more effective, innovative therapy that had more recently gained FDA approval. Research indicates that once these drugs were actually included in the bundle, utilization of the more effective, more innovative drug decreased sharply, which subsequently led to poorer health outcomes, disproportionately affecting Black patients. Ultimately, patients faced significant barriers to appropriate care due to the financial strain that bundled payments placed on many dialysis facilities. The impact on this patient population was highlighted in recent study that was published in the peer-reviewed medical journal, CJASN1.
CMS issued its final rule on implementing this new coverage change earlier in November, and, unfortunately, they intend to repeat the same flawed transition process used for calcimimetics—this time on an even shorter timeline. Fortunately, many members of Congress have recognized this issue and proposed the Kidney PATIENT Act (H.R. 5074/S.4510) to delay CMS’s plan once again. It is crucial for Congress to pass this bill to protect the progress made in kidney care and ensure every patient has access to the treatments they need for a healthy life. Without intervention, providers will face impossible decisions, and the most vulnerable patients will suffer the consequences.
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Kidney patients need your voice. Write to your representative today and urge them to support the Kidney PATIENT Act. This bill will help protect access to life-saving treatments for millions of people with kidney disease. Your letter can make a difference!
The patients are waiting…
Reference: 1. Karaboyas A. et al. Clin J Am Soc Nephrol. 2024 Oct 8. doi: 10.2215/CJN.0000000583.
Dr. Laura A. Williams, MD, MPH, has served as the Chief Medical Officer at Ardelyx since 2021. Prior to that role, she was Senior Vice President of Global Therapeutic Strategies and Patient Advocacy at Ardelyx. With over 25 years in the pharmaceutical industry, Dr. Williams has extensive experience as a pharmaceutical drug developer, healthcare policy advisor, patient advocate, and portfolio strategist.
