Patients with end-stage renal disease (ESRD) face enough hardships. In addition to undergoing multiple, hours-long dialysis sessions each week, they are particularly susceptible to many dangerous health conditions associated with kidney failure.
A condition known as hyperphosphatemia (excess levels of phosphate) is among the most common and life-threatening. If not controlled, this can cause calcium deposits in blood vessels and lead to heart attacks, strokes and even death.
Fortunately, doctors can prescribe medications to control this condition, but pending changes by the government may make it more difficult for patients to access these drugs.
Right now, Medicare-eligible patients can get these phosphate-lowering therapies, or PLTs, quite easily at the pharmacy with a prescription from their physician and coverage through the Medicare Part D prescription drug program. Congress, over the years, has passed legislation to protect this lifeline. But with that law expiring, there is an expectation that the Centers for Medicare and Medicaid Services will move these drugs into what is known as a “bundle” of services along with dialysis treatment and other necessities for ESRD patients that healthcare providers must manage for a fixed fee from Medicare. Doing this will be a huge disservice to these men and women already dealing with serious illness.
If this change occurs, we predict medical decisions will transform into just financial decisions, jeopardizing patients’ quality of care. Dialysis providers who must work within the Medicare payment bundle for ESRD cases are already finding their financial resources allocated by the government stretched thin. Now, they may be asked to distribute PLTs as well. This could result in decisions to keep patients on older and cheaper therapies that may not be the best, most effective therapy for the individual patient, thereby preventing access to newer, innovative treatments. This change will also likely result in a stifling of innovation, resulting in new therapies not being developed.
More broadly, the government would be forcing sick patients from a trusted model in which they work with their doctors and pharmacists to do what’s best for their health into an unfamiliar — but increasingly common — environment governed by strict bureaucratic protocols. And dialysis providers, many of them small operations in rural areas, will be asked to start stocking and distributing drugs with which they have had little or no familiarity.
I am particularly concerned about how this regulatory change will exacerbate already problematic health disparities in this country. Chronic kidney disease disproportionately affects Black, Hispanic and low-income patients. Today, they can benefit from the improvements Congress and the administration have made to the Medicare Part D program. They can take advantage of the statutory cap on out-of-pocket spending and, for those in the catastrophic phase of prescription drug purchasing, absolutely no cost-sharing requirements. Patients stand to lose these advantages and, possibly, see their dialysis costs rise as the presence of PLTs in the Medicare “bundle” creates new financial strains.
In addition, some patients already face hurdles in getting what they need nutritionally to keep their phosphorus levels in check. Restricting access to PLTs adds an additional burden for rural Americans and low-income patients who face food insecurity challenges and live in “food deserts.” Furthermore, linking dialysis sessions and PLTs does not make logistical sense. PLT users are supposed to accompany their daily medicine with healthy meals and snacks, not with the dialysis session. Eating is prohibited during dialysis and food is often not allowed inside dialysis centers.
As a physician and a former member of Congress, this planned Medicare change concerns me. Federal health programs aim to provide access to quality healthcare for our most vulnerable citizens and those who have paid taxes into the system their entire working lives. This does the opposite — patients will have more difficulty getting phosphate-lowering therapies and could see an increased rate of comorbidities in the form of cardiac and neurovascular events.
We still have time to avoid putting end-stage renal patients through this. I applaud Representatives Buddy Carter, Ann Kuster, Carol Miller, and Terri Sewell for sponsoring the Kidney PATIENT Act of 2023 (H.R. 5074) and it is my hope that Congress will act soon to pass this legislation or that the Biden administration will act in the best interests of Americans with serious illness and preserve their access to medicines they need. Protecting the well-being of sick patients is of paramount consideration for all of us.
