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Posted on July 10, 2019 at 6:47 PM

by Craig Klugman, Ph.D.

Few people would say that the system of payment and organ distribution is perfect. About 37 million Americans suffer from kidney disease and 94,831 are candidates (as of July 10, 2019) for kidney transplant. In 2018, 21,167 kidney transplants and 836 combined kidney/pancreas transplants were performed in the U.S. Many ESRD patients (468,000) receive dialysis treatment, usually in privately owned clinics, while 193,000 have received a transplant. The system of distribution of kidneys was changed a year ago, when the system sought to increase the number of successful transplants by decreasing the amount of time a hospital has to accept or refuse an organ. What makes end stage renal disease (ESRD) unique is that its treatment (dialysis and transplant) is the only medical condition that is 100% paid for by the federal government having cost $114 billion in Medicare dollars in 2016.

Art by Craig Klugman

A new Executive Order signed today calls on the Department of Health & Human Services to work toward three goals related to kidney health: “Fewer patients developing kidney failure, fewer Americans receiving dialysis in dialysis centers, and more kidneys available for transplant.” Specifically, the goal is to reduce the number of people who progress to ESRD by 25% in 10 years, to move new patients to home dialysis (versus clinic-based) in the next 5 years, and to increase the number of kidneys available for transplant.

One of the nonsensical elements of the U.S.’ s approach to kidney disease is that we will completely pay for treatment once the organs have failed, but we do not put a dollar toward preventing failure in the first place. Taking a more preventive approach and treating kidney disease as a public health concern would prevent the need for more expensive and invasive medical treatment downstream. HHS proposes increasing research into the causes of kidney failure, examine whether drugs can slow progression, and using electronic health records to better manage patients at risk. Such an approach means treating people more aggressively who have a family history, have diabetes or are at risk for it, and who have hypertension. Such an approach is laudable—prevent people from getting so sick in the first place—but it requires an approach that Americans have been reluctant to accept—to change their health choices and receive medical treatment when they feel fine and have no symptoms.

The second goal is to move people from receiving dialysis at the 7,000 mostly privately-owned clinics to the home through changing payment incentives. In the clinic, patients spend 3-4 hours, 3 times a week in a dialysis chair, having their blood filtered by an artificial kidney. The centers are lucrative since the federal government pays most costs. For patients, going to a center is a limitation as is the limited number of hours they spend in treatment. An advantage to the clinic is that they are supervised sites in case something goes wrong. Center dialysis costs $88,000 per year. At home, dialysis offers the opportunity to have more frequent sessions (such as every night or each day) which theoretically should leave patients healthier. The move toward home treatment is made possible by the development of cheaper, more portable dialysis machines. Home dialysis eliminates the needed travel time and can reduce staff costs—nurses can train patients and their family to perform dialysis, though the exact savings is not clear. The executive order also places priority on new technology including genetic research and creating an artificial kidney.

Third, increasing the number of kidney donors has always been a challenge, especially in our opt-in system. In recently years, several European nations have adopted opt-out programs which has increased the potential pool of donors. The HHS proposal is to examine guidelines that exclude donors with certain diseases (HIV, Hep B and C, HCV) as well as making living donation more affordable. The result would be not increasing the number of donors, but using more of those donated organs. Now, many organs are rejected for medical reasons, but perhaps more of those could be used. The ethical caveat here is that studies are necessary to ensure that such formerly-discarded organs do not lead to worse outcomes since protecting patients from harm should be the highest priority. Some proposals would reimburse living donors for more of their medical costs and lost wages. It is important to remember that financial incentives should never be coercive in encouraging people to donate since that tends to increase injustice.

On the surface, this approach looks like it aims to reduce the burden of illness. But a deeper dive into the national report released this week suggests that the main impetus may be finding ways to save money. Innovation is important and the plan is all over the map—from encouraging precision medicine, to cutting out the middleman (i.e. dialysis centers), to using big data, to giving more money to living donors. It is important to remember certain ethical foundations in this rush to change: The health and protection of patients must be paramount. Patients who are given alternative programs need to be monitored carefully and the data must be examined against more traditional delivery models to ensure that outcomes are the same or better. Other proposals use the power of electronic health records to identify and track patients at risk. It is important to remember that patients have privacy rights and patients should be consented for participating in any surveillance program, with protection of their identity if they are viewed as being at risk for developing ESRD. In other words, these approaches must be evaluated to be sure they are meeting the health needs to patients, not the financial needs to the government or insurers.

As a former journalist, I am a natural sceptic to large calls for changing how we do something. My usual response is to follow the money: Why the big change and why now? Is someone donating money to a political campaign? Has someone in power had a loved one injured by the current system? Has someone with a vested interest in going around the current system or private, clinic-based dialysis been appointed to a power post or influential position? For example, on April 29, 2019, The Denver Post reported that Kent Thiry, the CEO of DaVita (one of the two largest private dialysis companies in the US) stepped down from his position. He had run for governor of Colorado as a Republican candidate in 2017 and has donated to several political causes. As one of my journalism mentors taught me, follow the money.

The current system of paying for ESRD treatment and distributing organs is far from perfect, but change needs to be stepwise, supported by the evidence, and aimed at improving patient health. New approaches may save money or they may cost more, but the health of patients is the most important factor.

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