Flying solo: Hemodialysis at home by yourself is safe and now legal

The patient advocacy group Home Dialyzors United believes dialysis should always be about the patient. The choice of location, frequency, time and modality should be a decision made between the patient and his or her doctor and be based on optimal clinical care and quality of life goals as defined by the dialyzor.

Multiple studies have shown that patients who dialyze at home have better treatment outcomes and improved self-reported quality of life. Despite these findings, 90% of patients who need dialysis are treated in-center and patients are often discouraged from being active partners in their care. With conventional dialysis treatments, many patients live to dialyze, rather than dialyze to live.

As cited in a recent Government Accountability Office report, the number one barrier to initiating home dialysis has been the requirement of a care partner to assist with those treatments. Not having a care partner has been a huge deterrent for many dialyzors, barring them from home hemodialysis and hindering their quality of life. Many were forced to leave jobs and careers they loved because they needed to accommodate an inflexible in-center dialysis schedule that was not conducive to working, since they had no one to “train” as a care partner for home dialysis.

Additionally, the Social Security Act of 1972 (SSA Section 1881(c)(1)(A)(i)(6)) specified that Congress intended for any patient who is a suitable candidate for home dialysis to be so treated. Medicare also requires centers to educate patients about all treatment options, yet too often this law is disregarded and too many patients are still unaware that they can dialyze at home.

Reversing the tide

Home Dialyzors United (HDU) believes dialyzors should be able to choose home hemodialysis (HHD) with or without a care partner, as their training and comfort level dictate. However, the original FDA 510(k) approval for the NxStage System One dialysis machines (NxStage Medical Inc.) in 2007 for use in the home required the patient have a care partner who can assist in emergencies. This requirement, however, was interpreted different ways by nephrologists and clinics. It prevented people who lived alone or whose care partner was temporarily absent from doing HHD, and often placed an undue burden on family.

Since the care partner requirement was attached to the NxStage System One, in part to get it approved for home treatments, only NxStage could apply to change that requirement. HDU was diligent, if not relentless, in discussing this with the company at every opportunity and the company responded.

In May 2017, while attending a Kidney Health Initiative (KHI) conference, members of HDU sat down with several members of the FDA medical device division. The conversation started with, “The care partner requirement for the NxStage machine has got to go.” They replied, “We’ve been expecting that.” That evening was immortalized in a photo taken by KHI staff and subsequently appeared larger than life on the AV screens at breakfast the next morning. KHI chairman Prabir Roy-Chaudhury, MD, PhD, FASN, opened the session by saying, “This is what KHI is all about. It epitomizes the public private partnership we are striving for.”

Two months later, on Aug. 28, 2017, NxStage Medical announced the FDA had approved the System One for solo dialysis. Who says the wheels of government turn slowly?

The FDA announced at the meeting that, “For the first time, we cleared an expanded indication for a home hemodialysis machine so it could be used without a care partner being present, a decision based in part on asking kidney patients about their tolerance for risk.”

As part of the KHI August 2015 public workshop, the FDA heard from multiple patient representatives who argued that the care partner requirement effectively ruled out home treatment for patients who lived alone or who could not afford to hire a care partner. During the presubmission process, the FDA worked with NxStage to design a robust patient survey that could quantify the level of risk that patients would accept in exchange for doing hemodialysis in the home alone instead of at a dialysis center.

A new option

Upon hearing the news, HDU was excited to share it with our members. The response was overwhelming. While many dialyzors were already doing solo treatments, off label and approved by their nephrologists, there were more who were unable to do so. For the most part, dialyzors were delighted and those who had been previously denied access to home dialysis because they lacked a care partner, were literally calling their centers as they read the announcement.

A few commentors noted safety was an issue and would never do it alone, which is an opinion HDU respects. However, most voiced the view that solo home hemodialysis, done correctly and with proper training, is safer than most in-center dialysis.

Most solo dialyzors are working, travelling and enjoying an improved quality of life because they can manage and treat their dialysis on their terms. Now, many more can join their ranks. -by Nieltje Gedney

Reference:

U.S. Government Accountability Office. End-Stage Renal Disease: Medicare payment refinements could promote increased use of home dialysis. 12/16/2015, GAO-16-125.

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Nieltje Gedney is vice president of the patient advocacy group Home Dialyzors United and lives in the Washington, D.C. metro area. Disclosure: Gedney has no relevant financial disclosures.