Small, wearable dialysis machine crawls closer to working model

A much easier way to deliver dialysis treatments, and on a continuous basis, was just tested in a small trial. Although this small wearable device needs much more tweaking before it is ready for prime time, Dr. Victor Gura and his colleagues hope that his Wearable Artificial Kidney (WAK) will be available for use within two years. Gura’s efforts to create the WAK began due to his frustration with the lack of advancement in dialysis treatments in decades.

The WAK, in development for several years already, allows blood to be filtered continuously, just like a regular kidney. Currently, dialysis patients must remain hooked up to dialysis machines a few times a week for several hours. In the latest trial (which has not yet been published in a peer-reviewed journal), patients wore the device for 24 hours and were encouraged to eat foods that were banned before. Patients with end-stage kidney disease must avoid foods like bananas, orange juice, and ice cream which can cause vitamins and minerals to build up to dangerous levels.

Unfortunately, two of the machines suffered technical failures and had to be removed before the 24 hours was up. Leslie Spry, a spokesman for the National Kidney Foundation and the medical director for the Dialysis Center of Lincoln, remains skeptical about the device. He believes that the biggest challenge will be reliability, and plans to hold onto his doubts until patients can be stabilized for a week or two at a time. Spry is also concerned about the possibility of infection.

In addition to the technical issues, Gura has assigned himself the task of trying to reduce the weight of the machine by half, from 10 to five pounds. The WAK is worn on a belt and connects to the body through a catheter. Once a week, the WAK would need to be removed from the catheter in order to replace the filter, which separates water, salts, and minerals from the blood. Patients would also be required to add chemicals to the machine once a day to purify the filtered water.

End-stage renal disease and Medicare

End-stage renal disease (ESRD) is permanent kidney failure, requiring patients to undergo dialysis or seek a transplant. ESRD is commonly caused by hypertension or diabetes. As expected, these dialysis treatments are expensive. Many who suffer from this condition are covered by Medicare, and CMS has created specific provisions for coverage of dialysis and related services. For example, sometimes patients require non-emergency, scheduled, repetitive transportation by ambulance to their dialysis appointments. Sometimes, Part B covers self-dialysis training for at-home treatment and self-dialysis equipment and supplies, as well as support services from a local dialysis facility.

All ESRD patients with Part A and/or Part B coverage are eligible. However, patients are responsible for 20 percent of the approved amount for each treatment either in a facility or at home. According to the U.S. Renal Data System’s 2015 Annual Data Report, Medicare fee-for-service (FFS) expenditures on ESRD beneficiaries rose by $500 million between 2012 and 2013. The report pointed out that the amount of ESRD beneficiaries is less than 1 percent of the Medicare population, but spending for these patients accounts for just over 7 percent of FFS costs.

CMS created the ESRD prospective payment system (PPS) effective January 2011 to establish payment for dialysis facilities for up to three treatments per week per patient unless a medical reason justifies the patient’s need for more. CMS updates the base rate annually and accounts for case-mix adjustments, facility-level adjustments, training adjustments, and an outlier payment. The ESRD PPS also created consolidated billing for Part B items and services that are not separately payable when offered by providers other than the dialysis facility.