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Primary Cosponsor of Measure to Develop New Treatment Devices for End-Stage Renal Disease
WASHINGTON, D.C. – U.S. Senators Cindy Hyde-Smith (R-Miss.) on Thursday joined Senators John Cornyn (R-Texas) to introduce legislation to spur development of new treatment devices for people with end-stage renal disease (ESRD).
The Patient Access to ESRD New Innovative Devices Act (S.2751) would direct the Secretary of the U.S. Department of Health and Human Services (HHS) to change the Medicare payment program for dialysis to allow for new medical devices that can improve dialysis treatment and patient outcomes.
“For too long, Medicare rules have effectively held up research and innovation on new dialysis technologies, which has real consequences for many people in Mississippi and elsewhere who suffer from kidney disease,” Hyde-Smith said. “We want to update Medicare payment options to instead incentivize the development and use of improved dialysis options that can improve the quality of life for patients with renal failure issues.”
Specifically, the measure would create a three-year temporary add-on payment adjustment for new medical devices that provide meaningful clinical improvement for the diagnosis, treatment, or management of ERSD.
There are approximately 400,000 Medicare beneficiaries with ESRD, making up one percent of the Medicare population but accounting for approximately seven percent of all Medicare spending. Mississippi is one of the states with the greatest prevalence of ESRD, according to the Centers for Disease Control and Prevention Chronic Kidney Disease Surveillance System.
Unlike other disease states, there has been a significant lack of innovation in the devices used to treat kidney disease. Most people with ESRD receive in-center hemodialysis, a process that has changed little in the decades since its invention. According to the Journal of the American Society of Nephrology, from 1966 to 2002, the number of randomized controlled trials (RCTs) in the area of nephrology was lower than all other specialties of internal medicine. Within that same timeframe, there were 5,335 RCTs in hematology and 27,109 in cardiology.
With limited success, the federal government has recognized the need to spur device innovation in treating kidney disease. The Food and Drug Administration (FDA) awarded the FDA Expedited Access Pathway to the wearable artificial kidney in 2015. In April 2018, HHS announced the creation of Kidney X, a public-private partnership to promote innovation in treating kidney disease. In spite of this focus, there has only been one de novo application related to dialysis submitted to the FDA.
A copy of S.2751 is available here.
