, Dec. 3, 2019
/PRNewswire/ -- Renalytix AI plc
(LSE: RENX), a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, announced today that the Centers for Medicare and Medicaid Services ("CMS") has released the Final 2020 Clinical Laboratory Fee Schedule ("CLFS") and has set a national price for the Company's KidneyIntelX™
test. Under the 2020 fee schedule, the price for KidneyIntelX™
with a unique reimbursement code (0105U) is set at $950
and becomes effective on January 1, 2020
. This price will remain in effect for a three-year term from January 2020
until December 2022
The inclusion of KidneyIntelX™
on Medicare's CLFS will accelerate RenalytixAI's contracting efforts with private insurance payors as several large insurance plans in the United States
use Medicare's CLFS to determine test pricing. Based on this development RenalytixAI will expand the market focus for KidneyIntelX™
to a national U.S. program, with a significant expansion in covered lives expected to take place beginning in 2020 and 2021.
"We are pleased that CMS has priced KidneyIntelX™ in the year of our national launch program. Historically, coverage and pricing have lagged innovative test launches by three to five years," said Tom McLain
, President and Chief Commercial Officer. "We believe this accelerated timeframe for KidneyIntelX™ pricing reflects the benefit of improved patient outcomes by delaying or preventing the onset of end-stage renal disease and kidney failure, as well as the expected cost reductions that can be delivered to healthcare systems across the United States
About Kidney Disease
Kidney disease is now recognized as a public health epidemic affecting over 850 million people globally. In the United States
alone, over 40 million people are classified as having chronic kidney disease, with nearly 50 percent of individuals with advanced (Stage IV) disease unaware of the severity of their reduced kidney function. As a result, many patients progress to kidney failure in an unplanned manner, ending up having dialysis in the emergency room without ever seeing a clinical specialist, such as a nephrologist. Every day 13 patients die in the United States
while waiting for a kidney transplant.
RenalytixAI is a developer of artificial intelligence-enabled clinical diagnostic solutions for kidney disease, one of the most common and costly chronic medical conditions globally. The Company's solutions are being designed to make significant improvements in kidney disease diagnosis and prognosis, clinical care, patient stratification for drug clinical trials, and drug target discovery. For more information, visit renalytixai.com.
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