US national pricing comes into effect for Renalytix AI

The AIM-traded firm said the move established a national price of $950 (£725) for the test for Medicare patients, and would be in effect until December 2022.

It said the implementation followed the publication of the final 2020 ‘Clinical Laboratory Fee Schedule’ by CMS, announced on 3 December.

“For patients covered by Medicare the national price paid for outpatient laboratory testing is established through the CLFS process,” Renalytix AI said.

“Each year, new laboratory test codes are added to the CLFS and pricing is developed through a public comment process and review and finalisation by CMS.

“The pricing for tests like KidneyIntelX is set for a three-year period.”

At the end of that time, the company said the price would be reset based on an average of reported private payor payments for the test or laboratory service.

If the calculated average price would result in a reduction in the price paid for KidneyIntelX for Medicare patients, the decrease would be capped at no more than 15%.

“Leveraging the validation associated with a national price established by Medicare, the company is pursuing coverage determinations in 2020 and 2021 to ensure KidneyIntelX is available to patients with public and private health insurance coverage throughout the United States,” the board added.

At 0807 GMT, shares in Renalytix AI were up 0.6% at 366.2p.