Renalytix shares jump on draft US Medicare coverage decision

Renalytix shares were rocketing on Friday morning, after it announced that the Centers for Medicare and Medicaid Services (CMS) in the US had published a draft local coverage determination (LCD) for its ‘KidneyIntelX’ and ‘kidneyintelX.dkd’ testing products, outlining the coverage and pricing for the tests.

The AIM-traded firm said that according to the draft LCD, the established Medicare price for KidneyIntelX and kidneyintelX.dkd would be $950 per test.

Distinct common procedural terminology (CPT) codes, used in the US healthcare system for common billing across providers, had been set for each test and were available in the CMS 2024 clinical lab fee schedule.

The company said the draft LCD specified coverage for the use of KidneyIntelX or kidneyintelX.dkd for patients with diagnosed type-2 diabetes and stage 1 to 3b chronic kidney disease as reasonable and necessary.

Any limitations specified in the draft LCD aligned with the US Food and Drug Administration (FDA) label for kidneyintelX.dkd, it noted.

National Government Services (NGS), a subsidiary of Elevance Health, submitted the LCD.

NGS serves as a Medicare administrative contractor with CMS, responsible for claim review and payment for testing conducted in Renalytix's New York City laboratory.

A 45-day public comment period started on 8 February, and would end on 23 March.

Renalytix formally requested an LCD from NGS and provided substantial peer-reviewed published evidence supporting the coverage of KidneyIntelX and kidneyintelX.dkd.

NGS conducted a contractor advisory committee meeting on 29 August 2023, where a panel of external experts reviewed and discussed the clinical evidence.

Renalytix said it believed that, based on that evidence and the FDA's de Novo marketing authorisation for the kidneyintelX.dkd test, there was a strong basis for NGS to determine the tests as reasonable and necessary for Medicare beneficiaries.

Following the open public meeting, NGS would review public comments and issue a final LCD, expected within 2024.

At 1012 GMT, shares in Renalytix were up 30.54% at 13.38p.

Reporting by Josh White for Sharecast.com.