KidneyIntelX Medicare Update

October 25, 2022

NEW YORK and SALT LAKE CITY, October 25, 2022 — Renalytix plc (NASDAQ: RNLX) (LSE: RENX) today announced that, building on recently established private payer and Medicaid insurance coverage contracts for KidneyIntelX, the Federal Medicare Administrative Contractor (MAC) National Government Services (NGS) has initiated payment of claims for KidneyIntelX testing for patients with Medicare coverage that have met appropriate medical necessity criteria.

Medicare payment for KidneyIntelX is based on the National Limitation Amount (NLA) of $950 per reportable result established on the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Fee Schedule (CLFS).  KidneyIntelX has a CPT code (0105U) that was priced at $950 and became effective as of January 1, 2020.

Medicare patient samples are being processed in the Company’s New York laboratory.  Under Medicare billing rules, all claims for KidneyIntelX testing are evaluated by the regional MAC for New York, NGS, for payment.

CMS has various pathways for Medicare payment for innovative diagnostic tests like KidneyIntelX, including National Coverage Determination (NCD) by the CMS central office, Local Coverage Determination (LCD) by the MAC, and review of individual claims (ICR) by the MAC.  Effective July 1, 2022, claims for KidneyIntelX tests have been processed and paid by NGS using the ICR process.  Under this payment methodology, NGS reviews each claim to determine its medical necessity based on the clinical evidence supporting its intended use.  Payment timelines are within Medicare’s 30-day targeted timeframe for payment.

Separately, Renalytix has submitted a formal request to NGS to establish an LCD for KidneyIntelX.  NGS will continue to review claims individually for payment while the LCD review process is underway.

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