CMS publishes Draft Local Coverage Determination

LONDON and SALT LAKE CITY, February 9, 2024 - Renalytix plc (NASDAQ: RNLX) (LSE: RENX) announces that on February 8, 2024 the Centers for Medicare and Medicaid Services ("CMS") published a draft Local Coverage Determination ("LCD") for the Company's KidneyIntelX and kidneyintelX.dkd testing. The draft LCD can be accessed at https://www.cms.gov/medicare-coverage-database/. The established Medicare price for KidneyIntelX and kidneyintelX.dkd is $950 per test. Distinct CPT Codes (Common Procedural Terminology Codes) have been established for KidneyIntelX and kidneyintelX.dkd and are published in CMS' 2024 Clinical Lab Fee Schedule.

The draft LCD specifies coverage for use of KidneyIntelX or kidneyintelX.dkd for patients with diagnosed Type 2 diabetes and Stage 1-3b Chronic Kidney Disease is reasonable and necessary. Any specified limitations for use conform to the U.S. Food and Drug Administration ("FDA") label for kidneyintelX.dkd.

The LCD was submitted by National Government Services ("NGS"). NGS is a subsidiary of Elevance Health, Inc. (previously Anthem, Inc.), a Medicare Administrative Contractor with CMS and responsible for claim review and payment for testing performed in the Company's New York City laboratory. A 45-day public comment period began on February 8, 2024, and ends on March 23, 2024.

The Company formally requested an LCD from NGS, and submitted substantial peer reviewed published evidence in support of coverage of KidneyIntelX and kidneyintelX.dkd. NGS held a Contractor Advisory Committee meeting on August 29, 2023, where a panel of external experts reviewed and discussed the clinical evidence. We believe that based on the evidence, and the FDA's De Novo Marketing Authorization for the kidneyintelX.dkd ™ test, that there was a strong basis for NGS determining that these tests are reasonable and necessary for Medicare beneficiaries. Following the Open Public Meeting NGS will review public comments and issue a final LCD which is expected in calendar year 2024.