Renalytix plc announced that on February 8, 2024 the Centers for Medicare and Medicaid Services published a draft Local Coverage DeterPRODination for the Company's KidneyIntelX and kidneyintelX.dkd testing. 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 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.