Renalytix plc announced that on January 11, 2024, the Medicare Administrative Contractor (MAC), National Government Services (NGS) Inc., released the agenda for a Local Coverage Determination (LCD) Open Meeting taking place on February 29, 2024. The Renalytix KidneyIntelX?? and kidney IntelX.dkd prognostic test for adults with Type 2 diabetes and early-stage chronic kidney disease are one of five proposed LCDs for consideration on the agenda.

There are currently an estimated 14 million patients with Type 2 diabetes and early -stage kidney disease in the United States. The proposed LCDs will be published on February 8, 2024. A 45-day public comment period begins on February 8, and ends on March 23, 2024.

NGS is a subsidiary of Elevance Health Inc., contracting with the Centers for Medicare & Medicaid Services (CMS) for Jurisdiction 6, encompassing Illinois, Minnesota and Wisconsin, and Jurisdiction K, encompassing Maine, New Hampshire, Vermont, Massachusetts, Rhode Island, Connecticut, and New York. Any Medicare Fee For Service claims for patients tested anywhere in the United States and processed in the Renalytix New York City laboratory are submitted to NGS for payment at the rate established by CMS. Renalytix formally requested an LCD from NGS and submitted substantial peer reviewed published evidence in support of coverage of KidneyIntelX and kidney IntelX.dkD. NGS held a Contractor Advisory Board meeting on August 29, 2023, where a panel of external experts reviewed and discussed the clinical evidence.

Based on this evidence, along with the FDA's de novo marketing authorization for the kidney IntelX.dkd tm test, Renalytix believes that there is 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. Renalytix also continues to expand private payer coverage agreements across the United States.

This coverage includes a January 2024 contract with Velocity National Provider Network, covering 2.7 million member lives nationwide.