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Renalytix plc announces that on January 11, 2024, the Medicare Administrative Contractor (MAC), National Government Services (NGS) Inc., published the agenda for an open session on Local Coverage Determination (LCD) to be held on February 29 to take place in 2024. Renalytix KidneyIntelX prediction tests?? and Kidney IntelX.dkd for adults with type 2 diabetes and early-stage chronic kidney disease are one of five LCD proposals on the agenda.
There are an estimated 14 million patients with type 2 diabetes and early-stage kidney disease in the United States. LCD’s proposals will be published on February 8, 2024. A 45-day public comment period begins February 8 and ends March 23, 2024.
NGS is a subsidiary of Elevance Health Inc., which contracts with the Centers for Medicare & Medicaid Services (CMS) for Jurisdiction 6, which includes Illinois, Minnesota and Wisconsin, and Jurisdiction K, which includes Maine, New Hampshire, Vermont , Massachusetts and Rhode, includes Island, Connecticut and New York. All Medicare fee-for-service reimbursement claims for patients tested anywhere in the United States and treated at Renalytix’s New York laboratory will be submitted to NGS for payment at the rate established by CMS. Renalytix formally applied for an LCD to NGS and submitted extensive published, peer-reviewed evidence to support reporting on KidneyIntelX and Kidney IntelX.dkD. NGS hosted a Contractor Advisory Board meeting on August 29, 2023, at which a panel of external experts reviewed and discussed the clinical evidence.
Based on this evidence, as well as the FDA’s de novo marketing approval of the IntelX.dkd tm kidney test, Renalytix believes there is a strong basis for the NGS to determine that these tests are appropriate and necessary for Medicare beneficiaries . Following the public meeting, NGS will consider public comments and issue a final LCD, expected to be published in calendar year 2024. Renalytix also continues to expand coverage arrangements for private payers across the United States.
This coverage includes a January 2024 contract with the Velocity National Provider Network, covering 2.7 million members nationwide.
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