Renalytix (NASDAQ: RNLX) stock raced higher on Monday after revealing that the Centers for Medicare and Medicaid Services (CMS) in the US had published a draft local coverage determination (LCD) for its ‘KidneyIntelX’ and ‘kidneyintelX.dkd’ testing products. This LCD provides comprehensive information on the coverage and pricing of these tests.
The company listed on AIM has announced that the draft Local Coverage Determination (LCD) has set the Medicare price for KidneyIntelX and kidneyintelX.dkd at $950 per test and establishes distinct common procedural terminology (CPT) codes for billing purposes.
The draft LCD outlines coverage for KidneyIntelX or kidneyintelX.dkd in type-2 diabetes patients with stage 1 to 3b chronic kidney disease, in line with FDA guidelines.
National Government Services (NGS), a subsidiary of Elevance Health, submitted the LCD, initiating a 45-day public comment period starting on February 8 and expected to conclude on March 23.
Renalytix has officially submitted a request for an LCD to NGS, providing substantial evidence from peer-reviewed publications to support the coverage of KidneyIntelX and kidneyintelX.dkd.
On August 29, 2023, NGS convened a contractor advisory committee meeting, during which a panel of external experts examined and deliberated on the clinical evidence.
Renalytix has stated its conviction that given this evidence and the FDA’s de Novo marketing authorization for the kidneyintelX.dkd test, there is a substantial justification for NGS to consider the tests reasonable and necessary for Medicare beneficiaries.
Following the public meeting, NGS will evaluate the public comments and issue a final LCD, anticipated to be released sometime in 2024.
Renalytix (NASDAQ: RNLX) Stock Price Action
RNLX stock shot up 228% to close at $1.25 on Monday. The traders had exchanged hands with 51,822,183 (51.82 million) shares compared to the average daily trading volume of 303.73K.
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