Foundational LCD, to be effective May 14, 2023, incorporates key feedback to 2022 draft, including updated guidelines recommending non-endoscopic biomarker testing
Lucid positioned to submit EsoGuard for Technical Assessment and coverage under foundational LCD when sufficient clinical utility data available later this year. (Credit: Testalize.me on Unsplash)
Lucid Diagnostics, a commercial-stage cancer prevention diagnostics company and a majority-owned subsidiary of PAVmed, announced that, yesterday, the MolDX Program (“MolDX”) published a Future Effective Local Coverage Determination (“LCD”) L39256, on molecular testing for esophageal precancer and cancer in Medicare beneficiaries, to become effective May 14, 2023.
This foundational LCD, entitled “Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia” and published on CMS.gov, provides the criteria for future coverage of individual tests within this category, such as Lucid’s EsoGuard® Esophageal DNA Test, following submission of each test for Technical Assessment.
“We are very excited and gratified that the publication of this future effective LCD has now established a clear path for Medicare beneficiaries to have access to modern non-endoscopic biomarker testing, such as EsoGuard, for early detection of esophageal precancer to prevent esophageal cancer deaths,” said Lishan Aklog, M.D., Lucid’s Chairman & Chief Executive Officer.
“We are particularly pleased that the LCD incorporates substantially all of the constructive feedback provided by us and over a dozen other stakeholders during the comment period for the proposed LCD published in 2022. This includes highlighting the 2022 guideline updates which established non-endoscopic biomarker testing, such as EsoGuard, as an acceptable alternative to endoscopy and acknowledging the value of such testing given the failure of endoscopy as a widespread tool to detect esophageal precancer. It now, as the stakeholders recommended, firmly aligns the criteria for coverage with the American College of Gastroenterology’s recommendations. Its qualitative thresholds for performance data now also align with historical precedent and the actual risk of such tests in clinical practice,” Dr. Aklog added.
“We look forward to completing and publishing data from our ongoing prospective and retrospective clinical utility studies, which will allow us to submit EsoGuard for Technical Assessment and Medicare coverage under the foundational LCD later this year. In the meantime, our team will continue to drive test volume growth and aggressively pursue commercial payor engagements such as our recent in-network agreement with MultiPlan.”
Source: Company Press Release