MolDX to Convene Expert Medical Panel on Medicare Local Coverage Determination (LCD) for Lucid Diagnostics' EsoGuard® Esophageal DNA Test

Rhea-AI Summary

Lucid Diagnostics (NASDAQ:LUCD) announced that MolDX-participating Medicare Administrative Contractors will hold a critical Contractor Advisory Committee (CAC) meeting on September 4, 2025 to evaluate Medicare coverage for its EsoGuard® Esophageal DNA Test.

The virtual meeting will gather medical experts to reconsider Local Coverage Determination (LCD) L39256, following Lucid's November 2024 request. CEO Lishan Aklog highlighted the company's strong clinical evidence package and noted that nearly 40,000 patients have been referred for EsoGuard testing to date. The test's clinical utility is supported by professional society guidelines and peer-reviewed publications.

Positive

• Progress toward potential Medicare coverage for EsoGuard test
• Strong clinical evidence package supported by professional society guidelines
• Significant market validation with 40,000 patient referrals
• Company reports strengthened balance sheet to support commercialization

Negative

• Medicare coverage not yet secured, pending review process
• Public participation limited to listening only, without ability to ask questions

Insights

Healthcare Reimbursement Specialist

Lucid's Medicare coverage review progress for EsoGuard test is a significant regulatory milestone with substantial revenue implications.

The announcement of a MolDX Contractor Advisory Committee (CAC) meeting represents a crucial step forward in Lucid Diagnostics' quest to secure Medicare coverage for its EsoGuard Esophageal DNA Test. This development is significant because Medicare coverage decisions typically determine whether a diagnostic test becomes widely accessible and commercially viable.

The convening of medical experts by multiple Medicare Administrative Contractors (MACs) including Palmetto GBA, CGS, Noridian, and WPS signals that Lucid's November 2024 reconsideration request has progressed through initial reviews. CAC meetings are only scheduled when a technology has passed preliminary assessment hurdles and warrants expert clinical evaluation.

This meeting has substantial implications for Lucid's revenue potential. Medicare coverage would enable reimbursement for a significant portion of the nearly 40,000 patients referred for EsoGuard testing to date. More importantly, a positive coverage determination typically influences private payer policies, potentially opening broader commercial markets.

The timing of this meeting suggests a final coverage decision could come by late 2025 or early 2026. The fact that Lucid's CEO highlights their "strengthened balance sheet" indicates they have sufficient financial runway to sustain operations through this coverage determination process.

While the CEO's optimistic framing of this as "strong evidence of progress toward a positive Medicare coverage policy outcome" should be viewed with appropriate skepticism, the advancement to a formal CAC meeting does objectively represent meaningful progression through Medicare's coverage determination pathway.

Virtual public CAC meeting to be held September 4, 2025, at 2:00 p.m. ET

NEW YORK, July 16, 2025 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company"), a commercial-stage, cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM), today announced that  on Thursday, September 4, 2025, from 2:00 to 4:00 p.m. ET, MolDX-participating Medicare Administrative Contractors (MACs)—Palmetto GBA, CGS Administrators, Noridian Healthcare Solutions, and WPS Government Health Administrators—will convene a MolDX Contractor Advisory Committee (CAC) Meeting of medical experts as a critical step in the reconsideration of Local Coverage Determination (LCD) L39256, "MolDX: Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, Neoplasia," as requested by Lucid in November 2024 to secure Medicare coverage for its EsoGuard^® Esophageal DNA Test.

"We are grateful to the MolDX team for their rigorous evaluation of our clinical evidence package, which has culminated in this CAC meeting where medical experts will contribute deep domain expertise and real-world experience in nonendoscopic esophageal precancer testing," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "We view this meeting as strong evidence of progress toward a positive Medicare coverage policy outcome. There is broad consensus within the GI community on the clinical utility of EsoGuard for esophageal precancer testing, supported by professional society guidelines, peer-reviewed publications, and real-world experience from nearly 40,000 patients referred for EsoGuard testing to date. With our strengthened balance sheet, we are well equipped to successfully navigate the final stages of this process."

The CAC panel will discuss the clinical literature related to Local Coverage Determination (LCD) L39256, and medical experts will have the opportunity to provide important clinical context for the evidence. Discussions will occur between CAC panelists and Contractor Medical Directors. The public may attend; however, questions from the public will not be entertained. Interested stakeholders may register to listen to the CAC meeting via Microsoft Teams Webinar. Advance registration is required and must be completed by Wednesday, September 3, 2025, at 11:59 p.m. ET. To register, please visit: Register Here.

About Lucid Diagnostics
Lucid Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM). Lucid is focused on the millions of patients with gastroesophageal reflux disease (GERD), also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer. Lucid's EsoGuard^® Esophageal DNA Test, performed on samples collected in a brief, noninvasive office procedure with its EsoCheck^® Esophageal Cell Collection Device, represent the first and only commercially available tools designed with the goal of preventing cancer and cancer deaths through widespread, early detection of esophageal precancer in at-risk patients.

For more information about Lucid, please visit www.luciddx.com and for more information about its parent company PAVmed, please visit www.pavmed.com.

Forward-Looking Statements
This press release includes forward-looking statements that involve risk and uncertainties. Forward-looking statements are any statements that are not historical facts. Such forward-looking statements, which are based upon the current beliefs and expectations of Lucid's management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of Lucid's common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance Lucid's products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from Lucid's clinical and preclinical studies; whether and when Lucid's products are cleared by regulatory authorities; market acceptance of Lucid's products once cleared and commercialized; Lucid's ability to raise additional funding as needed; and other competitive developments. In addition, Lucid continues to monitor the COVID-19 pandemic and the pandemic's impact on Lucid's businesses. These factors are difficult or impossible to predict accurately and many of them are beyond Lucid's control. In addition, new risks and uncertainties may arise from time to time and are difficult to predict. For a further list and description of these and other important risks and uncertainties that may affect Lucid's future operations, see Part I, Item 1A, "Risk Factors," in Lucid's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, "Risk Factors" in any Quarterly Report on Form 10-Q filed by Lucid Diagnostics after its most recent Annual Report.  Lucid disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.

 

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SOURCE Lucid Diagnostics

FAQ

When is the Medicare CAC meeting for Lucid Diagnostics' (LUCD) EsoGuard test?

The MolDX Contractor Advisory Committee meeting is scheduled for September 4, 2025, from 2:00 to 4:00 p.m. ET via Microsoft Teams Webinar.

What is the purpose of Lucid Diagnostics' (LUCD) CAC meeting with MolDX?

The meeting aims to reconsider Local Coverage Determination (LCD) L39256 to potentially secure Medicare coverage for the EsoGuard® Esophageal DNA Test.

How many patients have been referred for Lucid Diagnostics' EsoGuard testing?

Nearly 40,000 patients have been referred for EsoGuard testing to date.

Who can participate in LUCD's Medicare CAC meeting?

The public may attend by registering for the Microsoft Teams Webinar by September 3, 2025, but questions from the public will not be entertained. Only CAC panelists and Contractor Medical Directors will participate in discussions.

What evidence supports Lucid Diagnostics' EsoGuard test?

The test is supported by professional society guidelines, peer-reviewed publications, and real-world experience from nearly 40,000 patient referrals.