Lucid Diagnostics Advances Multiple EsoGuard® and EsoCheck® Payment, Billing and Coding Pathways

Medicare, AMA, and ICD-10 panels advance payment and coding pathways that may broaden clinical and Medicare access to Lucid’s EsoGuard testing.

Rhea-AI Summary

Lucid Diagnostics (LUCD) reported progress on multiple payment, billing, and coding pathways for its EsoGuard esophageal DNA test and EsoCheck cell collection device following three U.S. healthcare policy meetings in mid-September 2026.

A Medicare Advisory Panel recommended maintaining EsoGuard’s original gapfill payment basis under the Clinical Laboratory Fee Schedule, with final CMS determinations expected in November after public comment. The AMA CPT Editorial Panel approved a new Category III CPT code for nonendoscopic esophageal cell collection procedures performed with EsoCheck. In addition, the ICD-10 Coordination and Maintenance Committee received a Lucid-backed proposal for diagnosis code R85.83 to report positive EsoGuard results, which the committee received positively and may finalize after comments.

Lucid plans to begin submitting Medicare claims under PLA code 0114U from its Texas laboratory this month and from its California laboratory once a revised Local Coverage Determination becomes effective.

Positive

• Medicare panel recommends maintaining EsoGuard’s original gapfill payment basis under the CLFS.
• New Category III CPT code approved for nonendoscopic esophageal cell collection with EsoCheck.
• Proposed ICD-10-CM code R85.83 for positive EsoGuard results received favorably by the CDC/NCHS committee.
• Medicare claims from Texas lab to begin this month under PLA code 0114U.
• Medicare claims from California lab planned once a revised EsoGuard LCD from Lucid’s reconsideration request is effective.

Negative

• None.

Key Figures

EsoGuard PLA code: 0114U Final payment determinations: November CPT code classification: Category III CPT code +2 more

EsoGuard PLA code

0114U

Medicare payment and claims processing

Final payment determinations

November

Following CMS public comment period

CPT code classification

Category III CPT code

Nonendoscopic esophageal cell collection with EsoCheck

Proposed diagnosis code

R85.83

Positive EsoGuard results and confirmatory endoscopy claims

CLIA-certified laboratories

2 laboratories

California and Texas EsoGuard testing facilities

Historical Context

2 past events · Latest: Aug 05

2 events

1. Aug 05

   commercial coverage policy

   24h Move

   +4.3%

   Commercial coverage policy deemed EsoGuard medically necessary for eligible patients

2. Aug 13

   2Q26 earnings update

   24h Move

   -0.6%

   Coverage policy adopted by multiple health plans alongside reported quarterly results

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

gapfill, clinical laboratory fee schedule, category iii cpt code, icd-10-cm diagnosis code, +1 more

5 terms

gapfill financial

"maintaining EsoGuard's original gapfill payment basis"

gapfill describes a stock price moving back to the price range left empty by a prior gap on the chart—when a share opened significantly higher or lower than the previous close, creating an untraded price interval, and later the market trades through that interval. It matters to investors because traders often view a gapfill as a test of whether the earlier buying or selling pressure has been sustained, like closing an open hole in a fence that reveals whether the original barrier still holds.

clinical laboratory fee schedule financial

"under the Clinical Laboratory Fee Schedule"

A clinical laboratory fee schedule is a set list of prices that a payer—such as a government program or insurance company—will reimburse for specific lab tests and services. Think of it as a menu of allowed payments that determines how much labs can charge and get paid; changes to those prices directly affect a lab’s revenue, profit margins and investment prospects because lower rates squeeze earnings while higher rates improve cash flow.

category iii cpt code regulatory

"a new Category III CPT code for reporting"

A Category III CPT code is a temporary billing code used by medical providers to report new, experimental or emerging procedures, technologies, or services that do not yet have a permanent billing code. It matters to investors because assignment of such a code signals early clinical or market adoption, provides a way to capture usage and potential reimbursement data, and can hint at future revenue growth or regulatory and payment uncertainty—much like a temporary SKU that lets a retailer track early demand for a new product.

icd-10-cm diagnosis code regulatory

"a proposed new ICD-10-CM diagnosis code"

An ICD-10-CM diagnosis code is a standardized alphanumeric code used in the United States to record and classify a patient's medical diagnosis or reason for a healthcare visit. These codes are the labels insurers, hospitals, and public-health agencies use to bill services, track disease trends, and compile statistics—like a product SKU for health conditions that makes care events measurable and payable.

clia-certified regulatory

"Lucid owns and operates two CLIA-certified laboratories"

CLIA-certified means a laboratory has passed U.S. federal standards for performing tests on human samples, showing its results are accurate, reliable and timely. For investors this matters because certification is often required to sell clinical test services, bill insurers, win hospital or physician partnerships and avoid regulatory penalties — much like a restaurant passing a health inspection or a car getting a safety sticker before it can be sold.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Medicare Advisory Panel recommends maintaining EsoGuard's original gapfill payment basis under the Clinical Laboratory Fee Schedule

AMA CPT Editorial Panel approves a new Category III CPT code for non-endoscopic cell collection procedures performed with EsoCheck

Proposal for a new ICD-10-CM diagnosis code identifying positive EsoGuard results draws a favorable response from the CDC/NCHS ICD-10 Coordination and Maintenance Committee

NEW YORK, Sept. 22, 2026 /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 advances in multiple payment, billing, and coding pathways for its EsoGuard^® Esophageal DNA Test and EsoCheck^® Esophageal Cell Collection Device, following three public meetings held last week.

The Centers for Medicare & Medicaid Services (CMS) held a special Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (CDLT) Meeting on September 15-16 to make recommendations on Medicare payment methodologies for certain CDLTs paid under the Clinical Laboratory Fee Schedule (CLFS), including EsoGuard. CMS convened the meeting in response to recent legislation resuming the reporting and payment update cycle under the Protecting Access to Medicare Act (PAMA) after repeated postponements. The panel recommended maintaining the original gapfill payment basis for EsoGuard (PLA code 0114U), whose payment rate took effect in the CY2021 CLFS Update. CMS has posted a consent agenda reflecting this recommendation and is expected to issue final determinations in November following a public comment period.

The American Medical Association (AMA) held its September 2026 Hybrid CPT^® Editorial Panel Meeting on September 17-19. The panel approved the addition of a new Category III CPT code for reporting nonendoscopic esophageal cell collection. Once effective, the code will allow physicians and health systems to report and track office-based esophageal cell collection procedures performed with EsoCheck, supporting systematic evaluation of utilization and clinical outcomes. The AMA is expected to publish the meeting's Summary of Panel Actions in the coming weeks.

The Centers for Disease Control and Prevention's National Center for Health Statistics (CDC/NCHS) hosted the diagnosis code portion of the ICD-10 Coordination and Maintenance Committee Meeting on September 15-16. The committee considered a proposed new ICD-10-CM diagnosis code (R85.83) to report positive results for the two methylated DNA biomarkers targeted by EsoGuard. The proposal, submitted by Lucid and supported by the American Foregut Society (AFS), would provide a dedicated code for reporting positive EsoGuard results on claims for subsequent confirmatory upper endoscopy. Once implemented, the code will help physicians document the clinical rationale for the endoscopy and enhance EsoGuard's clinical value as a triage tool. AFS President Felice Schnoll-Sussman, M.D., M.Sc., Professor of Clinical Medicine at Weill Cornell Medicine, presented the proposal, which was positively received by the committee. The Company expects the proposed code to be finalized following a public comment period.

These meetings addressed payment, billing and coding for EsoCheck cell collection, EsoGuard laboratory testing, and confirmatory endoscopy, including for Medicare beneficiaries. Lucid owns and operates two CLIA-certified laboratories in Lake Forest, California and Irving, Texas, where it performs EsoGuard testing on samples collected with EsoCheck. Medicare claims for each laboratory are processed by the Medicare Administrative Contractor (MAC) for its jurisdiction under applicable coverage policies. The MolDX program coordinates coverage determinations on behalf of a subset of participating MACs.

The California laboratory is located within a MolDX-participating MAC's jurisdiction. Lucid will begin submitting Medicare claims under EsoGuard's PLA code, 0114U, for tests performed at its California laboratory once a final revised EsoGuard Local Coverage Determination (LCD) resulting from Lucid's pending reconsideration request is effective.

The Texas laboratory is located within the jurisdiction of a MAC that does not participate in the MolDX program. Lucid will begin submitting Medicare claims this month under EsoGuard's PLA code, 0114U, for tests performed at its Texas laboratory.

"These three public meetings mark important positive milestones in advancing payment, billing and coding for EsoGuard esophageal precancer testing," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "We are encouraged by the near-term commercial opportunities to expand access to EsoGuard through both of our CLIA-certified laboratories, including for Medicare beneficiaries."

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, 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 Diagnostics' 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 Diagnostics' common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance Lucid Diagnostics' products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from Lucid Diagnostics' clinical and preclinical studies; whether and when Lucid Diagnostics' products are cleared by regulatory authorities; market acceptance of Lucid Diagnostics' products once cleared and commercialized; Lucid Diagnostics' ability to raise additional funding as needed; and other competitive developments. These factors are difficult or impossible to predict accurately and many of them are beyond Lucid Diagnostics' 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 Diagnostics' future operations, see Part I, Item 1A, "Risk Factors," in Lucid Diagnostics' 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 Diagnostics 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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did the Medicare Advisory Panel decide regarding EsoGuard’s payment basis?

The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests recommended maintaining EsoGuard’s original gapfill payment basis under the Clinical Laboratory Fee Schedule. CMS has posted a consent agenda reflecting this recommendation and is expected to issue final determinations in November following a public comment period.

What is the new CPT code related to EsoCheck, and what will it be used for?

The AMA CPT Editorial Panel approved a new Category III CPT code for reporting nonendoscopic esophageal cell collection. Once effective, this code will allow physicians and health systems to report and track office-based esophageal cell collection procedures performed with EsoCheck, supporting systematic evaluation of utilization and clinical outcomes.

What is the proposed new ICD-10-CM diagnosis code linked to EsoGuard?

The ICD-10 Coordination and Maintenance Committee considered a proposed new diagnosis code, R85.83, to report positive results for the two methylated DNA biomarkers targeted by EsoGuard. The proposal, submitted by Lucid and supported by the American Foregut Society, would provide a dedicated code for reporting positive EsoGuard results on claims for subsequent confirmatory upper endoscopy and was positively received, with finalization expected after a public comment period.

How will Lucid’s two laboratories bill Medicare for EsoGuard testing?

Lucid owns and operates CLIA-certified laboratories in Lake Forest, California, and Irving, Texas. The Texas laboratory, in a non-MolDX MAC jurisdiction, will begin submitting Medicare claims this month under EsoGuard’s PLA code 0114U. The California laboratory, in a MolDX-participating MAC jurisdiction, will begin submitting Medicare claims under the same PLA code once a final revised EsoGuard Local Coverage Determination from Lucid’s reconsideration request becomes effective.

How does the proposed ICD-10 code support EsoGuard’s role as a triage tool?

The proposed ICD-10-CM code R85.83 would let physicians report positive EsoGuard results on claims for confirmatory upper endoscopy. Lucid states that this will help document the clinical rationale for performing endoscopy and enhance EsoGuard’s clinical value as a triage tool for esophageal precancer testing.