Lucid Diagnostics gets Medicare panel support for EsoGuard

Q: What new CPT development did Lucid Diagnostics (LUCD) disclose for EsoCheck?

Lucid stated that the AMA CPT Editorial Panel approved a new Category III CPT code for nonendoscopic esophageal cell collection procedures performed with EsoCheck. Once effective, it will let physicians and health systems report and track office-based esophageal cell collection procedures.

Q: What ICD-10-CM coding change is proposed for EsoGuard according to LUCD?

Lucid described a proposed new ICD-10-CM diagnosis code R85.83 to report positive EsoGuard results for the two methylated DNA biomarkers it targets. The CDC/NCHS committee received the proposal favorably, and the company expects the code to be finalized after a public comment period.

Q: How do these coding and payment developments affect EsoGuard and EsoCheck for LUCD?

The Medicare panel recommendation, new Category III CPT code for EsoCheck procedures, and proposed ICD-10-CM code R85.83 together advance payment, billing, and coding pathways for EsoGuard and EsoCheck. Lucid highlighted these as important milestones for expanding access, including for Medicare beneficiaries.

Lucid Diagnostics details new Medicare payment support, a CPT code approval, and favorable ICD-10 coding feedback for EsoGuard and EsoCheck.

Filing Impact

(High)

Filing Sentiment

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

Lucid Diagnostics Inc. (LUCD) reports progress in payment, billing, and coding pathways for its EsoGuard Esophageal DNA Test and EsoCheck cell collection device. 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, enabling reporting and tracking once effective. The CDC/NCHS ICD-10 Coordination and Maintenance Committee gave a favorable response to a proposed new diagnosis code R85.83 for positive EsoGuard results, which the company expects to be finalized after public comment. Lucid will begin submitting Medicare claims under PLA code 0114U this month for tests at its Texas laboratory and after a revised Local Coverage Determination is effective for its California laboratory.

Positive

Medicare panel backs existing gapfill payment basis for EsoGuard, supporting continuity of reimbursement under the Clinical Laboratory Fee Schedule, with CMS final determinations expected in November.
The AMA approved a new Category III CPT code for nonendoscopic esophageal cell collection with EsoCheck, improving the ability of physicians and health systems to report and track these procedures.
A proposed ICD-10-CM diagnosis code R85.83 for positive EsoGuard results received favorable feedback from the CDC/NCHS committee, which the company expects to be finalized after public comment.

Negative

None.

Filing Explained

Medicare claim submissions are planned from Texas this month; CMS, coding, and California coverage steps remain pending.

On September 22, 2026, Lucid Diagnostics reported payment, billing, and coding developments for EsoGuard and EsoCheck that could expand its Medicare claim-submission pathways. The developments remain at mixed stages: a payment recommendation, a CPT code approval awaiting publication and effectiveness, and a proposed diagnosis code that received favorable committee feedback.

The disclosed structures concern reimbursement status, procedure reporting, diagnosis coding, and coverage conditions—not an issuance of securities or a change in common-stock ownership. Operationally, Lucid says it will begin submitting Medicare claims this month from its Texas laboratory, while submissions from California await an effective revised local coverage determination.

Although the company calls the developments “important positive milestones,” that description is qualified by their lifecycle: the CMS payment position still awaits a final determination, the CPT code still awaits publication and effectiveness, and the diagnosis code remains a proposal.

The named resolution points are CMS final determinations expected in November after public comment, publication of the AMA panel actions in the coming weeks, finalization of the proposed diagnosis code after public comment, and effectiveness of the revised California coverage determination.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

CMS Medicare Advisory Panel meeting dates: September 15–16, 2026 EsoGuard PLA code: 0114U Proposed ICD-10-CM diagnosis code for positive EsoGuard: R85.83 +3 more

6 metrics

CMS Medicare Advisory Panel meeting dates September 15–16, 2026 Special Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests considering payment methodologies, including EsoGuard

EsoGuard PLA code 0114U Code under which Lucid will submit Medicare claims for EsoGuard testing from its laboratories

Proposed ICD-10-CM diagnosis code for positive EsoGuard R85.83 Code proposed to report positive results for two methylated DNA biomarkers targeted by EsoGuard

AMA CPT Editorial Panel meeting dates September 17–19, 2026 Meeting at which a new Category III CPT code for EsoCheck nonendoscopic esophageal cell collection was approved

Year EsoGuard CLFS payment rate took effect 2021 Payment rate under the Clinical Laboratory Fee Schedule began in the CY2021 CLFS Update

Number of CLIA-certified laboratories 2 laboratories Lucid owns and operates CLIA-certified laboratories in Lake Forest, California, and Irving, Texas

Key Terms

gapfill payment basis, Clinical Laboratory Fee Schedule, Category III CPT code, ICD-10-CM diagnosis code, +2 more

6 terms

gapfill payment basis regulatory

"recommended maintaining the original gapfill payment basis for EsoGuard"

Clinical Laboratory Fee Schedule regulatory

"under the Clinical Laboratory Fee Schedule (CLFS), including EsoGuard"

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

"approved the addition of 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

"proposed new ICD-10- diagnosis code (R85.83) to report positive results"

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.

Local Coverage Determination regulatory

"final revised EsoGuard Local Coverage Determination (LCD) resulting from"

A local coverage determination is a region-specific decision by a public health insurer about whether a particular medical test, treatment, or device will be paid for in that area. Think of it like a local rulebook that says which procedures qualify for reimbursement; it matters to investors because such rules directly affect how much revenue health providers, device makers, or diagnostic companies can earn in that market and how widely a product will be adopted.

MolDX program regulatory

"The MolDX program coordinates coverage determinations on behalf"

FAQ

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

What did Lucid Diagnostics (LUCD) announce regarding Medicare payment for EsoGuard?

Lucid Diagnostics reported that a Medicare Advisory Panel recommended maintaining EsoGuard’s original gapfill payment basis under the Clinical Laboratory Fee Schedule. CMS has posted a consent agenda reflecting this and is expected to issue final determinations in November after a public comment period.

What new CPT development did Lucid Diagnostics (LUCD) disclose for EsoCheck?

Lucid stated that the AMA CPT Editorial Panel approved a new Category III CPT code for nonendoscopic esophageal cell collection procedures performed with EsoCheck. Once effective, it will let physicians and health systems report and track office-based esophageal cell collection procedures.

What ICD-10-CM coding change is proposed for EsoGuard according to LUCD?

Lucid described a proposed new ICD-10-CM diagnosis code R85.83 to report positive EsoGuard results for the two methylated DNA biomarkers it targets. The CDC/NCHS committee received the proposal favorably, and the company expects the code to be finalized after a public comment period.

When will Lucid Diagnostics (LUCD) start submitting Medicare claims for EsoGuard from its laboratories?

Lucid plans to begin submitting Medicare claims under PLA code 0114U this month for tests at its Texas laboratory. For its California laboratory, claims will begin under the same code once a final revised EsoGuard Local Coverage Determination from Lucid’s reconsideration request becomes effective.

How do these coding and payment developments affect EsoGuard and EsoCheck for LUCD?

The Medicare panel recommendation, new Category III CPT code for EsoCheck procedures, and proposed ICD-10-CM code R85.83 together advance payment, billing, and coding pathways for EsoGuard and EsoCheck. Lucid highlighted these as important milestones for expanding access, including for Medicare beneficiaries.

What role does the MolDX program play in Lucid Diagnostics’ (LUCD) Medicare coverage?

Lucid noted that its California laboratory is in a MolDX-participating MAC jurisdiction, where MolDX coordinates coverage determinations. The company will submit Medicare claims there under PLA code 0114U once a revised EsoGuard Local Coverage Determination from its pending reconsideration request is effective.

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

Understanding 8-K Material Events →

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Available on EDGAR 09/22/2026 - 09:07 AM Accepted by SEC EDGAR 09/22/2026 - 09:06 AM

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): September 22, 2026

LUCID DIAGNOSTICS INC.

(Exact Name of Registrant as Specified in Charter)

Delaware

001-40901

82-5488042

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

360 Madison Avenue, 25^th Floor, New York, New York		10017
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: (917) 813-1828

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425).

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12).

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)).

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)).

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, Par Value $0.001 Per Share		LUCD		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01.

Regulation FD Disclosure.

On September 22, 2026, Lucid Diagnostics Inc. (the “Company”) issued a press release announcing 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. A copy of the press release is attached to this report as Exhibit 99.1 and is incorporated herein by reference.

The information furnished under Item 7.01, including the exhibit related thereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any disclosure document of the Company, except as shall be expressly set forth by specific reference in such document.

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits:

Exhibit No.		Description
99.1		Press release.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: September 22, 2026	LUCID DIAGNOSTICS INC.

	By:	/s/ Dennis McGrath
		Dennis McGrath
		Chief Financial Officer

Exhibit 99.1

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

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, September 22, 2026 - 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.

Investor and Media Contact:

Matt Riley

PAVmed and Lucid Diagnostics

mjr@pavmed.com

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

4 documents

Press Releases

EX-99.1 EX-99.1 17.3 KB