Panel actions advance reimbursement under the CLFS, establish a new tracking code for cell collection, and support diagnostic coding for positive results.
Lucid Diagnostics has achieved progress across payment, billing, and coding pathways for its EsoGuard Esophageal DNA Test and EsoCheck Esophageal Cell Collection Device following three panel meetings.
At a Sept 15–16 meeting, the Centers for Medicare and Medicaid Services (CMS) Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests recommended maintaining the original gapfill payment basis for EsoGuard under the Clinical Laboratory Fee Schedule (CLFS), according to Lucid Diagnostics.
EsoGuard is billed under Proprietary Laboratory Analyses (PLA) code 0114U, which took effect in the CY2021 CLFS update. CMS convened the meeting in response to recent legislation resuming the reporting and payment update cycle under the Protecting Access to Medicare Act, and the agency is expected to issue final determinations in November following a public comment period, the release states.
New CPT and ICD-10-CM Coding Pathways
The American Medical Association CPT Editorial Panel approved the addition of a new Category III CPT code for reporting nonendoscopic esophageal cell collection during a Sept 17–19 meeting. Once effective, the code will allow healthcare providers and health systems to report and monitor office-based cell collections performed with the EsoCheck device, facilitating utilization tracking, and clinical outcome evaluations.
In addition, the Centers for Disease Control and Prevention National Center for Health Statistics ICD-10 Coordination and Maintenance Committee evaluated a proposed new ICD-10-CM diagnosis code, R85.83. Submitted by Lucid Diagnostics and supported by the American Foregut Society, the code would report positive results for the two methylated DNA biomarkers identified by EsoGuard.
Felice Schnoll-Sussman, MD, MSc, president of AFS and professor of clinical medicine at Weill Cornell Medicine, presented the proposal, which received a favorable response from the committee, according to a release from company. If finalized following a public comment period, the code will establish clinical rationale on claims for patients referred for follow-up upper endoscopy.
Laboratory Operations and Medicare Claims
Lucid Diagnostics operates two CLIA-certified laboratories in Lake Forest, California, and Irving, Texas, where it performs EsoGuard testing on samples collected via EsoCheck. Medicare claims for each site are processed by local Medicare Administrative Contractors.
The company states that it will begin submitting Medicare claims this month under PLA code 0114U for tests processed at its Texas facility, which falls under a Medicare Administrative Contractor that does not participate in the MolDX program. For its California laboratory, located in a MolDX-participating Medicare Administrative Contractor jurisdiction, Lucid Diagnostics plans to submit claims under code 0114U once a revised Local Coverage Determination becomes effective following a pending reconsideration request.
“These three public meetings mark important positive milestones in advancing payment, billing, and coding for EsoGuard esophageal precancer testing,” says Lishan Aklog, MD, chairman and CEO of Lucid Diagnostics, in a release. “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.”
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