Traditional MedicareCoverageMedium impact
MolDX: Phenotypic Biomarker Detection from Circulating Tumor Cells
Medicare/CMS - LCD·Oncology, Hematology, Pathology·Local Coverage Determination
Effective date
Jun 25, 2026
We identified it
Jun 25, 2026
Summary
WPS Insurance Corporation (Medicare MAC Part A/B contractor) has issued a new Local Coverage Determination (L38678) effective 6/25/2026 establishing coverage policies for phenotypic biomarker detection from circulating tumor cells (CTCs) using MolDX technology. This policy defines medical necessity criteria, covered indications, and billing requirements for this specialized molecular diagnostic test.
Action Required
By June 25, 2026: Billing team must obtain and review the complete LCD L38678 policy text from the CMS Medicare Coverage Database to identify: (1) specific CPT/HCPCS codes for CTC biomarker testing, (2) prior authorization requirements, (3) medical necessity documentation standards, and (4) covered diagnoses. Update billing system rules, encounter forms, and provider documentation templates to align with coverage criteria. Contact WPS Insurance directly or consult the full policy URL (https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=38678&ver=11) to obtain complete coding and coverage details. Without proper implementation, claims for CTC biomarker tests may be denied. Oncology and hematology practices should prioritize this review.