0340U — Dna assays for detection of minimal residual disease in cancer
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Documentation Required
- Enter 1 unit of service (UOS) for the Molecular Diagnostic Test on the claim.
- Report the appropriate CPT code for the Molecular Diagnostic Test on the claim.
- For Part B electronic (837P) claims, enter the appropriate DEX Z-Code identifier adjacent to the CPT code in Loop 2400 or the SV101-7 comment/narrative field.
- For Part B paper claims, enter the appropriate DEX Z-Code identifier adjacent to the CPT code in Box 19.
Key Coverage Criteria
- To report a Molecular Diagnostic Test (MDT) service, submit the appropriate CPT code, include the appropriate DEX Z-Code identifier adjacent to the CPT code in the claim comment/narrative field, and enter 1 unit of service (UOS).
- Initial MRD testing is covered for patients with cancer when baseline tumor profiling from a prior analysis is utilized, using listed bespoke/plasma-series MRD tests (e.g., Signatera Bespoke Assay Design + Plasma Series Bundle, RaDaR Bespoke Assay Design + Plasma Series Bundle, Oncodetect Bespoke Assay Design + Plasma Test Bundle, Guardant Reveal MRD Bundle, Guardant360 Response).
- Subsequent MRD testing for patients with cancer is covered only if there is clinical evidence of an a priori change in tumor genetic content in accordance with NCD 90.2.
- Initial MRD testing is covered for patients without current cancer (per policy definition) when baseline tumor profiling from a prior analysis is utilized, using listed recurrence-monitoring bespoke + single-plasma tests (e.g., Signatera Recurrence Monitoring Bespoke Assay Design + single Plasma Test, RaDaR Recurrence Monitoring, Oncodetect Bespoke Assay, Pathlight Recurrence Monitoring).
- Subsequent MRD testing for patients without cancer is covered as specified for listed single-plasma recurrence-monitoring tests (e.g., Signatera Recurrence Monitoring single Plasma Test, RaDaR Recurrence Monitoring single Plasma Test, Oncodetect single Plasma Test, Pathlight Recurrence Monitoring single Plasma Test).
- Tumor‑naïve MRD testing (baseline tumor profiling not utilized) is covered for specified single-plasma tests (e.g., NavDX single Plasma Test, Guardant Reveal single Plasma Test).
20 Active Policies
L36807 — MolDX: Molecular Diagnostic Tests (MDT)
J05
A57772 — Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT)
J05
L38835 — MolDX: Minimal Residual Disease Testing for Cancer
J05
A58468 — Billing and Coding: MolDX: Minimal Residual Disease Testing for Solid Tumor Cancers
J05
Related Codes
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