0422U
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).
- For patients with cancer, MRD testing is covered for an initial test when tumor profiling (prior tumor analysis/CGP) is utilized for the bespoke assay designs and plasma series bundles listed (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 genetic content consistent with NCD 90.2.
- For patients without active cancer (personal history of cancer), MRD testing is covered for initial and specified subsequent single-plasma-timepoint tests when tumor profiling was utilized for bespoke assay designs listed (e.g., Signatera Recurrence Monitoring Bespoke Assay Design, RaDaR Recurrence Monitoring, Oncodetect Bespoke Assay Design, Pathlight, NeXT Personal Dx Breast MRD).
- Tumor‑naïve single‑timepoint MRD tests are covered when baseline tumor profiling is not utilized for the specific tumor‑naïve tests listed (e.g., NavDx single plasma test, Guardant Reveal single plasma test).
- MRD testing is covered for diagnosis of disease progression, recurrence, or relapse in advanced colorectal cancer using Signatera, Guardant Reveal, or Oncodetect.
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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