Does 0578U require prior authorization?

No, 0578U does not require prior authorization (high confidence). Code is covered without prior authorization.

`0578U`

HCPCS/CPT

No Prior Auth Required

Code is covered without prior authorization (high confidence)

Select and report the appropriate CPT code for the melanoma risk stratification molecular diagnostic service.
Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for Part B electronic claims (Loop 2400 or SV101-7 for 837P) and for Part B paper claims (Box 19).
Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for Part A claims: Line SV202-7 for 837I electronic claims and Block 80 for the UB-04 claim form.
Select and report the appropriate ICD-10-CM diagnosis code on the claim.

Coverage and medical necessity determinations for melanoma risk stratification molecular testing are governed by the MolDX LCD D_L38016 and tests should be reported only when LCD clinical criteria are met.
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).
Molecular diagnostic tests (MDTs) that have completed MolDx registration and technical assessment (TA) and are listed as covered by MolDx are covered when they meet Medicare's reasonable and necessary criteria.
Tests that demonstrate analytical validity, clinical validity, and clinical utility sufficient to meet Medicare's reasonable and necessary requirement are covered.
Tests performed for a diagnosis-specific indication or to provide results that will improve patient outcomes or change clinician management are covered when other MolDx requirements are met.
The policy applies to non‑FDA laboratory developed tests (LDTs), modified FDA‑approved/cleared kits, and tests/assays billed with more than one HIPAA‑compliant code (including NOC) that meet MolDx registration/TA and validity/utility requirements.

L38018 — MolDX: Melanoma Risk Stratification Molecular Testing

J05

L36807 — MolDX: Molecular Diagnostic Tests (MDT)

J05

A57772 — Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT)

J05

A56636 — Billing and Coding: MolDX: Melanoma Risk Stratification Molecular Testing

J05

Ask Verity about documentation requirements, denial risks, or coverage in your state.