0516U
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
- Coverage for repeat germline testing is determined by the referenced Local Coverage Determination MolDX: Repeat Germline Testing L38429; consult that LCD for specific clinical indications that constitute covered testing.
- 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.
20 Active Policies
L36807 — MolDX: Molecular Diagnostic Tests (MDT)
J05
A57100 — Billing and Coding: MolDX: Repeat Germline Testing
J05
L38429 — MolDX: Repeat Germline Testing
J05
A57772 — Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT)
J05
A57332
Related Codes
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