81297
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- The medical record must document that the testing is expected to influence treatment of the condition for which the test is ordered and include an ordering physician/NPP requisition containing the relevant ICD-10-CM diagnosis code.
- Ordering physician/NPP documentation should include history and physical or exam findings, problems/diagnoses, and relevant data (e.g., lab tests, imaging) that support medical necessity.
- Performing laboratories must retain accreditation, test requisition, test records/procedures, preliminary and final reports, and quality control records and provide them when requested.
- For laboratory-developed tests (LDTs)/protocols, documentation must include the diagnostic test/assay, lab/manufacturer, comparable assays (if relevant), assay description, analytical validity, clinical validity, and clinical utility.
Key Coverage Criteria
- When a molecular panel of 5–50 genes is ordered, bill the appropriate panel CPT code (81445, 81449, 81450, or 81451) instead of submitting individual single-gene CPT codes.
- When 51 or more genes are ordered for molecular biomarkers, bill the appropriate large-panel CPT code (81455 or 81456) rather than individual gene codes.
- When a panel contains more than one but fewer than five genes, use the corresponding existing panel CPT code or CPT 81479 (unlisted molecular pathology procedure) if no specific panel CPT exists.
- Use modifier 91 only when a test is performed more than once on the same day for the same patient and the repeat testing is necessary to obtain multiple results in the course of treatment.
- Coverage determinations for biomarker testing follow Local Coverage Determination L35062 and services are covered when reasonable and necessary per that LCD.
- 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.
20 Active Policies
A57100 — Billing and Coding: MolDX: Repeat Germline Testing
J05
L36807 — MolDX: Molecular Diagnostic Tests (MDT)
J05
A58756 — Billing and Coding: MolDX: Lab-Developed Tests for Inherited Cancer Syndromes in Patients with Cancer
J05
L39040 — MolDX: Lab-Developed Tests for Inherited Cancer Syndromes in Patients with Cancer
J05
Related Codes
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