81535
HCPCS/CPT
Prior Authorization
Prior Auth Required
Conditional coverage; review criteria to confirm PA need (medium 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.
- A molecular or genomic test may be covered when it provides new clinical diagnostic information that cannot be obtained from any other test or combination of tests and is reasonable and necessary for management of the Medicare beneficiary.
- A molecular panel is coverable when the medical record documents that the entire panel is reasonable and necessary for the beneficiary’s specific medical problem and will be used in patient management.
16 Active Policies
L35000 — Molecular Pathology Procedures
J06
A56199 — Billing and Coding: Molecular Pathology Procedures
J06
A59926 — Billing and Coding: Molecular Pathology Procedures
J06
L34519 — Molecular Pathology Procedures
J09
L39367 — Genetic Testing in Oncology: Specific Tests
Related Codes
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