0010U
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Documentation Required
- Medical records must support the medical necessity of the billed molecular test and demonstrate analytic validity and clinical utility of the specific procedure performed.
- When billing CPT 81479, the specific gene(s) tested must be entered on the claim (block 80 Part A, box 19 Part B, or electronic equivalent) and medical records must explain why 81479 was billed.
- If multiple procedure codes are submitted on a claim, documentation supporting each billed code must be clearly identifiable and linkable to the specific service performed.
- For panels billed as a single service, the medical record must document why parallel testing of the included genes was reasonable and necessary; for serial (reflex) testing, documentation must show reflex criteria and rationale.
Key Coverage Criteria
- 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.
- Individual gene tests billed separately are coverable when the medical record documents that each individual gene test is reasonable and necessary for the beneficiary’s management.
- When using next generation sequencing (NGS), genes assayed in parallel for the same indication on the same date of service are considered a single panel and may be billed as such when reasonable and necessary.
- Advanced diagnostic laboratory tests (ADLTs) are allowable only when they provide new clinical diagnostic information that cannot be obtained from any other test or combination of tests (per 42 CFR 414.502).
- The referring/ordering practitioner must have an established relationship with the patient and must use the test results to manage the patient’s specific medical problem (per 42 CFR 410.32).
7 Active Policies
A58918 — Billing and Coding: Molecular Pathology and Genetic Testing
J09
L34519 — Molecular Pathology Procedures
J09
L39367 — Genetic Testing in Oncology: Specific Tests
J09
L35062 — Biomarkers Overview
J12
A58917 — Billing and Coding: Molecular Pathology and Genetic Testing
Related Codes
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