M1A.3521 — Chronic gout due to renal impairment, left hip, with tophus (tophi)
ICD-10-CM
Prior Authorization
No Prior Auth Required
No active coverage policies found for this code (low confidence)
Documentation Required
- When billing Part B claims, include the drug(s) being considered that require the PGx test on the applicable detail line (eg, 2400 loop on 837P); for Part A include Loop SV202-7 (837I) or Block 80 (UB04); for paper Part B include Box 19.
- When billing CPT 81418, list the names of all specific genes tested (in addition to CYP2C19 and CYP2D6) in the claim comment/narrative field appropriate to the claim type (Part A SV202-7/Block80; Part B Loop 2400/SV101-7/Box19).
- Document prior germline testing history and the clinical rationale or evidence of established clinical utility for any non-duplicative components to support that the service billed is reasonable and necessary.
- For multi-gene testing coding and billing guidance, follow the Molecular Pathology and Genetic Testing Article A58917 as applicable.
Key Coverage Criteria
- Pharmacogenomics (PGx) testing is covered when it is reasonable and necessary per LCD L39063 and Medicare coverage rules for the beneficiary's clinical indication.
- CPT 81418 (PGx multi-gene panel) is covered when the test assays at least 6 genes, including CYP2C19 and CYP2D6 and CYP2D6 duplication/deletion analysis, and the panel is clinically indicated to guide drug therapy.
- A clinician-ordered single gene or allele test is considered covered when the billed component corresponds to the single gene/allele that was reasonable and necessary, even if the laboratory platform concurrently interrogated other genes operationally.
- Germline testing panels that include some previously tested genetic content may be covered if there is established clinical utility for the remaining non-duplicative genetic components of the panel.
- Genes may be assayed serially or in parallel; additional gene analyses done after a reflex decision are covered when those reflexive analyses are reasonable and necessary for the beneficiary's care.
- Germline pharmacogenomic (PGx) testing is covered when the test results have established clinical utility to guide management of a specific drug therapy for the Medicare beneficiary.
20 Active Policies
A59434 — Billing and Coding: Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound
J05
L39624 — Amniotic and Placental Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound
J05
A59915 — Billing and Coding: Pharmacogenomic Testing
J06
A58893 — Billing and Coding: Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound
J06
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