J0172, Injection, aducanumab-avwa, 2 mg
HCPCS/CPT
Prior Authorization
Prior Auth Required
Conditional coverage; review criteria to confirm PA need (medium confidence)
Documentation Required
- Discern / NeuroDiagnostics: peripheral skin samples are collected via a standard 2-3mm punch biopsy taken from the bicep/forearm area (procedure description/collection requirement).
- MindX Blood Test - Memory/Alzheimer's: 'The test is available by prescription only.' (requires ordering provider prescription) and is 'indicated for middle aged or elderly patients presenting signs of forgetfulness, depression, periods of high stress, and a family history of dementia.'
- Discern / NeuroDiagnostics (skin fibroblast assays): 'Patients tested must first have a clinical diagnosis of dementia (the duration of such dementia to extend from the first year of dementia forward). The intended population will range in age from 55-90 years old.'
- PS-1 DNA Sequencing Test: described as 'used for evaluating patients with progressive demential with onset before age 65 with a positive family history of early-onset AD' (clinical scenario in which test has been applied, though evidence insufficient).
- General (implicit): many biomarker studies referenced required clinical characterization (e.g., clinical diagnosis of AD/MCI, neuropsychological testing, MMSE, Clinical Dementia Rating), APOE genotype status, imaging (MRI, PET), and CSF collection via lumbar puncture — meaning interpretation in research/clinical studies depends on paired clinical and imaging/CSF data.
- No explicit documentation requirements or coverage-certifying documentation are stated in the provided text.
Key Coverage Criteria
- Lumbar puncture (CSF testing) to confirm presence of elevated phosphorylated tau (P-tau) and/or elevated total tau (T-tau) and reduced beta amyloid-42 (Aβ42) or a low Aβ42/Aβ40 ratio as determined by the lab assay detected in cerebrospinal fluid (CSF) for the assessment of mild cognitive impairment (MCI) when Alzheimer's disease (AD) is suspected.
- Brain magnetic resonance imaging (MRI) for persons on aducanumab-avwa (Aduhelm) or lecanemab-irmb (Leqembi) therapy for the following indications: (a) within one year prior to initiating aducanumab or lecanemab therapy to indicate AD, or (b) to evaluate for evidence of amyloid-related imaging abnormalities (ARIA) prior to the 5th, 7th, 9th, and 12th aducanumab dose or prior to the 5th, 7th, and 14th lecanemab dose (see CPB 0996 and CPB 1026 for details).
- Genetic mutation testing for APP, PSEN1, or PSEN2 for members with MCI or mild AD dementia who are less than 50 years of age and who are being considered for enrollment in a clinical trial of aducanumab (Aduhelm) or lecanemab (Leqembi).
- Amyloid PET scan indications are referenced (see CPB 0071 - Positron Emission Tomography (PET)) — amyloid PET is handled under CPB 0071.
- Alzheimer's disease (G30.0 - G30.9)
- Neurology (mild cognitive impairment) — CSF B-amyloid 1-42 and 1-40 chemiluminescence enzyme immunoassay reported as positive/likely positive/negative (0358U) — covered if selection criteria are met
2 Active Policies
EVICORE-MEDICAL_DRUG-85C35C32FFD7, Aducanumab-avwa (Aduhelm) - TX MedicaidEffective 12/01/2022 - 11/30/2023
AETNA-CPB-0349, Alzheimer's Disease Tests
Related Codes
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