Anthem Blue Cross and Blue Shield will begin covering certain blood-based biomarker tests for Alzheimer’s disease, creating a potentially important reimbursement pathway for clinical laboratories and diagnostics companies.
C2N Diagnostics announced that eligible Anthem members will receive coverage for its PrecivityAD2 blood test beginning Oct. 1, 2026. The test helps clinicians estimate the likelihood that amyloid plaques are present in the brains of adults experiencing cognitive decline or other symptoms associated with Alzheimer’s disease.
Although C2N highlighted its test in announcing the decision, Anthem’s revised medical policy is not limited to PrecivityAD2. It establishes medical-necessity criteria that could support reimbursement for several blood-based Alzheimer’s assays.
Tests listed in the policy include C2N’s PrecivityAD2, Fujirebio Diagnostics’ Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, Roche Diagnostics’ Elecsys pTau181 assay, the ALZpath pTau217 test associated with Neurocode USA, Quanterix, and ALZpath, and Quanterix Corporation’s LucentAD Complete panel.
Dark Daily previously reported that the FDA authorized the first blood-based test designed to assist clinicians in evaluating patients for Alzheimer’s disease: Fujirebio’s Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio.
In another development, Abbott and ALZpath entered into a licensing agreement to create a pTau217-based in vitro diagnostic assay for Abbott’s Alinity systems. The collaboration reflects growing competition among IVD manufacturers seeking a position in the developing Alzheimer’s diagnostics market.
Today’s Clinical Lab, a sister publication of Dark Daily, has also reported that biomarkers including pTau217, pTau181, and amyloid-beta are emerging as more accessible and less invasive alternatives to PET scans and cerebrospinal fluid testing. Over time, these assays could broaden access to earlier diagnosis and disease-modifying treatments while becoming more integrated into routine clinical laboratory testing.
Coverage depends on documentation
For clinical laboratories, inclusion in the policy does not guarantee payment for every claim. Labs and ordering providers will need to demonstrate that patients meet Anthem’s coverage requirements. Patients generally must be at least 50 years old and have measurable mild cognitive impairment or dementia with an insidious onset and progressive decline. The diagnosis must remain unclear after a standard evaluation that includes a medical history, neurological examination, cognitive testing, and assessment for reversible causes of impairment.
Testing must also be expected to affect patient management. Covered uses may include determining whether cerebrospinal fluid testing or PET imaging is needed, evaluating patients who cannot undergo lumbar puncture, distinguishing Alzheimer’s disease from other dementias, or helping assess eligibility for amyloid-targeting therapies.
Anthem’s policy states that a blood test must either be FDA cleared or approved, or measure p-tau217 or percentage p-tau217. That provision may allow some laboratory-developed tests to qualify even without FDA clearance.
The policy identifies Fujirebio’s Lumipulse assay and Roche’s Elecsys test as the only FDA-cleared blood-based Alzheimer’s biomarker tests at the time of review. PrecivityAD2 and other p-tau217 assays may still be reimbursable when the policy’s clinical criteria are met.
For laboratories, the decision provides a clearer route to payment but also places greater emphasis on test selection, coding, medical-necessity documentation, and coordination with ordering clinicians.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
