Evaluation of Biomarkers for Alzheimer disease
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Defines medical necessity, prior authorization, and coding for cerebrospinal fluid, blood, and urinary biomarkers used to evaluate mild cognitive impairment or mild dementia due to Alzheimer disease for Medicare Advantage and Commercial products.
No material clinical or coverage changes in this revision.
Coverage Criteria — When tests are medically necessary or not
CSF biomarker testing — medically necessary conditions
Covered when ALL of the following are met
Must be for initiation of amyloid beta targeting therapy; not for continuation
CSF testing covered only in this specific context
Continuation evaluations are excluded
Tests considered not covered / not medically necessary
Not covered / Not medically necessary
Code 0361U deleted effective 12/31/2025
Blood and urinary biomarkers as adjuncts to clinical diagnosis are not covered
Urine testing not covered when used as adjunct to diagnosis
CSF biomarkers to determine eligibility for initial anti-amyloid therapy
Covered when ALL of the following are met
CSF biomarker testing intended for this clinical population
CSF may be used as an alternative to amyloid PET to identify patients who may benefit from anti-amyloid therapy
Medically necessary biomarker testing
Covered when ALL of the policy's clinical criteria are met (see other policy sections):
Refer to clinical criteria elsewhere in the policy for required documentation and indications
Not covered / Not medically necessary tests
Not covered / not medically necessary when filed with listed ICD-10 codes:
ICD-10 codes linked in policy text
Measurement of urinary and blood biomarkers as an adjunct to clinical diagnosis in individuals with mild cognitive impairment or mild dementia due to Alzheimer disease is not covered for Medicare Advantage Plans and not medically necessary for Commercial Products because the evidence is insufficient to determine impact on health outcomes. The policy specifically lists the PrecivityAD® blood test (CPT 0412U) as an example of a blood biomarker test that is not covered when used as an adjunct to clinical diagnosis.
Laboratories and their representatives are prohibited from obtaining prior authorization on behalf of ordering physicians. Only the ordering physician may be involved in prior authorization, appeals, or other administrative processes related to prior authorization/medical necessity. If a laboratory or third party participates in the authorization process on behalf of the ordering physician, BCBSRI will treat this as a policy violation and may take severe action up to and including termination from the BCBSRI provider network.
The policy explicitly identifies certain tests as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products. This includes the proprietary blood test PrecivityAD® (CPT 0412U) and specific Neurofilament Light Chain tests (CPTs 0361U and 0443U) when used in the contexts described elsewhere in the policy. These codes are called out in the Coding section as not covered when filed with the dementia-related ICD-10 codes listed in the policy.
Neurofilament Light Chain testing represented by CPTs 0361U and 0443U, and the PrecivityAD® blood test (CPT 0412U), are identified in this policy as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products. CPT 0361U is noted in the Coding section as having a code deletion effective 12/31/2025.
The policy states that neurofilament light chain tests (CPT 0361U, 0443U) and the PrecivityAD® blood test (CPT 0412U) are not covered / not medically necessary in the scenarios described, and lists these codes in the Coding section as tests that will be denied when submitted in the specified clinical contexts and with the listed dementia-related ICD-10 codes.
Coding — CPT/HCPCS/ICD-10 guidance
| 82233 | Beta-amyloid; 1-40 (Abeta 40) |
| 82234 | Beta-amyloid; 1-42 (Abeta 42) |
| 84393 | Tau, phosphorylated (eg, pTau 181, pTau 217), each |
| 84394 | Tau, total (tTau) |
| 0358U | Lumipulse® G ß-Amyloid Ratio (1-42/1-40) (Fujirebio Diagnostics, Inc) - CPT code 0358U |
| 0445U | Elecsys® PhosphoTau (181P) CSF (pTau181) and β -Amyloid (1-42) CSF II (Abeta 42) Ratio (Roche Diagnostics) - CPT code 0445U |
| 0459U | Elecsys® Total Tau CSF (tTau) and Β -Amyloid (1-42) CSF II (Abeta 42) Ratio (Roche Diagnostics Operations, Inc) - CPT code 0459U |
| 0361U | Neurofilament Light Chain (NfL) (Mayo Clinic) - CPT code 0361U (Code Deleted Effective 12/31/2025) |
| 0443U | Neurofilament Light Chain (NfL) (Washington University in St. Louis School of Medicine) - CPT code 0443U |
| 0412U | Beta amyloid, Aβ42/40 ratio, immunoprecipitation with quantitation by LC-MS/MS and qualitative ApoE isoform-specific proteotyping, plasma combined with age, algorithm reported as presence or absence of brain amyloid pathology (PrecivityAD®) - CPT code 0412U |
| 82233 | Beta-amyloid; 1-40 (Abeta 40) |
| 82234 | Beta-amyloid; 1-42 (Abeta 42) |
| 84393 | Tau, phosphorylated (eg, pTau 181, pTau 217), each |
| 84394 | Tau, total (tTau) |
| 0358U | Neurology (mild cognitive impairment), analysis of B-amyloid 1-42 and 1-40, chemiluminescence enzyme immunoassay, cerebral spinal fluid, reported as positive, likely positive, or negative (used for Lumipulse® G ß-Amyloid Ratio) - CPT code 0358U |
| 0445U | βamyloid (Abeta42) and Phospho Tau (181P) (pTau181), electrochemiluminescence immunoassay (ECLIA), cerebral spinal fluid, ratio reported as positive or negative for amyloid pathology - CPT code 0445U |
| 0459U | βamyloid (Abeta42) and Phospho Tau (181P) (pTau181), ECLIA, cerebral spinal fluid, ratio reported as positive or negative for amyloid pathology - CPT code 0459U |
| 0361U | Neurofilament light chain, digital immunoassay, plasma, quantitative (Code Deleted Effective 12/31/2025) - CPT code 0361U |
| 0443U | Neurofilament light chain (NfL), ultra-sensitive immunoassay, serum or cerebrospinal fluid - CPT code 0443U |
| 0412U | Beta amyloid, Aβ42/40 ratio, immunoprecipitation with quantitation by LC-MS/MS and qualitative ApoE isoform-specific proteotyping, plasma combined with age, algorithm reported as presence or absence of brain amyloid pathology (PrecivityAD®) - CPT code 0412U |
Provider actions — Authorization, verification, and denial risks
Verify eligibility and coverage before ordering biomarker tests
Certain biomarker tests in this policy are subject to coverage rules and must meet the policy's clinical criteria; providers must verify member eligibility and benefit coverage before ordering. For member‑specific coverage questions, contact the provider call center or refer to the member's subscriber agreement/employer contract.
- Verify benefits and eligibility prior to testing
- Tests listed as medically necessary require that the policy's clinical criteria are met
Prior authorization — provider responsibilities
(No additional requirement text provided in the source for this placeholder.)
Benefit verification — provider responsibilities
(No additional requirement text provided in the source for this placeholder.)
Ordering physician must own the authorization process
Only the ordering physician may initiate or participate in prior authorization, appeals, or other administrative processes related to authorization/medical necessity; laboratories and their representatives are prohibited from obtaining authorization on behalf of the ordering physician.
- Laboratories or third parties may not obtain authorization, facilitate the authorization process, or participate in appeals on behalf of the ordering physician
- Violations may result in severe action, including termination from the BCBSRI provider network
Verify member benefits and adhere to clinical criteria
Providers must verify member benefits and eligibility before testing; member coverage is determined by the subscriber agreement or employer contract and supersedes this policy. Tests identified as medically necessary are only covered when the policy's clinical criteria are met.
- Check member‑specific benefits with the provider call center
- Ensure the requested test meets the policy’s clinical criteria for medical necessity
Unauthorized laboratory services will be denied and billed to the lab
If a laboratory provides a laboratory service that has not been authorized, the service will be denied and the financial liability will be the participating laboratory; such services may not be billed to the member.
- Unauthorized lab services denied as financial liability of the laboratory
- Do not bill the member for unauthorized services
Denial risk: not‑covered CPT codes (PrecivityAD®, NfL) when billed with dementia ICD‑10 codes
Use of the listed CPT codes for tests identified as not covered (for example CPT 0412U PrecivityAD® and neurofilament codes 0361U/0443U) are considered not covered for Medicare Advantage and not medically necessary for Commercial Products when filed with the specified dementia‑related ICD-10 codes (F03.90‑F03.91, G30.0‑G30.9, G31.1).
Background — Clinical context
Alzheimer disease is a progressive neurodegenerative disorder characterized by accumulation of extracellular amyloid plaques and intracellular neurofibrillary tangles; biomarker abnormalities can precede clinical symptoms by years. Cerebrospinal fluid measures such as Aβ42, total tau (tTau), and phosphorylated tau (pTau) have established roles in diagnostic evaluation and prognosis for mild cognitive impairment and dementia, while blood and urine biomarkers remain under investigation and have less-established clinical validity.
Definitions — Biomarkers and assay terms
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