CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Biomarker testing for Alzheimer disease (CSF, blood, urine) — Coverage Criteria

This policy defines coverage and medical necessity determinations for cerebrospinal fluid, blood, and urine biomarker testing (including specific tests NfL and PrecivityAD) for individuals with mild cognitive impairment or Alzheimer disease for Blue Cross Blue Shield - Rhode Island members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyBiomarker testing for Alzheimer disease (CSF, blood, urine) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionDo not submit claims for CSF, blood, or urine biomarker testing for MCI or AD — these tests are designated not covered or not medically necessary.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2named commercial blood/CSF tests (NfL, PrecivityAD)

Not coveredCoverage stance for MCI/AD biomarkers

5CPT / unlisted codes referenced

NotedFDA Breakthrough / De Novo mentions

Coverage Criteria — Biomarker Testing for Alzheimer Disease

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Laboratories are prohibited from obtaining clinical authorization or participating in the authorization process on behalf of the ordering physician. Only the ordering physician shall be involved in authorization, appeals, or other administrative processes related to prior authorization or medical necessity for cerebrospinal fluid, blood, or urine biomarker testing. Use of a laboratory representative or any third party to obtain authorization, facilitate the authorization process, or prepare supporting documentation is not permitted and may be treated as a policy violation.

Services determined to be not medically necessary or otherwise non‑covered under a member's contract are excluded from coverage and may not be billed to the member unless the member has provided prior written agreement. Member benefits and eligibility are determined by the subscriber agreement, member certificate, or employer agreement, which supersede this policy. For member‑specific determinations, providers must contact the provider call center.

If a laboratory or third party is found to have supported any portion of the authorization process in violation of this policy, BCBSRI may treat the action as a policy violation and pursue sanctions up to termination from the provider network.

For Medicare Advantage Plans, cerebrospinal fluid, urinary, and blood biomarker testing for Alzheimer disease or mild cognitive impairment are not covered. For Commercial Products, these tests are considered not medically necessary. Specific CPT codes identified as not covered/not medically necessary include 0361U, 0412U, 83520, 86849, and 81099 when filed with the relevant ICD‑10 diagnoses.

Cerebrospinal fluid, urinary, and blood biomarker testing for Alzheimer disease or mild cognitive impairment are designated as not covered for Medicare Advantage and not medically necessary for Commercial Products. As such, these services are excluded from coverage under this policy and may not be billed to members except as allowed under the member’s contractual terms and only with prior written agreement.

Coding — CPT and Diagnosis Codes

Not covered / Not medically necessary CPT codes referencedCPTNot Covered

0361U	Neurofilament light chain, digital immunoassay, plasma, quantitative (NfL) — Mayo Clinic
0412U	Beta amyloid, Aβ42/40 ratio, immunoprecipitation with quantitation by liquid chromatography with tandem mass spectrometry (LC-MS/MS) and qualitative ApoE isoform-specific proteotyping, plasma (PrecivityAD®) — New code effective 10/01/2023
83520	Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise specified (used for tau/amyloid testing)
86849	Unlisted Immunology Procedure (may be used for CSF testing)
81099	Unlisted Urinalysis Procedure (may be used for urine testing)

ICD-10 Diagnosis Codes referencedICD-10

F03.90-F03.91	Unspecified dementia
G30.0-G30.9	Alzheimer disease codes
G31.1	Senile degeneration of brain
G31.84	Mild cognitive impairment, so stated
R41.81	Age-related cognitive decline

Provider Actions — Authorization, Billing, and Risk

Denial Risk

Not Covered / Not Medically Necessary

Cerebrospinal fluid, urinary, and blood biomarker testing described in this policy are designated Not Covered / Not Medically Necessary for the listed indications. Prior authorization is not applicable.

Prior Authorization

Prior authorization: Not applicable for this policy.

Documentation Required

Ordering Physician Responsibility — No Third‑Party Authorization

Only the ordering physician shall be involved in authorization, appeal, or other administrative processes related to prior authorization or medical necessity. Laboratories, laboratory representatives, or third parties must not obtain or facilitate authorizations on behalf of the ordering physician; doing so may result in denial or other actions.

Denial Risk

Unauthorized Lab Services Denied

If a laboratory provides a laboratory service that has not been authorized, the service will be denied and the financial liability rests with the participating laboratory or provider; such services may not be billed to the member.

Note

Benefits and Eligibility Determination

Member-specific benefits and eligibility are determined by the member's subscriber agreement/certificate or employer agreement. For information on member-specific benefits, the provider must call the BCBSRI provider call center.

Billing Rule

Member Billing and Denial Risk

If services are determined to be not medically necessary or are non‑covered benefits, the provider may not charge the member for those services unless the member was informed in advance and provided written agreement to pay privately. Refer to participation agreements for applicable provisions.

Background — Disease Context and Policy Scope

Alzheimer disease diagnoses are classified as possible, probable, or definite, with a definite diagnosis requiring postmortem confirmation. Mild cognitive impairment (MCI) is a prodromal state characterized by impairment in one or more cognitive domains with preserved functional independence and may progress to Alzheimer disease in some individuals. Biomarker testing (including CSF amyloid and tau measures, and emerging blood or urine markers) has been studied to support diagnosis and prognosis, but current evidence is insufficient to demonstrate improved health outcomes that would warrant coverage for routine clinical use in the contexts described in this policy.

Definitions — Clinical Terms and Biomarkers

Mild cognitive impairment (MCI) definition

DefinitionMild cognitive impairment (MCI): impairment in one or more cognitive domains with preserved functional independence; may represent a predementia phase of Alzheimer disease.

Clinical contextMCI may be diagnosed when a dementia diagnosis cannot be made yet there is a significant change in cognition; patients retain independence in activities of daily living.

Relation to ADIn some patients, MCI is a prodromal state that can progress to Alzheimer disease; ancillary testing (neuroimaging, labs, neuropsychological assessment) may be used to evaluate causes and risk of progression.

AD biomarkers

CSF Aβ42Cerebrospinal fluid amyloid-β 1-42 (Aβ42): low CSF Aβ42 levels have been associated with Alzheimer disease and may reflect plaque deposition.

Total tauElevated CSF total tau protein is associated with neuronal degeneration seen in Alzheimer disease.

Phosphorylated tau (p-tau) epitopesCSF phosphorylated tau at AD-specific epitopes (eg, p-tau181) has been studied as an AD biomarker.

Tau/Aβ42 ratioThe CSF tau/Aβ42 ratio has been suggested to provide greater diagnostic accuracy than either marker alone.

Neural thread protein (AD7C)Neural thread protein has been evaluated in CSF and urine (eg, AD7C test) as a potential marker of AD-related neurofibrillary tangles.

Alzheimer's disease biomarkers

Phosphorylated tau variantsPhosphorylated tau measured in CSF and plasma (eg, p-tau181, p-tau217) has been evaluated for diagnostic discrimination of AD versus other disorders.

Aβ42/40 ratioCSF Aβ42/40 ratio may correspond better than Aβ42 alone to amyloid PET and improve diagnostic performance.

Plasma phosphorylated tauPlasma p-tau assays (eg, p-tau181, p-tau217) have shown diagnostic value and are referenced in validation and discriminative accuracy studies.

Amyloid PET and other assaysAmyloid PET and standardized CSF/plasma assays are included among diagnostic biomarker modalities evaluated for AD.