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    v1.0.28
    OpenPayerPolicy UpdatesNeurology/Neurosurgeryharvard pilgrim biomarker testing Coverage Update …
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    Draftharvard pilgrim health carePolicy N/A

    Biomarker testing for Alzheimer disease (CSF and specified plasma assays)

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    Defines coverage for cerebrospinal fluid and specific plasma biomarker tests for individuals with suspected Alzheimer disease or mild cognitive impairment for Harvard Pilgrim Health Care commercial products.

    Policy Summary
    Payerharvard pilgrim health care
    PolicyBiomarker testing for Alzheimer disease (CSF and specified plasma assays)
    Policy CodePolicy N/A
    Change TypeCoding additions and annual administrative review
    Effective DateNov 1, 2025
    Next Review DateApr 1, 2026
    Key ActionVerify benefit-specific prior authorization and use listed biomarker assay codes when ordering CSF amyloid/tau or FDA-approved plasma p-tau217/Aβ42 tests.
    SourceLink

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    POLICY UPDATE CHANGES

    Added CPT and proprietary codes 82233, 82234, 83884, 84393, 84394, 0547U, 0548U, 0568U, 0596U to the coding grid effective for dates of service beginning June 1, 2026.

    Annual policy review with administrative edits was performed on 04/01/2026.

    Policy was created to support coverage guidelines effective for dates of service beginning Nov. 1, 2025.

    CSF + plasma p-tau217/Aβ42Covered biomarker tests
    Other fluid/multianalyte testsNot covered categories
    ~40+Codes enumerated
    CommercialApplies to
    9New codes added
    2Plans this applies to

    Coverage Criteria for Biomarker Testing

    CSF amyloid and tau biomarker testing (covered)

    Covered when ALL of the following are met

    Covered CSF biomarkers: For individuals with suspected Alzheimer disease or mild cognitive impairment, measurement of amyloid beta peptides in cerebrospinal fluid meets coverage criteria.clinical indication: suspected AD or MCI

    Reference: policy indications

    CSF t-tau/Aβ42 ratio: For individuals with suspected Alzheimer disease or mild cognitive impairment, measurement of the ratio of total tau (t-tau) to amyloid beta 1-42 (Aβ42) in cerebrospinal fluid meets coverage criteria.clinical indication: suspected AD or MCI

    Reference: policy indications

    CSF p-tau181/Aβ42 ratio: For individuals with suspected Alzheimer disease or mild cognitive impairment, measurement of the ratio of phosphorylated tau 181 (p-tau181) to Aβ42 in cerebrospinal fluid meets coverage criteria.clinical indication: suspected AD or MCI

    Reference: policy indications

    Plasma p-tau217/Aβ42 ratio testing (covered)

    Covered when ALL of the following are met

    Covered plasma test: For individuals with suspected Alzheimer disease or mild cognitive impairment, measurement of the ratio of phosphorylated tau 217 (p-tau217) to Aβ42 in plasma using an FDA-approved test (for example, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio) meets coverage criteria.FDA-approved plasma p-tau217/Aβ42 assay; clinical indication: suspected AD or MCI

    Reference: policy indications

    Measurement of cerebrospinal fluid analytes not specifically listed as covered in this policy is excluded. Examples of CSF tests that DO NOT MEET COVERAGE CRITERIA include assays for tau protein, α-synuclein, and neural thread proteins. In addition, the policy excludes urinary biomarkers and other CSF markers not enumerated among the covered CSF amyloid and tau measurements.

    This policy is not a guarantee of payment. Coverage and payment decisions remain subject to the member's benefits and eligibility on the date of service, coordination of benefits, any required referral or authorization, utilization management requirements, and the provider's network participation. An authorization, when provided, is not a guarantee of payment, and claims are adjudicated according to Plan policies and claims editing logic.

    Tests and assays listed in the policy exclusions do not meet coverage criteria due to insufficient evidence supporting their clinical utility for diagnosis, prognosis, or management of Alzheimer disease or dementia. This includes measurement of plasma/serum analytes cited as examples (for instance, individual p-tau217 or Aβ42 values, total tau, Aβ1‑40, ApoE/ApoE4) and the use of multianalyte or algorithmic assays not specifically covered.

    Procedure and Proprietary Codes

    Procedure CPT/HCPCS referencesmixed
    82233Beta-amyloid; 1-40 (Abeta 40) (Effective for DOS beginning June 1, 2026)
    82234Beta-amyloid; 1-42 (Abeta 42) (Effective for DOS beginning June 1, 2026)
    83520Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise specified.
    83884Neurofilament light chain (NfL) (Effective for DOS beginning June 1, 2026)
    84393Tau, phosphorylated (eg, pTau 181, pTau 217), each (Effective for DOS beginning June 1, 2026)
    84394Tau, total (tTau) (Effective for DOS beginning June 1, 2026)
    Proprietary/PLA codes and testsmixed
    0206UDISCERN™ - cell aggregation using morphometric imaging and PKC-e concentration in response to amylospheroid treatment by ELISA, cultured skin fibroblasts
    0207UDISCERN™ - imaging of phosphorylated ERK1/2 in response to bradykinin by in situ immunofluorescence, cultured skin fibroblasts
    0289UMindX Blood Test™ - Memory/Alzheimer's (mRNA gene expression profiling algorithm, 24 genes)
    0346UQUEST AD-Detect™, Beta-Amyloid 42/40 Ratio, Plasma (LC-MS/MS)
    0393USYNTap® Biomarker Test - CSF detection of misfolded α-synuclein by seed amplification assay
    0412UPrecivityAD® - Beta amyloid Aβ42/40 ratio by LC-MS/MS with ApoE proteotyping and algorithm
    0443UNeurofilament Light Chain (NfL) - ultra-sensitive immunoassay, serum or CSF
    0445Uβ-amyloid (Abeta42) and phospho tau (181p) (ptau181), ECLIA, CSF, ratio reported
    0459Uβ-amyloid (Abeta42) and total tau (tTau), ECLIA, CSF, ratio reported (Elecsys®)
    0479UpTau217 (ALZpath pTau217)
    1–10 of 15
    1/2
    Added coding grid entriesmixed
    82233code added to coding grid (per publication history)
    82234code added to coding grid (per publication history)
    83884code added to coding grid (per publication history)
    84393code added to coding grid (per publication history)
    84394code added to coding grid (per publication history)
    0547Uproprietary code added to coding grid (per publication history)
    0548Uproprietary code added to coding grid (per publication history)
    0568Uproprietary code added to coding grid (per publication history)
    0596Uproprietary code added to coding grid (per publication history)
    Test eligibility context — applicable population
    Applicable populationIndividuals with suspected Alzheimer disease or mild cognitive impairment (MCI)
    Clinical context requiredTesting is indicated to assist diagnosis in the setting of suspected AD or MCI; documentation should support this indication
    Test types covered for this populationCerebrospinal fluid measurements of amyloid beta peptides, t-tau/Aβ42 ratio, and p-tau181/Aβ42 ratio; plasma p-tau217/Aβ42 when using an FDA-approved assay
    Benefit-check & authorizationCoverage is subject to the member's benefits, eligibility, and any required prior authorization

    Provider Actions, Authorization, and Billing Guidance

    Prior Authorization

    Verify benefits & prior authorization

    Verify member benefits and prior authorization requirements for listed biomarker assay codes before ordering or billing. Coverage and PA requirements depend on the member's specific plan and eligibility on the date of service; contact the Plan or use the provider portal to confirm benefits and obtain any required authorizations.

    • Action: Confirm eligibility and benefit coverage on the date of service.
    • Action: Obtain prior authorization when required by the member's plan or product before performing the test.
    Denial Risk

    Denial triggers for non‑covered biomarker tests

    Tests that are not listed as meeting coverage criteria in this policy (for example: many plasma, urine, or other non-CSF biomarkers and multianalyte/algorithmic assays not specified as covered) will be denied as not meeting coverage. Ensure the ordered test matches a covered indication and code.

    Background and Rationale

    Alzheimer disease is a progressive neurodegenerative disorder characterized by declining memory and cognition, brain atrophy, and accumulation of extracellular amyloid plaques and intracellular neurofibrillary tangles. Cerebrospinal fluid biomarkers such as Aβ42, total tau (t‑tau), and phosphorylated tau (p‑tau181) and emerging plasma biomarkers (for example, the plasma p‑tau217/Aβ42 ratio) can assist in the evaluation of individuals with suspected Alzheimer disease or mild cognitive impairment. However, many other fluid analytes and multianalyte/algorithmic tests lack sufficient evidence and are explicitly not covered under this policy.

    Definitions and Biomarker Descriptions

    Alzheimer disease — summary
    DefinitionAlzheimer disease (AD) is a neurodegenerative disease defined by gradual decline in memory and cognition, brain atrophy, and accumulation of extracellular amyloid plaques and intracellular neurofibrillary tangles.
    Clinical courseCharacterized by progressive cognitive decline that may present as mild cognitive impairment progressing to dementia
    Diagnostic role of biomarkersCSF and plasma biomarkers (amyloid beta peptides, total tau, phosphorylated tau) support biological diagnosis and staging of AD when used in appropriate clinical context
    Plasma and CSF biomarkers — analytes and role
    Analytes measuredAmyloid beta peptides (Aβ42, Aβ40), total tau (t-tau), phosphorylated tau (p-tau181, p-tau217), neurofilament light (NfL), glial fibrillary acidic protein (GFAP)
    Sample types

    Policy Revisions and Effective Dates

    2026-04-01annual_reviewLatest

    Annual policy review with administrative edits; coding grid updated to add CPT and proprietary codes 82233, 82234, 83884, 84393, 84394, 0547U, 0548U, 0568U, and 0596U effective for dates of service beginning June 1, 2026.

    2025-09-01policy_created

    Policy created to support coverage guidelines effective for dates of service beginning Nov. 1, 2025.

    Policy Summary
    Payerharvard pilgrim health care
    PolicyBiomarker testing for Alzheimer disease (CSF and specified plasma assays)
    Policy CodePolicy N/A
    Change TypeCoding additions and annual administrative review
    Effective DateNov 1, 2025
    Next Review DateApr 1, 2026
    Key ActionVerify benefit-specific prior authorization and use listed biomarker assay codes when ordering CSF amyloid/tau or FDA-approved plasma p-tau217/Aβ42 tests.
    SourceLink
    On This Page
    Coverage Criteria for Biomarker TestingProcedure and Proprietary CodesProvider Actions, Authorization, and Billing GuidanceBackground and RationaleDefinitions and Biomarker DescriptionsPolicy Revisions and Effective Dates
    • Examples of tests likely to be denied: plasma p‑tau217 or Aβ42 as individual markers, total tau protein in plasma/serum, urinary neural thread proteins, multianalyte/algorithmic assays not specified as covered.
    • Denial basis: lack of evidence that the test is required and beneficial for diagnosis or treatment per policy.
    Billing Rule

    Claims payment is subject to member eligibility and plan rules

    Claims payment is subject to member eligibility and benefits on the date of service, coordination of benefits, referral/authorization requirements, utilization management rules, adherence to Plan policies and procedures, claims editing logic, and provider network participation. An authorization does not guarantee payment.

    • Payment depends on member benefits and eligibility on the DOS.
    • Claims are subject to coordination of benefits, referral/authorization, utilization management, and claims editing logic.
    Documentation Required

    Clinical indication documentation required

    When ordering covered amyloid/tau biomarker tests, document the clinical indication in the medical record. Documentation should support suspected Alzheimer disease (AD) or mild cognitive impairment (MCI) and include relevant clinical findings, cognitive testing results, and rationale for testing.

    • Document suspected diagnosis (e.g., suspected AD or MCI) and supporting clinical findings.
    • Include cognitive testing results, neurologic exam findings, and rationale for how results will impact diagnosis or management.
    Note

    Payment is based on member benefits and eligibility

    Payment and coverage are determined by member benefits and eligibility, medical necessity review where applicable, and the provider's network participation. For specific coding and coverage determinations, verify the member's plan, confirm prior authorization requirements, and follow the most recent CPT/HCPCS coding guidelines.

    • Payment is not guaranteed by policy language alone; each claim is adjudicated based on member benefits and medical necessity.
    • Follow current CPT/HCPCS coding when submitting claims; codes may be updated for future dates of service (see code effective dates).
    Cerebrospinal fluid (CSF) and plasma (blood) assays
    Role in careUsed as diagnostic and prognostic markers across the Alzheimer's disease continuum to support diagnosis of suspected AD or MCI; plasma p-tau217/Aβ42 via FDA-approved test is covered
    Limitations notedMany other fluid biomarkers and multianalyte/algorithmic assays lack sufficient published evidence and do not meet coverage criteria