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Biochemical Markers of Alzheimer Disease and Dementia
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Defines coverage criteria for biochemical (blood, plasma, CSF, urine, and other media) biomarkers used to aid diagnosis or evaluation of Alzheimer disease and other dementias for Oscar Health members.
No material clinical or coverage changes in this revision.
Coverage criteria for biochemical biomarkers
Covered biomarker testing (meets criteria)
Covered when ALL of the following are met:
CSF testing must be for individuals with suspected AD or MCI and interpreted in clinical context.
Only FDA-approved plasma p-tau217/Aβ42 assays are listed as meeting criteria; other plasma/serum tests do not meet criteria.
Not covered biomarker testing (does not meet criteria)
Guideline-based appropriate use / diagnostic criteria
Guideline-derived appropriate use principles and constraints
Alzheimer's Association operational guidance
Alzheimer's Association guidance
NIA-AA/Alzheimer's Association updates
NIA-AA and NINCDS/ADRDA guidance
Guideline-derived appropriateness and recommended use
Guideline-derived statements about when biomarkers are appropriate or recommended:
See SNMMI/Alzheimer's Association updated Appropriate Use Criteria
IWG guidance
JPND BIOMARKAPD findings
WHO preferred product characteristics
Biomarker interpretation and follow-up actions
Use combined amyloid and tau biomarker status to determine likelihood of Alzheimer's disease and need for further investigation:
Table 2 guidance
Table 2 guidance
Table 2 guidance
Table 2 guidance
Table 2 guidance
Phenotype-specific notes (Table 2)
Indications and test selection
Recommendations about when to perform biomarker testing:
IWG guidance
IWG recommendation
IWG and related guidance
IWG recommendation
The policy excludes the use of multianalyte assays, algorithmic analyses, and any tests not specifically listed as meeting criteria. Per the policy language, these methods when used for prognosis, diagnosis, or management of Alzheimer disease or dementia DOES NOT MEET CRITERIA and are therefore not covered under this policy.
Alzheimer's Association operational guidance identifies several clinical scenarios in which lumbar puncture/CSF testing is rated inappropriate. Examples include cognitively unimpaired individuals with no impairment or high-risk features, APOE ε4 carriers without cognitive impairment, use of lumbar puncture instead of genotyping for suspected autosomal dominant AD mutation carriers, and ADAD mutation carriers (with or without symptoms). These situations should not be considered appropriate indications for CSF biomarker testing.
Updated SNMMI/Alzheimer's Association Appropriate Use Criteria rate amyloid and tau PET as 'rarely appropriate' for cognitively unimpaired (CU) patients who are not considered at increased risk for AD (consensus rating 1). PET imaging in asymptomatic low-risk individuals is therefore not recommended under these criteria.
WHO guidance for blood-based diagnostics specifies an intended target population of individuals with established cognitive impairment and explicitly excludes individuals without established cognitive impairment as well as those undergoing treatment with disease-modifying therapies or participating in related clinical trials from the intended-use population for these tests.
The International Working Group (IWG) states that biomarker investigations in cognitively unimpaired individuals are not recommended in routine clinical practice because current evidence does not allow reliable prediction of clinical trajectories for asymptomatic biomarker-positive persons.
The IWG and related guidance recommend against routine investigation of pathophysiological biomarkers in asymptomatic (cognitively unimpaired) individuals at this time, noting the inability to predict reliable clinical outcomes and therefore advising against testing these individuals in clinical practice.
Within the provided excerpt there are no explicit coverage exclusions beyond the listed test-type exclusions and guideline-derived restrictions; the publication history section does not itself state additional payer exclusions.
The policy specifies that measurement of plasma/serum biomarkers (except for the specified FDA-approved plasma p-tau217/Aβ42 ratio), urinary biomarkers, and unspecified CSF assays does not meet criteria. Urinary biomarkers and CSF analytes not listed among approved CSF measures are also explicitly excluded from meeting criteria.
NIA/ADRDA and the NIA-AA workgroup have advised that the routine use of AD biomarker tests for general clinical diagnosis is discouraged. The workgroup emphasized that biomarkers are currently appropriate mainly for investigational studies, clinical trials, or as optional tools when available and when results are expected to change management.
The American Academy of Neurology's 2001 practice parameter stated that, at that time, no CSF or other biomarkers were recommended for routine clinical use in determining the diagnosis of Alzheimer disease because laboratory tests had not yet demonstrated clear added value over competent clinical diagnosis.
The IWG and related guidance note that plasma biomarkers for amyloid β and tau pathology are not currently recommended for routine clinical practice due to the need for further standardization and validation before they can be considered secure indicators of Alzheimer's disease pathology in clinical settings.
The excerpt provided does not contain explicit statements labeling any tests as universally 'not medically necessary' beyond the listings of tests that DOES NOT MEET CRITERIA and the guideline-derived recommendations; no additional not-medically-necessary declarations appear in the publication history fragment.
Procedure and proprietary test codes
| 82233 | Beta-amyloid; 1-40 (Abeta 40) |
| 82234 | Beta-amyloid; 1-42 (Abeta 42) |
| 83520 | Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise specified |
| 83884 | Neurofilament light chain (NfL) |
| 84393 | Neurofilament light chain (NfL) Tau, phosphorylated (eg, pTau 181, pTau 217), each |
| 84394 | Tau, total (tTau) |
| 0358U | Lab/Manufacturer: Fujirebio Diagnostics, Inc (Lumipulse® G β-Amyloid Ratio (1-42/1-40) Test) |
| 0459U | Proprietary test: Elecsys® Total Tau CSF (tTau) and β Amyloid (1-42) CSF II (Abeta 42) Ratio — Roche Diagnostics Operations, Inc |
| 0479U | Tau, phosphorylated, pTau217 (ALZpath pTau217) — Neurocode USA, Inc |
| 0503U | PrecivityAD2™ — C2N Diagnostics, LLC (blood algorithm reported as likelihood of amyloid plaques) |
Provider requirements, documentation, and prior authorization
Authorization and medical necessity
Services must meet authorization and medical necessity guidelines; coverage depends on the member's benefit and may require confirmation of elevated brain beta‑amyloid prior to certain therapies. Providers are responsible for accurate documentation and appropriate coding; failure to follow coding/billing guidelines or reimbursement policies may result in claim denials or recoupment.
- Coverage is subject to the member's state of residence and benefit design.
- Claims may be denied or recouped if coding/billing guidelines or current reimbursement policies are not followed.
Specialist-only use for blood‑based biomarkers
Blood‑based biomarkers (BBMs) with established thresholds should currently be used only in symptomatic patients at specialist memory clinics, and results should be confirmed with CSF or PET whenever possible; additional data are required before BBMs are used as stand‑alone diagnostics in primary care.
- Use limited to symptomatic patients in specialist clinics with established thresholds.
- Confirm BBM results with CSF or PET when possible; primary care use is not recommended pending more data.
Amyloid PET for therapy eligibility
Amyloid PET is considered appropriate to determine eligibility for approved amyloid‑targeting therapies and to inform treatment eligibility and monitoring; payers may require documentation of appropriateness under specified clinical scenarios.
- High appropriateness rating for determining eligibility for approved amyloid‑targeting therapy (Amyloid consensus rating = 9).
- Amyloid PET may also be used to monitor response to therapy where appropriate.
Procedure codes may require prior authorization
Specific CPT/HCPCS and proprietary (U‑code) tests relevant to Alzheimer biomarkers are listed in the policy and may be subject to payer prior authorization; follow payer‑specific prior authorization processes for these codes.
Prior authorization — not specified in excerpt
No payer prior authorization requirements are specified in the provided excerpt of this policy.
Confirm amyloid pathology before disease‑modifying therapy
Before initiating therapies that require confirmation of amyloid pathology (for example, lecanemab), clinicians must confirm elevated brain beta‑amyloid by an accepted diagnostic tool such as PET imaging or CSF testing.
- Lecanemab is appropriate only for people with early Alzheimer's who have been confirmed to have elevated brain beta‑amyloid.
- Examples of tools to confirm elevated beta‑amyloid include PET scan or lumbar puncture (CSF) tests.
- The FDA has not specified a single diagnostic tool for determining elevated beta‑amyloid.
Limit use to research or when results will change management
Biomarker testing is recommended primarily in investigational settings (research or clinical trials) or when results are expected to change clinical management; routine first‑line use without documented indication is discouraged.
- NINCDS‑ADRDA/NIA‑AA workgroup: biomarkers are useful in investigational studies, clinical trials, or as optional clinical tools when deemed appropriate by the clinician.
- NICE: consider further testing only if it would help diagnose a dementia subtype and knowing the subtype would change management.
Require confirmatory CSF or PET after plasma screening
If plasma biomarkers are used as an initial screening tool, confirmatory testing with CSF or PET is recommended before using biomarker status to establish an AD diagnosis or to direct disease‑modifying therapy because plasma assays require further validation.
- IWG: plasma biomarkers are not currently recommended in clinical practice and require further standardization and validation.
- WHO: blood‑based assays should achieve ≥90% sensitivity and specificity versus a valid reference standard; intended population excludes individuals without established cognitive impairment.
Step therapy — none specified
No step therapy requirements are specified in this section of the policy.
No additional step therapy requirements
No step therapy requirements appear elsewhere in this excerpt.
Documentation and confirmation required for therapy decisions
Providers must submit accurate documentation of services performed; for therapies requiring amyloid confirmation (e.g., lecanemab), documentation supporting confirmation of elevated brain beta‑amyloid (PET or CSF) should be included.
- Documentation should support the indication and the diagnostic confirmation used to justify treatment.
- Claims require appropriate coding and supporting documentation to avoid denials or recoupment.
Document clinical indication for CSF testing
Operational guidance lists specific clinical indications and appropriateness ratings for lumbar puncture and CSF testing; documentation should support indication matching these guideline criteria when ordering CSF testing.
- Alzheimer's Association appropriateness ratings identify scenarios where CSF testing is appropriate or inappropriate (e.g., some uses in behavior‑predominant presentations are appropriate; LP in lieu of genotyping is inappropriate).
Confirm BBM results with CSF or PET in specialty settings
For BBMs used in specialized memory clinics, results should be confirmed with CSF or PET whenever possible; primary care use requires additional data before adoption.
- BBMs with established thresholds should be used only in symptomatic patients at specialist clinics and confirmed with CSF or PET whenever possible.
- Additional data are required before BBMs are used as stand‑alone markers in primary care.
Document clinician evaluation of added value before ordering biomarkers
Physicians should document an objective evaluation of the added value of biomarker testing for each symptomatic patient, including age, comorbidity risk, phenotype complexity, patient preferences, trial eligibility, and how results will change management.
- Evaluate how biomarker results would alter management and consider availability, cost, and coverage.
- Document patient preferences and potential trial eligibility when ordering tests.
Record rationale that further testing will change management
Document that additional testing (CSF, PET, or other biomarker tests) is being ordered because results would change management; record clinical uncertainty and the rationale for further testing per NICE guidance.
- NICE: consider further tests only if they would help diagnose a dementia subtype and change management.
- Record rationale and expected management impact when ordering advanced biomarker tests.
Evidence references (informational)
Evidence references support clinical recommendations and do not themselves impose documentation actions on providers.
Follow coding and documentation guidelines to avoid denials
Claims may be denied or recouped if coding/billing guidelines or current reimbursement policies are not followed; providers are responsible for accurate coding and documentation.
- Follow industry standard coding guidelines (CPT, HCPCS, ICD‑10, CMS guidance) and payer reimbursement policies.
- Inaccurate coding or failure to follow guidelines may lead to denial or recoupment.
Non‑covered biomarker tests — expect denials for listed assays
Tests listed as 'DOES NOT MEET CRITERIA' (plasma/serum biomarkers except the specified FDA‑approved plasma p‑tau217/Aβ42 ratio, urinary biomarkers, and unspecified CSF biomarkers) are considered non‑covered and may be denied.
- Plasma/serum biomarkers not specifically approved (e.g., individual p‑tau217, Aβ42, total tau, Aβ40) do not meet criteria.
- Urinary biomarkers and multianalyte/algorithmic tests do not meet criteria.
Routine‑use limitation — testing asymptomatic individuals discouraged
Biomarker testing is not recommended for routine diagnostic use in cognitively unimpaired individuals; ordering such tests outside investigational or appropriate clinical contexts may risk noncoverage.
- NINCDS/ADRDA and NIA‑AA workgroup: do not advocate routine use of AD biomarker tests at present; use limited to investigational studies, trials, or optional clinical tools.
Do not rely on unvalidated blood assays — validation requirement
Avoid use of blood‑based assays that have not met validated clinical performance expectations (e.g., WHO minimum of ≥90% sensitivity and specificity versus a valid reference); insufficiently validated assays risk being considered inadequate for diagnostic use.
- WHO preferred product characteristics specify ≥90% sensitivity and specificity compared with a valid reference standard.
- Intended use restricted to individuals with established cognitive impairment; excludes those on disease‑modifying therapies or in trials.
Government policy takes precedence over this policy
If this policy conflicts with applicable government policies (e.g., Medicare LCDs/NCDs or state Medicaid rules), the government policy governs and may trigger denials if inconsistent with this policy.
- Consult current Medicare and state Medicaid policies; government policy supersedes when applicable.
Authorization/denial triggers — not specified in excerpt
No specific authorization triggers or denial criteria are detailed in the provided excerpt of the policy.
Background and scope
Alzheimer disease is a progressive neurodegenerative disorder characterized by cognitive decline associated with amyloid plaques and neurofibrillary tangles. Biomarkers discussed in this policy include cerebrospinal fluid and emerging blood and urine measures of amyloid β and tau species, which may aid early diagnosis and prognosis in mild cognitive impairment but vary in standardization, availability, and diagnostic performance across settings.
Key biomarker and tier definitions
Policy version and review history
Policy became effective.
Original documentation and governance approval recorded.
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