CurrentHumanaPolicy LAB2023026

Laboratory - Biochemical Markers of Alzheimer's Disease and Dementia

This Medicare Advantage payment policy governs reimbursement for laboratory measurement of biochemical biomarkers related to Alzheimer's disease, mild cognitive impairment, and dementia for Humana Medicare Advantage members.

Policy Summary

PayerHumana

PolicyLaboratory - Biochemical Markers of Alzheimer's Disease and Dementia

Policy CodePolicy LAB2023026

Change TypeNo material change indicated

Effective Date06/2023

Next Review Date04/2026

Key ActionSubmit claims for these biomarker tests only when medically necessary and consistent with plan requirements (eg, diagnosis of Alzheimer’s disease, mild cognitive impairment, or dementia).

SourceLink

Medicare AdvantageApplies to

Aβ42, Aβ40, t‑tau, p‑tauKey biomarkers

Several proprietary assaysNot reimbursable examples

CSF, plasma, saliva, urineModalities cited

Coverage Criteria

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ALL of the following

ONE of
- Amyloid beta peptides (CPT 82233, CPT 82234, CPT 0358U)
- Ratios reported by assays: t‑tau/Aβ42 (CPT 0459U), p‑tau181/Aβ42 (CPT 0445U), and p‑tau217/Aβ42 (CPT 84393, CPT 0479U)

ALL of the following

EXAMPLES (not reimbursable when not ordered with Aβ42)
- Total tau (t‑tau) (CPT 84394)
- Phosphorylated tau181 (p‑tau181) (CPT 84393)
- Phosphorylated tau217 (p‑tau217) (CPT 84393, CPT 0479U)

Claims are subject to other plan requirements including medical necessity and applicable referral or authorization rules; Original Medicare NCDs/LCDs may apply.

Operational: verify member plan requirements and any applicable NCD/LCD prior to payment.

Coverage — informational references only

Informational references and regulatory context cited (no additional Humana coverage rules provided in this extract):

Guideline and evidence citations referenced in the policy include systematic reviews, performance studies of plasma assays, and practice guidance (examples: JAMA Neurol 2019; Owens et al. USPSTF statement; reviews and meta-analyses).

Regulatory note: Roche cerebrospinal fluid (CSF) assays have received FDA clearance; this is cited as supporting more accurate and timely diagnosis, but no new coding or coverage thresholds are specified in this extract.

Coding and Reimbursement

Reimbursable when clinically indicatedCPTCovered

82233	Beta-amyloid; 1-40 (Abeta 40)
82234	Beta-amyloid; 1-42 (Abeta 42)
84394	Tau, total (tTau)
84393	Tau, phosphorylated (eg, pTau 181, pTau 217), each
0358U	B-amyloid 1- and 1-40 analysis, CSF (proprietary Lumipulse)
0445U	pTau181 / Abeta42 ratio, CSF (Elecsys)
0459U	tTau / Abeta42 ratio, CSF (Elecsys)
0479U	pTau217 (ALZpath)

Not reimbursable — Codes explicitly not reimbursablemixedNot Covered

83520	Immunoassay for analyte other than infectious agent antibody or antigen; quantitative, NOS
83884	Neurofilament light chain (NfL)
0412U	PrecivityAD® blood test (proprietary multianalyte plasma assay)
0206U	DISCERN™ proprietary test (cell aggregation using morphometric imaging and PKCe concentration)
0289U	Gene expression profiling (MindX)

No CPT/HCPCS/ICD-10 codes listed in this sectionmixed

No codes listed

Reimbursement conditionality — clinical conditions/ordering restrictions summary

Scope of conditional reimbursementCertain biomarkers are reimbursable ONLY when ordered for individuals with a diagnosis of Alzheimer’s disease, mild cognitive impairment, or dementia.

Requirement for Aβ42 co-orderingStandalone measurement of t-tau (CPT 84394), p-tau181 (CPT 84393), or p-tau217 (CPT 84393, CPT 0479U) is NOT reimbursable unless ordered in conjunction with Aβ42 (CPT 82234).

Reimbursable analytes when clinically indicatedAmyloid beta peptides (CPT 82233, CPT 82234, CPT 0358U) and specified assay ratios to Aβ42 (CPT 0459U, CPT 0445U, p-tau217 ratios including CPT 0479U) are reimbursable for eligible diagnoses.

Explicit non-reimbursable testsMeasurement of other biomarkers (eg CPT 83520, CPT 83884, CPT 0547U), all other CSF biomarkers (eg CPT 0393U, CPT 0443U, CPT 0548U), plasma biomarkers (eg CPT 0479U, CPT 0551U), and DISCERN(TM) (CPT 0206U/0207U) are not reimbursable.

Regulatory status note — mentions FDA clearance for CSF assays

FDA clearance referencedThe policy text cites Roche receiving FDA clearance for additional Alzheimer's disease cerebrospinal fluid (CSF) assays.

Context of mentionRegulatory clearance is presented as informational context supporting assay utility; no specific coding or coverage thresholds are tied to FDA clearance in the policy extract.

Related guideline citationsPolicy also cites professional and guideline literature (eg Alzheimer's Association, task force recommendations) alongside the regulatory note.

Provider Actions and Billing Guidance

Prior Authorization

Claims payment conditions — payments subject to plan requirements

In addition to this policy, claims payments are subject to plan requirements for processing and payment, including but not limited to medical necessity, reasonableness, and any applicable referral or prior authorization requirements.

Payments are subject to Medicare Advantage plan rules and any applicable Original Medicare NCDs/LCDs.

Note

Literature references — evidence supporting biomarker use; no authorization instructions

References supporting the current state of saliva and blood biomarkers for aging and Alzheimer's disease and related guidance. These citations provide background evidence and do not include explicit prior authorization or ordering instructions.

Definitions and Biomarker Terms

Aβ42 — code/short definition

TermAβ42 (Aβ 1-42) — Amyloid beta peptide measured in CSF or plasma; CPT code 82234.

Common useUsed in diagnostic evaluation of Alzheimer's disease and as the denominator for reimbursable assay ratios to assess amyloid pathology.

Related reimbursable codesTesting of Aβ42 reported under CPT 82234; amyloid analyses also include CPT 82233 and proprietary CPT 0358U for CSF ratios.

Total tau (t-tau) — code/short definition

TermTotal tau (t-tau) — neuronal protein measured in CSF; CPT code 84394.

Coverage ruleMeasurement of t-tau (CPT 84394) is reimbursable only when ordered in conjunction with Aβ42 (CPT 82234) for eligible diagnoses; standalone t-tau is not reimbursable.

Role in ratiost-tau is used in approved reimbursable ratios (eg CPT 0459U t-tau/Aβ42) to aid diagnostic assessment.

Phosphorylated tau (p-tau) — codes/short definition

TermPhosphorylated tau (p-tau) — phosphorylated isoforms such as p-tau181 and p-tau217; CPT code 84393 and proprietary CPT 0479U (p-tau217).

Coverage ruleMeasurement of p-tau181 (CPT 84393) or p-tau217 (CPT 84393, CPT 0479U) is reimbursable only when ordered with Aβ42 (CPT 82234); standalone p-tau measures are not reimbursable.

Use in reimbursable ratiosp-tau181/Aβ42 (CPT 0445U) and p-tau217/Aβ42 (including CPT 0479U) ratios are listed as reimbursable for eligible diagnoses.

Cerebrospinal fluid (CSF) biomarkers and assays — definition/context

DefinitionCerebrospinal fluid (CSF) biomarkers and assays — laboratory measurements of amyloid and tau species in CSF used to support diagnosis of Alzheimer's disease.

Examples notedPolicy references CSF assays including proprietary and automated tests (eg Lumipulse, Elecsys) and notes FDA clearance events for CSF assays.

Coverage stanceCertain CSF analytes and ratio assays are reimbursable when ordered for appropriate diagnoses; other CSF biomarkers are explicitly not reimbursable per the policy extract.

Blood-based biomarkers (plasma assays including p-tau and amyloid measures) — definition/context

DefinitionBlood-based biomarkers (plasma assays) — plasma or blood measurements of amyloid and phosphorylated tau species used as minimally invasive tests for Alzheimer's pathology.

Examples and evidencePolicy cites studies and reviews on plasma assays and automated plasma tests as screening tools (eg Palmqvist et al., Kim et al., systematic reviews), reflecting emerging diagnostic utility.

Coverage noteSome plasma/proprietary blood tests (eg PrecivityAD CPT 0412U, DISCERN CPT 0206U) are listed as not reimbursable in this policy extract.