CurrentBaylor Scott & White Health PlanPolicy 029

Biochemical Markers of Alzheimer's Disease

This policy governs coverage and medical necessity determination for biochemical biomarkers, tests, and measurements used in the diagnosis and management of Alzheimer's disease for Baylor Scott & White Health Plan members.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyBiochemical Markers of Alzheimer's Disease

Policy CodePolicy 029

Change TypeNo material change

Effective DateFeb 1, 2026

Next Review DateJan 22, 2027

Key ActionDo not submit claims for biomarkers/tests listed as experimental; document clinical rationale and verify member benefits because such tests are considered not medically necessary and may be denied.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~60+listed as experimental/not medically necessary

85%target biomarker sensitivity

75-85%desired specificity

Texasstatutory reference

Coverage Criteria — Not Medically Necessary / Investigational

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Experimental / Investigational / Not Medically Necessary

BSWHP considers the use of the following biomarkers, tests and measurements in the diagnosis and management of Alzheimer’s Disease to be experimental and investigational and NOT medically necessary.

Not medically necessary list: All listed biomarkers, tests and measurements (see enumerated list) are considered experimental and investigational and not medically necessary for diagnosis or management of Alzheimer’s disease.

Full enumerated list appears across policy chunks 1-3

Examples of biomarkers, tests, and measurements considered experimental and investigational and not medically necessary include: Aβ42 or Aβ42:Aβ40 ratio; ATP-binding cassette transporter assays; Bcl-2 rs956572 polymorphism testing; beta amyloid 42 (Aβ42) protein (CSF and plasma); beta-site amyloid precursor protein cleaving enzyme assays; cerebrospinal fluid (CSF) chitinase enzyme activity; circadian rhythm analysis; CSF microRNAs (e.g., hsa-miR-27a-3p); CSF neurogranin; CSF phosphorylated tau at threonine 181 (ptau181), tau/Aβ42, and ptau181/Aβ42; CSF prion protein concentration; CSF soluble amyloid precursor proteins (sAPP) level/CSF β-secretase activity; CSF stathmin protein level; CSF total tau (t-tau); CSF visinin-like protein-1 (VILIP-1); cognitive event-related potentials; DNA methylation profiling; electronystagmography (without signs of vertigo or balance disorder); genetic testing (e.g., PSEN1, PSEN2, apolipoprotein E epsilon 4 allele, amyloid precursor gene); genetic variation of mitochondrial DNA; homocysteine (serum); INNO-BIA AlzBio3 immunoassay; insulin degrading enzyme polymorphisms; long-term cortisol measurement; macular thickness; microtubule-associated protein tau (MAPT); NT-proBNP; olfactory screening tests; plasma clusterin; plasma prion protein; plasma tau; PACAP; red blood cell omega-3 fatty acid level; resting-state eye-closed cortical EEG; serum ceramides; serum IGF-1; serum microRNAs; serum neurofilament light concentration; total and phospho-tau measurements; TGF-β1; TREM2; tympanometry (without hearing loss); urinary AD7c-NTP; and videopupillography/tropicamide drop testing.

Coding — CPT and ICD-10 References

CPT Not CoveredCPTNot Covered

83015	CPT Not Covered for this indication
83018	CPT Not Covered for this indication
83520	CPT Not Covered for this indication
83825	CPT Not Covered for this indication

Potential ICD-10 CodesICD-10

F01.50 - F03.91	Dementia (range listed)
F07.0 - F07.9	Personality and behavioral disorders due to known physiological condition
G30.0 - G30.9	Alzheimer's disease
Z13.858	Encounter for screening for other nervous system disorders (screening for dementia)

Provider Actions — Authorization, Documentation, and Denial Risk

Note

Prior Authorization

Prior authorization is Not Applicable for biochemical markers of Alzheimer's disease under this policy. Providers should verify member-specific requirements in the applicable Evidence of Coverage (EOC) or Summary Plan Description (SPD) as benefit coverage is determined by the member's plan document.

Denial Risk

Denial Risk for Investigational Biomarkers

Claims for biomarkers, tests, and measurements listed in this policy as experimental and investigational will be considered not medically necessary and may be denied. Submit supporting medical documentation only when the service meets plan benefit criteria; absence of plan-covered benefit language may result in claim denial.

Documentation Required

Documentation and Benefit Determination

Providers must document the clinical rationale for testing and reference the member's benefit plan. Inclusion of a diagnosis or CPT code in this policy does not guarantee coverage. Confirm coverage by reviewing the member's EOC/SPD and, for Medicare or Medicaid members, applicable NCD/LCD or state Medicaid guidance.

Document clinical indications and rationale in the medical record
Reference the member's specific benefit plan (EOC/SPD) when submitting claims
Inclusion of a code in this policy is not a guarantee of coverage

Note

Additional Provider Actions

Additional provider action: verify member eligibility and plan-specific coverage before ordering tests; check for applicable Medicare NCD/LCD or state Medicaid TMPPM guidance when applicable.

Verify member eligibility and benefits prior to ordering
Check Medicare NCD/LCD or state Medicaid TMPPM if applicable

Background — Disease and Diagnostic Context

Alzheimer's disease (AD) is an irreversible, progressive neurodegenerative disorder characterized by gradual memory loss, personality and behavioral changes, and decline in cognitive function. Prevalence estimates range into the millions and incidence increases with age; early-onset AD affects a smaller subset of patients under age 65. The average duration from symptom onset to death has been reported to be approximately 8.5 years.

Currently, the diagnosis of AD is a clinical diagnosis that emphasizes history, physical examination, and the exclusion of other causes of dementia. Standard clinical tools such as the Mini-Mental State Examination (MMSE) and the Functional Activities Questionnaire are used in evaluation. Existing pharmacologic therapies provide only modest slowing of disease progression, and the policy notes that routine use of the biochemical biomarkers and tests listed has not been validated to improve diagnosis, prediction, or monitoring in clinical practice.

Definitions and Performance Expectations

Probable Alzheimer's disease (clinical category)

DefinitionProbable Alzheimer's disease: clinical diagnostic category in which clinical criteria (used for Probable AD) have approximately 85% sensitivity compared with autopsy-confirmed (Definite) AD; Definite AD requires histopathologic confirmation (brain biopsy or autopsy).

Sensitivity targetClinical criteria for Probable AD demonstrate ~85% sensitivity versus autopsy-confirmed cases.

Distinction from Definite ADDefinite AD differs only by requiring brain biopsy or autopsy confirmation of characteristic neurofibrillary tangles; Probable AD lacks histopathologic confirmation.

Implication for biomarker evaluationBiomarkers should be evaluated against the Probable AD clinical category since most studies to date have focused on patients labeled Probable AD.

Policy-stated desirable biomarker characteristics

Sensitivity expectationA biomarker should have sensitivity approaching or exceeding ~85% (the sensitivity of current clinical criteria for Probable AD).

Specificity expectationA biomarker should have a specificity of 75% to 85% or greater.

Positive predictive value (PPV)The positive predictive value for a clinically useful biomarker should be 80% or more.

Current statusThere are currently no biomarkers that meet these sensitivity, specificity, and PPV thresholds.