CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy | Biomarkers for Alzheimer Disease

Policy on measurement of cerebrospinal fluid (CSF) and urinary biomarkers for diagnosis/prognosis of Alzheimer disease (AD) and mild cognitive impairment (MCI) for Blue Cross Blue Shield - Rhode Island commercial and Medicare Advantage products; states coverage determinations and coding guidance.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy | Biomarkers for Alzheimer Disease

Policy CodePolicy N/A

Change Typeclarified

Effective DateOct 1, 2020

Next Review DateN/A

Key ActionSubmit claims for CSF and urinary biomarker testing for Alzheimer disease expecting denial or price adjustment because such testing is not covered for Medicare Advantage and is not medically necessary for Commercial Products.

SourceLink

POLICY UPDATE CHANGES

Effective 10/1/2020 specific PLA codes 0206U and 0207U listed as not covered/not medically necessary (clarified).

2Biomarker specimen types addressed

2PLA codes listed as not covered (eff 2020-10-01)

1CPT code cited for reporting quantitative immunoassay

Coverage Summary

Background: Cerebrospinal fluid (CSF) and urinary biomarkers (eg, tau, phosphorylated tau, Aβ42, neural thread protein) have been investigated for diagnosis and prognosis of Alzheimer disease (AD) and mild cognitive impairment (MCI). Clinical validity is uncertain because of large between-laboratory variability and lack of validated cutoffs, and the evidence is insufficient that use of these biomarkers improves patient health outcomes.

Scope: Measurement of CSF and urinary biomarkers for AD/MCI is considered not covered / not medically necessary due to insufficient evidence that earlier diagnosis leads to improved outcomes. This determination applies to Medicare Advantage and Commercial products. Effective date: 2020-10-01.

Policy covers CSF and urine testing for AD-related biomarkers and communicates coding and denial expectations for the listed codes and prior-to-effective-date unlisted codes.

Policy metadata

Effective date2020-10-01

Last review2021-04-01

Next review

Scope summaryPolicy on measurement of cerebrospinal fluid (CSF) and urinary biomarkers for diagnosis/prognosis of Alzheimer disease (AD) and mild cognitive impairment (MCI) for Blue Cross Blue Shield - Rhode Island commercial and Medicare Advantage products; states coverage determinations and coding guidance.

StatusCURRENT (not covered / not medically necessary for CSF and urinary biomarkers for AD/MCI)

Coverage / Medical Necessity Criteria

Medicare Advantage - CSF and Urinary Biomarkers

Measurement of CSF or urinary biomarkers is considered not covered when used for diagnosis/prognosis of AD or MCI because evidence is insufficient to show improved health outcomes.

CSF biomarker testing: Member is receiving testing of cerebrospinal fluid biomarkers of Alzheimer disease (including but not limited to tau protein, amyloidβ peptides, or neural thread proteins)
Considered not covered for Medicare Advantage
Urine biomarker testing: Member is receiving urinary biomarker testing of Alzheimer disease (including but not limited to neural thread proteins)
Considered not covered for Medicare Advantage
Rationale: Whether earlier diagnosis leads to improved health outcomes through delay of AD onset or improved quality of life is unknown; evidence is insufficient

Coding guidance: PLA codes 0206U and 0207U are listed as not covered effective 10/1/2020; CPT 83520 may be used to report quantitative immunoassays for tau and amyloidβ peptides; for services before 10/1/2020 report urine tests with 81099 and CSF tests with 86849.

Commercial Products - CSF and Urinary Biomarkers

Measurement of CSF or urinary biomarkers is considered not medically necessary for diagnosis/prognosis of AD or MCI.

CSF biomarker testing: Member is receiving testing of cerebrospinal fluid biomarkers of Alzheimer disease (including but not limited to tau protein, amyloidβ peptides, or neural thread proteins)
Considered not medically necessary for Commercial Products
Urine biomarker testing: Member is receiving urinary biomarker testing of Alzheimer disease (including but not limited to neural thread proteins / AD7C test)
Considered not medically necessary for Commercial Products
Rationale: Whether earlier diagnosis leads to improved health outcomes through delay of AD onset or improved quality of life is unknown; evidence is insufficient

Coding Guidance

Not covered / Not medically necessary codes (effective 2020-10-01)CPT|PLANot Covered

0206U	Neurology (Alzheimer disease); cell aggregation using morphometric imaging and protein kinase Cepsilon (PKCe) concentration in response to amylospheroid treatment by ELISA, cultured skin fibroblasts, each reported as positive or negative for Alzheimer disease (PLA code for the DiscernTM test from NeuroDiagnostics) (eff 10/1/2020)
0207U	Neurology (Alzheimer disease); quantitative imaging of phosphorylated ERK1 and ERK2 in response to bradykinin treatment by in situ immunofluorescence, using cultured skin fibroblasts, reported as a probability index for Alzheimer disease (List separately in addition to code for primary procedure) (eff 10/1/2020) (PLA code for the DiscernTM test from NeuroDiagnostics)

Reportable immunoassay code for tau and amyloidβ peptidesCPT

83520

Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative; not otherwise specified — may be used to report testing for tau protein and amyloidβ peptides

Unlisted / prior-to-effective-date codes (claims with date of service prior to 10/1/2020)CPT|HCPCS

81099	Unlisted urinalysis code — recommended for urine-based tests performed prior to 10/1/2020
86849	Unlisted immunology procedure — recommended for CSF-based tests performed prior to 10/1/2020

CPT guidance was updated to list PLA codes 0206U and 0207U as not covered / not medically necessary effective 10/1/2020. For claims with date of service prior to 10/1/2020, the guidance recommends filing with unlisted codes 81099 (urine) and 86849 (CSF). The guidance also notes that CPT 83520 may be used to report quantitative immunoassay testing for tau protein and amyloidβ peptides.

Provider Actions & Billing Impact

Denial Risk

CSF biomarker testing not covered / not medically necessary

Claims for measurement of cerebrospinal fluid biomarkers of Alzheimer disease (eg, tau protein, amyloidβ peptides, neural thread proteins) are not covered for Medicare Advantage and are not medically necessary for Commercial Products; expect denial/price adjustment.

0206U
0207U
83520
86849
expect denial/price adjustment

Denial Risk

Urine biomarker testing not covered / not medically necessary

Claims for measurement of urinary biomarkers of Alzheimer disease (including neural thread proteins / AD7C test) are not covered for Medicare Advantage and are not medically necessary for Commercial Products; expect denial/price adjustment.

81099
expect denial/price adjustment

Billing teams should review the claim date of service (pre- vs post- 10/1/2020) when submitting claims for CSF or urine biomarker testing and anticipate denials or price adjustments per this policy’s coverage determinations and coding guidance.

Background and Definitions

CSF and urinary biomarkers including tau, phosphorylated tau (p-tau), Aβ42, and neural thread protein (eg, AD7C) have been investigated as diagnostic and prognostic markers for Alzheimer disease, but between-laboratory variability, unvalidated cutoffs, and limited clinical validity leave uncertainty about their ability to improve patient outcomes; evidence is insufficient that use of these tests improves net health outcomes.

AD7C test: Urine and CSF tests for neural thread protein investigated as a potential marker of Alzheimer disease.

Definition note: AD7C refers to urine and CSF assays for neural thread protein; other referenced biomarkers include tau, phosphorylated tau, and Aβ42 assessed in CSF or blood/urine in investigational settings.

Evidence Summary

Evidence summary: Systematic reviews and prospective/retrospective studies have assessed CSF and urinary biomarkers for diagnosis of AD and prediction of progression from MCI, but many studies derive from select samples, use unvalidated cutoffs, and lack demonstration that earlier diagnosis changes management to improve quality of life or delay onset; therefore the evidence is insufficient to show improved net health outcomes.