CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Novel Biomarkers in Medical Coverage Policy | Risk Assessment and Management of Cardiovascular Disease

Defines medical necessity and noncoverage for measurement of select novel lipid and non-lipid biomarkers for cardiovascular disease risk assessment and management for Medicare Advantage Plans and Commercial products, and billing/reimbursement stance for specific CPT codes.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyNovel Biomarkers in Medical Coverage Policy | Risk Assessment and Management of Cardiovascular Disease

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2024

Next Review Date

Key ActionMedically necessary CPT codes (83700, 83701, 83704) must be filed with a covered ICD-10-CM diagnosis to be considered medically necessary for Commercial products and Medicare Advantage Plans.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes.

3CPT codes considered medically necessary

5CPT codes not covered / not medically necessary

1CPT codes covered but not separately reimbursed

Coverage Summary

Overview: This policy addresses coverage for novel lipid and non-lipid biomarkers used in cardiovascular risk assessment and management (subject: Novel Biomarkers for Cardiovascular Risk Assessment). Coverage stance is mixed: select lipoprotein measurements (CPT 83700, 83701, 83704) are considered medically necessary when filed with a covered ICD-10-CM diagnosis, while several other biomarkers (eg, cystatin C, lipoprotein[a], fibrinogen) are not covered or are not medically necessary; B-type natriuretic peptide (BNP) testing (CPT 83880) is covered but not separately reimbursed in the acute heart-failure evaluation context. Effective date: 2024-04-01; Policy last reviewed: 2023-12-20.

Medical-Necessity Criteria

Medically Necessary Measurements (Medicare Advantage and Commercial Products)

Measurement of the following novel lipid and non-lipid risk factors are medically necessary for Commercial products when filed with a covered diagnosis:

Medically necessary measurements

Lipoprotein electrophoretic separation: Lipoprotein, blood; electrophoretic separation and quantitation (CPT 83700)
High-resolution lipoprotein fractionation: Lipoprotein, blood; high resolution fractionation and quantitation of lipoproteins including lipoprotein subclasses when performed (eg, electrophoresis, ultracentrifugation) (CPT 83701)
Lipoprotein particle number quantitation: Lipoprotein, blood; quantitation of lipoprotein particle number(s) (eg, by nuclear magnetic resonance spectroscopy), includes lipoprotein particle subclass(es), when performed (CPT 83704)

Not Covered / Not Medically Necessary (Medicare Advantage and Commercial Products)

All other measurements of novel lipid and non-lipid risk factors are not covered for Medicare Advantage Plans and not medically necessary for Commercial Products:

Not covered / not medically necessary tests

Cystatin C testing (CPT 82610) - not covered/not medically necessary
Lipoprotein (a) (CPT 83695) - not covered/not medically necessary
Small dense LDL cholesterol: Lipoprotein, Direct Measurement; Small Dense LDL Cholesterol (CPT 83722) - not covered/not medically necessary
Fibrinogen activity: Fibrinogen; activity (CPT 85384) - not covered/not medically necessary

Covered but Not Separately Reimbursed

Tests covered but not separately reimbursed when used in specified clinical contexts:

Covered but not separately reimbursed

BNP (covered but not separately reimbursed in acute HF evaluation): B-type (brain) natriuretic peptide testing (CPT 83880) - covered but not separately reimbursed when used in conjunction with standard diagnostic tests, medical history and clinical findings during evaluation of heart failure in an acute care setting or other setting (eg, emergency department) where test results are immediately determined
CPT 83880 is covered but not separately reimbursed when used in conjunction with standard diagnostic tests, medical history and clinical findings during evaluation of heart failure in an acute care setting or other setting (eg, emergency department) where test results are immediately determined.

Coding

Medically Necessary CPT Codes (when filed with a covered diagnosis)CPTCovered

83700	Lipoprotein, blood; electrophoretic separation and quantitation
83701	Lipoprotein, blood; high resolution fractionation and quantitation of lipoproteins including lipoprotein subclasses when performed (eg, electrophoresis, ultracentrifugation)
83704	Lipoprotein, blood; quantitation of lipoprotein particle number(s) (eg, by nuclear magnetic resonance spectroscopy), includes lipoprotein particle subclass(es), when performed

Not Covered / Not Medically Necessary CPT CodesCPTNot Covered

82610	Cystatin C
83695	Lipoprotein (a)
83722	Lipoprotein, Direct Measurement; Small Dense LDL Cholesterol
85384	Fibrinogen; activity
85385	Fibrinogen; antigen

Covered but Not Separately Reimbursed CPT CodeCPTCovered

83880

Natriuretic peptide (B-type natriuretic peptide) - covered but not separately reimbursed when used in conjunction with standard diagnostic tests, medical history and clinical findings during evaluation of heart failure in an acute care or emergency setting where test results are immediately determined

Provider Actions

Documentation Required

File tests with covered diagnosis

Medically necessary CPT codes 83700, 83701, and 83704 must be filed with an appropriate covered ICD-10-CM diagnosis and supported by the clinical record to be considered medically necessary for Commercial products and Medicare Advantage Plans.

83700
83701
83704

Billing Rule

BNP not separately reimbursed in acute evaluation

CPT 83880 (BNP) is covered but not separately reimbursed when used in conjunction with standard diagnostic tests, medical history, and clinical findings during evaluation of heart failure in an acute care setting (eg, emergency department) where results are immediately determined.

83880
Note: Applies in acute care/emergency department heart failure evaluation when results are immediately determined.

Background & Evidence Summary

Background: The policy summarizes evidence and positions on several lipid and non-lipid biomarkers with the most clinical evidence, including HDL and LDL subclasses, lipoprotein(a), B-type natriuretic peptide, cystatin C, and fibrinogen. These tests have been studied as alternatives or additions to standard lipid panels for cardiovascular risk stratification or as treatment targets.

Evidence conclusion: Systematic reviews, cohort studies, and meta-analyses show that some markers (notably apolipoprotein B and apolipoprotein AI) may add incremental predictive value for cardiovascular risk. However, the policy states that it has not been established that this incremental accuracy provides clinically important information beyond traditional lipid measures, and no high-quality evidence demonstrates that measuring these markers changes management that improves health outcomes; therefore, the evidence is considered insufficient to show improved net health outcomes for most novel biomarkers.

Evidence bullets

Overall evidence conclusionInsufficient evidence that measurement of most novel biomarkers improves net health outcomes

BNP LCDLocal Coverage Determination supports BNP use in conjunction with other clinical data for evaluation of acute dyspnea/heart failure; BNP covered but not separately reimbursed when used with standard diagnostic tests and clinical findings

Covered when filed with a covered diagnosis: Tests are considered medically necessary only when billed with an appropriate ICD-10-CM diagnosis supported by the clinical record and member benefits; for Commercial products and Medicare Advantage Plans, CPT codes designated as medically necessary must be filed with one of the covered ICD-10-CM codes to be considered medically necessary.

Name	Number	Type	Effective Date
B-type Natriuretic Peptide (BNP) Testing	L33573	LCD