CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Novel Biomarkers in Risk Assessment and Management of Cardiovascular Disease

Defines medical necessity and coverage stance for measurement of multiple novel lipid and non-lipid cardiovascular biomarkers for Blue Cross Blue Shield Rhode Island Commercial Products and BlueCHiP for Medicare; describes evidence summary and billing/CPT code coverage decisions.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyNovel Biomarkers in Risk Assessment and Management of Cardiovascular Disease

Policy CodePolicy N/A

Change TypeClarified (non-material)

Effective DateJan 1, 2016

Next Review DateN/A

Key ActionDocument clinical context and concurrent diagnostic data when ordering or interpreting BNP testing and expect denial risk for claims for listed novel biomarker CPT codes for Commercial products.

SourceLink

POLICY UPDATE CHANGES

Policy last updated 08/07/2018; document states BNP coverage policy and lists not medically necessary biomarkers for Commercial products.

1Biomarker covered (BNP for select indications)

9Novel biomarkers considered

7CPT codes not medically necessary

Coverage Summary

This policy defines medical necessity and coverage stance for measurement of multiple novel lipid and non-lipid cardiovascular biomarkers for Blue Cross & Blue Shield of Rhode Island Commercial Products and BlueCHiP for Medicare. The policy was made effective on 01/01/2016 and last reviewed on 08/07/2018.

Overall, the coverage stance is mixed: most novel biomarkers listed are considered not medically necessary for Commercial products because evidence is insufficient to show measurement improves health outcomes, while BNP is supported for specific clinical indications when used with other clinical data.

Policy metadata

Policy titleNovel biomarkers for cardiovascular disease risk assessment (apoB, apoAI, apoE, BNP, cystatin C, fibrinogen, HDL/LDL subclasses, leptin, Lp(a))

PayerBlue Cross Blue Shield - Rhode Island

Effective date2016-01-01

Last review2018-08-07

Coverage stancemixed

StatusCURRENT

Medical Necessity Criteria

Commercial Products - Medically Necessary Determination

Measurement of novel lipid and non-lipid risk factors is considered:

ALL of the following

Measurement of apolipoprotein B (apo B), apolipoprotein AI (apo AI), apolipoprotein E (apo E), cystatin C, fibrinogen, leptin, low-density lipoprotein (LDL) subclass, high-density lipoprotein (HDL) subclass, lipoprotein(a) is NOT medically necessary for Commercial products because evidence is insufficient to determine effects on health outcomes.

BlueCHiP for Medicare - BNP testing

BNP (B-type natriuretic peptide) measurements are covered when used in conjunction with other clinical information for specific indications:

Covered indications (when analyzed with standard diagnostic tests, history, exam, imaging, ECG)

To distinguish cardiac cause of acute dyspnea from pulmonary or other non-cardiac causes (acute care or ED setting where results are immediately determined).
To distinguish decompensated congestive heart failure (CHF) from exacerbated COPD in symptomatic patients with combined chronic CHF and COPD.
To achieve optimal guideline-directed medical therapy (GDMT) in select clinically euvolemic patients followed in a structured heart failure disease management program.
To establish prognosis or disease severity in chronic CHF when needed to guide therapy.
To aid therapeutic decision-making in individuals who have amyloidosis.

ALL of the following

BNP testing must be analyzed in conjunction with standard diagnostic tests, medical history and clinical findings; efficacy as a stand-alone test is not established.
Clinicians should account for conditions (eg, ischemia, infarction, renal insufficiency) that may elevate BNP and alter interpretation.
BNP testing is covered but not separately reimbursed when used in conjunction with standard diagnostic tests in an acute care or ED setting where results are immediately determined.

BlueCHiP for Medicare and Commercial Products - Not Medically Necessary CPT codes

The following CPT codes are specified as not medically necessary for the indicated populations:

ALL of the following

The CPT codes listed under code_groups 'not_covered' are not medically necessary for Commercial Products.

Coding

Not medically necessary (Commercial Products)CPTNot Covered

83695	Lipoprotein (unspecified in doc)
83701	Lipoprotein, blood; high resolution fractionation and quantitation of lipoproteins including (description truncated in doc)
83700	Lipoprotein, blood; electrophoretic separation and quantitation of lipoprotein subclasses when performed (eg, electrophoresis, ultracentrifugation)
83722	Lipoprotein, Direct Measurement; Small Dense LDL Cholesterol (Effective 1/1/2019)
83704	Lipoprotein, blood; quantitation of lipoprotein particle number(s) (eg, by nuclear magnetic resonance spectroscopy), includes lipoprotein particle subclass(es), when performed
85384	Fibrinogen; activity
85385	Fibrinogen; antigen

Covered but not separately reimbursed (BlueCHiP for Medicare & Commercial)CPTCovered

83880

Natriuretic peptide

Covered/Listed (Commercial Products example)CPT

82610

Cystatin C

Provider Actions & Billing Guidance

Documentation Required

BNP interpretation requires clinical context

BNP measurements must be analyzed and interpreted in conjunction with standard diagnostic tests, medical history, physical exam, lab studies, chest X-ray and ECG; document concurrent clinical data and reason for testing.

83880

Billing Rule

BNP not separately reimbursed in certain settings

BNP testing (natriuretic peptide CPT 83880) is covered but not separately reimbursed when used with standard diagnostic tests in an acute care or ED setting where results are immediately determined.

83880 — acute care / emergency department (immediate results)

Denial Risk

Commercial coverage denial for novel biomarker tests

Claims for measurement of apoB, apoAI, apoE, cystatin C, fibrinogen, leptin, LDL/HDL subclass, lipoprotein(a), and related CPT codes listed as not medically necessary for Commercial products are subject to denial.

83695
83701
83700
83722
83704
85384
85385
82610

Background and Evidence Summary

BCBSRI evaluated multiple lipid and non-lipid biomarkers including apoB, apoAI, apoE, HDL/LDL subclasses, Lp(a), BNP, cystatin C, fibrinogen, and leptin. For Commercial products, measurement of apoB, apoAI, apoE, cystatin C, fibrinogen, leptin, LDL/HDL subclasses, and Lp(a) is not medically necessary because the evidence is insufficient to determine effects on health outcomes.

An important exception is BNP: BNP testing has established utility in acute dyspnea and heart-failure related contexts. BNP measurements are covered (but not separately reimbursed in certain acute/ED settings) when used in conjunction with standard diagnostic tests and clinical information to distinguish cardiac from non-cardiac causes of dyspnea and to guide select HF management decisions.

Conclusion: Evidence is insufficient to determine that measurement of listed novel biomarkers improves health outcomes for Commercial products.

Support for BNP: LCD and studies support BNP use in conjunction with other clinical data to distinguish cardiac vs non-cardiac dyspnea and guide HF management.

Definitions

BNPB-type (or brain) natriuretic peptide, a biomarker elevated in heart failure and cardiac stress.

Name	Number	Type	Effective
B-type Natriuretic Peptide (BNP) Testing	L33573	LCD	01/01/2016

Revision History

2018-08-07policy updateLatest

Policy last updated 08/07/2018; document states BNP coverage policy and lists not medically necessary biomarkers for Commercial products. No explicit clinical policy statement changes identified in revision history text provided.

2016-01-01effective date

Policy effective 01/01/2016; measurement of apoB, apoAI, apoE, cystatin C, fibrinogen, leptin, LDL/HDL subclasses, and Lp(a) considered not medically necessary for Commercial products due to insufficient evidence that measurement improves health outcomes.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyNovel Biomarkers in Risk Assessment and Management of Cardiovascular Disease

Policy CodePolicy N/A

Change TypeClarified (non-material)

Effective DateJan 1, 2016

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Novel Biomarkers in Risk Assessment and Management of Cardiovascular Disease

Coverage Summary

Medical Necessity Criteria

Coding

Provider Actions & Billing Guidance

Background and Evidence Summary

Medicare Determinations

Revision History