ModifiedBlue Cross Blue Shield - LouisianaPolicy AHS - G2150 - Biomarkers for Myocardial Infarction and Chronic Heart Failure, 1

Biomarkers for Myocardial Infarction and Chronic Heart Failure

Coverage policy for use of cardiac biomarkers (e.g., troponin, BNP/NT-proBNP, CKMB, AST, LDH, myoglobin, ST2, others) for diagnosis and prognosis of myocardial infarction and heart failure in outpatient and acute settings for Blue Cross and Blue Shield of Louisiana members.

Policy Summary

PayerBlue Cross Blue Shield - Louisiana

PolicyBiomarkers for Myocardial Infarction and Chronic Heart Failure

Policy CodePolicy AHS - G2150 - Biomarkers for Myocardial Infarction and Chronic Heart Failure, 1

Change TypeCPT additionscoverage clarification and reordering of criteria

Effective Date05/15/2022

Next Review DateN/A

Key ActionDocument symptom onset and timing of troponin sampling (presentation and 3–6 hours) when requesting quantitative troponin testing for suspected acute coronary syndrome.

SourceLink

POLICY UPDATE CHANGES

Added CPT code 86141.

Added CPT code 83880.

Reordered coverage criteria so that criteria that meet coverage are listed before criteria that do not meet coverage; former CC3 is now CC2.

New coverage criterion: Measurement of BNP or NT-proBNP meets coverage criteria in specified situations including diagnosis of heart failure in dyspnea and establishing disease severity up to four times per year in outpatient setting.

Edited CC4 wording: restricted phrase 'for all situations' changed to 'In the outpatient setting'.

≤4 / 72hAllowed outpatient quantitative troponin tests for suspected ACS

≤4 / yrAllowed outpatient BNP/NT-proBNP for chronic HF severity

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Biomarkers not meeting coverage for MI diagnosis/prognosis

qualitative troponinQualitative troponin testing not covered

96%Sites using troponin as primary biomarker

19enumerated CPT/HCPCS codes

Coverage Criteria for Cardiac Biomarkers

Covered Indications

Covered when ALL of the following are met for each stated use

Quantitative troponin for suspected ACS: For individuals presenting with signs and symptoms of acute coronary syndrome, quantitative measurement of cardiac troponin (troponin T or I) for the diagnosis of myocardial infarction meets coverage criteria up to four times within the first 72 hours following initial presentation.<=4 tests in 72 hours

Outpatient facility must be capable of performing an adequate clinical MI evaluation.

BNP/NT-proBNP uses: Measurement of BNP or NT-proBNP meets coverage criteria for: (a) diagnosing heart failure in individuals presenting with dyspnea; (b) establishing disease severity in individuals with chronic heart failure (up to four times per year in the outpatient setting).<=4 tests per year for chronic HF severity

Not Medically Necessary / Not Covered

The following biomarker measurements do NOT meet coverage criteria for individuals presenting with signs and symptoms of acute coronary syndrome

Not covered biomarkers for MI diagnosis/prognosis: Aspartate aminotransferase (AST), CK-MB, creatine kinase (CK), creatine kinase isoenzymes, lactate dehydrogenase (LD/LDH), myoglobin, copeptin, troponin C, C-reactive protein, heart-type fatty acid binding protein (H-FABP)

See policy for full list

Outpatient setting tests without adequate evaluation: Measurement of cardiac biomarkers in an outpatient setting that is not capable of performing an adequate clinical MI evaluation (e.g., independent lab or physician's office) does not meet coverage criteria.

Qualitative troponin outpatient: In the outpatient setting, qualitative measurement of cardiac troponin (T or I) does not meet coverage criteria.

ST2 and isoforms outpatient: Analysis of ST2 and/or its isoforms (e.g., Presage ST2) in the outpatient setting does not meet coverage criteria.

Biomarker-based diagnostic coverage criteria

Covered when ALL of the following are met

MI diagnosis with troponin: Use cardiac troponin I or T (high-sensitivity assays recommended for routine use). Diagnose acute MI when there is a rising/falling pattern with at least one value greater than the 99th percentile upper reference limit (URL).troponin >99th percentile URL and dynamic change

Serial sampling at presentation and 3–6 hours (or additional sampling if indicated) is recommended.

CK-MB use: CK-MB may be used only if cardiac troponin assay is not available; a measurement of CK‑MB above the 99th percentile of the URL should be designated as the decision level for MI diagnosis and sex-specific values should be used.CK-MB >99th percentile URL

CK‑MB is less sensitive and specific than troponin and is not preferred.

Heart failure biomarker use: Measure BNP or NT-proBNP in patients presenting with dyspnea to help establish or exclude heart failure; interpret values in clinical context and consider age-specific cutoffs for NT-proBNP.

Prognostic biomarker coverage

Covered when ANY of the following prognostic uses are documented

sST2 prognostic use: Use sST2 (e.g., Presage assay) to assess prognosis in chronic heart failure and for risk stratification; elevated sST2 thresholds (study-dependent, e.g., ~30 ng/mL to >43 ng/mL) associate with increased risk of adverse outcomes.study-specific cutoffs (eg, 30 ng/mL, 34.6 ng/mL, 43.43 ng/mL)

sST2 may add prognostic information beyond natriuretic peptides in some studies.

Copeptin adjunctive use: Copeptin may be used adjunctively with troponin for early rule-out of MI within the first hours after symptom onset; combination with troponin can improve early diagnostic performance in some studies.time-sensitive (within ~6 hours of symptom onset)

Copeptin is not encouraged as a standalone replacement for troponin.

Society guideline–based testing criteria

Testing recommended per major society guidance when clinically suspected:

Troponin testing for suspected ACS: Measure cardiac-specific troponin (I or T) at presentation and again 3–6 hours after symptom onset in all patients with suspected ACS to identify a rising/falling pattern; obtain additional troponin levels beyond 6 hours if initial serial troponins are normal but ECG changes or intermediate/high-risk clinical features are present.presentation and 3-6 hours; additional >6 hours if indicated

If symptom onset is unclear, use time of presentation as time zero for sampling.

When troponin unavailable: If troponin measurement is not possible, CK‑MB or copeptin may be considered as alternatives, recognizing CK‑MB is less sensitive/specific and copeptin may be useful adjunctively where hs‑cTn is not available.CK‑MB decision level: 99th percentile; SCAI higher thresholds apply post‑revascularization

Guidelines caution these are secondary options and troponin remains preferred.

Biomarker diagnostic criteria and preferred assays

Covered when testing and interpretation follow guideline recommendations:

MI diagnostic criteria: Diagnosis requires rise and/or fall of cardiac biomarker values (preferably cardiac troponin) with at least one value above the 99th percentile upper reference limit AND at least one of: ischemic symptoms; new or presumed new significant ST‑T changes or new LBBB; development of pathologic Q waves; imaging evidence of new loss of viable myocardium or new regional wall motion abnormality; identification of intracoronary thrombus by angiography.99th percentile

NICE-referenced diagnostic elements.

hs‑cTn use and sampling

Use high-sensitivity troponin assays for earlier rule‑in/rule‑out when available:

hs-cTn preference: High-sensitivity cardiac troponin assays are preferred because of greater sensitivity and negative predictive value; obtain an initial sample at assessment and repeat a second sample 30 minutes to 3 hours later when using early rule‑out/rule‑in strategies.30 minutes to 3 hours

Use thresholds at or near the assay limit of detection or the 99th percentile per NICE and guideline recommendations.

Covered Indications (as added)

Coverage statements added or clarified in revision history

BNP/NT-proBNP Meets Coverage: Measurement of B-type natriuretic peptide (BNP) or N-terminal proBNP (NT-proBNP) MEETS COVERAGE CRITERIA in any of the following situations: a) To diagnose heart failure in individuals presenting with dyspnea. b) To establish disease severity in individuals with chronic heart failure (up to four times per year in the outpatient setting).up to four times per year

Added 05/01/2024 per revision history.

Analysis of ST2 and its isoforms (for example, the Presage ST2 assay) does not meet coverage criteria when performed in the outpatient setting. The policy explicitly lists ST2 and/or its isoforms among tests that lack sufficient published evidence of clinical benefit for outpatient MI evaluation and therefore are excluded from coverage for outpatient use.

Use of CK‑MB or myoglobin alone for diagnosis of acute coronary syndrome is not recommended when contemporary troponin assays are available. The policy also states that H‑FABP and copeptin are not encouraged as replacements for troponin because troponins are generally superior; copeptin may have adjunctive early rule‑out data in some studies but is not supported as a standalone replacement.

CK‑MB and myoglobin are of limited utility for diagnosing ACS when contemporary cardiac troponin assays are available. The AHA/ACC guideline guidance and society statements cited in the policy emphasize troponin (I or T) as the recommended diagnostic biomarker, and older markers such as CK‑MB and myoglobin are not preferred for contemporary MI diagnosis.

The American Society for Clinical Pathology (ASCP) recommends against testing CK‑MB or myoglobin to diagnose an acute myocardial infarction and advises use of troponin I or T instead; the policy cites this guidance when discouraging CK‑MB or myoglobin testing for MI.

The policy review dated 10/15/2025 reported that the literature update did not necessitate any modifications to the coverage criteria. Revision notes describe ordering and formatting changes and list prior additions (for example CPT code additions), but do not change the stated coverage exclusions in the cited excerpt.

Qualitative measurement of cardiac troponin (troponin T or I) in the outpatient setting does not meet coverage criteria and is explicitly listed as not covered in the policy.

Routine use of H‑FABP or copeptin as replacements for troponin for MI diagnosis is not supported by the policy. H‑FABP and copeptin have been studied and may show early diagnostic signal or high NPV when combined with troponin in some cohorts, but the policy notes troponins remain generally superior and these alternatives are not encouraged as standalone replacements.

Routine serial measurements of BNP/NT‑proBNP to guide therapy are not supported by consistent evidence for improving mortality or cardiovascular outcomes; major society guidance cited in the policy indicates insufficient data to recommend serial natriuretic peptide monitoring as standard‑of‑care for therapeutic management, though BNP/NT‑proBNP remain useful for diagnosis and assessment of HF severity.

ASCP guidance discourages use of CK‑MB or myoglobin to diagnose acute MI and supports relying on troponin alone (troponin I or T) as the preferred cardiac biomarker for MI evaluation.

Within the provided final‑page revision excerpts there are no additional explicit 'not medically necessary' statements beyond those already listed elsewhere in the policy; the 10/15/2025 review stated the literature did not require changes to coverage criteria.

Procedure and Billing Codes

Enumerated laboratory/CPT/HCPCS procedure codesCPT

82550	Creatine kinase (CK), (CPK); total.
82552	Creatine kinase (CK), (CPK); isoenzymes.
82553	Creatine kinase (CK), (CPK); MB fraction only.
82554	Creatine kinase (CK), (CPK); isoforms.
82725	Fatty acids, nonesterified.
83006	Growth stimulation expressed gene 2 (ST2, Interleukin 1 receptor like-1).
83615	Lactate dehydrogenase (LD), (LDH);
83625	Lactate dehydrogenase (LD), (LDH); isoenzymes, separation and quantitation.
83874	Myoglobin.
83880	Natriuretic peptide.

1–10 of 16

1/2

Policy CPT additionsCPT

86141	CPT code 86141
83880	CPT code 83880

sST2 diagnostic/prognostic cutoffs

sST2 study cutoffsReported study cutoffs include 34.6 ng/mL (Wang et al. discrimination for acute aortic dissection), 30 ng/mL (studies associating with post‑OHT mortality risk), and an observed study cutoff ≈43.43 ng/mL for mortality risk

Presage assay measuring rangePresage ST2 assay measuring range reported 3.1–200 ng/mL (FDA‑cleared)

sST2 prognostic interpretationElevated sST2 values (>30–43 ng/mL depending on study) associate with higher risk of adverse outcomes in chronic HF

BNP / NT-proBNP equivalence

BNP/NT-proBNP equivalenceNT‑proBNP >900 pg/mL is roughly equivalent to BNP >100 pg/mL

Clinical use

Provider Actions, Documentation, and Billing Guidance

Billing Rule

Coding reference

Reference lab/test codes: Use the procedure codes listed in the policy as a general billing and documentation reference. The following CPT/HCPCS codes are included in the policy: 82550 (CK, total); 82552 (CK isoenzymes); 82553 (CK MB fraction only); 82554 (CK isoforms); 82725 (Fatty acids, nonesterified); 83006 (ST2); 83615/83625 (LD/LDH and isoenzymes); 83874 (Myoglobin); 83880 (Natriuretic peptide); 84450 (AST/SGOT); 84484 (Troponin, quantitative); 84512 (Troponin, qualitative); 84588 (Vasopressin/ADH); 86140 (C-reactive protein); 86141 (CRP, high sensitivity). Procedure codes appearing in Medical Policy documents are provided for general reference and may not be all-inclusive.

Use listed procedure codes as a general reference for billing and documentation.
Review payer-specific billing rules for code application and modifiers.

Documentation Required

Background and Context

Acute coronary syndromes (ACS) encompass a spectrum from unstable angina to myocardial infarction and are subclassified by ECG findings into STEMI and NSTEMI. Cardiac biomarkers, principally cardiac troponin I or T, rise and fall after myocardial injury and are central to the diagnosis of MI. Contemporary guidelines recommend measuring troponin at presentation and again at 3–6 hours to identify a rising/falling pattern with at least one value above the 99th percentile upper reference limit, and prefer troponin over older markers such as CK‑MB or myoglobin for routine diagnosis.

Definitions and Biomarker Glossary

cTnI / cTnT

cTnI definitionCardiac troponin I (cTnI) is a cardiac‑specific troponin isoform used as a biomarker for myocardial injury; high‑sensitivity assays are recommended

cTnT definitionCardiac troponin T (cTnT) is a cardiac‑specific troponin isoform used for MI evaluation; high‑sensitivity cTnT assays are preferred when available

Clinical rolecTnI and cTnT are the recommended biomarkers for diagnosis of MI, requiring serial sampling to demonstrate dynamic change

BNP / NT-proBNP

BNP definitionB‑type natriuretic peptide (BNP) is released from the left ventricle and helps establish or exclude heart failure in patients presenting with dyspnea

NT‑proBNP definitionN‑terminal pro‑BNP (NT‑proBNP) is a cleavage product of proBNP used to diagnose and prognosticate heart failure; optimal cutoffs vary by age

Policy Revision History

2025-10-15literature_review/maintenanceLatest

Routine literature review on 10/15/2025 found no modifications were necessary to the coverage criteria.

2024-05-01coverage_addition

Added new coverage criterion: measurement of BNP or NT-proBNP meets coverage for diagnosing heart failure in dyspnea and for establishing chronic HF disease severity (up to four times per year in the outpatient setting).

2024-05-01

Policy Summary

PayerBlue Cross Blue Shield - Louisiana

PolicyBiomarkers for Myocardial Infarction and Chronic Heart Failure

Policy CodePolicy AHS - G2150 - Biomarkers for Myocardial Infarction and Chronic Heart Failure, 1

Change TypeCPT additionscoverage clarification and reordering of criteria

Effective Date05/15/2022

Next Review DateN/A

Key ActionDocument symptom onset and timing of troponin sampling (presentation and 3–6 hours) when requesting quantitative troponin testing for suspected acute coronary syndrome.

SourceLink

On This Page

NT-proBNP >900 pg/mL approximates BNP >100 pg/mL

Serial measurements may inform prognosis and management, though optimal serial strategies are under investigation.

Biomarkers in heart failure:

Measure BNP or NT‑proBNP to support diagnosis or exclusion of heart failure and for prognosis in chronic HF; obtain baseline natriuretic peptide and/or troponin on admission for acutely decompensated HF to establish prognosis.

Not specified numerically in these excerpts

ACC/AHA/HFSA and ESC provide class-level recommendations for these uses.

Emerging biomarkers: sST2 and other novel markers may provide additional prognostic information and are promising for risk stratification (sST2 less affected by BMI/age/renal function), but routine diagnostic use is not recommended by major societies; use primarily for additive risk stratification where supported.None

Ongoing studies; evidence insufficient for routine serial-guided therapy.

Measure BNP or NT‑proBNP in patients presenting with dyspnea to help diagnose or exclude heart failure

Age-specific considerationsNT‑proBNP optimal cutoffs vary with patient age and clinical context

MI biomarker decision level

MI biomarker decision levelAcute MI is designated when a rising/falling pattern of cardiac troponin is seen with at least one value >99th percentile of the upper reference limit (URL)

Preferred biomarkersUse cTnI or cTnT (high‑sensitivity assays recommended) for MI diagnosis

Alternative when troponin unavailableCK‑MB decision level: measurement above the 99th percentile of the URL (use sex‑specific values)

Biomarker decision thresholds

Troponin MI decision thresholdTroponin decision level for MI: value >99th percentile of the upper reference limit (URL)

SCAI post‑revascularization thresholdsFor normal baseline: CK‑MB peak within 48 h >10× ULN (or >5× ULN with new Q‑waves/new persistent LBBB) OR cTn within 48 h >70× ULN (or >35× ULN with new Q‑waves/new persistent LBBB)

CK‑MB decision level when usedCK‑MB decision level: >99th percentile of the URL; CK‑MB may be used only if cTn not available

Troponin timing

Standard serial timingMeasure cardiac‑specific troponin at presentation and again 3–6 hours after symptom onset to identify a rising/falling pattern

Additional samplingObtain additional troponin levels beyond 6 hours when initial serial troponins are normal but ECG changes or intermediate/high clinical risk are present

Zero‑and‑two‑hour algorithmsZero and two hour algorithms are discussed but should be used with appropriate clinical risk stratification per guideline caveats

hs‑cTn threshold timing and values

hs‑cTn threshold guidanceUse thresholds at or near the assay limit of detection or the 99th percentile; if multiple samples taken, obtain initial sample at assessment and a second sample 30 minutes to 3 hours later

Assay preferenceHigh‑sensitivity cTn assays are preferred because of greater sensitivity and negative predictive value for early rule‑out/rule‑in

Early sampling windowhs‑cTn enables shorter interval from chest pain onset to detection compared with conventional assays, supporting earlier rule‑out strategies

Frequency for outpatient disease severity monitoring

Outpatient HF monitoring frequencyBNP or NT‑proBNP to establish disease severity in chronic heart failure: covered up to four times per year in the outpatient setting

Documentation noteUse in the outpatient setting should be interpreted in clinical context; serial measurements for therapy guidance remain investigational

Policy change sourceProvision added to coverage criteria in 05/01/2024 revision history

Serial troponin timing; timing and interpretation documentation

Serial troponin timing and interpretation must be documented. Measure cardiac-specific troponin (I or T using a contemporary/high-sensitivity assay when available) at presentation and again 3–6 hours after symptom onset to identify a rising and/or falling pattern; obtain additional troponin levels beyond 6 hours if initial serial troponins are normal but clinical or ECG features remain concerning. If symptom onset time is unclear, use time of presentation as time of onset. Interpret MI when a rise and/or fall pattern is present and at least one value exceeds the 99th percentile upper reference limit.

Document timing of symptom onset and each troponin sample (presentation, 3–6 hours, and any additional draws).
Document assay type (high-sensitivity vs contemporary) and the 99th percentile reference limit used by the performing laboratory.

Documentation Required

Clinical presentation documentation

Clinical presentation documentation: When requesting biomarker testing, document clinical signs and symptoms consistent with acute coronary syndrome (see Note 1) such as ischemic chest pain, radiation, diaphoresis, dyspnea, syncope, or other atypical presentations. For BNP/NT-proBNP testing document presence of dyspnea or need to establish chronic heart failure disease severity.

Include relevant history, physical exam findings, and ECG results or reason why ECG was not obtained.
For serial troponin testing, record time of symptom onset or time of presentation if onset is ambiguous.

Note

Preferred tests vs not covered

Preferred tests vs not covered: The policy prefers quantitative cardiac troponin (I or T, high-sensitivity when available) and BNP/NT-proBNP for the indicated uses. The following biomarkers are listed as not meeting coverage criteria for diagnosis/prognosis of MI or in outpatient settings: AST, CK, CK-MB, CK isoenzymes/isoforms, LD/LDH, myoglobin, qualitative troponin in outpatient settings, copeptin, troponin C, C-reactive protein (routine for MI), H-FABP, and ST2/Presage ST2 for outpatient situations. Outpatient biomarker testing performed in settings unable to perform adequate MI evaluation (e.g., independent lab or physician office) does not meet coverage criteria.

Preferred: quantitative troponin (high-sensitivity when available), BNP/NT-proBNP.
Not covered/Not preferred: CK/CK-MB, myoglobin, AST, LD/LDH, qualitative troponin outpatient, ST2, copeptin, troponin C, H-FABP, routine CRP for MI.

Step Therapy

Step therapy

Step therapy: No step therapy or sequencing prior authorization requirements are specified in this policy. The policy does, however, recommend using high-sensitivity troponin assays and following guideline-backed serial sampling (presentation and 3–6 hours) as the standard diagnostic approach; failure to follow recommended assay selection and sampling may affect clinical interpretation and coverage decisions.

No explicit step-therapy or prior-authorization sequence is required per this policy.
Follow guideline-recommended diagnostic sequence (hs-cTn and serial measurements).

Note

Laboratory-developed tests (LDTs) and regulation

Laboratory-developed tests (LDTs) and regulation: Many laboratories perform LDTs that are regulated by CMS as high-complexity tests under CLIA '88. LDTs are not FDA-approved or cleared but FDA clearance/approval is not required for clinical use at this time. When using LDTs, document the performing laboratory, assay characteristics, and reference limits to support interpretation.

LDTs are regulated under CLIA as high-complexity tests; they are not FDA-approved/cleared.
Document assay type, performing lab, and reference ranges when ordering or interpreting LDTs.

Denial Risk

No explicit denial triggers are present

No explicit denial triggers are present in this section of the document beyond the stated coverage limitations. The policy specifies which tests and scenarios do not meet coverage criteria (see "Preferred tests vs not covered") but does not list additional automatic denial triggers. Remember government policies (LCDs/NCDs) override this policy where conflicts exist.

Coverage exclusions are defined (e.g., qualitative troponin outpatient, certain biomarkers, outpatient settings unable to perform adequate MI evaluation) rather than additional denial rules.
Check applicable LCDs/NCDs which take precedence and may impose explicit denial triggers.

Note

Revision history documents criteria changes and CPT additions

Revision history and changes: The policy's revision history documents criteria changes and CPT code additions. Notable updates include addition of CPT code 83880 (05/01/2024) and CPT code 86141 (10/15/2025), reordering of coverage criteria for clarity, and literature reviews that did not necessitate modifications to coverage criteria for some reviews. Consult the revision history for the date-specific rationale and code changes.

05/15/2022: Initial policy implementation.
05/01/2024: Added CPT 83880 and added BNP/NT-proBNP coverage language.
10/15/2025: Added CPT 86141 and made formatting/clarity updates.

Clinical useMeasure BNP/NT‑proBNP to support diagnosis, prognosis, and disease severity assessment in chronic HF; baseline natriuretic peptide on admission aids prognosis in acutely decompensated HF

CK-MB, LDH, Myoglobin

CK‑MB/LDH/Myoglobin overviewCK‑MB, LDH, and myoglobin are older myocardial injury markers with poorer specificity than troponin and are generally not recommended for contemporary MI diagnosis

Myoglobin kineticsMyoglobin appears 1–3 hours after MI onset but has poor specificity and is discouraged for MI diagnosis

LDH kinetics and specificityLDH isoenzymes increase 5–10 hours after MI and remain elevated longer but have poor cardiac specificity

CK-MB

CK‑MB historical roleCK‑MB was historically used as the cardiac biomarker of choice before troponin assays; rises 3–9 hours after MI, peaks 10–20 hours, returns to normal ≈72 hours

Contemporary stanceCK‑MB is less sensitive and specific than troponin; may be used only if troponin is unavailable

Decision levelCK‑MB decision level should be the 99th percentile of the URL with sex‑specific values recommended

Cardiac troponins (cTnI, cTnT)

Preferred biomarkersCardiac troponins (cTnI, cTnT) are the preferred biomarkers for MI evaluation; high‑sensitivity assays are recommended for routine use

Interpretation requirementDiagnosis of MI requires a rise and/or fall in troponin with at least one value above the 99th percentile URL plus clinical/ECG/imaging evidence

Serial samplingSerial troponin measurements at presentation and 3–6 hours (or per early rule‑out protocols) are recommended to identify dynamic change

BNP / NT-proBNP

BNP/NT‑proBNP useBNP and NT‑proBNP assist in diagnosis and assessment of heart failure severity and are supported by guideline recommendations

Threshold variabilityNT‑proBNP thresholds vary by age and clinical context; interpret values in conjunction with clinical assessment

Prognostic roleNatriuretic peptides provide prognostic information in chronic HF and in acutely decompensated HF admissions

sST2

sST2 definitionSoluble ST2 (sST2) is a circulating isoform of the IL‑33 receptor family that reflects cardiomyocyte stress and fibrosis and provides prognostic information in heart failure

Presage assay and FDA statusPresage ST2 (Critical Diagnostics) is an FDA‑cleared quantitative assay indicated as an aid in assessing prognosis in chronic heart failure

Clinical utilitysST2 adds prognostic information beyond natriuretic peptides in some studies but routine outpatient ST2 testing is restricted by the policy

Acute myocardial infarction (MI)

MI diagnostic definitionAcute myocardial infarction is defined by a rise and/or fall of cardiac troponin values with at least one value above the 99th percentile URL together with ischemic symptoms or ECG/imaging evidence

Guideline sourcesDefinition aligned with 2018 Fourth Universal Definition of MI and NICE recommendations

Necessity of clinical correlationBiomarker criteria must be combined with clinical, ECG, or imaging evidence to establish MI diagnosis

SCAI clinically relevant MI after revascularization

SCAI clinically relevant MI definitionAfter revascularization with normal baseline: CK‑MB peak within 48 h >10× ULN (or >5× ULN with new Q‑waves/persistent LBBB) OR cTn within 48 h >70× ULN (or >35× ULN with new Q‑waves/persistent LBBB)

Baseline elevation scenariosIf baseline CK‑MB or cTn elevated but stable/falling, diagnosis uses absolute increments equal to these thresholds from most recent pre‑procedure level

Preference noteSCAI expresses preference for CK‑MB but includes cTn when CK‑MB not available

Appropriate use criteria (AUC) for coronary revascularization

AUC contextAppropriate use criteria (AUC) incorporate biomarker recommendations (eg, ACC/AHA guidance) for coronary revascularization decision‑making

Biomarker integrationNatriuretic peptides and troponin levels may be used to identify patients at increased risk of death, HF, and recurrent MACE when considering revascularization

Guideline linkage2014 AHA/ACC biomarker recommendations are referenced within AUC frameworks

High-sensitivity cardiac troponin (hs‑cTn)

hs‑cTn definitionHigh‑sensitivity cardiac troponin (hs‑cTn) assays detect lower concentrations of cTnI or cTnT with greater sensitivity and negative predictive value than conventional assays; preferred when available

NICE early rule‑out guidanceNICE recommends using thresholds at or near the assay limit of detection and repeat sampling 30 minutes to 3 hours after initial assessment for early rule‑out strategies

Clinical advantagehs‑cTn shortens time from chest pain onset to detectable levels, enabling earlier rule‑in/rule‑out

Universal MI diagnostic criteria

Universal MI diagnostic criteriaDiagnosis requires rise and/or fall of cardiac biomarker values (preferably troponin) with ≥1 value above the 99th percentile URL plus clinical/ECG/imaging evidence

Acceptable evidence elementsIschemic symptoms, new ST‑T changes or new LBBB, pathologic Q waves, imaging evidence of new loss of viable myocardium, or identification of intracoronary thrombus

Guideline alignmentNICE and the Fourth Universal Definition support this diagnostic construct

Laboratory-developed test (LDT)

LDT definitionLaboratory‑developed test (LDT) is a test developed and performed in‑house by a laboratory and regulated under CLIA as high‑complexity tests; not FDA‑cleared/approved

Regulatory noteLDTs must be validated by the performing laboratory; FDA clearance/approval is not required for clinical use under current regulations

Clinical implicationProviders should be aware of LDT status when interpreting assay performance and regulatory oversight

BNP/NT-proBNP

BNP/NT‑proBNP role summaryBNP and NT‑proBNP are blood biomarkers used to assist diagnosis and assessment of heart failure severity and are supported by multiple guideline documents

Clinical recommendationsMeasure natriuretic peptides in patients presenting with dyspnea to help diagnose or exclude HF; interpret with full clinical evaluation

Prognostic and serial useNatriuretic peptides provide prognostic information in chronic and acutely decompensated HF; serial measurement for therapy guidance remains under investigation

Added CPT code 83880 to the policy's enumerated CPT/HCPCS code list.

2022-05-15policy_effective_date

Policy initial implementation effective 05/15/2022 (original policy effective date).

2025-10-15coding_addition_recorded

Revision history notes addition of CPT code 86141 (recorded in 10/15/2025 revision).

Billing Rule

CPT code additions recorded in revision history

Revision history (10/15/2025 and 05/01/2024) documents addition of CPT codes including 86141 and 83880; providers should use these coding updates when applicable for billing and documentation.

10/15/2025: Added CPT code 86141.
05/01/2024: Added CPT code 83880.

Revision history entry dated 10/15/2025 documents that literature review did not necessitate changes to coverage criteria. The entry also records administrative edits (reordering of criteria for clarity) and notes prior material changes such as addition of BNP/NT‑proBNP coverage language and CPT code additions; these revision notes serve as the official record of the recent review outcome.