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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

04-78000-22

Original Effective Date: 12/15/17

Reviewed: 12/08/17

Revised: 00/00/00

Subject: Noninvasive Fractional Flow Reserve Measurement

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates      
           

DESCRIPTION:

Fractional flow reserve (FFR) derived by standard acquired coronary computed tomography angiography (FFRCT) enables computational assessment of coronary blood flow and pressure. Noninvasive calculation of FFR from coronary computed tomographic (FFRCT) applies computational fluid dynamics to determine the physiologic significance of coronary artery disease (CAD). Coronary physiology is a tool that can guide management decisions for intermediate lesions and multivessel coronary artery disease (CAD), determine whether the patient would benefit from coronary revascularization or medical therapy (Jesen et al. 2017, Min et al. 2012, Shlofmitz et al. 2017).

Fractional flow reserve (FFR) is the ratio of maximal blood flow in a stenotic artery to normal maximal flow. FFR is easily measured during coronary angiography by using a pressure guidewire to calculate the ratio of distal coronary pressure to aortic pressure. FFR in a normal coronary artery equals 1.0. An FFR value of 0.80 or less identifies ischemia-causing coronary stenosis with an accuracy of more than 90% (Tonino et al. 2009).

The HeartFlow fractional flow reserve (FFRCT); FFRCT v.1.4 simulation software was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the de novo 510(k) process (Nov 2014) and the FFRCT v2.0 device was cleared through a subsequent 510(k) process (Jan 2016). The HeartFlow FFRCT is classified as a coronary physiologic simulation software device. HeartFlow FFRCT is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography *DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides FFRCT, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. FFRCT analysis is intended to support the functional evaluation of coronary artery disease (FDA, 2017).

* Digital Imaging and Communications in Medicine (DICOM)

POSITION STATEMENT:

The use of noninvasive fractional flow reserve following a positive coronary computed tomography angiography meets the definition of medical necessity to guide decisions about the use of invasive coronary angiography in members with stable chest pain at intermediate risk of coronary artery disease (i.e., suspected or presumed stable ischemic heart disease).

The use of noninvasive fractional flow reserve for all other indications when the above criteria are not met is considered experimental or investigational. The evidence is insufficient to determine that noninvasive fractional flow reserve results in improvement in net health outcome.

Note: * Cardiac Risk Assessment Tools for Coronary Artery Disease (CAD)

BILLING/CODING INFORMATION:

CPT Coding:

0501T

Noninvasive estimated coronary fractional flow reserve (FFR) derived from coronary computed tomography angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to assess the severity of coronary artery disease; data preparation and transmission, analysis of fluid dynamics and simulated maximal coronary hyperemia, generation of estimated FFR model, with anatomical data review in comparison with estimated FFR model to reconcile discordant data, interpretation and report

0502T

Noninvasive estimated coronary fractional flow reserve (FFR) derived from coronary computed tomography angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to assess the severity of coronary artery disease; data preparation and transmission, analysis of fluid dynamics and simulated maximal coronary hyperemia, generation of estimated FFR model, with anatomical data review in comparison with estimated FFR model to reconcile discordant data, data preparation and transmission

0503T

Noninvasive estimated coronary fractional flow reserve (FFR) derived from coronary computed tomography angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to assess the severity of coronary artery disease; data preparation and transmission, analysis of fluid dynamics and simulated maximal coronary hyperemia, generation of estimated FFR model, with anatomical data review in comparison with estimated FFR model to reconcile discordant data, analysis of fluid dynamics and simulated maximal coronary hyperemia, and generation of estimated FFR model

0504T

Noninvasive estimated coronary fractional flow reserve (FFR) derived from coronary computed tomography angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to assess the severity of coronary artery disease; data preparation and transmission, analysis of fluid dynamics and simulated maximal coronary hyperemia, generation of estimated FFR model, with anatomical data review in comparison with estimated FFR model to reconcile discordant data, anatomical data review in comparison with estimated FFR model to reconcile discordant data, interpretation and report

ICD-10 Diagnosis Codes That Support Medical Necessity:

I20.9

Angina pectoris, unspecified

I25.118

Atherosclerotic heart disease of native coronary artery with other forms of angina pectoris

I25.119

Atherosclerotic heart disease of native coronary artery with unspecified angina pectoris

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

* Cardiac Risk Assessment Tools for Coronary Artery Disease for (CAD) (Note: Not all inclusive)

Determination of Pretest Probability for Coronary Artery Disease (CAD)

Table 1: Determination of Pretest Probability for Coronary Artery Disease Based on Age, Gender, and Symptoms (Source: American College of Cardiology Criteria for Pretest Probability of Coronary Artery Disease (CAD)).

The following risk assessment may be used to determine pre-test probability of coronary artery disease.

Table 1:

Age (years)

Gender

Typical/Definite Angina Pectoris

Atypical/Probable Angina Pectoris

Nonanginal Chest Pain

Asymptomatic

30 – 39

Men

Intermediate

Intermediate

Low

Very low

 

Women

Intermediate

Very low

Very low

Very low

40 – 49

Men

High

Intermediate

Intermediate

Low

 

Women

Intermediate

Low

Very low

Very low

50 – 59

Men

High

Intermediate

Intermediate

Low

 

Women

Intermediate

Intermediate

Low

Very low

60 – 69

Men

High

Intermediate

Intermediate

Low

 

Women

High

Intermediate

Intermediate

Low

High: Greater than 90% pre-test probability of CAD

Intermediate: Between 10% and 90% pre-test probability of CAD

Low: Between 5% and 10% pre-test probability of CAD

Very low: Less than 5% pre-test probability of CAD

Angina: As defined by the American College of Cardiology (ACC)/American Heart Association (AHA)

Typical Angina (Definite): 1.) Substernal chest pain or discomfort that is 2.) Provoked by exertion or emotional stress and 3.) Relieved by rest and/or nitroglycerine.

Atypical Angina (Probable): Chest pain or discomfort that lacks one of the characteristics of definite or typical angina.

Non-Anginal Chest Pain: Chest pain or discomfort that meets one or none of the typical angina characteristics.

Framingham Risk Assessment for Coronary Heart Disease (CHD) Risk

Table 2: Framingham Risk Assessment for Coronary Heart Disease (CHD) Risk

Framingham risk assessment is a calculation to predict the 10-year risk of heart disease. The calculation is based on the individual’s age, sex, most recent lipid values, blood pressure, smoking history, and presence of diabetes.

Table 2:

CHD Risk Level

Framingham Score

CHD Risk-Low Defined by the age-specific risk level that is below average. In general, low risk will correlate with a 10-year absolute CHD risk.

Less than 10%

CHD Risk-Moderate Defined by the age-specific risk level that is average or above average.

Between 10% and 20%

CHD Risk-High Defined as the presence of diabetes mellitus.

Greater than 20%

Duke Treadmill Score

The equation for calculating the Duke treadmill score (DTS) is, DTS = exercise time in minutes - (5 * ST deviation in mm or 0.1 mV increments) - (4 * exercise angina score), with angina score being 0 = none, 1 = non limiting, and 2 = exercise-limiting. The score typically ranges from -25 to +15. These values correspond to low-risk (with a score of >/= +5), intermediate risk (with scores ranging from - 10 to + 4), and high-risk (with a score of </= -11) categories.

Online cardiac risk calculator and assessment tools:

The links for the online cardiac risk calculator and assessment tools are to an outside source and is provided for your convenience. Use of the links and related calculator and assessment tools are subject to the terms and conditions of the website and is not warranted, maintained or affiliated with Florida Blue.

Framingham Risk Score Calculator

https://www.framinghamheartstudy.org/

http://tools.acc.org/ASCVD-Risk-Estimator/

Reynolds Risk Score

http://www.reynoldsriskscore.org/

Pooled Cohort Risk Assessment Equations

http://clincalc.com/Cardiology/ASCVD/PooledCohort.aspx

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) was found at the time of the last guideline reviewed date.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

NOTE: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

REFERENCES:

  1. Bilbey N, Blanke P, Naoum C. Potential impact of clinical use of noninvasive FFRCT on radiation dose exposure and downstream clinical event rate. Clinical Imaging. 2016 Sep-Oct;40(5):1055-1060.
  2. Blue Cross an d Blue Shield Association Technology Evaluation Center (TEC). Fractional flow reserve and coronary artery revascularization. TEC Assessments. 2011; Volume 26: No. 2.
  3. Blue Cross and Blue Shield Association Medical Policy Reference Manual Coronary computed tomography angiography with selective noinvasive fractional flow reserve 6.01.59, 06/17.
  4. Bundhun PK, Yanamala CM, Huang F. Comparing the adverse clinical outcomes associated with fraction flow reserve-guided versus angiography-guided percutaneous coronary intervention: a systematic review and meta-analysis of randomized controlled trials. BMC Cardiovascular Disorders. 2016 Dec 3;16 (1):249.
  5. Chinnaiyan KM, Akasaka T, Amano T et al. Rationale, design and goals of the HeartFlow assessing diagnostic value of non-invasive FFRCT in Coronary Care (ADVANCE) registry. Journal of Cardiovascular Computed Tomography. 2017 Jan - Feb;11(1):62-67.
  6. Christou MA, Siontis GC, Katritsis DG et al. Meta-analysis of fractional flow reserve versus quantitative coronary angiography and noninvasive imaging for evaluation of myocardial ischemia. American Journal of Cardiology 2007 Feb 15;99(4):450-456.
  7. Coenen A, Lubbers MM, Kurata A et al. Fractional flow reserve computed from noninvasive CT angiography data: diagnostic performance of an on-site clinician-operated computational fluid dynamics algorithm. Radiology. 2015 Mar;274(3):674-683.
  8. Colleran R, Douglas PS, Hadamitzky M et al. An FFRCT diagnostic strategy versus usual care in patients with suspected coronary artery disease planned for invasive coronary angiography at German sites: one-year results of a subgroup analysis of the PLATFORM (Prospective Longitudinal Trial of FFRCT: Outcome and Resource Impacts) study. Open Heart 2017 Mar 22; 4(1):e000526.
  9. Danad I, Szymonifka J, Twisk JWR et al. Diagnostic performance of cardiac imaging methods to diagnose ischaemia-causing coronary artery disease when directly compared with fractional flow reserve as a reference standard: a meta-analysis. European Heart Journal 2017 Apr 1;38(13):991-998.
  10. De Bruyne B, Fearon WF, Pijls NH et al. Fractional flow reserve-guided PCI for stable coronary artery disease. New England Journal of Medicine 2014 Sep 25;371(13):1208-1217.
  11. De Bruyne B, Pijls NH, Kalesan B et al. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. New England Journal of Medicine 2012 Sep 13;367(11):991-1001.
  12. Dewey M, Rief M, Martus P et al. Evaluation of computed tomography in patients with atypical angina or chest pain clinically referred for invasive coronary angiography: randomised controlled trial. British Medical Journal 2016 Oct 24;355:i5441.
  13. Douglas PS, De Bruyne B, Pontone G et al. 1-Year outcomes of FFRCT-guided care in patients with suspected coronary disease: the PLATFORM study. Journal of the American College of Cardiology 2016 Aug 2; 435-445.
  14. Douglas PS, Hoffmann U, Lee KL et al. PROspective multicenter imaging study for evaluation of chest pain: rationale and design of the PROMISE trial. American Heart Journal 2014 Jun;167(6):796-803.e1.
  15. Douglas PS, Pontone G, Hlatky MA et al. Clinical outcomes of fractional flow reserve by computed tomographic angiography-guided diagnostic strategies vs. usual care in patients with suspected coronary artery disease: the prospective longitudinal trial of FFR (CT): outcome and resource impacts study. European Heart Journal. 2015 Dec 14;36(47):3359-67.
  16. Food and Drug Administration (FDA) 510(k) Approval FFRCT v 2.0/Coronary Physiologic Simulation Software Device (HeartFlow, Inc.) K161772, 2016.
  17. Gaur S, Achenbach S, Leipsic J et al. Rationale and design of the HeartFlowNXT (heartflow analysis of coronary blood flow using CT angiography: NeXt sTeps) study. Journal of Cardiovascular Computed Tomography 2013 sept-Oct; 7(5): 279-288.
  18. Gaur S, Ovrehus KA, De D, et al. Coronary plaque quantification and fractional flow reserve by coronary computed tomography angiography identify ischaemia-causing lesions. European Heart Journal 2016; 37, 1220–1227.
  19. Hendel RC, Patel MR, Kramer CM et al. ACCF/ACR/SCCT/SCMR/ ASNC/NASCI/SCAI/SIR 2006 Appropriateness Criteria for Cardiac Computed Tomography and Cardiac Magnetic Resonance Imaging-A Report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group, American College of Radiology, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, American Society of Nuclear Cardiology, North American Society for Cardiac Imaging, Society for Cardiovascular Angiography and Interventions, and Society of Interventional Radiology. Journal of the American College of Cardiology 2006; 48(7): 1475 – 1497.
  20. Jensen JM, Botker HE, Mathiassen ON et al. Computed tomography derived fractional flow reserve testing in stable patients with typical angina pectoris: influence on downstream rate of invasive coronary angiography. European Heart Journal of Cardiovascular Imaging 2017 Apr 20.
  21. Ko BS, Wong DT, Norgaard BL et al. Diagnostic performance of transluminal attenuation gradient and noninvasive fractional flow reserve derived from 320-detector row CT angiography to diagnose hemodynamically significant coronary stenosis: an NXT substudy. Radiology. 2016 Apr;279(1):75-83.
  22. Levine GN, Bates ER, Blankenship JC et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention. Journal of the American College of Cardiology 2011; 58(24): e44-122.
  23. Lotfi A, Jeremias A, Fearon WF et al. Expert consensus statement on the use of fractional flow reserve, intravascular ultrasound, and optical coherence tomography: a consensus statement of the Society of Cardiovascular Angiography and Interventions. Catheterization and Cardiovascular Interventions. 2014 Mar 1;83(4):509-18.
  24. Min JK, Koo BK, Erglis A et al. Effect of image quality on diagnostic accuracy of noninvasive fractional flow reserve: results from the prospective multicenter international DISCOVER-FLOW study. Journal of Cardiovascular Computed Tomography 2012. May-Jun;6(3):191-199.
  25. Min JK, Leipsic J, Pencina MK et al. Diagnostic accuracy of fractional flow reserve from anatomic CT angiography. JAMA Sept 26, 2012: 308(12): 1245-1237.
  26. Montalescot G, Sechtem U, Achenbach S et al. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology.
  27. Morris PD, van de Vosse FN, Lawford PV et al. “Virtual” (computed) fractional flow reserve: current challenges and limitations. JACC Cardiovasc Interventions. 2015 Jul; 8(8): 1009–1017.
  28. Nakanishi R, Budoff MJ. Noninvasive FFR derived from coronary CT angiography in the management of coronary artery disease: technology and clinical update. Vascular Health and Risk Management. 2016 Jun 22;12:269-278.
  29. Nakazato R, Park HB, Berman DS et al. Noninvasive fractional flow reserve derived from computed tomography angiography for coronary lesions of intermediate stenosis severity: results from the DeFACTO study. Circulation Cardiovascular Imaging. 2013 Nov;6(6):881-889.
  30. National Institute for Health and Care Excellence. HeartFlow FFRCT for estimating fractional flow reserve from
  31. coronary CT angiography [MTG32]. 2017.
  32. Patel MR, Calhoon JH, Dehmer GJ et al. ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 Appropriate use criteria for coronary revascularization in patients with stable ischemic heart disease. Journal of the American College of Cardiology 2017.
  33. Pijls NH, De Bruyne B, Peels K et al. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. New England Journal of Medicine 1996 Jun 27;334(26):1703-8.
  34. Pijls NH, Van Gelder B, Van der Voort P et al. Fractional flow reserve. A useful index to evaluate the influence of an epicardial coronary stenosis on myocardial blood flow. Circulation 1995 Dec 1;92(11):3183-93.
  35. Renker M, Schoepf UJ, Wang R et al. Comparison of diagnostic value of a novel noninvasive coronary computed tomography angiography method versus standard coronary angiography for assessing fractional flow reserve. Amerian Journal of Cardiology 2014 Nov 1;114(9):1303-1308.
  36. Shlofmitz E, Herenuas A. American College of Cardiology FFR in 2017: current status in PCI management expert analysis, May 25, 2017.
  37. Tonino PA, De Bruyne B, Pijls NH et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. New England Journal of Medicine 2009 Jan 15;360(3):213-224
  38. Windecker S, Kolh P, Alfonso F et al. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European...European Heart Journal 2014 Oct 1;35(37):2541-619.
  39. Wu W, Pan DR, Foin N et al. Noninvasive fractional flow reserve derived from coronary computed tomography angiography for identification of ischemic lesions: a systematic review and meta-analysis. Scientific Reports. 2016 Jul 5;6:29409.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 12/08/17.

GUIDELINE UPDATE INFORMATION:

01/01/18

New Medical Coverage Guideline.

Date Printed: May 24, 2018: 11:54 AM