mp-117 - Medical Policies - Alabama
Intracoronary Physiologic Measurements
Policy Number: MP-117
Latest Review Date: January 2021
Policy Grade: Effective 06/29/2011: Active Policy but no longer scheduled for regular literature reviews and updates.
Intracoronary Physiologic Measurements (e.g. myocardial fractional flow [FFR] and intravascular ultrasound [IVUS]) may be considered medically necessary when performed on intermediate coronary lesions (30% to 70% stenosis by visual inspection) in patients with anginal symptoms to determine if revascularizations procedures are indicated.
Post-stent deployment IVUS may be considered medically necessary.
DESCRIPTION OF PROCEDURE OR SERVICE:
Coronary angiography is considered to be the gold standard technique for the detection and evaluation of coronary artery disease. However, a number of limitations of this technique have become apparent. Limitations include the two-dimensional nature of the images, the absence of information about the blood vessel wall, insensitivity to substantial plaque burden in outwardly remodeled vessels and inability to detect vessel wall disruption during angioplasty. Myocardial fractional flow reserve (FFR) and intravascular ultrasound (IVUS) have been developed to help overcome these limitations.
Fractional Flow Reserve (FFR)
FFR is an index of the functional severity of coronary stenosis. It is defined as the ratio of the hyperemic flow in a stenotic artery to the hyperemic flow in the same artery in the hypothetical case when there is no stenosis present. FFR is calculated from simultaneous pressure measurements proximal and distal to a stenosis obtained with a pressure monitoring guidewire during a cardiac catheterization procedure during maximal hyperemia, obtained with intra-coronary or intravenous adenosine or intracoronary papaverine. Unlike coronary flow reserve using Doppler methods, FFR is independent of variables such as heart rate and blood pressure as well as gross abnormalities of the microcirculation. The normal FFR value for all vessels under all hemodynamic conditions regardless of the status of microcirculation is 1.0. Hemodynamically significant coronary stenosis is defined as FFR <0.75. This information can be used to determine if revascularization procedures such as percutaneous transluminal coronary angioplasty (PTCA) or stent placement are necessary.
Intravascular Ultrasound (IVUS)
IVUS is commonly performed as an adjunctive imaging modality following coronary angiography. It allows visualization from inside blood vessels into the endothelium of blood vessels. In clinical practice IVUS is often used as an adjunct to balloon angioplasty to detect dissection, stent under-deployment, stent thrombosis and to predict restenosis risk. It is also used as an accessory to diagnostic angiography to evaluate lesions of uncertain severity (especially in the left main coronary artery) and to detect disease, which is not visible on an angiogram (as in the case of transplant coronary artery disease).
The most recent literature update was performed through January 12, 2021.
Summary of Evidence
For individuals with anginal symptoms who receive FFR to determine if revascularizations procedures are indicated, the evidence consists of prospective studies, meta-analyses, and randomized trials. Multiple studies have demonstrated that deferring angioplasty based on physiologic criteria such as FFR is feasible, safe, and associated with improved patient outcome. FFR has been found to be independent of hemodynamic variation, has an unequivocal normal value of 1.0 for each vessel in a normal patient, and a value of 0.75 has shown a good correlation with traditional noninvasive stress testing indicating inducible myocardial ischemia. If the FFR is less than 0.75, there is at least 80% sensitivity and 85% specificity for an abnormal exercise test result. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.
For individuals with anginal symptoms who receive IVUS to determine if revascularizations procedures are indicated, the evidence consists of randomized controlled trials, cohort studies and retrospective reviews. IVUS offers unique capabilities to assess coronary atherosclerosis. In patients with clinical symptoms of coronary disease, IVUS commonly detects atherosclerosis at angiographically normal sites. The value of IVUS is its tomographic perspective and direct imaging of coronary atheroma. Angiography depicts the coronary anatomy as a planar silhouette of the lumen. Ultrasound, in contrast, directly images the atheroma within the vessel wall, allowing measurement of plaque size, distribution, and to some extent composition. IVUS has been performed safely in a wide variety of clinical situations with few serious side effects. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.
Practice Guidelines and Position Statements
American College of Cardiology, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, et al.
In 2017, the ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS published Appropriate Use Criteria for Coronary Revascularization in Patients with Stable Ischemic Heart Disease. They state the following related to FFR and IVUS:
“The writing group recognizes that not all patients referred for revascularization will have previous noninvasive testing. In fact, there are several situations in which patients may be appropriately referred for coronary angiography on the basis of symptom and ECG presentation and a high pretest probability of CAD. In these settings, there may be situations where angiography shows a coronary narrowing of questionable hemodynamic importance in a patient with symptoms that can be related to myocardial ischemia. In such patients, the use of additional invasive measurements (such as FFR or intravascular ultrasound) at the time of diagnostic angiography may be very helpful in further defining the need for revascularization and may substitute for stress test findings. Accordingly, many of the indications now include FFR test results.”
“FFR is considered as part of an invasive evaluation and is cited separately in some scenarios. An emerging technology, computed tomography-derived FFR is a combination technique that is noninvasive like computed tomography but provides FFR, which has traditionally only been an invasive test.”
“….the angiographic assessment of the severity of left main disease has several shortcomings, and other assessments such as IVUS or FFR may be needed…… A minimum lumen area between 6 and 7.5 mm2 requires further physiological assessment, such as measurement of FFR.”
U.S. Preventive Services Task Force Recommendations
Fractional flow reserve, flow, coronary flow reserve, intravascular ultrasound, intravascular Doppler, IVUS, Intravascular Doppler velocity, pressure derived coronary flow reserve measurement, FFR, intracoronary ultrasound
APPROVED BY GOVERNING BODIES:
Several devices that measure bone density have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity. Special benefit consideration may apply. Refer to member’s benefit plan.
|93571||Intravascular doppler velocity and/or pressure derived coronary flow reserve measurement (coronary vessel or graft) during coronary angiography including pharmacologically induced stress; initial vessel (List separately in addition to code for primary procedure).|
|93572||Each additional vessel (List separately in addition to code for primary procedure).|
|92978||Intravascular ultrasound (coronary vessel or graft) during diagnostic evaluation and/or therapeutic intervention including imaging, supervision, interpretation and report; initial vessel (List separately in addition to code for primary procedure)|
;each additional vessel (List separately in addition to code for primary procedure)
- Ahn JM, Park DW, Shin ES, et al. Fractional flow reserve and cardiac events in coronary artery disease: Data from a prospective IRIS-FFR Registry. Circulation. 2017 Jun6;135 (23): 2241-2251.
- American College of Cardiology. American College of Cardiology/American Heart Association Task Force on Practice Guidelines, 2007 Writing Group to Review New Evidence band Update the ACC/AHA/SCAI 2005 guideline Update for Percutaneous Coronary Intervention, Writing on behalf of the 2005 Writing Committee, Spencer B. King, III, Sidney C Smith, Jr, John W. Hirshfeld, Jr, Alice K Jacobs, Douglass A Morrison and David O Williams. 2007 Focused update of the ACC/AHA/SCAI 2005 Guideline update for Percutaneous Coronary Intervention. JACC 2008; 51: 172-209.
- Braunwald: heart disease: a textbook of cardiovascular medicine, 6th ed., 2001 W.B. Saunders Company.
- Chamuleau SAJ, Meuwissen M, Koch KT, et al. Usefulness of fractional flow reserve for risk stratification of patients with multivessel coronary artery disease and an intermediate stenosis. Amer J of Cardio; 89(4): 2002.
- De Ribamar Costa J Jr, Mintz GS, Carlier SG, et al Intravascular ultrasound assessment of drug-eluting stent expansion. Am Heart J, February 2007; 153(2): 297-303.
- Dove JT, Jacobs AK, Kennedy JW, et al. ACC/AHA Guidelines for percutaneous coronary intervention (revision of the 1993 PTCA guidelines)---executive summary. J Amer Coll of Cardio; 37(8): 2001.
- Fischer JJ, Samady H, McPherson JA, et al. Comparison between visual assessment and quantitative angiography versus fractional flow reserve for native coronary narrowings of moderated severity. Amer J of Cardio; 90(3): 2002.
- Hoffmann R, Morice MC, Moses JW, et al. Impact of late incomplete stent apposition after sirolimus-eluting stent implantation on 4-year clinical events: Intravascular ultrasound analysis from the multicentre, randomized, RAVEL, E-SIRIUS an SIRIUS trials. Heart, March 2008; 94(3): 253-254.
- Jeremiasa A, Whitbourn RJ, Filardo SD, et al. Acute ischemic heart disease: adequacy of intracoronary versus intravenous adenosine-induced maximal coronary hyperemia for factional flow reserve measurements. Amer J of Cardio; 140(4): 2000.
- Johnson NP, Toth GG, Lai D, et al. Prognostic value of fractional flow reserve: linking physiologic severity to clinical outcomes. J Am Coll Cardiol. 2014; 64(16): 1641 – 54.
- Mueller C, Hodgson JMcB, Schindler C et al. Cost-effectiveness of intracoronary ultrasound for percutaneous coronary interventions. Amer J of Cardio: 91(2); 2003.
- Nissen SE. Application of intravascular ultrasound to characterize coronary artery disease and assess the progression or regression of atherosclerosis. Amer J of Cardio; 89(4A): 2002.
- 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. J Am Coll Cardiol. 2017 May2;69(17):2212-2241.
- Rieber J, Schiele TM, Koenig A, et al. Long-term safety of therapy stratification in patients with intermediate coronary lesions based on intracoronary pressure measurements. Amer J of Cardio; 90 (10): 2002.
- Tonino PA, DeBruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15; 360 (3): 213-24.
- Tsuchida K, Serruys PW, Bruining N, Dudek D, et al. Two-year serial coronary angiographic and intravascular ultrasound analysis of in-stent angiographic late lumen loss and ultrasonic neointimal volume from the TAXUS II trial. Am J Cardiology, March 2007; 99(5): 607-615.
Medical Policy Group, February 2003
Medical Review Committee, March 2003
Medical Policy Group, May 2003 (2)
Medical Policy Administration Committee, June 2003
Available for comment July 1-August 14, 2003
Medical Policy Group, December 2003
Medical Policy Group, February 2003
Medical Policy Administration Committee, February 2004
Available for comment February 7-March 22, 2004
Medical Review Committee, March 2004
Medical Policy Group, March 2004
Medical Policy Administration Committee, March 2004
Medical Policy Group, March 2005 (1)
Medical Policy Group, March 2007 (1)
Medical Policy Group, March 2009 (1)
Medical Policy Group, June 2011 (1): Policy retired. Medical policy is no longer scheduled for regular literature updates. Removed policy statements prior to March 24, 2004.
Medical Policy Group, December 2019 (4): Updates to Description, Key Points, and References.
Medical Policy Group, January 2021 (4): Reviewed by consensus. No change to policy statement.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.