mp-020 - Medical Policies - Alabama
Computerized Pulse Waveform Analysis
Policy Number: MP-020
Latest Review Date: May 2018
Policy Grade: Active Policy but no longer scheduled for regular literature reviews and updates.
Description of Procedure or Service:
The CV Profilor®DO-2020 CardioVascular Profiling System and the SphygmoCor® Cardiovascular Management System are examples of non-invasive medical devices that provide an indication of arterial compliance (elasticity indices for both large and small arteries), which can be used to determine if patients have potential underlying vascular disease. The devices also measure systolic, diastolic and mean arterial pressures and pulse rate, and calculates body surface area, body mass index and pulse pressure.
These devices obtain upper-arm blood pressure values and waveform data by non-invasive methods, via the use of an oscillometric blood pressure module and via the application of specially designed equipment.
The acquisition of calibrated radial artery blood pressure waveform data involves, the coordinated use of a blood pressure cuff placed on the left upper-arm and a piezoelectric-based, direct contact, acoustical transducer placed over the right radial artery adjacent to the styloid process of the radius (by the wrist). The cuff systolic and diastolic pressures are utilized to calibrate the radial artery waveform data into units of pressure based on the median high and low value contained in a 30-second collection of blood pressure waveform data.
An embedded computer performs a “pulse contour analysis” of the calibrated, digitized blood pressure waveform data, and generates a report. The clinical data collected and analyzed are accurate and repeatable, and can be used in determining hemodynamic parameters relating to the structure, function and changes of a patient’s cardiovascular system.
The report summarizes the pulse contour analysis performed on a 30-second collection of the radial artery blood pressure waveforms. The results are based on the use of an electrical analog model which represents the vasculature as consisting of a capacitative compliance element (Large Artery Elasticity Index), an oscillatory or reflective compliance element (Small Artery Elasticity Index), an inductance and a resistance, during the diastolic decay portion of the cardiac cycle.
Computerized Pulse Waveform Analysis (CV Profilor®, SphygmoCor®) is considered not medically necessary and investigational.
Blood pressure is the most frequently measured property of peripheral vasculature. However, compliance reflecting the change in vascular dimensions relative to the pulse pressure may be a more subtle index of vasculary dysfunction associated with aging and diseases such as hypertension, diabetes mellitus, coronary heart disease or congestive heart failure. The development of computerized pulse waveform analysis (CAPWA) has simplified the acquisition and analysis of data, and has made these measurements accessible in an outpatient setting.
Previous studies indicate that patients with documented vascular disease or with a history of vascular events tend to have less compliant arteries than patients with documented vascular disease. Patients with a history of vascular events also tend to have less compliant arteries than control subjects. In addition, multiple risk factors for the future development of vascular disease may also be associated with a less compliant arterial circulation. Therefore, a reduced arterial compliance may provide an index of early arterial damage that could predispose patients to the development of major vascular disease.
In 2005, Woodman et al evaluated several techniques for measuring arterial stiffness and compared them with central pulse wave velocity (PWV). A total of 30 men participated in the study, 15 with coronary artery disease and 15 healthy men. Measures performed included central and distal pulse wave velocity, large and small artery compliance (C1 and C2, respectively), and stroke volume/pulse pressure (SV/PP), augmentation index (Aix) and central pulse pressure (CPR) (Sphygmocor), stiffness index (SI), systemic arterial compliance (SAC), and brachial PP. The authors concluded that large and small artery compliance, and stroke volume/pulse pressure, and systemic arterial compliance show poor agreement with central pulse wave velocity, an established measure of central arterial stiffness.
No controlled studies were found in the published literature that validates the application of non-invasive medical devices for the measuring of arterial elasticity for cardiovascular disease. No evidence was found to show that evaluation of the status of the arterial elasticity is predictive and, thus, that type of evaluation cannot be used to alter the treatment of individuals. The evidence is insufficient to demonstrate that non-invasive measurements of arterial elasticity alters patient management or improves net health outcomes.
Practice Guidelines and Position Statements
American College of Cardiology (ACC)/ American Heart Association (AHA)
In 2010, the ACC/AHA made the following recommendation:
Measures of arterial stiffness outside of research settings are not recommended for cardiovascular risk assessment in asymptomatic adults. (Level of Evidence: C)
Hypertension, Computerized Pulse Waveform Analysis, vascular compliance, CAPWA, blood pressure waveform, arterial elasticity, CVProfilor®, SphygmoCor® , SCOR-Px, MaxPulse
Approved by Governing Bodies:
CVProfilor® DO-2020 CardioVascular Profiling System (Hypertension Diagnostics, Inc.) was FDA approved November 1, 2000 (K001948).
SphygmoCor® Cardiovascular Management System (CvMS) (AtCor Medical Pty. Ltd) was FDA approved August 31, 2007 (K070795).
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.
93050 Arterial pressure waveform analysis for assessment of central arterial pressures, includes obtaining waveform(s), digitization and application of nonlinear mathematical transformations to determine central arterial pressures and augmentation index, with interpretation and report, upper extremity artery, noninvasive
93799 Unlisted cardiovascular service or procedure
93922 Limited bilateral noninvasive physiologic studies of upper or lower extremity arteries
American College of Cardiology Foundation and American Heart Association. 2010 Guidelines.
Borlaug BA, Olson TP, Mohamed SA, et al. A randomized pilot study of aortic waveform guided therapy in chronic heart failure. J Am Heart Assoc. April 2014; 3(2) e000745.
Chirinos JA, Kips JG, Jacobs DR, et al. Arterial wave reflections and incident cardiovascular events and heart failure: the multiethnic study of atherosclerosis. JACC. 2012; 60(21):2170-7.
Cohn J.N. Vascular wall function as a risk marker for cardiovascular disease, J of Hypertension 1999, S41-S44.
CVProfilor®DO-2020. Technical specifications, Hypertension Diagnostics Inc. 2000
Kampus P, Serg M, Kals J, et al. Differential effects of nebivolol and metoprolol on central aortic pressure and left ventricular wall thickness. Hypertension. 2011; 57:1122-1128.
McVeigh G.E., et al. Age-related abnormalities in arterial compliance identified by pressure pulse contour analysis; aging and arterial compliance, Hypertension 1999; 33:1392-1398
McVeigh G.E. Arterial compliance in hypertension and diabetes mellitus, Am J Nephrol 1996; 16:217-272.
Prisant L.M., Resnick L.M., Hollenberg S.M., and Jupin D. Arterial elasticity among normotensive subjects and treated and untreated hypertensive subjects. Influence of race, ethnicity and disease. January 2002; 12(1):63-8
Prisant L.M., Resnick L.M., and Hollenberg S.M. Arterial elasticity among normotensive subjects and treated and untreated hypertensive subjects. Blood Pressure Monitoring. October 2001; 6(5):233-7.
Resnick LM, et al. Pulse waveform analysis of arterial compliance: relation to other techniques, age, and metabolic variables, AJH 2000, 12:1243-1249.
Roman MJ, Devereux RB, Kizer JR, et al. High central pulse pressure is independently associated with adverse cardiovascular outcome: the strong heart study. J Am Coll Cardiol. 2009;54:1730-1734.
Sharman JE, Marwick TH, Gilroy D, et al. Randomized trial of guiding hypertension management using central aortic blood pressure compared with best-practice care. Hypertension, August 2015; 62:1138-1145.
U. S. Food and Drug Administration. (2000, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K001948. Retrieved June 21, 2011 from //www.accessdata.fda.gov/cdrh_docs/pdf/K001948.pdf.
U. S. Food and Drug Administration. (2007, August). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K070795. Retrieved June 21, 2011 from //www.accessdata.fda.gov/cdrh_docs/pdf7/K070795.pdf
Woodman RJ, Kingwell BA, Beilin LJ et al. Assessment of central and peripheral arterial stiffness: studies indicating the need to use a combination of techniques. Am J Hypertens. 2005 Feb;18(2 Pt 1):249-60.
Medical Policy Group, September 2001
Medical Review Committee, September 2001
Medical Policy Administration Committee, October 2001
Medical Policy Group, February 2004
Medical Policy Group, February 2006 (1)
Medical Policy Group, February 2007 (1)
Medical Policy Group, February 2008 (1)
Medical Policy Group, February 2009 (1)
Medical Policy Group, February 2010 (1) No changes
Medical Policy Group, December 2010; 2011 Coding update
Medical Policy Group, June 2011, (1) Update to Description, Policy, Key Points, Key Words, Approved by Governing Bodies and References related to addition of SphygmoCor® device; also removed code 93922, as this is not an appropriate code for usage.
Medical Policy Administration Committee, July 2011
Medical Policy Group, September 2012 (3): Active Policy but no longer scheduled for regular literature reviews and updates.
Medical Policy Group, August 2015 (4): Updates to Key Points and References. No change to policy statement. Policy remains active, but not scheduled for regular literature reviews and updates.
Medical Policy Group, November 2015: 2016 Annual Coding Update. Added new CPT code 93050 to the current coding section. Also added existing CPT code 93922 to policy. Created Previous coding section and added deleted code 0311T.
Medical Policy Group, May 2016 (4): Updates to Key Points, Key Words, and References. No change to policy statement.
Medical Policy Group, May 2018 (4): Updates to Key Points and References. 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.