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DESCRIPTIONLeft ventricular end diastolic pressure (LVEDP) is elevated in the setting of congestive heart failure, and its measurement may be useful in the management of patients with heart failure. However, to date, measurement of LVEDP has only been performed in the inpatient setting, since its measurement requires cardiac catheterization, either by direct measurement by placing a catheter in the left ventricle or indirect measurement by placing a catheter in the pulmonary artery to measure the pulmonary capillary wedge pressure. Non-invasive measurements of LVEDP have been developed based on the observation that the arterial pressure during the strain phase of the Valsalva maneuver may directly reflect the LVEDP. For example, arterial pressure response during the Valsalva maneuver generally shows 4 distinct phases, which can be recorded and analyzed. The VeriCor device (CVP Diagnostics, Boston, MA) is an example of a device for the non-invasive measurement of LVEDP that has received U.S. Food and Drug Administration (FDA) clearance through the 510(k) process with the following labeled indication:
“The VeriCor is indicated for use in estimating non-invasively, left ventricular end-diastolic (LVEDP) pressure. This estimate, when used along with clinical signs and symptoms and other patient test results, including weights on a daily basis, can aid the clinician in the selection of further diagnostic tests in the process of reaching a diagnosis and formulating a therapeutic plan when abnormalities of intravascular volume are suspected. The device has been clinically validated in males only. Use of the device in females has not been investigated.”
The VeriCor device consists of a digital expiratory manometer coupled with a continuous arterial pressure monitor and a medical grade computer. A tonometric sensor is attached to the patient’s wrist with a blood pressure cuff attached to the arm. After an 8-minute tonometric calibration period is completed, the VeriCor system is ready for use. For the test, the patient is prompted to perform a Valsalva maneuver by blowing into the mouthpiece of the digital monometer to produce an expiratory pressure of 20 to 30 mmHg for a minimum of 8 seconds. The digital signals are collected and stored on a medical grade computer. The arterial pressure signals are then analyzed according to algorithms that were developed to most accurately predict pulmonary capillary wedge pressure.
The FDA labeling also notes that the Valsalva maneuver may be contraindicated in a variety of cardiovascular conditions, including, for example, hypertrophic obstructive cardiomyopathy, significant aortic valvular disease, and recent myocardial infarction.
POLICYNon-invasive measurement of left ventricular end diastolic pressure (LVEDP) in the outpatient setting is considered investigational.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY12/27/2006: Policy added.
3/22/2007: Reviewed and approved by the Medical Policy Advisory Committee (MPAC)
1/14/2008: Policy reviewed, no changes
03/11/2010: Coding Section revised for 2010 CPT4 and HCPCS revisions; HCPCS Code 0086T was deleted 12-31-2009; added CPT Code 93799 to the Non-Covered Codes Table.
07/31/2015: Code Reference section updated for ICD-10. Removed deleted CPT code 0086T.
06/08/2016: Policy number added. Investigative definition updated in Policy Guidelines section.
SOURCE(S)Blue Cross Blue Shield Association Policy # 2.02.21
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.