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DESCRIPTIONA variety of outpatient cardiac hemodynamic monitoring devices have been proposed to decrease episodes of acute decompensation in patients with heart failure and thus reduce morbidity and improve quality of life. These new outpatient devices include bioimpedance, inert gas rebreathing, and estimating left-ventricular end-diastolic pressure by arterial pressure during Valsalva or use of an implantable pressure sensor.
Patients with chronic heart failure are at elevated risk of developing acute decompensated heart failure, often requiring hospital admission. Patients with a history of acute decompensation have additional risk of future episodes of decompensation, and death. Reasons for the transition from a stable, chronic state to an acute, decompensated state include disease progression as well as acute coronary events and dysrhythmias. While precipitating factors are frequently not identified, the most common preventable cause is non-compliance with medication and dietary regimens. Strategies for reducing decompensation, and thusly the need for hospitalization, are aimed at early identification of patients at risk for imminent decompensation. Programs for early identification of heart failure are characterized by frequent contact with patients to review signs and symptoms with a healthcare provider, and with education or adjustment of medications as appropriate. These encounters may occur face-to-face in office or in home, or via transmission of symptoms and conventional vital signs, including weight, telephonically or electronically.
Precise measurement of cardiac hemodynamics is often employed in the intensive care setting to carefully manage fluid status in acutely decompensated heart failure. Echocardiography, transesophageal echocardiography (TEE), and Doppler ultrasound are noninvasive methods for monitoring cardiac output on an intermittent basis for the more stable patient, but are not addressed in this policy. A variety of biomarkers and radiological techniques may be utilized in the setting of dyspnea when the diagnosis of acute decompensated heart failure is uncertain.
A number of novel approaches have been investigated as techniques to measure cardiac hemodynamics in the outpatient setting. It is postulated that real-time values of cardiac output or left ventricular end diastolic pressure (LVEDP) will supplement the characteristic signs and symptoms, and improve the clinician’s ability to intervene early to prevent acute decompensation. Four methods will be reviewed here: thoracic bioimpedance, inert gas rebreathing, arterial waveform during Valsalva, and implantable pressure monitoring devices.
Inert Gas Rebreathing
Arterial Pressure during Valsalva to estimate LVEDP
Pulmonary artery pressure measurement to estimate LVEDP
The following devices have received specific FDA clearance for marketing through the 510(k) process:
Note: This policy only addresses use of these techniques in ambulatory care and outpatient settings.
POLICYIn the ambulatory care and outpatient setting, cardiac hemodynamic monitoring for the management of heart failure utilizing thoracic bioimpedance, inert gas rebreathing, arterial pressure/Valsalva, and implantable direct pressure monitoring of the pulmonary artery is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/11/2010: Approved by Medical Policy Advisory Committee.
08/11/2011: Policy reviewed; no changes.
09/25/2012: Policy reviewed; no changes.
05/07/2013: Removed deleted CPT codes 0104T and 0105T from the Code Reference section.
11/06/2013: Policy reviewed; no changes.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.02.24
This may not be a comprehensive list of procedure codes applicable to this policy.