Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting

POLICY NUMBER

A.2.02.24

DESCRIPTION

A variety of outpatient cardiac hemodynamic monitoring devices are intended to improve quality of life and reduce morbidity for patients with heart failure by decreasing episodes of acute decompensation. Monitors can identify physiologic changes that precede clinical symptoms and thus allow preventive intervention. These devices operate through various mechanisms, including implantable pressure sensors, thoracic bioimpedance measurement, inert gas rebreathing, and estimation of left ventricular end-diastolic pressure by arterial pressure during the Valsalva maneuver.

Chronic Heart Failure

Patients with chronic heart failure are at risk of developing acute decompensated heart failure, often requiring hospital admission. Patients with a history of acute decompensation have the 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 events such as coronary ischemia and dysrhythmias. While precipitating factors are frequently not identified, the most common preventable cause is non-compliance with medication and dietary regimens.

ManagementStrategies for reducing decompensation, and thus 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 health care provider, education, and medication adjustments as appropriate. These encounters may occur face-to-face in the office or at home, or via cellular or computed technology.

Precise measurement of cardiac hemodynamics is often employed in the intensive care setting to carefully manage fluid status in acutely decompensated heart failure. Transthoracic echocardiography, transesophageal echocardiography, 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 radiologic techniques may be used for dyspnea when the diagnosis of acute decompensated heart failure is uncertain.

The criterion standard for hemodynamic monitoring is pulmonary artery catheters and central venous pressure catheters. However, they are invasive, inaccurate, and inconsistent in predicting fluid responsiveness. Several studies have demonstrated that catheters fail to improve outcomes in critically ill patients and may be associated with harm. To overcome these limitations, multiple techniques and devices have been developed that use complex imaging technology and computer algorithms to estimate fluid responsiveness, volume status, cardiac output and tissue perfusion. Many are intended for use in outpatient settings, but can be used in the emergency department, intensive care unit, and operating room. Four methods are reviewed here: implantable pressure monitoring devices, thoracic bioimpedance, inert gas rebreathing, and arterial waveform during the Valsalva maneuver. Use of the last three is not widespread because of several limitations including use of proprietary technology making it difficult to confirm their validity and lack of large randomized controlled trials to evaluate treatment decisions guided by these hemodynamic monitors.

Noninvasive Left Ventricular End-Diastolic Pressure Measurement DevicesIn 2004, the VeriCor® (CVP Diagnostics), a noninvasive left ventricular end-diastolic pressure measurement device, was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices for the following indication:

“The VeriCor is indicated for use in estimating non-invasively, left ventricular end-diastolic pressure (LVEDP). 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.”

FDA product code: DXN.

Thoracic Bioimpedance Devices

Multiple thoracic impedance measurement devices that do not require invasive placement have been cleared for marketing by the FDA through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices for use for peripheral blood flow monitoring. The table below presents an inexhaustive list of representative devices (FDA product code: DSB).

Noninvasive Thoracic Impedance Plethysmography Devices

Also, several manufacturers market thoracic impedance measurement devices integrated into implantable cardiac pacemakers, cardioverter defibrillator devices, and cardiac resynchronization therapy devices. Thoracic bioimpedance devices integrated into implantable cardiac devices are addressed in the  Biventricular Pacemakers (Cardiac Resynchronization Therapy) for the Treatment of Heart Failure medical policy.

Inert Gas Rebreathing DevicesIn 2006, the Innocor® (Innovision), an inert gas rebreathing device, was cleared for marketing by the FDA through the 510(k) process. The FDA determined that this device was substantially equivalent to existing inert gas rebreathing devices for use in computing blood flow. FDA product code: BZG.

Implantable Pulmonary Artery Pressure Sensor DevicesIn 2014, the CardioMEMS™ Heart Failure Monitoring System (CardioMEMS, now Abbott) was approved for marketing by the FDA through the premarket approval process. This device consists of an implantable pulmonary artery (PA) sensor, which is implanted in the distal PA, a transvenous delivery system, and an electronic sensor that processes signals from the implantable PA sensor and transmits PA pressure measurements to a secure database. The device originally underwent FDA review in 2011, at which point the FDA found no reasonable assurance that the monitoring system would be effective, particularly in certain subpopulations, although the FDA agreed this monitoring system was safe for use in the indicated patient population. In 2022, the CardioMEMS Heart Failure Monitoring System received expanded approval for the treatment of New York Heart Association (NYHA) Class II-III patients who had been hospitalized at least 1 time in the prior year and/or had elevated natriuretic peptides.

In 2024, the Cordella™ PA Sensor System (Endotronix, Inc.) received FDA approval through the premarket approval process. This system consists of an implantable PA sensor placed in the right PA, a catheter delivery system, a handheld patient reader with a dock, calibration equipment, and a data analysis platform that transmits PA pressure measurements to a secure database for clinician review. The device was approved for measuring PA pressure in NYHA Class III heart failure patients who are at home on diuretics and guideline-directed medical therapy, with the goal of reducing hospitalizations for heart failure. The FDA is requiring a post-approval study to collect additional evidence of continued safety and effectiveness in the NYHA Class III patient population.

Several other devices that monitor cardiac output by measuring pressure changes in the PA or right ventricular outflow tract have been investigated in the research setting but have not received the FDA approval. They include the Chronicle® implantable continuous hemodynamic monitoring device (Medtronic), which includes a sensor implanted in the right ventricular outflow tract, and the ImPressure® device (Remon Medical Technologies), which includes a sensor implanted in the PA.

Note: This policy only addresses the use of these technologies in ambulatory care and outpatient settings.

POLICY

In the ambulatory care and outpatient setting, cardiac hemodynamic monitoring for the management of heart failure using implantable direct pressure monitoring of the pulmonary artery, thoracic bioimpedance, inert gas rebreathing, and arterial pressure during the Valsalva maneuver is considered investigational.

POLICY EXCEPTIONS

Federal 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 GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

This policy refers only to the use of stand-alone cardiac output measurement devices designed for use in ambulatory care and outpatient settings. The use of cardiac hemodynamic monitors or intrathoracic fluid monitors that are integrated into other implantable cardiac devices, including implantable cardioverter defibrillators, cardiac resynchronization therapy devices, and cardiac pacing devices, is addressed in the  Biventricular Pacemakers (Cardiac Resynchronization Therapy) for the Treatment of Heart Failure  medical policy.

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 HISTORY

11/11/2010: 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.

09/15/2014: Policy reviewed; no changes.

07/08/2015: Code Reference section updated for ICD-10.

11/02/2015: Policy description updated regarding devices. Policy statement unchanged. Policy guidelines updated to state that this policy refers only to the use of stand-alone cardiac output measurement devices that are designed to be used in ambulatory care and outpatient settings. Investigative definition updated.

06/06/2016: Policy number A.2.02.24 added.

07/05/2016: Policy description updated. Policy statement updated to change "arterial pressure/Valsalva" to "arterial pressure during Valsalva maneuver." Policy intent unchanged.

06/06/2017: Policy description updated regarding devices. Policy statement unchanged.

05/23/2018: Medical policy links updated.

07/11/2018: Policy description updated regarding hemodynamic monitoring and devices. Policy statement unchanged.

06/05/2019: Policy description revised to remove information regarding left ventricular end-diastolic pressure estimation. Policy statement unchanged.

06/16/2020: Policy description updated. Policy statement unchanged.

07/26/2021: Policy reviewed; no changes.

10/25/2022: Policy description updated regarding devices. Policy statement unchanged. Code Reference section updated to add CPT codes 33289 and 93264.

09/01/2023: Policy description updated regarding devices. Policy statement unchanged.

07/11/2024: Policy description updated regarding devices. Policy statement unchanged.

12/18/2024: Code Reference section updated to add new CPT codes 0933T and 0934T effective 01/01/2025.

08/19/2025: Policy description updated regarding devices. Policy statement unchanged.

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.02.24 

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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