CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Cardiac hemodynamic monitoring devices for heart failure

Defines coverage and medical necessity positions for outpatient cardiac hemodynamic monitoring methods (implantable pulmonary artery pressure sensors, thoracic electrical bioimpedance, inert gas rebreathing, arterial pressure during Valsalva/ LVEDP estimation) for Medicare Advantage and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyCardiac hemodynamic monitoring devices for heart failure

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2019

Next Review Date

Key ActionProviders should follow CMS national and local coverage determinations for Medicare Advantage beneficiaries; Medicare Advantage policies may differ from Commercial product coverage.

SourceLink

POLICY UPDATE CHANGES

No material changes: has_material_change=false in the brief; there are no listed policy update changes.

1Covered indications (Medicare Advantage - TEB)

3Methods not covered/not medically necessary

2CPT codes not covered/not medically necessary

Coverage Summary

Scope: This policy (effective 2019-10-01) from Blue Cross & Blue Shield of Rhode Island addresses outpatient cardiac hemodynamic monitoring methods for heart failure and takes a mixed coverage stance. BCBSRI covers thoracic electrical bioimpedance (TEB) for Medicare Advantage plans but does not cover (Medicare Advantage) or considers not medically necessary (Commercial) implantable pulmonary artery pressure sensors, inert gas rebreathing, and arterial pressure during the Valsalva maneuver; coverage for specific codes is detailed in the policy.

Medical-Necessity Criteria

Medicare Advantage - Thoracic Electrical Bioimpedance (TEB)

Covered when used for the management of heart failure in Medicare Advantage Plans.

Medicare Advantage - Thoracic Electrical Bioimpedance (TEB): Cardiac hemodynamic monitoring for the management of heart failure using thoracic electrical bioimpedance is covered for Medicare Advantage Plans.

BCBSRI follows CMS guidelines (NCDs/LCDs) for Medicare Advantage Plan policies; benefits may differ from Commercial products.

Commercial Products - Thoracic Electrical Bioimpedance (TEB)

Not medically necessary when used for management of heart failure in Commercial products.

Commercial Products - Thoracic Electrical Bioimpedance (TEB): Cardiac hemodynamic monitoring for the management of heart failure using thoracic electrical bioimpedance (TEB) is considered not medically necessary as the evidence is insufficient to determine the effects of the technology on health outcomes.

Medicare Advantage - Implantable PA pressure sensors, inert gas rebreathing, arterial pressure during Valsalva

Not covered for Medicare Advantage Plans.

Not Covered: Cardiac hemodynamic monitoring for the management of heart failure using implantable direct pressure monitoring of the pulmonary artery is not covered for Medicare Advantage Plans as the evidence is insufficient to determine the effects of the technology on health outcomes.

Includes implantable PA sensors (e.g., CardioMEMS), which have FDA approval but insufficient evidence for outpatient use per policy.

Not Covered: Cardiac hemodynamic monitoring using inert gas rebreathing is not covered for Medicare Advantage Plans as the evidence is insufficient to determine the effects of the technology on health outcomes.

Inert gas rebreathing devices (e.g., Innocor) have FDA 510(k) clearance but outpatient outcome evidence is insufficient per policy.

Not Covered: Cardiac hemodynamic monitoring using arterial pressure during the Valsalva maneuver to estimate LVEDP is not covered for Medicare Advantage Plans as the evidence is insufficient to determine the effects of the technology on health outcomes.

Commercial Products - Implantable PA pressure sensors, inert gas rebreathing, arterial pressure during Valsalva

Not medically necessary for Commercial products.

Not Medically Necessary: Cardiac hemodynamic monitoring for the management of heart failure using implantable direct pressure monitoring of the pulmonary artery is considered not medically necessary for Commercial products as the evidence is insufficient to determine the effects of the technology on health outcomes.

CPT codes 33289 and 93264 for implantation and monitoring of wireless PA sensors are listed as not covered/not medically necessary.

Not Medically Necessary: Cardiac hemodynamic monitoring using inert gas rebreathing is considered not medically necessary for Commercial products as the evidence is insufficient to determine the effects of the technology on health outcomes.

There is no specific CPT code for inert gas rebreathing; report using unlisted code 93799 when applicable.

Not Medically Necessary: Cardiac hemodynamic monitoring using arterial pressure during the Valsalva maneuver to estimate LVEDP is considered not medically necessary for Commercial products as the evidence is insufficient to determine the effects of the technology on health outcomes.

Coding

Covered for Medicare Advantage - Thoracic electrical bioimpedanceCPTCovered

93701

Bioimpedance-derived physiologic cardiovascular analysis

Not covered / Not medically necessary - Implantation and monitoring of wireless PA pressure sensorCPTNot Covered

33289	Transcatheter implantation of wireless pulmonary artery pressure sensor for long-term hemodynamic monitoring, including deployment and calibration of the sensor, right heart catheterization, selective pulmonary catheterization, radiological supervision and interpretation, and pulmonary artery angiography, when performed
93264	Remote monitoring of a wireless pulmonary artery pressure sensor for up to 30 days, including at least weekly downloads of pulmonary artery pressure recordings, interpretation(s), trend analysis, and report(s) by a physician or other qualified health care professional

No specific code - inert gas rebreathing measurement or LVEDP estimationCPT

93799

Unlisted cardiovascular service or procedure

Provider Actions

Documentation Required

Follow CMS guidance for Medicare Advantage

Providers should follow CMS national and local coverage determinations for Medicare Advantage beneficiaries; Medicare Advantage policies may differ from Commercial product coverage.

Note: Benefits may differ for Commercial products.

Billing Rule

Report inert gas rebreathing or LVEDP estimation using unlisted code

Because there is no specific CPT code for inert gas rebreathing measurement or LVEDP estimation, report using CPT 93799 (Unlisted cardiovascular service or procedure).

93799

Billing Rule

Do not bill implants/monitoring for wireless PA sensor as covered for Commercial

CPT codes 33289 and 93264 are not covered for Medicare Advantage and are considered not medically necessary for Commercial products; billing these may result in denial per coverage policy.

33289
93264
Billing these codes may result in claim denial per the coverage policy.

Background & Evidence

Background: Outpatient cardiac hemodynamic monitoring technologies include implantable pulmonary artery pressure sensors (for example, the FDA-approved CardioMEMS Champion HF System), noninvasive LVEDP estimation devices cleared by FDA (for example, VeriCor), inert gas rebreathing systems cleared by FDA (for example, Innocor), and thoracic bioimpedance/impedance cardiography devices cleared via 510(k). The policy states that while some devices have FDA clearance or approval, the evidence is insufficient to determine the effects of many of these technologies on health outcomes in the outpatient heart failure setting, and therefore several methods are not covered or are considered not medically necessary per the policy.

Evidence	Reference
CMS NCD for TEB	CardioMEMS FDA approval (PMA)
CMS National coverage determination for cardiac output monitoring by thoracic electrical bioimpedance (20.16) referenced	CardioMEMS Champion HF System FDA PMA referenced (2014 SSED)

Term	Definition
Thoracic electrical bioimpedance (TEB)	A noninvasive technique measuring electrical resistance through the thorax to estimate cardiac output via impedance cardiography.
LVEDP	Left ventricular end-diastolic pressure; can be approximated by implantable pulmonary artery sensors or estimated by arterial pressure response during the Valsalva maneuver.

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