Currentblue cross blue shield - south dakotaPolicy 02.02.22

02.02.22 Noninvasive Heart Failure and Arrythmia Management and Monitoring Systems

This Wellmark Blue Cross Blue Shield medical policy addresses use, clinical evidence, regulatory status, coding, and coverage stance for noninvasive heart failure and arrhythmia management and monitoring systems (example: µ-Cor Heart Failure and Arrhythmia Management System) for outpatient monitoring of thoracic fluid and arrhythmias.

Policy Summary

Payerblue cross blue shield - south dakota

Policy02.02.22 Noninvasive Heart Failure and Arrythmia Management and Monitoring Systems

Policy CodePolicy 02.02.22

Change TypeAnnual Review; Policy Revised (Jan 2025)

Effective DateJan 1, 2016

Next Review Date

Key ActionIf a Category III code is available for the service, providers must use that code instead of an unlisted or deleted Category I code.

POLICY UPDATE CHANGES

January 2025: Annual Review; Policy Revised.

1Primary policy stance (investigational for all indications)

2CPT Category III codes listed

2024Latest literature search through

Coverage Summary

Scope: This policy addresses use, clinical evidence, regulatory status, coding, and the coverage stance for noninvasive heart failure and arrhythmia management and monitoring systems (example: µ-Cor Heart Failure and Arrhythmia Management System) for outpatient monitoring of thoracic fluid and arrhythmias.

Medical‑Necessity Criteria

Coverage Determination

Policy statement

ALL of the following

The use of non-invasive heart failure and arrhythmia management and monitoring system (for example µ-Cor™ Heart Failure and Arrhythmia Management System) is considered investigational for all indications.
The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.
ALL Category III codes will be considered investigational unless the code is explicitly addressed as a covered service in a Wellmark BlueCross BlueShield Medical Coverage Policy.

Relevant Codes

Relevant CPT Category III codes for µ-Cor HFAMSCPT

0607T

Remote monitoring of an external continuous pulmonary fluid monitoring system, including measurement of radiofrequency-derived pulmonary fluid levels, heart rate, respiration rate, activity, posture, and cardiovascular rhythm (e.g., ECG data), transmitted to a remote 24-hour attended surveillance center; set-up and patient education on use of equipment.

0608T

Billing Rule

Use Category III codes when available

If a Category III code is available for the service, providers must use that code instead of an unlisted or deleted Category I code.

0607T
0608T

Provider Actions & Billing Impact

Denial Risk

Investigational coverage denial risk

Claims for non-invasive heart failure and arrhythmia management and monitoring systems (e.g., µ-Cor HFAMS) are considered investigational for all indications and therefore are subject to denial unless explicitly covered by another Wellmark medical policy.

0607T
0608T

Providers must report services using available Category III (T) CPT codes (for example 0607T and 0608T) when applicable, rather than unlisted or deleted Category I codes.

Per policy, investigational services may be denied; ALL Category III codes will be considered investigational unless explicitly addressed as a covered service in a Wellmark BlueCross BlueShield Medical Coverage Policy (policy number: 02.02.22).

If there are questions about policy interpretation or coverage applicability, follow your parent system’s instructions for contacting medical policy or benefits staff.

Background and Evidence Summary

Background: The µ-Cor Heart Failure and Arrhythmia Management System (HFAMS) is a patch-based, water-resistant sensor intended to be worn continuously up to 30 days. It measures a radiofrequency-derived Thoracic Fluid Index (pulmonary fluid levels) and continuously records/stores ECG, heart rate, respiration rate, activity, and posture to aid detection of early heart failure decompensation and non-lethal arrhythmias.

Regulatory and validation studies: The device received FDA 510(k) clearance (K172510) in 2019 based on premarket validation studies (MaTcH and ViVUS) that provided performance data for thoracic fluid monitoring, vital sign and rhythm detection.

Evidence limitations: Clinical evidence includes small premarket validation studies and a nonrandomized, prospective concurrent-control trial (Boehmer et al. 2024) with methodological limitations; overall the evidence is judged insufficient to conclude improved net health outcomes.

Study	Summary
BMAD-TX/BMAD-HF (Boehmer et al 2024)	Multicenter, prospective concurrent-control trial (n=522); intervention arm using µ‑Cor HFMS data had 38% relative reduction in 90-day HF rehospitalization (HR 0.62; p=0.03), but study was nonrandomized with important methodological limitations; evidence judged insufficient.
Premarket validation studies	MaTcH and ViVUS provided device performance/validation data (small, nonrandomized/safety/validation studies used for FDA 510(k) clearance); limited sample sizes and designs.

Category III codes: Temporary CPT (T) codes for emerging technologies, services, and procedures used for data collection; should be used instead of unlisted or deleted Category I codes when available.

NYHA class II-IV: New York Heart Association functional classification indicating moderate to severe limitation from heart disease; the relevant population for the intended device use includes individuals with NYHA class II-IV heart failure.

Revision History

2025-01Annual Review; Policy RevisedLatest

January 2025: Annual Review; Policy Revised. Document states no clinical coverage statement change beyond investigational determination.

2024-01Annual Review; Policy Renewed

January 2024: Annual Review; Policy Renewed.

2023-01Annual Review; Policy Revised

January 2023: Annual Review; Policy Revised.

2022-01Annual Review; Policy Revised; Content Moved and New Medical Policy Created

January 2022: Annual Review; Policy Revised; Content moved and new medical policy created.