CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

rehabilitative_devices_with_remote_monitoring_and_adjustment_capabilities

Defines the coverage position for rehabilitative devices that offer remote monitoring or remote adjustment (e.g., ROMTech PortableConnect, AccuAngle, Sensoria diabetic foot ulcer boot) for improving muscle strength and range of motion; addresses commercial and Medicare Advantage products and coding guidance.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

Policyrehabilitative_devices_with_remote_monitoring_and_adjustment_capabilities

Policy CodePolicy N/A

Change Typeclarified

Effective DateOct 1, 2024

Next Review Date

Key ActionProviders must verify member-specific benefits and eligibility with the member's Evidence of Coverage Agreement and cannot assume coverage; benefits may vary by group/contract.

SourceLink

POLICY UPDATE CHANGES

Policy states rehabilitative devices with remote monitoring or adjustment capabilities are not covered due to insufficient evidence of improved net health outcome.

3Example devices discussed

1HCPCS code recommended for billing

Coverage Summary

This policy defines the coverage position for rehabilitative devices that offer remote monitoring or remote adjustment (for example, ROMTech PortableConnect, AccuAngle, and the Sensoria diabetic foot ulcer boot) used to evaluate or improve muscle strength and range of motion. The use of these devices is not covered because evidence is insufficient to demonstrate that the technology results in an improvement in the net health outcome. (Effective: 2024-10-01; Last review: 2024-06-05.)

Policy Statement / Medical Necessity

The use of rehabilitative devices with remote monitoring or adjustment capabilities is not covered because evidence is insufficient to demonstrate improved net health outcome.

Not covered for all indications: Use of rehabilitative devices with remote monitoring or adjustment capabilities is not covered for all indications
Commercial products: not medically necessary: Commercial products: use is not medically necessary for all indications due to insufficient evidence to determine improvement in net health outcome
Guidelines: No nationally recognized published guidelines recommend use of such devices for any medical purpose

Coverage Variability / Benefit Determination

Benefit determination note

Benefit determination: Benefits may vary between groups/contracts; refer to Evidence of Coverage Agreement for member-specific coverage/benefit determination

Providers must verify member-specific benefits and eligibility with the member's Evidence of Coverage Agreement

Provider Actions & Billing Guidance

Documentation Required

Refer to Evidence of Coverage for benefit determination

Providers must verify member-specific benefits and eligibility with the member's Evidence of Coverage Agreement and cannot assume coverage; benefits may vary by group/contract.

Billing Rule

Use HCPCS E1399 for billing

Because there is no specific CPT or HCPCS code for these devices, file claims using HCPCS code E1399 (Durable medical equipment, miscellaneous).

E1399

Denial Risk

Services considered not medically necessary

Claims for rehabilitative devices with remote monitoring or adjustment capabilities are considered not medically necessary and may be denied as not covered.

Background & Evidence

Device examples described in this policy include the ROMTech PortableConnect, the ROMTech AccuAngle, and the Sensoria diabetic foot ulcer boot. The PortableConnect is described as a rehabilitative therapy device intended to increase range of motion and functions similarly to a recumbent exercise bicycle; it shares session data (time used, effort, ROM) with a remote clinician and permits remote adjustment of settings such as active/passive motion, resistance, and radius. The manufacturer’s claims of improved ROM over 3–6 weeks are not supported by published studies.

The ROMTech AccuAngle is an AC-powered goniometer placed on the side of the leg that measures knee flexion and extension and reports data via Bluetooth to the individual’s app; it is used in conjunction with the PortableConnect device.

The Sensoria diabetic foot ulcer boot monitors patient compliance with prescribed offloading and stabilization protocols and provides real-time updates to the clinician on activity and how long the boot is removed.

The U.S. Food and Drug Administration classifies these device types (isokinetic testing/evaluation systems and goniometers) as exempt from premarket notification.

Published studiesLimited published studies; no high-quality evidence demonstrating incremental health outcome benefit

GuidelinesNo nationally recognized published guidelines recommend use of these devices for any medical purpose

Definition — Remote monitoring or adjustment capabilities

Definition: Remote monitoring or adjustment capabilities: Device features that report session data to the clinician and/or permit remote clinician adjustment of device settings (e.g., resistance, radius, active/passive motion).

Revision History

2024-10-01policy_effectiveLatest

Effective date applied from document header: policy effective 2024-10-01; clarifies that rehabilitative devices with remote monitoring or adjustment capabilities are not covered.

2024-06-05policy_review

Policy last reviewed on 2024-06-05; restates that use of rehabilitative devices with remote monitoring or adjustment capabilities is not covered because evidence is insufficient to demonstrate improved net health outcome.

2024-10-01material_changeLatest

Clarified policy (material): policy states rehabilitative devices with remote monitoring or adjustment capabilities are not covered for commercial and Medicare Advantage products due to insufficient evidence of improved net health outcome; examples provided include ROMTech PortableConnect, ROMTech AccuAngle, and Sensoria diabetic foot ulcer boot.

coding_guidanceLatest

Coding guidance: no specific CPT/HCPCS code exists for these devices; file claims using HCPCS E1399 (Durable medical equipment, miscellaneous).