DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Rehabilitative Devices with Remote Monitoring

Defines coverage stance for rehabilitative devices that monitor or remotely adjust therapy (e.g., ROM devices, diabetic foot ulcer boots) for Medicare Advantage and commercial products under BCBSRI.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyRehabilitative Devices with Remote Monitoring

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 10, 2024

Next Review DateMay 6, 2024

Key ActionFile using HCPCS E1399 when billing and verify subscriber benefits with the Evidence of Coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not covered / NMNCoverage stance

InsufficientEvidence

E1399HCPCS

PortableConnect et al.Examples

Coverage Determination

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Overall coverage determination: Rehabilitative devices with remote monitoring or adjustment capabilities are not covered for Medicare Advantage plans and are not medically necessary for commercial products for all indications because the evidence is insufficient to demonstrate improved net health outcomes.

Examples cited in the source include ROMTech PortableConnect®, ROMTech AccuAngle®, and the Sensoria diabetic foot ulcer boot.

Provider Responsibilities & Billing

Prior Authorization

Prior authorization

Not applicable

Note

Benefits variability

Benefits may vary by group or contract. Refer to the member's Evidence of Coverage or Subscriber Agreement for applicable benefit restrictions and to determine whether the service is covered, excluded, or considered not medically necessary under the member's plan.

Billing Rule

Billing and benefits verification

File using HCPCS code E1399 (Durable medical equipment, miscellaneous). Verify member benefits and any applicable coverage restrictions with the Evidence of Coverage or Subscriber Agreement prior to billing.

HCPCS: E1399 - Durable medical equipment, miscellaneous

Denial Risk

Coverage denial risk

Coverage for rehabilitative devices with remote monitoring or adjustment capabilities: not covered for Medicare Advantage plans (evidence insufficient to show improved net health outcome) and considered not medically necessary for Commercial products.

Background

Rehabilitative devices with remote monitoring or adjustment capabilities are intended to evaluate and support improvements in range of motion (ROM) and muscle strength by delivering therapy sessions and reporting session-level data (for example, compliance, duration, and activity logs) to the treating clinician in near–real time. Examples include wearable ROM devices and diabetic foot ulcer boots that send status updates and removal times to clinicians. Published studies are limited, and no national guidelines currently endorse these devices; available evidence has not demonstrated an incremental clinical benefit over standard rehabilitation approaches.

Key Definitions

Rehabilitative devices with remote monitoring or adjustment capabilities — definition and examples

DefinitionDevices intended to evaluate and improve muscle strength and range of motion (ROM) while reporting session data to the individual's provider; may permit remote adjustment of settings (e.g., active vs. passive motion, resistance).

Example: ROMTech PortableConnect®A rehabilitative therapy device similar to a recumbent exercise bicycle with an adaptive pedal to match the individual's ROM; shares time used, effort, and ROM data with a remote clinician and allows remote adjustment of settings.

Example: ROMTech AccuAngle®A Bluetooth-enabled goniometer placed on the side of the leg that measures knee extension and flexion and reports session data to the individual's app; used in conjunction with the PortableConnect®.

Regulatory noteFDA identifies these types as devices for evaluating/measuring ROM or joint function and classifies them as exempt from premarket notification procedures.

Mechanical offloading devices — definition and examples related to diabetic foot ulcer offloading

DefinitionDevices designed to reduce pressure on diabetic foot ulcers by offloading mechanical stress during ambulation, thereby supporting ulcer healing.

ExamplesShoe modifications, cast walkers (prefabricated braces providing offloading and contact fit), total contact casts, and other ambulation aids.

Example with remote monitoringSensoria Health diabetic foot ulcer boot — monitors patient compliance with prescribed stabilization and offloading protocol and provides real-time updates (including time the boot is removed) to the clinician.

Clinical evidence noteReducing pressure by mechanical offloading benefits ulcers subjected to frequent pressure and stress; however, limited published studies assess remote-monitoring offloading devices' impact on health outcomes.