Rehabilitative Devices with Remote Monitoring Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 10|01|2024 POLICY LAST REVIEWED: 10|15|2025 OVERVIEW This policy addresses the use of rehabilitative devices with remote monitoring and adjustment capabilities intended to evaluate and improve muscle strength and range of motion (ROM) while reporting session data to the individual’s provider. MEDICAL CRITERIA Not applicable
PRIOR AUTHORIZATION Not applicable
POLICY STATEMENT Medicare Advantage Plans The use of rehabilitative devices with remote monitoring or adjustment capabilities is not covered for all indications as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome. Commercial Products The use of rehabilitative devices with remote monitoring or adjustment capabilities is not medically necessary for all indications as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome. COVERAGE Benefits may vary between groups/contracts. Please refer to the Evidence of Coverage or Subscriber Agreement for applicable not medically necessary/not covered benefits/coverage. BACKGROUND Post-operative rehabilitation after knee arthroplasty
Although it is generally accepted that rehabilitation following knee arthroplasty is essential to achieve optimal results, no single rehabilitation protocol has been established as the standard of medical practice. Moderate quality evidence suggests that multi-disciplinary rehabilitation may improve treatment outcomes. Rehabilitation programs in this setting typically address ROM, strengthening, gait, and modification of daily activities as needed. Unresolved questions remain about the optimal setting, intensity, and frequency of therapy sessions. ROMTech PortableConnect® The PortableConnect is a rehabilitative therapy device to increase ROM. It is similar in appearance and function to a recumbent exercise bicycle. An adaptive pedal adjusts the turning radius to the individual’s current ROM. Used in conjunction with the ROMTech AccuAngle®, the device shares data on time used, effort, and ROM with a remote physician or therapist. The physician or therapist can remotely adjust settings such as active vs. passive motion, resistance, and pedal radius. The manufacturer asserts that the PortableConnect® improves recovered ROM over a 3 to 6 week treatment course. No published scientific studies are available to verify this assertion.
Medical Coverage Policy | Rehabilitative Devices with Remote Monitoring

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

The U.S. Food and Drug Administration (FDA) identifies the PortableConnect device as an isokinetic testing and evaluation system intended for medical purposes, such as to evaluate, measure, and increase the muscle strength and ROM. The FDA classifies this type of devices as exempt from the premarket notification procedures.

ROMTech AccuAngle®
The AccuAngle measures knee extension and flexion and reports these data to the individual’s app. It is placed on the side of the leg and uses Bluetooth technology to measure and report flexion and extension during each therapy session. It is used in conjunction with the PortableConnect® device.

The U.S. Food and Drug Administration (FDA) identifies the AccuAngle device as an AC-powered goniometer, a device intended to evaluate joint function by recording and measuring ranges of motion and forces exerted by a joint. The FDA classifies this type of devices as exempt from the premarket notification procedures.

Mechanical Offloading for Diabetic Foot Ulcer
Reducing pressure by mechanical offloading benefits ulcers subjected to frequent pressure and stress. Various types of offloading devices include shoe modifications, cast walkers, total contact cast and other devices aiding ambulation. Cast walkers are prefabricated brace designed to provide offloading capability and maintain contact fit.

Sensoria Health Diabetic Foot Ulcer Boot
The Sensoria diabetic foot ulcer boot monitors an individual’s compliance to the clinician’s prescribed stabilization and mechanical offloading rehabilitation protocol. Real-time updates on the individual’s activities and for how long the boot is taken off is provided to the clinician.

Limited published studies have evaluated the effects of any rehabilitation therapy device with remote monitoring or adjustment capabilities (for example, ROMTech PortableConnect®, ROMTech AccuAngle®, and Sensoria Health Diabetic Foot Ulcer Boot) on improving health outcomes. No nationally recognized published guidelines recommend the use of such devices for any medical purpose.

At this time, there is insufficient evidence to demonstrate that the use of rehabilitative devices with remote monitoring or adjustment capabilities provides any incremental health outcome benefit compared to the other widely accepted alternative therapies. Until such time, it is unclear if the use of this device provides any benefits beyond standard devices.

The devices addressed in this policy are not intended to represent an all-inclusive list of rehabilitative devices with remote monitoring.

CODING Medicare Advantage Plans and Commercial Products There is no specific CPT or HCPCS code for these devices. Therefore, the following HCPCS code should be filed:
E1399 Durable medical equipment, miscellaneous

RELATED POLICIES Unlisted Procedures

PUBLISHED Provider Update, December 2025 Provider Update, August 2024

REFERENCES

1. Elraiyah T, Prutsky G, Domecq JP, et al. A systematic review and meta-analysis of off-loading methods for diabetic foot ulcers. J Vasc Surg. 2016 Feb;63(2 Suppl):59S-68S.e1-2.

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

2. Minns Lowe CJ, Barker KL, Dewey M, et al. Effectiveness of physiotherapy exercise after knee arthroplasty for osteoarthritis: systematic review and meta-analysis of randomised controlled trials. BMJ. 2007 Oct 20;335(7624):812.
3. Mistry JB, Elmallah RD, Bhave A, et al. Rehabilitative Guidelines after Total Knee Arthroplasty: A Review. J Knee Surg. 2016 Apr;29(3):201-217.

4. Summers SH, Nunley RM, Slotkin EM. A Home-Based, Remote-Clinician-Controlled, Physical Therapy Device Leads to Superior Outcomes When Compared to Standard Physical Therapy for Rehabilitation After Total Knee Arthroplasty. J Arthroplasty. 2023 Mar;38(3):497-501. i

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   This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association.

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