CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Powered Exoskeleton for Ambulation in Patients with Lower-Limb Disabilities

This policy governs coverage determinations for powered lower-limb exoskeleton devices used to enable ambulation in individuals with lower-limb disabilities for Medicare Advantage and commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyPowered Exoskeleton for Ambulation in Patients with Lower-Limb Disabilities

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 1, 2021

Next Review DateN/A

Key ActionVerify member-specific benefits and obtain any required authorizations per subscriber or employer agreements by contacting the provider call center.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not coveredMedicare Advantage stance

Not medically necessaryCommercial stance

K1007Not covered code

InsufficientEvidence status

FDA clearancesRegulatory

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Coverage determinations

Coverage stances

Medicare Advantage stance: Use of a powered exoskeleton for ambulation in individuals with lower-limb disabilities is not covered as the evidence is insufficient to determine the effects of the technology on health outcomes.

Commercial Products stance: Use of a powered exoskeleton for ambulation in individuals with lower-limb disabilities is considered not medically necessary as the evidence is insufficient to determine the effects of the technology on health outcomes.

HCPCS code K1007 is explicitly listed in the policy as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products. The code description in the policy is: "K1007 Bilateral knee, ankle, foot device, powered, includes component, single or double upright(s), knee joints any type, with or without ankle joints any type, includes all components and accessories, motors, microprocessors, sensors."

For Commercial Products, the policy states that "Use of a powered exoskeleton for ambulation in individuals with lower-limb disabilities is considered not medically necessary" because the evidence is insufficient to determine effects on health outcomes. The policy also identifies HCPCS K1007 as the specific code associated with powered bilateral knee–ankle–foot devices and lists it as not medically necessary for Commercial Products.

Coverage and payment are determined by the member’s subscriber agreement or the employer agreement, which supersede this medical policy. Providers should contact the provider call center for member-specific benefits and eligibility information, since benefits vary by group and contract.

Services that are determined to be not medically necessary or that are non-covered benefits are not guaranteed for payment. Providers must obtain the member’s written agreement in advance before charging the member for such services; otherwise the provider should not bill the member. Refer to participation and subscriber agreements for applicable provisions.

Codes and device eligibility

Not covered / Not medically necessaryHCPCSNot Covered

K1007

Bilateral knee, ankle, foot device, powered, includes component, single or double upright(s), knee joints any type, with or without ankle joints any type, includes all components and accessories, motors, microprocessors, sensors hip, pelvic

Device candidate anthropometrics

Maximum weightDoes not exceed 100 kg (220 lb)

Candidate abilityHands and shoulders able to support crutches or walker

What providers should do

Prior Authorization

Not applicable

Note

Benefit Verification

Benefits may vary between groups and contracts. Refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for coverage details and to determine if use is a covered benefit or considered not medically necessary.

Denial Risk

Denial Triggers

For Medicare Advantage plans: use of a powered exoskeleton for ambulation in individuals with lower-limb disabilities is not covered. For Commercial products: use is considered not medically necessary. Claims may be denied on these bases.

Clinical and device background

Powered lower-limb exoskeletons are external, wearable robotic frameworks with joints, motors, sensors, control algorithms, and a power source designed to provide powered lower-limb movement to enable standing and ambulation in individuals with paralysis or severe weakness from conditions such as spinal cord injury, stroke, multiple sclerosis, ALS, Guillain–Barré syndrome, and spina bifida. Devices (examples cited in the policy include ReWalk, Indego, Ekso, HAL, Keeogo) require user ability to use upper extremities for balance and often substantial training; while some devices have received FDA clearances, the clinical evidence is limited and heterogeneous, leading the policy authors to judge the evidence insufficient to determine effects on health outcomes.

Terms and relevant outcomes

Definition of powered exoskeleton — device components and purpose

Core definitionAn external, wearable framework with joints, motors, power source, sensors, and control algorithms designed to provide powered lower-limb movement to enable standing and ambulation.

Primary componentsFramework (uprights/joints), motors, microprocessors/control algorithms, sensors, power source, and user interface/mode selector.

Intended purposeProvide powered lower-limb movement to enable standing and ambulation for individuals with paralysis or severe weakness, with supervised use and training.

Relevant outcomes — functional outcomes, quality of life, and treatment-related morbidity

Functional outcomesWalking performance measures (eg, Timed Up & Go, 6-minute walk, 10-meter walk) and gait function.

Quality of life

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyPowered Exoskeleton for Ambulation in Patients with Lower-Limb Disabilities

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 1, 2021

Next Review DateN/A

Key ActionVerify member-specific benefits and obtain any required authorizations per subscriber or employer agreements by contacting the provider call center.

SourceLink

On This Page

Medicare Advantage: Not covered (evidence insufficient).

Commercial: Not medically necessary (evidence insufficient).

Billing Rule

Billing / Code Guidance

The following code is not covered for Medicare Advantage Plans and is considered not medically necessary for Commercial Products. Do not bill as covered.

K1007 – Bilateral knee, ankle, foot device, powered, includes component, single or double upright(s), knee joints any type, with or without ankle joints any type, includes all components and accessories, motors, microprocessors, sensors

Prior Authorization

Authorization and Benefit Verification

Verify member-specific benefits and obtain any required authorizations before providing services. Contact provider services or the member's plan for eligibility and authorization requirements.

Note

Member Financial Liability

If services are determined to be non-covered or not medically necessary, do not charge the member unless the member has been informed in advance and has agreed in writing to accept financial liability. Refer to participation and provider agreements for applicable terms.

Documentation Required

Provider Guidance

Provider action highlight: Confirm coverage, document medical necessity thoroughly in the record, and retain written member acknowledgment if billing the member for non-covered services.

Note

Contact for Benefits and Eligibility

For member-specific questions or to confirm benefits and eligibility, contact the provider call center or member services. The member's subscriber agreement or employer agreement governs final benefit determinations.

Patient-reported quality-of-life measures comparing exoskeleton use plus wheelchair versus wheelchair alone.

Treatment-related morbiditySafety concerns including fall risk and community/home use safety; need for evaluation of trip/fall potential.

Exoskeleton-assisted gait training — supervised use for overground walking and gait rehabilitation

DefinitionSupervised use of powered exoskeleton devices to enable overground walking and gait rehabilitation in individuals with spinal cord injury or long-term manual wheelchair users.

Setting and supervisionTypically performed under close supervision in rehabilitation or outpatient settings by trained personnel; devices often require a specially trained companion or physical therapist for use.

Training requirementsSignificant user training and certification programs are required; devices require users to have adequate upper-extremity function for balance and use of assistive aids (eg, crutches).

Evidence contextClinical studies are small and heterogeneous (feasibility studies, pilot RCTs, case series); outcomes primarily measured in institutional/outpatient settings with limited community/home evidence.