ModifiedUnitedHealthcarePolicy N/A

Upper Extremity Prosthetic Devices (for Kentucky Only): CS360KY.04

This section provides clinical evidence summary, guidance references (VA/DoD 2022), FDA device classification notes, and a policy history entry updating HCPCS codes for upper-extremity prosthetic devices; it supports UnitedHealthcare coverage interpretation for upper extremity prostheses and related training/prescription components.

Policy Summary

PayerUnitedHealthcare

PolicyUpper Extremity Prosthetic Devices (for Kentucky Only): CS360KY.04

Policy CodePolicy N/A

Change TypeHCPCS code additions and description revisions

Effective DateNovember 1, 2025

Next Review Date

Key ActionDocument pre-prosthetic training and comprehensive assessment components to support prosthesis selection.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS codes L6034, L6035, L6036, L6038, and L6039 to the list of applicable codes.

Revised descriptions for HCPCS codes L6028 and L7406.

Archived previous policy version CS360KY.03.

VA/DoD 2022Guideline Source

FDA de novo 2014DEKA Arm clearance

Hayes 2023Recent evidence reviews referenced

2Material changes

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Coverage Summary

Scope: Upper extremity prostheses including myoelectric and multi-grip hands, advanced externally powered systems (DEKA/LUKE), Utah arm technologies, osseointegration approaches, pediatric prosthetic outcomes, and associated training/prescription practices. (Scope summary: supports UnitedHealthcare coverage interpretation.)

Coverage stance/status: Mixed—policy modified (status MODIFIED) with material updates to HCPCS codes; recommendations reflect limited and heterogeneous evidence supporting some advanced devices and the need for individualized assessment and training.

Guideline highlight: VA/DoD (2022) expert-opinion recommendations emphasize pre-prosthetic training and a comprehensive, multidisciplinary assessment to determine device appropriateness and to support prescription details (design, control strategy, socket, suspension, terminal device, and relevant joint units).

Evidence-review highlights: Hayes reviews (2021–2023) and related evidence syntheses report limited or very low-quality evidence for DEKA/LUKE and Utah/Utah-type arms and insufficient evidence for multi-grip myoelectric hands; studies show inconsistent functional benefits and call for larger, long-term comparative trials.

Regulatory note: The DEKA Arm System received FDA clearance through the de novo (DEN120016) 2014 pathway; FDA classification information is informational only and not a basis for coverage decisions.

Medical-Necessity Criteria and Clinical Guidance

VA/DoD Pre-Prosthetic Training and Assessment Recommendations

Expert opinion recommendations from VA/DoD 2022 Clinical Practice Guideline:

ALL of the following

Patients should undergo pre-prosthetic training to help determine the most appropriate type of device to achieve functional goals
Expert Opinion
Components of a comprehensive assessment include
- Present health status
- Level of function
- Modifiable/controllable health risk factors
- Pain assessment
- Cognition and behavioral health

VA/DoD Prosthesis Prescription Recommendations

Expert opinion recommendations for prescription content:

ALL of the following

ALL of the following
- Prescription components for upper extremity prostheses should include: Design (e.g., preparatory vs. definitive)
- Control strategy (e.g., passive, externally powered, body powered, task specific)
- Anatomical side and amputation level of the prosthesis
- Type of socket interface (e.g., soft insert, elastomer liner, flexible thermoplastic)

Actions for Providers (Documentation, Billing)

Documentation Required

Comprehensive pre-prosthetic assessment documentation

Document a comprehensive pre-prosthetic assessment before selecting and prescribing an upper‑extremity prosthesis. Ensure the record summarizes the patient’s current health and function, modifiable health risks, pain status, cognitive and behavioral health, learning capacity, detailed residual limb and non‑amputated limb/trunk exams, prosthetic assessment (if applicable), and vocational considerations to support device selection and training.

Present health status
Level of function
Modifiable/controllable health risk factors
Pain assessment
Cognition and behavioral health
Personal, family, social, and cultural context
Learning assessment
Residual limb assessment
Non-amputated limb and trunk assessment
Prosthetic assessment (if applicable)
Vocational assessment

Codes

Applicable HCPCS codes (updated)HCPCS

L6034
L6035
L6036
L6038
L6039
L6028	description revised per 11/01/2025 update
L7406	description revised per 11/01/2025 update

FDA product codes referencedmixed

GXY	FDA product code (informational)
IQZ	FDA product code (informational)
DEN120016	DEKA Arm de novo decision (2014) - informational reference

Clinical Evidence & Background

Background: The clinical literature includes small observational studies, single-case designs, and a few comparative or training studies evaluating multi-grip myoelectric hands (MHP), single-grip myoelectric hands (SHP), the DEKA/LUKE arm systems, the Utah arm and wrist devices, pediatric prosthesis use, training and pattern-recognition control methods, and osseointegration/OPRA implants.

Evidence scope and limitations: Overall evidence is limited in quantity and quality—many studies are small, nonrandomized, or single-center and outcome measures vary. Systematic and HTA reviews (Hayes, ECRI) found very low-quality or insufficient evidence for LUKE/DEKA and Utah systems and unclear/no support for multi-grip MHPs, noting inconsistent functional improvements versus conventional prostheses.

Study findings: Comparative studies (e.g., Resnik et al. on DEKA) reported reduced perceived disability but mixed or slower performance on some functional tests initially, with some improvements after home training; Kerver et al. (2023) found no clear benefit of MHP over SHP and in some measures SHP outperformed MHP; single-case work (Widehammar et al. 2022) suggested possible self-perceived benefits but was inconclusive.

Training and control research: Pattern-recognition and dual-window classifiers (Earley et al., 2016) and targeted electrode strategies have shown promise for partial-hand control and reduced classification errors in experimental settings, but clinical generalizability is limited.

Pediatrics: Small pediatric series indicate myoelectric prostheses can be successful in young children with strong family support and structured training, but long-term preferences often favor multiple or simpler prostheses.

Osseointegration: Systematic reviews and case series show potential functional advantages (improved ROM, intuitive control via bidirectional interfaces) but are limited by small sample sizes, heterogenous designs, and notable infectious and mechanical complication rates; further comparative and long-term safety studies are needed.

Revision History

11/01/2025code_additionLatest

Added HCPCS codes L6034, L6035, L6036, L6038, and L6039 to the list of applicable codes (updated list of applicable HCPCS codes to reflect quarterly edits).

11/01/2025description_revisionLatest

Revised descriptions for HCPCS codes L6028 and L7406 as part of the 11/01/2025 policy update.

prior to 11/01/2025

Policy Summary

PayerUnitedHealthcare

PolicyUpper Extremity Prosthetic Devices (for Kentucky Only): CS360KY.04

Policy CodePolicy N/A

Change TypeHCPCS code additions and description revisions

Effective DateNovember 1, 2025

Next Review Date

Key ActionDocument pre-prosthetic training and comprehensive assessment components to support prosthesis selection.

SourceLink

On This Page

Personal, family, social, and cultural context

Residual limb assessment

Non-amputated limb and trunk assessment

Prosthetic assessment (if applicable)

Vocational assessment

Type of socket frame (e.g., thermoplastic or laminated)

Suspension mechanism (e.g., harness, suction, anatomical)

Wrist unit (if applicable)

Elbow unit (if applicable)

Shoulder unit (if applicable)

Documentation Required

Prosthesis prescription detail

Include complete prescription details when the appropriate prosthesis is identified. The prescription should state the device design and control strategy, anatomical side and amputation level, socket interface and socket frame types, suspension mechanism, the terminal device, and any applicable wrist, elbow, or shoulder units to clearly define the intended components and support reimbursement and fitting.

Design (e.g., preparatory vs. definitive)
Control strategy (e.g., passive, externally powered, body powered, task specific)
Anatomical side and amputation level of the prosthesis
Type of socket interface (e.g., soft insert, elastomer liner, flexible thermoplastic)
Type of socket frame (e.g., thermoplastic or laminated)
Suspension mechanism (e.g., harness, suction, anatomical)
Terminal device
Wrist unit (if applicable)
Elbow unit (if applicable)
Shoulder unit (if applicable)

Billing Rule

Use updated HCPCS codes

Report prosthetic components using the updated HCPCS code list effective 11/01/2025. Use the newly added partial‑hand and digit codes and the revised code descriptions as documented in the policy to ensure correct coding for initial issue or replacement components.

L6034
L6035
L6036
L6038
L6039
L6028 (description revised 11/01/2025)
L7406 (description revised 11/01/2025)
Note: codes L6034, L6035, L6036, L6038, and L6039 were added; descriptions for L6028 and L7406 were revised

Conclusion: Across device types and populations, the evidence shows inconsistent functional benefits; larger, well-designed, long-term comparative trials and standardized, validated outcome measures are needed to define which patients benefit from specific advanced prosthetic technologies.

Evidence	Key finding
Hayes evidence briefs (2021-2023)	Found limited or very low-quality evidence for DEKA/LUKE and Utah Arm; insufficient evidence for multi-grip myoelectric hands; guidance documents give weak or unclear support.
Kerver et al. 2023	No clear benefit of multi-grip MHP vs standard SHP; SHP outperformed MHP on several outcomes; small sample and nonrandomized design.
Widehammar 2022	Single-case study reported favorable effects of multi-grip MHP on self-perceived performance, satisfaction, increased wear time and reduced pain-related disability, but overall inconclusive and further studies needed.
Resnik et al. 2018/2020	DEKA (LUKE) arm may reduce perceived disability and increase engagement; functional performance findings mixed versus conventional prostheses; survey found no differences between body-powered and myoelectric devices for ADL assistance or QoL.
Earley et al. 2016	Dual-window pattern recognition and inclusion of additional EMG sources reduced classification error and improved real-time control metrics for partial-hand prosthesis control in study participants.
Carey et al. / systematic reviews (e.g., 2015) and performance-measure limitations	Evidence comparing myoelectric and body-powered devices is conflicting; validated performance-based outcome measures are sparse and heterogeneous, limiting conclusions.
Utah Arm / MyoPro / device assessments (ECRI, Hayes) 2023-2024	Insufficient published peer-reviewed literature to fully evaluate Utah Arm; device-specific evidence too limited in quantity/quality to be conclusive.
Egermann 2009 (Pediatric)	Myoelectric prostheses in very young children can be successful with family support and structured training; high rates of daily use in suitable candidates.
Crandall 2002 (Pediatric long-term)	Long-term pediatric follow-up shows many children prefer multiple or simpler prostheses; only a minority selected myoelectric as primary long-term device.
Osseointegration / neuromusculoskeletal interfaces (Ortiz‑Catalan, Tsikandylakis, Tereshenko, Sabharwal)	Osseointegrated implants may improve intuitive control, range of motion, and ADL performance but evidence is limited, with infection and complication concerns; larger comparative studies needed.

Definitions (glossary):

• MHP = Multi-grip myoelectric prosthetic hand — an externally powered terminal device with multiple programmable grasp patterns.

• SHP = Standard myoelectric prosthesis (single-grip) — a myoelectric terminal device that provides a single primary grasp pattern or single degree-of-freedom grasp.

• DEKA Arm / LUKE arm = Externally powered advanced prosthetic arm systems evaluated in the literature (DEKA marketed; LUKE trade name referenced); DEKA received FDA de novo clearance (DEN120016, 2014).

• AM-ULA = Activities Measure for Upper Limb Amputees — a validated performance-based outcome measure developed for assessing activity performance in upper limb prosthesis users.

Archived previous policy version CS360KY.03 (administrative archival of prior version).