UnitedHealthcare mechanical stretching device Coverage Update

Coverage Criteria

Covered indications

Covered when meeting InterQual criteria (upper extremity) or when LLPS is used as an adjunct to therapy for existing contractures of the upper or lower extremities.

InterQual-specified upper-extremity coverage: Mechanical stretching devices of the upper extremities when criteria in InterQual CP: Durable Medical Equipment, Stretching Devices, Upper Extremity are met.

Refer to InterQual CP for the specific clinical coverage criteria for upper-extremity devices.

LLPS adjunctive coverage for existing contractures: Low-load prolonged-duration stretch (LLPS) devices used as an adjunct to therapy not addressed in InterQual criteria are proven and medically necessary for treating existing joint contractures of the upper and lower extremities.

Applies to dynamic splinting systems used during rest or sleep; prefabricated or custom devices may be considered when clinically indicated.

Unproven / Not medically necessary

Not covered / Not medically necessary

Unproven device types: Patient-actuated serial stretch (PASS) devices and static progressive stretch (SPS) splint devices are unproven and not medically necessary for treating joint contractures of the upper and lower extremities, alone or combined with standard physical therapy.

Insufficient evidence of efficacy and safety; well-designed clinical trials are lacking.

General coverage/evidence summary

Coverage stance and evidence summary

Evidence-based conclusions

Support for LLPS in lower extremity: Furia et al. (2013) systematic review reported mean aggregate AROM improvement of 23.5° and a correlation between total hours stretched and restored AROM.
(Lower-extremity evidence)
Adjunct benefit for adhesive capsulitis: A controlled cohort study (Gaspar and Willis, 2009) found greatest improvement in active external rotation when LLPS was combined with standardized physical therapy, attributed to additional home stretching hours.
(Shoulder/adhesive capsulitis evidence)
Short-term finger rehabilitation benefit: An RCT (Chester et al., 2002) showed improved total active motion at four weeks for LLPS combined with active mobilization versus static splinting, but differences were not maintained at three months.
(Early post-surgical finger evidence; long-term equivalence observed)

There is insufficient evidence to support the use of dynamic low-load prolonged-duration stretch (LLPS) devices for some chronic conditions and for joints beyond those with demonstrated benefit. Randomized controlled trials, observational studies, case series, and clinical acceptance support LLPS for relieving persistent joint stiffness after injury or surgery, but published literature provides only minimal evidence for joints other than finger, wrist, elbow, knee, and toe. The evidence is inadequate to support LLPS for treatment of chronic fixed contractures or chronic conditions such as rheumatoid arthritis, cerebral palsy, or plantar fasciitis.

A Hayes technology report (2018; updated 2022) concluded the available evidence is insufficient to determine the efficacy of static progressive stretch (SPS), patient-actuated serial stretch (PASS), or LLPS devices for most joint contracture indications. The Hayes review specifically notes there are no or only a limited number of studies addressing most applications (knee, hand, wrist, elbow, shoulder, toes), precluding consistent conclusions, with the exception of some evidence for finger extensor injury.

Patient-actuated serial stretch (PASS) and static progressive stretch (SPS) devices are regarded as unproven. Systematic reviews and technology assessments, including Hayes and recent literature summaries, find the evidence base for PASS and SPS to be inconsistent or inadequate to demonstrate clear safety and efficacy across indications, and well-designed clinical trials are lacking.

Because clinical evidence for PASS and SPS devices is limited and inconclusive, these devices are considered not medically necessary for treatment of joint contractures. LLPS devices retain evidence of benefit in select joints and post-injury or post-surgical stiffness, but evidence is limited for many chronic conditions and for some joints; coverage of LLPS therefore depends on meeting the policy’s clinical criteria and documentation requirements.

Coding

Applicable HCPCS E-codes (partial list)HCPCS

E1399	Durable medical equipment, miscellaneous.
E1800	Dynamic adjustable elbow extension and flexion device, includes soft interface material.
E1801	Static progressive stretch/patient actualized serial stretch elbow device, extension and/or flexion, with or without range of motion adjustment, includes all components and accessories.
E1802	Dynamic adjustable forearm pronation/supination device, includes soft interface material.
E1803	Dynamic adjustable elbow extension only device, includes soft interface material.
E1804	Dynamic adjustable elbow flexion only device, includes soft interface material.
E1805	Dynamic adjustable wrist extension and flexion device, includes soft interface material.
E1806	Static progressive stretch wrist device, flexion and/or extension, with or without range of motion adjustment, includes all components and accessories.
E1807	Dynamic adjustable wrist extension only device, includes soft interface material.
E1808	Dynamic adjustable wrist flexion only device, includes soft interface material.

1–10 of 17

1/2

Applicable HCPCS E-codes (continued)HCPCS

E1818	Static progressive stretch/patient actualized serial stretch forearm pronation/supination device, with or without range of motion adjustment, includes all components and accessories.
E1822	Dynamic adjustable ankle extension only device, includes soft interface material.
E1823	Dynamic adjustable ankle flexion only device, includes soft interface material.
E1825	Dynamic adjustable finger extension and flexion device, includes soft interface material.
E1826	Dynamic adjustable finger extension only device, includes soft interface material.
E1827	Dynamic adjustable finger flexion only device, includes soft interface material.
E1828	Dynamic adjustable toe extension only device, includes soft interface material.
E1829	Dynamic adjustable toe flexion only device, includes soft interface material.
E1830	Dynamic adjustable toe extension and flexion device, includes soft interface material.
E1831	Static progressive stretch toe device, extension and/or flexion, with or without range of motion adjustment, includes all components and accessories.

1–10 of 13

1/2

Evidence‑supported joints

Evidence-supported jointsFinger, wrist, elbow, knee, and toe — LLPS devices have evidence for these joints; minimal evidence for others.

Limited evidence for other jointsMinimal peer-reviewed evidence supports LLPS effectiveness for joints other than finger, wrist, elbow, knee, and toe.

Insufficient evidence for chronic conditionsInsufficient evidence to support LLPS for chronic fixed contractures from conditions such as rheumatoid arthritis, cerebral palsy, or plantar fasciitis.

Provider Actions & Billing Notes

Documentation Required

Medical records required

The patient's medical record must contain documentation that fully supports the medical necessity for the requested services. This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures. Documentation supporting medical necessity should be legible, maintained in the patient's medical record, and must be made available upon request. Lack of supporting documentation may result in denial of the request.

Medical history, exam findings, and diagnostic test results must be present
Records must be legible and retained in the patient’s chart
Medical records must be produced upon request

Denial Risk

Documentation-related denial risk

Medical records documentation may be required to assess whether the member meets the clinical criteria for coverage but does not guarantee coverage of the services requested. Absence of required documentation or inability to produce records upon request may lead to denial of coverage.

Medical Necessity

General DME medical necessity

Devices are intended to prevent or treat joint contractures and to restore or maintain range of motion when supported by clinical indications and documentation.

Intent and appropriate use: Mechanical stretching devices (LLPS, SPS, PASS) are intended to provide frequent, controlled joint mobilization to maintain or restore ROM and may replace some therapist-directed sessions in hospital or home settings when clinically appropriate.

Custom devices may be considered when prefabricated units are ineffective due to limb size, shape, or load requirements.

Documentation requirement: Medical record documentation must fully support the clinical indication for use including relevant history, physical examination, and results of pertinent diagnostic tests or procedures; documentation must be legible and available upon request.

Lack of supporting documentation may result in denial of coverage.

Coverage application by device type: LLPS devices: considered proven and may be medically necessary when used as adjunctive therapy or when InterQual criteria are met (upper extremity). SPS and PASS devices: considered unproven and not medically necessary due to insufficient evidence.

Definitions

LLPS — definition & characteristics

DefinitionLow-load prolonged-duration stretch (LLPS) devices are adjustable spring-loaded dynamic splinting systems designed to provide prolonged low-load stretch, often used during rest or sleep, available prefabricated or custom.

Primary purposeIntended to prevent or treat joint contractures and to maintain or restore range of motion by providing frequent, controlled joint mobilization as home or hospital therapy.

Typical joints treatedPrefabricated units available for elbow, wrist, fingers, knee, ankle, and toes; custom devices used when prefabricated units are ineffective due to limb size/shape or load requirements.

MechanismDynamic load generated via concentric joint or elastic strap; provides prolonged passive stretch correlated with hours of use and improved AROM per Furia et al.

SPS — definition

Rental & Purchase Rules

Topic	Details
FDA device classification
Mechanical stretching devices (e.g., Dynasplint, Ultraflex, Pro-glide Knee/Elbow/Wrist) are classified by the U.S. Food and Drug Administration as Class I medical devices (product code ION) and are 510(k) exempt; FDA information provided for reference only — FDA classification alone is not a basis for coverage.

Replacement

Replacement (policy placeholder)

Replacement policy placeholderNo specific replacement interval or replacement guidance provided in this policy section; refer to plan contract and supplier guidelines.

Documentation noteMedical necessity and documentation requirements apply to replacement requests; records must be legible and produced on request.

Operational notePolicy does not specify rental or purchase rules in this section; consult applicable DME rental/purchase rules elsewhere.

Documentation Requirements

Billing Rule

Submit legible documentation with claims/PA to demonstrate medical necessity

Submit legible documentation with claims or prior authorization requests to demonstrate medical necessity; include relevant history, exam findings, and diagnostic test results.

Documentation should be maintained in the patient's medical record and be available upon request.

Documentation Required

Provide medical records upon request to support coverage decisions

Provide the patient's medical record upon request to support coverage determinations; the record must fully support medical necessity with history, examination, and diagnostic results.

Documentation does not guarantee coverage but is required for review when requested.

Not Covered / Exclusions

PASS and SPS devices are classified as unproven and not medically necessary for treating joint contractures because current literature does not adequately demonstrate safety, efficacy, or improved long-term outcomes. The body of evidence for LLPS is likewise limited for many chronic conditions and for joints outside the finger, wrist, elbow, knee, and toe; therefore LLPS use for those indications is not supported without meeting the specific clinical criteria described in this policy.

Use of PASS devices to treat joint contractures is unsupported due to insufficient evidence of safety and efficacy. Similarly, SPS and many applications of LLPS lack adequate peer-reviewed evidence to establish effectiveness for a range of contracture etiologies and joints; these devices should be considered not medically necessary unless documentation demonstrates an indication covered by the policy.

For joint contractures, the literature does not provide sufficient evidence to support routine use of PASS devices, and SPS or LLPS devices have limited or inconclusive evidence for many indications. As a result, PASS and SPS are considered not medically necessary for these uses, and LLPS coverage is limited to the supported clinical scenarios outlined in this policy.

Background

A joint contracture is a reduction in range of motion caused by structural changes in periarticular soft tissues and can result from immobilization after surgery, from disease, or from trauma. Mechanical stretching devices are intended to prevent or treat contractures by providing frequent, controlled joint mobilization to help maintain or restore range of motion and are used as adjuncts to therapist-directed care or in the home setting.

OpenPayer

Mechanical Stretching Devices (for Kansas Only)