ModifiedUnitedHealthcarePolicy CS077NM.E

Mechanical Stretching Devices (for New Mexico Only)

Policy governing coverage of mechanical stretching devices (LLPS, SPS, PASS) for prevention and treatment of joint contractures in New Mexico members; defines which device types are considered medically necessary versus unproven.

Policy Summary

PayerUnitedHealthcare

PolicyMechanical Stretching Devices (for New Mexico Only)

Policy CodePolicy CS077NM.E

Change TypeAdded documentation requirement language

Effective DateDec 1, 2025

Next Review Date

Key ActionEnsure the patient's medical record documents relevant history, physical exam, and diagnostic tests to support medical necessity and make records available upon request.

SourceLink

POLICY UPDATE CHANGES

Added language specifying that medical records documentation may be required to assess whether the member meets the clinical criteria for coverage and that documentation must fully support medical necessity.

Updated clinical evidence and references sections to reflect the most current information.

LLPS = provenLLPS stance

SPS/PASS = unprovenSPS/PASS stance

State-limitedJurisdiction

Extremity coverageSupported joints

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Coverage Criteria for Mechanical Stretching Devices

inv-01: COVERAGE CRITERIA — Covered when ALL of the following are met

Covered when ALL of the following are met

LLPS coverage criteria (high-level): Low-load prolonged-duration stretch (LLPS) devices are proven and medically necessary as an adjunct to therapy for treating existing joint contractures of the upper and lower extremities.

Adjunct to physical therapist–directed therapy; may replace some PT sessions by providing frequent, controlled mobilization

Joints with supporting evidence: Evidence supports LLPS effectiveness primarily for finger, wrist, elbow, knee, and toe contractures; minimal evidence for other joints.

Insufficient evidence for other joints or chronic contractures from conditions such as rheumatoid arthritis or cerebral palsy

inv-02: COVERAGE CRITERIA — Not covered / Not medically necessary (SPS/PASS)

Not covered / Not medically necessary (SPS/PASS)

SPS and PASS: Static progressive stretch (SPS) splint devices and patient-actuated serial stretch (PASS) devices are unproven and not medically necessary, alone or combined with standard physical therapy, for treating joint contractures of the upper and lower extremities due to insufficient evidence of efficacy.

Well-designed clinical trials are lacking for PASS; systematic reviews show mixed or insufficient evidence for SPS

inv-03: Coverage summaries by device class — Coverage stance driven by evidence strength and device classification

Coverage stance is driven by clinical evidence strength and device classification:

LLPS summary: Some controlled trials and observational studies report short-term improvements and in select cases reduced surgical rates for LLPS devices; overall evidence is inconsistent across indications — consider LLPS as an adjunct to PT for select joints (finger, wrist, elbow, knee, toe) based on clinical judgment.

See randomized controlled trials and cohort studies summarized in policy

SPS summary: Systematic reviews and multiple controlled trials show mixed or insufficient evidence that SPS devices are superior to alternative interventions; effects are not consistently favorable across indications.

See Harvey et al. 2017 systematic review

PASS summary: Evidence is insufficient to demonstrate safety, efficacy, and long-term outcomes for PASS devices for any indication; lack of well-designed trials prevents conclusions of benefit.

See Aspinall et al. 2021 and related statements

Insufficient evidence exists to support use of LLPS devices for chronic joint stiffness or chronic fixed contractures resulting from longstanding medical conditions. The source literature notes minimal evidence for rehabilitation of joints beyond the finger, wrist, elbow, knee, and toe, and explicitly states there is insufficient evidence to support LLPS for conditions such as rheumatoid arthritis, cerebral palsy, or plantar fasciitis.

Systematic reviews (including Harvey et al.) and targeted reviews conclude that current evidence is inadequate to draw definitive conclusions about the efficacy of SPS, PASS, or LLPS devices across many indications. Harvey et al. (2017) pooled 49 studies (2,135 participants) and found no clear advantage for splinting interventions on joint mobility, and other reviews report that well‑designed trials for PASS are lacking; collectively these assessments characterize the evidence as insufficient or mixed for SPS/PASS/LLPS in many clinical settings.

Based on the available evidence and technology assessments, static progressive stretch (SPS) and patient‑actuated serial stretch (PASS) devices are considered not medically necessary for treatment of joint contractures of the upper and lower extremities. The policy states these device classes are unproven and not medically necessary, whether used alone or combined with standard physical therapy, due to insufficient evidence of efficacy.

Use of SPS or PASS devices for indications lacking adequate clinical evidence is considered not medically necessary. Systematic reviews and summaries note insufficient data on safety, efficacy, and long‑term outcomes for PASS and mixed or inconclusive results for SPS, supporting a noncoverage stance when supporting clinical evidence is absent.

Coding and Billing References

Applicable DME HCPCS codes (reference 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.

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Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Codes Referenced for Potential Prior Authorization

The following codes are provided for reference and may require prior authorization depending on the member's benefit plan. Inclusion here does not guarantee coverage or payment. Verify benefit-specific prior authorization requirements before billing.

E1399, Durable medical equipment, miscellaneous
E1800–E1818, Various dynamic and static progressive stretch/adjustable joint devices (see policy code list)

Note

Adjunct-to-Therapy Positioning

Mechanical stretch devices are intended to be used as an adjunct to physical therapy and may replace some therapist-directed sessions by providing frequent, controlled joint mobilization. Document the treatment plan showing how device use complements or substitutes specific PT services.

Clinical Background

Joint contracture is a reduction in range of motion caused by structural changes in periarticular soft tissues (muscle, tendon, ligament, skin) after immobilization, surgery, disease, or trauma. Mechanical stretching devices—including dynamic LLPS systems, SPS splints, and PASS devices—are intended to provide controlled mobilization to prevent or treat contractures, typically as an adjunct to therapist‑directed physical therapy.

Device Definitions

LLPS (Low-load prolonged-duration stretch) — adjustable spring-loaded dynamic splinting devices description

DefinitionAdjustable spring-loaded dynamic splinting devices designed to deliver a low continuous load over prolonged periods (often during rest or sleep) to restore or maintain joint range of motion; available prefabricated or custom for elbow, wrist, fingers, knee, ankle, and toes.

MechanismProvides dynamic low-load prolonged-duration stretch (LLPS) by applying a consistent, gentle tension (spring or elastic strap) to achieve end-range stretching over hours.

Typical useIntended as an adjunct to physical therapist–directed therapy to provide frequent, controlled mobilization in the home or hospital setting, potentially replacing some PT sessions.

Indications with evidenceEvidence supports use primarily for finger, wrist, elbow, knee, and toe contractures; some trials (e.g., Dynasplint in adhesive capsulitis and finger rehab RCTs) report short-term improvements when combined with PT.

CustomizationCustom units may be used when prefabricated devices cannot provide effective treatment due to limb size/shape or required load/material needs.

Policy Summary

PayerUnitedHealthcare

PolicyMechanical Stretching Devices (for New Mexico Only)

Policy CodePolicy CS077NM.E

Change TypeAdded documentation requirement language

Effective DateDec 1, 2025

Next Review Date

Key ActionEnsure the patient's medical record documents relevant history, physical exam, and diagnostic tests to support medical necessity and make records available upon request.

SourceLink

On This Page

FDA classification: Mechanical stretching devices (e.g., Dynasplint, Ultraflex, Pro-glide) are classified by the FDA as Class I (510[k] exempt); FDA clearance alone is not a basis for coverage.

Informational only

Documentation Required

Medical Records Documentation Required

Medical records must fully support the medical necessity of the requested device. Required documentation includes, but is not limited to: relevant medical history, physical examination findings, and results of pertinent diagnostic tests or procedures. Documentation should be legible, maintained in the member's record, and made available upon request.

History: onset, prior treatments, functional limitations
Physical exam: joint range of motion, contracture measurements, neurovascular status
Diagnostic tests: imaging or other studies supporting diagnosis or severity
Treatment plan: goals, duration, and how device use will address functional impairment

Documentation Required

Documentation Insufficiency

Insufficient or missing documentation may lead to an adverse coverage determination or denial. Ensure all requested supporting records are provided with the prior authorization request or claim submission.

Failure to include history, exam findings, or diagnostic results may result in delay or denial
Unclear or illegible records are subject to denial

Denial Risk

Documentation-Based Denial Risk

If records do not adequately demonstrate medical necessity according to the policy criteria and applicable benefit terms, the request or claim may be denied. Providers should include objective measures and evidence that the device is medically necessary for the member's condition.

Denial risk if documentation lacks objective findings or functional impairment evidence
Denial risk if benefit terms or federal/state/contractual requirements are not met

Note

Check Benefit Terms and Document Medical Necessity

Before relying on this policy, verify the member's federal, state, or contractual benefit terms as they govern coverage decisions and may impose specific requirements not reflected here.

Check benefit plan for prior authorization rules and any state or contractual mandates
Provide documentation showing compliance with applicable benefit requirements

Prior Authorization

Provider Action — Submit Complete Records

Provider action: submit complete, legible medical records that demonstrate how the requested device meets policy clinical criteria and the member's benefit requirements. Include objective measures, prior conservative treatments, and a clear treatment plan.

SPS (Static progressive stretch) — static progressive splinting devices description

DefinitionSplinting devices that hold the joint at a set position and allow manual modification of joint angle (inelastic traction); they do not permit active or passive motion while set.

MechanismApplies a static, progressively increased stretch by repositioning the splint to a new angle as tolerated (static progressive stretch, SPS).

Evidence summaryClinical evidence is mixed or insufficient to demonstrate SPS devices are superior to alternatives; systematic reviews and controlled trials report no clear advantage across indications.

Clinical noteSPS may be comparable to dynamic splinting or serial casting for select conditions (e.g., elbow flexion contractures in children) but overall evidence is inconsistent and further well‑designed trials are needed.

LimitationsStudies are heterogeneous, often small, and short-term; conclusions about long-term outcomes and superiority over other stretch interventions are not established.

PASS (Patient-actuated serial stretch) — patient-actuated serial stretch devices description

DefinitionDevices in which the patient actively applies serial cycles of stretch using adjustable pneumatic or hydraulic systems (patient-actuated serial stretch, PASS); examples include displacement- or load-control approaches.

MechanismProvides adjustable low- to high-level load under patient control (e.g., pneumatic Extensionaters/Flexionaters or traction/load-control devices) per a customized treatment protocol.

Evidence summaryThere is insufficient evidence to demonstrate safety, efficacy, or long-term benefit of PASS devices for joint contractures; well-designed clinical trials are lacking.

Clinical implicationsAvailable studies are heterogeneous and unable to determine whether PASS devices, alone or adjunctive to PT, improve outcomes compared with standard care.

Low-Load Prolonged-Duration Stretch (LLPS) — additional description and examples

Devices/examplesCommercial examples include Dynasplint and other dynamic splinting systems marketed for elbow, wrist, fingers, knee, ankle, and toes.

FunctionApply a low, continuous load over prolonged periods (end-range stretching) to improve joint ROM; often worn during rest or sleep as a home-based adjunct to therapy.

Clinical evidenceControlled cohort and randomized trials report some short-term benefits (e.g., Gaspar & Willis 2009 for adhesive capsulitis; Chester et al. 2002 for early finger rehabilitation), particularly when combined with structured PT, but long-term benefits are inconsistent across studies.

When custom is usedCustom dynamic splints are indicated when prefabricated units cannot meet limb size/shape or required load/material specifications.

Static Progressive Stretch (SPS) — description and evidence note

SPS descriptionSPS devices maintain a set joint position and are adjusted manually to increase angle and apply a progressive static stretch; they do not permit continuous active or passive motion while set.

Evidence overviewSystematic review (Harvey et al. 2017) and controlled trials show mixed or insufficient evidence that SPS provides superior outcomes; meta-analysis of splinting found no mean difference in joint mobility compared with other interventions.

Clinical contextSPS may be comparable to other modalities (dynamic orthosis, serial casting) for specific indications, but study heterogeneity and limited sample sizes preclude definitive conclusions.

Patient-Actuated Serial Stretch (PASS) — description and evidence note

PASS descriptionPASS devices allow patients to self-administer serial stretch cycles using pneumatic or hydraulic mechanisms; device type varies by joint (e.g., knee/ankle, shoulder).

Evidence statementCurrent evidence is insufficient to conclude PASS devices are effective for treating joint contractures; systematic reviews note heterogeneity in devices and protocols and call for well-designed randomized trials.

Study findingsSystematic reviews (Aspinall et al. 2021) and policy reviews report improvements in ROM in some studies (e.g., knee arthrofibrosis), but heterogeneity and methodological limitations prevent firm conclusions about benefit.