CurrentColorado Rocky Mountain Health PlansPolicy 2026T0481BB

Mechanical Stretching Devices (Coverage Criteria)

Defines coverage and medical necessity for mechanical stretching devices (LLPS, SPS, PASS) to treat joint contractures for UnitedHealthcare Commercial and Individual Exchange members; describes which device types are proven, unproven, and not medically necessary.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyMechanical Stretching Devices (Coverage Criteria)

Policy CodePolicy 2026T0481BB

Change TypeTemplate Update

Effective DateJan 1, 2026

Next Review Date

Key ActionVerify member benefits and obtain prior authorization when required, and submit medical records documenting that clinical criteria for LLPS are met.

SourceLink

POLICY UPDATE CHANGES

01/01/2026: Template update; created shared policy version to support application to Oxford.

LLPS = provenLLPS stance

SPS/PASS = unprovenSPS/PASS stance

Many E-codesE-codes listed

Evidence mixedEvidence by joint

49 / 2,135Studies / participants

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23.5°Mean AROM change (LLPS)

Coverage Criteria — Medical Necessity and Limitations

Medical Necessity and Not Medically Necessary Statements

Covered when ALL of the following are met

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

Coverage Rationale; intended as adjunct to therapy

Device types not covered as medically necessary: 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 due to insufficient evidence of efficacy.

Explicit non-covered stance

Evidence and Limitations — joint-specific evidence notes and limitations

Evidence limitations and joint-specific notes

Evidence strongest for certain joints: Randomized controlled trials, observational studies, case series, and medical community acceptance support LLPS benefit for finger, wrist, elbow, knee, and toe; there is minimal evidence for other joints and insufficient evidence to support use for chronic fixed contractures caused by chronic conditions (for example, rheumatoid arthritis, cerebral palsy, plantar fasciitis).

Evidence summary

Clinical outcomes variable: Some studies demonstrate improvements in range of motion but show inconsistent or small effects on function (for example, hand function and grip strength). Many studies are limited by small sample sizes, short follow-up, lack of blinding, and other methodologic limitations; higher-quality, long-term RCTs are needed for many indications.

From Hayes evidence review and systematic reviews

Coverage summary (evidence-based)

Summary coverage stance from evidence presented

Evidence summary: Overall clinical evidence is mixed: LLPS/dynamic splinting has some positive studies showing improvements in ROM and a correlation between total hours of stretch and restored active ROM, but heterogeneity and limited quality of evidence restrict broad conclusions. Evidence for SPS and PASS devices is insufficient or mixed and does not establish definitive efficacy across indications.

See individual study summaries and systematic reviews for details.

When device use has some supportive evidence

Situations with supportive evidence

LLPS supportive findings: A systematic review (Furia et al., 2013) of dynamic splinting for lower extremity contractures reported a mean aggregate improvement in active ROM of 23.5° and a positive linear correlation between total hours of stretching and restored AROM. A randomized study in children with cerebral palsy (Heymann 2012) found dynamic orthoses superior to static orthoses for reduction of knee flexion contracture over months of follow-up.

Evidence drawn from Furia et al. and Heymann RCT; results support LLPS in specific settings.

SPS/Multimodal PT outcomes: Some observational and small controlled studies (for example, multimodal physical therapy plus static progressive stretch after TKA) report increases in ROM and, in limited series, a proportion of patients avoided manipulation under anesthesia; however, systematic reviews and technology assessments conclude evidence is insufficient to support SPS or PASS effectiveness broadly.

Evidence heterogeneous and limited by small sample sizes and study design.

There is insufficient evidence to support the use of dynamic low-load prolonged-duration stretch (LLPS) devices for rehabilitation of joints outside of the fingers, wrist, elbow, knee, and toe, and for treatment of chronic joint stiffness or chronic fixed contractures caused by chronic medical conditions (for example, rheumatoid arthritis, cerebral palsy, plantar fasciitis). Randomized controlled trials and observational studies support LLPS for certain post‑injury or post‑surgical contractures, but published literature does not establish effectiveness for these chronic conditions.

A Hayes technology assessment and subsequent reviews conclude that the overall evidence base is limited and insufficient to draw definitive conclusions about the efficacy of stretching devices across most indications. The Hayes report specifically found too few or no studies for many joint applications, which precludes assessing consistency of results and confirming treatment efficacy; therefore broader claims of effectiveness for SPS, PASS, or LLPS beyond well‑studied indications are not supported.

While some RCTs and observational studies exist for LLPS in selected joints, reviewers note that further investigation and higher‑quality trials are needed before clinical usefulness can be considered proven for additional indications.

The policy designates static progressive stretch (SPS) and patient‑actuated serial stretch (PASS) devices as unproven and not medically necessary for treatment of joint contractures. Clinical evidence for SPS and PASS is insufficient to demonstrate they are effective treatment options either alone or combined with standard physical therapy.

Available studies of SPS include small observational series and limited controlled trials with methodological constraints; PASS devices lack well‑designed clinical trials demonstrating safety, efficacy, or long‑term outcomes.

Multiple systematic reviews and individual studies conclude that current literature does not support SPS or PASS as established therapies for joint contractures. The Hayes review and recent observational and randomized studies report heterogeneous results, small sample sizes, or insufficient follow‑up, so the evidence is inadequate to establish medical necessity for SPS or PASS across indications.

In practice, this means claims that rely solely on SPS or PASS without robust supporting clinical documentation and evidence of benefit are considered not medically necessary based on current published data.

Coding and Billing

Applicable HCPCS E-codesHCPCS

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.
E1803	Dynamic adjustable elbow extension only device, includes soft interface material.
E1804	Dynamic adjustable elbow flexion only 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.
E1810	Dynamic adjustable knee extension and flexion device, includes soft interface material.
E1811	Static progressive stretch/patient actualized serial stretch knee device, extension and/or flexion, with or without range of motion adjustment, includes all components and accessories.

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Provider Actions, Authorization, and Documentation

Prior Authorization

Codes referenced for authorization

The following codes may be referenced for prior authorization and billing. Listing of a code does not guarantee coverage; verify member-specific benefits and prior authorization requirements prior to service.

Applicable HCPCS: E1399, E1800, E1801, E1803, E1804, E1806, E1807, E1808, E1810, E1811, E1812, E1813, E1814, E1815, E1816, E1818, E1822, E1823
Providers should obtain prior authorization when required by the member's benefit plan or plan-admin rules; inclusion here is for reference only

Documentation Required

Documentation-dependent coverage

Coverage decisions depend on adequate medical record documentation demonstrating that the device is medically necessary per the policy criteria. Lack of required documentation may lead to denial of the request.

Medical records may be requested to assess clinical criteria and support medical necessity determinations

Background and Clinical Context

Joint contracture is reduced range of motion due to structural changes in periarticular soft tissues that can follow immobilization, injury, surgery, or disease. Mechanical stretching devices are intended to maintain or restore joint range of motion by providing controlled mobilization and may be used as an adjunct to therapist‑directed care.

Mechanical stretch approaches differ by device type: LLPS devices deliver prolonged, low‑load stretch (often during rest or sleep) and have the strongest evidence for improving active range of motion in selected joints; SPS devices hold the joint at set angles allowing stepwise increases in stretch; and PASS devices let patients control serial increases in stretch via pneumatic or hydraulic systems. Choice of device should be informed by the evidence specific to the joint and clinical scenario.

Device Definitions

inv-19: Low-load prolonged-duration stretch (LLPS) definition

TermLow-load prolonged-duration stretch (LLPS)

DefinitionAdjustable spring-loaded dynamic splinting systems that provide prolonged low-load stretch, often used during rest or sleep to restore joint range of motion; available as prefabricated or custom units for elbow, wrist, fingers, knee, ankle, and toes.

Typical mechanismDynamic load generated by adjustable springs, elastic straps, or concentric joint components to deliver continuous low-level tension over prolonged periods.

Intended useUsed as home therapy to provide frequent, controlled mobilization and may replace some therapist-directed sessions for treatment or prevention of joint contractures.

inv-20: Static progressive stretch (SPS) definition

Term

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyMechanical Stretching Devices (Coverage Criteria)

Policy CodePolicy 2026T0481BB

Change TypeTemplate Update

Effective DateJan 1, 2026

Next Review Date

Key ActionVerify member benefits and obtain prior authorization when required, and submit medical records documenting that clinical criteria for LLPS are met.

SourceLink

On This Page

Documentation should include prior conservative therapy, physical therapy details, functional limitations, and progress notes demonstrating need

Note

FDA status and coverage implication

FDA classification is informational only. FDA 510(k) exemption or Class I status does not by itself establish coverage.

Mechanical stretching devices are Class I, 510(k)-exempt (product code ION) — this does not imply coverage
Reference: FDA classification/source information may be included in the record but is not a sole basis for payment

Note

Benefit plan and Medicare guidance

Verify the member-specific benefit plan and any applicable Medicare guidance before authorization or billing.

Benefit coverage is determined by the member specific benefit plan document and applicable federal/state mandates; in case of conflict, the member specific plan governs
When applied to Medicare Advantage, in absence of an NCD or LCD the MAO may use objective evidence-based rationale to determine coverage

Note

Role relative to physical therapy

Mechanical stretching devices are intended to supplement and in some cases partially replace physical therapist–directed sessions, not to fully substitute for a comprehensive PT program.

Devices provide frequent, controlled mobilization and may reduce the number of PT sessions needed but are considered adjuncts or partial replacements for therapist-directed care
Clinical documentation should show how device use integrates with the patient’s PT plan of care

Step Therapy

Conservative therapy sequencing

Evidence supports use of multimodal physical therapy programs (manual therapy, therapeutic exercise, and static progressive splinting) prior to more invasive interventions in many cases.

Conservative therapy sequencing: document trial of and response to multimodal PT before pursuing manipulation under anesthesia or other invasive procedures when clinically appropriate
Studies suggest that a structured multimodal PT program including splinting may allow some patients to avoid manipulation under anesthesia

Static progressive stretch (SPS)

DefinitionSplinting devices that hold the joint in a set position and allow manual modification of the joint angle (inelastic traction); the device does not exert cyclic stress and does not permit active or passive motion during application.

Typical mechanismIntermittent, incrementally increased static stretch applied by adjusting the device to a new joint angle over time.

Evidence summaryClinical evidence is mixed and not sufficient to conclusively demonstrate efficacy across indications; comparative studies show variable results versus dynamic splinting or casting.

inv-21: Patient-actuated serial stretch (PASS) definition

TermPatient-actuated serial stretch (PASS)

DefinitionDevices that provide adjustable low- to high-level loads to the joint using patient-controlled pneumatic or hydraulic systems; load and protocols are adjusted by the individual per a customized treatment plan.

Typical mechanismPneumatic or hydraulic actuators (e.g., extensionaters or flexionaters) delivering serial increments of stretch controlled by the patient.

Evidence summaryPublished literature is insufficient to demonstrate safety and long-term efficacy; well-designed trials are lacking for PASS devices across indications.

inv-22: LLPS (Low-Load Prolonged-Duration Stretch) — additional definition/details

Primary outcome reportedSystematic review (Furia et al. 2013) reported a mean aggregate improvement in active ROM of 23.5° for dynamic splinting in lower extremity contractures.

Dose–response relationshipDynamic splinting with prolonged passive stretching showed a significant direct, linear correlation between total hours of stretching and restored active ROM.

Device availabilityPrefabricated LLPS units exist for extension and flexion for multiple joints; custom devices used when prefabricated units are not suitable due to limb size/required load.

Typical settingIntended for home therapy and nighttime use to supplement or replace some physical therapy sessions.

inv-23: SPS (Static Progressive Stretch) — additional definition/details

MechanicsDelivers intermittent, incrementally increased stretch by manually adjusting the orthosis to a new static joint angle over time.

Clinical findingsEvidence is mixed: some trials (e.g., Op de Coul et al. 2022) found dynamic night orthosis comparable to serial casting for elbow contractures; systematic reviews report insufficient high-quality evidence overall.

Comparative outcomesSome studies show small differences versus dynamic splinting or casting; choice of SPS versus dynamic devices may be based on patient and surgeon preference and specific clinical circumstances.

LimitationsAvailable trials are heterogeneous, often small, and sometimes subject to selection bias and limited follow-up; well-designed comparative studies are needed.

inv-24: PASS (Patient-Actuated Serial Stretch) — additional definition/details

MechanicsPatient-controlled pneumatic or hydraulic systems deliver serial stretch; devices are adjusted per individualized protocols and patient education.

Evidence limitationsSystematic reviews and clinical literature conclude there is insufficient evidence to demonstrate the safety and efficacy of PASS devices for joint contractures.

Typical applicationsDevices are marketed for joints such as knee, ankle, and shoulder; protocols often require customized treatment plans and patient training.

Research gapsLack of well-designed randomized trials and heterogeneous terminology/techniques across studies impede interpretation of effectiveness data.