ModifiedUnitedHealthcarePolicy CS077TN.P

Mechanical Stretching Devices (for Tennessee Only)

Defines medical necessity and coverage for mechanical stretching devices (LLPS, SPS, PASS) used to prevent or treat joint contractures for Tennessee Medicaid/CoverKids members.

Policy Summary

PayerUnitedHealthcare

PolicyMechanical Stretching Devices (for Tennessee Only)

Policy CodePolicy CS077TN.P

Change TypeMaterial changes to documentation requirements and supporting references

Effective DateDec 1, 2025

Next Review Date

Key ActionEnsure the patient medical record fully documents relevant history, physical exam, and diagnostic test results to support medical necessity; records must be legible and available upon request.

SourceLink

POLICY UPDATE CHANGES

Added language clarifying that medical records documentation may be required to assess whether the member meets clinical criteria for coverage and does not guarantee coverage.

Supporting Information and References sections were updated to reflect the most current information.

Related Billing Codes

HCPCS-E1803-DYNAMIC-ELBOW-EXTENSION-DEVICE-WITH-SOFT-INTERFACE

HCPCS E1803: Dynamic Adjustable Elbow Extension Device, With Soft Interface

HCPCS-E1814-DYNAMIC-KNEE-FLEXION-DEVICE-WITH-SOFT-INTERFACE

HCPCS Level II E1814: Dynamic Adjustable Knee Flexion Device, Soft Interface

HCPCS-E1806-STATIC-PROGRESSIVE-WRIST-STRETCH-DEVICE

HCPCS E1806: Static Progressive Stretch Wrist Device, Flexion/Extension

HCPCS-E1807-DYNAMIC-WRIST-EXTENSION-DEVICE

HCPCS E1807: Dynamic Adjustable Wrist Extension Device

HCPCS-E1811-STATIC-PROGRESSIVE-STRETCH-KNEE-DEVICE

HCPCS E1811: Static Progressive Stretch Knee Device, Extension/Flexion

HCPCS-E1822-DYNAMIC-ADJUSTABLE-ANKLE-EXTENSION-DEVICE

HCPCS E1822: Dynamic Adjustable Ankle Extension Device

HCPCS-E1801-ELBOW-STATIC-PROGRESSIVE-STRETCH-DEVICE

HCPCS E1801: Static Progressive Elbow Stretch Device

HCPCS-E1826-DYNAMIC-ADJUSTABLE-FINGER-EXTENSION-DEVICE

HCPCS E1826: Dynamic Adjustable Finger Extension Device, Soft Interface

HCPCS-E1827-DYNAMIC-ADJUSTABLE-FINGER-FLEXION-DEVICE

HCPCS E1827: Dynamic Adjustable Finger Flexion Device, With Soft Interface Material

HCPCS-E1818-FOREARM-PRONATION-SUPINATION-STATIC-PROGRESSIVE-STRETCH-DEVICE

HCPCS E1818: Forearm Pronation/Supination Static Progressive Stretch Device

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LLPS coveredLLPS covered

SPS & PASS not coveredSPS & PASS not covered

TennesseeState-specific

MultipleHCPCS listed

Class IClass I

Coverage Criteria for Mechanical Stretching Devices

LLPS (Covered)

Covered when ALL of the following are met

LLPS Medical Necessity: 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.

Applies to joints with contractures where LLPS evidence exists (finger, wrist, elbow, knee, toe).

SPS and PASS (Not Medically Necessary)

Not Medically Necessary

SPS and PASS Not Medically Necessary: Static progressive stretch (SPS) splint devices and patient-actuated serial stretch (PASS) devices are considered unproven and not medically necessary for treating joint contractures of the upper and lower extremities due to insufficient evidence of efficacy.

Applies when used alone or combined with standard physical therapy.

General evidence-based coverage summary

Summary of evidence-based coverage considerations

Evidence conclusions: Systematic reviews and technology assessments conclude evidence is insufficient to draw definitive conclusions about the efficacy of SPS, PASS, and LLPS devices for most indications; some small randomized or cohort studies report short-term range-of-motion (ROM) improvements or comparable outcomes versus alternative treatments in specific settings, but results are heterogeneous and limited by small sample sizes and study design.

See specific study citations in supporting information.

Selected device-specific findings

Selected clinical findings (informational) that may support consideration in individual cases

LLPS evidence: Randomized and controlled studies show LLPS/dynamic orthoses can produce early and/or meaningful ROM improvements in select populations (e.g., children with CP knee flexion contracture, adhesive capsulitis when combined with physical therapy, finger rehabilitation after tendon injury) though long-term advantages may be inconsistent.

Examples: Heymann 2012; Gaspar & Willis 2009; Chester 2002.

SPS evidence: Observational studies report ROM gains with SPS in some settings (e.g., post-TKA hemophilia patients), and comparative trials show SPS or dynamic splinting can be comparable to serial casting for certain pediatric contractures; however, high-quality, consistent evidence across indications is limited.

Examples: Pompe 2022; Op de Coul 2022; systematic reviews cited.

PASS evidence: Evidence for PASS devices is insufficient to determine safety and long-term outcomes; systematic reviews note heterogeneity and lack of well-designed trials, precluding conclusions about efficacy.

See Aspinall 2021 and policy evidence summaries.

Evidence supporting LLPS devices is limited to specific joints and contexts. Randomized trials, observational studies, and clinical experience support use of dynamic LLPS devices as an adjunct to therapy for persistent stiffness after injury or surgery in selected joints (notably finger, wrist, elbow, knee, and toe). However, the literature provides minimal evidence for effectiveness of LLPS devices for other joints or for chronic fixed contractures from conditions such as rheumatoid arthritis, cerebral palsy, or plantar fasciitis, and additional research is needed to establish broader effectiveness.

Overall, systematic reviews and technology assessments conclude that evidence is insufficient to draw definitive conclusions about the efficacy of mechanical stretching devices (SPS, PASS, and LLPS) for most indications. Published studies are heterogeneous, often small, and limited by short follow-up or methodological drawbacks, and no consistent superiority of one stretch intervention over another has been demonstrated.

Static progressive stretch (SPS) splints and patient-actuated serial stretch (PASS) devices are considered not medically necessary for treating joint contractures of the upper and lower extremities because available evidence does not demonstrate sufficient safety and efficacy when used alone or as an adjunct to standard physical therapy.

Use of SPS, PASS, or LLPS devices is generally not supported by sufficient evidence for most clinical indications. The literature lacks well-designed trials with adequate size and follow-up to establish consistent benefit across conditions, so these devices should be considered investigational or not medically necessary when documentation does not demonstrate clear individual benefit.

Applicable Codes and Regulatory Identifiers

Applicable HCPCS Codes (referenced)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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FDA Product Codemixed

ION	FDA product code for mechanical stretching devices (informational, not a billing code)

Coding quick facts

Primary HCPCS referenceE1399 and multiple E18xx/E18xx series codes are listed for mechanical stretching devices (see Applicable HCPCS Codes).

Common dynamic device codesE1800, E1802, E1803, E1804, E1805, E1810, E1815, E1822, E1823, E1825, E1826, E1827, E1828, E1829, E1830, E1840

Common static/SPS & PASS codesE1801, E1806, E1811, E1816, E1818, E1831, E1832, E1841

Coding noteListing of HCPCS codes is for reference; inclusion does not guarantee coverage or replace benefit-specific prior authorization requirements.

Provider Actions, Prior Authorization, and Documentation

Note

Applicable Codes — coder note

The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by federal, state, or contractual requirements and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.

Applicable HCPCS codes include, but are not limited to: E1399, E1800, E1801, E1802, E1803, E1804, E1805, E1806, E1807, E1808, E1810, E1811, E1812, E1813, E1814, E1815, E1816, E1818.

Prior Authorization

Prior Authorization and Documentation May Be Requested

Medical records documentation may be requested to determine whether the member meets the clinical criteria for coverage; however, submission of records does not guarantee coverage of the requested services.

Documentation may be requested as part of prior authorization or claim review.

Background on Joint Contractures and Stretching Devices

A joint contracture is a reduction in range of motion resulting from structural changes in non-bony tissues after immobilization, disease, or trauma. Mechanical stretching devices (including LLPS, SPS, and PASS) are intended to provide controlled mobilization to maintain or restore range of motion, sometimes as an adjunct or partial substitute for therapist-directed stretching. LLPS devices (dynamic orthoses) deliver a low-load, prolonged-duration stretch and have the clearest evidence in selected post-injury or post-operative settings; SPS and PASS devices apply progressively increasing static or patient-controlled loads, respectively, but have limited high-quality evidence of long-term benefit.

Definitions

Low-Load Prolonged-Duration Stretch (LLPS) - key facts

DefinitionLow-Load Prolonged-Duration Stretch (LLPS) devices are dynamic splinting systems that apply a low load over a prolonged duration to maintain or restore joint range of motion; examples include Ultraflex and Dynasplint.

MechanismAdjustable spring-loaded or elastic strap systems that provide continuous low-load stretch while the individual is at rest or asleep.

Typical jointsPrefabricated and custom units are available for elbow, wrist, fingers, knee, ankle, and toes.

Static Progressive Stretch (SPS) - key facts

DefinitionStatic Progressive Stretch (SPS) devices are splints that hold the joint in a set position with manual adjustment of angle to apply progressively increasing static stretch over time.

Mechanism

Policy Summary

PayerUnitedHealthcare

PolicyMechanical Stretching Devices (for Tennessee Only)

Policy CodePolicy CS077TN.P

Change TypeMaterial changes to documentation requirements and supporting references

Effective DateDec 1, 2025

Next Review Date

SourceLink

On This Page

Failure to provide requested records may delay review or result in denial.

Documentation Required

Medical Records Documentation 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 findings, and results of pertinent diagnostic tests or procedures. Documentation should be legible, maintained in the patient's medical record, and made available upon request.

Denial Risk

Insufficient Documentation May Result in Denial

Documentation that is incomplete, illegible, or does not substantiate the medical necessity for the requested service may be insufficient and can trigger a denial of the request.

Examples of missing documentation that may trigger denial: absent baseline exam, missing diagnostic test results, no documentation of failed conservative therapies when required.

Note

Clinical Sequencing — begin with nonoperative options when appropriate

When requesting coverage for orthotic or splinting devices, sequence conservative care before device provision when clinically appropriate (for example: nonoperative management such as physical therapy, home exercise program, casting or serial casting, and documented inadequate response to these measures). Include documentation of prior treatments and response.

Document dates and duration of prior conservative therapies.
If therapy was not appropriate or attempted, provide rationale in the record.

Inelastic traction that does not allow active or passive joint motion while maintaining a static stretch position; angle is manually modified to increase stretch.

Evidence/stanceClinical evidence is insufficient to demonstrate SPS as an effective treatment option for joint contractures in general.

Patient-Actuated Serial Stretch (PASS) - key facts

DefinitionPatient-Actuated Serial Stretch (PASS) devices provide patient-controlled incremental stretching using adjustable pneumatic or hydraulic loads (creep or stress-relaxation mechanisms).

Use protocolsDevices require individualized treatment plans and patient education; different PASS devices are available depending on the joint treated (e.g., knee, ankle, shoulder).

Evidence/stanceThere is insufficient evidence to demonstrate safety, efficacy, or long-term outcomes for PASS devices; well-designed trials are lacking.

Regulatory classification - Class I mechanical stretching devices

FDA classificationMechanical stretching devices (e.g., Dynasplint, Ultraflex) are classified as FDA Class I medical devices (product code ION).

Regulatory implicationsClass I devices have the least regulatory control and are 510(k) exempt; manufacturers are not required to provide safety and effectiveness data prior to marketing.

Informational noteFDA status alone is not a basis for coverage determinations.

LLPS — additional definition & clarification

Typical devices/examplesDynamic orthoses such as Ultraflex and Dynasplint that apply low-load prolonged-duration stretch to reduce contracture and improve ROM.

Clinical roleIntended as adjuncts to therapy to provide frequent, controlled mobilization and may replace some therapist-directed sessions when appropriate.

Evidence nuanceRandomized and controlled studies show LLPS can produce early or meaningful ROM improvements in select populations (e.g., knee flexion contracture in children with CP, adhesive capsulitis, finger rehab), but long-term advantages may be inconsistent.

Static Progressive Stretch (SPS) — definition & clarification

Device descriptionSPS devices are elastic or rigid splints applying progressively increasing static stretch to improve joint ROM over time (examples include JAS orthosis).

Clinical evidenceObservational studies report ROM gains in some small series, but systematic reviews conclude evidence is insufficient to draw definitive conclusions for most indications.

Typical use caseUsed as an adjuvant when standard physiotherapy has not achieved desired ROM (e.g., post-TKA extension lag), often for weeks to months.

Patient-Actuated Serial Stretch (PASS) — definition & clarification

Device descriptionPASS devices allow the patient to control pneumatic or hydraulic loads to incrementally stretch a joint using creep or stress-relaxation principles.

Clinical protocolsProtocols typically include a customized treatment plan and individualized patient education; devices vary by joint treated.

Evidence/coverage stanceAvailable literature is heterogeneous and limited; PASS devices are considered unproven with insufficient evidence to demonstrate improved patient outcomes.