CurrentUnitedHealthcarePolicy CS077NJ.P

Mechanical Stretching Devices Nj Cs

State of New Jersey–only UnitedHealthcare medical policy for mechanical stretching devices (LLPS, SPS, PASS) addressing medical necessity, evidence review, and applicable HCPCS E-codes; defines which device types are proven/medically necessary versus unproven/not medically necessary.

Policy Summary

PayerUnitedHealthcare

PolicyMechanical Stretching Devices Nj Cs

Policy CodePolicy CS077NJ.P

Change TypeDocumentation updatesHCPCS coverage notereferences updated

Effective DateDecember 1, 2025

Next Review Date

Key ActionPatient medical record must contain documentation supporting medical necessity including relevant medical history, physical exam, and pertinent diagnostic test/procedure results; records must be legible and available upon request.

SourceLink

POLICY UPDATE CHANGES

Added language clarifying that benefit coverage is determined by federal, state, or contractual requirements and applicable laws, and that medical records documentation may be required to assess coverage but does not guarantee coverage.

Added notation that HCPCS code E1832 is not on the State of New Jersey Medicaid Fee Schedule and therefore is not covered by the State of New Jersey Medicaid Program.

Updated Clinical Evidence and References sections to reflect the most current information.

Archived previous policy version CS077NJ.O

3Device type positions (LLPS vs SPS vs PASS)

~30HCPCS codes listed

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E1832 excluded for NJ Medicaid

multipleReferences cited

Coverage Summary

This New Jersey–only UnitedHealthcare medical policy (Policy Number CS077NJ.P) for mechanical stretching devices is effective December 1, 2025 and is CURRENT in status. It addresses device types, applicable HCPCS E-codes, medical necessity criteria, and documentation requirements for coverage determinations. Coverage stance is mixed: LLPS (low‑load prolonged‑duration stretch) devices are supported as proven and medically necessary as an adjunct to therapy for treating existing joint contractures of the upper and lower extremities, whereas SPS (static progressive stretch) and PASS (patient‑actuated serial stretch) devices are considered unproven and not medically necessary due to insufficient evidence.

Policy summary

Policy numberCS077NJ.P

Effective dateDecember 1, 2025

PayerUnitedHealthcare

Geographic scopeState of New Jersey only

StatusCURRENT

Number of HCPCS codes listed~30

HCPCS code explicitly excluded for NJ MedicaidE1832

Medical-Necessity Criteria

Medically Necessary - Low-Load Prolonged-Duration Stretch (LLPS) devices

Covered when ALL of the following are met:

ALL of the following

Device is a low-load prolonged-duration stretch (LLPS) device (dynamic splinting system).
Used as an adjunct to therapy for treating existing joint contractures of the upper and/or lower extremities.

Evidence summary: Clinical evidence (RCTs, observational studies, case series) and medical community acceptance support LLPS devices for relieving persistent joint stiffness after injury or surgery.

Limitations and Indication Specifics for LLPS

Conditional statements and evidence-based limitations:

Coding

Applicable HCPCS / DME 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.

1–10 of 30

1/3

Codes not on NJ Medicaid Fee Schedule (asterisked in document)HCPCS

E1801	Static progressive stretch/patient actualized serial stretch elbow device (not on NJ Medicaid Fee Schedule)
E1806	Static progressive stretch wrist device (not on NJ Medicaid Fee Schedule)
E1811	Static progressive stretch/patient actualized serial stretch knee device (not on NJ Medicaid Fee Schedule)
E1816	Static progressive stretch/patient actualized serial stretch ankle device (not on NJ Medicaid Fee Schedule)
E1818	Static progressive stretch/patient actualized serial stretch forearm device (not on NJ Medicaid Fee Schedule)
E1831	Static progressive stretch toe device (not on NJ Medicaid Fee Schedule)
E1832	Static progressive stretch finger device (not on NJ Medicaid Fee Schedule)
E1841	Static progressive stretch/patient actualized serial stretch shoulder device (not on NJ Medicaid Fee Schedule)
E1840	Dynamic adjustable shoulder device (marked with asterisk in doc; not on NJ Medicaid Fee Schedule)

Applicable HCPCS noted in policy historyHCPCSNot Covered

E1832

Static progressive stretch finger device, extension and/or flexion, with or without range of motion adjustment, includes all components and accessories.

Provider Actions

Documentation Required

Medical record documentation required

The patient's medical record must contain documentation that fully supports the medical necessity for the requested device and services. Documentation should demonstrate why the device is needed and how it meets clinical criteria for treatment of an existing joint contracture.

Relevant medical history
Physical examination findings
Results of pertinent diagnostic tests or procedures

Documentation Required

Medical record documentation must support medical necessity

Documentation must be legible, maintained in the patient's medical record, and made available upon request. This reiterates the requirement that records fully support medical necessity (see prior callout) and that providing documentation for review does not by itself guarantee coverage.

Legible records retained in the medical record
Relevant history, physical exam, and diagnostic test results available upon request

Background

Mechanical stretching devices (also called dynamic splinting systems) include three primary types: LLPS (low‑load prolonged‑duration stretch) dynamic splints, SPS (static progressive stretch) splints that hold a joint at a set position with manual angle adjustment, and PASS (patient‑actuated serial stretch) devices that use patient‑adjustable pneumatic or hydraulic load. These devices are used clinically to prevent and treat joint contractures and to maintain or restore joint range of motion (ROM), often as adjuncts to therapist‑directed care or home therapy. The FDA classifies these products under product code ION as Class I, 510(k)-exempt (no premarket notification required). This succinct description is provided for clinical and billing staff to support operational understanding and coding.

Definitions

LLPSLow-load prolonged-duration stretch devices (dynamic splinting systems) providing prolonged low-load stretch, often used during rest or sleep to restore/maintain joint ROM.

SPSStatic progressive stretch devices that hold the joint at a set position allowing manual modification of angle; inelastic traction without active or passive motion.

PASSPatient-actuated serial stretch devices that provide adjustable load (e.g., pneumatic or hydraulic systems) controlled by the patient.

Revision History

2025-12-01material_addedLatest

Added documentation language clarifying that benefit coverage is determined by federal, state, or contractual requirements and applicable laws; medical records documentation may be required to assess coverage but does not guarantee coverage; medical records must fully support medical necessity (examples given for acceptable documentation).

2025-12-01material_addedLatest

Operational coding limitation added: HCPCS code E1832 (Static progressive stretch finger device) is not on the State of New Jersey Medicaid Fee Schedule and therefore is not covered by the State of New Jersey Medicaid Program.

Policy Summary

PayerUnitedHealthcare

PolicyMechanical Stretching Devices Nj Cs

Policy CodePolicy CS077NJ.P

Change TypeDocumentation updatesHCPCS coverage notereferences updated

Effective DateDecember 1, 2025

Next Review Date

SourceLink

On This Page

Evidence supports LLPS devices for finger, wrist, elbow, knee, and toe joint rehabilitation; evidence minimal or lacking for other joints.

Insufficient evidence for chronic conditions

Examples of chronic conditions with insufficient evidence: Rheumatoid arthritis (RA), cerebral palsy, plantar fasciitis.

Evidence limitations note: Further investigation and long-term randomized studies are needed; some trials have limitations (small samples, follow-up issues).

Not Medically Necessary / Unproven

The following are unproven and not medically necessary, alone or combined with standard physical therapy, due to insufficient evidence:

Static progressive stretch (SPS) splint devices

Clinical evidence insufficient; not medically necessary

Patient actuated serial stretch (PASS) devices (patient controlled mechanical stretching)

Clinical evidence insufficient; not medically necessary

Medical Records Documentation Used for Reviews (Policy History 12/01/2025)

Coverage determinations may require medical record documentation; added language on documentation requirements:

Operational governance statement: Benefit coverage for health services is determined by federal, state, or contractual requirements and applicable laws that may require coverage for a specific service.

Documentation requirement for review: Medical records documentation may be required to assess whether the member meets the clinical criteria for coverage but does not guarantee coverage of the service requested.

Must support medical necessity

Documentation examples: This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.
Operational requirement: Documentation supporting the medical necessity should be legible, maintained in the patient's medical record, and must be made available upon request.

Prior check advisory: Before using this policy, check federal, state, or contractual requirements for benefit plan coverage as they may differ and govern in case of conflict.

Device Classification and Regulatory Status

FDA classification and regulatory notes:

FDA classification: Mechanical stretching devices are categorized under product code ION and are Class I, 510(k) exempt devices.

Regulatory implication: Class I devices are exempt from premarket notification procedures and manufacturers are not required to provide safety and effectiveness data prior to marketing.

Reference to FDA informational resource

NJ Medicaid code notes: Codes marked with an asterisk in the policy are not on the State of New Jersey Medicaid Fee Schedule and therefore may not be covered by the State of New Jersey Medicaid Program (e.g., E1832 noted as not on NJ Medicaid Fee Schedule).

Billing Rule

Code use advisory

The HCPCS codes listed in the policy are provided for reference only; inclusion does not imply coverage or guarantee payment. Providers should confirm coverage with applicable federal, state, or contractual requirements and payor fee schedules.

Asterisked codes are not on the State of New Jersey Medicaid Fee Schedule and may not be covered: E1801, E1806, E1811, E1816, E1818, E1831, E1832, E1840, E1841

Prior Authorization

Reference federal/state/contractual coverage requirements

Benefit coverage is determined by federal, state, or contractual requirements and applicable law; these requirements may differ from this policy. Prior authorization or other payor-specific requirements may apply per the member's benefit rules, so providers should verify plan-specific coverage before obtaining or billing for a device.

Check federal, state, or contractual benefit requirements that govern coverage
Prior authorization may be required per applicable benefit rules

Mechanical stretching devices

Devices used to apply passive or dynamic stretching to joints (product code ION); used to treat joint contractures, arthrofibrosis, and similar conditions; FDA Class I, 510(k) exempt.

The evidence summary notes that multiple randomized controlled trials, observational studies, systematic reviews, and case series support the effectiveness of LLPS (dynamic) devices for improving ROM and treating contractures of specific joints (finger, wrist, elbow, knee, and toe), with demonstrated benefits in many trials and reviews. By contrast, the clinical evidence for SPS and PASS devices is insufficient to demonstrate effectiveness or long‑term outcomes, and these device types are therefore considered unproven/not medically necessary. Policy references include RCTs, systematic reviews, and technology reviews spanning 2001–2024 that inform these determinations.

2025-12-01revisedLatest

References and clinical evidence sections updated to reflect the most current information (multiple citations through 2024 and 2025).

2025-12-01archivedLatest

Archived previous policy version CS077NJ.O.