ModifiedCignaPolicy 0069

Airway clearance devices (DME)

Defines medical necessity, coverage stance, and replacement criteria for home airway clearance devices (PEP, MI-E, HFCWC, IPV) for Cigna-administered health benefit plans and explains applicability to members and providers.

Policy Summary

PayerCigna

PolicyAirway clearance devices (DME)

Policy CodePolicy 0069

Change TypeAnnual Review — material and formatting updates

Effective Date

Next Review Date

Key ActionSubmit prior authorization and documentation showing the device meets the policy's medical necessity criteria when requesting coverage for HCPCS E1399, E0482, or E0483.

SourceLink

POLICY UPDATE CHANGES

Removed policy statements for acoustical percussor, positive expiratory pressure and aerosol drug delivery system combination devices, mechanical percussors, and oscillatory (vibratory) positive expiratory pressure devices.

Revised policy statement for positive expiratory pressure devices.

Removed medical necessity criteria for non-managed services.

Updated to new template and formatting standards (Focused Review).

4device categories

E1399,E0482,E0483,E0481HCPCS codes referenced

allowedreplacement policy

1experimental code (E0481)

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70ICD-10 codes listed

Coverage Criteria for Airway Clearance Devices

PEP (E1399) — Medical Necessity

Positive expiratory pressure (PEP) devices — covered when ALL of the following are met

PEP coverage: Diagnosis characterized by excessive mucus production and difficulty clearing secretions (e.g., cystic fibrosis, chronic bronchitis)

HCPCS E1399

MI-E (E0482) — Medical Necessity

Mechanical insufflation-exsufflation (MI-E) — covered when ALL of the following are met

MI-E coverage: Individual has a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis) with significant impairment of chest wall and/or diaphragmatic movement resulting in difficulty clearing secretions

HCPCS E0482; examples: muscular dystrophy, multiple sclerosis

HFCWC (E0483) — Medical Necessity

High-frequency chest wall compression (HFCWC) — covered when ANY of the following indication groups are met (each group may have internal AND requirements)

HFCWC overall

Cystic fibrosis when there is failure, intolerance or contraindication to home chest physiotherapy, or it cannot be provided
Bronchiectasis confirmed by high-resolution computed tomography (CT) and characterized by BOTH: (1) daily productive cough for at least six continuous months OR frequent exacerbations requiring antibiotic therapy more than two times per year; AND (2) failure of standard treatments (e.g., pharmacotherapy, postural drainage, chest percussion, vibration) to mobilize secretions
Chronic neuromuscular disease (e.g., amyotrophic lateral sclerosis, muscular dystrophy) when BOTH: (1) disease is characterized by excessive mucus production, infection and difficulty clearing secretions; AND (2) failure, intolerance or contraindication to standard treatment (e.g., pharmacotherapy, postural drainage, daily chest percussion) and standard airway clearance device (e.g., mechanical percussors, positive expiratory pressure device)

IPV (E0481) — Not Medically Necessary / Experimental

IPV coverage stance: Intrapulmonary percussive ventilation device for home use

Considered experimental, investigational or unproven (not covered)

Replacement of airway clearance device

Replacement criteria — replacement is covered when EITHER condition is met

Replacement: (1) Documentation confirming that the airway clearance device is malfunctioning, is no longer under warranty and cannot be repaired; OR (2) recommendation by a health care provider that replacement due to growth or change of patient's condition is needed

Medically necessary conditions and linkage to device codes

Considered medically necessary when criteria in the applicable policy statements are met

General requirement: Device type must match HCPCS listed (e.g., E1399, E0482) and meet the policy-specific medical necessity criteria.

See specific ICD-10 diagnoses listed for eligible conditions.

Device coverage classifications

Device coverage status in this section

High-Frequency Chest Wall Compression Device: Considered medically necessary when criteria in the applicable policy statements listed above are met.

References HCPCS E0483 as covered.

Intrapulmonary Percussive Ventilation: Considered experimental/investigational/unproven.

References HCPCS E0481 as unproven.

A mechanical insufflation-exsufflation device (HCPCS E0482) for any indication not listed in this policy is not covered or reimbursable.

A high-frequency chest wall compression device (HCPCS E0483) for any indication not listed in this policy is considered not medically necessary.

All other diagnosis codes not explicitly listed in this policy are not covered or reimbursable.

ICD-10-CM diagnosis codes listed under 'Not Covered or Reimbursable' are excluded from coverage.

An intrapulmonary percussive ventilation device (HCPCS E0481) for home use is considered experimental, investigational, or unproven and is not a covered DME option under this policy.

Routine home use of intrapulmonary percussive ventilation (IPV) is not supported by sufficient, homogeneous evidence. Systematic reviews and primary studies are limited by small sample sizes, heterogeneous comparators and outcomes, and were unable to demonstrate consistent clinical benefit; therefore IPV cannot be recommended for routine home use.

The intrapulmonary percussive ventilation system and related accessories (HCPCS E0481) are considered experimental, investigational, or unproven for home use and are not covered under this policy.

Coding and Diagnosis Listings

Covered HCPCS (PEP)HCPCSCovered

E1399

Positive expiratory pressure devices (PEP) — HCPCS referenced as covered when medically necessary

Covered HCPCS (MI-E)HCPCSCovered

E0482

Mechanical insufflation-exsufflation device (MI-E) — HCPCS; covered for an individual with a neuromuscular disorder with significant impairment of chest wall and/or diaphragmatic movement resulting in difficulty clearing secretions

Covered HCPCS (HFCWC)HCPCSCovered

E0483

High-frequency chest wall compression device (HFCWC) — HCPCS; high frequency chest wall oscillation system, includes all accessories and supplies; considered medically necessary for listed indications when criteria are met

Not covered / Experimental HCPCS (IPV)HCPCSExperimental

E0481

Intrapulmonary percussive ventilation device (IPV) — HCPCS; considered experimental, investigational or unproven for home use (not covered)

Positive Expiratory Pressure DevicesHCPCSCovered

E1399

Durable medical equipment, miscellaneous

Cough stimulating devicesHCPCSCovered

E0482

Cough stimulating device, alternating positive and negative airway pressure

ICD-10 Codes considered medically necessary when criteria metICD-10Covered

G12.0	Infantile spinal muscular atrophy, type I [Werdnig-Hoffman]
G12.1	Other inherited spinal muscular atrophy
G12.20	Motor neuron disease, unspecified
G12.21	Amyotrophic lateral sclerosis
G12.22	Progressive bulbar palsy
G12.23	Primary lateral sclerosis
G12.24	Familial motor neuron disease
G12.25	Progressive spinal muscle atrophy
G12.8	Other spinal muscular atrophies and related syndromes
G12.9	Spinal muscular atrophy, unspecified

1–10 of 70

1/7

FDA-approved devices (examples)mixed

Device listings

Vest, SmartVest, inCourage, RespIn 11, Monarch; Volara/Maximus IPV/HC Impulsator (examples) — FDA 510(k) approvals referenced

Considered medically necessary diagnosis examplesICD-10Covered

S14.112S

Complete lesion at C2 level of cervical spinal cord, sequela

Not covered diagnosesICD-10Not Covered

No codes listed

Covered HCPCS CodesHCPCSCovered

E1399	Durable medical equipment, miscellaneous
E0483	High frequency chest wall oscillation system, with full anterior and/or posterior thoracic region receiving simultaneous external oscillation, includes all accessories and supplies, each
E0482	Cough stimulating device, alternating positive and negative airway pressure

Experimental/Investigational HCPCS CodesHCPCSExperimental

E0481

Intrapulmonary percussive ventilation system and related accessories

Peak expiratory cough flow — study threshold (> 360 L/min)

Peak expiratory cough flow (study threshold)> 360 L/min

ContextUsed as inclusion criterion in a COPD trial comparing IPV and HFCWO; denotes effective cough needed for enrollment.

Source populationStudy subjects had chronic bronchitis with airway obstruction on spirometry.

Daily sputum volume — study threshold (> 20 mL for at least two consecutive days)

Provider Actions, Documentation & Billing Guidance

Note

Coverage Linked to Policy Criteria

Coverage for airway clearance devices (e.g., HCPCS E1399, E0482, E0483) is contingent on meeting the applicable medical necessity criteria in this policy and the member's benefit plan. When coverage applies and all policy criteria are met, these HCPCS codes may be considered medically necessary. Claims submitted without covered codes under the applicable Coverage Policy will be denied as not covered.

Applicable codes include, but may not be limited to: E1399, E0482, E0483.
Verify member benefit plan for specific DME coverage before ordering or billing.

Documentation Required

HFCWO (E0483) — Documentation Required

When billing HCPCS E0483 (high-frequency chest wall oscillation/HFCWO), include documentation that the individual meets the medical necessity criteria in this policy (e.g., cystic fibrosis with failure/intolerance of chest physiotherapy; bronchiectasis confirmed by HRCT with chronic productive cough or frequent exacerbations and failure of standard treatments; or qualifying neuromuscular disease with failure/intolerance of standard therapies).

Background and Evidence Summary

Respiratory disorders characterized by excessive secretions (for example, cystic fibrosis, chronic bronchitis, and bronchiectasis) and neuromuscular diseases can impair airway clearance. A range of airway clearance devices (PEP, MI-E, HFCWC, IPV) are used to mobilize and remove secretions; device selection and coverage depend on the underlying condition, device-specific medical necessity criteria, and available evidence.

Device Definitions

Positive Expiratory Pressure (PEP) — definition and brief description

DefinitionA device that provides expiratory resistance to keep airways open and increase collateral ventilation to promote mucus clearance.

MechanismUser breathes in normally and exhales against resistance via a one-way valve and adjustable expiratory resistor to mobilize secretions.

Use considerationsCan be taught to children as young as five years and can be passively administered to infants via mask.

Mechanical Insufflation-Exsufflation (MI-E) — definition and brief description

DefinitionPortable electric devices that alternately apply positive and rapid negative pressure to the airway to simulate cough and aid secretion clearance.

Mechanism

Policy Revision History

2025-01-15Annual Review - materialLatest

Removed policy statements for acoustical percussor, PEP combination devices, mechanical percussors, and oscillatory (vibratory) PEP devices; revised the policy statement for positive expiratory pressure devices.

2023-11-02Focused Review - formatting

Updated to new template and formatting standards (Focused Review).

2023-10-15Annual Review - non-material

Removed medical necessity criteria for non-managed services.

Policy Summary

PayerCigna

PolicyAirway clearance devices (DME)

Policy CodePolicy 0069

Change TypeAnnual Review — material and formatting updates

Effective Date

Next Review Date

Key ActionSubmit prior authorization and documentation showing the device meets the policy's medical necessity criteria when requesting coverage for HCPCS E1399, E0482, or E0483.

SourceLink

On This Page

Daily sputum volume (study threshold)> 20 mL for at least two consecutive days

RolePart of inclusion criteria defining bronchial hypersecretion in the COPD study comparing IPV and HFCWO.

Assessment timingMeasured prior to enrollment to confirm eligibility for the trial.

Age — study inclusion threshold (> 35 years)

Age (study inclusion)> 35 years

Study contextInclusion criterion for a COPD trial comparing IPV and HFCWO (n=60).

Population implicationThreshold reflects adult COPD population rather than pediatric groups.

E0483 requires documentation of prior conservative therapy failure, intolerance, contraindication, or inability to provide standard therapies.
Include imaging (e.g., HRCT) or clinical records supporting bronchiectasis when applicable.

Denial Risk

Not Covered Diagnosis Codes — Denial Risk

Claims with diagnosis codes that are not listed as covered in this policy risk denial. Review and code to the most appropriate and supported ICD-10-CM diagnosis; diagnoses not specified as covered or reimbursable in this policy may be considered not covered.

Not Covered/Reimbursable: unspecified other diagnosis codes not listed in the policy.

Documentation Required

Replacement Documentation

Replacement of an existing airway clearance device is medically necessary only when EITHER documentation confirms the device is malfunctioning, no longer under warranty and cannot be repaired, OR a healthcare provider documents that replacement is needed due to patient growth or change in condition.

Provide repair/warranty records or provider statement recommending replacement.
Replacement requests without supporting documentation may be denied.

Billing Rule

Coding Currency Note

Coding lists in this policy may not be exhaustive. AMA and CMS code updates can occur more frequently than policy updates, and deleted or ineffective codes at the time of service may not be eligible for reimbursement. Always use the most appropriate and current codes when billing.

Confirm code currency at time of service; deleted/ineffective codes may be ineligible.
This policy's code lists are illustrative and may not include all relevant codes.

Documentation Required

Documentation for HFCWO (E0483)

For claims involving HFCWO (E0483), include clinical documentation demonstrating that the specific medical necessity criteria were met (see policy statements): prior failure, intolerance or contraindication to standard airway clearance therapies, imaging or clinical evidence for bronchiectasis when required, and provider notes supporting the need for HFCWO.

Attach records of prior therapies tried and the reason for failure/intolerance/contraindication.
Attach HRCT reports or other supporting diagnostic documentation for bronchiectasis cases.

Note

Medicare Determinations Referenced

References to Medicare National and Local Coverage Determinations may inform coverage decisions. Review current Medicare NCDs and LCDs (e.g., Durable Medical Equipment Reference List; High frequency chest wall oscillation devices L33785; Mechanical in-exsufflation devices L33795; Intrapulmonary percussive ventilation L33786) for additional guidance.

NCDs/LCDs referenced: Intrapulmonary percussive ventilator (NCD 240.5), Durable Medical Equipment Reference List (NCD 280.1).
Noridian LCDs: L33785, L33786, L33795 — review for details and revision dates.

Step Therapy

Step Therapy / Treatment Sequence

This policy does not prescribe explicit step therapy rules; however, HFCWC and other advanced airway clearance devices are considered after standard therapies have failed, are contraindicated, or are not tolerated. Verify any plan-specific step therapy requirements in the member's benefit document.

No explicit step therapy algorithm is described in this policy.
Confirm plan-level step therapy or prior authorization requirements before device provision.

Creates a rapid shift in pressure producing high expiratory flow to stimulate cough and increase secretion clearance (cough assist).

IndicationConsidered an established treatment option for patients with neuromuscular disorders with compromised chest wall or diaphragmatic movement.

High-Frequency Chest Wall Compression (HFCWC) — definition and brief description

DefinitionA system composed of a fitted vest and pneumatic compressor that inflates and deflates to produce high-frequency oscillatory chest compression to loosen and mobilize mucus.

MechanismCompressor inflates/deflates the vest, compressing and releasing the chest wall to create airflow and vibrations that loosen mucus.

IndicationsMay be used when conventional postural drainage and other devices have failed or are contraindicated (e.g., cystic fibrosis, bronchiectasis, select neuromuscular patients).

Intrapulmonary Percussive Ventilation (IPV) — definition and policy stance (experimental)

Policy stanceConsidered experimental, investigational, or unproven for home use (not covered).

Definition/MechanismA device proposed for home use to provide intrapulmonary percussion; delivers superimposed high-frequency mini-bursts of air/oxygen with aerosol to loosen secretions and stimulate cough.

Evidence summaryLiterature is limited, heterogeneous, and insufficient to support routine home use; primarily studied in inpatient settings or small trials.

Intrapulmonary percussive ventilation (IPV) — technical description (mini-bursts plus aerosol)

Technical descriptionDelivers intermittent positive-pressure breathing with superimposed high-frequency mini-bursts of air or oxygen while simultaneously delivering therapeutic aerosol.

Physiologic effectCombination of vibrations, aerosol, and pressure loosens secretions, stimulates cough, and increases sputum production.

Typical settingPrimarily designed for hospital use but has been proposed for in-home use; home use is not established per policy.

High-Frequency Chest Wall Compression Device / HFCWO — HFCWO system (E0483) definition and coverage note

HCPCS / DeviceE0483 — High frequency chest wall oscillation system (vest and compressor) including all accessories and supplies.

DefinitionExternal oscillation system providing simultaneous anterior and/or posterior thoracic region oscillation to mobilize secretions.

Coverage noteConsidered medically necessary when the applicable policy criteria listed in this document are met; billing should include documentation that criteria are satisfied.

Intrapulmonary Percussive Ventilation — IPV system (E0481) described as experimental/investigational

HCPCS / DeviceE0481 — Intrapulmonary percussive ventilation system and related accessories

Policy classificationClassified as experimental, investigational, or unproven for home use and therefore not covered under this policy.

Implication for billingClaims for E0481 are considered experimental/investigational and are not reimbursable when intended for home use per the policy.