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    v1.0.30
    OpenPayerPolicy UpdatesDurable Medical Equipment (DME)Texas Children's Mucus Clearance Prior Auth | Open…
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    CurrentTexas Children's Health PlanPolicy 10577

    Secretion and Mucous Clearance Devices Guideline

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    This guideline governs Texas Children's Health Plan authorization and medical-necessity review for secretion and mucous clearance devices, including cough augmentation, HFCWO, IPV, electrical percussors, and IPPB devices. It also identifies devices that do not require prior authorization and establishes rental, purchase, replacement, and recertification requirements.

    Policy Summary
    PayerTexas Children's Health Plan
    PolicySecretion and Mucous Clearance Devices Guideline
    Policy CodePolicy 10577
    Change TypeNo material change
    Effective DateAug 31, 2023
    Next Review DateN/A
    Key ActionSubmit the required physician-completed prior-authorization form and clinical medical-necessity documentation.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    5Device categories requiring prior authorization

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    5
    Device categories not requiring prior authorization
    3 monthsCommon initial rental period
    10 monthsRental-to-purchase period
    <270 lpmPeak cough flow threshold
    50%HFCWO compliance minimum

    Coverage Criteria

    General Medical Necessity

    A secretion and mucus clearance device may be considered medically necessary when documentation clearly shows that the member has at least one of the following:

    ONE of the following

    • Evidence of retained respiratory secretions.
    • Evidence that the member has difficulty clearing respiratory secretions.
    • Atelectasis caused by mucus plugging.

    Cough Augmentation — Initial Rental

    A cough augmentation device (mechanical insufflator-exsufflator or cough assist machine; E0482) may be considered for an initial three-month rental when ALL applicable requirements are met:

    ALL of the following

    • The member has chronic pulmonary disease or a neuromuscular disorder, including but not limited to spinal cord injury with quadriplegia, muscular dystrophy, or spinal muscular atrophy, affecting the respiratory musculature and causing a weak, ineffectual, or absent cough.
    • The treating physician submits documentation that is completed, signed, and dated, including diagnosis and medical history, recent illnesses, complications, medications, recent hospitalizations, and pulmonary function study results when applicable.
    • Clinical evidence supports natural deterioration to the level requiring cough augmentation to clear the airways, such as pulmonary function studies or peak cough flow assessing cough strength in an adolescent or adult with a result below 270 L/min.< 270 L/min
    • Documentation explains why the member's parent, guardian, or caregiver cannot perform chest physiotherapy or why those therapies were previously ineffective.
    • Following the initial three-month trial, the treating physician documents compliance with equipment use and treatment effectiveness for continued rental.
    • For continued rental through an out-of-network provider, the request is limited to up to 90 days and documents either that the provider was in-network when the initial rental was requested or that the member received the services under prior authorization from another Managed Care Organization or Fee-for-Service provider.

    HFCWO — Initial Rental

    An HFCWO system (CPT Vest; E0483) may be considered for an initial three-month rental when ALL applicable requirements are met:

    ALL of the following

    • HFCWO is not being requested as first-line treatment; the member has trialed other percussion and postural drainage therapy for at least three months before the request, and the documentation explains why prior therapy was ineffective. An exception may be considered for cystic fibrosis or bronchiectasis with chronic mucopurulent bronchitis.
    • ONE qualifying condition

      • Bronchiectasis confirmed by CT scan and characterized by either a continuous daily productive cough for six months or frequent pulmonary infection exacerbations, more than twice per year, requiring antibiotic therapy.
      • Cystic fibrosis or other documented chronic suppurative endobronchitis.
      • A chronic neuromuscular disorder affecting the member's ability to cough or clear respiratory secretions.

    HFCWO — Purchase After Rental

    After the initial three-month rental, purchase of an HFCWO system may be considered when ALL applicable requirements are documented:

    ALL of the following

    • The HFCWO system therapy results are submitted and document that the system is effective.
    • Effectiveness and tolerance are documented, including evidence of vest tolerance.
    • The treating physician provides a description and assessment of effectiveness and tolerance, including the member's diagnosis and respiratory-related history.
    • The documentation shows respiratory-related complications and a decrease in those complications.
    • The documentation addresses recent hospitalizations related to the respiratory condition and shows shorter hospital lengths of stay and decreased hospitalizations.

    IPV — Initial Rental

    An intrapulmonary percussive ventilation (IPV) system (E0481) may be considered for an initial three-month rental when ALL applicable requirements are met:

    ALL of the following

    • HFCWO is contraindicated, and the member has chronic pulmonary disease or a neuromuscular disorder, including spinal cord injury with quadriplegia, affecting the respiratory musculature and causing a weak, ineffectual, or absent cough.
    • ONE qualifying condition

      • Bronchiectasis confirmed by CT scan and characterized by either a continuous daily productive cough for six months or frequent pulmonary infection exacerbations, more than twice per year, requiring antibiotic therapy.
      • A history of chronic respiratory illness with inability to adequately clear respiratory secretions, leading to complications such as chronic bronchitis or recurrent pneumonia.
    • Other appropriate chest physiotherapy, based on age, ability, and skill, such as percussion and postural drainage therapy or a mechanical device, was trialed by the member's parent, guardian, or caregiver for at least three months, and the request documents why the therapy was ineffective or contraindicated.

    An IPV system is not a benefit when requested primarily for the convenience of the caregiver.

    A member generally may not have both an HFCWO system and an IPV system because the devices have similar actions on mucus clearance. An exception may be considered with a detailed letter of medical necessity from the treating pulmonologist describing how a purchased device failed to meet the member's airway-clearance needs and why the other device is medically necessary; during the rental period, one device must be discontinued to obtain the other. A member with severe neuromuscular disease, ineffective cough, and recurrent pneumonia may require both cough assist and HFCWO or IPV when the treating pulmonologist documents the recurrent pneumonia, ineffective cough, and need to loosen mucus for adequate clearance.

    IPPB is not the therapy of first choice for delivering aerosol or providing lung hyperinflation when other therapies can reliably meet the member's prescribed clinical objectives. Rental of an IPPB device includes all supplies, including humidification and tubing.

    Medical Necessity Framework

    General DME Medical Necessity

    Covered when at least one qualifying secretion-clearance problem is documented:

    ONE of

    • Evidence of retained respiratory secretions.
    • Evidence that the member has difficulty clearing respiratory secretions.
    • Atelectasis caused by mucus plugging.

    Device-Specific DME Criteria

    The general medical-necessity requirement must be met. In addition, the requested device must meet ALL applicable device-specific requirements:

    ALL applicable:

    Covered Device Coding and Thresholds

    Devices not requiring prior authorizationHCPCSCovered
    A9284Incentive spirometers
    S8185Mucous clearance valved chamber; oscillating positive expiratory pressure, such as Flutter, Acapella, or AeroBika devices
    E1399Percussion cups
    A4483Heat moisture exchangers when used for mechanically ventilated clients who own their ventilator
    A4481Tracheostoma filters, such as Thermovent T, for clients with a tracheostomy who are not mechanically ventilated
    Devices requiring prior authorizationHCPCSCovered
    E0483High-frequency chest wall oscillation system
    E0482Insufflation-exsufflation devices, such as Cough Assist or Vital Cough
    E0480Electrical percussors
    E0481Intrapulmonary percussion ventilation system
    E0500Intermittent positive-pressure breathing devices
    HFCWO replacementHCPCSCovered
    A7025Vest replacement
    Peak cough flow
    ThresholdPeak cough flow below 270 lpm
    PopulationAdolescent or adult
    Clinical useSupports assessment of cough strength and deterioration requiring cough augmentation
    Bronchiectasis productive cough
    Required findingContinuous daily productive cough
    Duration6 months
    Condition

    Authorization and Provider Actions

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for rental or purchase of the following secretion and mucus-clearance devices:

    • HFCWO or CPT Vest system (E0483)
    • Insufflation-exsufflation or cough-assist devices (E0482)
    • Electrical percussors (E0480)
    • Intrapulmonary percussive ventilation (IPV) systems (E0481)
    • Intermittent positive-pressure breathing (IPPB) devices (E0500)
    Note

    Devices Exempt From Prior Authorization

    The following devices or procedures do not require prior authorization when used under the stated conditions:

    • Incentive spirometers (A9284)
    • Mucus-clearance valved chambers, such as Flutter, Acapella, or AeroBika devices (S8185)

    Rental and Purchase Rules by Device

    Device / codeRental termsPurchase terms
    Electrical percussor (E0480)May be considered for rental when medical necessity and previous therapy history are documented. Continued out-of-network rental may be approved through the 10-month rent-to-purchase period when applicable network or prior-authorization conditions are met.Considered purchased after 10 months of rental through the same provider. Purchase or further rental is not considered after that point.
    Device / codeRental termsPurchase terms
    Cough augmentation device (E0482)Initial rental may be authorized for 3 months. Continued rental requires treating-physician documentation that the member is compliant and treatment is effective. Out-of-network continued rental may be approved for up to 90 days when applicable network or prior-authorization conditions are met.No purchase provision is specified in the guideline.
    Device / codeRental termsPurchase terms
    High-frequency chest wall oscillation system (E0483)Initial rental may be authorized for 3 months. An additional 3-month rental may be considered when purchase cannot yet be determined, if the required documentation and compliance evidence are submitted.Considered purchased after 10 months of rental through the same provider. Purchase requires documentation of therapy results, effectiveness, tolerance, clinical improvement, hospitalization outcomes, compliance, and safety. Purchase is reimbursed once per lifetime.
    Device / codeRental termsPurchase terms
    Intrapulmonary percussive ventilation system (E0481)Initial rental may be authorized for 3 months. The device is rental-only. Continued rental requires treating-physician documentation that the member is compliant and treatment is effective. Out-of-network continued rental may be approved for up to 90 days when applicable network or prior-authorization conditions are met.Not applicable; the device is rental-only.
    Device / codeRental termsPurchase terms
    Intermittent positive-pressure breathing device (E0500)The device is rented. Rental includes supplies such as humidification and tubing.No purchase provision is specified in the guideline.

    Replacement Rules

    HFCWO vest replacement
    HCPCS codeA7025
    Replacement intervalNo fixed interval stated; replacement is condition-based
    DocumentationDocument that the member can no longer wear the vest because of a change in condition, such as a change in height, weight, or skin abrasions
    HFCWO system replacement
    HCPCS codeE0483
    Replacement limitOnce per lifetime
    Rationale and timingThe system is considered purchased after 10 months of rental through the same provider; reimbursement is limited to once per lifetime because of the manufacturer's lifetime warranty

    Required Documentation

    Documentation Required

    Submit the physician-completed authorization package

    For rental or purchase, submit the applicable Texas Medicaid Prior Authorization Request for Secretion and Mucus Clearance Devices Initial Request or Renewal Request form, completed, signed, and dated by the treating physician, together with clinical medical-necessity documentation.

    • Initial Request form
    • Renewal Request form
    Documentation Required

    Document cough-augmentation medical necessity

    For initial cough-augmentation rental, document the diagnosis and history, clinical evidence of cough deterioration to the level requiring augmentation, and medical reasons the parent, guardian, or caregiver cannot perform chest physiotherapy or why it was ineffective.

    • Include relevant illnesses, complications, medications, hospitalizations, and pulmonary-function results.
    • Include PFTs or peak cough flow when applicable.

    Device Definitions

    Cough augmentation device
    DeviceCough augmentation device
    Pressure sequencePositive pressure followed by negative pressure
    PurposeStimulates a natural cough
    High-frequency chest wall oscillation system
    DeviceHigh-frequency chest wall oscillation system
    DesignWearable vest applied to the chest wall
    MechanismApplies vibrations at different frequencies to loosen mucus

    Background

    Secretion and mucous clearance devices support members who retain respiratory secretions, cannot clear secretions effectively, or develop mucus-plugging complications such as atelectasis. The guideline addresses mechanical cough augmentation, high-frequency chest wall oscillation, intrapulmonary percussion, electrical percussion, and intermittent positive-pressure breathing. For certain devices, documentation of failure or contraindication of simpler airway-clearance methods is required before authorization.

    Not Covered and Excluded Scenarios

    The following are not covered: IPV requested primarily for caregiver convenience; concurrent HFCWO and IPV when the specified pulmonologist-supported medical-necessity exception is not documented; and use of both systems without the required explanation of the purchased device’s failure and the medical necessity for the second device.

    Policy Summary
    PayerTexas Children's Health Plan
    PolicySecretion and Mucous Clearance Devices Guideline
    Policy CodePolicy 10577
    Change TypeNo material change
    Effective DateAug 31, 2023
    Next Review DateN/A
    Key ActionSubmit the required physician-completed prior-authorization form and clinical medical-necessity documentation.
    SourceLink
    On This Page
    Coverage CriteriaMedical Necessity FrameworkCovered Device Coding and ThresholdsAuthorization and Provider ActionsRental and Purchase Rules by DeviceReplacement RulesRequired DocumentationDevice DefinitionsBackgroundNot Covered and Excluded Scenarios
  1. A weak, ineffective, or absent cough caused by chronic pulmonary disease or a neuromuscular disorder, resulting in respiratory complications from inability to clear mucus.
  2. Documentation identifies other appropriate chest physiotherapy modes, based on age, ability, and skill, such as percussion and postural drainage therapy or a mechanical device, that were trialed by the member, parent, guardian, or caregiver and explains why the therapy was ineffective or contraindicated.
  3. Documentation shows that any previous HFCWO use did not result in aspiration, exacerbation of a gastrointestinal or pulmonary condition, or exacerbation of seizure activity.
  4. If purchase cannot be determined at the end of the initial three-month rental, an additional three-month rental may be considered when the above documentation and compliance with ordered therapy are submitted.
  5. Frequency-of-use and compliance graphs for the three-month period show the prescribed frequency for each day and use of the system at least 50% of the prescribed time.≥ 50% of prescribed time
  6. The treating physician states that prior HFCWO use did not result in aspiration, exacerbation of a gastrointestinal or pulmonary issue, or exacerbation of seizure activity.
  7. ≥ 3 months
  8. The member's pulmonologist provides documentation describing the medical reasons HFCWO is contraindicated.
  9. IPV is a rental-only device; after the initial three-month trial, continued rental requires treating-physician documentation of compliance with equipment use and treatment effectiveness.
  10. Continued rental through an out-of-network provider may be approved for up to 90 days when the provider was in-network at initial rental or the member received the services under prior authorization from another Managed Care Organization or Fee-for-Service provider.
  11. The requested device meets its applicable disease, prior-treatment, contraindication, documentation, rental, and effectiveness requirements under this guideline.

    Applies separately to electrical percussors (E0480), cough augmentation devices (E0482), HFCWO systems (E0483), IPV systems (E0481), and IPPB devices (E0500).

    Bronchiectasis confirmed by CT scan
    Pulmonary infection exacerbations
    FrequencyMore than 2 times per year
    Clinical eventPulmonary infection exacerbations
    Treatment requirementExacerbations requiring antibiotic therapy
    Prior airway-clearance therapy
    Minimum durationAt least 3 months when specified
    HFCWOTrial percussion and postural drainage therapy before the request
    IPVTrial appropriate chest physiotherapy or mechanical therapy before the request
    HFCWO compliance
    Minimum complianceAt least 50% of prescribed time
    Measurement periodThree-month period
    Required evidenceFrequency-of-use and compliance graphs showing prescribed frequency and actual use
  12. Percussion cups (E1399)
  13. Heat-moisture exchangers (A4483) only for mechanically ventilated clients who own their ventilator
  14. Tracheostoma filters, such as Thermovent T (A4481), for clients with a tracheostomy who are not mechanically ventilated
  15. Note

    Submission Channels

    Submit prior authorization requests to the Utilization Management Department during normal business hours through any of the following channels:

    • Online submission
    • Fax
    • Phone
    • Mail
    Step Therapy

    Electrical Percussor: Prior Therapy

    Requests for an electrical percussor (E0480) must describe all previous courses of therapy and explain why they did not adequately assist with airway mucus clearance.

    • Document prior manual percussion and postural drainage (P&PD), valved-device therapy, or other relevant airway-clearance therapy.
    • Explain the member's response to each prior therapy and why it was ineffective or insufficient.

    Unsupported block type: step_therapy teamp

    Step Therapy

    IPV Prerequisite Therapy

    Before an IPV system (E0481) is considered, the member's parent, guardian, or caregiver must trial an appropriate chest-physiotherapy modality for at least three months.

    • Document percussion and postural drainage therapy or another appropriate mechanical modality.
    • Explain why the trialed therapy was ineffective or contraindicated.
    Step Therapy

    IPPB: Failed Alternatives

    IPPB (E0500) requests must document an ineffective response to other treatment modalities, including cough-assist therapy, when applicable.

    • Document failure of other modalities and why they cannot meet the clinical objective.
    • Include the relevant inability to cooperate or inability to ventilate or cough effectively when applicable.
    Documentation Required

    Initial or Renewal Request Form

    For an initial or renewal request for rental or purchase, submit the applicable Texas Medicaid Prior Authorization Request for Secretion and Mucus Clearance Devices form with clinical documentation supporting medical necessity.

    • Use the Initial Request form or Renewal Request form, as applicable.
    • The form must be completed, signed, and dated by the member's treating physician.
    Documentation Required

    General Medical-Necessity Evidence

    Clinical documentation must clearly establish medical necessity for the selected secretion and mucus-clearance device.

    • Evidence of retained respiratory secretions
    • Difficulty clearing respiratory secretions
    • Atelectasis caused by mucus plugging
    Documentation Required

    Cough Augmentation Documentation

    Cough-augmentation requests (E0482) require documentation completed, signed, and dated by the treating physician showing the qualifying condition and respiratory impairment.

    • Diagnosis and medical history, including recent illnesses, complications, medications, recent hospitalizations, and pulmonary-function results when applicable
    • Clinical evidence of deterioration requiring cough augmentation, such as PFTs or peak cough flow below 270 L/min in an adolescent or adult
    • Medical reasons the parent, guardian, or caregiver cannot perform chest physiotherapy, or why it was previously ineffective
    • For continued rental after the initial three-month trial, document equipment compliance and treatment effectiveness
    Documentation Required

    HFCWO Supporting Documentation

    HFCWO requests (E0483) must document a qualifying condition, the response or contraindication to prior therapy, and the member's airway-clearance therapy history.

    • Qualifying disease, such as CT-confirmed bronchiectasis with the required productive cough or exacerbation history, cystic fibrosis or chronic suppurative endobronchitis, chronic neuromuscular disease, or weak, ineffective, or absent cough caused by chronic pulmonary or neuromuscular disease
    • Results of at least three months of appropriate prior chest physiotherapy and why it was ineffective or contraindicated
    • Any prior HFCWO use and documentation that it did not cause aspiration, gastrointestinal or pulmonary exacerbation, or seizure exacerbation
    • For an additional rental period, document compliance with ordered therapy
    Documentation Required

    HFCWO Purchase Documentation

    A purchase request after the initial three-month HFCWO rental must document that the system was effective and tolerated and include the treating physician's assessment of respiratory outcomes.

    • Results of HFCWO therapy and evidence of effectiveness and vest tolerance
    • Treating physician's assessment, diagnosis, and respiratory history
    • Respiratory complications and decreases in those complications
    • Recent respiratory hospitalizations, shorter lengths of stay, and decreased hospitalizations
    • Three-month frequency-of-use and compliance graphs showing use at least 50% of prescribed time
    • Physician statement that HFCWO did not cause aspiration, gastrointestinal or pulmonary exacerbation, or seizure exacerbation
    Documentation Required

    IPV Supporting Documentation

    IPV requests (E0481) require documentation that HFCWO is contraindicated, the member has a qualifying disease and respiratory impairment, and appropriate prior therapy was unsuccessful or contraindicated.

    • Pulmonologist's description of the medical reasons HFCWO is contraindicated
    • Chronic pulmonary disease or neuromuscular disorder affecting respiratory musculature with weak, ineffective, or absent cough
    • Qualifying bronchiectasis or chronic respiratory illness with inadequate secretion clearance and resulting complications
    • At least three months of caregiver-trialed, appropriate chest physiotherapy and the reason it was ineffective or contraindicated
    Documentation Required

    IPPB Supporting Documentation

    IPPB (E0500) requires documentation that other modalities were ineffective, the device is prescribed consistently with AARC recommendations, and there is medical necessity to improve lung expansion or achieve aerosol delivery.

    • Document ineffective response to other modalities, including cough-assist therapy when applicable
    • Document clinically significant atelectasis, inability to clear secretions, or inability to ventilate or cough effectively
    • For aerosol delivery, document unsuccessful alternative delivery methods and applicable ventilatory muscle weakness or severe hyperinflation
    • Include the prescribing physician's clinical rationale and applicable AARC-based requirements
    Step Therapy

    HFCWO Is Not First-Line

    HFCWO is not considered first-line therapy. The member must complete the required trial of other percussion and postural-drainage therapy before an HFCWO request is considered, subject to the stated exception.

    • Minimum prior-therapy period: three months
    • Exception may be considered for cystic fibrosis and bronchiectasis with chronic mucopurulent bronchitis
    Denial Risk

    Caregiver Convenience

    An IPV request is not a benefit when made primarily for caregiver convenience.

    • The request must be supported by the member's clinical needs and medical necessity.
    Denial Risk

    Duplicate Airway-Clearance Systems

    A member generally may not receive both an HFCWO system and an IPV system because the devices have similar actions on mucus clearance.

    • An exception may be considered with a detailed medical-necessity letter from the treating pulmonologist explaining why a purchased device failed and why the other device is medically necessary.
    • For severe neuromuscular disease with ineffective cough and recurrent pneumonia, both cough assist and HFCWO or IPV may be requested with the required pulmonologist letter.
    Denial Risk

    IPPB Is Not Clinically Preferred

    IPPB is not the therapy of first choice for aerosol delivery or lung hyperinflation when other therapies can reliably meet the member's clinical objectives.

    • Use IPPB only when alternatives are unsuccessful or cannot meet the prescribed clinical objective.
    • Rental includes supplies such as humidification and tubing.
    Note

    Criteria Not Met

    Requests that do not meet the guideline criteria will be reviewed case by case by a Texas Children's Health Plan Medical Director or Physician Reviewer.

    • Prior authorization is based on medical necessity and is not a guarantee of benefits or eligibility.
    • Approved authorization applies only to the medical necessity of the treatment or service; benefit limitations and exclusions still apply.
    Documentation Required

    Document HFCWO qualification and safety

    For HFCWO, document a qualifying condition, failure or contraindication of prior therapy, prior appropriate therapy trials, and that previous HFCWO use did not cause aspiration or gastrointestinal, pulmonary, or seizure exacerbation.

    • Document why the prior therapy was ineffective or contraindicated.
    • Include the required safety history.
    Documentation Required

    Document HFCWO effectiveness before purchase

    Before HFCWO purchase, submit therapy results, effectiveness and tolerance, vest tolerance, physician assessment, respiratory and hospitalization outcomes, use and compliance graphs, and the treating physician’s safety statement.

    • Compliance graphs must show use at least 50% of prescribed time during the three-month period.
    • Document evidence of decreased respiratory complications and hospitalizations.
    Documentation Required

    Document IPV-specific medical necessity

    For IPV, document the qualifying pulmonary or neuromuscular disease, respiratory impairment and complications, at least three months of prior appropriate therapy with its outcome or contraindication, and the HFCWO contraindication documented by the member’s pulmonologist.

    • Include the pulmonologist’s medical reasons HFCWO is contraindicated.
    • Document inability to adequately clear secretions or other qualifying respiratory complications.
    Documentation Required

    Support rental recertification

    For continued rental after the initial three-month trial, submit treating-physician documentation that the member is compliant with equipment use and that treatment is effective.

    • Applies to continued cough-augmentation rental.
    • Applies to continued IPV rental.
    • Certain out-of-network continued rentals may be approved for up to 90 days when the stated authorization conditions apply.
    Intrapulmonary percussive ventilation system
    DeviceIntrapulmonary percussive ventilation system
    Delivery methodShort bursts of air through a mouthpiece or mask
    PurposeLoosens mucus
    Intermittent positive-pressure breathing
    DeviceIntermittent positive-pressure breathing device
    Breathing supportProvides short-term or intermittent positive-pressure breaths
    UsesAugments lung expansion, delivers aerosol medication, or assists ventilation
    Electrical percussor
    DeviceElectrical percussor
    TypeElectrical device
    PurposeUsed for chest percussion or vibration
    Percussion cup
    DevicePercussion cup
    TypeManual chest-physical-therapy cup
    TechniqueUsed for pounding and postural drainage