Humana Airway Clearance Devices Form

Description

Individuals with impaired ability to cough due to respiratory muscle weakness or pulmonary restriction have difficulty clearing secretions from the lungs. The accumulated secretions may allow growth of pathogens, leading to a higher risk for chronic infections and deterioration of lung function as the bronchial tubes can be occluded. Conditions that can lead to this problem include amyotrophic lateral sclerosis (ALS), bronchiectasis, cystic fibrosis (CF), muscular dystrophy, myasthenia gravis and spinal cord injuries.

Airway clearance devices are an alternative to standard manual chest physiotherapy (CPT), which includes percussion, postural drainage, forced expiratory maneuvers, huffing and coughing. These techniques usually require the aid of another individual. Several types of airway clearance devices have been developed, which include, but may not be limited to:

• High-frequency chest compression vests – These consist of an air generator and an inflatable vest that covers the chest. Increases in air pulses are delivered to the vest with oscillating airflow patterns, causing external manipulations of the chest. Examples of these devices include, but may not be limited to, AffloVest, InCourage System, Monarch Airway Clearance System, SmartVest Airway Clearance System, SmartVest SQL Airway Clearance System and Vest Airway Clearance System.
• Oscillating positive expiratory pressure (OPEP) devices – These deliver mini bursts of oxygen while also delivering therapeutic aerosols through a nebulizer. The intended purpose of this treatment is that through a combination of bursts of oxygen and medication, it loosens secretions, stimulates cough and increases sputum production. An example of this type of device includes, but may not be limited to, the Impulsator.
• Cough-assist devices with a facemask that covers the nose and mouth, delivering alternating positive and negative pressure allowing air to be pumped into the lungs and then rapidly evacuated. This produces a high expiratory flow rate from the lungs and stimulates a cough and increasing secretion clearance. Examples of these include, but may not be limited to, BiWaze Cough System, CoughAssist and Synclara.
• Mechanical percussors – These electrical devices provide clapping, percussion and/or vibration to the external chest wall and are used in place of manual chest percussion to assist with secretion clearance. Examples of these types of devices include, but may not be limited to, Frequencer and Vibralung.
• Positive expiratory pressure (PEP) devices – These devices increase resistance to expiratory airflow which helps improve secretion clearance by creating pressure in the lungs and preventing airway closure. The individual breathes into the device normally, but breathes out harder against resistance. An example of this device includes, but may not be limited to, Pari Pep S.

Airway Clearance Devices Effective Date: 03/01/2023
Revision Date: 03/01/2023
Review Date: 03/01/2023
Policy Number: HUM-0310-020

TheraPEP is another PEP device; however, this device is available over-the-counter without a prescription.

(Refer to Coverage Limitations section)

Hand-held devices combine PEP with high-frequency air flow oscillations using a stainless-steel ball or a counterweight plug and magnet. These devices utilize deep breathing and forced exhalation to create a vibration of the airway walls which loosen secretions. An example of this type of device includes, but may not be limited to, Flutter.

Acapella and Aerobika are examples of other OPEP devices; however, these devices are available over-the-counter without a prescription.

(Refer to Coverage Limitations section)

The Volara System and BiWaze Clear System combine several noninvasive therapies into one device. These devices purportedly provide oscillation and lung expansion (OLE) therapy using PEP, oscillation and delivery of aerosol medications.19 Volara was voluntarily recalled by the manufacturer on April 26, 2022 due to the risk of respiratory distress in ventilated patients during home use with the US Food & Drug Administration (FDA) categorizing it as a Class I recall.50

Coverage Determination

Humana members may be eligible under the Plan for the following types of airway clearance devices for an individual diagnosed with conditions that cause the lungs to produce excessive amounts of mucous and who have difficulty clearing secretions (e.g., bronchiectasis, CF or neuromuscular diseases with impaired clearance of secretions*):

• Mechanical percussors (E0480)
• PEP devices (E1399)
• OPEP devices (E0484, S8185)
• Mechanical Insufflation-Exsufflation Devices (E0482, A7020)

Humana members may be eligible under the Plan for an MIE device when the following criteria are met:

Airway Clearance Devices Effective Date: 03/01/2023
Revision Date: 03/01/2023
Review Date: 03/01/2023
Policy Number: HUM-0310-020
Page: 4 of 18

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High-Frequency Chest Compression Vests (94669, A7025, A7026, E0483)

Humana members may be eligible under the Plan for an FDA-approved high- frequency chest compression vest when ALL of the following criteria are met:

• Absence of contraindications; AND
• A prescribed order for chest physiotherapy at least twice daily; AND
• Failure, intolerance or contraindication to alternative airway clearance methods**; AND
• Use of the Monarch Airway Clearance System requires the individual to be 15 years of age or older49; AND
• For treatment of the following:

Bronchiectasis confirmed by computed tomography (CT) scan and the following:

• Daily productive cough for at least 6 consecutive months; OR
• Documentation of at least 3 separate exacerbation episodes that required antibiotic therapy within the prior 12 months; OR

CF with the following:

Airway Clearance Devices Effective Date: 03/01/2023
Revision Date: 03/01/2023
Review Date: 03/01/2023
Policy Number: HUM-0310-020
Page: 5 of 18

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• Ability to use vest without assistance (eg, older pediatric individuals and adults) when family members or other resources are unable to deliver prescribed therapy; OR

1. One or more of the following neuromuscular diseases with impaired clearance of secretions*:
   • Acid maltase deficiency; OR
   • Acquired or congenital myopathies affecting respiratory system (eg, centronuclear, mitochondrial or nemaline myositis, polymyositis); OR
   • Anterior horn cell diseases, including ALS; OR
   • Multiple sclerosis; OR
   • Muscular dystrophy; OR
   • Myotonic disorders (eg, channelopathies, myotonia congenita, myotonic muscular dystrophy); OR
   • Paralysis of the diaphragm; OR
   • Post-polio; OR
   • Quadriplegia

**Alternative airway clearance methods include the following:

• Breathing techniques (eg, active cycle of breathing technique [ACBT], assisted inflation maneuvers, autogenic drainage, stacked breaths); OR
• Cough assist (manual assist, quad cough); OR
• Huff coughing; OR
• Hypertonic saline; OR
• Manual or percussor chest physiotherapy; OR
• MIE; OR
• Mucomyst; OR
• PEP/OPEP; OR
• Postural drainage; OR
• Suctioning

Coverage for high-frequency chest compression vests may begin with a 3 month trial of device rental if the above criteria are met. At the end of the 3 month trial period, review of physician documentation regarding compliance with prescribed therapy and stable or improved respiratory status will be required. If it is determined that continued therapy is medically necessary, device rental may be extended until 13 months, at which time it may be purchased. Coverage will extend up to limitations and exclusions found in the member’s individual certificate.

Telecommunication or wireless transmission for high-frequency chest wall compression compliance is considered integral to the prescribed use of the device and not separately reimbursable.

Note: It is the Plan’s option to determine if the durable medical equipment (DME) item shall be rented or purchased. If the cost of renting the item is more than the cost to buy it, only the cost of the purchase is considered to be a covered expense. In either case (rent or purchase), total covered expenses shall not exceed the purchase price. In the event the Plan determines to purchase the DME, any amount paid as rent for such equipment will be credited toward the purchase price.

There is a limit of one approved air pulse generator per member. Additional vests may be covered if original vest no longer fits appropriately due to sizing changes (eg, child has outgrown vest).

Airway Clearance Devices Effective Date: 03/01/2023
Revision Date: 03/01/2023
Review Date: 03/01/2023
Policy Number: HUM-0310-020
Page: 7 of 18

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Coverage Limitations

Humana members may NOT be eligible under the Plan for airway clearance devices for any indications other than those listed above. All other indications are considered not medically necessary as defined in the member’s individual certificate.

Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for high-frequency chest compression vests for any of the following:

CONTRAINDICATIONS

Applicable to high-frequency chest compression vests or manual chest physiotherapy

Absolute Contraindications

• Active hemorrhage with hemodynamic instability; OR
• Head and neck injury until stabilized

This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Relative Contraindications

• Active hemoptysis; OR
• Acute spinal injury; OR
• Bronchopleural fistula; OR
• Bronchospasm; OR
• Burns, open wounds or skin infections of the thorax; OR
• Cardiac pacemaker and/or defibrillator placement within the past 90 days (requires documentation by the physician who performed the procedure that a high-frequency chest compression vest or manual CPT is appropriate); OR
• Chest wall pain; OR
• Coagulopathy; OR
• Confused or anxious individual; OR
• Empyema; OR
• Epidural spinal infusion or spinal anesthesia within the past 90 days (requires documentation by the physician who performed the procedure that a high-frequency chest compression vest or manual CPT is appropriate); OR
• Intracranial pressure (ICP) greater than 20 mm Hg; OR
• Large pleural effusions; OR
• Lung contusion; OR
• Osteomyelitis of the ribs; OR
• Osteoporosis; OR
• Pulmonary edema associated with congestive heart failure; OR
• Pulmonary embolism; OR
• Rib fracture, with or without flail chest; OR
• Skin grafts or flaps on the thorax within the past 90 days (requires documentation by the physician who performed the procedure that a high-frequency chest compression vest or manual CPT is appropriate); OR
• Spinal surgery (eg, laminectomy) within the past 90 days (requires documentation by the physician who performed the procedure that a high-frequency chest compression vest or manual CPT is appropriate); OR
• Subcutaneous emphysema; OR
• Surgical wound or healing tissue on the thorax; OR
• Suspected pulmonary tuberculosis; OR
• Uncontrolled airway at risk for aspiration (eg, tube feeding)

This is considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Duplicate Equipment

Rental or purchase of more than one high-frequency chest compression vest at a time is considered duplicate and may be excluded by certificate. Please consult the member’s individual certificate regarding Plan coverage for duplicate or similar equipment, which includes, but may not be limited to, equipment with the same function for use in another location (eg, school, second residence, travel, work) as it may be excluded by certificate. In the absence of a certificate exclusion, this is considered not medically necessary as defined in the member’s individual certificate.

Humana members may NOT be eligible under the Plan for Acapella, Aerobika (E0484) or TheraPEP (E1399).

Although these devices may be prescribed by a health care practitioner, these devices are also available without a prescription and may be obtained over-the-counter (OTC) and are therefore generally excluded in the certificate. In the absence of a certificate exclusion for OTC items, these devices are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for BiWaze Clear System (E1399), IPV (E0481) or Volara (E1399). These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Note: The criteria for IPV are consistent with the Medicare National Coverage Policy and therefore apply to Medicare members.

Additional information about bronchiectasis, CF and other respiratory diseases may be found from the following websites:

Background

• American College of Chest Physicians
• American Lung Association
• National Heart, Lung and Blood Institute
• National Library of Medicine

Medical Alternatives

Alternatives to airway clearance devices include, but may not be limited to, the following:

• Manual chest physiotherapy
• Prescription drug therapy

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Humana may offer a disease management program for this condition. The member may call the number on his/her identification card to ask about our programs to help manage his/her care.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure. Provider Claims Codes

Airway Clearance Devices Effective Date: 03/01/2023
Revision Date: 03/01/2023
Review Date: 03/01/2023
Policy Number: HUM-0310-020
Page: 11 of 18

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

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CPT® Code(s)

• Mechanical chest wall oscillation to facilitate lung function, per session - 94669

CPT® Category Ill Code(s)

• Description - No code(s) identified

Code(s)

• Interface for cough stimulating device, includes all components, replacement only - A7020
• High frequency chest wall oscillation system vest, replacement for use with patient-owned equipment, each - A7025
• High frequency chest wall oscillation system hose, replacement for use with patient-owned equipment, each - A7026
• Percussor, electric or pneumatic, home model - E0480
• Intrapulmonary percussive ventilation system and related accessories and/or supplies - £0481 (Not Covered)
• Cough stimulating device, alternating positive and negative airway pressure - £0482
• High frequency chest wall oscillation system, includes all accessories and supplies, each - £0483
• Oscillatory positive expiratory pressure device, nonelectric, any type, each - E0484 (Not Covered if used to report any device outlined in Coverage Limitations section)
• Durable medical equipment, miscellaneous - E1399 (Not Covered if used to report any device outlined in Coverage Limitations section)
• Flutter device - $8185 (Not Covered if used to report any device outlined in Coverage Limitations section)

Airway Clearance Devices Effective Date: 03/01/2023
Revision Date: 03/01/2023
Review Date: 03/01/2023
Policy Number: HUM-0310-020
Page: 12 of 18

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

References

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• American Academy of Pediatrics (AAP). Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. https://www.aap.org. Published November 1, 2014. Accessed January 19, 2023.
• American Association for Respiratory Care (AARC). AARC Clinical Practice Guideline (ARCHIVED). Postural drainage therapy. https://www.aarc.org. Published 1991. Accessed January 26, 2023.
• American College of Chest Physicians (ACCP). CHEST Expert Panel Report. Chronic cough due to stable chronic bronchitis. https://www.chestnet.org. Published February 24, 2020. Accessed January 19, 2023.
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• Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Intrapulmonary percussive ventilator (IPV) (240.5). https://www.cms.gov. Published July 14, 1997.

Accessed January 13, 2023.8.Airway Clearance Devices Effective Date: 03/01/2023 Revision Date: 03/01/2023 Review Date: 03/01/2023 Policy Number: HUM-0310-020 Page: 13 of 18

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Postural drainage procedures and pulmonary exercises (240.7). https://www.cms.gov. Published September 1, 1988. Accessed January 13, 2023.9.

10. ClinicalKey. Lindenberger E, Meier D. What special considerations are needed for individuals with amyotrophic lateral sclerosis, multiple sclerosis or Parkinson disease? In: Goldstein N, Morrison R. Evidence-Based Practice in Palliative Medicine. Saunders; 2013:317-329. https://www.clinicalkey.com. Accessed January 17, 2023.11.

12. ClinicalKey. Phan H, Daines C. Cystic fibrosis. In: Kellerman R, Rakel D, Heidelbaugh J et al. Conn’s Current Therapy 2023. Elsevier; 2023:904-908. https://www.clinicalkey.com. Accessed January 27, 2023.13.

14. Cystic Fibrosis Foundation (CFF). Clinical practice guidelines from the Cystic Fibrosis Foundation for preschoolers with cystic fibrosis. https://www.cff.org. Published April 2016. Accessed January 26, 2023.15.

16. ECRI Institute. Hotline Response (ARCHIVED). High-frequency chest compression for airway clearance. https://www.ecri.org. Published April 7, 2004. Updated September 24, 2013. Accessed January 13, 2023.

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.17.

18. ECRI Institute. Product Brief. The Vest airway clearance system (Hill-Rom, Inc.) for clearing lung and airway secretions in hospitalized patients without cystic fibrosis. https://www.ecri.org. Published June 3, 2019. Accessed January 13, 2023.

19. ECRI Institute. Product Brief. Volara system (Hill-Rom, Inc.) for clearing lung and airway secretions in hospitalized patients. https://www.ecri.org. Published April 30, 2020. Accessed January 13, 2023.

20. ECRI Institute. Technology Forecast. Bronchiectasis. https://www.ecri.org. Published September 3, 2008. Updated September 30, 2014. Accessed January 13, 2023.

21. Hayes, Inc. Clinical Research Response (ARCHIVED). Volara (Hillrom) for respiratory therapy. https://evidence.hayesinc.com. Published January 18, 2021. Accessed January 13, 2023.

22. Hayes, Inc. Health Technology Brief (ARCHIVED). CoughAssist mechanical insufflation-exsufflation device (Respironic/Phillips) for respiratory insufficiency. https://evidence.hayesinc.com. Published April 30, 2015. Updated April 4, 2017. Accessed January 13, 2023.

23. Hayes, Inc. Medical Technology Directory (ARCHIVED).

• High frequency chest wall compression for cystic fibrosis. https://evidence.hayesinc.com. Published December 22, 2016. Updated April 26, 2021. Accessed January 13, 2023.24.
• Hayes, Inc. Search & Summary (ARCHIVED). Aerobika oscillating positive expiratory pressure (OPEP) therapy system (Trudell Medical International) for chronic obstructive pulmonary disease. https://evidence.hayesinc.com. Published March 16, 2019. Accessed February 24, 2022.25.
• MCG Health. High frequency chest compression device. 26th edition. https://www.mcg.com. Accessed December 20, 2022.
• Airway Clearance Devices Effective Date: 03/01/2023
  Revision Date: 03/01/2023
  Review Date: 03/01/2023
  Policy Number: HUM-0310-020
  Page: 15 of 18
  Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.26.
• MCG Health. Intrapulmonary percussive ventilation (IPV). 26th edition. https://www.mcg.com. Accessed December 20, 2022.27.
• MCG Health. Mechanical insufflation-exsufflation device. 26th edition. https://www.mcg.com. Accessed December 20, 2022.28.
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• UpToDate, Inc. Atelectasis in children. https://www.uptodate.com. Updated December 2022. Accessed January 13, 2023.30.
• UpToDate, Inc. Bronchiectasis in adults: maintaining lung health. https://www.uptodate.com. Updated December 2022. Accessed January 13, 2023.31.
• UpToDate, Inc. Bronchiectasis in children without cystic fibrosis: management. https://www.uptodate.com. Updated December 2022. Accessed January 18, 2023.32.
• UpToDate, Inc. Bronchiolitis in infants and children: treatment, outcome and prevention. https://www.uptodate.com. Updated December 2022. Accessed January 13, 2023.33.
• UpToDate, Inc. COPD exacerbations: management. https://www.uptodate.com. Updated January 2022. Accessed January 13, 2023.34.
• UpToDate, Inc. Cystic fibrosis: overview of the treatment of lung disease. https://www.uptodate.com. Updated December 2022. Accessed January 13, 2023.35.
• Airway Clearance Devices Effective Date: 03/01/2023
  Revision Date: 03/01/2023
  Review Date: 03/01/2023
  Policy Number: HUM-0310-020
  Page: 16 of 18
  Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.36.
• UpToDate, Inc. Guillain-Barré syndrome in children: treatment and prognosis. https://www.uptodate.com. Updated December 2022. Accessed January 13, 2023.37.
• UpToDate, Inc. Hereditary sensory and autonomic neuropathies. https://www.uptodate.com. Updated December 2022. Accessed January 13, 2023.38.
• UpToDate, Inc. Locked-in syndrome. https://www.uptodate.com. Updated December 2022. Accessed January 13, 2023.39.
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• UpToDate, Inc. Role of mucoactive agents and secretion clearance techniques in COPD. https://www.uptodate.com. Updated December 2022. Accessed January 13, 2023.42.
• UpToDate, Inc. Spinal cord infarction: prognosis and treatment. https://www.uptodate.com. Updated December 2022. Accessed January 13, 2023.43.

Accessed January 13, 2023.44. UpToDate, Inc. Symptom-based management of amyotrophic lateral sclerosis. https://www.uptodate.com. Updated December 2022. Accessed January 13, 2023.

Airway Clearance Devices Effective Date: 03/01/2023
Revision Date: 03/01/2023
Review Date: 03/01/2023
Policy Number: HUM-0310-020
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

45. US Department of Veterans Affairs (VA). VA/DoD Clinical Practice Guideline. The management of chronic obstructive pulmonary disease. https://www.va.gov. Published April 2021. Accessed January 13, 2023.

46. US Food & Drug Administration (FDA). 510(k) summary: BiWaze cough. https://www.fda.gov. Published March 27, 2020. Accessed April 2, 2021.

47. US Food & Drug Administration (FDA). 510(k) summary: Flutter D mucus clearance device. https://www.fda.gov. Published June 5, 1998. Accessed March 3, 2017.

48. US Food & Drug Administration (FDA). 510(k) summary: Maximus system. https://www.fda.gov. Published February 14, 2020. Accessed March 3, 2022.

49. US Food & Drug Administration (FDA). 510(k) summary: Monarch airway clearance system. https://www.fda.gov. Published March 17, 2017. Accessed March 3, 2022.

50. US Food & Drug Administration (FDA). 510(k) summary: Pari PEP S. https://www.fda.gov. Published July 21, 2009. Accessed January 31, 2023.

51. US Food & Drug Administration (FDA). Safety Communication. Baxter Healthcare Corporation recalls Volara System for risk of respiratory distress in ventilated patients during home use. https://www.fda.gov. Published June 23, 2022. Accessed January 27, 2023.

52. US Food & Drug Administration (FDA). Summary of safety and effectiveness data: AffloVest. https://www.fda.gov. Published March 27, 2013. Accessed March 2, 2017.

53. US Food & Drug Administration (FDA). Summary of safety and effectiveness data: Emerson CoughAssist. https://www.fda.gov. Published August 18, 2000. Accessed March 3, 2017.

54. US Food & Drug Administration (FDA). Summary of safety and effectiveness data: Frequencer powered Percussor. https://www.fda.gov. Published March 15, 2007. Accessed March 3, 2017.

Airway Clearance Devices Effective Date: 03/01/2023
Revision Date: 03/01/2023
Review Date: 03/01/2023
Policy Number: HUM-0310-020
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

55. US Food & Drug Administration (FDA). Summary of safety and effectiveness data: InCourage system. https://www.fda.gov. Published May 17, 2005. Accessed March 3, 2017.

56. US Food & Drug Administration (FDA). Summary of safety and effectiveness data: Modified Vest airway clearance system. https://www.fda.gov. Updated February 21, 2003. Accessed March 3, 2015.

57. US Food & Drug Administration (FDA). Summary of safety and effectiveness data: SmartVest airway clearance system. https://www.fda.gov. Published December 1, 2005. Accessed March 3, 2017.

58. US Food & Drug Administration (FDA). Summary of safety and effectiveness data: Vibralung. https://www.fda.gov. Published May 23, 2014. Accessed March 3, 2017.