Humana Commercial Clinical Policy

Humana Noninvasive Home Ventilators Form

Effective Date

09/28/2023

Last Reviewed

NA

Original Document

  Reference



Description

A ventilator is a machine that helps an individual breathe, or takes over the breathing function completely, by forcing air into the lungs at a preset volume and frequency, reproducing the normal breathing pattern as closely as possible. Ventilators may be classified as invasive or noninvasive.

An invasive mechanical ventilator administers the ventilation via a securely intubated airway, either by way of an endotracheal (ET) tube or a tracheostomy tube. Invasive ventilation is generally continuous; interruption could result in a life-threatening situation.

Noninvasive ventilation (NIV) refers to positive airway pressure delivered via a noninvasive interface (nasal and/or oral mask, mouthpiece or nasal prongs) between the individual and the ventilator. NIV may also be referred to as Noninvasive Positive Pressure Ventilation (NPPV). NIV may be used intermittently during the day and/or during sleep, though most frequently they are used at night.

Examples of US Food & Drug Administration (FDA) approved NIV devices include, but may not be limited to:

  • Astral 100
  • Astral 150
  • Breas Vivo (eg, 30 Bi-Level Ventilator, Vivo 45, Vivo 55, Vivo 65 USA)
  • Stellar 150
  • Trilogy 100*
  • Trilogy 200*
  • Trilogy EVO*

The Life2000 (also referred to as ambulatory [wearable] ventilation) is another example of an NIV. It is a modular system with three different configurations: stationary; ambulatory near the main unit using 50 feet of tubing provided; or ambulatory using a one-pound detachable unit that can be worn on the waistband or with a strap for up to 6 hours at a time via the self-contained rechargeable battery. (Refer to Coverage Limitations section)

Another variation of NIV is the Hayek Biphasic Cuirass Ventilation (BCV) system, which uses a lightweight plastic shell that includes a foam seal to form an airtight fit around the individual. The shell is then connected via a hose to the power unit. This type of ventilator works on the theory of negative pressure breathing, which is purported to function in the same manner as the inspiration and expiration cycles of unassisted (normal) breathing. In its inspiratory phase, the negative pressure from the BCV pulls the diaphragm down, helping to draw air into the lungs, and in its expiratory phase uses positive pressure to push the air back out of the lungs. This device also offers high-frequency chest wall oscillation and an assisted cough function, without the need to change the interface or devices. (Refer to Coverage Limitations section)

The VOCSN Unified Respiratory System, a multifunctional respiratory device, has been proposed as an alternative to traditional invasive and noninvasive ventilators. This device combines and delivers up to five different therapies into one machine: ventilator support (invasive or noninvasive), oxygen therapy (concentrator), cough assistance, suctioning and delivery of medications with a nebulizer (delivery of liquid medication via a fine mist).

(Refer to Coverage Limitations section) While these noninvasive ventilators are capable of delivering positive airway pressure, they are more advanced than traditional devices used for the treatment of obstructive sleep apnea (OSA).

(Refer to Coverage Limitations section) The Lung Assist Exsufflation Belt is a device that has been proposed as an alternative to noninvasive home ventilators. It is described as a stand-alone intermittent abdominal daytime pressure ventilation device, which is a wearable, noninvasive belt that works by forcing diaphragmatic exhalation; inhalation occurs passively.

(Refer to Coverage Limitations section) For information regarding invasive mechanical home ventilators or VOCSN as an invasive ventilator, please refer to Durable Medical Equipment (DME) Medical Coverage Policy.

For information regarding devices used for the treatment of sleep apnea and other sleep related breathing disorders (eg, continuous positive airway pressure [CPAP], bilevel positive airway pressure [BiPAP]), please refer to Obstructive Sleep Apnea and Other Sleep Related Breathing Disorders Nonsurgical Treatments Medical Coverage Policy.

The Trilogy 100, Trilogy 200 and Trilogy EVO are currently the subject of an FDA class I safety recall.

Coverage Determination

Humana members may be eligible under the Plan for a noninvasive home ventilator when the following criteria are met:

  • Absence of contraindications; AND
  • Device requested is FDA-approved; AND
  • Chronic obstructive pulmonary disease (COPD) with ALL of the following:
    • Absence of clinical evidence of OSA/central sleep apnea (CSA)** OR a previously negative polysomnogram (sleep study); AND
    • Chronic hypercapnia with PaCO2 greater than or equal to 52 mmHg; OR
  • COPD with OSA when traditional positive airway pressure devices (eg, CPAP, BIPAP) have failed to improve hypercapnia or oxygen saturation level; OR
  • Neuromuscular diseases (eg, amyotrophic lateral sclerosis [ALS], Guillain-Barre syndrome, muscular dystrophy, post-polio syndrome) with respiratory insufficiency, as evidenced by:
    • Arterial oxygen saturation less than or equal to 88% for 5 consecutive minutes during nocturnal oximetry; OR
    • Arterial PaCO2 greater than or equal to 45 mmHg; OR
    • Forced vital capacity (FVC) at less than 50% of predicted; OR
    • Maximum inspiratory pressure (MIP) less than 60 cm H2O; OR
  • Obesity hypoventilation syndrome with ALL of the following:
    • Body mass index (BMI) greater than 30; AND
    • Daytime hypercapnia with PaCO2 greater than or equal to 45 mmHg; AND
    • Polysomnogram (sleep study) has ruled out OSA or CSA; OR
  • Restrictive thoracic cage abnormalities (eg, chest wall deformities, kyphoscoliosis) with the following:
    • Absence of clinical evidence of OSA/CSA** OR a previously negative polysomnogram (sleep study); AND either of the following:
    • Hypercapnia with PaCO2 greater than or equal to 45 mmHg; OR

Noninvasive Home Ventilators Effective Date: 09/28/2023 Revision Date: 09/28/2023 Review Date: 09/28/2023 Policy Number: HUM-0560-009 Page: 4 of 13

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.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Oxygen saturation less than or equal to 88% for 5 consecutive minutes during nocturnal oximetry**Clinical evidence of OSA may include excessive daytime sleepiness (eg, inability to remain fully awake or alert) despite a full night’s sleep, nonrestorative sleep (waking up from sleep without feeling rested), bed partner reports loud snoring, gasping, choking, snorting or interruptions in breathing while sleeping. Clinical evidence of CSA, which is the result of either a neurological injury or disease process that interferes with the transmission of signals to the muscles that control breathing, may include repetitive cessation or decrease in ventilatory effort during sleep and symptoms of disrupted sleep, such as excessive daytime sleepiness, inattention and poor concentration.

Continuation of Coverage

NIV is initially authorized for 90 days rental. Compliance may be verified by a smartcard^. Compliance is defined as usage of at least 4 hours per 24 hour period, 5 days each week over a 30 day period. Verification of compliance may be determined at any time within the first 90 days of therapy in order to make an extended rental decision.^Smartcards are used to view compliance data of an individual on NIV and are an integral component of NIV management and are therefore not separately reimbursable.

Coverage Limitations

Humana members may NOT be eligible under the Plan for noninvasive home ventilators for any indications other than those listed above including, but not limited to:

  • Acute respiratory distress syndrome (ARDS); OR
  • Treatment is solely for OSA; OR
  • Ventilation is required continuously (24 hours/day)

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.
Noninvasive Home Ventilators Effective Date: 09/28/2023
Revision Date: 09/28/2023
Review Date: 09/28/2023
Policy Number: HUM-0560-009
Page: 6 of 13
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.

Humana members may NOT be eligible under the Plan for NIV for any of the following contraindications:

  • Confusion or altered mental status; OR
  • Drowsiness or loss of consciousness; OR
  • Excessive respiratory secretions (mucus production); OR
  • Facial abnormalities/trauma; OR
  • Hemodynamic instability; OR
  • Nausea/vomiting; OR
  • Presence of a tracheostomy; OR
  • Respiratory arrest

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

Duplicate Equipment

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 a multifunction ventilator (E0467) including, but not limited to, the VOCSN (in the noninvasive mode). 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.

Humana members may NOT be eligible under the Plan for any of the following noninvasive ventilators including, but may not be limited to:

  • Ambulatory (wearable) noninvasive ventilator (eg, Life2000 system); OR
  • Biphasic cuirass ventilation (BCV) (eg, Hayek BCV)

Noninvasive Home Ventilators Effective Date: 09/28/2023
Revision Date: 09/28/2023
Review Date: 09/28/2023
Policy Number: HUM-0560-009
Page: 7 of 13

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.

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.

Humana members may NOT be eligible under the Plan for the Lung Assist Exsufflation Belt for any indication. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Additional information about conditions for which NIV may be appropriate may be found from the following websites: Background

  • ALS Association
  • American Lung Association
  • National Library of Medicine

Medical AlternativesAlternatives to noninvasive home ventilators include, but may not be limited to, the following:

  • Invasive (traditional) mechanical ventilator

Alternatives to multifunction ventilators include, but may not be limited to, the following:

  • Cough assist device
  • Invasive (traditional) mechanical ventilator
  • Nebulizer
  • Noninvasive home ventilator
  • Oxygen delivery system (eg, concentrator)
  • Suction machine

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

Noninvasive Home Ventilators Effective Date: 09/28/2023
Revision Date: 09/28/2023
Review Date: 09/28/2023
Policy Number: HUM-0560-009
Page: 8 of 13

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.

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.

Limitations section

K1021 Exsufflation belt, includes all supplies and accessories Not Covered

References

Agency for Healthcare Research and Quality (AHRQ). Technology Assessment. Noninvasive positive pressure ventilation in the home. https://www.ahrq.gov. Published February 4, 2020. Accessed September 7, 2023.

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American Academy of Neurology (AAN). Practice Parameter. The care of the patient with amyotrophic lateral sclerosis: drug, nutritional, and respiratory therapies (an evidence-based review). https://www.aan.com. Published October 13, 2009. Updated January 25, 2023. Accessed September 14, 2023.

American Thoracic Society (ATS). Evaluation and management of obesity hypoventilation syndrome. An official American Thoracic Society clinical practice guideline. https://www.thoracic.org. Published May 2019. Accessed September 13, 2023.

American Thoracic Society (ATS). Long-term noninvasive ventilation in chronic stable hypercapnic chronic obstructive pulmonary disease. An official American Thoracic Society clinical practice guideline. https://www.thoracic.org. Published August 15, 2020. Accessed September 13, 2023.

American Thoracic Society (ATS). Management of COPD exacerbations: a European Respiratory Society/American Thoracic Society guideline. https://www.thoracic.org. Published 2017. Accessed September 13, 2023.

Amin R, Verma R, Bai Y, et al. Incidence and mortality of children receiving home mechanical ventilation. Pediatrics. 2023;151(4). https://publications.aap.org. Published March 10, 2023. Accessed April 3, 2023.

ClinicalKey. Brochard L, Slutsky A. Mechanical Ventilation. In: Goldman L, Cooney K. Goldman-Cecil Medicine. 27th edition. Elsevier; 2024:652-658.e1. https://www.clinicalkey.com. Accessed September 15, 2023.

ECRI Institute. Hotline Response (ARCHIVED). Noninvasive home mechanical ventilation for patients with obesity hypoventilation syndrome. https://www.ecri.org. Published October 20, 2017. Accessed September 6, 2023.

ECRI Institute. Hotline Response (ARCHIVED). Noninvasive positive-pressure ventilation for treating patients with respiratory insufficiency due to amyotrophic lateral sclerosis and other neuromuscular diseases. https://www.ecri.org. Published October 24, 2014. Accessed September 6, 2023.

ECRI Institute. Hotline Response (ARCHIVED). Patient selection criteria for home-noninvasive ventilation for treating chronic obstructive pulmonary disease. https://www.ecri.org. Published October 25, 2018. Accessed September 6, 2023.

Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. https://www.goldcopd.org. Published 2011. Updated 2023. Accessed September 13, 2023.

Hayes, Inc. Clinical Research Response (ARCHIVED). Product Comparison. Noninvasive bilevel ventilators. https://evidence.hayesinc.com. Published December 22, 2016. Accessed October 4, 2019.

Hayes, Inc. Evidence Analysis Research Brief (ARCHIVED). VOCSN multi-function ventilator. https://evidence.hayesinc.com.

Published November 12, 2020. Accessed September 7, 2023.

14. Hayes, Inc. Search & Summary (ARCHIVED). NIOV Noninvasive Open Ventilation System (Breathe Technologies Inc.) for chronic obstructive pulmonary disease. https://evidence.hayesinc.com. Published June 9, 2016. Accessed September 29, 2017.

15. Hayes, Inc. Search & Summary (ARCHIVED). Noninvasive positive pressure ventilation using the Trilogy 100 for intermittent home use in adults with severe chronic obstructive pulmonary disease. https://evidence.hayesinc.com. Published July 7, 2017. Accessed September 11, 2018.

16. MCG Health. Home ventilator (invasive or noninvasive interface). 27th edition. https://www.mcg.com. Accessed August 1, 2023.

17. UpToDate, Inc. COPD exacerbations: management.https://www.uptodate.com. Updated August 2023. Accessed September 7, 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.

18. UpToDate, Inc. Management of refractory chronic obstructive pulmonary disease. https://www.uptodate.com. Updated August 2023. Accessed September 7, 2023.

19. UpToDate, Inc. Mode of mechanical ventilation. https://www.uptodate.com. Updated August 2023. Accessed September 12, 2023.

20. UpToDate, Inc. Nocturnal ventilatory support in COPD. https://www.uptodate.com. Updated August 2023. Accessed September 7, 2023.

21. UpToDate, Inc. Noninvasive positive airway pressure therapy for the obesity hypoventilation syndrome. https://www.uptodate.com. Updated August 2023. Accessed September 7, 2023.

22. UpToDate, Inc. Noninvasive ventilation for acute and impending respiratory failure in children. https://www.uptodate.com. Updated August 2023. Accessed September 7, 2023.

23. UpToDate, Inc. Noninvasive ventilation in adults with acute respiratory failure: benefits and contraindications. https://www.uptodate.com. Updated August 2023. Accessed September 7, 2023.

24. UpToDate, Inc. Noninvasive ventilation in adults with chronic respiratory failure from neuromuscular and chest wall diseases: patient selection and alternative modes of ventilatory support. https://www.uptodate.com. Updated August 2023. Accessed September 7, 2023.

25. UpToDate, Inc. Noninvasive ventilation in adults with chronic respiratory failure from neuromuscular and chest wall diseases: practical aspects of initiation. https://www.uptodate.com. Updated August 2023. Accessed September 7, 2023.

26. UpToDate, Inc. Noninvasive ventilatory support and mechanical insufflation- exsufflation for patients with respiratory muscle dysfunction.

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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. https://www.uptodate.com. Updated August 2023. Accessed September 7, 2023.

27. UpToDate, Inc. Respiratory muscle weakness due to neuromuscular disease: management. https://www.uptodate.com. Updated August 2023. Accessed September 7, 2023.

28. UpToDate, Inc. Symptom-based management of amyotrophic lateral sclerosis. https://www.uptodate.com. Updated August 2023. Accessed September 7, 2023.

29. UpToDate, Inc. Treatment and prognosis of the obesity hypoventilation syndrome. https://www.uptodate.com. Updated August 2023. Accessed September 7, 2023.

30. US Food & Drug Administration (FDA). 510(k) summary: Breas Vivo 50. https://www.fda.gov. Published June 18, 2013. Accessed October 2, 2017.

31.

30. US Food & Drug Administration (FDA). 510(k) summary: Breas Vivo 50. https://www.fda.gov. Published June 18, 2013. Accessed October 2, 2017.

31. US Food & Drug Administration (FDA). 510(k) summary: Breathe Technologies Life2000 Ventilation System. https://www.fda.gov. Published August 11, 2017. Accessed August 31, 2020.

32. US Food & Drug Administration (FDA). 510(k) summary: Trilogy 100 Ventilator. https://www.fda.gov. Published March 13, 2009. Accessed September 29, 2017.

33. US Food & Drug Administration (FDA). 510(k) summary: Trilogy 200 Ventilator. https://www.fda.gov. Published January 29, 2010. Accessed May 1, 2018.

34. US Food & Drug Administration (FDA). 510(k) summary: VOCSN Unified Respiratory System. https://www.fda.gov. Published April 7, 2017. Accessed October 8, 2019.

35. US Food & Drug Administration (FDA). Safety Communication. Update: Certain Philips Respironics ventilators, BiPAP, and CPAP machines recalled due to potential health risks. https://www.fda.gov. Published June 30, 2021. Updated June 2, 2023. Accessed September 12, 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.

36. Wilson M, Dobler C, Morrow A, et al. Association of home noninvasive positive pressure ventilation with clinical outcomes in chronic pulmonary disease. JAMA. 2020;323(5):455-465. https://jamanetwork.com. Accessed October 5, 2020.