Clinical Policy: Home Ventilators

Reference Number: CP.MP.184
Date of Last Revision: 03/25

[Coding Implications](Coding Implications)
[Revision Log](Revision Log)

See Important Reminder at the end of this policy for important regulatory and legal information.

Description

This policy describes medical necessity criteria for noninvasive and invasive home ventilators. Noninvasive ventilation (NIV) describes the administration of positive pressure to the lungs using interfaces such as, but not limited to, nasal masks, orofacial masks, full face masks, mouthpieces, nasal pillows, or helmets.¹,² Invasive ventilatory support describes the administration of positive pressure to the lungs through an invasive interface, such as a tracheostomy tube or endotracheal tube.¹

Note: For criteria applicable to Medicare plans, please see MC.CP.MP.184 Home Ventilators.

Policy/Criteria

I. It is the policy of non-Medicare health plans affiliated with Centene Corporation® that noninvasive home ventilators are medically necessary for the following indications:
A. Initial request for the first three months of noninvasive home ventilator use for restrictive thoracic disorders, all of the following:⁴,⁵,⁹

1. Documentation of a neuromuscular disease (ex. amyotrophic lateral sclerosis) or a severe thoracic cage abnormality (ex. post-thoracoplasty for tuberculosis or severe kyphoscoliosis) and one of the following taken while member/enrollee was stable (not in acute respiratory failure):⁴,⁵,⁹,¹⁰
   a. An arterial blood gas partial pressure of carbon dioxide (PaCO₂) was measured while awake and breathing room air or on prescribed oxygen with a measurement of PaCO₂ ≥ 45 mm Hg;⁴,⁹
   b. Sleep oximetry demonstrates O₂ saturation ≤ 88% for at least five minutes while breathing prescribed O₂;⁴,⁹
   c. If neuromuscular disease is present maximal inspiratory pressure is < 60 cm H₂O, or forced vital capacity is < 50% predicted;⁴,⁹
2. Documentation supports both of the following:
   a. Member/enrollee could not be appropriately treated with a respiratory assist device (RAD); ⁴,⁵,¹⁰
   b. The non-invasive home ventilator will not be used to provide RAD or CPAP therapy (i.e. will be used to provide average volume assured pressure support);⁴,⁵,¹⁰

3. Chronic obstructive pulmonary disease (COPD) does not contribute significantly to the pulmonary limitation;⁴

   C. Initial request for the first three months of noninvasive home ventilator use for obesity hypoventilation syndrome (OHS) (also known as Pickwickian syndrome), all of the following:

4. BMI ≥ 30;¹³,¹⁴
5. An initial arterial blood gas PaCO₂, done while awake and breathing at baseline and the prescribed FIO₂ is ≥ 45 mm Hg;¹³,¹⁴
6. Sleep-disordered hypoventilation has been documented by polysomnography and other conditions are not considered the primary cause of hypoventilation (ex. lung parenchymal or airway disease, chest wall disorder (other than mass loading from obesity), medication use, neurologic disorder, muscle weakness, or a known congenital or idiopathic central alveolar hypoventilation syndrome); ¹³,¹⁴
7. Documentation supports both of the following:
   a. Member/enrollee could not be appropriately treated with a respiratory assist device (RAD); ⁴,⁵,¹⁰
   b. The non-invasive home ventilator will not be used to provide RAD or CPAP therapy (i.e. will be used to provide average volume assured pressure support);⁴,⁵,¹⁰

II. It is the policy of non-Medicare Health Plans affiliated with Centene Corporation that continued use of noninvasive home ventilators after the initial three-month certification period is medically necessary when meeting the following:
A. The device is used for at least an average of four hours per 24-hour period;⁵
B. Documentation supports both of the following:

1. Ongoing benefits from use of the device;⁵,¹⁰
2. The noninvasive home ventilator is not being used provide RAD or CPAP therapy (i.e. will be used to provide average volume assured pressure support);⁴,⁵,¹⁰

III.It is the policy of non-Medicare Health Plans affiliated with Centene Corporation that noninvasive home ventilators for overlap syndromes (presence of more than one condition, such as COPD and sleep apnea) require secondary review by a medical director.⁴,¹⁰

IV.It is the policy of non-Medicare Health Plans affiliated with Centene Corporation that initial and ongoing use of an invasive ventilator is medically necessary for a long-term/chronic condition or disease affecting the ability to effectively maintain an adequate respiratory

status. Examples of conditions may include neuromuscular disease, thoracic restrictive disease, or chronic respiratory failure following COPD.⁵

V. It is the policy of non-Medicare Health Plans affiliated with Centene Corporation that a second or back up noninvasive or invasive ventilator is considered medically necessary for the following indications:
A. A second ventilator to serve a different purpose from the first ventilator, based on medical needs. (e.g., two different types of ventilators are needed for each day, such as, a negative pressure ventilator with chest shell for one indication and a positive pressure ventilator with nasal mask the rest of the day);¹¹
B. A back-up ventilator for one of the following:

1. Member/enrollee is confined to a wheelchair and requires a wheel-chair mounted ventilator during the day and another ventilator of the same type for use while in bed (unable to position the wheelchair-mounted ventilator close enough to the bed for use while sleeping). Without both pieces of equipment, member/enrollee may be prone to medical complications, unable to achieve appropriate medical outcomes, or may not be able to use the equipment effectively;¹¹
2. Residence in remote areas with poor emergency access.

Background

The term respiratory failure refers to the inability to adequately perform the fundamental functions of respiration, delivery of oxygen to the blood stream and removal of carbon dioxide. Respiratory failure has many causes and can be acute or chronic in nature. Typically, respiratory failure initially affects the ability to effectively move oxygen into the body, also known as oxygenation failure, or to eliminate carbon dioxide, also known as ventilatory failure.²,¹⁵

Routine use of noninvasive ventilation has increased over the previous two decades, and as a result, noninvasive ventilation has become an essential tool in the management of acute and chronic respiratory failure in both the home and critical care settings.¹ Noninvasive ventilation offers increased flexibility and has become a valuable treatment option for patients with acidosis in moderate to severe respiratory distress and tachypnea with increased labored breathing due to COPD (chronic obstructive pulmonary disease) exacerbation.¹,¹⁵

Ventilatory support is achieved through a variety of interfaces such as oronasal mask, nasal mask, nasal prongs or full-face mask and by using a variety of ventilatory modes (e.g., volume ventilation, pressure support, cuirass ventilation, bi-level positive airway pressure (BiPAP), proportional-assist ventilation [PAV], continuous positive airway pressure [CPAP]). Oxygen is delivered via tubing through a positive pressure ventilator circuit and should be heated and humidified to improve tolerance and prevent mucosal dryness, a common side effect of prolonged noninvasive ventilation. The primary goals of home noninvasive ventilation are reduction of symptoms, improvement of quality of life, reduced readmission risk and reduction of mortality.¹,²,³

Invasive mechanical ventilation is primarily used to facilitate the exchange of oxygen and carbon dioxide, fully or partially, in patients with respiratory failure who no longer have the capacity to breathe spontaneously or whose ventilatory needs exceed their own ability to do so adequately. It

is beneficial for protecting the airway of patients with a decreased level of consciousness, upper gastrointestinal hemorrhage, emesis, or other conditions with an increased risk of aspiration in whom noninvasive ventilation is contraindicated.¹⁶,¹⁷

Coding Implications

This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2024, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.

2. Hyzy RC, McSparron JI. Noninvasive ventilation in adults with acute respiratory failure: Practical aspects of initiation. UpToDate. www.uptodate.com. Updated October 17 2024. Accessed February 19, 2025.
3. Heulitt, Mark J. MD, FCCM; Ranallo, Courtney MD. Breathing in america: Disease, progress, and hope. Pediatric/Critical Care Medicine 12(3):p e159, May 2011. doi: 10.1097/PCC.0b013e3182137d7c
4. Local Coverage Determination: Respiratory Assist Devices (L33800). Centers for Medicare and Medicaid Services Web site. https://www.cms.gov/medicare-coverage-database/ICD-10-CM-CPT-Procedure-and-Service-Codes.html?bc=AAAAQgAAAAAA%3d%3d&. Published October 1, 2015 (revised January 1, 2024). Accessed February 19, 2025.
5. National Coverage Determinations Manual (Internet-Only Manual, Publ. 100-03, Chapter 1, Part 4, Section 280.1). Centers for Medicare and Medicaid Services Web site.
   https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/ncd103c1_part4.pdf. Published October 1, 2003. (revised May 16, 2023). Accessed February19, 2025.
6. Simonds AK. Home Mechanical Ventilation: An Overview. Ann Am Thorac Soc. 2016;13(11):2035 to 2044. doi:10.1513/AnnalsATS.201606-454FR
7. Gay PC. Nocturnal ventilator support in COPD. UpToDate. www.uptodate.com. Updated February 5, 2025. Accessed February 19, 2025.
8. Hyzy RC, McSparron JI. Noninvasive ventilation in adults with acute respiratory failure: Benefits and contraindications. UpToDate. www.uptodate.com. Updated October 9, 2024. Accessed February 19, 2025.
9. Wilson M, Wang Z, Dobler CC, et al. Noninvasive Positive Pressure Ventilation in the Home (with addendum). Rockville (MD): Agency for Healthcare Research and Quality (US); April 2, 2020.
10. Sleep Management, LLC: Audit of Claims for Monthly Rental of Noninvasive Home Ventilators. Department of Health and Human Services. Office of Inspector General. https://oig.hhs.gov/oas/reports/region4/41804066.pdf. Published May 2021. Accessed February 19, 2025.
11. Correct Coding and Coverage of Ventilators – Revised. Joint DME MAC Publication. Published May 9, 2024. Accessed February 19, 2025.
    https://www.cgsmicare.com/jb/pubs/news/2024/05/scope155502a.html
12. Martin TJ. Noninvasive positive airway pressure therapy for the obesity hypoventilation syndrome. UpToDate. www.uptodate.com. Updated March 4, 2024. Accessed February 19, 2025.
13. Piper A, Yee B. Clinical manifestations and diagnosis of obesity hypoventilation syndrome. UpToDate. www.uptodate.com. Published July 11, 2024. Accessed February 19, 2025.
14. Mokhlesi B, Masa JF, Brozek JL, et al. Evaluation and Management of Obesity Hypoventilation Syndrome. An Official American Thoracic Society Clinical Practice Guideline [published correction appears in Am J Respir Crit Care Med. 2019 Nov

15:200(10):1326. doi: 10.1164/rccm.v200erratum7.]. Am J Respir Crit Care Med. 2019;200(3):e6-e24. doi: 10.1164/rccm.201905-1071ST

15. Feller-Kopman DJ, Schwartzstein RM. The evaluation, diagnosis, and treatment of the adult patient with acute hypercapnic respiratory failure. UpToDate. www.uptodate.com. Updated April 1, 2024. Accessed February 19, 2025.
16. Harmon EM. Acute respiratory distress syndrome (ARDS) treatment & management. Medscape. https://emedicine.medscape.com/article/165139-treatment#d9. Updated December 20, 2024. Accessed February 19, 2025.
17. Hyzy RC, McSparron JI. Overview of initiating invasive mechanical ventilation in adults in the intensive care unit. UpToDate. www.uptodate.com. Updated December 20, 2024. Accessed February 19, 2025.
18. Nagler JN. Noninvasive ventilation for acute and impending respiratory failure in children. UpToDate. www.uptodate.com. Updated November 7, 2024. Accessed February 19, 2025.
19. Hill NS, Kramer NR. Noninvasive ventilation in adults with chronic respiratory failure from neuromuscular and chest wall diseases: practical aspects of initiation. UpToDate. www.uptodate.com. Updated April 1, 2024. Accessed February 19, 2025.
20. Bach JR. Noninvasive ventilatory support and mechanical insufflation-exsufflation for patients with respiratory muscle dysfunction. UpToDate. www.uptodate.com. Updated February 52, 2025. Accessed February 19, 2025.
21. Hill NS, Kramer NR. Noninvasive ventilation in adults with chronic respiratory failure from neuromuscular and chest wall diseases: patient selection and alternative modes of ventilatory support. UpToDate. www.uptodate.com. Updated November 13, 2024. Accessed February 19, 2025.

Important Reminder

This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.

The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures.

This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time.

This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members/enrollees. This clinical policy is not intended to recommend treatment for members/enrollees. Members/enrollees should consult with their treating physician in connection with diagnosis and treatment decisions.

Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan.

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members/enrollees and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members/enrollees and their representatives agree to be bound by such terms and conditions by providing services to members/enrollees and/or submitting claims for payment for such services.

Note: For Medicaid members/enrollees, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy.

Note: For Medicare members/enrollees, to ensure consistency with the Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs, LCDs, and Medicare Coverage Articles should be reviewed prior to applying the criteria set forth in this clinical policy. Refer to the CMS website at http://www.cms.gov for additional information.

©2019 Centene Corporation. All rights reserved. All materials are exclusively owned by Centene Corporation and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Centene Corporation. You may not alter or remove any trademark, copyright or other notice contained herein. Centene® and Centene Corporation® are registered trademarks exclusively owned by Centene Corporation.

Page 8 of 8