Medical Policy

This document addresses the use of intermittent abdominal pressure ventilation devices.

For a high-level overview of this document, please see “Summary for Members and Families” below.

Investigational and Not Medically Necessary:

Intermittent abdominal pressure ventilation devices are considered investigational and not medically necessary for all indications.

Medical policies are based on medical evidence. This document describes clinical studies and expert recommendations and explains whether certain medical services are appropriate. The following summary does not replace information in the Position Statement section, and may not contain all of the information that is relevant. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information about Intermittent Abdominal Pressure Ventilation (IAPV)
Intermittent abdominal pressure ventilation is a type of breathing support that uses a wearable device to help people with serious muscle or nerve diseases breathe more easily. The device is worn like a belt and uses gentle air pressure to push on the belly, which helps move air into and out of the body. It may be used by people who can't tolerate masks or other common ventilators. IAPV is intended to support breathing during the daytime when the person is sitting upright. It is not used while lying down or at night.

What the Studies Show
Some small studies suggest that IAPV may improve breathing in people with conditions like muscular dystrophy or amyotrophic lateral sclerosis. These studies report that it may increase the amount of air breathed in and out. However, most of these studies are very small, with only a few participants. These studies do not compare IAPV to more common types of breathing support in a rigorous way. There is also little evidence on how well IAPV works over time or how it compares to standard devices in terms of improving health or quality of life.

Some studies note that IAPV becomes less effective over time and may lead to complications, such as pressure sores. A group of experts suggested that IAPV might be an option for some people who cannot tolerate traditional devices, but even those experts noted the lack of strong scientific data. Additionally, there are some people for whom this device may not be appropriate, including those who are unable to sit up, have certain digestive problems, or are extremely underweight or overweight.

Is this Clinically Appropriate?
Intermittent abdominal pressure ventilation is not clinically appropriate because it has not been proven to improve health. The available studies are too limited, small, and varied to show that IAPV is better or as effective as other breathing support methods. Most studies involve a small number of people and do not include long-term follow-up or comparisons to standard treatments. In addition, people with certain health conditions or body types may not be good candidates for this treatment, and complications like skin sores can occur.

(Return to Description/Scope)

Independent breathing may not be possible for those with severe thoracic restriction or paralysis. These individuals may require assisted breathing via external ventilators. Intermittent abdominal pressure ventilation (IAPV) uses abdominal compression to produce positive pressure ventilation. These “abdominal respirators” move the abdominal contents to increase the movement of the thoracic diaphragm during breathing.

A 1991 study by Bach and colleagues reported on 54 individuals who used the IAPV for long-term ventilatory support. Diagnoses included polio, spinal cord injury, myopathy, Duchenne muscular dystrophy, and other motor neuron diseases. None of the participants had tracheostomies. There were 48 participants who used the IAPV for daytime support for a mean of 12.9 ± 11.5 years. One participant used IAPV for nocturnal ventilatory support for 6 months but switched to nocturnal nasal intermittent positive pressure ventilation (IPPV) in order to be able to lie supine. The other 5 participants used IAPV for ventilatory support 24 hours a day for a mean of 13.4 ± 11.2 years. There were 11 participants who died while using IAPV after a mean of 9.3 ± 4.4 years of use. Causes of death were lung cancer, myocardial infarction, sepsis from decubitus, motor vehicle accident, drug abuse, pneumonia, seizures, inadequate nocturnal ventilatory support while using a rocking bed, and two causes unknown. Of the 5 participants using the IAPV for 24 hours, 2 developed sacral decubiti with 1 death. After 12.3 ± 9.5 years, IAPV became ineffective for 12 participants, and they switched to daytime mouth IPPV.

A 2021 study by Fiorentino and colleagues reported on 8 individuals with neuromuscular diseases who used IAPV. Diagnoses included congenital myopathy (n=1), Duchenne muscular dystrophy (n=3), and amyotrophic lateral sclerosis (n=4). Participants had previously rejected or had poor compliance with noninvasive mechanical ventilation due to claustrophobia or poor tolerance of the mask. All participants had a baseline functional respiratory assessment performed during spontaneous breathing and while using the IAPV. Baseline mean spontaneous tidal volume was 316.375 ± 146.80 mL which increased to 678 ± 334mL using the IAPV. Baseline peak expiratory flow was 29.5 ± 10.9 mL with an average of 54 ± 18.04 mL during IAPV. With 3 years of follow-up, all participants continued to use IAPV with 3 participants relying on IAPV as their sole method of respiratory support 24 hours/day. After 2 years, IAPV became ineffective as the sole means of ventilatory support and 2 participants switched to daytime IAPV and nocturnal positive pressure ventilation with nasal mask.

A 2022 narrative review by Pierucci and colleagues reported on 10 studies in which IAPV was used for ventilatory support. Many of the studies were clinical series for which statistical analyses were not possible due to limited and heterogenous data. Most of the studies were published prior to 2017 as this technology has been used less frequently over the years due to the increasing use of tracheotomies. The authors propose that IAPV is becoming more prevalent with a paradigm shift back to non-invasive ventilatory (NIV) management and improvements in the portability and convenience NIV devices. The authors concluded “The paucity of long-term follow-up studies underlines the need for more clinical studies on larger patient populations with longer observation times.”

A retrospective pilot study by Volpi and colleagues in 2023 reported the practicability and efficacy of IAPV for those with neuromuscular diseases. With a sample size of 28 persons, the study’s inclusion criteria required at least one of the following: a diagnosis of neuromuscular disease, an ongoing non-invasive interface intolerance, or clinical stability, age ≥18 years, and having been on non-invasive ventilator support >16 h/day for at least one year. Primary outcomes included the change in respiratory parameters (defined as an improvement in hypoxemia of at least 5mmHg and the normalization of hypercapnia) during use of IAPV. Neuromuscular diagnoses included amyotrophic lateral sclerosis (n=19), Duchenne muscular dystrophy (n=5), Pompe disease (n=2), limb girdle muscular dystrophy (n=1) and mitochondrial myopathy (n=1). Data were collected at baseline, after two hours of ventilation, at three months, and at six months. Baseline blood gas results were as follows: pH 7.41, PaCO₂ (partial pressure of carbon dioxide) 50.1, PaO₂ (partial pressure of oxygen) 62.6, HCO₃ (bicarbonate) 32.3. The six-month blood gas results are as follows: pH 7.40, PaCO₂ 42.85, PaO₂ 72.32, HCO₃ 28.53. One limitation was this study’s lack of a randomized comparison to non-invasive ventilator support. The authors conclude “Further research in this emerging field is strongly warranted to further improve the quality of life and breathing of neuromuscular patients.”

Annunziata (2023) conducted a 3-step modified Dephi process to establish consensus among physicians regarding the use of IAPV in the treatment of individuals with neuromuscular diseases. Fourteen physicians participated and considered five topics: indications for IAPV, parameter settings for IAPV, potential limitations, contraindications and complications for IAPV, monitoring during IAPV, and long-term follow-up. Initially, a systematic review of existing research was done, and then recommendations were shared for voting by the doctors. The physician participants agreed IAPV may be indicated for those with neuromuscular conditions, those with kyphoscoliosis after spinal correction surgery, spinal cord injury, and those who require many hours of ventilation during the day or who have intolerance to interfaces for negative pressure ventilation. The physician participants agreed an IAPV machine setup should be personalized to everyone’s needs and preferences. In terms of potential limitations, contraindications and complications, the physician participants agreed the IAPV should be used on an empty stomach to avoid vomiting or regurgitation. Participants should be able to maintain a sitting position. It should not be used at night and a potential contraindication is a severe hiatal hernia with the presence of regurgitation during meals. Arterial blood gas (ABGs) should be evaluated yearly, peripheral oxygen saturation (SpO2) and transcutaneous/exhaled CO2 monitoring should be done to assess hypoventilation and peak cough flow should be measured to evaluate cough efficacy. In terms of long-term follow-up, IAPV may become ineffective over time due to progressive deterioration of respiratory function, hypercapnia, weight loss or complications such as decubitus ulcer or intolerance. Physical exam and evaluation of respiratory function should be completed every 6 months. Although the panel reached a consensus, the findings are mainly based on observation and case studies, not rigorous trials or established guidelines.

Many of the current peer-reviewed publications regarding IAPV are uncontrolled case series studies with limited utility in understanding the appropriate use for such devices (Bach, 2019; Banfi, 2019; Pierucci, 2021; Puricelli, 2021). Additionally, there are body habitus issues which could be considered contraindications to IAPV which have not been fully evaluated in clinical studies, including severe scoliosis, obesity or extremely lean individuals and inability to maintain a sitting position. As noted above, the efficacy of IAPV can decline over time. However, the current evidence has not investigated this issue adequately. The current guidance for advocates of IAPV is for regular follow-up to assess for efficacy and the development of complications.

Currently available published evidence does not permit reasonable conclusions concerning the effect of IAPV on health outcomes in relation to the effects of more standard assisted-breathing techniques.

IAPV is a system of noninvasive respiratory care. Individuals wear a corset- or belt-type device placed on the body at the level of the thoracic diaphragm. Inside the corset is an inflatable sac or bladder which, when connected to a portable positive pressure ventilator, inflates the sac. This inflation compresses the abdomen which elevates the diaphragm causing forced exhalation. When the sac deflates, the diaphragm returns to the normal resting position and causes passive inhalation of air into the lungs. IAPV may make speaking or eating more convenient since there is no nasal or face mask involved. It has been proposed as an alternative to noninvasive mechanical ventilation particularly during the day when a person is in an upright position.

Ventilator: A mechanical device capable of providing pressurized air with or without supplemental oxygen and two or more of the following features: pressure support, rate support, volume support or various combinations of pressure, rate, and volume support.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the following procedure code, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Annunziata A, Pierucci P, Banfi P, et al. Intermittent abdominal pressure ventilation management in neuromuscular diseases: a Delphi panel consensus. Expert Rev Respir Med. 2023; 17(6):517-525.
2. Bach JR, Alba AS. Intermittent abdominal pressure ventilator in a regimen of noninvasive ventilatory support. Chest. 1991; 99(3):630-636.
3. Bach JR, Radbourne M, Potpally N, Chiou M. A mechanical intermittent abdominal pressure ventilator. Am J Phys Med Rehabil. 2019; 98(12):e144-e146.
4. Banfi P, Volpato E, Bach JR. Efficacy of new intermittent abdominal pressure ventilator for post-ischemic cervical myelopathy ventilatory insufficiency. Multidiscip Respir Med. 2019; 14:4.
5. Fiorentino G, Annunziata A, Coppola A, et al. Intermittent Abdominal pressure ventilation: an alternative for respiratory support. Can Respir J. 2021; 2021:5554765.
6. Pierucci P, Bach JR, Di Leece V, et al. Daytime non-invasive ventilatory support via intermittent abdominal pressure for a patient with Pompe disease. Pulmonology. 2021; 27(2):182-184.
7. Pierucci P, Di Lecce V, Carpagnano E, et al. The intermittent abdominal pressure ventilator as an alternative modality of noninvasive ventilatory support: a narrative review. Am J Phys Med Rehabil. 2022; 101(2):179-183.
8. Puricelli C, Volpato E, Sciurello S, et al. Intermittent abdominal pressure ventilation: feasibility and efficacy in neuromuscular disease. A case report. Monaldi Arch Chest Dis. 2021; 91(4).
9. Volpi V, Volpato E, Compalati E, et al. Is intermittent abdominal pressure ventilation still relevant? A multicenter retrospective pilot study. J Clin Med. 2023; 12(7):2453.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Thoracic Society, ATS Consensus Statement, Respiratory Care of the Patient with Duchenne Muscular Dystrophy, 2004. Available at: https://www.atsjournals.org/doi/epdf/10.1164/rccm.200307-885ST?role=tab. Accessed on March 18, 2025.

1. International Ventilator Users Network. Home Mechanical Ventilation: The Basics. 2024. Available at: https://www.ventnews.org/m-hmv-the-basics. Accessed on March 18, 2025.

PBAir^™ corset
Pneumobelt
Luna belt

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