Medical Policy
Subject: Intermittent Abdominal Pressure Ventilation Devices
Document #: DME.00046 Publish Date: 07/01/2025
Status: Reviewed Last Review Date: 05/08/2025
Description/Scope

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

Position Statement

Investigational and Not Medically Necessary:

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

Rationale

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.

Background/Overview

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.

Definitions

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.

Coding

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.

HCPCS

 

A4468

Exsufflation belt, includes all supplies and accessories

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

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.
Websites for Additional Information
  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.
Index

PBAir corset
Pneumobelt
Luna belt

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Reviewed

05/08/2024

Medical Policy & Technology Assessment Committee (MPTAC) review. Revised Rationale, Background/Overview, References, and Websites for Additional Information sections.

Reviewed

05/09/2024

MPTAC review. Revised Rationale and References sections.

 

12/28/2023

Updated Coding section with 01/01/2024 HCPCS changes, added A4468 replacing K1021 deleted as of 01/01/2024.

Reviewed

05/11/2023

MPTAC review. Updated References section.

New

05/12/2022

MPTAC review. Initial document development.

 

 


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