| Coverage Policy Manual | |
| Policy #: | 2022005 |
| Category: | DME |
| Initiated: | February 2022 |
| Last Review: | April 2024 |
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| Non-Invasive Positive Airway Pressure for Chronic Obstructive Pulmonary Disease | |
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| Description: |
THIS POLICY ADDRESSES DEVICES USED IN THE TREATMENT OF SEVERE COPD.
PLEASE SEE POLICY #1997195 FOR DETAILS REGARDING TREATMENT OF SLEEP APNEA AND OTHER PULMONARY DISEASES.
Respiratory failure is characterized by low arterial blood oxygen (hypoxemia, PaO2) and/or high arterial carbon dioxide (hypercapnia, PaCO2 greater than 45 mmHg). Chronic respiratory insufficiency or failure can occur with chronic obstructive pulmonary disease (COPD) and may result in poor quality of life, sleepiness, hospital admission, intubation, and death. Non-invasive positive airway pressure ventilation (NPPV) including continuous positive airway pressure (CPAP), bilevel positive airway pressure (BPAP) and home mechanical ventilators (HMV) that are pressure, rate, and volume targeted are proposed for the treatment of COPD.
Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) is a common condition, affecting more than 5% of the population, and is associated with high morbidity and mortality. COPD is the fourth leading cause of death in the United States. It is a clinical syndrome with multiple etiologies that is characterized by chronic respiratory symptoms, structural pulmonary abnormalities, and/or lung function impairment. Chronic obstructive pulmonary disease is most frequently associated with cigarette smoking or other air pollutants, and a majority of patients with COPD in the United States have a history of cigarette smoking. Chronic obstructive pulmonary disease is progressive, with expiratory airflow limitation, air trapping/hyperinflation, and destruction of alveoli (emphysema). The Global Initiative for Chronic Obstructive Lung Disease (GOLD) defines COPD as "a heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction" (GOLD, 2023; Macrea, 2020).
Respiratory failure in patients with COPD is characterized by the inability to sustain normal gas exchange, leading to low arterial blood oxygen (hypoxemia, PaO2) and/or high arterial carbon dioxide (hypercapnia, PaCO2). Hypercapnia develops in about one-third of patients with COPD and is associated with poor quality of life, sleepiness, frequent hospital admissions due to exacerbations, and an increase in mortality compared to patients with COPD who are normocapnic. The hypercapnia is due in large part to poor lung biomechanics including low inspiratory muscle reserve, high CO2 production, and a reduced ventilatory capability (Mathews, 2020). The imbalance between the respiratory load and respiratory capability may in turn affect the ventilatory control center in the brain stem. Physiological changes in responsiveness to hypoxemia and hypercapnia during sleep can be particularly pronounced in patients with COPD, with overnight increases in PaCO2 affecting daytime PaCO2, possibly through bicarbonate retention or changes in cerebrospinal fluid (Orr, 2020). Patients with COPD may also have comorbid obstructive sleep apnea and/or obesity hypoventilation syndrome due to decreased ventilatory motor output and upper airway muscle activity during sleep.
Thoracic Restrictive Disorders Due to Neuromuscular Disease
Thoracic restrictive disorders result from a variety of underlying diseases all characterized by restrictive patterns on pulmonary function testing (Martinez-Pitre, 2022). Neuromuscular disorders such as muscular dystrophy, amyotrophic lateral sclerosis (ALS), polio, and phrenic neuropathies can result in weakness of the respiratory muscles affecting inspiration and expiration, ultimately resulting in hypoventilation. Impaired cough and swallowing associated with neuromuscular disease increases the risk of respiratory complications in these patients (Carmona, 2023). Nocturnal hypoventilation due to muscular atonia during sleep leads to nocturnal hypercapnia. Frequent nocturnal episodes can result in renal compensation and ultimately result in daytime hypercapnia. Non-invasive positive airway pressure ventilation (NPPV) is often necessary for patients with thoracic restrictive disorders due to neuromuscular disease.
Hypoventilation Syndromes
Hypoventilation syndromes are nonspecific disorders characterized by hypercapnia (PaCO2 greater than 45 mm Hg) that is not otherwise categorized (Gay, 2021). Obesity hypoventilation syndrome (OHS), central respiratory depression due to substance or medication use, and decompensated hypercapnic respiratory failure that is not COPD are all included in this category. In patients with OHS, weight loss is useful in normalizing PaCO2; however, NPPV should be initiated early while weight loss is attempted (McConville, 2022).
Treatment With Non-invasive Positive Airway Pressure
A major goal of management of patients with COPD is to reduce hospitalizations and mortality. Long-term oxygen therapy is recommended for patients with poor clinical status and noninvasive positive airway pressure ventilation (NPPV) devices for patients with severe chronic hypercapnia and a history of hospitalization for acute respiratory failure. Noninvasive positive airway pressure ventilation devices include nocturnal continuous positive airway pressure (CPAP) for individuals with hypercapnia due to obstructive sleep apnea or hypoventilation and bilevel positive airway pressure (BPAP) devices or non-invasive home mechanical ventilators that are pressure, rate, and volume targeted. The objective of this evidence review is to describe which features of NPPV are required to improve the net health outcome in patients with COPD.
Benefits of nocturnal NPPV persist into the daytime with improved breathing patterns (lower frequencies and larger tidal volumes) and improved gas exchange. Explanations for the improvement in daytime respiration with nocturnal NPPV include increased respiratory drive, improved diaphragm function by unloading the respiratory muscles during sleep, increased CO2 sensitivity, and reduction in air trapping and hyperinflation. It is not known which factors (e.g., muscle unloading, gas exchange normalization, decrease in hyperinflation) underlie the benefits of NPPV on health outcomes. It is also unclear if the reduction in PaCO2 has an effect on health outcomes or if it is only a marker of effective ventilation (Orr, 2020).
Respiratory Assist Devices
The Centers for Medicare and Medicaid Services (CMS) defines respiratory assist devices (RADs) as bilevel devices with or without back-up respiratory rate capability. While CPAP devices provide continuous air at a pressure that prevents the collapse of the airway during inspiration, BPAP devices work by increasing pressure during inspiration and lowering it during expiration (pressure cycled). In some devices a backup respiratory rate is triggered when the patient's nocturnal respiratory rate decreases below a set threshold. The backup rate is typically set 2 breaths below the patient's spontaneous respiratory rate during wakefulness.
Home Mechanical Ventilators
In some patients, nocturnal respiratory assist devices are insufficient to address the respiratory failure. Non-invasive home mechanical ventilators (HMV) are proposed for the treatment of chronic respiratory failure that is refractory to a respiratory assist device. Mechanical ventilators are devices that deliver more controlled breathing with bilevel ventilation at a higher pressure. The ventilators may also have additional features compared to BPAP machines such as alarms and battery backup power. Home mechanical ventilators can be used for patients with tracheostomy in the home but may also be used with a non-invasive interface such as a mask or mouthpiece in patients who do not depend on 24 hour ventilation for survival. Current technology has decreased the size of home ventilators to around 10 pounds. In addition, some models may be wireless with battery backup, allowing greater mobility during the day.
Titration
Early studies with low intensity NPPV did not demonstrate health benefits in patients with hypercapnia. More recent studies have reinforced the importance of high-intensity NPPV (> 18 cm H2O) that is titrated to decrease hypercapnia. A high respiratory backup rate that is increased to the level of spontaneous breathing has also been shown to be important to achieve positive health outcomes. Manually set, laboratory or hospital titration of NPPV with pressure control and backup rate have been recommended for stable hypercapnic COPD (Wiles, 2020). The goal of titration of inspiratory positive airway pressure is to achieve normocapnia, a reduction in transcutaneous CO2, or maximum tolerable inspiratory pressure. A fast rise in inspiratory pressure (rise time) allows enough time for expiration within the normal rate of breathing. In patients with air trapping and hyperinflation, use of positive end-expiratory pressure can also be beneficial.
A suggested protocol for in-laboratory titration of NPPV in patients with COPD in the U.S. is described by Orr et al (Orr, 2020). Titration of NPPV is usually performed in a monitored environment after the patient has stabilized, as studies have not found an improvement in health outcomes when NPPV is started soon after an acute exacerbation. Polysomnography or respiratory monitoring may be used during titration to evaluate the presence of obstructive sleep apnea or hypoventilation. The inspiratory pressure is typically started at 6 to 8 cm H2O of pressure support above the expiratory pressure and titrated to reduce hypercapnia. A Bilevel-ST (with backup rate) or a VAPS (volume assured) may be used if a Bilevel-S (without backup rate) fails to adequately reduce hypercapnia. Although titration in European studies has been performed with a hospital stay, this is not feasible in the U.S., and titration might be performed over several weeks in the patient's home by an external durable medical equipment (DME) provider.
Pulmonary Rehabilitation
Pulmonary rehabilitation is a personalized intervention that includes physical activity (e.g., activities of daily living, endurance exercises and muscle strengthening), health education, and psychological support. It may be performed in the hospital, outpatient clinic, or home, and has been shown to reduce mortality, exacerbation rate, intensive care admissions, and emergency department visits. Pulmonary rehabilitation is common in Europe but is less frequently provided in the U.S.
Regulatory Status
Numerous CPAP and BPAP devices are available in the U.S. Examples of HMV devices that have both invasive and non-invasive interfaces and are available in the U.S. are described below:
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Policy/ Coverage: |
Effective October 2023
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Nocturnal bilevel positive airway pressure with backup rate meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for individuals with COPD and chronic respiratory failure who meet either of the following:
Non-invasive home mechanical ventilation meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for individuals with COPD who meet the following criteria:
Individuals with COPD who are started on bilevel positive airway pressure at discharge from hospitalization may continue for up to 3 months to provide time to stabilize and complete reevaluation.
Bilevel positive airway pressure meets member benefit certificate primary coverage criteria of effectiveness in improving health outcomes for individuals with thoracic restrictive disorders due to neuromuscular disease who meet any of the following:
Non-invasive home mechanical ventilation meets member benefit certificate primary coverage criteria of effectiveness in improving health outcomes for individuals with thoracic restrictive disorders due to neuromuscular disease who meet the following:
Bilevel positive airway pressure meets member benefit certificate primary coverage criteria of effectiveness in improving health outcomes for individuals with hypoventilation syndromes who meet the following criteria:
Non-invasive home mechanical ventilation meets member benefit certificate primary coverage criteria of effectiveness in improving health outcomes for individuals with hypoventilation syndromes who meet the following:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Nocturnal bilevel positive airway pressure with backup rate for patients with COPD and chronic respiratory failure not meeting the criteria listed above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, nocturnal bilevel positive airway pressure with backup rate for patients with COPD and chronic respiratory failure not meeting the criteria listed above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Non-invasive home mechanical ventilation for patients with COPD not meeting the criteria listed above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, non-invasive home mechanical ventilation for patients with COPD not meeting the criteria listed above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Bilevel positive airway pressure for individuals with thoracic restrictive disorders due to neuromuscular disease not meeting the criteria listed above or for any other indication does not meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, bilevel positive airway pressure for individuals with thoracic restrictive disorders due to neuromuscular disease not meeting the criteria listed above or for any other indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Non-invasive home mechanical ventilation for individuals with thoracic restrictive disorders due to neuromuscular disease not meeting the criteria listed above or for any other indication does not meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, non-invasive home mechanical ventilation for individuals with thoracic restrictive disorders due to neuromuscular disease not meeting the criteria listed above or for any other indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Bilevel positive airway pressure for individuals with hypoventilation syndromes not meeting the criteria listed above or for any other indication does not meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, bilevel positive airway pressure for individuals with hypoventilation syndromes not meeting the criteria listed above or for any other indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Non-invasive home mechanical ventilation for individuals with hypoventilation syndromes not meeting the criteria listed above or for any other indication does not meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, non-invasive home mechanical ventilation for individuals with hypoventilation syndromes not meeting the criteria listed above or for any other indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective May 15, 2022 through September 2023
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Nocturnal bilevel positive airway pressure with backup rate meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for patients with COPD and chronic respiratory failure who meet either of the following:
Non-invasive home mechanical ventilation meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for patients with COPD who meet the following criteria:
Individuals with COPD who are started on bilevel positive airway pressure at discharge from hospitalization may continue for up to 3 months to provide time to stabilize and complete reevaluation.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Nocturnal bilevel positive airway pressure with backup rate for patients with COPD and chronic respiratory failure not meeting the criteria listed above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, nocturnal bilevel positive airway pressure with backup rate for patients with COPD and chronic respiratory failure not meeting the criteria listed above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Non-invasive home mechanical ventilation for patients with COPD not meeting the criteria listed above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, non-invasive home mechanical ventilation for patients with COPD not meeting the criteria listed above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
This evidence review was created in December 2021 with a search of the PubMed database. The most recent literature update was performed through November 9, 2021.
Continuous Positive Airway Pressure
A 2021 evidence review by the American Thoracic Society found several studies suggesting that identification and treatment with CPAP in patients with overlap syndrome improves outcomes (Macrea, 2020). However, no trials were identified that compared an OSA screening strategy with no screening strategy in patients with stable hypercapnic COPD or with use of CPAP in patients already on other modes of positive airway pressure (PAP).
Marin et al evaluated outcomes of patients who have both COPD and OSA from a prospective database of patients referred to a university sleep clinic (Marin, 2010). The authors analyzed 3 groups of patients; those with overlap syndrome who were started on CPAP (n=228), those with overlap syndrome not treated with CPAP (n=213), and patients with COPD who did not have OSA (n=210). Patients were seen at least once a year or until death, and the primary outcome was time to death from any cause. The secondary outcome was the time to first severe COPD exacerbation requiring hospitalization. There were 589 patients with overlap syndrome and 210 with COPD and simple snoring. Positive pressure was recommended for 468 patients, another 121 patients did not qualify for CPAP and were given other options for treatment.
Of the 468 patients with overlap syndrome who received a recommendation for PAP, 228 were treated with CPAP, 27 were treated with bilevel positive airway pressure (BPAP), and 213 did not accept treatment. The apnea/hypopnea index (AHI) was similar (35 vs. 34) in the 2 groups; these patients would have received a recommendation for treatment based on presence of clinically significant OSA. Median follow-up was 9.4 years (range, 3.3 to 12.7). When compared to patients with COPD only, patients with overlap syndrome who were not treated with PAP had a higher mortality risk (42.2% vs. 24.2%; relative risk [RR] 1.79; 95% confidence interval [CI]: 1.16 to 2.77) and were more likely to suffer a severe COPD exacerbation leading to hospitalization (RR 1.70; 95% CI: 1.21 to 2.38). Patients with overlap syndrome treated with CPAP did not have a statistically significant increased risk for death from any cause (31.6%) compared to patients with COPD only (24.2%). There were a number of baseline differences between the COPD only and the overlap syndrome groups which may impact mortality, but the 2 overlap groups were well matched for baseline characteristics. The main conclusion of the study was that patients with COPD should be screened for OSA and offered treatment.
Similar findings were reported by Machado et al, who reported a prospective comparative study of 95 patients with moderate to severe OSA and hypoxemic COPD who were offered CPAP treatment (Machado, 2010). Of the 95 patients, 61 (64%) accepted CPAP and were adherent while 34 did not accept or were not adherent. After adjusting for confounders, patients treated with CPAP had a significantly lower risk of death (hazard ratio of 0.19; 95% CI: 0.08 to 0.48).
Other studies have evaluated the patient characteristics that show most benefit from PAP. Jaoude et al evaluated 271 consecutive patients with overlap syndrome who were seen at a Veterans Administration sleep center (Kapide. 2014). Of the 271 overlap patients identified, 104 were considered hypercapnic (mean PaCO2 = 51.6 + 4.3 mmHg), indicating that the level of hypercapnia was lower than in other studies that had a threshold of 52 mmHg. The normocapnic and hypercapnic patients had similar AHI (29.3 + 23.8 and 35.2 + 29.2 events per hour, respectively; p=.07) and similar adherences rates to CPAP (43% and 42%, respectively). During a median follow-up of 71 months, mortality was higher in patients who were hypercapnic (35%) compared to patients who were normocapnic (17%, p=.001). Mortality in patients who were hypercapnic was lower in those who were adherent to CPAP compared to those who were not (p=.04), but adherence to CPAP had little impact on mortality in normocapnic patients (p=.42).
Singh et al evaluated the impact of PAP therapy on emergency room visits and hospitalization rates in Medicare beneficiaries with overlap syndrome (Singh, 2019). Using a 5% Medicare sample of claims data from 2010 to 2012, they identified 319 patients with overlap syndrome who were new users of PAP therapy in 2011. Subjects were categorized by age (66-74, 75-84, greater than or equal to 85), gender, race, socioeconomic status, CMS geographic region, comorbidity score, COPD complexity, tobacco use, and selected comorbidities. Comorbidities included hypertension (84%), diabetes (42%), and congestive heart failure (32%); 63% of individuals had 3 or more comorbidities. COPD complexity was based on pulmonary and non-pulmonary comorbid conditions and the prevalence of exacerbations and utilization of healthcare services; 26.0% of individuals were considered low complexity, 57.7% moderate complexity, and 16.3% high complexity. When compared with the year before PAP initiation, hospitalization for COPD-related conditions was significantly reduced (19.4% vs. 25.4%, p=.03). Rates of emergency room visits and hospitalization for any cause were not significantly different for the pre- and post-initiation periods. Although the benefit was seen primarily in patients who were considered to be of higher complexity, no information could be obtained from the claims data on the severity of COPD and OSA.
Bilevel Positive Airway Pressure
An updated Cochrane review by Raveling et al evaluated the evidence for nocturnal NPPV for the treatment of either stable COPD or COPD after an acute exacerbation (Raveling, 2021). The primary outcomes were arterial blood gas and exercise capacity measured with the 6-minute walk distance (6MWD) as well as readmissions for acute exacerbations. Where available, the meta-analysis included individual patient data (chronic: n=778; acute exacerbation: n=364) along with missing data from the primary RCTs. Criteria for inclusion were RCT, NPPV prescribed for at least 4 hours per night, and use for greater than 3 weeks; trials that allowed daytime use were excluded from the review. Most of the trials were conducted in Europe and excluded patients with OSA or high body mass index (BMI).
The update included 17 trials on stable COPD and 4 trials on NPPV after an acute exacerbation of COPD. Bilevel positive airway pressure with a backup rate was used in 3 studies, including the trials in 2014 by Kohnlein, 2017 by Murphy et al, and 2014 by Struik et al described below. Eight studies were judged to be at low risk of bias, including the 3 by Kohnlein et al, Murphy et al and Struik et al. Sources of heterogeneity were baseline hypercapnia (PaCO2 < 7.3 kPa vs. greater than or equal to 7.3 kPa) and the mean inspiratory pressure of NPPV (< 18 cm H2O vs. greater than or equal to 18 cm H2O). Sensitivity analysis removing studies with high or unclear risk of bias in the chronic COPD cohort increased the treatment effects for PaO2, PaCO2, 6MWD, and health related quality of life (HRQL). The authors concluded that the addition of chronic NPPV to standard treatment improves diurnal hypercapnia (high certainty), and there was evidence that NPPV improved PaO2 and all cause mortality (moderate certainty) and HRQL (very low certainty). In patients with stable COPD, the effect on gas exchange seemed to be larger in people with more severe hypercapnia (PaCO2 greater than or equal to 7.3 kPa), better treatment compliance (> 5 hours per night), and treated with a high inspiratory pressure (IPAP greater than or equal to > 18 cm H2O). The uncertain contribution of improvements in gas exchange, along with possible mechanisms, for an improvement in health outcomes were discussed.
Wilson et al published a meta-analysis that included 21 RCTs and 12 observational studies (N=51,085) on patients with COPD and hypercapnia treated with NPPV (Wilson, 2020). Of these, 15 RCTs and 6 observational studies evaluated BPAP compared with no device. The BPAP modes were spontaneous/timed, volume-assured pressure support, pressure-controlled ventilation, or the mode was not specified. The primary outcomes were mortality, all-cause hospital admissions, intubation, and quality of life. Analysis indicated that overall, use of BPAP, compared with no device, was significantly associated with a lower risk of mortality (odds ratio [OR] 0.66), fewer patients with hospital admissions (OR 0.22), and lower need for intubation (OR 0.34). There was no significant difference in quality of life, and sensitivity analysis indicated that observational studies were driving the significant results. Further analysis of subgroups evaluated the timing of the initiation of NPPV (stable vs. recent exacerbation) and separated the PaCO2 threshold categories as 45 to 49 mmHg, 50 to 51 mmHg, and at least 52 mmHg. Post-hoc subgroup analysis found no significant differences in mortality or all-cause hospital admissions based on PaCO2 levels, but improved quality of life in patients with higher PaCO2 levels.
A 2020 evidence review by the American Thoracic Society evaluated NPPV on health outcomes in patients with stable hypercapnic COPD (Macrea, 2020). Studies varied in the severity of baseline hypercapnia and lung disease, mode of ventilation, pressure settings, and comparator, all of which may have contributed to the imprecision of the studies.
Chronic Hypercapnic Respiratory Failure
Kohnlein et al conducted a multicenter RCT to determine whether BPAP would improve survival in patients with COPD and stable hypercapnic respiratory failure when ventilator settings were targeted to reduce hypercapnia (Kohnlein, 2014). Patients (N=195) with GOLD stage IV COPD, PaCO2 51.9 mmHg or higher, and pH higher than 7.35 were randomized into treatment as usual (including O2), or BPAP plus treatment as usual. Excluded were patients with BMI of 35 kg/m2 or greater, abnormalities of the lung or thorax other than COPD, or other conditions resulting in hypercapnia. Titration was performed in the hospital over a mean of 5.6 days with pressure targeted to reduce the baseline PaCO2 by at least 20% or to achieve PaCO2 < 48.1 mmHg. The mean inspiratory pressure in the NPPV group was 21.6 cm H2O with a backup rate of 16.1. Patients in both groups were admitted to the hospital at 3, 6, 9, and 12 months after randomization to ensure optimized treatment and additionally contacted by telephone every 4 weeks to ensure adherence to therapy. At 12 months, the PaCO2 was 48.8 mmHg in the NPPV group (mean use of 5.9 hours per day) compared to 55.5 in the control group. The primary outcome of 1-year all cause mortality was 12% in the NPPV group compared to 33% in the control group, with a hazard ratio of 0.24 (95% CI: 0.11 to 0.49; p=.004). Emergency hospital admissions were limited to 3 patients (3%) in the control group. The study utilized intention-to-treat analysis with blinded outcomes assessors. Previous studies that had not shown a significant improvement in survival with NPPV included patients with mild hypercapnia who did not have reduced hypercapnia or improved blood gases with treatment (McEvoy, 2009).
Post-Acute Hypercapnic Respiratory Failure
Murphy et al reported an RCT on the use of BPAP in addition to home oxygen therapy in patients with persistent hypercapnia following acute respiratory failure in the Home Oxygen Therapy Home Mechanical Ventilation (HOT-HMV) trial (Murphy, 2017). Patients (N=116) who had persistent hypercapnia following hospitalization for an acute exacerbation of COPD were randomized to a BPAP device with home oxygen therapy (NPPV+O2) or to oxygen therapy alone (O2). Randomization occurred between 2 to 4 weeks after resolution of decompensated acidosis (arterial pH > 7.30) in patients who had persistent hypercapnia (PaCO2 > 53 mmHg) and hypoxemia (PaO2 < 55 mmHg or < 60 mmHg; greater than or equal to 1 of polycythemia, pulmonary hypertension, or cor pulmonale; > 30% of sleep time with oxygen saturation < 90% as measured by pulse oximetry) and arterial pH greater than 7.30 while breathing room air. Patients were admitted for inpatient titration with either the Harmony 2 ST (Philips-Respironics) or VPAP IIIST (ResMed) with pressure support and backup rate. Settings were adjusted during overnight sleep studies to control hypoventilation and hypoxemia with a median inspiratory positive airway pressure of 24 cm H2O. Respiratory failure was attributed to COPD if FEV1 was less than 50% predicted, the FEV1/FVC ratio was less than 60%, and the patient had a smoking history in the absence of 1) obesity (BMI > 35), 2) clinically significant obstructive sleep apnea, or 3) neuromuscular or chest wall disease. PaCO2 levels improved significantly more in the NPPV group at 6 weeks (between group difference of -5.0; 95% CI: -9.0 to -1.3) and 3 months (-4.0; 95% CI:-7.1 to -0.8) but not at 6 or 12 months. Improvements in PaO2 levels were not significantly different in the 2 groups. There was a significant reduction in the composite endpoint of readmission or death within 12 months (63.4% in the NPPV+O2 group vs. 80.4% in the O2 alone group), with an adjusted hazard ratio of 0.49 (95% CI: 0.31 to 0.77; p=.002) and a number needed to treat of 5.8 to prevent 1 readmission or death. The median time to readmission or death was 4.3 months in the NPPV+O2 group and 1.4 months in patients receiving oxygen alone, and the exacerbation rate in 12 months was reduced to 3.8 for the NPPV+O2 group compared to 5.1 with O2 alone (adjusted rate ratio 0.66; 95% CI: 0.46 to 0.95, p=.02). Twelve month mortality was not significantly different between the groups. The study utilized intention-to-treat analysis with blinded outcomes assessors.
Several differences were noted between the results of the HOT-HMV trial and the RESCUE trial, which failed to demonstrate an improvement in hospitalizations or mortality Struik, 2014). In the RESCUE trial there was less stringent PaCO2 criteria (>45 mmHg) and treatment began immediately following cessation of acute ventilation rather than after a 2 week stabilization period, so that patients with spontaneously reversible hypercapnia would have been included in the study. For example, in the HOT-HMV trial 21% of potential patients were excluded due to not meeting the PaCO2 criteria 2 weeks after the acute exacerbation. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) notes that several factors may account for discrepancies in study results, including differences in patient selection, underpowered studies, NPPV settings, and poor adherence (GOLD, 2021).
Home Mechanical Ventilation
A technology assessment by the Agency for Healthcare Research and Quality (AHRQ, 2019) for the Centers for Medicare and Medicaid Services identified 5 studies on the initiation of HMV (Wilson, 2019). No studies were identified that compared initiation criteria for HMV versus BPAP. The AHRQ systematic review found low quality evidence that HMV compared to BPAP, CPAP, or no device was associated with significantly fewer hospital admissions. This was based on 2 observational studies that compared HMV to no device and a large study of administrative claims data by Vasquez et al in 2017 that compared HMV, BPAP, and CPAP.
In 2020 the AHRQ authors published a meta-analysis of RCTs and comparative observational studies of patients with COPD and hypercapnia treated with BPAP or HMV (Wison, 2020). The primary outcomes were mortality, all-cause hospital admissions, intubation, and quality of life. Based on 2 observational studies, HMV was significantly associated with fewer all-cause hospital admissions (rate ratio, 0.50; 95% CI, 0.35 to 0.71) compared with no device, but there was not a statistically significant difference in mortality (21.84% vs. 34.09%; OR, 0.56 (0.29 to 1.08). However, the evidence was low to moderate in quality and based on small numbers of studies.
Vasquez et al performed a retrospective analysis of claims data of hospitalization in patients with COPD who did or did not receive therapy with CPAP, BPAP, or HMV (Vasquez, 2017). Differences in COPD-related hospitalization were compared from 6 months before the prescription of a device to 6 months after prescription of a device across the device types. Models were stratified by sleep disordered breathing, congestive heart failure, age less than or greater than 65 years, and chronic respiratory failure. There were 1,881,652 enrollees with at least 2 COPD-related claims; 28,774 were on BPAP, 112,119 on CPAP, and 1011 enrolled on HMV. After exclusion criteria (health plan coverage for 12 month before and 6 months after the index date) were applied, there were 39,385 patients on CPAP, 9,156 patients on BPAP, and 315 patients on HMV who were included in the analysis. Propensity matching was used to compare the NPPV groups to medication groups. Most patients (92.5%) were not receiving any form of NPPV. Continuous positive airway pressure was prescribed for 5.6% of patients, BPAP for 1.5% of patients, and HMV in less than 1% of patients. Most patients prescribed HMV were older and there was high geographic variability; a majority (59.1%) of HMV users resided in the south. A majority of patients prescribed CPAP or BPAP had co-morbid sleep-disordered breathing (57.4% and 59.1%, respectively), while HMV was prescribed most frequently in patients with acute respiratory failure (56.5%), hypoxemia (30.2%), and chronic respiratory failure (28.3%). Sleep disordered breathing was present in 20.3% of patients using HMV. Hospitalization rates were highest in the HMV group. While all forms of NPPV reduced hospitalization rates, HMV was associated most strongly with a reduction in hospitalizations (p<.001).
Supplemental Information
The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.
Practice Guidelines and Position Statements
American Thoracic Society
Chronic Obstructive Pulmonary Disease
In 2020, the American Thoracic Society published an evidence-based clinical practice guideline on long-term non-invasive ventilation in chronic stable hypercapnic chronic obstructive pulmonary disease (COPD) (Macrea, 2020). The society included the recommendations, all of which were conditional due to moderate to very low certainty in the evidence base and are listed below.
American Thoracic Society Recommendations
Recommendation: "We suggest the use of nocturnal noninvasive ventilation (NIV) in addition to usual care for patients with chronic stable hypercapnic COPD."
Strength of Recommendation: Conditional
Level of Certainty: Moderate
Recommendation: "We suggest that patients with chronic stable hypercapnic COPD undergo screening for obstructive sleep apnea before initiation of long-term NIV."
Strength of Recommendation: Conditional
Level of Certainty: Very low
Recommendation: "We suggest not initiating long-term NIV during an admission for acute on-chronic hypercapnic respiratory failure, favoring instead reassessment for NIV at 2–4 weeks after resolution."
Strength of Recommendation: Conditional
Level of Certainty: Low
Recommendation: "We suggest not using an in-laboratory overnight polysomnogram (PSG) to titrate NIV in patients with chronic stable hypercapnic COPD who are initiating NIV."
Strength of Recommendation: Conditional
Level of Certainty: Very low
Recommendation: "We suggest NIV with targeted normalization of PaCO2 in patients with hypercapnic COPD on long-term NIV."
Strength of Recommendation: Conditional
Level of Certainty: Low
American College of Chest Physicians et al
In 2021, the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society published a technical expert panel report on optimal noninvasive ventilation for COPD (Hill, 2021). The panel recommends that overnight oxygen saturation should not be part of the criteria for bilevel positive airway pressure (BPAP) and that home mechanical ventilators be considered when patients need any of the following:
The panel strongly recommended the use of respiratory therapists in the home for initiation and ongoing support for positive pressure ventilation with either BPAP or home ventilators.
National Institute for Health and Care Excellence Global
In 2019, the United Kingdom's National Institute for Health and Care Excellence (NICE) published a guideline for the diagnosis and management of COPD (Hill, 2021). NICE recommends that patients with COPD who have chronic hypercapnic respiratory failure despite adequate pharmacologic and oxygen therapy should be referred to a specialist center for consideration of long-term, non-invasive ventilation.
Global Initiative for Chronic Obstructive Pulmonary Disease
The Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) published a revised report for 2022 (GOLD, 2021). GOLD recommendations include:
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed below.
Ongoing
NCT01037387 Effect of the Noninvasive Mechanical Ventilation on the Daily Physical Activity and the Inflammatory Biomarkers in Stable Patients With COPD
Planned Enrollment: 50
Completion Date: December 2021
NCT02811588 Registry of Stable Hypercapnic Chronic Obstructive Pulmonary Disease Treated With Non-Invasive Ventilation Amendment: Home Tele-Monitoring of Non-Invasive Ventilation in Chronic Obstructive Pulmonary Disease
Planned Enrollment: 550
Completion Date: Jun 2023
NCT03647462 The Impact of Early Diagnosis and Treatment of OSA on Hospital Readmission in Hospitalized Chronic Obstructive Pulmonary Disease Patients: the COPD Readmit Clinical Trial
Planned Enrollment: 100
Completion Date: Apr 2025
NCT03221101 Home Non Invasive Ventilation Versus Long Term Oxygen Therapy Alone in COPD Survivors After Acute Hypercapnic Respiratory Failure. A French Multicenter Randomized Controlled Trial
Planned Enrollment: 86
Completion Date: Dec 2025
Unpublished
NCT01513655a Home Non Invasive Ventilation (NIV) Treatment for COPD-patients After a NIV-treated Exacerbation
Planned Enrollment: 150
Completion Date: July 2020 (unknown)
NCT03766542 Optimal Positive Airway Pressure in Overlap Syndrome: a Randomized Controlled Trial
Planned Enrollment: 70
Completion Date: Sep 2020 (unknown)
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2023. No new literature was identified that would prompt a change in the coverage statement.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A Cochrane systematic review by Annane et al identified 10 clinical trials (N=173) evaluating nocturnal mechanical ventilation (volume‐cycled mechanical ventilation or BPAP) in patients with hypoventilation due to neuromuscular or chest wall disorders (Annane, 2014). The included trials enrolled patients with motor neuron disease (n=3), chest wall deformity (n=3), Duchenne muscular dystrophy (n=1), or mixed populations (n=3). Trials comparing mechanical ventilation to standard of care or those evaluating different methods of ventilation were included. Only 2 trials evaluated HMV; thus, the majority of the evidence is for BPAP. The largest study (N=70) was conducted specifically in patients with Duchenne muscular dystrophy. Although the quality of the studies was low, nocturnal mechanical ventilation lowered mortality among patients with neuromuscular or chest wall disorders.
Other systematic reviews have included only observational studies. AlBalawi et al evaluated long-term non-invasive ventilation in children with neuromuscular disease (AlBalawi, 2022). A total of 57 studies in 1948 children were identified. Neuromuscular diseases were classified as spinal muscular atrophy, Duchenne muscular dystrophy, or other/multiple neuromuscular diseases. Methods of ventilation were either not reported or specific to BPAP. Overall, NPPV resulted in lower mortality compared with standard care (risk ratio, 0.30; 95% CI, 0.19 to 0.46; p<.00001; I2=68%), but mortality was not significantly improved compared with invasive mechanical ventilation (risk ratio, 0.91; 95% CI, 0.24 to 3.48; p=.89; I2=88%).
A technology assessment by the AHRQ (2019) for CMS identified 3 observational studies on the initiation of HMV in patients with neuromuscular disease (Wilson, 2019). One study (N=144) compared HMV versus BPAP in patients with amyotrophic lateral sclerosis (ALS) (Sancho, 2014). The other studies were not relevant to this review of evidence.
Sancho et al retrospectively compared BPAP with volume-cycled ventilation in patients with ALS (Sancho, 2014). A total of 144 patients were identified with 82 receiving BPAP and 62 receiving HMV. No differences in survival were found between groups (median 15.00 months in both groups; p=.533). More patients had effective ventilation (gas exchange and hypoventilation symptoms) with HMV than BPAP (72.41% vs. 48.78%; p<.001).
A technology assessment by the AHRQ for CMS identified 1 trial comparing CPAP to no device in patients with OHS and OSA (Wilson, 2019). This study by Masa et al is summarized below (Masa, 2015).
Masa et al conducted a series of open-label, multicenter RCTs evaluating NPPV in patients with OHS (Masa, 2015; Masa, 2016; Masa, 2019; Masa 2020). The initial study, Masa et al, enrolled patients with concomitant OHS and OSA. Patients (N=221) were randomized to NPPV (as mixed mechanical ventilation/BPAP), CPAP, or lifestyle modification (Masa, 2015). Lifestyle modifications included a low-calorie diet, sleep hygiene, and avoidance of alcohol or tobacco. NPPV was administered throughout the entire sleep period at bilevel pressure. Daytime use was to be adjusted to normal oxygen saturation (if possible). Both CPAP and NPPV resulted in greater improvements in PaCO2 compared with lifestyle interventions, but no significant difference in PaCO2 was found between CPAP and NPPV. Other outcomes including HRQL, 6MWD, and spirometry had greater improvement with NPPV than CPAP. The trial was limited by a short follow-up duration of 2 months and lack of comparative risk calculations. After this 2 month trial, patients were enrolled in the long-term extension trial (Masa, 2019). Patients treated with only lifestyle interventions were re-randomized to NPPV or CPAP. At a median follow up of 5.44 years, patients treated with NPPV had lower mean hospitalization days compared with CPAP treatment, but the difference was nonsignificant. Mortality was also similar between groups (15% with CPAP vs. 11% with NPPV; hazard ratio [HR], 0.92, 95% CI, 0.36 to 1.87; p=.631).
In 2016, Masa et al published a trial conducted in patients with OHS but without severe OSA (Masa, 2016). Patients (N=86) were randomized to BPAP or lifestyle modification. Patients treated with BPAP had greater improvement in PaCO2 than those who received lifestyle modification. Daytime sleepiness and some health-related quality of life parameters were also improved. Similar to the 2015 study previously described, the follow-up was limited to 2 months (Masa, 2015; Masa, 2016). Long-term outcomes were also published by Masa et al in patients (N=98) without severe OSA (Masa, 2020). Compared with control, BPAP did not significantly reduce mean hospitalization days per year, cardiovascular events, or mortality but did improve PaCO2, quality of life, and daytime sleepiness at a median follow-up of 4.98 years.
Howard et al compared CPAP and BPAP for initial treatment in patients with OHS and severe OSA in a double-blind RCT (Howard, 2017). A total of 57 patients were treated for 3 months. Outcomes were similar between groups, but the trial is limited by the small sample size and short duration of follow-up prohibiting any conclusions regarding differences in mortality.
Arellano-Maric et al conducted a prospective observational trial to determine whether patients with OHS and OSA could be switched from NPPV to CPAP (Arellano-Maric, 2020). Patients were recruited from the sleep units of 3 hospitals in Germany. All patients had received successful NPPV (PaCO2 ≤45 mm Hg and <20% total sleep time with oxygen saturation <20%) for at least 3 months. Those patients who were successfully switched to CPAP (n=37) continued CPAP for 4 to 6 weeks. Five patients who did not meet criteria for CPAP switch requested to be switched to CPAP for a total sample size of 42 patients. During the study period, 30 of 42 patients (71%) maintained daytime PaCO2 ≤45 mm Hg. Quality of life, sleep parameters, and lung function were similar after the switch to CPAP. The authors concluded that CPAP is a feasible alternative to NPPV in patients with concomitant OHS and OSA.
Multiple systematic reviews have evaluated various NPPV methods in patients with hypoventilation syndromes. Xu et al conducted a network meta-analysis evaluating various NPPV methods (CPAP and BPAP) in patients with OHS (Xu, 2022). Trials enrolled obese patients (BMI ≥30 mg/m2) with hypercapnia (PaCO2 ≥45 mmHg) who had no other causes for the hypercapnia. BPAP-average volume-assured pressure support (AVAPS) and BPAP-spontaneous timed (ST) pressure support were the most effective methods for improving sleep and PaCO2.
Afshar et al conducted a systematic review of 25 studies (3 RCTs) evaluating NPPV (CPAP and BPAP) in patients with OHS (Afshar, 2020). 3 RCTS were included in the analysis (the 12 nonrandomized comparative studies and 10 studies without a comparator group are not included). Overall, NPPV was associated with improved mortality, daytime sleepiness, and hospital visits; however, the evidence had low to very low certainty and was considered very low quality.
The evidence for NPPV in patients with hypoventilation syndromes unrelated to obesity is limited to case reports and case series primarily in patients with congenital central hypoventilation. In some cases, NPPV may avoid the need for invasive mechanical ventilation (Kam, 2014; Yang, 2022; Xu, 2022).
In 2023, the American College of Chest Physicians (ACCP) published clinical practice guidelines for respiratory management of patients with neuromuscular weakness (Khan, 2023). Most evidence is based on observational data from patients with amyotrophic lateral sclerosis. The guidelines recommend non-invasive ventilation (NIV) for patients with neuromuscular disease and chronic respiratory failure for patients who meet the following pulmonary function test criteria:
The panel found no strong evidence to support one method of NIV over another.
In 2021, the ACCP, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society published a technical expert panel report on optimal NIV for chronic obstructive pulmonary disease (COPD), thoracic restrictive disorders, and hypoventilation syndromes (Hill, 2021: Wolfe, 2021; Mokhlesi, 2021).
For COPD the panel recommends that overnight oxygen saturation should not be part of the criteria for bilevel positive airway pressure (BPAP) and that home mechanical ventilators be considered when patients need any of the following (Hill, 2021):
For thoracic restrictive disorders, the panel recommends BPAP for patients with any of the following (Wolfe, 2021):
Home mechanical ventilation is recommended in patients with vital capacity less than 30% or if BPAP fails.
For patients with hypoventilation syndromes who are obese the recommendations include (Mokhlesi, 2021):
For patients with hypoventilation syndromes due to reduced respiratory drive or advanced lung disease that is not COPD, BPAP (spontaneous/timed) or VAPS is recommended. Patients with hypoventilation syndromes who fail BPAP/VAPS should receive home mechanical ventilation.
In 2019, the American Thoracic Society published a clinical practice guideline on OHS (Mokhlesi). These guidelines recommend positive airway pressure for patients with OHS. Generally, CPAP is recommended over other NIV because the majority (greater than 70%) of patients have concomitant obstructive sleep apnea (OSA). The guidelines do recommend non-invasive positive airway pressure ventilation (NPPV) initiation at discharge for patients hospitalized with respiratory failure suspected of having OHS until they undergo outpatient workup and titration of positive airway pressure therapy. Both recommendations were conditional with very low level of certainty in the evidence.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A systematic review was conducted of 5 observational studies evaluating CPAP in patients with overlap syndrome (Srivali, 2023). Definitions of OSA, COPD, and CPAP use were inconsistent among the studies, and the data were not pooled. However, all-cause mortality was reported in 3 studies and was significantly reduced with CPAP in each study (hazard ratios,0.19 to 0.71).
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PMID 35272117 Yang L, Qiu S, Zhong J, et al.(2022) Noninvasive ventilation via bilevel positive airway pressure improved sleep in a child with congenital central hypoventilation syndrome: A case report. Clin Case Rep. Oct 2022; 10(10): e6320. PMID 36276908 |
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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