|Clinical UM Guideline|
|Subject: Noninvasive Home Ventilator Therapy for Respiratory Failure|
|Guideline #: CG-DME-47||Publish Date: 07/06/2022|
|Status: Revised||Last Review Date: 05/12/2022|
This document addresses the medically necessary indications for home use of noninvasive home ventilators. A home ventilator is 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. A noninvasive home ventilator delivers the air through a mask or nasal interface tightly sealed to the face.
Notes: This document does not address the use of ventilation therapy:
Noninvasive positive pressure ventilation therapy (NPPV) with a home ventilator is considered medically necessary for the following conditions (A, B, or C):
Continuing use of NPPV therapy with a home ventilator is considered medically necessary when BOTH of the following are met (A and B):
Not Medically Necessary:
Home use of NPPV therapy with a home ventilator is considered not medically necessary when the above criteria are not met and for all other conditions, including but not limited to: chronic stable COPD without hypercapnia, and central sleep apnea of heart failure.
The following codes for treatments and procedures applicable to this guideline 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 may be Medically Necessary when criteria are met:
Home ventilator, any type, used with non-invasive interface (e.g., mask, chest shell)
Home ventilator, multi-function respiratory device, also performs any or all of the additional functions of oxygen concentration, drug nebulization, aspiration, and cough stimulation, includes all accessories, components and supplies for all functions [when specified as used with a non-invasive interface]
All diagnoses, including, but not limited to, the following:
Morbid (severe) obesity with alveolar hypoventilation
Cystic fibrosis with pulmonary manifestations
Motor neuron disease
Other chronic obstructive pulmonary disease
Respiratory failure, not elsewhere classified
Acquired deformity of chest and rib
Other congenital deformities of chest
Other/unspecified congenital malformations of bony thorax
Dependence on respirator [ventilator] status
When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or when the code describes a procedure or situation designated in the Clinical Indications section as not medically necessary.
Noninvasive positive pressure ventilation therapy (NPPV) uses a mechanical ventilator with a face or nasal mask interface to deliver pressurized air or a gaseous mix to the individual with or without preset rates and volumes. In general, these devices have provided benefit when used intermittently in the treatment of conditions associated with ventilatory compromise or failure resulting in hypercapnia (CO2 retention) and hypoxemia (insufficient oxygenation of circulating arterial blood). This may result from restrictive and/or obstructive ventilatory impairments. Common causes include:
A systematic review and data meta-analysis, conducted in 2002 and updated in 2012, assessed the effects of nocturnal NPPV administered at home via a nasal or facial mask for 245 hypercapnic subjects with stable COPD. Seven studies evaluated the effects of nocturnal NPPV when used at home for 3 and 12 month durations. The studies evaluated the effects of this treatment on the partial pressure of CO2 and O2 in arterial blood, 6-minute walking distance (6MWD), health-related quality of life (HRQoL), forced expiratory volume in one second (FEV1), forced vital capacity (FVC), maximal inspiratory pressure (PImax) and sleep efficiency. Results for nocturnal NPPV delivered at home for at least 3 months showed no consistent clinically significant or statistically significant effect on gas exchange, exercise tolerance, HRQoL, lung function, respiratory muscle strength or sleep efficiency. Meta-analysis of the two long-term studies with 12-month data reflected no significant improvements in blood gases, HRQoL or lung function after 12 months of NPPV. The small sample size of these studies precluded definitive conclusions. Although this analysis was limited, the authors summarized the findings to report that NPPV therapy in stable COPD demonstrated little or no difference in clinical outcomes, and further study is needed (Struik, 2014).
The GOLD Report (Global Initiative for Chronic Obstructive Lung Disease) was initiated in 1998 with the goal to provide recommendations for the management of COPD, based on the best scientific information available. This large ongoing project, created with cooperation from the National Heart, Lung and Blood Institute; the National Institutes of Health and the World Health Organization, has been reviewed and updated on a regular basis with the focus on diagnosis, assessment and treatment for COPD. Based on the critical review of the most current published evidence by members of the GOLD Science Committee, recommendations regarding state-of-the-art management of COPD have been reissued, as warranted in the science. In 2019, the GOLD Report provided the following recommendations for NPPV in COPD:
The recommendations of the 2019 GOLD report were based on the results of a randomized controlled trial of 116 subjects with persistent hypercapnia (PaCO2 > 53mm Hg) 2 weeks to 4 weeks after resolution of respiratory acidemia, who were recruited from 13 UK centers between 2010 and 2015 to receive either home oxygen therapy alone or home oxygen plus NPPV. It is noted that the NPPV was initiated using a “high pressure strategy” with mean inspiratory pressure of 24 cm H2O and expiratory pressure of 4 cm H2O. The primary outcome of time to readmission or death within 12 months was significantly improved for the home oxygen therapy plus home NPPV group, with the median time to readmission or death of 4.3 months, compared with 1.4 months in the home oxygen therapy alone group. The difference in the estimated 1-year risk of readmission or death was 17.0% (63.4% in the home oxygen plus home NPPV group vs. 80.4% in the home oxygen alone group, adjusted hazard ratio of 0.49 (95% confidence interval [CI], 0.31-0.77; p=0.002). At 12 months, 16 subjects had died in the home oxygen plus home NPPV group vs. 19 in the home oxygen alone group. The authors concluded that the addition of home NPPV to home oxygen “Should be considered” in the setting of severe COPD with persistent hypercapnia after a life-threatening exacerbation (Murphy, 2017).
In 2014, Köhnlein and colleagues conducted a prospective, randomized controlled trial that compared NPPV with standard treatment for 195 subjects with stable GOLD stage IV COPD and a PaCO2 of 7 kPa (51.9 mm Hg) or higher and a pH higher than 7.35. All subjects from the control group and the NPPV group were included in the primary analysis. At 1 year, mortality was 12% (12 of 102 subjects) in the intervention group and 33% (31 of 93 subjects) in the control group; with hazard ratio 0-24 (95% CI, 0.11–0.49; p=0.0004). The only intervention-related adverse event reported by 14 (14%) of trial participants was facial skin rash, which could be managed by changing the type of mask. The authors concluded that the addition of NPPV to standard treatment improves survival in individuals with hypercapnic stable COPD when the NPPV is targeted to greatly reduce hypercapnia, (that is, mean pressure, 21.6 cm H2O inspiratory and 4.8 cm H2O expiratory to achieve a 20% reduction in the PaCO2).
Many ventilator devices have obtained clearance from the U.S. Food and Drug Administration (FDA) as class II devices used to provide ventilator support for a variety of conditions. On March 13, 2009 the Trilogy100 Ventilatory Support System (Philips Healthcare, Andover MA; formerly Respironics, Inc., Monroeville, PA), a portable ventilator device, obtained FDA 510(k) clearance for the following indications:
The Respironics Trilogy l00 system provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.).
The device is intended to be used in home, institution/hospital, and portable applications, such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator (FDA, 2009).
This FDA clearance considers the Trilogy100 system substantially equivalent to other predicate devices currently marketed and includes ventilator devices with the capability to adjust delivery features, such as tidal volume, pressure and backup rate control. According to Philips Respironics, the Trilogy series of ventilators includes devices with patented AVAPS™ (Average Volume Assured Pressure Support) technology, described as follows:
AVAPS-AE is a bi-level therapy mode that automatically adjusts Expiratory Positive Airway Pressure (EPAP), pressure support, and the backup breath rate. AVAPS-AE automatically adjusts EPAP to maintain a patent airway. It also monitors delivered tidal volume and adjusts pressure support accordingly to provide the average target tidal volume. AVAPS-AE has the ability to maintain a backup breath rate* based on the patient's own spontaneous breathing rate (Philips Healthcare/Respironics, Inc.).
*Note: This document addresses NPPV therapy with BiPAP devices that are capable of delivering back-up rate support/control, when the back-up rate support feature is needed, in order to ensure adequate respiratory function. One such device is the Trilogy100 ventilatory system.
Respiratory assist devices are covered by the Center for Medicare and Medicaid (CMS) under the Durable Medical Equipment benefit. According to the CMS Administrative Carrier policy for durable medical equipment (DME MAC):
Noninvasive positive pressure respiratory assistance provided by a respiratory assist device, (that is, a ventilator), is the administration of positive air pressure, using a nasal and/or oral mask interface which creates a seal, avoiding the usage of more invasive airway access (for example, a trachea tube via a tracheostomy). It may be applied to assist insufficient respiratory efforts in the treatment of conditions that may involve sleep-associated hypoventilation. It is to be distinguished from the invasive ventilation administered via a securely intubated airway, in a patient for whom interruption or failure of ventilatory support would lead to the imminent demise of the patient (CMS, 2002).
According to the American Thoracic Society (ATS) clinical practice guideline, Evaluation and Management of Obesity Hypoventilation Syndrome, OHS is a condition defined by:
The combination of obesity (body mass index [BMI] > 30 kg/m2), sleep-disordered breathing (SDB), and awake daytime hypercapnia (awake resting PaCO2 > 45 mm Hg at sea level), after excluding other causes for hypoventilation. OHS is the most severe form of obesity-induced respiratory compromise and leads to serious sequelae, including increased rates of mortality, chronic heart failure, pulmonary hypertension, and hospitalization, due to acute-on-chronic hypercapnic respiratory failure, among others (Mokhlesi, 2019).
The ATS multidisciplinary panel of experts conducted a full systematic review of the literature, in order to make the following recommendations:
The ATS recommendation for use of CPAP or BiPAP during sleep hours as first-line treatment for the majority of persons with stable OHS is based on limited available studies. These have demonstrated that, although CPAP does not increase alveolar ventilation, it can improve awake respiratory failure by facilitating the unloading of CO2 accumulated during complete or partial airflow obstruction during sleep.
The Pickwick Study (Masa, 2015) followed 221 individuals with OHS in a prospective, randomized, unblinded trial comparing use of CPAP during sleep, use of volume-targeted non-invasive ventilatory (NIV) support during sleep and awake periods, and lifestyle modification. The study enrolled subjects with severe OHS, defined as obesity (BMI ≥ 30), stable daytime hypercapnia (PaCO2 > 45 mm Hg, pH > 7.35, no clinical worsening during the previous 2 months) and the absence of other conditions related to daytime hypercapnia. The lifestyle modification group received instructions about a 1000-calorie diet, sleep hygiene, avoidance of drugs affecting sleep (including caffeine, alcohol and tobacco), and supplemental oxygen if needed. The CPAP and NIV groups also received lifestyle modification instructions and supplemental oxygen if needed. CPAP was provided at fixed levels. NIV was provided as bilevel pressure with assured volume support. Outcomes were assessed at baseline and after 1 and 2 months of participation. The primary outcome was room air PaCO2 assessed by arterial blood gas. Secondary outcomes included anthropomorphic measures, symptom intensity, sleepiness measured with the Epworth Scale (ESS), quality-of-life measures, polysomnography, spirometry, 6-minute walk distance (6MWD), and other arterial blood gas measures. The study found that the PaCO2 improved in all 3 groups (-5.5 for NIV, -3.7 for CPAP, and -3.2 for lifestyle modification) but the only statistically significant difference in improvement was between the NIV and lifestyle modification groups. NIV produced a statistically significant change between baseline and 2 months for forced vital capacity (FVC) and 6MWD while the other interventions did not. The difference in FVC and 6MWD improvement between the NIV group and the CPAP group was not significant. There were no significant differences in changes to sleepiness, quality-of-life, or weight. NIV and CPAP were both better than lifestyle modification alone in improving polysomnography results and clinical symptoms, but the difference between NIV and CPAP was not significant. The investigators found that NIV or CPAP adherence for more than 4 hours/day was associated with more significant changes in daytime PaCO2.
The authors of the Pickwick Study theorized that CPAP is not itself a treatment for daytime hypercapnia, but that reducing the number of nocturnal obstructive apneas could explain the reduction in daytime CO2 associated with CPAP treatment in this study. Because they could not theorize another mechanism for daytime CO2 reduction, they did not assign subjects with low AHI values to treatment with CPAP.
The Spanish Sleep Network reported longer-term results for the NIV and CPAP cohorts of the Pickwick Study in 2019 (Masa, 2019). The median follow-up was 5.44 years. The investigators did not find a statistically significant between-group difference during this period for the primary outcome of hospitalization days for any cause or for the secondary outcomes of hospital admissions, emergency visits, ICU admissions, cardiovascular events or mortality. The authors note that priori power estimations were not done for the secondary measures, and the results for these outcomes need additional study for confirmation. The authors concluded that, “Non-invasive ventilation and continuous positive airway pressure seem to have similar long-term effectiveness.”
In 2017, Orfanos and colleagues conducted a small prospective pilot study of 15 stable subjects with OHS and moderate to severe concomitant OSA but without obstructive pulmonary disease. Measurements were taken, first while on NPPV for more than 2 months and after being switched to CPAP. There were no significant differences for pooled data in diurnal alveolar blood gases, nocturnal capnometry (p=0.534), nocturnal oximetry (p=0.218), mean compliance (p=0.766), mean AHI (p=0.334), quality of life or quality of sleep. It was noted that, (of the 15 individuals who completed the study), 80% favored CPAP over NPPV. The authors concluded that use of CPAP in stable OHS resulted in similar efficacy for diurnal and nocturnal alveolar gas exchange, quality of life and quality of sleep. These findings need further confirmation in larger trials with longer term outcomes data. Individuals presenting with a greater degree of initial ventilatory failure, worse lung function, advanced age, or less severe OSA may be less likely to respond to CPAP.
In 2017, Howard and colleagues conducted a multicenter, parallel, double-blind trial for initial treatment of OHS, with participants randomized to nocturnal BiPAP or CPAP for 3 months. Of the initial 60 participants, 57 completed follow-up and were included in analysis (mean age 53 years, BMI 55 kg/m2, PaCO2 60 mm Hg). There was no difference in treatment failure between groups (BiPAP - 14.8% vs. CPAP - 13.3%; p=0.87). Treatment adherence and awake PaCO2 values were similar after 3 months (5.3 hours/night for BiPAP, 5.0 hours/night for CPAP, p=0.62; PaCO2 44.2 and 45.9 mm Hg, respectively; p=0.60). Between-group differences were not significant for improvement in sleepiness (ESS 0.3 [95% CI; 2.8, 3.4]; p=0.86) and health-related quality of life (HRQoL) using a questionnaire (Short Form [SF] 36-SF6d 0.025 [95% CI; -0.039, 0.088]; p=0.45). Baseline severity of ventilatory failure (PaCO2) was the only significant predictor of persistent ventilatory failure at 3 months (OR 2.3; p=0.03). The authors concluded that in newly diagnosed severe OHS, BiPAP and CPAP resulted in similar improvements in ventilatory failure, HRQoL and adherence. Baseline PaCO2 predicted persistent ventilatory failure to treatment with BiPAP and CPAP.
Central sleep apnea (CSA): Refers to periods during sleep when normal airflow to and from the lungs is absent resulting in abnormally low levels of PaO2 in arterial blood due to inadequate respirations.
Chronic obstructive pulmonary disease (COPD): Any disorder that persistently obstructs bronchial airflow and mainly involves two related diseases -- chronic bronchitis and emphysema. Both cause chronic obstruction of airflow through the airways and in and out of the lungs. COPD is generally permanent and progresses (becomes worse) over time. According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD, 2019 Report), the stages of COPD are defined as follows:
Stage 1: Very mild COPD with a FEV1 about 80 percent or more of normal.
Stage 2: Moderate COPD with a FEV1 between 50 and 80 percent of normal.
Stage 3: Severe emphysema with FEV1 between 30 and 50 percent of normal.
Stage 4: Very severe COPD with a lower FEV1 than Stage 3, or those with Stage 3 FEV1 and low blood oxygen levels.
Forced expiratory volume (FEV1): The volume of oxygen expressed during expiration in 1 second. FEV1 is a marker used to monitor lung function and severity of lung disease, such as COPD.
Fractional concentration of oxygen (FIO2): The concentration of oxygen delivered for inspiration. The usual FIO2 refers to the oxygen concentration in normal breaths when on room air (that is, without oxygen supplementation).
Forced vital capacity (FVC): The amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Measurements of the FVC are useful in distinguishing obstructive from restrictive lung disease.
Home ventilator: A VENTILATOR device used in the home.
Hypercapnia (also referred to as hypoventilation): Refers to an elevation in the arterial carbon dioxide tension (PaCO2). The carbon dioxide (CO2) level in arterial blood is directly proportional to the rate of carbon dioxide (VCO2) production and inversely proportional to the rate of CO2 elimination by the lung (referred to as alveolar ventilation).
Invasive positive pressure ventilation support (IPPV): This is another form of ventilator support that is distinguished from noninvasive positive pressure ventilator support (see below), in that the pressurized oxygen is administered directly into the trachea via a securely intubated airway or tracheostomy tube. The use of IPPV is not addressed in this document.
Minute ventilation: The number of breaths per minute times the volume of each breath.
Neuromuscular disease (also referred to as neuromuscular disorders): Refers to multiple conditions that impair the functioning of various nerves of the peripheral nervous system, including motor and sensory nerves, and also affects communication between nerves and muscles resulting in wasting and weakness of muscles. One such neuromuscular disease is amyotrophic lateral sclerosis (ALS) which is a progressive nervous system disease that attacks the nerve cells of the brain and spinal cord with resultant degeneration of motor neurons and progressive muscle weakness and atrophy with loss of muscle function.
Nocturnal hypoventilation (also referred to as nocturnal hypoxemia): Refers to a respiratory condition where inadequate gaseous exchange during sleep results in abnormally high CO2 in arterial blood, which is also known as CO2 retention.
Noninvasive positive pressure ventilation support (NPPV): A device that delivers pressurized air to the individual through a facemask or nasal interface tightly sealed to the face. Supplemental oxygen may be added to the pressurized air.
NPPV may be provided through several modes including:
Pressure support: Provision of pressurized air with or without supplemental oxygen at a specified inspiratory pressure or with a set level of positive end-expiratory pressure (PEEP). Inspiration ends when the preset inspiratory pressure is achieved.
Rate support: Provision of pressurized air with or without supplemental oxygen at a specified minimum number of breaths per minute.
Partial pressure of oxygen (also known as PaO2): A measurement of oxygen in arterial blood.
Partial pressure of carbon dioxide (also known as PaCO2): A measurement of carbon dioxide in arterial blood.
Respiratory failure, acute or chronic: A respiratory disorder where insufficient oxygenation, insufficient alveolar ventilation, or both, are experienced by the individual in his/her attempts to breathe. Chronic respiratory failure is associated with certain conditions, such as chronic obstructive pulmonary disease (COPD) which, over time or emergently, may progress to acute respiratory failure (ARF) which is life threatening.
Restrictive thoracic disorders: Refers to a variety of neuromuscular and anatomical anomalies of the chest/rib cage area that may result in hypoventilation, particularly during sleep. Nocturnal hypoventilation is associated with a host of health hazards and can also significantly impact the quality of life. The use of mechanical NPPV devices has been found helpful in reducing the episodes of nocturnal hypoventilation and the associated complications for a significant number of those who are able to tolerate the therapy.
Sleep-disordered breathing (SDB): Abnormalities of respiration during sleep. Episodes often result in reductions in blood oxygen saturation and are usually terminated by brief arousals from sleep. This common disorder often results in oxidative stress and inflammation and is associated with multiple age-related health disorders.
Sleep-related hypoventilation: A condition is identified for adults when the arterial PCO2 (or surrogate) during sleep is > 55 mm Hg for ≥ 10 minutes or there is an increase in the arterial PCO
2 (or surrogate) during sleep of ≥ 10 mm Hg (in comparison to an awake supine value) to a value exceeding 50 mm Hg for ≥ 10 minutes. For pediatric subjects, sleep-related hypoventilation is identified when the arterial PCO2 (or surrogate) is > 50 mm Hg for > 25% of total sleep time.
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.
Volume support: Provision of pressurized air with or without supplemental oxygen at a specified tidal volume. Inspiration ends when a preset tidal volume or minute ventilation is achieved.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Websites for Additional Information|
Bi-lateral positive airway pressure (BiPAP)
Non-Invasive Positive Pressure
Noninvasive Respiratory Assist Devices
Positive Pressure Respiratory Assist Devices
S9 VPAP™ ST-A with iVAPS, ResMed
Trilogy100, Philips Healthcare (formerly Respironics)
Trilogy200, Philips Healthcare (formerly Respironics)
Ventilator, Continuous, Non-life supporting
Ventilators, Home use
VPAP™ COPD, ResMed
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.
Medical Policy & Technology Assessment Committee (MPTAC) review. The MN criteria for NPPV in neuromuscular disease were revised to add maximum inspiratory pressure of less than or equal to 60 mm H2O. The MN criteria for NPPV in persistent hypercapnic end-stage COPD have been revised to remove the requirement for PaO2 level and for NPPV therapy without the rate support feature the O2 saturation range requirement has been removed. Deleted the words, “for adults” from the MN statement for home NPPV therapy. The Definitions and References sections were updated.
Updated References section. Reformatted Coding section.
MPTAC review. The indication of OHS was added to the MN indications for NPPV when criteria are met. The Discussion, Coding and References sections were updated.
MPTAC review. Initial document development.
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