Latest Review Date: March 2024

Category:  Durable Medical Equipment (DME)

POLICY:

Effective for dates of service 11/16/23 and after:

Severe Chronic Obstructive Pulmonary Disease (COPD)

Nocturnal bi-level positive airway pressure with backup rate may be considered medically necessary for individuals with COPD and chronic respiratory failure who meet either of the following:

• Chronic stable daytime (awake) hypercapnia (PaCO2>52 mmHg) OR
• Daytime (awake) hypercapnia (PaCO2>52 mmHg) at least 2 weeks after discharge from the hospital for an acute exacerbation with decompensated respiratory acidosis.

Individuals with COPD who are started on bi-level positive airway pressure at discharge from hospitalization may continue for up to 3 months to provide time to stabilize and complete reevaluation.

Non-invasive positive airway pressure for COPD is considered investigational under all other conditions.

Restrictive Thoracic Disorders

Bi-level positive airway pressure may be considered medically necessary for individuals with thoracic restrictive disorders due to neuromuscular disease who meet any of the following:

• Pulmonary function tests:
  • Spirometry (upright or supine) with vital capacity <50% predicted or <80% predicted with associated symptoms (orthopnea, dyspnea, morning headaches, excessive daytime sleepiness, or unrefreshing sleep); OR
  • Maximal inspiratory pressure <60 cm H2O or maximum expiratory pressure (MEP) <40 cm H2O; OR
  • Peak cough flow (PCF) <270 L/min for age ≥12 years or PCF <5th percentile for age <12 years; OR
  • Sniff nasal inspiratory pressure (SNIP) <70 cm H2O in males, SNIP <60 cmH2O in females for age ≥12 years.
• Hypercapnia
  • Chronic stable daytime (awake) hypercapnia with PaCO2 >45 mmHg (capillary blood gas can be used in children); OR
  • Venous blood gas PCO2, end-tidal PCO2, or transcutaneous PCO2, >50 mmHg; OR
• Hypoxia
  • Overnight oximetry in-laboratory with saturation <88% for 5 minutes;
  • Overnight oximetry: SpO2 ≤ 90% for ≥ 2% of sleep time.

Hypoventilation Syndrome

Bi-level positive airway pressure may be considered medically necessary for individuals with hypoventilation syndromes who meet the following criteria:

• Awake or sleep hypoventilation with hypercapnia (one of the following is met):
  • Awake hypoventilation with chronic stable daytime (awake) hypercapnia (PaCO2 ≥ 45 mmHg); OR
  • Venous blood gas PCO2, end-tidal PCO2, or transcutaneous PCO2 ≥50 mmHg; OR
  • Sleep hypoventilation with hypercapnia:
    • ≥10 mmHg increase from baseline awake PCO2 and to a value > 50 mmHg for ≥10 min; OR
    • PCO2 ≥55 mmHg for ≥10 min; AND
• Low clinical suspicion for COPD or neuromuscular disease; AND
• One of the following conditions are met:
  • Obesity with body mass index (BMI) ≥30 kg/m2; OR
  • Decreased respiratory drive due to opioid or substance use; OR
  • Advanced lung disease other than COPD (e.g., end-stage or advanced interstitial lung disease); AND
• Individual was discharged from inpatient stay with persistent awake hypoventilation (hypercapnia) on BiPap.
  • A reassessment with a provider within 3 months (30 to 90 days) is required and an attended (in-lab) polysomnogram (PSG) should be performed to assess appropriateness of positive airway pressure modality OR
• Individual is ambulatory and sleep study indicates that BiPap is necessary for sleep-disordered breathing, or individual with severe obstructive sleep apnea is continuous positive airway pressure intolerant or continuous positive airway pressure was proven ineffective.

Non-invasive Positive Pressure Ventilation Device with a Back-up Rate

Non-invasive positive pressure respiratory assist devices (BiPap) with back-up rate may be considered medically necessary for any one of the above disorders when the coverage criteria are met AND BiPap has failed as evidenced by continued hypoxemia or CO2 retention.

Central Sleep Apnea (CSA)

Central Sleep Apnea (CSA), (apnea not due to airway obstruction) when, prior to initiating therapy, a complete, (full or split night) approved facility based, attended polysomnography has been performed and the test results have revealed ALL of the following:

• The diagnosis of central sleep apnea has been confirmed, defined as a AHI > 5, central apneas/hypopneas consist of 50% or more of the total apneas/hypopneas; AND
• The presence of obstructive sleep apnea has been excluded as the predominant cause of the sleep-associated hypoventilation; AND
• If OSA is a component of the sleep-associated hypoventilation, CPAP has been ruled out as an effective therapy; AND
• Significant clinical improvement of the individual's sleep-associated hypoventilation has been demonstrated with the use of a BiPap, adjusted to the settings that will be prescribed for initial home use, while breathing the individual's usual FiO₂.

Non-invasive positive pressure ventilation device with back-up is standard treatment used for this diagnosis.

Adaptive –Servo ventilation bi-level devices may be considered medically necessary when the following conditions are met:

• The diagnosis of central sleep apnea (CSA) or Complex Sleep Apnea (CompSA) has been confirmed; AND
• Coverage criteria for BiPap has been met as defined above; AND
• Individual has failed a BiPap trial 

Phrenic Nerve Stimulation for central sleep apnea (e.g. Remede) is addressed in MP#730 Phrenic Nerve Stimulation for Central Sleep Apnea.

*Obstructive Sleep Apnea treatment is addressed in MP #065 Diagnosis and Medical Management of Obstructive Sleep Apnea Syndrome.

Compliance Documentation

Compliance documentation should be maintained in the supplier’s record.  This documentation should include that the physician certifies the individual is compliant with the treatment and the sleep disorder has improved based on the treatment OR a recorded compliance document indicating proper utilization. (≥ 4 hours per night on 70% of the nights during a 30 consecutive day period during the initial 90 days of usage.)

Compliance documentation that extended beyond the 90 days will be reviewed on an individual basis (e.g. Accidents, change in physical status, surgery, etc.)

Replacement Devices

Previously covered devices may be considered medically necessary to be replaced when the following criteria are met: (Repeat sleep study is not required)

• The equipment has suffered irreparable damage (cost more to repair than to replace) and has been in the home for 3 years or longer; OR
• The individual’s condition has changed and a different piece of equipment is determined to be medically necessary.

Replacement devices will not be covered for replacing functioning equipment with a newer more advanced model.

• Compliance documentation is not required on replacement equipment
• Replacement devices should be filed with modifier “RA” to indicate they are not the initial device but a replacement piece of equipment.

If the individual-owned DME is being repaired, up to one month’s rental for that piece of durable medical equipment may be considered medically necessary.

Payment is based on the type of replacement device that is provided, but will not exceed the rental allowance for the equipment that is being repaired.

Effective for dates of service prior to 11/16/23:

Non-invasive Positive Pressure Ventilation Devices may be considered medically necessary for any one of the following disorders when the coverage criteria are met:

Restrictive Thoracic Disorders / Neuromuscular Abnormalities when ALL of the following criteria are met:

• The member has been diagnosed with a progressive neuromuscular disease, e.g., amyotrophic lateral sclerosis (ALS) or a severe thoracic cage abnormality, (e.g., post-thoracoplasty for TB); AND
• COPD does not contribute significantly to the individual's pulmonary limitation; and ONE or more of the following criteria are met:
• • An arterial blood gas PaCO₂ level is ≥45 mmHg, done while awake and breathing the patient's usual FiO₂ (fractionated inspired oxygen concentration); OR
  • Sleep oximetry demonstrates an oxygen saturation ≤ 88% for at least 5 continuous minutes, done while breathing the patient's usual FiO2; OR
  • Maximal inspiratory pressure is < 60 cm H₂O or forced vital capacity is < 50% of predicted (for patients with a progressive neuromuscular disease only).

*Obstructive Sleep Apnea treatment is addressed in medical policy #065 Diagnosis and Medical Management of Obstructive Sleep Apnea Syndrome.

Severe Chronic Obstructive Pulmonary Disease (COPD) when ALL of the following are met:

• An arterial blood gas PaCO₂, done while awake and breathing the individual's usual FiO₂, is ≥ 52 mmHg or greater; OR
• Sleep oximetry demonstrates oxygen saturation ≤ 88% for at least 5 continuous minutes, done while breathing oxygen at 2 L/min. or the individual's usual FiO₂ (whichever is higher); AND
• Prior to initiating therapy, obstructive sleep apnea and treatment with CPAP has been considered and ruled out.

Hypoventilation Syndrome when ALL of the following criteria are met:

• An initial arterial blood gas PaCO₂, done while awake and breathing the patient’s prescribed FiO₂, is ≥ 45 mmHg; AND
• Spirometry shows an FEV1/FVC ≥ 70% and an FEV1 ≥ 50% of predicted; OR
• An arterial blood gas PaCO₂, done during sleep or immediately upon awakening, and breathing the patient’s prescribed FiO2, shows a PaCO₂ worsened ≥ 7 mmHG compared to the original result in criterion 1 (above); OR
• An approved facility-based PSG demonstrates oxygen saturation ≤ 88% for ≥ 5 minutes of nocturnal recording time (minimum recording time of 2 hours unless an emergency protocol was activated) that is not caused by obstructive upper airway events (i.e., AHI < 5).

Non-invasive Positive Pressure Ventilation with back up when ALL the criteria are met:

• A covered E0470 device is being used; AND
• Spirometry shows an FEV1/FVC ≥ 70% and an FEV1 ≥ 50% of predicted; AND
• An arterial blood gas PaCO₂, done while awake, and breathing the individuals prescribed FIO₂, shows that the beneficiary’s PaCO₂ worsens ≥ mmHG compared to the ABG result performed to qualify the individual for the E0470 device; OR
• A facility-based PSG demonstrates oxygen saturation ≤ 88% for ≥ 5 minutes of nocturnal recording time (minimum recording time of 2 hours unless an emergency protocol was activated) that is not caused by obstructive upper airway events (i.e., AHI < 5 while using an E0470 device).

Central Sleep Apnea (CSA), (apnea not due to airway obstruction) when, prior to initiating therapy, a complete, (full or split night) approved facility based, attended polysomnography has been performed and the test results have revealed ALL of the following:

• The diagnosis of central sleep apnea (CSA) has been confirmed, defined as a AHI > 5, central apneas/hypopneas consist of 50% or more of the total apneas/hypopneas; AND
• The presence of obstructive sleep apnea (OSA) has been excluded, as the predominant cause of the sleep-associated hypoventilation; AND
• If OSA is a component of the sleep-associated hypoventilation, CPAP has been ruled out as an effective therapy; AND
• Significant clinical improvement of the patient's sleep-associated hypoventilation has been demonstrated with the use of a BiPap, adjusted to the settings that will be prescribed for initial home use, while breathing the individual's usual FiO₂.

A non-invasive positive pressure ventilation device with back-up would usually be the equipment used for this diagnosis.

Non-invasive Positive Pressure Ventilation Device with a Back-up Rate

Non-invasive positive pressure respiratory assist devices (BiPAP) which includes a Back-up Rate may be considered medically necessary for any one of the above disorders when the coverage criteria are met AND BiPAP has failed as evidenced by continued hypoxemia or CO₂ retention.

Adaptive –Servo ventilation bi-level devices may be considered medically necessary when the following conditions are met:

• The diagnosis of central sleep apnea (CSA) or Complex Sleep Apnea (CompSA) has been confirmed; AND
• Coverage criteria for BiPap has been met as defined above; AND
• Individual has failed a BiPap trial.

Phrenic Nerve Stimulation for central sleep apnea (e.g. Remede) is addressed in MP#730 Phrenic Nerve Stimulation for Central Sleep Apnea.

Compliance Documentation

Compliance documentation should be maintained in the supplier’s record.  This documentation should include that the physician certifies the patient is compliant with the treatment and the sleep disorder has improved based on the treatment OR a recorded compliance document indicating proper utilization.  (≥ 4 hours per night on 70% of the nights during a 30 consecutive day period during the initial 90 days of usage.) (Compliance documentation that extended beyond the 90 days will be reviewed on an individual basis (i.e. Accidents, change in physical status, surgery, etc.)

Related Supply Coverage – Supply information can be obtained by contacting our Customer Service department.

Replacement Devices

Previously covered devices may be considered medically necessary to be replaced when the following criteria are met: (Repeat sleep study is not required)

• The equipment has suffered irreparable damage (cost is more to repair than to replace) and has been in the home for 3 years or longer; OR
• The patient’s condition has changed and a different piece of equipment is determined to be medically necessary.

Replacement devices will not be covered for replacing functioning equipment with a newer more advanced model (Compliance documentation is not required on replacement equipment).

Replacement devices should be filed with modifier “RA” to indicate they are not the initial device but a replacement piece of equipment.

If the patient-owned DME is being repaired, up to one month’s rental for that piece of durable medical equipment may be considered medically necessary.

Payment is based on the type of replacement device that is provided, but will not exceed the rental allowance for the equipment that is being repaired.

DESCRIPTION OF PROCEDURE OR SERVICE:

Respiratory failure is characterized by low arterial blood oxygen (hypoxemia, PaO₂) and/or high arterial carbon dioxide (hypercapnia, PaCO₂ > 45 mmHg). Chronic respiratory insufficiency or failure can occur with chronic obstructive pulmonary disease (COPD), thoracic restrictive disorders, and hypoventilation syndromes, 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), bi-level positive airway pressure (BPAP), and home mechanical ventilators (HMV) that are pressure, rate and volume targeted are proposed for the treatment of COPD and other forms of chronic hypoventilation.

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".

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 ventilator capability. 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. 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. 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. 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 >45 mmHg) that is not otherwise categorized. 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.

Treatment with Non-invasive Positive Airway Pressure

A major goal of management of patients with chronic hypoventilation COPD is to reduce hospitalizations and mortality. Long-term oxygen therapy is recommended for patients with poor clinical status and NPPV devices for patients with severe chronic hypercapnia and a history of hospitalization for acute respiratory failure. Non-invasive positive airway pressure ventilation devices include nocturnal continuous positive airway pressure (CPAP) for individuals with hypercapnia due to obstructive sleep apnea or hypoventilation and bi-level 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, thoracic restrictive disorders due to neuromuscular disease, or those with hypoventilation syndromes.

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.

Respiratory Assist Devices

The Centers for Medicare and Medicaid Services (CMS) defines respiratory assist devices (RADs) as bi-level 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.

Terminology on device features is described in Table 1.

Table 1. Device Features

Term	Definition	Description
Bi-level-S	Bi-level without a backup rate	Positive airway pressure that is higher during inspiration than expiration that is triggered by patient inspiration.
Bi-level-ST	Bi-level with a backup rate	Positive airway pressure that is higher during inspiration than expiration with a backup respiratory cycle length if the patient's breathing is slower than the preset rate.
VAPS	Volume-assured pressure support modes	Bi-level ST modes that use an algorithm to adjust inspiratory pressure support to meet a set tidal volume.
iVAPS	Intelligent volume-assured pressure support modes	Bi-level ST modes that use an algorithm to adjust inspiratory pressure support within a predetermined range to meet a set target ventilation.

 

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. 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 (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 Bi-level-ST (with backup rate) or a VAPS (volume assured) may be used if a Bi-level-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.

Adaptive servo-ventilation (ASV)

Adaptive servo-ventilation (ASV), a bi-level PAP system with a backup rate feature, uses an automatic, minute ventilation-targeted device (VPAP Adapt, ResMed, Poway, CA) that performs breath-to-breath analysis and adjusts its settings accordingly.  Depending on breathing effort, the device will automatically adjust the amount of airflow it delivers in order to maintain a steady minute ventilation.  Most studies on the use of ASV have investigated its use for heart failure patients with central apnea or Cheyne-Stokes respiration.

Central Sleep Apnea

Central sleep apnea is a disorder in which your breathing repeatedly stops and starts during sleep. Central sleep apnea occurs because your brain doesn't send proper signals to the muscles that control your breathing. This condition is different from obstructive sleep apnea; in which you can't breathe normally because of upper airway obstruction. Central sleep apnea is less common than obstructive sleep apnea. Central sleep apnea may occur as a result of other conditions, such as heart failure and stroke. Treatments for central sleep apnea may involve treating existing conditions, using a device to assist breathing or using supplemental oxygen. Central sleep apnea (CSA) is common in heart failure (HF) patients. Traditional treatment of CSA includes continuous positive airway pressure (CPAP), adaptive servo ventilation (ASV), oxygen therapy, and CO₂ inhalation.

Central apnea-hypopnea index (CAHI) - For diagnosis of CSA, the central apnea-central hypopnea index (CAHI) is defined as the average number of episodes of central apnea and central hypopnea per hour of sleep without the use of a positive airway pressure device. For CompSA, the CAHI is determined during the use of a positive airway pressure device after obstructive events have disappeared.  If the CAHI is calculated based on less than 2 hours of continuous recorded sleep, the total number of recorded events used to calculate the CAHI must be at least the number of events that would have been required in a 2-hour period (i.e., greater than or equal to 10 events).

KEY POINTS:

This evidence review was created with a search of the PubMed database. The most recent literature update was performed through January 11, 2024.

Summary of Evidence:

For individuals who have chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) who receive continuous positive airway pressure (CPAP), the evidence includes observational studies. Relevant outcomes are mortality, symptoms, morbid events, functional outcomes, quality of life, and hospitalization. Studies of patients with both COPD and OSA who do or do not use CPAP show a mortality benefit in patients with overlap syndrome who are treated with positive airway pressure. The greatest benefits occur in patients with COPD and hypercapnia and in older adults, and individuals with more comorbid conditions and higher complexity ratings. It should be noted that the threshold for what was considered hypercapnia was lower than in other studies on bi-level positive airway pressure (BPAP) that used a threshold of arterial blood carbon dioxide (PaCO₂) > 52 mmHg. Although the literature indicates that patients with COPD should be screened for OSA due to increased mortality in overlap syndrome, no studies were identified to indicate that CPAP would be prescribed in any manner other than would typically be recommended for patients with clinically significant OSA. Patients with overlap syndrome can be treated with CPAP and, when CPAP is not tolerated, with BPAP. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have COPD and chronic respiratory failure who receive BPAP, the evidence includes randomized controlled trials (RCTs) and systematic reviews of RCTs. Relevant outcomes are mortality, symptoms, morbid events, functional outcomes, quality of life, and hospitalization. The primary limitation of the evidence base is the heterogeneity of patient selection criteria and treatment parameters. The most recent trials indicate that bi-level non-invasive positive airway pressure ventilation(NPPV) improves hypercapnia in both patients with stable hypercapnia and in patients who have stabilized following an acute exacerbation. There is evidence that some health outcomes including function, readmissions, and death are improved; however, the strength of evidence is low. Several factors have been reported to be important to achieve benefit of NPPV. These are severe hypercapnia with PaCO₂ > 52 mmHg, use for at least 5 hours per night, and treatment with high intensity pressure. In addition, for patients with hypercapnia following an acute exacerbation, titration should occur at least 2 weeks after hospitalization when hypercapnia has stabilized. Under these conditions, the evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have hypoventilation as a result of thoracic disorder due to neuromuscular disease who receive BPAP, the evidence includes systematic reviews. Relevant outcomes are mortality, symptoms, morbid events, functional outcomes, quality of life, and hospitalization. Clinical trials included in a systematic review of 10 RCTs (or quasi-RCTs) evaluated the use of nocturnal NPPV (primarily BPAP) in individuals with neuromuscular or chest wall disorders. One-year mortality rates were significantly reduced with NPPV use (risk ratio, 0.62; 95% confidence interval [CI], 0.42 to 0.91). Patients treated with NPPV also had lower hospital admission rates and greater symptom improvement. Although the studies were limited by heterogeneity, nocturnal NPPV was found to improve outcomes in patients with restrictive thoracic disorders including neuromuscular disease. A systematic review of observational studies in children with neuromuscular diseases found improved mortality with NPPV compared with standard of care. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have obesity hypoventilation syndrome (OHS) and OSA who receive CPAP, the evidence includes RCTs. In the largest RCT, PaCO₂ improved with both CPAP and NPPV (mixed BPAP/mechanical ventilation) compared with lifestyle interventions. There was no significant difference between CPAP and NPPV in PaCO₂ in the short-term or in hospitalized days at long-term follow-up. An RCT comparing CPAP and BPAP found similar outcomes with these treatments. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have OHS and chronic respiratory failure who receive BPAP, the evidence includes systematic reviews and RCTs. Relevant outcomes are mortality, symptoms, morbid events, functional outcomes, quality of life, and hospitalization. The majority of evidence specific to BPAP in OHS without OSA comes from a single RCT. In patients with OHS without OSA, BPAP resulted in better PaCO2 outcomes than lifestyle modifications in the short-term, but long-term outcomes failed to find significant improvement in hospitalization days between groups. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with hypoventilation as a result of hypoventilation syndromes unrelated to OHS, the evidence is limited to case reports and case series primarily in patients with congenital central hypoventilation. In some cases, NPPV minimized the need for invasive mechanical ventilation. Due to the severity of the condition, high quality prospective controlled trials are unlikely inpatients who have hypoventilation due to hypoventilation syndromes. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Practice Guidelines and Position Statements:

American College of Chest Physicians

In 2023, the American College of Chest Physicians (ACCP) published clinical practice guidelines for respiratory management of patients with neuromuscular weakness. 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:

• Forced vital capacity (FVC) <80% predicted with symptoms or FVC <50% predicted without symptoms;
• Maximum inspiratory pressure (MIP) <60 cm H₂O or maximum expiratory pressure (MEP) <40 cm H₂O;
• Peak cough flow (PCF) <270 L/min for age ≥12 years or PCF <5th percentile for age <12 years;
• Sniff nasal inspiratory pressure (SNIP) <70 cm H₂O in male patients, SNIP <60 cmH2O in female patients for age ≥12years.

The panel found no strong evidence to support one method of NIV over another.

American College of Chest Physicians et al

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.

Chronic Obstructive Pulmonary Disease

For COPD the panel recommends that overnight oxygen saturation should not be part of the criteria for bi-level positive airway pressure (BPAP) and that home mechanical ventilators be considered when patients need any of the following:

• "Higher inspiratory pressures than those deliverable by E0471,
• FIO₂ [fraction of inspired oxygen] higher than 40% or 5 L/min nasally,
• Ventilator support for 10 h per day or greater (i.e., daytime use),
• Both sophisticated alarms and accompanying internal battery (high-dependency patient),
• Mouthpiece ventilation during the day,
• Persistence of hypercapnia with PaCO₂ [arterial blood carbon dioxide]> 52 mmHg despite adequate adherence to BPAP therapy"
• 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.

Thoracic Restrictive Disorders

For thoracic restrictive disorders, the panel recommends BPAP for patients with any of the following:

• "Spirometry (upright or supine) with vital capacity <50% predicted or <80% predicted with associated symptoms (i.e. Orthopnea, dyspnea, morning headaches, excessive daytime sleepiness, or unrefreshing sleep),
• Force testing with maximal inspiratory pressure <60 cm H₂O,

Hypercapnia:

• Chronic stable daytime (awake) hypercapnia with PaCO₂ >45 mmHg,
• Venous blood gas PCO₂, end-tidal PCO₂, or transcutaneous PCO₂, >50 mmHg, or

Hypoxia:

• Overnight oximetry in-laboratory or home sleep test with saturation <88% for 5 minutes."

Home mechanical ventilation is recommended in patients with vital capacity <30% or if BPAP fails.

Hypoventilation Syndromes

For patients with hypoventilation syndromes who are obese the recommendations include:

• BPAP (spontaneous/timed) or volume-assured pressure support (VAPS) for those who are discharged from the hospital, for those with obesity hypoventilation syndrome (OHS) without obstructive sleep apnea, and for those who have failed continuous positive airway pressure (CPAP).

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.

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 COPD chronic obstructive pulmonary disease (COPD). The society included the recommendations in Table 2, all of which were conditional due to moderate to very low certainty in the evidence base.

Table 2. American Thoracic Society Recommendations for COPD

Recommendation	Strength of Recommendation	Level of Certainty
"We suggest the use of nocturnal noninvasive ventilation (NIV) in addition to usual care for patients with chronic stable hypercapnic COPD."	Conditional	Moderate
"We suggest that patients with chronic stable hypercapnic COPD undergo screening for obstructive sleep apnea before initiation of long-term NIV."	Conditional	Very low
"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."	Conditional	Low
"We suggest not using an in-laboratory overnight polysomnogram (PSG) to titrate NIV in patients with chronic stable hypercapnic COPD who are initiating NIV."	Conditional	Very low
"We suggest NIV with targeted normalization of PaCO2 in patients with hypercapnic COPD on long-term NIV."	Conditional	Low

COPD: chronic obstructive pulmonary disease; NIV: non-invasive ventilation; PaCO₂: pressure of carbon dioxide; PSG: polysomnogram. Hypercapnic COPD defined as PaCO₂ > 45 mmHg.

Obesity Hypoventilation Syndrome

In 2019, the American Thoracic Society published a clinical practice guideline on OHS. These guidelines recommend positive airway pressure for patients with OHS. Generally, CPAP is recommended over other NIV because the majority (>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.

Global Initiative for Chronic Obstructive Pulmonary Disease

The Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) published a revised report for 2024, GOLD guidelines recommend at least 1 of the following as an indication for non-invasive mechanical ventilation:

• Respiratory acidosis (PaCO₂ ≥45 mmHg and arterial pH ≤7.35);
• Severe dyspnea with clinical signs suggestive of respiratory muscle fatigue, increased work of breathing, or both;
• Persistent hypoxemia despite supplemental oxygen therapy.

National Institute for Health and Care Excellence Global

In 2019, the United Kingdom's NICE published a guideline for the diagnosis and management of COPD. 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.

KEY WORDS:

BiPap® ST, Synchrony ® S/T, respiratory assist devices with backup rate feature, noninvasive positive pressure respiratory assistance (NPPRA) , BiPap®,  Adaptive –Servo ventilation bi-level devices, BiPap AUTO SV, VPAP, Variable PAP, VPAP ST, VPAP adapt SV, CSA, Central Sleep Apnea, ASV, COPD, ALS

APPROVED BY GOVERNING BODIES:

Numerous CPAP and BiPap devices are available in the U.S.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

A7027	Combination oral/nasal mask, used with continuous positive airway pressure device, each
A7028	Oral cushion for combination oral/nasal mask, replacement only, each
A7029	Nasal pillows for combination oral/nasal mask, replacement only, pair
A7030	Full facemask used with positive airway pressure device, each
A7031	Face mask, interface, replacement for full-face mask, each
A7032	Replacement cushion for nasal application device, each
A7033	Replacement pillows for nasal application device, pair
A7034	Nasal interface (mask or cannula type), used with positive airway pressure device, with or without head strap
A7035	Headgear
A7036	Chin strap
A7037	Tubing
A7038	Filter, disposable
A7039	Filter, non-disposable
A7044	Oral interface used with positive airway pressure device, each
A7045	Exhalation port with or without swivel used with accessories for positive airway devices, replacement only
A7046	Water chamber for humidifier, used with positive airway pressure device, replacement, each
E0470	Respiratory assist device, bi-level pressure capability, without backup rate feature, used with non-invasive interface, e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure device
E0471	Respiratory assist device, bi-level pressure capability, with backup rate feature, used with noninvasive interface, e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure)
E0472	Respiratory assist device, bi-level capability, with backup rate feature, used with invasive interface, e.g., tracheostomy tube (intermittent assist device with continuous positive airway pressure)
E0561	Humidifier, non-heated, used with positive airway pressure   device
E0562	Humidifier, heated, used with positive airway pressure device

REFERENCES:

1. Afshar M, Brozek JL, Soghier I, et al. The Role of Positive Airway Pressure Therapy in Adults with Obesity Hypoventilation Syndrome. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. Mar 2020; 17(3): 344-360.
2. AlBalawi MM, Castro-Codesal M, Featherstone R, et al. Outcomes of Long-Term Noninvasive Ventilation Use in Children with Neuromuscular Disease: Systematic Review and Meta-Analysis. Ann Am Thorac Soc. Jan 2022; 19(1): 109-119.
3. American Thoracic Society. New Clinical Practice Guidelines on Non-Invasive Ventilation in Chronic Stable Hypercapnic COPD Published by the American Thoracic Society. https://www.atsjournals.org/doi/full/10.1164/rccm.202006-2382ST .August 2020.
4. Amra B, Balouchianzadeh S, Soltaninejad F, et al. Heart rate variability changes by noninvasive ventilation in obesity hypoventilation syndrome. Clin Respir J. 2021;15(7):770-778.
5. Arellano-Maric MP, Hamm C, Duiverman ML, et al. Obesity hypoventilation syndrome treated with non-invasive ventilation: Is a switch to CPAP therapy feasible?. Respirology. Apr 2020; 25(4): 435-442.
6. Borel JC, Tamisier R, Gonzalez-Bermejo J, et al. Noninvasive ventilation in mild obesity hypoventilation syndrome: a randomized controlled trial. Chest. Mar 2012; 141(3): 692-702.
7. Bourke SC, Tomlinson M, Williams TL, et al. Effects of non-invasive ventilation on survival and quality of life in patients with amyotrophic lateral sclerosis: a randomised controlled trial. Lancet Neurol. Feb 2006; 5(2): 140-7.
8. Claman DM, Piper A, Sanders MH, et al. Nocturnal non-invasive positive pressure ventilatory assistance-review article. Chest 1996.
9. Collaborative Research Group of Non-invasive Mechanical Ventilation for Chronic Obstructive Pulmonary Disease. Early use of non-invasive positive pressure ventilation for acute exacerbations of chronic obstructive pulmonary disease: A multicentre randomized controlled trial. Chin Med J (Engl). 2005;118(24):2034-2040.
10. Curtis JR, Cook DJ, Sinuff T, et al; Society of Critical Care Medicine Palliative Non-invasive Positive Ventilation Task Force. Noninvasive positive pressure ventilation in critical and palliative care settings: Understanding the goals of therapy. Crit Care Med. 2007;35(3):932-939.
11. Evensen AE. Management of COPD exacerbations. Am Fam Physician. 2010;81(5):607-613.
12. Gay PC, Owens RL, Gay PC, et al. Executive Summary: Optimal NIV Medicare Access Promotion: A Technical Expert Panel Report From the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society. Chest. Nov 2021; 160(5): 1808-1821.
13. Gomes Neto M, Duarte LFG, Rodrigues ES Jr, et al. Effects of noninvasive ventilation with bi-level positive airway pressure on exercise tolerance and dyspnea in heart failure patients. Hellenic J Cardiol. 2018;59(6):317-320.
14. Guilleminault C, Phillip P, Robinson A. Sleep and neuromuscular disease: bi-level positive airway pressure by nasal mask as a treatment for sleep disordered breathing in patients with neuromuscular disease. J Neurol Neurosurg Psychiatry. 1998; 65:225-232.
15. Hastings PC, Vazir A, Meadows GE, et al. Adaptive servo-ventilation in heart failure patients with sleep apnea: A real world study. Int J Cardiol. 2010;139(1):17-24.
16. Hillberg RE, Johnson DC. Current concepts: Noninvasive ventilation. N Engl J Med. 1997;337(24):1746-1752.
17. Howard ME, Piper AJ, Stevens B, et al. A randomised controlled trial of CPAP versus non-invasive ventilation for initial treatment of obesity hypoventilation syndrome. Thorax. May 2017; 72(5): 437-444.
18. Jackson CE, Rosenfeld J, Moore DH, et al. A preliminary evaluation of a prospective study of pulmonary function studies and symptoms of hypoventilation in ALS/MND patients. J Neurol Sci. Oct 15 2001; 191(1-2): 75-8.
19. Jaye J, Chatwin M, Dayer M, et al. Autotitrating versus standard noninvasive ventilation: a randomised crossover trial. Eur Respir J. Mar2009; 33(3): 566-71.
20. Jiang H, Han Y, Xu C, et al. Noninvasive positive pressure ventilation in chronic heart failure. Can Respir J. 2016;2016:3915237.
21. Kam K, Bjornson C, Mitchell I. Congenital central hypoventilation syndrome; safety of early transition to non-invasive ventilation. Pediatr Pulmonol. Apr 2014; 49(4): 410-3.
22. Khan A, Frazer-Green L, Amin R, et al. Respiratory Management of Patients With Neuromuscular Weakness: An American College of Chest Physicians Clinical Practice Guideline and Expert Panel Report. Chest. Mar 13 2023.
23. Loube DI, Gay PC, Strohl KP, et al. ACCP consensus statement: indications for positive airway pressure treatment of adult sleep apnea patients. Chest. 1999; 115:863-866.
24. Masa JF, Benítez I, Sánchez-Quiroga MÁ, et al. Long-term Noninvasive Ventilation in Obesity Hypoventilation Syndrome Without Severe OSA: The Pickwick Randomized Controlled Trial. Chest. Sep 2020; 158(3): 1176-1186.
25. Masa JF, Corral J, Alonso ML, et al. Efficacy of Different Treatment Alternatives for Obesity Hypoventilation Syndrome. Pickwick Study. Am J Respir Crit Care Med. Jul 01 2015; 192(1): 86-95.
26. Masa JF, Corral J, Caballero C, et al. Non-invasive ventilation in obesity hypoventilation syndrome without severe obstructive sleep apnoea. Thorax. Oct 2016; 71(10): 899-906.
27. Masa JF, Mokhlesi B, Benítez I, et al. Long-term clinical effectiveness of continuous positive airway pressure therapy versus non-invasive ventilation therapy in patients with obesity hypoventilation syndrome: a multicentre, open-label, randomised controlled trial. Lancet. Apr 27 2019; 393(10182): 1721-1732.
28. Mokhlesi B, Masa JF, Brozek JL, et al. Evaluation and Management of Obesity Hypoventilation Syndrome. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. Aug 01 2019; 200(3): e6-e24.
29. Mokhlesi B, Won CH, Make BJ, et al. Optimal NIV Medicare Access Promotion: Patients With Hypoventilation Syndromes: A Technical Expert Panel Report From the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society. Chest. Nov 2021; 160(5): e377-e387.
30. Momomura S, Seino Y, Kihara Y, et al. Adaptive servo-ventilation therapy using an innovative ventilator for patients with chronic heart failure: A real-world, multicenter, retrospective, observational study (SAVIOR-R). Heart Vessels. 2015;30(6):805-817.
31. Morgenthaler TI, Gay PC, Gordon N, Brown LK. Adaptive servoventilation versus noninvasive positive pressure ventilation for central, mixed, and complex sleep apnea syndromes. Sleep. 2007 Apr;30(4):468-75.
32. Morrell MJ, Meadows GE, Hastings P, et al. The effects of adaptive servo ventilation on cerebral vascular reactivity in patients with congestive heart failure and sleep-disordered breathing. Sleep. 2007; 30(5):648-653.
33. Murphy PB, Davidson C, Hind MD, et al. Volume targeted versus pressure support non-invasive ventilation in patients with super obesity and chronic respiratory failure: a randomised controlled trial. Thorax. Aug 2012; 67(8): 727-34.
34. National Association for Medical Direction of Respiratory Care. (NAMDRC).  Clinical indications for noninvasive positive pressure ventilation in chronic respiratory failure due to restrictive lung disease, COPD, and nocturnal hypoventilation---A consensus conference report.  Chest.  1999; 116(2): 521-534.
35. National Institute for Health and Care Excellence (NICE). Chronic obstructive pulmonary disease in over 16s: diagnosis and management [NG115]. 2019 https://www.nice.org.uk/guidance/ng115 
36. Patout M, Gagnadoux F, Rabec C, et al. AVAPS-AE versus ST mode: A randomized controlled trial in patients with obesity hypoventilation syndrome. Respirology. Oct 2020; 25(10): 1073-1081.
37. Quon BS, Gan WQ, Sin DD. Contemporary management of acute exacerbations of COPD: A systematic review and metaanalysis. Chest. 2008;133(3):756-766.
38. Ram FSF, Picot J, Lightowler J, Wedzicha JA. Non-invasive positive pressure ventilation for treatment of respiratory failure due to exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2004;(3):CD004014.
39. Sancho J, Servera E, Morelot-Panzini C, et al. Non-invasive ventilation effectiveness and the effect of ventilatory mode on survival in ALS patients. Amyotroph Lateral Scler Frontotemporal Degener. Mar 2014; 15(1-2): 55-61.
40. Srivali N, Thongprayoon C, Tangpanithandee S, et al. The use of continuous positive airway pressure in COPD-OSA overlap syndrome:A systematic review. Sleep Med. Aug 2023; 108: 55-60.
41. Struik FM, Duiverman ML, Meijer PM, et al. Volume-targeted versus pressure-targeted noninvasive ventilation in patients with chest-wall deformity: a pilot study. Respir Care. Oct 2011; 56(10): 1522-5.
42. Tsai CL, Lee WY, Delclos GL, et al. Comparative effectiveness of noninvasive ventilation vs invasive mechanical ventilation in chronic obstructive pulmonary disease patients with acute respiratory failure. J Hosp Med. 2013;8(4):165-172.
43. Vasquez MM, McClure LA, Sherrill DL, et al. Positive Airway Pressure Therapies and Hospitalization in Chronic Obstructive Pulmonary Disease. Am J Med. Jul 2017; 130(7): 809-818.
44. Wilson ME, Dobler CC, Morrow AS, et al. Association of home noninvasive positive pressure ventilation with clinical outcomes in chronic obstructive pulmonary disease: A systematic review and meta-analysis. JAMA. 2020;323(5):455-465.
45. Wolfe LF, Benditt JO, Aboussouan L, et al. Optimal NIV Medicare Access Promotion: Patients With Thoracic Restrictive Disorders: A Technical Expert Panel Report From the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society. Chest. Nov 2021; 160(5): e399-e408.
46. Xu J, Wei Z, Li W, et al. Effect of different modes of positive airway pressure treatment on obesity hypoventilation syndrome: a systematic review and network meta-analysis. Sleep Med. Mar 2022; 91: 51-58.
47. Xu Z, Wu Y, Li B, et al. Noninvasive ventilation in a young infant with congenital central hypoventilation and 7-year follow-up. Pediatr Investig. Dec 2019; 3(4): 261-264.

POLICY HISTORY:

Medical Policy Group, June 1998

Medical Policy Group, May 2001

Medical Policy Group, August 2004 (2)

Medical Policy Administration Committee, September 2004

Available for comment November 2-December 16, 2004

Medical Policy Group, February 2006 (1)

Medical Policy Group, April 2007 (2)

Medical Policy Administration Committee, April 2007

Available for comment April 20-June 4, 2007

Medical Policy Group, October 2008 (1)

Medical Policy Group, March 2010 (3)

Medical Policy Administration Committee, April 2010

Available for comment March 24-May 7, 2010

Medical Policy Group, June 2010 (3)

Medical Policy Administration Committee, July 2010

Medical Policy Group, July 2010 (3)

Medical Policy Administration Committee, August 2010

Available for comment August 6-September 18, 2010

Medical Policy Group, July 2013 (3): 2013 Update – no updated literature to add; no change in policy statement

Medical Policy Group, July 2013: Effective July 31, 2013, this policy will remain active but will no longer be scheduled for regular literature updates and reviews.

Medical Policy Group, October 2013 (3):  Corrected error in policy statement – no change in content of coverage

Medical Policy Group, April 2014 (5):  Updated Maximums for tubing.

Medical Policy Administration May 2014

Available for comment May 6 through June 19, 2014

Medical Policy Group, April 2016 (6):  Removed policy statement regarding non-invasive pressure ventilation for obstructive sleep apnea and moved to policy #065 Diagnosis and Medical Management of Obstructive Sleep Apnea Syndrome and removed table with supply maximums. Policy name changed for clarification to Non-invasive Positive Pressure Ventilation for Conditions Other Than Obstructive Sleep Apnea; no changes to policy intent.

Medical Policy Group, June 2017 (6): Removed old policy statement from 2014. No change to policy statement.

Medical Policy Group, November 2018 (6): Updates to Description, policy statement, Key Words (Remede, ASV, CSA, Central Sleep Apnea, Phrenic nerve stimulation), Practice Guidelines, Coding (0424T- 0436T,94660) and References.

Medical Policy Group, June 2019 (6): All information regarding phrenic nerve stimulation moved to MP 203 Phrenic Nerve Stimulation for Central Sleep Apnea.

Medical Policy Group, December 2020 (6): Updates to Description, Key Points, Current Coding (A7027/A7028/A7029/A7044/A7045/A7046) removed CPT 94660, Practice Guidelines and References.

Medical Policy Group, January 2022 (6):Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy. Updates to Policy statement, Key Points, Practice Guidelines and References.

Medical Policy Group, November 2022 (6): Updates to Key Points and Practice Guidelines.

Medical Policy Panel, September 2023 (Adopting BCBSA medical policy)

Medical Policy Group, September 2023 (6): Updates to Policy title: Non-invasive Positive Pressure Devices for the Treatment of Respiratory Insufficiency and Failure, Policy Statement expanded, Key Points, Practice Guidelines, Governing Bodies, Key Words, Benefit Application and References. Draft October 1, 2023- November 15, 2023.

Medical Policy Panel, March 2024

Medical Policy Group, March 2024 (6): Updates to Key Points, Governing Bodies and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.