Apnea Monitors for Infants Form

This policy is supported by a statement by the American Academy of Pediatrics (2003) on home apnea monitoring of infants.

There are 3 types of infant apnea:

central

obstructive

mixed central and obstructive apnea.

In central or diaphragmatic apnea, the infant makes no effort to breathe; the chest is still, and no air passes through the mouth or nose. In obstructive apnea, the chest is moving but no air passes through the mouth or nose (usually due to soft tissue such as the tongue blocking the upper airway). In mixed apnea, the infant has episodes of both central and obstructive apnea all within the same event. Most home infant apnea monitors measure chest movements and heart rate. Normally, the monitor's alarm is set to go off if the infant stops breathing for 20 seconds or if the heart rate slows to less than 80 beats/min (Stehlin, 1991).

Bani Amer and colleagues (2010) presented a contactless method for monitoring infant sleep apnea. The method uses a remote infrared sensor to monitor the motion of the infant's abdomen. According to the developers, this method has potential important clinical advantages in comparison with conventional methods. First, it has the potential to improve the comfort and compliance of the infants. Second, it may eliminate the effects of motion artefacts and skin irritation. Third, it may enhance infant safety. Fourth, it does not require frequent calibration and thus enables a continuous monitoring of sleep apnea. Finally, it is suitable for home applications. Experimental evaluation of this method showed that it has 85 % accuracy, 85.71 % specificity and 84.62 % sensitivity, which imply that it is a promising technique for the detection of infant sleep apnea.

Silvestri et al (1994) examined children referred to their apnea program who were greater than or equal to 12 months of age, beyond the at-risk period for sudden infant death syndrome (SIDS), but for whom home cardiorespiratory monitoring had continued. The objectives of this study were to

determine reasons for initiation and continuation of monitoring,

apply documented monitoring of transthoracic impedance, electrocardiographic signals, and, in a subset of patients, pulse oximetry, to determine the types of cardiorespiratory events that these children experienced, and

describe how documented monitoring was applied for eventual discontinuation of monitoring.

Among 45 patients (median age of 22 months), 263 disks were collected, representing 2,982 monitor days. Indications for initiation of monitoring included an apparent life-threatening event in 51.1 % of patients, apnea of prematurity in 35.5 %, history of SIDS or apparent life-threatening event in a relative in 9 %, and intra-uterine drug exposure in 4.4 %. Continuation of monitoring had been based on continued alarms and, in 31 % of patients, documented apnea, bradycardia, or hemoglobin desaturation. In 40 of 45 patients, 2,292 episodes of apnea (17.5 % of all events) were recorded (range of 16 to 31 seconds). Five patients had 223 episodes of bradycardia (1.7 % of all events). Of all 13,075 recorded events, 76.8 % resulted in audible alarms, but only 3.9 % of these alarms were for apnea and 2.2 % were for bradycardia. Of 19 patients studied with pulse oximetry, 18 had 663 episodes of hemoglobin desaturation less than 90 %. All children were thriving at the time of referral. Discontinuation of monitoring was based on a child's ability to resume breathing spontaneously or on normalization of heart rate or hemoglobin saturation before the audible alarm sounded, for a minimum of 2 to 3 months. By extension of the audible apnea alarm to 25 or 30 seconds, lowering of the cut-off point for bradycardia alarm, or lowering of the cut-off point for the oximetry alarm, a recommendation to discontinue monitoring could be made for 41 patients. Of these, no child had a recurrence of cardiorespiratory events or died of SIDS. Documented monitoring proved to be a useful clinical tool for investigation of the clinical and physiologic importance of these cardiorespiratory events in children beyond the at-risk period for SIDS; recommendations about discontinuation of monitoring could be made knowledgeably and safely.

Congenital Myasthenic Syndromes

Abicht and colleagues (2016) stated that congenital myasthenic syndromes (CMS) are characterized by fatigable weakness of skeletal muscle (e.g., ocular, bulbar, limb muscles) with onset at or shortly after birth or in early childhood; rarely, symptoms may not manifest until later in childhood. Cardiac and smooth muscle are usually not involved. Severity and course of disease are highly variable, ranging from minor symptoms to progressive disabling weakness. In some subtypes of CMS, myasthenic symptoms may be mild, but sudden severe exacerbations of weakness or even sudden episodes of respiratory insufficiency may be precipitated by fever, infections, or excitement. Major findings of the neonatal-onset subtype include: respiratory insufficiency with sudden apnea and cyanosis; feeding difficulties; poor suck and cry; choking spells; eyelid ptosis; and facial, bulbar, and generalized weakness. Arthrogryposis multiplex congenita may also be present. Stridor in infancy may be an important clue to CMS. Later childhood-onset subtypes show abnormal muscle fatigability with difficulty in activities such as running or climbing stairs; motor milestones may be delayed; fluctuating eyelid ptosis and fixed or fluctuating extraocular muscle weakness are common presentations. Parents of infants are advised to use apnea monitors and be trained in cardio-pulmonary resuscitation (CPR).

An UpToDate review on "Neuromuscular junction disorders in newborns and infants" (Bodamer and Miller, 2017) states that "Affected infants may have fluctuating generalized hypotonia and weakness and life-threatening episodes of apnea. Congenital myasthenia often improves with age, but spontaneous exacerbations may occur and sometimes result in sudden death in infancy … Respiratory care is an important aspect of management, since hypoventilation can occur in all subtypes of CMS. Some patients may benefit from noninvasive ventilation at home".

Scope of Policy

This Clinical Policy Bulletin addresses apnea monitors for infants.

Medical Necessity

Aetna considers apnea monitors medically necessary durable medical equipment (DME) for infants less than 12 months of age with documented apnea or who have known risk factors for life threatening apnea according to the following indications:

Diagnosis of pertussis, with positive cultures, upon discharge from acute care facility. If monitored for pertussis, use of an apnea monitor is considered medically necessary for up to 1 month post diagnosis.

Documented apnea accompanied by bradycardia to less than 80 beats per minute; use of an apnea monitor is considered medically necessary until the infant remains event free for 6 weeks.

Documented apnea accompanied by marked hypotonia; use of an apnea monitor is considered medically necessary until the infant remains event free for 6 weeks.

Documented apnea accompanied by oxygen desaturation (oxygen saturation below 90 %), cyanosis or pallor; use of an apnea monitor is considered medically necessary until the infant remains event free for 6 weeks.

Documented gastro-esophageal reflux disease that results in apnea, bradycardia, or oxygen desaturation, until the infant remains event free for 6 weeks.

Documented prolonged apnea of greater than 20 seconds in duration; use of an apnea monitor is considered medically necessary until the infant remains event free for 6 weeks.

Infants with an apparent life-threatening event (ALTE), defined as an episode that is characterized by some combination of apnea (central or occasionally obstructive), color change (usually cyanotic or pallid but occasionally erythematous or plethoric), marked change in muscle tone (usually marked limpness), choking, or gagging. If monitored due to ALTE, use of an apnea monitor is considered medically necessary until the baby remains event free for 6 weeks.

Infants with apnea of prematurity, defined as sudden cessation of breathing that lasts for at least 20 seconds or is accompanied by bradycardia (heart rate less than 80 beats/min) or oxygen desaturation (oxygen saturation less than 90 % or cyanosis) in an infant younger than 37 weeks' gestational age. Continued use is considered medically necessary until they are past a post-conceptional age of 43 weeks and are event free for 6 weeks.

Infants with bradycardia on caffeine, theophylline, or similar agents, until event free for 6 weeks off medication.

Infants with chronic lung disease (bronchopulmonary dysplasia), especially those requiring supplemental oxygen, continuous positive airway pressure, or mechanical ventilation

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Infants with congenital myasthenic syndromes

Infants with neurologic or metabolic disorders affecting respiratory control (medical necessity reviewed on an individual case basis)

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Infants with tracheostomies or anatomic abnormalities that make them vulnerable to airway compromise (medical necessity reviewed on an individual case basis)

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Later siblings of infants who died of sudden infant death syndrome (SIDS), use of an apnea monitor is considered medically necessary until the later siblings are 1 month older than the age at which the earlier sibling died and they remain event free.

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Except as specified for certain indications noted above, infant apnea monitors are usually considered medically necessary for approximately 3 months. Continued use of an apnea monitor is considered medically necessary for the durations noted in this policy, even when infants reach 12 months of age during the course of specified medically necessary duration of use. Apnea monitoring for children beyond 12 months old requires physician documentation supporting the continuation of monitoring (e.g., continued alarms, documented apnea, bradycardia, or hemoglobin desaturation).

The later siblings of infants who died of SIDS present a unique emotional and clinical dilemma. Many clinicians suggest monitoring such infants until they are 1 month older than the age at which the sibling died, and remain event free, although such use is not directly supported by specific evidence in the peer-reviewed medical literature. Aetna considers apnea monitors medically necessary in such circumstances.

The term "post-conceptional age" is defined as gestational age at birth plus age in weeks from birth. According to the American Academy of Pediatrics, this is more accurately designated as "postmenstrual age".

Types of Monitors/Studies

Because of the capabilities of a smart monitor, continuing sleep studies and pneumograms are not typically necessary. Should the ordering doctor wish to continue obtaining pneumograms for a child on a smart monitor, Aetna will alert the ordering doctor that continued use of a smart monitor is not considered medically necessary. Aetna considers a regular apnea monitor medically necessary for the duration of time that the doctor continues to want ongoing studies.

Experimental and Investigational

The following procedures are considered experimental and investigational because the effectiveness of these approaches has not been established:

Infant apnea monitors for all other indications because their effectiveness for indications other than the ones listed above Remote infrared sensor for the detection of infant sleep apnea

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