Policy. ( Number: *Pleasesee amendment forpennsylvaniamedicaidattheend ofthis CPB.

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1 1 of 12 ( Number: 0003 Policy *Pleasesee amendment forpennsylvaniamedicaidattheend ofthis CPB. 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: Last Review 03/09/2018 Effective: 07/21/1995 Next Review: 01/10/2019 Review History Definitions 1. 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. 2. 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. 3. Documented apnea accompanied by marked hypotonia; use of an apnea monitor is considered medically necessary until the infant remains event free for 6 weeks. 4. 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. Clinical Policy Bulletin Notes

2 2 of Documented gastro esophageal reflux disease that results in apnea, bradycardia, or oxygen desaturation, until the infant remains event free for 6 weeks. 6. 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. 7. 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. 8. 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. 9. Infants with bradycardia on caffeine, theophylline, or similar agents, until event free for 6 weeks off medication. 10. Infants with chronic lung disease (bronchopulmonary dysplasia), especially those requiring supplemental oxygen, continuous positive airway pressure, or mechanical ventilation *. 11. Infants with congenital myasthenic syndromes 12. Infants with neurologic or metabolic disorders affecting respiratory control (medical necessity reviewed on an individual case basis) *. 13. Infants with tracheostomies or anatomic abnormalities that make them vulnerable to airway compromise (medical necessity reviewed on an individual case basis) *. 14. 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

3 3 of 12 than the age at which the earlier sibling died and they remain event free. Aetna considers infant apnea monitors experimental and investigational for all other indications because their effectiveness for indications other than the ones listed above has not been established. Aetna considers the use of remote infrared sensor for the detection of infant sleep apnea experimental and investigational because its effectiveness for has not been established. * 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:

4 4 of 12 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. Background 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: (i) central (ii) obstructive (iii) 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

5 5 of 12 of sleep apnea. Finally, it is suitable for home applications. Experimental evaluation of this method showed that it has 85 % accuracy, % specificity and % 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 (i) determine reasons for initiation and continuation of monitoring, (ii) 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 (iii) 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 lifethreatening 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

6 6 of 12 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 cardiopulmonary resuscitation (CPR). An UpToDate review on Neuromuscular junction disorders in newborns and infants (Bodamer and Miller, 2017) states that

7 7 of 12 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. CPT Codes / HCPCS Codes / ICD 10 Codes Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+": Code Code Description ICD 10 codes will become effective as of October 1, 2015 : CPT codes covered if selection criteria are met: Pediatric home apnea monitoring event recording including respiratory rate, pattern and heart rate per 30 day period of time; includes monitor attachment, download of data, physician review, interpretation, and preparation of a report monitor attachment only (includes hook up, initiation of recording and disconnection) monitoring, download of information, receipt of transmission(s) and analyses by computer only physician review, interpretation and preparation of report only HCPCS codes covered if selection criteria are met: A4556 A4557 E0618 E0619 Electrodes (e.g., apnea monitor), per pair Lead wires (e.g., apnea monitor), per pair Apnea monitor, without recording feature Apnea monitor, with recording feature

8 8 of 12 Code Code Description Other HCPCS codes related to the CPB: J0706 J2810 Injection, caffeine citrate, 5 mg Injection, theophylline, per 40 mg ICD 10 codes covered if selection criteria are met (not allinclusive): A37.00 A37.91 Whooping cough G93.1 Anoxic brain damage, not elsewhere classified I49.5 Sick sinus syndrome I49.8 Other specified cardiac arrhythmias K21.9 Gastro esophageal reflux disease without esophagitis P07.00 P07.18 P07.21 P07.39 P22.0 P28.89 Disorders of newborn related to short gestation and low birthweight, not elsewhere classified Respiratory disorders specific to the perinatal period P29.12 Neonatal bradycardia P84 Q30.0 Q34.9 Q39.0 Q39.9 Other problems with newborn Congenital malformations of the respiratory system Congenital malformations of esophagus R00.1 Bradycardia, unspecified R06.81 Apnea, not elsewhere classified R23.0 Cyanosis R23.1 Pallor

9 9 of 12 Code Code Description Z93.0 Tracheostomy status Z99.11 Dependence on respirator [ventilator] status Z99.81 Dependence on supplemental oxygen The above policy is based on the following references: 1. American Academy of Pediatrics, Committee on Fetus and Newborn. Hospital discharge of the high risk neonate proposed guidelines. Pediatrics. 1998;102(2 Pt 1): Corwin MJ, Lister G, Silvestri JM, et al. Agreement among raters in assessment of physiologic waveforms recorded by a cardiorespiratory monitor for home use. Collaborative Home Infant Monitoring Evaluation (CHIME) Study Group. Pediatr Res. 1998;44(5): Steinschneider A, Richmond C, Ramaswamy V, Curns A. Clinical characteristics of an apparent life threatening event (ALTE) and the subsequent occurrence of prolonged apnea or prolonged bradycardia. Clin Pediatr (Phila). 1998;37(4): Darnall RA, Kattwinkel J, Nattie C, Robinson M. Margin of safety for discharge after apnea in preterm infants. Pediatrics.1997;100(5): Eichenwald EC, Aina A, Stark AR. Apnea frequently persists beyond term gestation in infants delivered at 24 to 28 weeks. Pediatrics. 1997;100(3 Pt 1): Malloy MH, Hoffman HJ. Home apnea monitoring and sudden infant death syndrome. Prev Med. 1996;25(6): Spinner S, Gibson E, Wrobel H, Spitzer AR. Recent advances in home infant apnea monitoring. Neonatal Netw. 1995;14(8): Malloy MH, Graubard B. Access to home apnea monitoring and its impact on rehospitalization among very low birth

10 10 of 12 weight infants. Arch Pediatr Adolesc Med. 1995;149(3): Keens TG, Ward SL. Apnea spells, sudden death, and the role of the apnea monitor. Pediatr Clin North Am. 1993;40(5): Carbone MT. Sudden infant death syndrome and subsequent siblings. N J Med. 1992;89(9): No authors listed. Infantile apnea and home monitoring. Natl Inst Health Consens Dev Conf Consens Statement. 1986;6(6): Kahn A, Blum D, Montauk L. Polysomnographic studies and home monitoring of siblings of SIDS victims and of infants with no family history of sudden infant death. Eur J Pediatr. 1986;145(5): Tudehope DI, Cleghorn G. Home monitoring for infants at risk of the sudden infant death syndrome. Aust Paediatr J. 1984;20(2): Duffty P, Bryan MH. Home apnea monitoring in 'near miss' sudden infant death syndrome (SIDS) and in siblings of SIDS victims. Pediatrics. 1982;70(1): Aberdroth D, Moser DK, Dracup K, Doering LV. Do apnea monitors decrease emotional distress in parents of infants at high risk for cardiopulmonary arrest? J Pediatr Health Care. 1999;13(2): Cote A, Hum C, Brouillette RT, Themens M. Frequency and timing of recurrent events in infants using home cardiorespiratory monitors. J Pediatr. 1998;132(5): Baker L, Thyer B. Promoting parental compliance with home infant apnea monitor use. Behave Res Ther. 2000;38(3): Santin RL, Porat R. Apnea of prematurity. emedicine Pediatrics Topic Omaha, NE: emedicine.com; updated January 2, Committee on Fetus and Newborn. American Academy of Pediatrics. Apnea, sudden infant death syndrome, and home monitoring. Pediatrics. 2003;111(4 Pt 1): Bhatt Mehta V, Schumacher RE. Treatment of apnea of prematurity. Paediatr Drugs. 2003;5(3): Poets CF. Apparent life threatening events and sudden

11 11 of 12 infant death on a monitor. Paediatr Respir Rev. 2004;5 Suppl A:S383 S Silvestri JM, Lister G, Corwin MJ, et al. Factors that influence use of a home cardiorespiratory monitor for infants: The collaborative home infant monitoring evaluation. Arch Pediatr Adolesc Med. 2005;159(1): Stehlin D. Infant apnea monitors help parents breathe easy. FDA Consumer. 1991;25(5). 24. Eyssen M, Kohn L, Lambert ML, Van Den Steen D. Home monitoring of infants in prevention of sudden infant death syndrome. KCE Reports 46. Brussels, Belgium: Belgian Health Care Knowledge Centre (KCE); Naulaers G, Daniels H, Allegaert K, et al. Cardiorespiratory events recorded on home monitors: The effect of prematurity on later serious events. Acta Paediatr. 2007;96(2): Carbone T, McEntire B, Kissin D, et al. Absence of an increase in cardiorespiratory events after diphtheriatetanus acellular pertussis immunization in preterm infants: A randomized, multicenter study. Pediatrics. 2008;121(5):e1085 e Halbower AC. Pediatric home apnea monitors: Coding, billing, and updated prescribing information for practice management. Chest. 2008;134(2): Silvestri JM. Indications for home apnea monitoring (or not). Clin Perinatol. 2009;36(1): Bani Amer MM, Az Zaqah R, Aldofash AK, et al. Contactless method for detection of infant sleep apnoea. J Med Eng Technol. 2010;35(5 6): Silvestri JM, Weese Mayer DE, Kenny AS, Hauptman SA. Prolonged cardiorespiratory monitoring of children more than twelve months of age: Characterization of events and approach to discontinuation. J Pediatr. 1994;125(1): Marinez Monseny A, Bobillo Pérez S, Marinez Planas A, García García JJ. The role of complementary examinations and home monitoring in patient at risk from apparent life threatening event, apneas and sudden infant death syndrome. An Pediatr (Barc). 2015;83(2): Abicht A, Muller J S, Lochmuller H. Congenital Myasthenic

12 12 of 12 Syndromes. GeneReviews [Internet]. Seattle (WA): University of Washington, Seattle; May 9, 2003 [Updated: July 14, 2016]. 33. Bodamer OA, Miller G. Neuromuscular junction disorders in newborns and infants. UpToDate Inc., Waltham, MA. Last reviewed September 2017.

13 13 of 12 Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change. Copyright Aetna Inc.

14 AETNA BETTERHEALTH OF PENNSYLVANIA Amendment to Aetna Clinical Policy Bulletin Number: 0003 Apnea Monitors for Infants There are no amendments for Medicaid. betterhealth. com/pennsylvania revised 3/9/2018

SmartMonitor Helpful for Filing

SmartMonitor Helpful for Filing Apnea Monitor HCPCS E0618 or E0619 Overview The following information describes coverage and payment information regarding the use of the Circadiance SmartMonitor: Coding, coverage, payment, and documentation