POLICY PRODUCT VARIATIONS DESCRIPTION/BACKGROUND RATIONALE DEFINITIONS BENEFIT VARIATIONS DISCLAIMER CODING INFORMATION REFERENCES POLICY HISTORY

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1 Original Issue Date (Created): 7/1/2002 Most Recent Review Date (Revised): 3/24/2015 Effective Date: 6/1/2015 POLICY PRODUCT VARIATIONS DESCRIPTION/BACKGROUND RATIONALE DEFINITIONS BENEFIT VARIATIONS DISCLAIMER CODING INFORMATION REFERENCES POLICY HISTORY I. POLICY Home cardio respiratory (pneumogram) monitoring may be considered medically necessary in infants younger than 12 months of age in the following situations: Those who have experienced an apparent life- threatening event (see policy guidelines;; or Those with tracheostomies or anatomic abnormalities that make them vulnerable to airway compromise; or Those with neurologic or metabolic disorders affecting respiratory control, including central apnea and apnea of prematurity; or Those with chronic lung disease (i.e., bronchopulmonary dysplasia), particularly those requiring supplemental oxygen; continuous positive airway pressure; or mechanical ventilation; Home cardio respiratory monitoring (pneumogram) is considered not medically necessary in infants with any siblings with a history of sudden infant death syndrome (SIDS), but without at least one of the indications cited. Home cardio respiratory monitoring (pneumogram) in all other conditions, including but not limited to the diagnosis of obstructive sleep apnea is considered investigational, as there is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure. Policy guidelines This policy does not address the use of home monitoring for the diagnosis and management of obstructive sleep apnea. If obstructive sleep apnea is a consideration, refer to MP Page 1

2 An apparent life-altering event is defined as an episode that is frightening to observe and is characterized by some combination of apnea, color change, marked change in muscle tone, choking, or gagging. As suggested by a Policy Statement from the American Academy of Pediatrics, the physician should also establish a specific plan for periodic review and termination. Should monitoring beyond forty-three (43) weeks' gestational age be recommended, clear documentation of the reasons for continuing monitoring is necessary. Home cardiorespiratory monitoring for apnea is generally not considered appropriate for pediatric patients older than 1 year of age. There may be a subset of young children who require cardiorespiratory monitoring beyond 1 year of age, such as certain patients with home noninvasive or invasive ventilator use or chronic lung disease. Home monitors should be equipped with an event recorder. Home cardio respiratory monitoring is intended, in part, to alert caregivers of the need for intervention at the time of an event in patients with apnea, and is not appropriate for diagnosis of sleep-disordered breathing (central or obstructive). Cross-reference: MP Diagnosis and Medical Management of Obstructive Sleep Apnea II. PRODUCT VARIATIONS [N] = No product variation, policy applies as stated [Y] = Standard product coverage varies from application of this policy, see below [N] Capital Cares 4 Kids [N] PPO [N] HMO [N] SeniorBlue HMO [N] SeniorBlue PPO [N] Indemnity [N] SpecialCare [N] POS [Y] FEP PPO* * Refer to FEP Medical Policy Manual MP , Home Apnea Monitoring in Children. The FEP Medical Policy Manual can be found at: III. DESCRIPTION/BACKGROUND Home apnea monitors track respiratory effort and heart rate, and are typically utilized to monitor central apnea of prematurity in newly discharged at-risk or high-risk premature infants (infants are at increased risk of cardio respiratory events until 43 weeks post-gestational age) and in other infants at risk of apnea. An alarm will sound if there is respiratory cessation (central apnea) beyond a predetermined time limit (e.g., 20 seconds) or if the heart rate falls below a preset rate (bradycardia) to notify the parent that intervention (stimulation, mouth-to- Page 2

3 mouth resuscitation, cardiac compressions) is required. Unless an oximeter is added to the twochannel devices, home apnea monitors are not effective at detecting obstructive sleep apneas. False alarms due to movement artifact are common with pulse oximeters, and these devices are not intended for the diagnosis of sleep-disordered breathing in a child. Sudden infant death syndrome (SIDS) is the sudden death of an infant under 1 year of age; the circumstances are unexplained after a thorough investigation that includes autopsy, examination of the death scene, and review of the family history. As a means to decrease the incidence of SIDS, in the 1970s, cardio respiratory monitoring was suggested. However over time, scientific medical studies have failed to establish that the use of home monitoring reduces the incidence of SIDS. In 2011, the American Academy of Pediatrics Task Force on Sudden Infant Death Syndrome reiterated the recommendations of its previous policy statements that home monitoring should not be used as a strategy to prevent SIDS (1). Instead AAP recommends that proven practices should be promoted to reduce the incidence of SIDS, which includes supine sleeping, use of a firm bed surface, routine immunizations, breast-feeding and avoidance of exposure to tobacco smoke, alcohol and illegal drugs. One of these proven practices, supine sleeping, has been promoted in the Safe to Sleep campaign (formerly called the Back to Sleep campaign) initiated in 1994 by AAP, as well as by the National Institute of Child Health and Development and the Maternal Child Health Bureau of Human Resources and Services Administration, AAP. The campaign is a national process to educate health care professionals, parents, and caregivers about the significance of placing infants in the supine sleeping position to reduce SIDS.(2) The incidence of SIDS in the U.S. decreased dramatically between 1992 and 2001, especially in the years after the first supine sleep position recommendations were issued. The incidence of SIDS has remained relatively constant since 2001, and SIDS remains a major cause of infant mortality in the U.S. Regulatory Status A number of infant apnea monitors have been cleared for marketing by the U.S. Food and Drug Administration (FDA). One device is the SmartMonitor 2 Apnea Monitor (Philip Children s Medical Ventures, Respironics), which was cleared for marketing through the 510(k) process in October The intended use is for continuous monitoring of respiration, heart rate, and SpO2 (pulse oximetry of infant patients in a hospital or home environment. IV. RATIONALE Sudden Infant Death Syndrome (SIDS) As noted in the Background section of the policy, during the 1970s and 1980s, it was hypothesized that prolonged periods of apnea and bradycardia were markers for sudden infant death syndrome (SIDS) risk in the susceptible infant and preceded the ultimate SIDS event; if this was the case, home apnea monitors could alert caregivers to the presence of an impending Page 3

4 event. A 2011 technical report from AAP s Task Force on Sudden Infant Death Syndrome does not recommend home apnea monitoring to prevent SIDS.(1) The AAP report cites a lack of evidence that home monitors are effective for this purpose. The Collaborative Home Infant Monitoring Evaluation (CHIME) study, a longitudinal cohort study conducted from 1994 to1998, was designed to address the question of whether severe episodes of apnea and bradycardia occur more commonly in infants considered at higher risk for SIDS. (4) The study included 1079 infants, both healthy and considered at high risk for SIDS based on a history of an apparent life-threatening event (ALTE), siblings with SIDS, and preterm gestation, who were observed with home cardiorespiratory monitoring for the first 6 months after birth. Alarming of the monitors occurred frequently across all risk groups, occurring in 41% of all subjects. So-called extreme events occurred in all groups, but preterm infants were at higher risk until 43 weeks postconceptual age. The authors concluded that episodes of prolonged apnea or bradycardia primarily occurred before the developmental age when most SIDS deaths occurred. Follow-up analyses to the CHIME study found that extreme events were not significantly associated with any known SIDS risk factors. (5) In 2012, Strehle et al published a systematic review of literature on the impact of home monitoring (apnea monitoring, respiratory monitoring or cardiorespiratory monitoring) on mortality in infants at increased risk of SIDS.(6) The review identified 1 pilot study to assess the feasibility of a randomized controlled trial evaluating home monitoring and 10 unique case series. The authors concluded that there is a lack of high-level evidence that home monitoring is beneficial in preventing SIDS. Other Respiratory Conditions There is a lack of evidence for use of home apnea monitors in other conditions. For many of these conditions, trials would be difficult to perform due to small numbers of patients and logistic difficulties for these conditions that make enrollment in trials difficult. As a result, the best available recommendations for treatment currently rely on expert consensus. A consensus document published in 2003 by the AAP Committee on Fetus and Newborn addressed the use of home apnea monitors for other respiratory conditions.(3) The AAP policy statement identified infants who could benefit from home monitoring, not because of an increased risk of SIDS but because of other factors that increase the risk of sudden death. These infants include those who have: experienced an ALTE tracheostomies or anatomic abnormalities that make them vulnerable to airway compromise neurologic or metabolic disorders affecting respiratory control chronic lung disease (i.e., bronchopulmonary dysplasia), particularly those requiring supplemental oxygen; continuous positive airway pressure; or mechanical ventilation. Page 4

5 The 2003 AAP consensus statement was retired in 2012.(7) Although the consensus guidelines have been retired, a review of the literature since that time did not identify major studies that address outcomes from home apnea monitoring that would significantly call into question the 2003 policy statement s criteria for home cardiorespiratory monitoring. Summary There is insufficient evidence from published studies and a lack of support from national guidelines for home apnea monitoring to prevent sudden infant death syndrome (SIDS). For other respiratory conditions, there is also a lack of published evidence; however national guidelines published by the American Academy of Pediatrics (AAP) have identified specific groups of infants who might benefit from home monitoring because of other factors that increase the risk of sudden death (e.g., tracheostomies, chronic lung disease, etc.). These conditions identified by the AAP as benefiting from home apnea monitor may therefore be considered medically necessary. Practice Guidelines and Position Statements AAP s Committee on Fetus and Newborn published a policy on home apnea monitoring in 2003.(3) In 2012, the policy was retired.(7) The document noted that infants who may benefit from home monitoring include those who have experienced an ALTE, have tracheostomies, have anatomic abnormalities that make them vulnerable to airway compromise, or have neurologic or metabolic disorders affecting respiratory control, including central sleep apnea, chronic lung disease including bronchopulmonary dysplasia and especially those individuals requiring supplemental oxygen, continuous positive airway pressure or mechanical ventilation. Furthermore, AAP recommended that if monitoring is to be used at home, parents and other caregivers must be trained in observation techniques, operation of the monitor, and infant cardiopulmonary resuscitation. Medical and technical support staff should always be available for direct or telephone consultation. AAP s Committee on Fetus and Newborn published a policy on the hospital discharge of the high-risk neonate in 2008 that addresses the role of home apnea monitors for preterm and otherwise high-risk infants. (11) The guideline states: Home monitors are rarely indicated for detection of apnea solely because of immature respiratory control, in part because infants with immature respiratory control, in general, are still hospitalized until they are no longer at risk of apnea of prematurity. Use of a home monitor does not preclude the need for demonstrated maturity of respiratory control before discharge and should not be used to justify discharge of infants who are still at risk of apnea. Home monitors are not indicated for prevention of sudden infant death syndrome (SIDS) in preterm infants, although preterm infants are at increased risk of SIDS. Page 5

6 V. DEFINITIONS APNEA is defined in infants as cessation of breathing for twenty (20) seconds or longer. CENTRAL SLEEP APNEA refers to a form of sleep apnea which results from the lack of neurologic stimulation to breathe. VI. BENEFIT VARIATIONS The existence of this medical policy does not mean that this service is a covered benefit under the member's contract. Benefit determinations should be based in all cases on the applicable contract language. Medical policies do not constitute a description of benefits. A member s individual or group customer benefits govern which services are covered, which are excluded, and which are subject to benefit limits and which require preauthorization. Members and providers should consult the member s benefit information or contact Capital for benefit information. VII. DISCLAIMER Capital s medical policies are developed to assist in administering a member s benefits, do not constitute medical advice and are subject to change. Treating providers are solely responsible for medical advice and treatment of members. Members should discuss any medical policy related to their coverage or condition with their provider and consult their benefit information to determine if the service is covered. If there is a discrepancy between this medical policy and a member s benefit information, the benefit information will govern. Capital considers the information contained in this medical policy to be proprietary and it may only be disseminated as permitted by law. VIII. CODING INFORMATION Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement. Covered when medically necessary: CPT Codes Page 6

7 Current Procedural Terminology (CPT) copyrighted by American Medical Association. All Rights Reserved. HCPCS Code A4556 A4557 E0618 E0619 Description 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 ICD-9-CM Diagnosis Description Code* Choanal atresia Other anomalies of nose Web of larynx Other anomalies of larynx, trachea, and bronchus Congenital cystic lung Agenesis, hypoplasia, and dysplasia of lung Congenital bronchiectasis Other anomalies of lung Other specified anomalies of respiratory system Tracheoesophageal fistula, esophageal atresia and stenosis Other specified anomalies of esophagus 769 Respiratory distress syndrome Chronic respiratory disease arising in the perinatal period Other respiratory problems after birth, code range Primary apnea of newborn Other apnea of newborn Cyanotic attacks of newborn Respiratory failure of newborn Aspiration of postnatal stomach contents without respiratory symptoms Aspiration of postnatal stomach contents with respiratory symptoms Respiratory arrest of newborn Hypoxemia of newborn Other respiratory problems after birth Neonatal bradycardia Cardiac arrest of newborn V44.0 Tracheostomy V46.1 Respirator [Ventilator] Page 7

8 V46.2 Supplemental oxygen *If applicable, please see Medicare LCD or NCD for additional covered diagnoses. The following ICD-10 diagnosis codes will be effective October 1, 2015: ICD-10-CM Diagnosis Description Code* P22.0 Respiratory distress syndrome of newborn P22.1 Transient tachypnea of newborn P22.8 Other respiratory distress of newborn P22.9 Respiratory distress of newborn, unspecified P24.30 Neonatal aspiration of milk and regurgitated food without respiratory symptoms P24.31 Neonatal aspiration of milk and regurgitated food with respiratory symptoms P24.81 Neonatal aspiration with respiratory symptoms P27.0 Wilson-Mikity syndrome P27.1 Bronchopulmonary dysplasia originating in the perinatal period P27.8 Other chronic respiratory diseases in the perinatal period P27.9 Unspecified chronic respiratory disease originating in the perinatal period P28.2 Cyanotic attacks of newborn P28.3 Primary sleep apnea of newborn P28.4 Other apnea of newborn P28.5 Respiratory failure of newborn P28.81 Respiratory arrest of newborn P28.89 Other specified respiratory conditions of newborn P28.9 Respiratory condition of newborn, unspecified P29.12 Neonatal bradycardia P84 Other problems with newborn Q30.0 Choanal atresia Q30.1 Agenesis and underdevelopment of nose Q30.2 Fissured, notched and cleft nose Q30.3 Congenital perforated nasal septum Q30.8 Other congenital malformations of nose Q30.9 Congenital malformation of nose, unspecified Q31.0 Web of larynx Q31.1 Congenital subglottic stenosis Q31.2 Laryngeal hypoplasia Q31.3 Laryngocele Q31.5 Congenital laryngomalacia Page 8

9 Q31.8 Other congenital malformations of larynx Q31.9 Congenital malformation of larynx, unspecified Q32.0 Congenital tracheomalacia Q32.1 Other congenital malformations of trachea Q32.2 Congenital bronchomalacia Q32.3 Congenital stenosis of bronchus Q32.4 Other congenital malformations of bronchus Q33.0 Congenital cystic lung Q33.1 Accessory lobe of lung Q33.2 Sequestration of lung Q33.3 Agenesis of lung Q33.4 Congenital bronchiectasis Q33.6 Congenital hypoplasia and dysplasia of lung Q34.0 Anomaly of pleura Q34.1 Congenital cyst of mediastinum Q34.8 Other specified congenital malformations of respiratory system Q39.0 Atresia of esophagus without fistula Q39.1 Atresia of esophagus with tracheo-esophageal fistula Q39.2 Congenital tracheo-esophageal fistula without atresia Q39.3 Congenital stenosis and stricture of esophagus Q39.4 Esophageal web Q39.5 Congenital dilatation of esophagus Q39.6 Congenital diverticulum of esophagus Q39.8 Other congenital malformations of esophagus Q39.9 Congenital malformation of esophagus, unspecified R68.13 Apparent life threatening event in infant (ALTE) Z93.0 Tracheostomy status Z99.11 Dependence on respirator [ventilator] status Z99.81 Dependence on supplemental oxygen *If applicable, please see Medicare LCD or NCD for additional covered diagnoses. IX. REFERENCES 1. Task Force on Sudden Infant Death S, Moon RY. SIDS and other sleep-related infant deaths: expansion of recommendations for a safe infant sleeping environment. Pediatrics 2011; 128(5): Page 9

10 2. National Institute of Child Health and Human Development (NICHD). Safe to Sleep campaign. Available online at: Last accessed January, American Academy of Pediatrics Committee on Fetus and Newborn. Apnea, sudden infant death syndrome, and home monitoring. Pediatrics 2003; 111(4 pt 1): Ramanathan R, Corwin MJ, Hunt CE et al. Cardiorespiratory events recorded on home monitors: Comparison of healthy infants with those at increased risk for SIDS. JAMA 2001; 285(17): Hoppenbrouwers T, Hodgman JE, Ramanathan A et al. Extreme and conventional cardiorespiratory events and epidemiologic risk factors for SIDS. J Pediatr 2008; 152(5): Strehle EM, Gray WK, Gopisetti S et al. Can home monitoring reduce mortality in infants at increased risk of sudden infant death syndrome: a systematic review. Acta Paediatr 2012; 101(1): AAP Publications Reaffirmed and Retired. Pediatrics 2012; 130(2):e467-e Tieder JS, Cowan CA, Garrison MM et al. Variation in inpatient resource utilization and management of apparent life-threatening events. J Pediatr 2008; 152(5):629-35, 35 e McGovern MC, Smith MB. Causes of apparent life threatening events in infants: a systematic review. Arch Dis Child 2004; 89(11): Mittal MK, Donda K, Baren JM. Role of pneumography and esophageal ph monitoring in the evaluation of infants with apparent life-threatening event: a prospective observational study. Clin Pediatr 2013; 52(4): Fetus Co, Newborn. Hospital Discharge of the High-Risk Neonate. Pediatrics 2008; 122(5): Other: Taber s Cyclopedic Medical Dictionary, 20th edition. IX. POLICY HISTORY MP CAC 2/24/04 CAC 5/31/05 CAC 4/25/06 CAC 3/27/07 Discussion tabled until April meeting CAC 4/24/07 CAC 3/25/08 CAC 3/31/09 Consensus CAC 3/30/2010 Consensus CAC 5/25/2010 Policy criteria revised to include central sleep apnea. Investigational statement added for all other conditions not specifically indicated in medical necessity criteria. Page 10

11 CAC 4/24/12 Adopted BCBSA. Added age criteria of younger than 12 months to the medically necessary statement. Removed medically necessary statement for premature infants under 37 weeks gestation. CAC 6/4/13 Consensus list review. No coding changes. CAC 3/25/14 Consensus review. References updated. No changes to the policy statements. Rationale added. Codes reviewed. CAC 3/24/15. Minor review. Policy statements changed as follows: The phrase and apnea of prematurity was added to the indication those with neurologic or metabolic disorders affecting respiratory control, including central apnea. The word sleep was removed from central sleep apnea. A statement that certain children may require monitoring beyond one year added to the policy guidelines. A statement was added to the policy guidelines that this policy does not address the diagnosis or management of obstructive sleep apnea. Rationale and reference list updated. Policy coded. Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage Insurance Company and Keystone Health Plan Central. Independent licensees of the Blue Cross and Blue Shield Association. Communications issued by Capital BlueCross in its capacity as administrator of programs and provider relations for all companies. Page 11