Clinical Policy Title: Apnea monitors for infants in-home use

Transcription

1 Clinical Policy Title: Apnea monitors for infants in-home use Clinical Policy Number: Effective Date: October Initial Review Date: March Most Recent Review Date: April 10, 2018 Next Review Date: April 2019 Policy contains: Apnea monitors. Cardiorespiratory monitors. Sudden infant death syndrome. Related policies: None. ABOUT THIS POLICY: Prestige Health Choice has developed clinical policies to assist with making coverage determinations. Prestige Health Choice s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by Prestige Health Choice when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Prestige Health Choice s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Prestige Health Choice s clinical policies are reflective of evidencebased medicine at the time of review. As medical science evolves, Prestige Health Choice will update its clinical policies as necessary. Prestige Health Choice s clinical policies are not guarantees of payment. Coverage policy Prestige Health Choice considers the use of apnea monitors for infants less than 12 months to be clinically proven and, therefore, medically necessary durable medical equipment when any of the following criteria are met: Infants who have experienced any Brief Resolved Unexplained Events until they remain eventfree for six weeks. Infants diagnosed with pertussis with positive cultures, upon discharge from an acute care facility. If monitored for pertussis, use of an apnea monitor is considered medically necessary for up to one month post-diagnosis. Infants with tracheostomies or anatomic abnormalities that make them vulnerable to airway compromise.* Infants with neurologic or metabolic disorders affecting respiratory control, including central sleep apnea.* 2

2 Infants with chronic lung disease (i.e., bronchopulmonary dysplasia), especially those requiring supplemental oxygen, continuous positive airway pressure or mechanical ventilation.* Infants at high risk of recurrent episodes of prolonged apnea with duration greater than 20 seconds, bradycardia (heart rate less than 80 beats per minute) and hypoxemia (oxygen saturation below 90 percent) after hospital discharge, until the infant remains event-free for six weeks. Infants with gastroesophageal reflux disease that results in apnea, bradycardia or oxygen desaturation, until the infants remain event-free for six weeks. Infants with apnea accompanied by marked hypotonia; use of an apnea monitor until the infants remain event-free for six weeks. Infants with tracheostomies or anatomic abnormalities that make them vulnerable to airway compromise. Infants with neurologic or metabolic disorders affecting respiratory control. Infants with chronic lung disease (bronchopulmonary dysplasia), especially those requiring supplemental oxygen, continuous positive airway pressure, or mechanical ventilation.the use of home cardiorespiratory monitoring for infants with apnea of prematurity, defined as sudden cessation of breathing that lasts for at least 20 seconds or at least 10 seconds if accompanied by bradycardia or hypoxemia in infants younger than 37 weeks gestational age. Continued use is considered medically necessary until infants are past post-conceptional age of 43 weeks and are event-free for six weeks (AAP, 2003). * Except as specified for certain indications noted in this policy, infant apnea monitors are usually considered medically necessary for approximately three months. Continued use of an apnea monitor, during the course specified as medically necessary, is considered medically necessary for the durations noted in this policy, even when infants reach age 12 months. 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). Limitations: Coverage determinations are subject to benefit limitations and exclusions as delineated by the state Medicaid authority. The Florida Medicaid website may be accessed at All other uses for apnea monitoring for infants are not medically necessary. The use of apnea monitors for remote infrared sensor for the detection of infant sleep apneas is not medically necessary because its effectiveness has not been established. Home cardiorespiratory monitoring is intended in part to alert caregivers to intervene at the time of an event in patients with apnea and is not medically necessary to diagnose sleepdisordered breathing (central or obstructive). Alternative covered services: 3

3 Increased network physician office visits and evaluation. Background The American Academy of Pediatrics defines clinically significant apnea in infants as an unexplained episode of cessation of breathing for 20 seconds or longer, or a shorter respiratory pause associated with bradycardia, cyanosis, pallor, and/or marked hypotonia (AAP, 2003). Apnea that occurs in premature infants (gestation under 37 weeks) includes a sudden cessation of breathing for more than 20 seconds or is accompanied by bradycardia or oxygen desaturation (cyanosis). Only a minority of such cases remain unresolved after 37 weeks postmenstrual age, mostly in very premature (gestation under 28 weeks) infants; nearly all of these cases resolve by 43 weeks postconception (AAP, 2003). Even among premature infants, apnea and bradycardia are not common; one study of 1403 infants born earlier than 34 weeks gestation found that only 15.8 and 21.5 percent had apnea and bradycardia events after they were otherwise ready for discharge (Lorch, 2011). Apnea monitors were introduced in the mid-1960s for the management of apnea of prematurity in hospital settings. Subsequently, cardiorespiratory monitoring became widely used in the care of infants with a variety of acute and chronic disorders. There are three types of infant apnea: Central apnea Both the inspiratory effort and airflow cease simultaneously (absence of chest wall movement and airflow). Obstructive apnea Airflow is absent in the presence of inspiratory efforts (presence of chest wall movement, but no airflow). Mixed apnea Central apnea is preceded or followed by airway obstruction. At one time, experts speculated that sudden infant death syndrome could be caused by sleep apnea (AAP, 2003). However, apnea is now recognized as not predictive of SIDS, as most apnea cases resolve prior to the usual age of sudden infant death syndrome (45.8 weeks and 52.3 weeks postmenstrual for infants born weeks and all infants). Known practices to reduce sudden infant death syndrome include supine sleep position, firm sleeping surfaces, breastfeeding, room sharing without bed-sharing, routine immunizations, avoidance of soft bedding and overheating, and elimination of prenatal/postnatal exposure to tobacco smoke. In addition, risk of sudden infant death syndrome in later siblings is known to be extremely low (AAP, 2003, AAP, 2011, Eichenwald, 2016). Many premature newborns are successfully treated for sleep apnea while in the hospital; caffeine citrate has been shown to be an effective means of treatment, achieving results superior to those from methylxanthamine therapy (Schmidt, 2007; Schmidt, 2014). The decision of whether or not to discharge an infant after a life-threatening event such as apnea or brachycardia/tachycardia is a difficult one, with limited ability to predict future risk of such an event, according to a systematic review of 37 studies (Tieder, 2013). 4

4 However, if an infant with apnea is otherwise cleared for discharge, the physician recommends the monitor, and the discharge planner, social worker, or case manager coordinates the process. A home apnea monitor is a belt-like device, or involves electrodes. Recently, a remote infrared sensor that does not contact the infant has been developed (Bani Amer, 2010). While apnea is relatively common among premature infants, the condition is associated only with acute, not chronic, conditions (Fairchild, 2016). Searches: Prestige Health Choice searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on February 9, Search terms were: home apnea monitor infant and home apnea monitor prematurity. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings The 2003 American Association of Pediatrics guideline on infant apnea, updated in 2007, recommended home cardiorespiratory monitoring: Should not be used to prevent sudden infant death syndrome. May be warranted for premature infants at high risk for recurring apnea, bradycardia, or hypoxemia after discharge, up to 43 weeks postmenstrual age or after cessation of episodes (whichever is last). Infants dependent on devices such as tracheostomy and continuous positive airway pressure, or who have unstable airways, have rare conditions affecting breathing, or have chronic lung disease. Should only use monitors with an event recorder. 5

5 Should ensure parents are advised that the technology has not been proven to prevent sudden infant death syndrome. Should ensure promotion by pediatricians of proven practices to decrease sudden infant death syndrome risk (AAP, 2003). A study of 741 infants born with a gestational age over 34 weeks at two Boston neonatal intensive care units from 2009 to 2013 documented the likelihood of home monitor use was greater in infants with either a prolonged inpatient stay or greater gestational age at birth (Veit, 2016). Studies have shown that premature infants who are discharged needed a home monitor for cardiorespiratory functions. One study of 1058 infants found that 96 needed home monitoring, and that 61 of these experienced alarms at home. The mean post-conceptional age of stopping alarms was 46 weeks (Naulaers, 2007). A 2014 review of 272 discharged infants confirmed that home apnea or pulse oximetry use significantly raised the chance of a readmission within 30 days of discharge (Jurgens, 2014). A systematic review of 11 studies (n=2210) assessed the ability of home monitoring to reduce sudden infant death syndrome, but only one study compared results to a control group; the others were cohort studies considered to be level III evidence. The one randomized controlled trial calculated the sudden infant death syndrome mortality rate for babies with home monitors to be 5.0 per 1,000, compared to a rates for nonmonitored infants ranging from 1.2 to 5.6 per 1,000 (Strehle, 2012). An earlier systematic review of 51 studies (n=5901) assessed the ability of portable monitors to diagnose sleep apnea in infants. Results were mixed for likelihood ratios, rates of false negatives/positive, and whether the evidence level was low or high. Researchers concluded that some studies show increased or decreased chance of diagnosing the disorder via the apnea/hypopnea index, and that the best evidence came from high-quality studies of type 3 monitors (Flemons, 2003). A study of 1079 infants monitored at home for apnea or bradycardia (over 700,000 hours) found a link between infants with multiple events and less favorable outcomes after one year. Apnea and bradycardia among these infants tended to be preceded by cardiorespiratory and hemoglobin O 2 saturation changes (Hunt 2008). In addition to cardiorespiratory monitors, pulse oximeters with low false-alarm rates can be used to provide information on oxygenation status during events. One study of 37 infants found that 69 percent of 13,228 events lasted fewer than 10 seconds, and that 13 patients needed intervention following alarms, 10 of whom were readmitted to a hospital (Gelinas, 2008). Compliance with home sleep apnea monitors has been a concern for practitioners. One review covering 175 families who used 12,862 days of home monitoring documented that families who used telemedicine 6

6 to report results had a higher compliance rate than those using the conventional system, i.e., 70 to 50 percent (Piumelli, 2012). Standardizing the definition of clinically significant cardiopulmonary and concurrent education improved outcomes for premature infants (gestation 24 to 36 weeks) who were discharged from the neonatal intensive care unit in a Kansas medical center. Incidence fell from 74 percent diagnosed with apnea of prematurity at baseline to 49 percent diagnosed with clinically significant cardiopulmonary events after implementing the new definition (p<0.001). The proportion of infants discharged on caffeine declined from 17 to 5 percent (p<0.001), and home monitor use also fell from 54 to 16 percent (p<0.001) (Powell, 2017). Policy updates: A total of two peer-reviewed references were added to, and one guideline/other and one peer-reviewed reference were removed from this policy in February Summary of clinical evidence: Citation Veit (2016) Content, Methods, Recommendations Key points: Patterns of home monitor use in preterm to term infants with apnea, bradycardia, or desaturations A study of 741 infants born with a gestational age over 34 weeks at two Boston neonatal intensive care units from 2009 to Study identified variables associated with home monitor use. Diagnostic evaluations on blood culture, blood glucose, and head ultrasound most common. The likelihood of home monitor use was greater in infants with either a prolonged inpatient stay or greater gestational age at birth. Strehle (2012) Key points: Ability of home apnea monitors to reduce SIDS Systematic review of 11 studies (n=2210) of infants with home apnea monitors. 10 were cohort studies, 1 was randomized controlled trial. 11 deaths documented to be SIDS = event rate of 5.0 deaths per 1000, not different than the rate for non-monitored infants (1.2 to 5.6 per 1000). Flemons (2003) Ability of portable monitors to diagnose sleep apnea in infants AAP (2003) Key points: Systematic review of 51 studies (n=5901). Studies carried out both in the home and in a laboratory. Two of four Type 3 studies conducted at home rated as evidence level II, along with 4 of 8 Type 4 studies rated as evidence level I or II, worse than those conducted in a lab. Results were mixed for likelihood ratios, rates of false negatives/positive, and whether the evidence level was low or high. Some studies show increased or decreased chance of diagnosing the disorder via the apnea/hypopnea index. The best evidence came from high-quality studies of type 3 monitors. Key points: Guideline on use of infant sleep apnea American Academy of Pediatrics guideline on apnea, SIDS, and home monitoring. Home apnea monitoring should not be used to prevent SIDS. 7

7 Citation Content, Methods, Recommendations monitoring Home apnea monitoring may be warranted for premature infants at high risk for recurring apnea, bradycardia, or hypoxemia after discharge, up to 43 weeks postmenstrual age or after cessation of episodes (whichever is last). Home apnea monitoring should be only for infants dependent on devices such as tracheostomy and continuous positive airway pressure, or who have unstable airways, have rare conditions affecting breathing, or have chronic lung disease. References Professional society guidelines/other: American Academy of Pediatrics (AAP). Task Force on Sudden Infant Death Syndrome. Moon RY. SIDS and other sleep-related infant deaths: expansion of recommendations for a safe infant sleeping environment. Pediatrics. 2011;128(5): American Academy of Pediatrics (AAP). Policy Statement: AAP publications reaffirmed and retired. Pediatrics. 2012;130(2):e467 e468. Committee on Fetus and Newborn. American Academy of Pediatrics (AAP). Apnea, sudden infant death syndrome, and home monitoring. Pediatrics. 2003;111(4 Pt. 1): Reaffirmed May, Eichenwald EC and AAP Committee on Fetus and Newborn. Apnea of prematurity. Pediatrics. 2016;137(1):e1 e7. Peer-reviewed references: Bani Amer MM, Az-Zaqah R, Aldofash AK, Mohammad AY, Dameer AM. Contactless method for detection of infant sleep apnoea. J Med Eng Technol. 2010;34(5-6): Fairchild K, Mohr M, Paget-Brown A, et al. Clinical associations of immature breathing in preterm infants: part 1-central apnea. Pediatr Res. 2016;80)1): Flemons WW, Littner MR, Rowley JA, et al. Home diagnosis of sleep apnea: a systematic review of the literature; an evidence review cosponsored by the American Academy of Sleep Medicine, the American College of Chest Physicians, and the American Thoracic Society. Chest. 2003;124(4): Gelinas JF, Davis GM, Arlegui C, Cote A. Prolonged, documented home-monitoring of oxygenation in infants and children. Pediatr Pulmonol. 2008;43(3): Hunt CE, Corwin MJ, Lister G, et al. Precursors of cardiorespiratory events in infants detected by home memory monitor. Pediatr Pulmonol. 2008;43(1):

8 Jurgens V, Spaeder MC, Pavuluri P, Waldman Z. Hospital readmission in children with complex chronic conditions discharged from subacute care. Hosp Pediatr. 2014;4(3): Lorch SA, Srinivasan L, Escobar GJ. Epidemiology of apnea and bradycardia resolution in premature infants. Pediatrics. 2011;128:e366. Naulaers G, Daniels H, Allegaert K, Rayyan M, Debeer A, Devlieger H. Cardiorespiratory events recorded on home monitors: the effect of prematurity on later serious events. Acta Paediatr. 2007;96(2): Piumelli R, Nassi N, Liccioli G, Ernst CM, Donzelli G. Telemonitoring for infants at risk of apnoea, bradycardia, and hypoxaemia: transmission of data improves the family compliance during home monitoring. J Telemed Telecare. 2012;18(6): Powell MB, Ahlers-Schmidt CR, Engel M, Bloom BT. Clinically significant cardiopulmonary events and the effect of definition standardization on apnea of prematurity management. J Perinatol. 2017;37(1): Schmidt B, Roberts RS, Davis P, et al. Caffeine for Apnea of Prematurity Trial Group. Long-term effects of caffeine therapy for apnea of prematurity. N Engl J Med. 2007;357(19): Schmidt B, Davis PG, Roberts RS. Timing of caffeine therapy in very low birth weight infants. J Pediatr. 2014;164(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):8 13. Tieder JS, Altman RL, Bonkowsky JL, et al. Management of apparent life-threatening events in infants: a systematic review. J Pediatr. 2013;163(1): Veit L, Amberson M, Freiberger C, Montenegro B, Mukhopadhyay S, Rhein LM. Diagnostic evaluation and home monitor use in late preterm to term infants with apnea, bradycardia, and desaturations. Clin Pediatr (Phila). 2016;55(13): Wise MS, Nichols CD, Grigg-Damberger MM, et al. Executive summary of respiratory indications for polysomnography in children: an evidence-based review. Sleep. 2011; 34(3): AW. CMS National Coverage Determinations (NCDs): No NCDs identified as of the writing of this policy. Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. 9

9 Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comment 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, review, interpretation, and preparation of a report by a physician or other qualified health care professional Pediatric home apnea monitoring event recording, including respiratory rate, pattern and heart rate per 30-day period of time; monitor attachment only (includes hook-up, initiation of recording and disconnection), Pediatric home apnea monitoring event recording, including respiratory rate, pattern and heart rate per 30-day period of time; monitoring, download of information, receipt of transmission(s) and analyses by computer only Pediatric home apnea monitoring event recording, including respiratory rate, pattern and heart rate per 30-day period of time; review, interpretation and preparation of report only by a physician or other qualified health care professional. One per day One per day One per day ICD-10 Code Description Comment A37.00 Whooping cough due to Bordetella pertussis without pneumonia A37.01 Whooping cough due to Bordetella pertussis with pneumonia A37.10 Whooping cough due to Bordetella parapertussis without pneumonia A37.11 Whooping cough due to Bordetella parapertussis with pneumonia A37.80 Whooping cough due to other Bordetella species without pneumonia A37.81 Whooping cough due to other Bordetella species with pneumonia K21.9 Gastro-esophageal reflux disease without esophagitis P27.1 Bronchopulmonary dysplasia originating in the perinatal period P28.2 Cyanotic attacks of newborn P28.3 Primary sleep apnea of newborn P28.4 Other apnea of newborn P29.12 Neonatal bradycardia Q31.0 Web of larynx Q31.1 Congenital subglottic stenosis Q31.5 Congenital laryngomalacia 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 Q33.4 Congenital bronchiectasis Q34.8 Other specified congenital malformations of respiratory system Q34.9 Congenital malformation of respiratory system, unspecified Q39.0 Atresia of esophagus without fistula Q39.1 Atresia of esophagus with tracheo-esophageal fistula Q39.2 Congenital tracheo-esophageal fistula without atresia Q39.4 Esophageal web 10

10 ICD-10 Code Description Comment 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 Z93.0 Tracheostomy status Z99.11 Dependence on respirator Z99.81 Dependence on supplemental oxygen HCPCS Level II Code Description Comment A4556 Electrodes (e.g., apnea monitor), per pair. A4557 Lead wires (e.g., apnea monitor), per pair. E0618 Apnea monitor, without recording feature. One per month (rental) E0619 Apnea monitor, with recording feature. One per month (rental) 11