Clinical UM Guideline



Subject: Infant Home Apnea Monitors
Guideline #:  CG-DME-08 Current Effective Date:    09/27/2017
Status: Reviewed Last Review Date:    08/03/2017

Description

This document addresses the use of apnea (cardiorespiratory) monitors for use in the home to monitor both respiratory and heart rates on infants.  An alarm will sound if there is respiratory cessation (apnea) beyond a predetermined time limit (for example, 20 seconds), or if the heart rate falls below a preset rate (bradycardia).

Clinical Indications

Medically Necessary:

Home cardiorespiratory (that is, apnea) monitoring is considered medically necessary in any of the following infants:

  1. Those who have experienced a brief resolved unexplained event (BRUE). If monitored due to BRUE, use of an apnea monitor is considered medically necessary until event free for 2 to 3 months.
  2. Those with tracheostomies or anatomic abnormalities of the face, tongue, jaw or airway that make them vulnerable to airway compromise.*
  3. Those with neurologic or metabolic disorders affecting respiratory control.*
  4. Those with chronic lung disease (that is, bronchopulmonary dysplasia), particularly those requiring supplemental oxygen; continuous positive airway pressure; or mechanical ventilation.*
  5. Those 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 per minute) or oxygen (O2 ) desaturation (O2 saturation less than 90% or cyanosis) in an infant with early home discharge prior to term (38 weeks). Continued use is considered medically necessary up to 43 weeks postmenstrual age or event free for 2 weeks, whichever comes later.
  6. Those discharged home on a schedule of weaning narcotics.*
  7. Those with bradycardia on caffeine, theophylline, or similar agents, until event free for 2 weeks off medication.
  8. Those with diagnosis of pertussis, with positive cultures. If monitored for pertussis, use of a monitor is considered medically necessary for up to one month post diagnosis.
  9. Those with diagnosis of gastroesophageal reflux disease (GERD) that results in apnea (at least 20 seconds), bradycardia (heart rate less than 80 beats per minute), or oxygen desaturation (O2 saturation less than 90% or cyanosis), until event free for 6 weeks.

*Note: See Duration section below.

Other considerations:

  1. The home monitor should be equipped with an event recorder.
  2. The physician should establish a specific plan for periodic review and termination of the home monitor before initiating therapy.

Note: Short-term monitoring to assist the family transition to home may be indicated in some cases following a previous sibling death from sudden infant death syndrome (SIDS) or following a particularly complex and protracted neonatal hospital course.

Not Medically Necessary:

Home apnea monitoring is considered not medically necessary for infants who do not meet the medically necessary criteria listed above.

Duration

Duration:

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

CPT  
94774 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
94775 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)
94776 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
94777 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
   
HCPCS  
E0618 Apnea monitor, without recording feature
E0619 Apnea monitor, with recording feature
   
ICD-10 Diagnosis  
  All diagnoses
   
Discussion/General Information

Infant home apnea monitors were designed with the purpose of protecting infants by identifying central apnea or bradycardia and signaling for parental intervention to prevent death (Halbower, 2008).  Data recording devices are used with the monitor so the health care provider can study the event.  The U.S. Food and Drug Administration (FDA, 2002) 510K premarket review process for class II devices defines apnea monitors as:

A complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath.  The apnea monitor also includes indirect methods of apnea detection, such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.

The American Academy of Pediatrics (AAP) 2003 policy statement regarding apnea, SIDS, and home cardiorespiratory monitoring (such as apnea monitoring) does not recommend apnea monitoring to prevent SIDS, noting the theory that apneic episodes related to SIDS has never been proven in spite of extensive research over several decades.  The AAP also notes there is no evidence to demonstrate that the presence of apnea or bradycardia can identify a group at increased risk of SIDS; that home monitoring can provide warning in time for intervention to prevent sudden death; or that intervention would be successful in preventing unexpected death.  The policy concludes: "Given the lack of evidence that home cardiorespiratory monitoring has any impact on SIDS, prevention of SIDS is not an acceptable indication for home cardiorespiratory monitoring."  The AAP recommends that pediatricians should promote proven practices that decrease the risk of SIDS such as supine sleep position, safe sleeping environments, and elimination of prenatal and postnatal exposure to tobacco smoke.  Parents should be advised that home cardiorespiratory monitoring has not been proven to prevent sudden unexpected deaths in infants.

The AAP policy statement was reaffirmed in 2005, and also 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 that have:

In the 2011 update of expanded recommendations for apnea monitors as a strategy to reduce SIDS, the AAP policy notes, "There is no evidence that use of such devices decreases the incidence of SIDS.  They might be of value for selected infants but should not be used routinely."

A recent AAP clinical practice guideline (2016) addresses the evaluation of lower-risk infants who have experienced ALTEs.  The AAP Subcommittee on Apparent Life Threatening Events committee recommends replacing the term ALTE with BRUE.  AAP defines BRUE as:

An event occurring in an infant < 1 year of age when the observer reports a sudden, brief*, and now resolved episode of ≥ 1 of the following:

Moreover, clinicians should diagnose a BRUE only when there is no explanation for a qualifying event after conducting an appropriate history and physical examination

* By consensus, the subcommittee established < 1 minute as the upper limit of a "brief event," understanding that objective, verifiable measurements were rarely, if ever, available.

The authors note that the use of BRUE, which uses more objective, specific defining criteria, and excludes symptomatic infants (such as those with fever or respiratory events), allows for a more precise diagnosis to "prevent the overuse of medical interventions by helping clinicians distinguish infants with lower risk".  In order to be designated as lower risk, the following criteria need to be met:

In those infants classified as lower risk, AAP does not recommend the use of home cardiorespiratory monitoring, noting "Clinicians Should Not Initiate Home Cardiorespiratory Monitoring in Infants Presenting with a Lower-Risk BRUE (Grade B, Moderate Recommendation)."  While AAP does not recommend the use of home cardiorespiratory monitoring, it is noted this recommendation may result in missing an infant with recurrent central apnea or cardiac arrhythmias.  In those infants determined to be higher risk, the guideline notes "Although it is beyond the scope of this clinical practice guideline, future research may show that home monitoring (cardiorespiratory and/ or oximetry) is appropriate for some infants with higher-risk BRUE."

It is recognized that the later sibling(s) of an infant who died of SIDS presents 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, it may be impossible to preclude monitoring if one or more siblings has died of SIDS.  Short-term monitoring to assist the family transition to home may be indicated in some cases following a previous sibling death from SIDS or following a particularly complex and protracted neonatal hospital course.

Types of Apnea
There are three types of infantile apnea: central, obstructive, and mixed. 

Central Apnea: Central apnea is characterized by complete cessation of respiratory efforts on the monitor and is usually related to central nervous system injury, very premature infants in whom the respiratory center in the brain is immature, depressant medications (for example, narcotics, sedatives), or metabolic conditions (for example, hypoglycemia).  The chest is still and no air passes through the nose or mouth.

Obstructive Apnea: A common type of apnea in children, obstructive apnea is caused by an obstruction of the airway (such as enlarged tonsils and adenoids) and is most likely to happen during sleep when the soft tissue at back of the throat is most relaxed.  In obstructive apnea, there is no airflow below the glottis though the monitor will continue to demonstrate breathing movements.  The chest is moving, but no air passes through the nose or mouth. Infant home monitoring may identify heart rate changes that can accompany episodes of obstructive apnea.

Mixed Apnea: Mixed apnea is a combination of central and obstructive apnea and is seen particularly in infants or young children who have abnormal control of breathing.  Mixed apnea may occur when a child is awake or asleep.

Monitors that are equipped with an event recorder are able to capture and store data surrounding significant events, such as heart rate and rhythm, for later analysis by a physician.  If home cardiorespiratory monitoring is prescribed, the monitor should be equipped with an event recorder.  Information from the monitor can be used to distinguish the type of apnea and allow for a distinct treatment plan based on the etiology.

References

Peer Reviewed Publications:

  1. Freed GE, Meny R, Glomb WB, Hageman JR. Effect of home monitoring on a high-risk population. J Perinatol. 2002; 22(2):165-167.
  2. Halbower AC. Pediatric home apnea monitors: coding, billing, and updated prescribing information for practice management. Chest. 2008; 134(2):425-429.
  3. Hoppenbrouwers T, Hodgman JE, Ramanathan A, Dorey F. Extreme and conventional cardiorespiratory events and epidemiologic risk factors for SIDS. J Pediatr. 2008; 152(5):636-641.
  4. Jobe AH. What do home monitors contribute to the SIDS problem? JAMA. 2001; 285(17):2244-2245.
  5. Lorch SA, Srinivasan L, Escobar GJ. Epidemiology of apnea and bradycardia resolution in premature infants. Pediatrics. 2011; 128(2):e366-e373.
  6. Naulaers G, Daniels H, Alleqaert K, et al. Cardiorespiratory events recorded on home monitors: the effect of prematurity on later serious events. Acta Paediatr. 2007; 96(2):195-198.
  7. 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):2199-2207.
  8. Silvestri JM. Indications for home apnea monitoring (or not). Clin Perinatol. 2009; 36(1):87-99.
  9. 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. 

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Academy of Pediatrics. Policy Statement 2003. Committee on Fetus and Newborn. Apnea, sudden infant death syndrome, and home monitoring. Pediatrics. 2003, 111(4):914-917.
  2. American Academy of Pediatrics. Committee on Fetus and Newborn. Hospital discharge of the high-risk neonate. Pediatrics. 2008; 122(5):1119-1126.
  3. American Academy of Pediatrics. Task Force on Sudden Infant Death Syndrome. The changing concept of Sudden Infant Death Syndrome: diagnostic coding shifts, controversies regarding the sleeping environment, and new variables to consider in reducing risk. Policy Statement. Pediatrics. 2005; 116(5):1245-1255.
  4. American Academy of Pediatrics. Task Force on Sudden Infant Death Syndrome. SIDS and other sleep-related infant deaths: expansion of recommendations for a safe infant sleeping environment. Pediatrics. 2011; 128(5):1030-1039.
  5. Tieder JS, Bonkowsky JL, Etzel RA, et al.; Subcommittee on Apparent Life Threatening Events. Brief resolved unexplained events (formerly apparent life-threatening events) and evaluation of lower-risk infants. Pediatrics. 2016; 137(5).
  6. U.S. Food and Drug Administration. Class II special controls guidance document: apnea monitors; guidance for Industry and FDA. July 17, 2002. Available at: http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm072846.htm. Accessed on June 26, 2017.
Websites for Additional Information
  1. American Academy of Pediatrics (AAP). Apnea Monitors. Updated November 21, 2015. Available at: https://www.healthychildren.org/English/ages-stages/baby/preemie/Pages/Apnea-Monitors.aspx . Accessed on June 24, 2017.
  2. Medline Plus. Home apnea monitor use-infants. Reviewed July 10, 2015. Available at: https://medlineplus.gov/ency/patientinstructions/000755.htm . Accessed on June 24, 2017.
  3. National Institute of Child Health and Human Development (NICHD). Safe to Sleep campaign. Available at: http://www.nichd.nih.gov/SIDS/Pages/sids.aspx. Accessed on June 24, 2017.
Index

Apnea
Apnea Monitor
Apparent Life Threatening Event (ALTE)
Brief Resolved Unexplained Events (BRUE)
Home Cardiorespiratory Monitor
Infant Home Apnea Monitors
SIDS
Sudden Infant Death Syndrome

History
Status Date Action
Reviewed 08/03/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Updated References and Websites sections.
Revised 08/04/2016 MPTAC review. Revised criteria #1 from ALTE to BRUE to reflect updated term. Updated Discussion, References, Websites and Index sections. Updated formatting in Clinical Indications section. Removed ICD-9 codes from Coding section.
Revised 08/06/2015 MPTAC review. Clarified criteria- spelled out abbreviation "i.e." Updated Discussion and References sections.
Reviewed 08/14/2014 MPTAC review.
Reviewed 08/08/2013 MPTAC review. Added Web Site section.
Reviewed 08/09/2012 MPTAC review. Updated Discussion and References.
Reviewed 08/18/2011 MPTAC review. Updated Coding, Discussion and References.
Reviewed 08/19/2010 MPTAC review. Discussion and references updated.
Reviewed 08/27/2009 MPTAC review. Discussion and references updated. Place of service section deleted. Coding section updated with 10/01/2009 ICD-9 changes.
Reviewed 08/28/2008 MPTAC review. Description, discussion, and references updated.
Revised 08/23/2007 MPTAC review. Clarified continued use of monitor for apnea of prematurity. Clarified Not Medically Necessary statement. References updated.
  01/01/2007 Updated coding section with 01/01/2007 CPT/HCPCS changes.
Reviewed 09/14/2006 MPTAC review. References and coding updated.
Revised 09/22/2005 MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.
Pre-Merger Organizations

Last Review Date

Guideline Number

Title

 

Anthem BCBS

06/25/2005

Memo 102 Coverage Guidelines (S.E. Region) Sudden Infant Death Syndrome (SIDS) Monitors
WellPoint Health Networks, Inc.

07/14/2004

Clinical Guideline Infant Home Apnea Monitor