Latest Review Date: June 2024

Category: Durable Medical Equipment (DME)                                                                     

POLICY:

Home cardiorespiratory monitoring may be considered medically necessary in infants with special health care needs or dependence on home technological support when initiated in infants younger than 12 months of age in the following situations:

• Those with tracheostomies or anatomic abnormalities that make them vulnerable to airway compromise: OR
• Those with neurologic or metabolic disorders affecting respiratory control; OR
• Those with chronic lung disease (i.e., bronchopulmonary dysplasia), particularly those requiring supplemental oxygen; continuous positive airway pressure; or mechanical ventilation.

Home cardiorespiratory monitoring is considered not medically necessary when used as a strategy to reduce the risk of Sudden Infant Death Syndrome (SIDS). 

Home cardiorespiratory monitoring in all other conditions, including but not limited to the diagnosis of obstructive sleep apnea, is considered investigational.

Home cardiorespiratory monitoring is considered not medically necessary when used for cardiopulmonary evaluation in lower-risk infants following a brief resolved unexplained event (BRUE)*, which was previously known as an apparent life-threatening event (ALTE).

*An event occurring in an infant younger than 1 year when the observer reports a sudden, brief, and now resolved episode of ≥1 of the following: (1) cyanosis or pallor; (2) absent, decreased, or irregular breathing; (3) marked change in tone (hyper- or hypotonia); and (4) altered level of responsiveness. A BRUE is diagnosed only when there is no explanation for a qualifying event after conducting an appropriate history and physical examination.

DESCRIPTION OF PROCEDURE OR SERVICE:

Home cardiorespiratory monitors track respiratory effort and heart rate to detect episodes of apnea. They have been used for a variety of indications that may be associated with increased risk of respiratory compromise.

Home Cardiorespiratory Monitoring

Home apnea monitors track respiratory effort and heart rate, and have been used to monitor central apnea of prematurity in newly discharged at-risk or high-risk premature infants (infants are at increased risk of cardiorespiratory events until 43 weeks postconceptual 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-mouth resuscitation, cardiac compressions) is required. Unless an oximeter is added to the 2-channel 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

The American Academy of Pediatrics (AAP) defines Sudden Unexpected Infant Death (SUID), also known as Sudden Unexpected Death In Infancy (SUDI) as “any sudden and unexpected death, whether explained or unexplained” that occurs during infancy. Sudden Infant Death Syndrome (SIDS) is a subcategory of SUID/SUDI, which is defined as the sudden death of an infant younger than one year of age whereby 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, cardiorespiratory monitoring was suggested. However, clinical studies have failed to establish that the use of home monitoring reduces the incidence of SIDS. The American Academy of Pediatrics reiterated its recommendations that home monitoring should not be used as a strategy to prevent SIDS. Instead, AAP recommended that proven practices should be promoted to reduce the incidence of SIDS, which include 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. The campaign is a national effort to educate health care professionals, parents, and caregivers about the significance of placing infants in the supine sleeping position to reduce SIDS. 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.

Brief Resolved Unexplained Event (BRUE)

The 2016 AAP clinical practice guideline published by Tieder et al., defined brief resolved unexplained event (BRUE; formerly apparent life-threatening event [ALTE]) as: "An event occurring in an infant younger than 1 year when the observer reports a sudden, brief, and now resolved episode of ≥1 of the following:

• cyanosis or pallor;
• absent, decreased, or irregular breathing;
• marked change in tone (hyper- or hypotonia); and altered level of responsiveness."

Infants with Special Health Care Needs or Dependence on Home Technological Support

According to AAP’s 2008 Policy Statement on Hospital Discharge of the High-Risk Neonate reported by Stark et al. (Reaffirmed in 2018), there has been recent increases in discharge of infants dependent on some form of supportive technology due to special health care needs or unresolved medical problems. Conditions that may necessitate use of technological support include apnea of prematurity and bronchopulmonary dysplasia for preterm infants, and upper airway anomalies, central nervous system disorders, and neuromuscular disorders for term infants. For example, home ventilation can be required for infants with tracheostomy for upper airway abnormalities or who cannot be weaned from assisted ventilation prior to discharge. Additionally, to avoid the potential risks of growth failure and cor pulmonale resulting from marginal oxygenation, discharge with home oxygen therapy has been used for infants with bronchopulmonary dysplasia. In both of these cases, home cardiorespiratory monitoring is recommended to accompany the supportive technology for use in detecting airway obstructions or dislodging of the oxygen.

Bronchopulmonary Dysplasia

The diagnosis of bronchopulmonary dysplasia (BPD) depends on gestational age, and is outlined in Table PG1 based on the 2001, consensus definition from the U.S. National Institute of Child Health and Human Development (Jobe & Bancalari, 2001).

Table PG1. Diagnosis of Bronchopulmonary Dysplasia

Diagnosis	Gestational Age
	< 32 weeks	≥ 32 weeks
Time point of assessment	36 wk PMA or discharge to home, whichever comes first	>28 d but <56 d postnatal age or discharge to home, whichever comes first
	Treatment With Oxygen >21% for at Least 28 Days Plus
Mild BPD	Breathing room air at 36 wk PMA or discharge, whichever comes first	Breathing room air by 56 d postnatal age or discharge, whichever comes first
Moderate BPD	Need for <30% oxygen at 36 wk PMA or discharge, whichever comes first	Need for <30% oxygen at 56 d postnatal age or discharge, whichever comes first
Severe BPD	Need for ≥30% oxygen and/or positive pressure at 36 wk postnatal age or discharge, whichever comes first	Need for ≥30% oxygen and/or positive pressure at 56 d postnatal age or discharge, whichever comes first

Adapted from Jobe & Bancalari (2001).

BPD: bronchopulmonary dysplasia; PMA: postmenstrual age.

Brief Resolved Unexplained Event (BRUE) Risk Assessment: Lower- versus Higher-Risk of a Repeat Event or a Serious Underlying Disorder

The 2016 clinical practice guideline from the American Academy of Pediatrics reported by Tieder et al. (2016) on BRUE and evaluation of lower-risk infants identified the following patient factors as determining a lower risk:

• Age > 60 days
• Prematurity: gestational age ≥32 weeks and postconceptional age ≥45 weeks
• First BRUE: no previous BRUE ever and not occurring in clusters
• Duration of event <1 minute
• No CPR required by trained medical provider
• No concerning historical features as detailed in the 2016 AAP guideline (e.g., considerations for possible child abuse, history of the event, recent history, past medical history, family history, environmental history, social history)
• No concerning physical examination findings as detailed in the 2016 AAP guideline (e.g., general appearance, growth variables, vital signs, skin, head, eyes, ears, nose and mouth, neck, chest, heart, abdomen, genitalia, extremities, neurologic)
• No concerning physical examination findings as detailed in the 2016 AAP guideline (e.g., general appearance, growth variables, vital signs, skin, head, eyes, ears, nose and mouth, neck, chest, heart, abdomen, genitalia, extremities, neurologic)

Higher Risk

The guidelines committee was not able to establish a definition of higher risk BRUE. “Outcomes data from ALTE studies in the heterogeneous high risk population are unclear and preclude the derivation of evidence based recommendations regarding management”, which would require further research. However, no such trials are listed in clinicaltrials.gov.

Age Limits

Upon initiation of home cardiorespiratory monitoring in infants, the physician should establish a review of the problem, a plan of care, and a specific plan for periodic review and termination. Clear documentation of the reasons for continuing monitoring is necessary should monitoring beyond 43 weeks of postmenstrual age be recommended. Home cardiorespiratory monitoring for apnea is generally not considered appropriate for infants 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 individuals with home noninvasive or invasive ventilator use or chronic lung disease.

KEY POINTS:

This policy has been updated regularly with searches of the PubMed database. The most recent literature update was performed through April 16, 2024.

Summary of Evidence

For individuals with risk of respiratory failure in infancy who receive home cardiorespiratory monitoring for prevention of Sudden Infant Death Syndrome (SIDS), the evidence includes a systematic review and large epidemiological studies, including the Collaborative Home Infant Monitoring Evaluation (CHIME) study. Relevant outcomes are overall survival and morbid events. The systematic review and epidemiological studies consistently found that the use of home cardiorespiratory monitors did not decrease the incidence of SIDS. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with risk of respiratory failure in infancy who receive home cardiorespiratory monitoring for other respiratory conditions, the evidence includes a systematic review and several observational cohort studies. Relevant outcomes are overall survival and morbid events. For lower-risk infants following a brief resolved unexplained event (BRUE), which was previously known as an apparent life-threatening event (ALTE), the systematic review and observational cohort studies found no significant differences between infants with and without respiratory abnormalities in the frequency of respiratory pauses and bradycardia identified by home cardiorespiratory monitors. There is a lack of published evidence for other respiratory conditions, which is likely due to small numbers of patients and the difficulty of enrolling infants with respiratory conditions. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Clinical input obtained in 2017 and national guidelines published by the American Academy of Pediatrics 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). These conditions identified by the Academy as benefiting from home cardiorespiratory monitoring may, therefore, be considered medically necessary.

PRACTICE GUIDELINES AND POSITION STATEMENTS:

American Academy of Pediatrics (AAP)

Sudden Infant Death Syndrome (SIDS)

In 2016, the American Academy of Pediatrics (AAP) (reported by Moon et al.) issued a Policy Statement on SIDS and other Sleep-Related Infant Deaths, which addressed the use of home cardiorespiratory monitors. Based on a literature review that identified evidence from 4 large epidemiological studies conducted between 1986-2001, this Policy Statement issued an A-level recommendation against the use of home cardiorespiratory monitoring as a SIDS-prevention strategy. The recommendation stated "Do not use home cardiorespiratory monitors as a strategy to reduce the risk of SIDS.” The A-level recommendation indicates that "there is good-quality patient-oriented evidence" based on the Strength-of-Recommendation Taxonomy (SORT)." Conflict of interest management was described as including authors filing conflict of interest statements with the AAP and resolution of any conflicts through a process approved by the Board of Directors. A 2022 update to the AAP policy statement included no additional evidence regarding cardiorespiratory monitoring and maintained an A-level recommendation against the use of home cardiorespiratory monitoring as a SIDS-prevention strategy.

Brief Resolved Unexplained Events (BRUE)

In 2016, the AAP issued clinical practice guidelines on brief resolved unexplained events (BRUE), which addressed the use of home cardiorespiratory monitoring for low-risk infants. This clinical practice guideline was based on a systematic review with searches through December 31, 2014, and the evidence and strength of the recommendations were formally rated using a well-described approach. As with the AAP SIDS Policy Statement described above, conflict of interest management was described as including authors filing conflict of interest statements with the AAP and resolution of any conflicts through a process approved by the Board of Directors. The recommendation stated "Clinicians should not initiate home cardiorespiratory monitoring for cardiopulmonary evaluation." The evidence quality was rated as B, which indicates it was based on "Trials or diagnostic studies with minor limitations; consistent findings from multiple observational studies." The strength of the recommendation was moderate, indicating that "A particular action is favored because anticipated benefits clearly exceed harms (or vice versa) and the quality of evidence is good but not excellent (or is unobtainable). Clinicians would be prudent to follow a moderate recommendation but should remain alert to new information and sensitive to patient preferences."

Infants with Special Health Care Needs or Dependence on Home Technological Support

The AAP (2008, reaffirmed in 2018) also published a Policy Statement by Stark et al. on the hospital discharge of high-risk neonates that addressed the role of home apnea monitors for preterm and otherwise high-risk infants. This Policy Statement was not clearly based on a systematic review, strength of the policy statements was not formally rated, and clear documentation of conflict of interest management is lacking. Relevant statements include:

• Hospitalized infants still at risk of apnea: "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."

• Bronchopulmonary dysplasia: “Home oxygen therapy for infants with bronchopulmonary dysplasia has been used as a means of achieving earlier hospital discharge while avoiding the risks of growth failure and cor pulmonale resulting from marginal oxygenation.” “Infants who are discharged on supplemental oxygen are often also discharged on a cardiorespiratory monitor or pulse oximeter in case the oxygen should become dislodged or the supply depleted.”

• Tracheostomy: “Tracheostomy is sometimes required for neonates with upper airway abnormalities or occasionally for infants who cannot be weaned from assisted ventilation. Good parental teaching and coordinated multidisciplinary follow-up care are essential for these infants. Infants who require home ventilation should also be on a cardiorespiratory monitor in case the airway should become obstructed, but the home ventilator should also have a disconnect alarm to alert caregivers to ventilator disconnection. Home ventilation requires qualified personnel to provide bedside care; in most cases, home-nursing support will be needed for at least part of the day.”

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Apnea, Infant, Home Monitoring, Monitoring, Siblings of SIDS Victims, Sudden Infant Death Syndrome (SIDS), SmartMonitor 2 Apnea Monitor

APPROVED BY GOVERNING BODIES:

A number of infant apnea monitors have been cleared for marketing by FDA through the 510(k) process. This includes the SmartMonitor 2 Apnea Monitor (Philip Children’s Medical Ventures, Respironics), which is intended use is for continuous monitoring of respiration, heart rate, and SpO2 (pulse oximetry of infant patients) in a hospital or home environment.A search of the U.S. FDA 510(k) website in May 2023 did not identify any new safety information that would likely influence this policy.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING:

CPT codes:

The following CPT codes may be used:

94772	Circadian respiratory pattern recording (pediatric pneumogram), 12-24 hour continuous recording, infant
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	;monitor attachment only (includes hook-up, initiation of recording and disconnection)
94776	;monitoring, download of information, receipt of transmission(s) and analyses by computer only
94777	;review, interpretation and preparation of report only by a physician or other qualified health care professional.

HCPCS:

A4556	Electrodes (e.g., apnea monitor), per pair
A4557	Lead wires (e.g., apnea monitor), per pair
E0618	Apnea monitor, without recording feature
E0619	Apnea monitor, with recording feature

REFERENCES:

1. American Academy of Pediatrics (AAP). AAP Publications Reaffirmed and Retired. Pediatrics 2012; 130(2):e467-e68.
2. American Academy of Pediatrics. Committee on Fetus and Newborn.  Apnea, sudden infant death syndrome, and home monitoring.  Pediatrics 2003; 111(4 pt 1):914-7.
3. American Academy of Pediatrics. Task Force on Sudden Infant Death Syndrome. Diagnostic coding shifts, controversies regarding the sleep environment, and new variables to consider in reducing risk. Pediatrics 2005; 116(5):1245-55.
4. Eichenwald EC, Committee on Fetus Newborn, American Academy of Pediatrics. Apnea of Prematurity. Pediatrics. Jan 2016; 137(1).
5. 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):338-43.
6. Moon RY, Moon RY, Darnall RA, et al. SIDS and other sleep-related infant deaths: expansion of recommendations for a safe infant sleeping environment. Pediatrics. Nov 2011; 128(5): 1030-9.
7. Moon RY, Darnall RA, Feldman-Winter L, et al. SIDS and Other Sleep-Related Infant Deaths: Evidence Base for 2016 Updated Recommendations for a Safe Infant Sleeping Environment. Pediatrics. Nov 2016; 138(5).
8. Moon RY, Carlin RF, Hand I. Evidence Base for 2022 Updated Recommendations for a Safe Infant Sleeping Environment to Reduce the Risk of Sleep-Related Infant Deaths. Pediatrics. Jul 01 2022; 150(1).
9. Moon RY, Carlin RF, Hand I. Sleep-Related Infant Deaths: Updated 2022 Recommendations for Reducing Infant Deaths in the Sleep Environment. Pediatrics. Jul 01 2022; 150(1).
10. National Institute of Child Health and Human Development (NICHD). Safe to Sleep. n.d.; https://www1.nichd.nih.gov/sts/Pages/default.aspx. 
11. 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.
12. 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):1030-9.
13. Tieder JS, Altman RL, Bonkowsky JL, et al. Management of apparent life-threatening events in infants: a systematic review. J Pediatr. Jul 2013; 163(1):94-99 e91-96.
14. Tieder JS, Bonkowsky JL, Etzel RA, et al. Brief resolved unexplained events (formerly apparent life-threatening events) and evaluation of lower-risk infants. Pediatrics. May 2016; 137(5).
15. Veit L, Amberson M, Freiberger C, et al. Diagnostic evaluation and home monitor use in late preterm to term infants with apnea, bradycardia, and desaturations. Clin Pediatr (Phila). Mar 7 2016.
16. Velumula P, Jani S, Kanike N, et al. Monitoring of Infants Discharged Home with Medical Devices. Pediatr Ann. Feb 01 2020; 49(2): e88-e92.

POLICY HISTORY:

Medical Policy Group, February 2010 (3)

Medical Policy Administration Committee, February 2010

Available for comment February 23-April 8, 2010

Medical Policy Group, March 2012 (3): 2012 Update-Policy Statement defining infants that “do not meet criteria”, Key Points, Approved by Governing Bodies, References

Medical Policy Group, December 2012 (3): 2013 Coding Updates – Verbiage change to codes 94774 & 94777 – added “by a physician or other qualified health care professional”.

Medical Policy Panel, April 2013

Medical Policy Group, April 2013 (3): 2013 Update to Description, Key Points and References; no change in policy statement

Medical Policy Panel, March 2014

Medical Policy Group, March 2014 (3):  2014 Updates to Description, Key Points & References; no change in policy statement – did remove the word “(pneumogram)” from policy statements

Medical Policy Panel, March 2015

Medical Policy Group, March 2015 (6):  Updates to Key Points, Key Words, Approved by Governing Bodies and References; no change to policy statement.

Medical Policy Panel, January 2017

Medical Policy Group, January 2017 (6): Updates to Description, Policy statement, added “brief resolved unexplained event (previously known as apparent life-threatening event)” no change to policy coverage, Key points, Practice Guidelines and References.

Medical Policy Panel, June 2018

Medical Policy Group, June 2018 (6): Updates to Key Points and Practice Guidelines.

Medical Policy Panel, June 2019

Medical Policy Group, June 2019 (6): Updates to Key Points.

Medical Policy Panel, June 2019

Medical Policy Group, June 2019 (6): Updates to Description to Key Points, Practice Guidelines and References.

Medical Policy Panel, July 2020

Medical Policy Group, July 2020 (6): Updates to Description, Policy statement clarified, Key Points, Practice Guidelines and References. No change to policy intent.

Medical Policy Panel, June 2021

Medical Policy Group, June 2021 (6): Updates to Description, Key Points, Governing Bodies, and Practice Guidelines. Removed not medically necessary from policy statement, no change to policy intent.

Medical Policy Panel, June 2022

Medical Policy Group, June 2022 (6): Updates to Key Points and References.

Medical Policy Panel, June 2023

Medical Policy Group, June 2023 (6): Updates to Key Points, Practice Guidelines, Governing Bodies, Benefit Application and References.

Medical Policy Panel, June 2024

Medical Policy Group, June 2024 (6): Updates to Description and Key Points.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.