Medical Policy

Policy Num:       01.001.021
Policy Name:     Home Cardiorespiratory Monitoring
Policy ID:          [01.001.021]  [Ac / B / M+ / P+]  [1.01.06]


Last Review:       July 18, 2024
Next Review:      July 20, 2025

 

Related Policies:

02.005.010 - Diagnosis of Obstructive Sleep Apnea Syndrome

Home Cardiorespiratory Monitoring

Population Reference No.

Populations

Interventions

Comparators

Outcomes

1

Individuals:

        ·       With risk of respiratory failure in infancy

Interventions of interest are:

         ·    Home cardiorespiratory monitoring for prevention           of Sudden Infant Death Syndrome (SIDS)

Comparators of interest are:

·       Standard care without monitoring

Relevant outcomes include:

·       Overall survival

·       Morbid events

2

Individuals:

 

·       With risk of respiratory failure in infancy

Interventions of interest are:

·     Home cardiorespiratory monitoring for other respiratory conditions

Comparators of interest are:

·       Standard care without monitoring

Relevant outcomes include:

·       Overall survival

·       Morbid events

Summary

Description

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.

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, which was previously known as an apparent life threatening event, 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.

Additional Information

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 (eg, tracheostomies, chronic lung disease). These conditions identified by the Academy as benefiting from home cardiorespiratory monitoring may, therefore, be considered medically necessary.

Objective

The objective of this evidence review is to determine whether home cardiorespiratory monitoring improves the net health outcome for infants at risk of respiratory failure.

Policy Statements

Home cardiorespiratory monitoring may be considered medically necessary when initiated in infants younger than 12 months of age in the following situations (see Policy Guidelines):

Home cardiorespiratory monitoring is considered investigational when used as a strategy to reduce the risk of Sudden Infant Death Syndrome (SIDS).

Home cardiorespiratory monitoring is considered investigational 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) (see Policy Guidelines for further discussion of BRUE risk).

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

Policy Guidelines

This policy does not address the use of an unattended (unsupervised) home sleep study for the diagnosis and management of obstructive sleep apnea. If obstructive sleep apnea is a consideration, refer to evidence review 02.005.006.

This policy applies only to the use of U.S. Food and Drug Administration (FDA) approved home monitoring systems. Various commercially available infant monitoring devices are marketed to parents for monitoring infants' sleep, breathing, and behavior. Although some of the devices include pulse oximetry, they are not sold as medical devices and are therefore not cleared for marketing by FDA. Home monitors should be equipped with an event recorder.

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.

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 weeks PMA or discharge to home, whichever comes first >28 days but <56 days 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 weeks PMA or discharge, whichever comes first Breathing room air by 56 days postnatal age or discharge, whichever comes first
Moderate BPD Need for <30% oxygen at 36 weeks PMA or discharge, whichever comes first Need for <30% oxygen at 56 days postnatal age or discharge, whichever comes first
Severe BPD Need for ≥30% oxygen and/or positive pressure at 36 weeks postnatal age or discharge, whichever comes first Need for ≥30% oxygen and/or positive pressure at 56 days postnatal age or discharge, whichever comes first
Adapted from Jobe & Bancalari (2001).BPD: bronchopulmonary dysplasia; PMA: postmenstrual age.

Brief Resolved Unexplained Event 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:

Higher Risk

The guidelines committee was not able to establish a definition of higher risk BRUE. “Outcomes data from ALTE studies in the heterogenous 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.

Coding

See the Codes table for details.

Benefit Application

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

BlueCard/National Account Issues

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Background

Home Cardiorespiratory Monitoring

Home cardiorespiratory 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 of postconceptual age) and in other infants at risk of apnea. An alarm sounds if there is respiratory cessation (central apnea) beyond a predetermined time limit (eg, 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 for 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 1 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 (AAP) recommends that home monitoring should not be used as a strategy to prevent SIDS.1, 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.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.

Brief Resolved Unexplained Event

The 2016 AAP clinical practice guideline published by Tieder et al 3, 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:

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),4, 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.5, 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.

Regulatory Status

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

Rationale

This evidence review was created in March 1996 and archived from 2003 until 2010 when it returned to active status to address questions regarding use of new CPT codes in older children. It has since been updated regularly with searches of the PubMed database. The most recent literature update was performed through April 16, 2024

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Population Reference No. 1 

Home Cardiorespiratory Monitoring for Prevention of Sudden Infant Death Syndrome

Clinical Context and Therapy Purpose

The purpose of home cardiorespiratory monitoring is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as standard care without monitoring, in patients with risk of respiratory failure in infancy.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with risk of respiratory failure in infancy.

Interventions

The therapy being considered is home cardiorespiratory monitoring for sudden infant death syndrome (SIDS) prevention.

Comparators

Comparators of interest include standard care without monitoring. Standard care includes blood pressure support, involuntary nervous system blockers, and antiarrhythmics.

Outcomes

The general outcomes of interest are overall survival and morbid events.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

Review of Evidence

Systematic Reviews

In a 2022 literature review that supported the American Academy of Pediatrics' (AAP) 2022 Policy Statement on SIDS, Moon et al (2022) identified 4 large epidemiological studies conducted between 1986 and 2001 which found that the use of home cardiorespiratory monitors did not decrease the incidence of SIDS.6, Among those 4 studies is the Collaborative Home Infant Monitoring Evaluation (CHIME) study, a longitudinal cohort study conducted from 1994 to 1998, which was designed to address whether severe episodes of apnea and bradycardia occur more commonly in infants considered at higher risk for SIDS. 7, The study included 1079 infants, both healthy and 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. Monitor alarms were set off 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. In a subsequent multivariate logistic regression analysis of the CHIME study data, Hoppenbrouwers et al (2008) found that extreme events were not significantly associated with any known SIDS risk factors.7,

Findings from a prior systematic review of the literature on the impact of home monitoring (apnea monitoring, respiratory monitoring, or cardiorespiratory monitoring) published by Strehle et al (2012)8, are consistent with the 2022 AAP literature review.6, The systematic review by Strehle et al (2012) searched the literature through June 2010 and included 1 pilot study that assessed the feasibility of an RCT to evaluate home monitoring (level I evidence) and 10 unique case series (level III evidence). The body of case series evidence included the CHIME study. Reviewers concluded that there was a lack of high-level evidence that home monitoring would be beneficial in preventing SIDS.

Section Summary: Home Cardiorespiratory Monitoring for Prevention of Sudden Infant Death Syndrome (SIDS)

Evidence for the use of home cardiorespiratory monitoring for prevention of SIDS consists of a systematic review and large epidemiological studies, including the CHIME study. These studies consistently found that the use of home cardiorespiratory monitors did not decrease the incidence of SIDS.

Summary of Evidence

For individuals with risk of respiratory failure in infancy who receive home cardiorespiratory monitoring for prevention of SIDS, the evidence includes a systematic review and large epidemiological studies, including the 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.

Population

Reference No. 1

Policy Statement

[X] MedicallyNecessary [ ] Investigational

Population Reference No. 2

Home Cardiorespiratory Monitoring for Other Respiratory Conditions

Clinical Context and Therapy Purpose

The purpose of home cardiorespiratory monitoring is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as standard care without monitoring, in patients with risk of respiratory failure in infancy.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with various respiratory conditions and who are at risk of respiratory failure in infancy.

Interventions

The therapy being considered is home cardiorespiratory monitoring for other respiratory conditions.

Comparators

Comparators of interest include standard care without monitoring. Treatment includes blood pressure support, involuntary nervous system blockers, and antiarrhythmics.

Outcomes

The general outcomes of interest are overall survival and morbid events.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

Review of Evidence

Brief Resolved Unexplained Event

Systematic Reviews

In a 2016 systematic review that supported the AAP's 2016 Clinical Practice Guideline on BRUE, Tieder et al (2016) assessed studies relevant to use of home cardiorespiratory monitoring in infants presenting with a lower-risk BRUE.3, Based on searches of numerous bibliographic databases through December 31, 2014, this systematic review identified several studies published between 1986 and 2008 demonstrating that the frequency of respiratory pauses and bradycardia identified by home cardiorespiratory monitors is similar in infants with and without respiratory abnormalities. In addition, the review noted that other studies have shown no improvements in outcomes or SIDS prevention with home apnea monitors, and “a lack of correlation between ALTEs [now referred to as BRUE] and SIDS.

Observational Studies

In addition to the studies summarized in the 2016 AAP systematic review, an observational cohort study by Mittal et al (2013)9, reported on 4-week follow-up outcomes for 300 infants seen in an emergency department with a diagnosis of apparent life threatening event (ALTE). Of the 228 patients admitted, 110 (48.2%) had in-hospital pneumography (101 with esophageal pH monitoring, 9 without esophageal pH monitoring). Of those with pneumography, 33 patients had apnea, with or without evidence of gastroesophageal reflux. There was no significant association between positive findings on pneumography and recurrent ALTE in the 4 weeks after hospitalization. Study limitations included nonstandardized evaluation of patients with ALTE and whether results of an in-hospital pneumography study translate to the home setting.

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

Case Series

Home apnea monitors are sometimes used in neonates with apnea, bradycardia, and oxygen desaturation events. Apnea of prematurity is extremely common in preterm infants but may also occur in late preterm infants. In many cases, infants with these events are observed in the hospital until a "safe" period without an event occurs, but some infants are discharged to home with a home monitor. For example, in a 3-center, 5-year case series reporting on the evaluation and management of apnea, bradycardia, and oxygen desaturation events in infants born at 34 or more weeks of gestational age, Veit et al (2016) reported that 4.5% of infants were discharged to home with a monitor.10, However, there is a lack of evidence on the effectiveness of home cardiorespiratory monitors in these conditions. For many conditions, trials would be difficult to perform due to small numbers of patients and logistic difficulties for these conditions that would make trial enrollment difficult. As a result, the best available recommendations for treatment currently rely on expert consensus.

Section Summary: Use of Home Cardiorespiratory Monitors in Other Respiratory Conditions

Evidence for the use of home cardiorespiratory monitoring for lower-risk BRUE consists of a systematic review and several observational cohort studies. These 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.

Summary of Evidence

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 BRUE, which was previously known as an 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.

Population

Reference No. 2

Policy Statement

[ ] MedicallyNecessary [X] Investigational

Supplemental Information

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Clinical Input From Physician Specialty Societies and Academic Medical Centers

While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

In response to requests, input was received from 2 specialty societies and 2 academic medical centers while this policy was under review in 2017. There was general agreement with the existing medically necessary statements, including those that addressed use for tracheostomies or anatomic abnormalities that make them vulnerable to airway compromise; those with neurologic or metabolic disorders affecting respiratory control, including central apnea and apnea of prematurity; or those with chronic lung disease (ie, bronchopulmonary dysplasia).

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Academy of Pediatrics

Sudden Infant Death Syndrome

In 2016, the American Academy of Pediatrics (AAP) (reported by Moon et al) issued a policy statement on sudden infant death syndrome (SIDS) and other sleep-related infant deaths,11, 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. 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.1,

Brief Resolved Unexplained Events

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.3,12, 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.4, 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:

U.S. Preventive Services Task Force Recommendations

Not applicable.

Medicare National Coverage

There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in May 2023 did not identify any ongoing or unpublished trials that would likely influence this review.

References

  1. 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). PMID 35726558
  2. National Institute of Child Health and Human Development (NICHD). Safe to Sleep. n.d.; https://www1.nichd.nih.gov/sts/Pages/default.aspx. Accessed April 16, 2024.
  3. 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). PMID 27244835
  4. Stark AR, Adamkin DH, Batton DG, et al. Hospital discharge of the high-risk neonate. Pediatrics. Nov 2008; 122(5): 1119-26. PMID 18977994
  5. 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. PMID 32045488
  6. 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). PMID 35921639
  7. Hoppenbrouwers T, Hodgman JE, Ramanathan A, et al. Extreme and conventional cardiorespiratory events and epidemiologic risk factors for SIDS. J Pediatr. May 2008; 152(5): 636-41. PMID 18410765
  8. 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. Jan 2012; 101(1): 8-13. PMID 21910748
  9. 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 (Phila). Apr 2013; 52(4): 338-43. PMID 23393308
  10. 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). Nov 2016; 55(13): 1210-1218. PMID 26957524
  11. 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). PMID 27940805
  12. AAP Publications Reaffirmed and Retired. Pediatrics. August 1 2012;130(2):e467-e468.

Codes

Codes

Number

Description

CPT

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

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

A4556

Electrodes (eg, apnea monitor), per pair

 

A4557

Lead wires (eg, apnea monitor), per pair

 

E0618

Apnea monitor, without recording feature

 

E0619

Apnea monitor, with recording feature

ICD-10-CM

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

 

P24.81

Neonatal aspiration with respiratory symptoms

 

P27.1

Bronchopulmonary dysplasia originating in the perinatal period

 

P27.8

Other chronic respiratory disease originating in the perinatal period

 

P28.2

Cyanotic attacks of newborn

 

P28.30-P28.49

Sleep apnea of newborn code range

 

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

 

P84

Other problems with newborn

 

R68.13

Apparent life threatening event in infant (ALTE)

 

Z93.0

Tracheostomy status

ICD-10 PCS

 

Not applicable. ICD-10-PCS is for use only on inpatient services. Policy is only for outpatient services.

Place of Service

Home

 

Type of Service

Medicine/DME

 

Policy History

Date Action Description
07/18/2024 Annual Review Policy updated with literature review through April 16, 2024; no references added. Policy statements unchanged.
07/18/2023 Annual Review Policy updated with literature review through April 17, 2023; references added. Policy statements unchanged.
09/28/2022 Coding update Updated sleep apnea of newborn code range due to icd-10-cm 2023 changes
07/20/2022 Annual Review Policy updated with literature review through March 22, 2022; no references added. Minor editorial refinements to policy statements (ie, changed "not medically necessary" to "investigational"); intent unchanged.
07/21/2021 Annual Review Policy updated with literature review through May 10, 2021; no references added. Policy statements unchanged.
08/11/2020 Revision due to MPP Policy updated with literature review through June 29, 2020; references added. Policy substantially edited to improve overall readability and increase clarity of the policy statements which are unchanged. A second PICO was added to differentiate between the populations reflected in the evidence review, clinical input, and guidelines.
07/27/2020 Annual Review No changes.
07/19/2019 Annual Review Policy updated with new format.  Policy updated with literature review through April 3, 2019, no references added. Policy statements unchanged.
01/12/2017    
06/15/2016    
03/11/2015    
03/13/14    
04/04/13    
04/30/12    
01/19/2012    
08/27/2010