Home Cardiorespiratory Monitoring

POLICY NUMBER

A.1.01.06

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.

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 post-conceptual age) and in other infants at risk of apnea. An alarm sounds 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 two-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 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 (AAP) recommends that home monitoring should not be used as a strategy to prevent SIDS. Instead, the 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 United States 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 and colleagues 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 the AAP’s 2008 Policy Statement on Hospital Discharge of the High-Risk Neonate reported by Stark and colleagues (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.

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 (Circadiance, formerly Philips 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.

POLICY

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):

• Those with tracheostomies or anatomic abnormalities that make them vulnerable to airway compromise; OR

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

Home cardiorespiratory monitoring is considered investigationalwhen 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 EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

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 the Sleep Disorders medical policy.

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 the 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 the table below based on the 2001 consensus definition from the U.S. National Institute of Child Health and Human Development.

Diagnosis of Bronchopulmonary Dysplasia

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 and colleagues 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 cardiopulmonary resuscitation (CPR) required by trained medical provider

• No concerning historical features as detailed in Table 2 of 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 Table 3 of 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. 

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

6/1992: Pneumogram policy approved by Medical Policy Advisory Committee (MPAC).

8/1992: Home Apnea Monitor policy approved by Medical Policy Advisory Committee (MPAC).

9/1999: Policies merged; interim policy changes made.

11/1999: Revisions to interim policy approved by MPAC.

2/27/2002: Managed Care Requirements deleted.

3/6/2002: Individual consideration requirement deleted.

5/1/2002: Type of Service and Place of Service deleted.

3/12/2003: Code Reference section updated.

7/2003: Reviewed by MPAC, adapted American Academy of Pediatrics recommendations, HCPCS A4556, A4557completed description added, note E0608 deleted 2003.

11/1/2004: Code Reference section updated, ICD-9 diagnosis code 768.2, 768.3, 768.5, 768.6, 768.9, 769, 770.0, 770.2, 770.4, 770.5, 770.6, 770.7, 779.81, 786.09 added, ICD-9 diagnosis 770.8 5th digit added, HCPCS E0608, E1340 deleted, HCPCS E0618, E0619 effective date of 1/1/2003 added.

9/12/2006: Coding updated. ICD9 2006 revisions added to policy.

10/18/2006: Policy reviewed, no changes.

12/28/2006: Code Reference section updated per the 2007 CPT/HCPCS revisions.

7/17/2008: Policy statements revised, but materially remain unchanged. Removed the following policy statements: home apnea monitoring is considered medically necessary until 43 weeks postmenstrual age or after the cessation of extreme episodes, whichever comes last in infants less than 12 months of age, as documented by a letter from the prescribing physician; and physician certification of close supervision and continuous care plan requirement. Pneumogram information removed from policy. Removed performance of a pneumogram in the hospital and home setting is considered medically necessary for patients with documented clinically significant apnea. Removed the following not medically necessary indications: backup electrical system or any alteration to the living quarters for the monitor, parental training sessions (ie., CPR), and standby medical, technical or counseling assistance. CPT 94772 removed. ICD-9 diagnosis codes 770.20, 770.12, 770.14, 770.16, 770.18 added.

9/29/2009: Code Reference section updated. New ICD-9 diagnosis codes 768.70, 768.71, 768.72, 768.73 added to covered table. Deleted statement added to ICD-9 diagnosis code 768.7.

06/24/2010: Policy Description was revised with additional information about home apnea monitors. The Policy Statement section was revised to add "pneumogram" and clarify home cardiorespiratory monitoring may be considered medically necessary for specific situations in infants younger than 12 months of age. An additional statement was added - Home cardiorespiratory monitoring (pneumogram) in all other conditions, including but not limited to the diagnosis of obstructive sleep apnea, is considered investigational. Policy Guidelines section was revised to add definition of an apparent life-altering event, home monitoring is generally not considered appropriate for pediatric patients older than one (1) year of age, and home monitors should be equipped with an event recorder.

04/20/2011: Policy reviewed; no changes.

04/19/2012: Policy reviewed; no changes.

04/19/2013: Policy reviewed; no changes.

05/02/2014: Policy reviewed; description updated. Removed the word sleep from "central sleep apnea," and added "and apnea of prematurity" in the medically necessary policy statement. Replaced the word apnea with "cardiorespiratory" in the second policy statement. Added statement to the policy guidelines section that certain children may require monitoring beyond one (1) year. Removed the deleted ICD-9 code 768.7 from the Code Reference section.

03/31/2015: Policy description updated regarding SIDS. Policy statements unchanged. Policy guidelines updated to state that this policy does not address the use of home monitoring for the diagnosis and management of obstructive sleep apnea. This policy only applies to the use of U.S. FDA-approved home monitoring systems. Added medically necessary and investigational definitions to the policy guidelines.

08/28/2015: Medical policy revised to add ICD-10 codes. Code descriptions updated for CPT codes 94774 and 94777.

05/26/2016: Policy number A.1.01.06 added.

03/08/2017: Policy title changed from "Home Apnea Monitors" to "Home Cardiorespiratory Monitoring." Policy description updated regarding other home monitoring indications. Policy statement updated to clarify that home cardiorespiratory monitoring may be considered medically necessary when initiated in infants younger than 12 months when certain criteria are met. Policy statement updated to replace "apparent life threatening event" with "brief resolved unexplained event" and to add those who "are not considered lower risk following clinical evaluation" to the medically necessary criteria. Policy guidelines updated to define brief resolved unexplained event and to add information regarding diagnosis of bronchopulmonary dysplasia.

09/29/2017: Code Reference section updated to add new ICD-10 diagnosis code R06.03. Effective 10/01/2017.

05/25/2018: Medical policy link updated in Policy Guidelines.

07/27/2018: Policy description updated. Policy statements unchanged. Policy Guidelines updated regarding bronchopulmonary dysplasia.

07/01/2019: Policy reviewed; no changes.

11/03/2020: Policy description updated regarding Sudden Infant Death Syndrome, Brief Resolved Unexplained Event, and infants with special health care needs or dependence on home technological support. Policy statements revised for clarity. Revised policy statement to state that home cardiorespiratory monitoring is considered not medically necessary when used as a strategy to reduce the risk of Sudden Infant Death Syndrome. Added statement that 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). Policy Guidelines updated regarding age limits, BRUE Risk Assessment, and those considered at higher risk.

08/25/2021: Policy description updated. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

07/11/2022: Policy description updated. Policy statements updated to change "not medically necessary" to "investigational." Policy intent unchanged.

07/17/2023: Policy description updated. Policy statements unchanged. Policy Guidelines updated to change "patients" to "individuals."

07/08/2024: Policy reviewed; no changes.

08/14/2025: Policy description updated regarding devices. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association Policy #1.01.06

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

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