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Polysomnography for Respiratory Sleep Disorders Testing

Policy Number: MP-305

Latest Review Date: July 2020

Category:  Medicine                                                              

Policy Grade:  C

POLICY:

A single unattended (unsupervised) home sleep study may be considered medically necessary with a Type II or III device (minimum of 4 recording channels including oxygen saturation, respiratory movements, airflow and ECG or heart rate) in adult patients who are at high risk for obstructive sleep apnea (OSA) as described in the Policy Guidelines and have no evidence by history or physical examination of any of the following health conditions which might alter ventilation or require alternative treatment including, but not limited, to the following:

  • Central Sleep Apnea
  • Heart Failure
  • Chronic Pulmonary disease
  • Obesity Hypoventilation Syndrome
  • Neuromuscular disorders with sleep-related symptoms
  • Injurious or potentially injurious parasomnias
  • Narcolepsy;

Unattended (unsupervised) home sleep study, with a minimum of recording channels as described above, may be considered medically necessary as a screening tool in patients who are scheduled for bariatric surgery and have no evidence by history or physical examination of a health condition that might alter ventilation or require alternative treatment as described in the criteria directly above.

A single unattended (unsupervised) home sleep study in children (younger than 18 years of age) is considered not medically necessary and investigational.

Uncomplicated OSA patients diagnosed with a home sleep study, who meet the criteria below, will be required to utilize an auto/titrating/auto-adjusting positive airway pressure (APAP) trial in the home setting for titration of pressure. 

Home titration to determine a fixed CPAP pressure using APAP may be considered medically necessary for the titration of pressure in adult patients with clinically significant OSA defined as those patients who have:

  • An Apnea/Hypopnea Index (AHI), Respiratory Disturbance Index (RDI) or Respiratory Event Index (REI) of at least 15 per hour,

OR

  • An AHI, RDI or REI of at least 5 per hour in a patient with any of the following associated symptoms:  
  1. Excessive daytime sleepiness
  2. Documented hypertension
  3. Mood disorders
  4. Insomnia
  5. Ischemic heart disease
  6. History of stroke
  7. Unexplained dysrhythmia

Repeat unattended (unsupervised) home sleep study may be considered medically necessary with a Type II or III device (minimum of 4 recording channels including oxygen saturation, respiratory movement, airflow, and ECG/heart rate) in adult patients under the following circumstances:

  1. To assess efficacy of surgery or oral appliances/devices; OR
  2. To reevaluate the diagnosis of OSA and need for continued continuous positive airway pressure (CPAP), e.g., if there is a significant change in weight or change in symptoms suggesting that CPAP should be retitrated or possibly discontinued.

A supervised (In-lab) polysomnography or sleep study performed after a previous unattended (unsupervised) home sleep study may be considered medically necessary in the following circumstances:

  1. A previous home study failed to establish the diagnosis or OSA in a patient with a high pretest probability of OSA;  OR
  2. A previous home study was technically inadequate; OR
  3. To titrate CPAP in a patient for whom an attempt at unattended (unsupervised) home APAP titration has been unsuccessful.

*Note: There are varying benefit plans for unattended (unsupervised) home sleep studies. Please verify benefits prior to applying policy criteria, as benefit coverage will supersede this policy.

A supervised (in-lab) polysomnography or sleep study may be considered medically necessary as a diagnostic test in patients who present with pronounced snoring or restlessness in association with any one of the following:

  1. Witnessed apneic events while sleeping (i.e., sleep apnea);
  2. Excessive daytime sleepiness (defined as an Epworth sleepiness scale score of greater than 10);
  3. Unexplained hypertension or arrhythmia;
  4. A body mass index (BMI) greater than 35; OR
  5. High risk for obstructive sleep apnea (OSA) as described in the policy guidelines;
  6. Children seven years of age and under with one or more of the following:
    1. Observed gross or subtle snoring which may be continuous; cessation or difficulty breathing, and sleep disturbances, or;
    2. Observed symptoms related to cardio-pulmonary, growth and development, and/or behavior problems that may be caused by upper-airway obstruction.
    3. Pronounced snoring or disrupted sleep.

A supervised (in-lab) polysomnography or sleep study must include all of the following:

  1. Electroencephalography (EEG)
  2. Electro-oculography (EOG)
  3. Submental (or chin) electromyography (EMG)
  4. Extremity muscle activity
  5. Respiratory effort
  6. Airflow
  7. Arterial oxygen saturation
  8. Electrocardiography (ECG) or heart rate

A supervised (in-lab) polysomnography or sleep study may be considered medically necessary as a technique to initiate or titrate CPAP in patients with clinically significant OSA defined as those patients who meet any of the following criteria:

  1. An AHI ≥ 15; OR
  2. An AHI between 5 and 14 with any of the following associated symptoms:
    1. Excessive daytime sleepiness (as evidenced by a pre-testing Epworth score of > 10 or other evidence);
    2. Impaired cognition;
    3. Mood disorders;
    4. Insomnia;
    5. Documented hypertension;
    6. Ischemic heart disease;
    7. History of stroke;
    8. Unexplained dysrhythmia.

Split-night polysomnography may be considered medically necessary as recommended by the American Academy of Sleep Medicine (AASM) Standards of Practice Committee (see Practice Guidelines).

Two separate full night (6 to 7 hours) polysomnography studies, one for the diagnosis of sleep disorders and the second to titrate CPAP may be considered medically necessary when circumstances are such that a split-night polysomnography with titration of CPAP performed in the second part of the study is not possible. For example, significant obstructive sleep apnea is not identified in time to allow for at least 3 hours of CPAP titration including both REM and non-REM sleep.

Supervised (in lab) Polysomnography or sleep study may be considered medically necessary for the evaluation of sleep disorders for the following indications when diagnostic questions remain after completion of the standard evaluation, when treatment decisions will be made based on the results of the study, and when the symptoms are of a severity to place the individual at risk for serious complications or injury:

  1. Patients with neuromuscular disorders and sleep-related symptoms;
  2. Infant or child under the age of 7 years who is being considered for removal of a tracheostomy;
  3. Infant or child under the age of 7 years with suspected Ondine’s Curse (Central Alveolar Hypoventilation Syndrome) in which the patient stops breathing when they sleep;
  4. Unexplained hypersomnolence;
  5. Central nervous system hypoventilation;

A repeat supervised (in lab) polysomnography or sleep study may be considered medically necessary for coverage in patients who meet the following criteria:

  1. After good clinical response to oral appliance treatment in patients with moderate to severe OSA, to ensure therapeutic benefit;
  2. After surgical treatment of patients with moderate-to-severe OSA, to ensure satisfactory response;
  3. After surgical or dental treatment of patients with SRBDs whose symptoms return despite a good initial response to treatment;
  4. After substantial weight loss (e.g., 10% of body weight) has occurred in patients on CPAP for treatment of SRBDS to ascertain whether CPAP is still needed at the previously titrated pressure;
  5. After substantial weight gain (e.g., 10% body weight) has occurred in patients previously treated with CPAP successfully, who are again symptomatic despite the continued use of CPAP, to ascertain whether pressure adjustments are needed;
  6. When clinical response is insufficient or when symptoms return despite a good initial response to treatment with CPAP.  In these circumstances, testing should be devised with consideration that a concurrent sleep disorder may be present (e.g., OSA and narcolepsy). (AASM, 2005).

Diagnostic sleep testing for the following conditions are considered not medically necessary, as they can be diagnosed through more appropriate means. These conditions are, including but not limited to, the following:

  1. Bruxism;
  2. Drug dependency;
  3. Enuresis;
  4. Hypersomnia, without other signs/symptoms of OSA;
  5. Insomnia;
  6. Night terrors or dream anxiety attacks;
  7. Nocturnal myoclonus;
  8. Routine diagnosis of restless leg syndrome, periodic limb movements;
  9. Shift work and schedule disturbances;
  10. Somnambulism;
  11. Migraine headaches;
  12. Snoring without other signs/symptoms of OSA;
  13. Chronic obstructive pulmonary disease;
  14. Asthma;
  15. Neuromuscular disease;
  16. Depression;
  17. Determining risk of sudden infant death syndrome (SIDS);
  18. Circadian rhythm-sleep disorders.

Follow-up polysomnography is considered not medically necessary in the following condition:

  • Patients treated with CPAP whose symptoms continue to be resolved with CPAP treatment.

The following types of sleep studies or tests related to sleep studies are considered not medically necessary:

  1. Electrosleep therapy, which uses the passage of weak electric currents to the brain to induce sleep;
  2. Topographic electroencephalogram (EEG) mapping for the diagnosis and/or medical management of obstructive sleep apnea syndrome;
  3. Multiple sleep latency testing (MSLT) for the diagnosis of obstructive sleep apnea syndrome. This test may be used in the diagnostic work up of narcolepsy; refer to Medical Policy #619 – Polysomnography for Non-Respiratory Sleep Disorders
  4. Actigraphy ;refer to Medical Policy # 164 Wrist Actigraphy Home Monitoring;
  5. Acoustic pharyngometer (e.g., Eccovision™ Acoustic Pharyngometer);
  6. Reflective acoustic devices (e.g., Bedbugg testing);
  7. Obstructive pressure measuring (e.g. ApLab testing).

The use of an abbreviated daytime sleep study (PAP-NAP) as a supplement to standard sleep studies is considered not medically necessary and investigational.

POLICY GUIDELINES

Although not an exclusive list, patients with all of the following symptoms are considered to be at high risk for obstructive sleep apnea (OSA):

  • habitual snoring;
  • observed apneas;
  • excessive daytime sleepiness;
  • a body mass index (BMI) greater than 35kg/m²

If no bed partner is available to report snoring or observed apneas, other signs and symptoms suggestive of OSA (e.g., age of the patient, male gender, thick neck, craniofacial or upper airway soft tissue abnormalities, or unexplained hypertension) may be considered. Objective clinical prediction rules are being developed; however, at the present time, risk assessment is based primarily on clinical judgment.

The physician performing, and interpreting a polysomnogram or home sleep study must meet one of the following:

  • be a diplomate of the American Board of Sleep Medicine (ABSM) AND
  • Board Certified Pulmonologist or a Board Certified Neurologist OR
  • has a Sleep Certification issued by ONE of the following Boards:
  • American Board of Internal Medicine (ABIM),
  • American Board of Family Medicine (ABFM),
  • American Board of Pediatrics (ABP),
  • American Board of Psychiatry and Neurology (ABPN),
  • American Board of Otolaryngology (ABOTO),
  • American Osteopathic Board of Neurology and Psychiatry (AOBNP),
  • American Osteopathic Board of Family Medicine, (AOBFP)
  • American Osteopathic Board of Internal Medicine, (AOBIM)
  • American Osteopathic Board of Ophthalmology and Otorhinolaryngology (AOBOO),

OR

  • Be an active staff member of an accredited sleep center or laboratory. The sleep facility accreditation must be from the American Academy of Sleep Medicine (AASM), inpatient or outpatient, Accreditation Commission for Health Care (ACHC), or the Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) accreditation for Ambulatory care sleep centers.

All centers billing sleep studies must maintain proper certification/ accreditation documentation as defined above, which include: Accreditation of sleep centers to include—AASM, ACHC, or Joint Commission.

The medical professional who is performing, evaluating, and interpreting a polysomnogram or home sleep study must have performed a thorough review of the patient’s history and physical prior to any polysomnography or sleep disorders testing being performed. This history and physical should include a thorough sleep history and a physical examination that includes the respiratory, cardiovascular, and neurological systems (AASM Practice Standard 4.1.1).

DESCRIPTION OF PROCEDURE OR SERVICE:

Obstructive sleep apnea (OSA) syndrome is characterized by repetitive episodes of upper airway obstruction due to the collapse of the upper airway during sleep. Polysomnography and portable sleep apnea testing (with sensors for respiratory effort, airflow, and oxygen saturation, or alternatively with peripheral arterial tone (PAT), actigraphy, and oxygen saturation are proposed methods for diagnosing OSA. Other proposed methods of diagnosing OSA include limited channel home sleep monitors. Conventional medical management of OSA includes weight loss, avoidance of stimulants, body position adjustment, oral appliances, and use of continuous positive airway pressure (CPAP) during sleep. Novel treatments include nasal expiratory positive airway pressure and oral pressure therapy.

Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) syndrome is characterized by repetitive episodes of upper airway obstruction due to the collapse of the upper airway during sleep. This causes a drop in blood oxygenation and brief arousal and can occur as frequently as every minute throughout the night. The most common signs and symptoms in adults are snoring, excessive daytime sleepiness, and hypertension. Excessive daytime sleepiness may be subjective and is assessed by questionnaires such as the Epworth Sleepiness Scale, a short self-administered, questionnaire that asks patients how likely they are to fall asleep in different scenarios such as watching TV, sitting quietly in a car, or sitting and talking to someone. Daytime sleepiness is uncommon in young children with OSA. Symptoms in children may include disturbed sleep and daytime neurobehavioral problems. In otherwise healthy children, OSA is usually associated with adenotonsillar hypertrophy and/or obesity.

The hallmark clinical symptom of OSA is snoring. The snoring abruptly ceases during the apneic episodes and during the brief period of patient arousal and then resumes when the patient again falls asleep. The sleep fragmentation associated with repeated sleep disruption can lead to impairment of almost any daytime activity. Adults with OSA-associated daytime somnolence are thought to be at higher risk for collisions involving motorized vehicles (i.e., cars, trucks, heavy equipment), while OSA in children may result in neurocognitive impairment and behavioral problems.

OSA can also affect the cardiovascular and pulmonary systems. For example, apnea leads to periods of hypoxemia, alveolar hypoventilation, hypercapnia, and acidosis. This, in turn, can cause systemic hypertension, cardiac arrhythmias, pulmonary hypertension, and cor pulmonale. Systemic hypertension is common in patients with OSA. Severe OSA is also associated with decreased survival, presumably related to severe hypoxemia, hypertension, or an increase in automobile collisions related to daytime sleepiness. It is estimated that about 7% of adults have moderate or severe OSA, 20% have mild OSA, and the referral population of OSA patients represents a small proportion of patients who have clinically significant and treatable disease.

Diagnosis

The standard diagnostic criterion for sleep disorders is a polysomnogram performed in a sleep laboratory. A standard polysomnogram includes EEG, submental electromyogram (EMG) and electrooculogram (to detect rapid eye movement [REM] sleep) for sleep staging. PSG also typically includes electrocardiography and monitoring of respiratory airflow, effort, snoring, oxygen desaturation, and sleep position. An attended study ensures that the electrodes and sensors are functioning adequately and do not become dislodged during the night. In addition, an attendant is able to identify severe OSA in the first part of the night and titrate continuous positive airway pressure (CPAP) in the second part of the night, commonly known as a "split-night" study. If successful, this strategy can eliminate the need for additional PSG for CPAP titration. Auto-adjusting positive airway pressure (APAP) may also be used to determine the most effective pressure.

Table 1. Definitions of Terms for OSA

Terms

Definition

Respiratory event

Apnea

The frequency of apneas and hypopneas is measured from channels assessing oxygen desaturation, respiratory airflow, and respiratory effort. In adults, apnea is defined as a drop in airflow by 90% or more of pre-event baseline for at least 10 seconds. Due to faster respiratory rates in children, pediatric scoring criteria define an apnea as 2 or more missed breaths, regardless of its duration in seconds.

Hypopnea

Hypopnea in adults is scored when the peak airflow drops by at least 30% of pre-event baseline for at least 10 seconds in association with either at least 4% arterial oxygen desaturation or an arousal. Hypopneas in children are scored by a 50% or greater drop in nasal pressure and either a 3% or more decrease in oxygen saturation or an associated arousal.

RERA

Respiratory event-related arousal is defined as an event lasting at least 10 seconds associated with flattening of the nasal pressure waveform and/or evidence of increasing respiratory effort, terminating in an arousal but not otherwise meeting criteria for apnea or hypopnea

Respiratory event reporting

AHI

The apnea/hypopnea index is the average number of apneas or hypopneas per hour of sleep

RDI

The respiratory disturbance index is the number of apneas, hypopneas, or respiratory event-related arousals per hour of sleep time. RDI is often used synonymously with the AHI.

REI

The respiratory event index is the number of events per hour of monitoring time. Used as an alternative to AHI or RDI in home sleep studies when actual sleep time from EEG is not available.

OSA

Obstructive sleep apnea is repetitive episodes of upper airway obstruction due to the collapse and obstruction of the upper airway during sleep

  • Mild OSA
  • In adults: AHI or RDI of 5 to <15
  • In children: AHI ≥1.0 to <5
  • Moderate OSA

AHI or RDI of 15 to < 30; Children: AHI of ≥ 5 to <10

  • Severe OSA
  • Adults: AHI or RDI ≥30
  • Children: AHI of ≥10

UARS

Upper airway resistance syndrome is characterized by a partial collapse of the airway and results in increased resistance to airflow. The increased respiratory effort is associated with multiple sleep fragmentations, as measured by very short alpha EEG arousals.

Positive airway pressure

APAP

Auto-adjusting positive airway pressure may be used either to provide treatment or to determine the most effective pressure for CPAP

CPAP

Positive airway pressure (PAP) may be continuous (CPAP) or auto-adjusting (APAP) or bi-level (bi-PAP). CPAP is a more familiar abbreviation and will refer to the 3 types of devices for delivery of positive airway pressure.

CPAP failure

Usually defined as an AHI >20 events per hour while using CPAP

CPAP intolerance

CPAP use for <4 hours per night for ≥5 nights per week, or refusal to use CPAP. CPAP intolerance may be observed in patients with mild, moderate, or severe OSA

AHI: Apnea/hypopnea Index; APAP: auto-adjusting positive airway pressure; CPAP: continuous positive airway pressure; EEG: electroencephalogram; OSA: obstructive sleep apnea; RDI: Respiratory Disturbance Index; REI: Respiratory Event Index; RERA: respiratory event-related arousal: UARS: upper airway resistance syndrome.

Due to faster respiratory rates in children, pediatric scoring criteria define an apnea as 2 or more missed breaths, regardless of its duration in seconds. In pediatric patients, an AHI greater than 1.5 events per hour is considered abnormal, and an AHI of 10 or more may be considered severe.

A variety of devices have been developed specifically to evaluate OSA at home. They range from portable full polysomnography systems to single-channel oximeters. Available devices evaluate different parameters, which may include oximetry, respiratory and cardiac monitoring, and sleep/wake activity, but most portable monitors do not record EEG activity.

The STOP-BANG questionnaire, a method developed for non-sleep specialists, assesses the signs and symptoms of OSA (Snore, Tired, Observed apnea, blood Pressure, BMI, Age, Neck, Gender), has been shown to have 97% sensitivity and 96% negative predictive value (specificity, 33%) for the identification of patients with severe OSA (Apnea/Hypopnea Index [AHI] >30 events per hour). Overnight oximetry has been used by some sleep specialists as a component of the risk assessment but is inadequate for the diagnosis of OSA. Therefore, a follow-up polysomnography (PSG) or home sleep apnea test would still be required to confirm or exclude a diagnosis of OSA.

Treatment

Medical management of OSA in adults may include weight loss, avoidance of stimulants, body position adjustment, oral appliances, and use of various types of positive airway pressure therapy (i.e., fixed CPAP, bi-level positive airway pressure, or auto-adjusting positive airway pressure) during sleep.

Medical management of OSA (e.g. CPAP, BIPAP) is discussed in Medical Policy #065 Medical Management of Obstructive Sleep Apnea Syndrome.

Surgical management of OSA (e.g. adenotonsillectomy, uvulopalatopharyngoplasty) is discussed in Medical Policy #621 (Surgical Treatment of Snoring and Obstructive Sleep Apnea Syndrome).

Refer to Policy #619 – Polysomnography for Non-Respiratory Sleep Disorders

*Note: There are varying benefit plans for unattended (unsupervised) home sleep studies. Please verify benefits prior to applying policy criteria, as benefit coverage will supersede this policy.

KEY POINTS:

This evidence review has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through May 11, 2020.

SUMMARY OF EVIDENCE:

For individuals who have suspected OSA who receive home sleep testing with at least four recording channels, the evidence includes RCTs. Relevant outcomes are test accuracy, symptoms, functional outcomes, and resource utilization. RCTs have reported that home sleep testing with type 3 monitors (those with ≥4 recording channels) is noninferior to testing in the sleep lab for adults with a high pretest probability of OSA and absence of comorbid conditions as determined by clinical evaluation. A positive portable monitoring study with channels that include arterial oxygen saturation, airflow, and respiratory effort has a high positive predictive value for OSA and can be used as the basis for a CPAP trial to determine the efficacy of treatment. A negative portable monitoring study cannot be used to rule out OSA. Patients who have a negative result from portable monitoring or have a positive study but do not respond to CPAP should undergo further evaluation. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have suspected OSA who receive limited channel home sleep testing, the evidence includes studies on diagnostic accuracy. Relevant outcomes are test accuracy, symptoms, functional outcomes, and resource utilization. The ability to detect clinically significant OSA without sensors for heart rate, respiratory effort, airflow, and oxygen saturation lacks support in the literature. The evidence is insufficient to determine the effects of the technology on health outcomes.

PRACTICE GUIDELINES AND POSITION STATEMENTS:

American Academy of Sleep Medicine

The AASM (2017) published clinical practice guidelines on diagnostic testing for adult OSA. The AASM provided the following recommendations (see Table 2).

Table 2. Recommendations on Diagnostic Testing for Adult OSA

Recommendation Statement

SOR

QOE

Benefits vs Harms

We recommend that clinical tools, questionnaires, and prediction algorithms not be used to diagnose OSA in adults, in the absence of PSG or HSAT

Strong

Moderate

High certainty that harms outweigh benefits

We recommend that PSG, or HSAT with a technically adequate device, be used for the diagnosis of OSA in uncomplicated adult patients presenting with signs and symptoms that indicate an increased risk of moderate to severe OSA.

Strong

Moderate

High certainty that benefits outweigh harms

We recommend that if a single HSAT is negative, inconclusive, or technically inadequate, PSG be performed for the diagnosis of OSA.

Strong

Low

High certainty that benefits outweigh harms

We recommend that PSG, rather than home sleep testing, be used for patients with significant cardiorespiratory disorder, potential respiratory muscle weakness, awake or suspected sleep hypoventilation, chronic opioid medication use, history of stoke or severe insomnia.

Strong

Very low

High certainty that benefits outweigh harms

We suggest that, if clinically appropriate, a split-night diagnostic protocol, rather than a full-night diagnostic protocol for PSG be used for the diagnosis of OSA

Weak

Low

Low certainty that benefits outweigh harms

We suggest that when the initial PSG is negative, and there is still clinical suspicion for OSA, a second PSG be considered for the diagnosis of OSA.

Weak

Very low

Low certainty that benefits outweigh harms

HSAT: home sleep apnea testing; OSA: obstructive sleep apnea; PSG: polysomnography; QOE: quality of evidence; SOR: strength of recommendation.

The AASM considers a technically adequate home sleep apnea test (HSAT) device to incorporate "a minimum of the following sensors: nasal pressure, chest and abdominal respiratory inductance plethysmography, and oximetry; or else PAT [peripheral arterial tone] with oximetry and actigraphy." The guidelines refer to the AASM Manual for the Scoring of Sleep and Associated Events for additional information regarding HSAT sensor requirements.

The AASM also issued guidelines in 2009 on the evaluation, management, and long-term care of adults with OSA. The levels of recommendation are “standard” (generally accepted patient-care strategy, with high degree of certainty; level 1 to 2 evidence), “guideline” (moderate degree of clinical certainty; level 2 to 3 evidence), or “option” (uncertain clinical use; insufficient or inconclusive evidence).

Diagnosis

AASM recommended that patients who are obese, retrognathic, hypertensive, or who complain of snoring or daytime sleepiness should be assessed for presence or absence as well as the severity of OSA using the following methods (standard):

  • Sleep history assessment includes “witnessed apneas, gasping/choking at night, excessive sleepiness … total sleep amount, nocturia, morning headaches … and decreased concentration and memory.”
  • Physical assessment includes evaluation of “respiratory, cardiovascular, and neurologic systems…. signs of upper respiratory narrowing….”
  • Objective testing, under an AASM-accredited program, and attended by trained technical personnel. The diagnosis of OSA is confirmed if the number of obstructive events (apneas, hypopneas plus respiratory event related to arousals) is greater than 15 events/hour or greater than 5 events/hour in a patient reporting any of the following: unintentional sleep episodes during wakefulness; daytime sleepiness, unrefreshing sleep; fatigue; insomnia; waking up breath holding, gasping, or choking; or a bed partner describing loud snoring, breathing interruptions, or both.
    • In laboratory polysomnography (standard) records “electroencephalogram … electrooculogram … chin electromyogram, airflow, oxygen saturation, respiratory effort, … and heart rate.”
    • Home testing with portable monitors should “at minimum, record air flow, respiratory effort, and blood oxygenation.”

The AASM (2011) published evidence-based guidelines on respiratory indications for PSG in children. "Standard" recommendations were made for the following: PSG in children should be performed and interpreted in accordance with the AASM Manual for the Scoring of Sleep and Associated Events; PSG is indicated when the clinical assessment suggested the diagnosis of OSA in children; children with mild OSA preoperatively should have clinical evaluation following adenotonsillectomy to assess for residual symptoms. If there are residual symptoms of OSA, PSG should be performed; PSG was indicated following adenotonsillectomy to assess for residual OSA in children with preoperative evidence for moderate-to-severe OSA, obesity, craniofacial anomalies that obstruct the upper airway, and neurologic disorders; PSG was indicated for positive airway pressure titration in children with OSA.

The AASM (2017) published a position statement on the clinical use of a home sleep apnea test. The AASM indicated that a home sleep apnea test should be ordered by a physician after "a face-to-face examination" to diagnose OSA or evaluate treatment efficacy and should not be used for general screening of asymptomatic populations. The AASM supported the review of raw data and interpretation by a physician board certified in sleep medicine, stating that automatically scored data "could lead to sub-optimal care that jeopardizes patient health and safety".

Split-Night Studies

American Academy of Sleep Medicine practice parameters (2005) have indicated that a split-night study (initial diagnostic PSG followed by CPAP titration during PSG on the same night) is an alternative to 1 full night of diagnostic PSG followed by a second night of titration if the following 4 criteria are met:

  1. An AHI of at least 40 events per hour is documented during a minimum of 2 hours of diagnostic PSG. Split-night studies may sometimes be considered at an AHI between 20 and 40 events per hour, based on clinical judgment (e.g., if there are also repetitive long obstructions and major desaturations). However, at AHI values below 40, determination of CPAP-level requirements, based on split-night studies, may be less accurate than in full-night calibrations.
  2. CPAP titration is carried out for more than 3 hours (because respiratory events can worsen as the night progresses).
  3. PSG documents that CPAP eliminates or nearly eliminates the respiratory events during rapid eye movement (REM) and non-REM sleep, including REM sleep with the patient in the supine position.
  4. A second full night of PSG for CPAP titration is performed if the diagnosis of a sleep-related breathing disorder is confirmed, but criteria b and c are not met.

American College of Physicians

The 2014 guidelines on the diagnosis of OSA in adults from the American College of Physicians (ACP) recommend that clinicians should target their assessment of OSA to individuals with unexplained daytime sleepiness. ACP recommends PSG for diagnostic testing in patients suspected of OSA, and portable sleep monitors in patients without serious comorbidities as an alternative to PSG when PSG is not available for diagnostic testing (weak recommendation, moderate-quality evidence). Inconclusive areas of evidence included preoperative screening for OSA, phased testing for the diagnosis of OSA, and the utility of portable monitors for diagnosis OSA in patients with comorbid conditions.

The 2013 ACP guidelines on the management of OSA in adults from the ACP recommend that all overweight and obese patients diagnosed with OSA should be encouraged to lose weight (strong recommendation, low quality evidence). ACP recommends CPAP as initial therapy for patients diagnosed with OSA (strong recommendation; moderate-quality evidence), and mandibular advancement devices as an alternative therapy to CPAP for patients diagnosed with OSA who prefer mandibular advancement devices or for those with adverse effects associated with CPAP (weak recommendation, low quality evidence).

American Academy of Craniofacial Pain

The American Academy of Craniofacial Pain published a position paper in 2013. It indicated that oral appliance therapy was recognized as an effective therapy for many with primary snoring and mild-to-moderate OSA, as well as those with more severe OSA who cannot tolerate PAP therapies, but that oral appliance therapy has the potential to cause adverse events, including temporomandibular joint pain and dysfunction. The Academy recommended that dentists engaged in, or who want to engage in, the assessment and management of patients with snoring and OSA using mandibular advancement OA be properly trained and experienced in the assessment, diagnosis, and management of temporomandibular joint and craniofacial pain.

American Society of Metabolic and Bariatric Surgery

The American Society of Metabolic and Bariatric Surgery (2012) published guidelines on the perioperative management of OSA (reviewed in October 2015). The guidelines noted that while some reports in the literature have recommended routine screening for OSA prior to bariatric surgery, other reports have suggested clinical screening only does not result in any increase in postoperative pulmonary complications after laparoscopic Roux-en-Y gastric bypass, and that most current surgical practices refer patients with clinical symptoms of OSA for PSG, but do not make this a routine preoperative test prior to bariatric surgery. The Society provided, based on the evidence in the literature to date, the following guidelines on OSA in the bariatric surgery patient and its perioperative management:

  1. “OSA is highly prevalent in the bariatric patient population….

4.   [Patients with moderate to severe OSA] should bring their CPAP machines, or at least their masks, with them at the time of surgery and use them following bariatric surgery at the discretion of the surgeon.

7.   Routine pulse oximetry or capnography for postoperative monitoring of patients with OSA after bariatric surgery should be utilized, but the majority of these patients do not routinely require an ICU [intensive care unit] setting.

8.   No clear guidelines exist upon which to base recommendations for retesting for OSA following bariatric surgery….”

American Academy of Otolaryngology – Head and Neck Surgery

The American Academy of Otolaryngology – Head and Neck Surgery (2011) published guidelines on PSG for sleep-disordered breathing prior to tonsillectomy in children, which included the following:

  1. “Before determining the need for tonsillectomy, the clinician should refer children with SDB [sleep-disordered breathing] for PSG if they exhibit the following: obesity, Down syndrome, craniofacial abnormalities, neuromuscular disorders, sickle cell disease, or mucopolysaccharidoses.
  2. The clinician should advocate for PSG prior to tonsillectomy for SDB in children without any of the comorbidities [listed above] for whom the need for surgery is uncertain or when there is discordance between tonsillar size of physical examination and the reported severity of SDB
  3. Clinicians should communicate PSG results to the anesthesiologist prior to the induction of anesthesia for tonsillectomy in a child with SDB.
  4. Clinicians should admit children with OSA documented on PSG for inpatient, overnight monitoring after tonsillectomy if they are younger than age 3 years or have severe OSA (apnea-hypopnea index of 10 or more obstructive events/hour, oxygen saturation nadir less than 80%, or both).
  5. In children for whom PSG is indicated to assess SDB prior to tonsillectomy, clinicians should obtain laboratory-based PSG, when available.”

American Thoracic Society

The American Thoracic Society (2016) published a statement on the long-term effects and treatment of mild OSA in adults. The Society’s systematic review concluded:

  • Daytime sleepiness: subjective improvement with CPAP; unclear effect of non-CPAP therapies
  • Quality of life: small improvements seen in different domains in different studies
  • Neurocognition: treatment effects inconsistent.

U.S. Preventive Services Task Force Recommendations

The U.S. Preventive Services Task Force (2017) reported on the evidence for screening for OSA in adults and concluded that "the current evidence is insufficient to assess the balance and harms of screening for obstructive sleep apnea (OSA) in asymptomatic adults. Evidence on screening tools to accurately detect persons in asymptomatic populations who should receive further testing and treatment of subsequently diagnosed OSA to improve health outcomes is lacking, and the balance of benefits and harms cannot be determined."

KEY WORDS:

Sleep study, polysomnography, polysomnogram, obstructive sleep apnea, central sleep apnea, hypopnea, Upper Airway Resistance Syndrome, narcolepsy, apnea hypopnea index(AHI), respiratory disturbance index (RDI), continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP), demand positive airway pressure (DPAP), Epworth Sleepiness Scale (ESS), split-night study, Auto-adjusting positive airway pressure (APAP), Respiratory Event Index, REI, home sleep study

APPROVED BY GOVERNING BODIES:

Various PAP devices have been cleared by FDA through the 510(k) process since 1977. Bilevel positive airway pressure devices were first cleared for marketing in 1996.

In 2017, SleepImage System (MyCardio) was cleared for marketing by the FDA through the 510(k) process to aid in the evaluation of sleep disorders (K163696). The SleepImage System is considered software as a medical device that provides automated analysis of sleep data from a single photoplethysmogram sensor.

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

CURRENT CODING: 

***The performance of multiple nights of an unattended home sleep study will be reimbursed as one service regardless of the number of multiple nights of patient data obtained to successfully and appropriately complete testing.

CPT:

95782

Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, attended by a technologist

95783

Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, with initiation of continuous positive airway pressure therapy or bi-level ventilation, attended by a technologist

95800

Sleep study, unattended, simultaneous recording; heart rate, oxygen saturation, respiratory analysis (e.g., by airflow or peripheral arterial tone), and sleep time)

95801

Sleep study, unattended, simultaneous recording; minimum of heart rate, oxygen saturation, and respiratory analysis (e.g., by airflow or peripheral arterial tone)

95803

Actigraphy testing, recording, analysis, interpretation, and report (minimum of 72 hours to 14 consecutive days of recording)

95805

Multiple sleep latency or maintenance of wakefulness testing, recording, analysis and interpretation of physiological measurements of sleep during multiple trials to assess sleepiness

95806

Sleep study, unattended, simultaneous recording of, heart rate, oxygen saturation, respiratory airflow, and respiratory effort (e.g., thoracoabdominal movement)

95807

Sleep study, simultaneous recording of ventilation, respiratory effort, ECG or heart rate, and oxygen saturation, attended by a technologist

95808

Polysomnography; any age, sleep staging with 1-3 additional parameters of sleep, attended by a technologist

95810

Polysomnography; age 6 years or older, sleep staging with 4 or more additional parameters of sleep, attended by a technologist

95811

Polysomnography; age 6 years or older, sleep staging with 4 or more additional parameters of sleep, with initiation of continuous positive airway pressure therapy or bi-level ventilation, attended by a technologist

95999

Unlisted neurological or neuromuscular diagnostic procedure

HCPCS:

E1399

Durable medical equipment, miscellaneous

G0398

Home sleep study test (HST) with type II portable monitor, unattended; minimum of 7 channels: EEG, EOG, EMG, ECG/heart rate, airflow, respiratory effort and oxygen saturation.

G0399

Home sleep test (HST) with type III portable monitor, unattended; minimum of 4 channels: 2 respiratory movement/airflow, 1 ECG/heart rate and 1 oxygen saturation

G0400

Home sleep test (HST) with type IV portable monitor, unattended; minimum of 3 channels

REFERENCES:

  1. Agency for Healthcare Policy and Research. Systematic Review of the Literature Regarding the Diagnosis of Sleep Apnea. Evidence Report/Technology Assessment No. 1, AHCPR Publication No. 99-E002, December 1998.
  2. American Society of Anesthesiologists Task Force on Perioperative Management of Patients with Obstructive Sleep Apnea. Practice guidelines for the perioperative management of patients with obstructive sleep apnea. Anesthesiology. 2014; 120(2):1-19.
  3. Andreu AL, Chiner E, Sancho-Chust JN, et al. Effect of an ambulatory diagnostic and treatment programme in patients with sleep apnea. Eur Respir J. Feb 2012; 39(2):305-312.
  4. Aurora RN, Zak RS, Karippot A, et al. Practice parameters for the respiratory indications for polysomnography in children. Sleep. Mar 01 2011; 34(3): 379-88.
  5. Ayappa I, Norman RG, Seelall V, et al. Validation of a self-applied unattended monitor for sleep disordered breathing. J Clin Sleep Med. Feb 15 2008; 4(1):26-37.
  6. Balk EM, Moorthy D, Obadan NO, et al. Diagnosis and Treatment of Obstructive Sleep Apnea in Adults. Comparative Effectiveness Review No. 32 (AHRQ Publication No. 11-EHC052-EF). Rockville, MD: Agency for Healthcare Research and Quality; 2011.
  7. Berry RB, Budhiraja R, Gottlieb DJ, et al. Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. Oct 15 2012; 8(5):597-619.
  8. Berry RB, Kryger MH, Massie CA. A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial. Sleep 2011; 34(4):479-485.
  9. Bibbins-Domingo K, Grossman DC, Curry SJ, et al. Screening for Obstructive Sleep Apnea in Adults: US Preventive Services Task Force Recommendation Statement. JAMA. Jan 24 2017; 317(4): 407-414.
  10. Boynton G, Vahabzadeh A, Hammoud S, et al. Validation of the STOP-BANG Questionnaire among Patients Referred for Suspected Obstructive Sleep Apnea. J Sleep Disord Treat Care. Sep 23 2013; 2(4).
  11. Bruyneel M, Ninane V. Unattended home-based polysomnography for sleep disordered breathing: current concepts and perspectives. Sleep Med Rev. Aug 2014; 18(4):341-347.
  12. Chai-Coetzer CL, Antic NA, Rowland LS, et al. Primary care vs specialist sleep center management of obstructive sleep apnea and daytime sleepiness and quality of life: a randomized trial. JAMA. Mar 13 2013; 309(10):997-1004.
  13. Chesson AL, et al. Practice parameters for the indications for polysomnography and related procedures. Polysomnography Task Force, American Sleep Disorders Association Standards of Practice Committee. Sleep, June 1997; 20(6): 406-422.
  14. Chesson AL, et al. The indications for polysomnography and related procedures. Sleep 1997; 20(6): 423-487.
  15. Epstein LJ, Kristo D, Strollo PJ, et al. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009; 5(3):263-276.
  16. Flemons WW. Clinical practice obstructive sleep apnea. NEJM, August 2002; 347(7): 498-504.
  17. Fox N, Hirsch-Allen AJ, Goodfellow E, et al. The impact of a telemedicine monitoring system on positive airway pressure adherence in patients with obstructive sleep apnea: a randomized controlled trial. Sleep. Apr 2012; 35(4):477-481.
  18. Garcia-Diaz E, Quintana-Gallego E, Ruiz A, et al. Respiratory polygraphy with actigraphy in the diagnosis or sleep apnea-hypopnea syndrome. Chest 2007; 131(3):725-32.
  19. Giles TL, et al. Continuous positive airways pressure for obstructive sleep apnea in adults. Cochrane Database System Review 2006.
  20. Hilmisson H, Berman S, Magnusdottir S. Sleep apnea diagnosis in children using software-generated apnea-hypopnea index (AHI) derived from data recorded with a single photoplethysmogram sensor (PPG) : Results from the Childhood Adenotonsillectomy Study (CHAT) based on cardiopulmonary coupling analysis. Sleep Breath. Mar 28 2020.
  21. Jonas DE, Amick HR, Feltner C, et al. Screening for Obstructive Sleep Apnea in Adults: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. Jan 24 2017; 317(4): 415-433.
  22. Kapur VK, Auckley DH, Chowdhuri S, et al. Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. Mar 15 2017; 13(3): 479-504.
  23. Kayyali HA, Weimer S, Frederick C, et al. Remotely attended home monitoring of sleep disorders. Telemed J E Health. May 2008; 14(4):371-374.
  24. Krakow B, Ulibarri V, Melendrez D et al. A daytime, abbreviated cardio-respiratory sleep study (CPT 95807-52) to acclimate insomnia patients with sleep disordered breathing to positive airway pressure (PAP-NAP). J Clin Sleep Med 2008; 4(3): 212-22.
  25. Kuna ST, Gurubhagavatula I, Maislin G, et al. Noninferiority of functional outcome in ambulatory management of obstructive sleep apnea. Am J Respir Crit Care Med. May 1 2011; 183(9):1238-1244.
  26. Kushida CA, Littner MR, et al. Practice parameters for the indications for polysomnography and related procedures: An update for 2005. Sleep 2005, Vol. 28, No. 4, pp. 499-519.
  27. Kvale PA, Wagner PD, Epstein LJ. Pulmonary physicians in the practice of sleep medicine. Chest 2005; 128:2788-3790.
  28. Leibowitz SM, et al.  Excessive daytime sleepiness: Considerations for the psychiatrist.  Psychiatric Clinics of North America, December 2006, Vol. 29, No. 4.
  29. Marcus CL, Brooks LJ, Draper KA, et al. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. Sep 2012; 130(3):576-584.
  30. Mulgrew AT, et al. Diagnosis and initial management of obstructive sleep apnea without polysomnography: A randomized validation study. Annals of Internal Medicine, February 2007; 146(3): 157-166.
  31. National Institute for Health and Clinical Excellence. NICE technology appraisal guidance 139. Continuous positive airway pressure for the treatment of obstructive sleep apnea/hypopnea syndrome. 2010; //www.nice.org.uk/nicemedia/pdf/TA139Guidance.pdf. Accessed August, 2014.
  32. Pelletier-Fleury N, Lanoe JL, Philippe C, et al. Economic studies and 'technical' evaluation of telemedicine: the case of telemonitored polysomnography. Health Policy. Nov 1999; 49(3):179-194.
  33. Penzel T, Kesper K, Pinnow I, et al. Peripheral arterial tonometry, oximetry and actigraphy for ambulatory recording of sleep apnea. Physiol Meas. Aug 2004; 25(4):1025-1036.
  34. Pittman SD, Pillar G, Berry RB, et al. Follow-up assessment of CPAP efficacy in patients with obstructive sleep apnea using an ambulatory device based on peripheral arterial tonometry. Sleep Breath. Sep 2006; 10(3):123-131.
  35. Polysomnography Task Force - American Sleep Disorders Association Standards of Practice Committee. Practice parameters for the indications for polysomnography and related procedures Sleep. Jun 1997; 20(6):406-422.
  36. Qaseem A, Dallas P, Owens DK, et al. Diagnosis of obstructive sleep apnea in adults: a clinical practice guideline from the American College of Physicians. Ann Intern Med. Aug 2014; 161(3):210-20.
  37. Qaseem A, Holty JE, Owens DK, et al. Management of Obstructive Sleep Apnea in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. Sept 2013; 159(7):471-83.
  38. Roland PS, Rosenfeld RM, Brooks LJ, et al. Clinical practice guideline: Polysomnography for sleep-disordered breathing prior to tonsillectomy in children. Otolaryngology Head Neck Surg. Jul 2011; 145(1 Suppl):S1-15.
  39. Rosen IM, Kirsch DB, Chervin RD, et al. Clinical Use of a Home Sleep Apnea Test: An American Academy of Sleep Medicine Position Statement. J Clin Sleep Med. Oct 15 2017; 13(10):1205-1207.
  40. Rosen CL, Auckley D, Benca R, et al. A multisite randomized trial of portable sleep studies and positive airway pressure autotitration versus laboratory-based polysomnography for the diagnosis and treatment of obstructive sleep apnea: the HomePAP study. Sleep. Jun 2012; 35(6):757-767.
  41. Schutte-Rodin S, Broch L, Buysse D, et al. Clinical Guideline for the Evaluation and Management of Chronic Insomnia in Adults. J Clin Sleep Med 2008; 4(5): 487
  42. Section on Pediatric Pulmonology, Subcommittee on Obstructive Sleep Apnea Syndrome, American Academy of Pediatrics. Clinical practice guideline: diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics 2002; 109(4):704-12.
  43. Senn O, et al. A continuous positive airway pressure trial as a novel approach to the diagnosis of the obstructive sleep apnea syndrome. Chest, January 2006; 129(1): 67-75.
  44. Skomro RP, Gjevre J, Reid J, et al. Outcomes of home-based diagnosis and treatment of obstructive sleep apnea. Chest. Aug 2010; 138(2):257-263.
  45. Strohl KP, Brown DB, Collop N et al. An official American Thoracic Society Clinical Practice Guideline: sleep apnea, sleepiness, and driving risk in noncommercial drivers. An update of a 1994 Statement. Am J Respir Crit Care Med 2013; 187(11):1259-66.
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POLICY HISTORY:

Medical Policy Group, February 2007 (2)

Medical Policy Group, May 2007 (1, 2)

Medical Policy Administration Committee, May 2007

Available for comment May 26-July 9, 2007

Medical Policy Group, July 2007 (3)

Medical Policy Administration Committee, July 2007

Available for comment July 13-August 26, 2007

Medical Policy Group, August 2008 (3)

Medical Policy Administration Committee, September 2008

Available for comment September 8-October 22, 2008

Medical Policy Group, December 2008 (2)

Medical Policy Administration Committee, January 2009

Available for comment January 9-February 23, 2009

Medical Policy Group, June 2009 (3)

Medical Policy Administration Committee, June 2009

Coding update effective January 1, 2011, December 2010 (1): Added 2 new CPT codes for unattended sleep studies, 95800 & 95801, deleted 0203T and 0204T

Medical Policy Group, July 2011, Updated Key Points and References.

Medical Policy Group, November 2012; 2013 Coding updates: Added Codes 95782 & 95783; changed the verbiage on Codes 95808, 95810, and 95811; all effective 1/1/13.

Medical Policy Panel, June 2013

Medical Policy Group, June 2013 (3):  2013 Updates to Policy statement, Key Points and References; added to policy statement the use of an abbreviated daytime sleep study (PAP-NAP) as a supplement to standard sleep studies as investigational

Medical Policy Administration Committee, August 2013

Available for comment July 31 through September 20, 2013

Medical Policy Panel, June 2014

Medical Policy Group, June 2014 (5):  Policy updated with literature review; Updated key points and references; No change in Policy Statement.

Medical Policy Panel, November 2014

Medical Policy Group, November 2014 (5): Policy updated with literature review; Updated key points and references; No change in Policy Statement

Medical Policy Panel, November 2015

Medical Policy Group, December 2015 (6): Update to Description and clarification to policy statement; no change in policy intent.

Medical Policy Group, October 2016 (5):  Updates to Description, Policy Statement, Key Points, Key Words and Practice Guidelines, Position Statements, and Benefit Application removed references to polysomnography for non-respiratory sleep disorders (See new policy #619 – Polysomnography for Non-Respiratory Sleep Disorders) and to add information regarding Unsupervised (Home) polysomnography or sleep study.

Medical Policy Panel October 2016

Available for comment October 14 through November 28, 2016

Medical Policy Group, November 2016 (5):  Updated policy description of procedures or services, guidelines, and removed language regarding “Diplomate of the American Board of Sleep Medicine and added criteria for the Physician Performing the service must be credentialed as outlined; Removed face to face evaluation and added must perform a thorough review of the History and Physical prior to any polysomnography being performed. Also added additional criteria to lab based sleep study i.e. BMI and high risk OSA criteria.

Medical Policy Group, November 2016 (6): Updated references. Updated policy guidelines to remove “The evaluation”, replaced with “This history and physical”.

Medical Policy Group, December 2016 (6): Added the following for home titration to determine a fixed CPAP pressure using APAP in the policy statement: “Documented hypertension, Mood disorders, Insomnia, Impaired cognition, Ischemic heart disease, History of stroke, Unexplained dysrhythmia.” Added “unexplained dysrhythmia” to in-lab criteria for CPAP initiation/titration. Clarified in Description AASM certifications.

Medical Policy Group, March 2018 (6): Removed old policy statements including “strike-through” sections for clarification. No change to policy intent.

Medical Policy Panel, June 2018 (Diagnosis information pulled from MP 2.01.18 update)

Medical Policy Group, July 2018 (6): Updates to Description, Policy statement (added REI), Key Points, Key Words (respiratory event index, REI, home sleep study), Governing Bodies, Practice Guidelines and References.

Medical Policy Panel, June 2019

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

Medical Policy Panel, June 2020

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

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.