Latest Review Date: June 2024

Category: Medicine

POLICY:

Polysomnography and a multiple sleep latency test performed on the day after the polysomnography may be considered medically necessary for coverage in the evaluation of suspected narcolepsy or idiopathic hypersomnia.

Polysomnography may be considered medically necessary in the evaluation of individuals with parasomnias when there is a history of sleep related injurious or potentially injurious disruptive behaviors.

Polysomnography may be considered medically necessary with a diagnosis of periodic limb movement disorder when there is:

• A complaint of repetitive limb movement during sleep by the individual or an observer; AND
• No other concurrent sleep disorder; AND
• At least one of the following is present:
  • Frequent awakenings; OR
  • Fragmented sleep; OR
  • Difficulty maintaining sleep; OR
  • Excessive daytime sleepiness

Polysomnography may be considered medically necessary in the evaluation of individuals with the following:

• Organic impotence
• Sleep related epilepsy that does not respond to conventional therapy
• Paroxysmal arousal or other sleep disturbances thought to be seizure related

Polysomnography for the diagnosis of periodic limb movement disorder is considered investigational when there is concurrent untreated obstructive sleep apnea, restless leg syndrome, narcolepsy, or REM sleep behavior disorder.

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

• Bruxism;
• Drug dependency;
• Enuresis;
• Hypersomnia, without other signs/symptoms of OSA;
• Insomnia;
• Night terrors or dream anxiety attacks;
• Nocturnal myoclonus;
• Routine diagnosis of restless leg syndrome, periodic limb movements;
• Shift work and schedule disturbances;
• Somnambulism;
• Migraine headaches;
• Snoring without other signs/symptoms of OSA;
• Chronic obstructive pulmonary disease;
• Asthma;
• Neuromuscular disease;
• Depression;
• Determining risk of sudden infant death syndrome (SIDS);
• Circadian rhythm-sleep disorders;
• Noninjurious disorders of arousal;
• Infertility.

Sleep studies performed outside a health care facility, for non-respiratory related sleep disorders (i.e., home sleep studies, whether supervised, attended, or not) are non-covered.

POLICY GUIDELINES:

The physician performing, and interpreting a polysomnogram 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 must have performed a thorough review of the patient’s history and physical prior to any polysomnography or sleep disorders testing being performed. The evaluation 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:

Polysomnography (PSG) records multiple physiologic parameters relevant to sleep. Video recording may also be performed during PSG to assess parasomnias such as rapid eye movement (REM) sleep behavior disorder.

Hypersomnias

The hypersomnias include such disorders as narcolepsy, Klein-Levine syndrome, and idiopathic hypersomnolence. Narcolepsy is a neurologic disorder characterized predominantly by abnormalities of rapid eye movement REM sleep, some abnormalities of non-REM (NREM) sleep, and the presence of excessive daytime sleepiness that cannot be fully relieved by any amount of sleep. The classic symptoms include hypersomnolence, cataplexy, sleep paralysis, and hypnagogic (onset of sleep) hallucinations. Cataplexy refers to the total or partial loss of muscle tone in response to sudden emotion. Most patients with cataplexy have abnormally low levels of hypocretin-1 (orexin A) in the cerebrospinal fluid. Narcolepsy Type 1 (narcolepsy with cataplexy) is defined as excessive daytime sleepiness (EDS) and at least one of the following criteria: (a) hypocretin deficiency or (b) cataplexy and a positive multiple sleep latency test (MSLT). In the MSLT, the patient lies down in a dark quiet room to assess the time to enter the different stages of sleep. The test is repeated every two hours throughout the day, and the maximum time allowed to fall asleep is typically set at 20 minutes. Patients with narcolepsy often have a mean sleep latency of less than five minutes and two or more early-onset REM periods during the MSLT naps. People with idiopathic hypersomnia fall asleep easily but typically do not reach REM sleep during the MSLT. Narcolepsy Type 2 (narcolepsy without cataplexy) is defined by chronic sleepiness plus a positive MSLT; hypocretin-1 levels are in the normal range in most patients.

Parasomnias

Parasomnias are abnormal behavioral, experiential, or physiologic events that occur during entry into sleep, within sleep, or during arousals from sleep. Parasomnias can result in a serious disruption of sleep-wake schedules. Some, particularly sleepwalking, sleep terrors, and REM sleep behavior disorder, can cause injury to the patient and others. Parasomnias are classified into parasomnias associated with REM sleep, parasomnias associated with NREM sleep, and other parasomnias.

Parasomnias Associated With REM Sleep

REM sleep is accompanied by muscle atonia, in which there is almost complete paralysis of the body through inhibition of motor neurons. In patients with REM sleep behavior disorder (RBD), muscle tone is maintained during REM sleep. This can lead to abnormal or disruptive behaviors associated with vivid dreams such as talking, laughing, shouting, gesturing, grabbing, flailing arms, punching, kicking, sitting up or leaping from bed, and running. Violent episodes that carry a risk of harm to the patient or bed partner may occur up to several times nightly. Idiopathic RBD is associated with the development of degenerative synucleinopathies (Parkinson disease, dementia with Lewy bodies, multiple systems atrophy) in about half of patients. Guidelines recommend maintaining a safe sleeping environment for both the patient and bed partner along with medical therapy. Other parasomnias associated with REM sleep are recurrent isolated sleep paralysis and nightmare disorder.

Parasomnias Associated With Non-REM Sleep

Disorders of arousal from NREM sleep result from the intrusion of wake into NREM sleep. These include confusional arousals, sleepwalking, and sleep terrors. In these parasomnias, the patient has incomplete awakening from NREM sleep, usually appears awake with eyes open, is unresponsive to external stimuli, and is amnestic to the event. Sleepwalking can range from calm behaviors such as walking through a house to violent and/or injurious behaviors such as jumping out of a second story window. Patients with sleep terrors (also called night terrors) typically awaken with a loud scream and feeling of intense fear, jump out of bed, and occasionally may commit a violent act.

Other Parasomnias

The category of “other parasomnias” has no specific relationship to sleep stage and includes Sleep related dissociative disorders, sleep-related enuresis, sleep-related groaning, exploding head syndrome, sleep-related hallucinations, and a sleep-related eating disorder. Diagnosis of these disorders is primarily clinical, although PSG may be used for differential diagnosis.

• In sleep-related dissociative disorders, behaviors occur during an awakening, but the patient is amnestic to them.
• Sleep-related enuresis (bedwetting) is characterized by recurrent involuntary voiding in patients greater than five years of age.
• Sleep-related groaning is a prolonged vocalization that can occur during either NREM or REM sleep.
• Exploding head syndrome is a sensation of a sudden loud noise or explosive feeling within the head upon falling asleep or during awakening from sleep.
• Sleep-related hallucinations are hallucinations that occur upon falling asleep or on awakening.
• Sleep-related eating disorder is characterized by recurrent episodes of arousals from sleep with involuntary eating or drinking. Patients may have several episodes during the night, typically eat foods that they would not eat during the day, and may injure themselves by cooking during sleep

Sleep-Related Movement Disorders

Sleep-related movement disorders include restless legs syndrome (RLS) and periodic limb movement disorder (PLMD).

Restless Legs Syndrome

RLS is a neurologic disorder characterized by uncomfortable or odd sensations in the leg that usually occur during periods of relaxation, such as while watching television, reading, or attempting to fall asleep. Symptoms occur primarily in the evening. The sensations are typically described as creeping, crawling, itchy, burning, or tingling. There is an urge to move in an effort to relieve these feelings, which may be partially relieved by activities such as rubbing or slapping the leg, bouncing the feet, or walking around the room.

Periodic Limb Movement Disorder

PLMs are involuntary, Stereotypic, repetitive limb movements during sleep, which most often occur in the lower extremities, including the toes, ankles, knees, and hips, and occasionally in the upper extremities. The repetitive movements can cause fragmented sleep architecture, with frequent awakenings, a reduction in slow wave sleep and decreased sleep efficiency, leading to excessive daytime sleepiness. PLMD alone is thought to be rare as PLMS are typically associated with RLS, RBD, or narcolepsy and represent a distinct diagnosis from PLMD.

Diagnosis

Polysomnography is a recording of multiple physiologic parameters relevant to sleep. The standard full polysomnogram includes:

• Electroencephalography to differentiate the various stages of sleep and wake,
• Chin electromyography and electrooculography to assess muscle tone and detect REM sleep,
• Respiratory effort, airflow, blood oxygen saturation (oximetry), and electrocardiography to assess apneic events,
• Anterior tibialis electromyogram to assess periodic limb movements during sleep, and
• Video recording to detect any unusual behavior.

This review addresses polysomnography for non‒respiratory sleep disorders, which include the hypersomnias (e.g., narcolepsy), parasomnias, and movement disorders (e.g., RLS, PLMD).

Refer to medical policy #305 – Polysomnography for Respiratory Sleep Disorders Testing.

KEY POINTS:

The most recent literature update was performed through May 7, 2024.

Summary of Evidence

For individuals who have suspected hypersomnia who receive PSG, the evidence includes a systematic review on diagnostic accuracy. The relevant outcomes are test accuracy, symptoms, functional outcomes, and QOL. The evidence has suggested that PSG followed by the MSLT is associated with moderate sensitivity and high specificity in support of the diagnosis of narcolepsy. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have typical or benign parasomnia who receive PSG, the evidence includes systematic reviews of studies on diagnostic accuracy and controlled cohort studies. The relevant outcomes are test accuracy, symptoms, functional outcomes, and QOL. The evidence has suggested that typical and benign parasomnias (e.g., sleepwalking, sleep terrors) may be diagnosed on the basis of their clinical features and do not require PSG. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have violent or potentially injurious parasomnia who receive PSG, the evidence includes systematic reviews of studies on diagnostic accuracy and controlled cohort studies. The relevant outcomes are test accuracy, symptoms, functional outcomes, and QOL. For the diagnosis of RBD, the combined use of clinical history and PSG to document the loss of muscle tone during REM sleep increases diagnostic accuracy and is considered the criterion standard for diagnosis. Diagnostic accuracy is increased with video recording during PSG to assess parasomnias such as RBD. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have RLS who receive PSG, the evidence includes systematic reviews of studies on diagnostic accuracy and controlled cohort studies. The relevant outcomes are test accuracy, symptoms, functional outcomes, and QOL. RLS does not require PSG because the syndrome is a sensorimotor disorder, the symptoms of which occur predominantly when awake; therefore, PSG results are generally not useful. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have PLMD who receive PSG, the evidence includes a systematic review. The relevant outcomes are test accuracy, symptoms, functional outcomes, and QOL. PSG with electromyography of the anterior tibialis is the only method available to diagnose PLMD, but this sleep-related movement disorder is rare and should only be evaluated using PSG in the absence of symptoms of other disorders. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

The American Academy of Sleep Medicine (AASM; 2005) published practice parameters for polysomnography (PSG) and related procedures. AASM made the following recommendations on the use of PSG for nonrespiratory indications (see Table 1).

Table 1. Practice Parameters on PSG for Nonrespiratory Indications

Recommendation	Grade
Polysomnography and a multiple sleep latency test performed on the day after the polysomnographic evaluation are routinely indicated in the evaluation of suspected narcolepsy	Standard
Common, uncomplicated, noninjurious parasomnias, such as typical disorders of arousal, nightmares, enuresis, sleep-talking, and bruxism, can usually be diagnosed by clinical evaluation alone	Standard
Polysomnography is not routinely indicated in cases of typical, uncomplicated, and noninjurious parasomnias when the diagnosis is clearly delineated	Option
A clinical history, neurologic examination, and a routine EEG obtained while the patients is awake and asleep are often sufficient to establish the diagnosis and permit the appropriate treatment of a sleep-related seizure disorder. The need for a routine EEG should be based on clinical judgment and the likelihood that the patient has a sleep-related seizure disorder.	Option
Polysomnography is not routinely indicated for patients with a seizure disorder who have no specific complaints consistent with a sleep disorder	Option
Polysomnography is indicated when evaluating patients with sleep behaviors suggestive of parasomnias that are unusual or atypical because of the patient’s age at onset; the time, duration or frequency of occurrence of the behavior; or the specifics of the particular motor patterns in question	Guideline
Polysomnography … is indicated in evaluating sleep-related behaviors that are violent or otherwise potentially injurious to the patient or others	Option
Polysomnography may be indicated in situations with forensic considerations (e.g., if onset follows trauma or if the events themselves have been associated with personal injury)	Option
Polysomnography may be indicated when the presumed parasomnia or sleep-related seizure disorder does not respond to conventional therapy	Option
Polysomnography is indicated when a diagnosis of periodic limb movement disorder is considered because of complaints by the patient or an observer of repetitive limb movement during sleep and frequent awakenings, fragmented sleep, difficulty maintaining sleep, or excessive daytime sleepiness	Standard
Intra-individual night-to-night variability exists in patients with periodic limb movement sleep disorder, and a single study might not be adequate to establish this diagnosis	Option
Polysomnography is not routinely indicated to diagnose or treat restless legs syndrome, except where uncertainty exists in the diagnosis	Standard
Polysomnography is not routinely indicated for the diagnosis of circadian rhythm sleep disorders	Standard

EEG: electroencephalography.

The AASM (2012) published practice parameters on nonrespiratory indications for PSG and multiple sleep latency testing in children. Table 2 lists recommendations for PSG and multiple sleep latency testing.

Table 2. Practice Parameters on PSG for Nonrespiratory Indications in Children

Recommendation	Grade
PSG is indicated for children suspected of having PLMD for diagnosing PLMD	Standard
The MSLT, preceded by nocturnal PSG, is indicated in children as part of the evaluation for suspected narcolepsy	Standard
Children with frequent NREM parasomnias, epilepsy, or nocturnal enuresis should be clinically screened for the presence of comorbid sleep disorders, and polysomnography should be performed if there is a suspicion for sleep-disordered breathing or periodic limb movement disorder	Guideline
The MSLT, preceded by nocturnal PSG, is indicated in children suspected of having hypersomnia from causes other than narcolepsy to assess excessive sleepiness and to aid in differentiation from narcolepsy	Option
The polysomnogram using an expanded EEG montage is indicated in children to confirm the diagnosis of an atypical or potentially injurious parasomnia or differentiate a parasomnia from sleep-related epilepsy when the initial clinical evaluation and standard EEG are inconclusive	Option
Polysomnography is indicated in children suspected of having RLS who require supportive data for diagnosing RLS	Option
Polysomnography is not routinely indicated for evaluation of children with sleep-related bruxism	Standard

EEG: electroencephalography; MSLT: multiple sleep latency test; NREM: non‒rapid eye movement; PLMD: periodic limb movement disorder; PSG: polysomnography; RLS: restless legs syndrome.

The AASM (2012) issued a practice parameter on the treatment of restless legs syndrome and periodic limb movement disorder in adults. The practice parameter noted different treatment efficacy measures are used to assess restless legs syndrome due to its multifaceted nature. Measures included a number of subjective scales; the only objective measurements were sleep-related parameters by PSG or actigraphy.

The AASM (2010) issued a position paper on the treatment of nightmare disorders in adults (classified as a parasomnia). The AASM stated that overnight PSG is not routinely used to assess nightmare disorder but may be used to exclude other parasomnias or sleep-disordered breathing. PSG may underestimate the incidence and frequency of posttraumatic stress disorder-associated nightmares. In 2018, the AASM updated its position paper; however, there was no mention of PSG.

The AASM (2023) issued best practice guidelines on the treatment of rapid eye movement (REM) sleep behavior disorder (RBD). All forms of RBD (primary, secondary, and drug-induced) are defined in the guideline as emergence of dream enactment with a documented elevation in REM sleep motor tone on PSG. In patients with secondary RBD, these findings occur in the context of an underlying disorder, and in patients with drug-induced RBD, they occur after starting or increasing the dose of a serotonergic medication. PSG was mentioned in the context of treatment selection, since pramipexole was noted to be most effective among patients with periodic limb movements seen on PSG.

International RBD Study Group

The Neurophysiology Working Group of the International RBD Study Group (IRBDSG) (2022) issued guidelines on video PSG procedures for the diagnosis of RBD. The working group states that video PSG "is mandatory to diagnose RBD, following technical requirements for sleep recording described in Technical Requirements for v-PSG Recording section and scoring REM sleep as described in REM Sleep Scoring section and in the AASM manual". The group also states that video PSG is mandatory to identify prodromal RBD.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Rapid Eye Movement, REM, RBD, PSG, periodic limb movement disorder, PLMD, multiple sleep latency test, MSLT, restless leg syndrome, RLS, infertility, depression, migraine

APPROVED BY GOVERNING BODIES:

Numerous polysomnography devices have been approved since 1986.

BENEFIT APPLICATION:

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

ITS: Home Policy provisions apply.

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

CURRENT CODING:

CPT Codes:

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 bilevel 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 bilevel ventilation, attended by a technologist.

 

HCPCS:

E1399

Durable medical equipment, miscellaneous

REFERENCES:

1. Aurora RN, Kristo DA, Bista SR, et al. The Treatment of Restless Legs Syndrome and Periodic Limb Movement Disorder in Adults-an update for 2012: Practice Parameters with an Evidence-based Systematic Review and Meta-analyses. SLEEP 2012; 35(8):1039-1062. www.aasmnet.org/Resources/PracticeParameters/TreatmentRLS.pdf.
2. Aurora RN, Zak RS, Auerbach SH, et al. Best Practice Guide for the Treatment of Nightmare Disorder in Adults. J Clin Sleep Med 2010; 6(4):389-401. www.aasmnet.org/Resources/bestpracticeguides/NightmareDisorder.pdf.
3. Aurora RN, Zak RS, Maganti RK, et al. Best practice guide for the treatment of REM sleep behavior disorder (RBD) J Clin Sleep Med 2010; 6(1):85-95. www.aasmnet.org/Resources/bestpracticeguides/PP_RBD.pdf.
4. Aurora RN, Lamm CI, Zak R, et al. Practice Parameters for the Non-Respiratory Indications for Polysomnography and Multiple Sleep Latency Testing in Children. SLEEP 2012; 35(11):1467-1473. www.aasmnet.org/resources/practiceparameters/pediatricpolysomnographymslt.pdf.
5. Cesari M, Heidbreder A, St Louis EK, et al. Video-polysomnography procedures for diagnosis of rapid eye movement sleep behavior disorder (RBD) and the identification of its prodromal stages: guidelines from the International RBD Study Group. Sleep. Mar 14 2022; 45(3).
6. Drakatos P, Marples L, Muza R, et al. Video polysomnographic findings in non-rapid eye movement parasomnia. J Sleep Res. Apr 2019; 28(2): e12772.
7. Goldstein CA. Parasomnias. Dis Mon. Jul 2011; 57(7):364-388.
8. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
9. Howell M, Avidan AY, Foldvary-Schaefer N, et al. Management of REM sleep behavior disorder: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. Apr 01 2023; 19(4): 759-768.
10. 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.
11. Kloss JD, Perlis ML, Zamzow JA, Culnan EJ, Gracia CR. Sleep, sleep disturbance, and fertility in women. Sleep Med Rev. 2015 Aug;22:78-87. doi: 10.1016/j.smrv.2014.10.005. Epub 2014 Oct 18.
12. Kushida CA, Littner MR, Morgenthaler T, et al. Practice parameters for the indications for polysomnography and related procedures: an update for 2005. Sleep 28(4):499-521. www.aasmnet.org/practiceparameters.aspx?cid=120.
13. Morgenthaler TI, Auerbach S, Casey KR, et al. Position Paper for the Treatment of Nightmare Disorder in Adults: An American Academy of Sleep Medicine Position Paper. J Clin Sleep Med. Jun 15 2018; 14(6): 1041-1055.
14. Neikrug AB, Ancoli-Israel S. Diagnostic tools for REM sleep behavior disorder. Sleep Med Rev. Oct 2012; 16(5):415-429.

POLICY HISTORY:

Medical Policy Panel, August 2015

Medical Policy Group, October 2016 (5): Newly adopted policy. Previously addressed in policy #305 Polysomnography/Sleep Disorders Testing. No change in policy intent.

Medical Policy Administration Committee, October 2016

Available for comment October 14 through November 28, 2016

Medical Policy Group, November 2016 (6): Updates to credentialing under Policy Guidelines and references.

Medical Policy Panel, November 2016

Medical Policy Group, December 2016 (6): Updates to Key Points, removed HST codes from coding section and Summary of Evidence. No change to policy intent.

Medical Policy Panel, September 2017

Medical Policy Group, September 2017 (6): Updates to Key Points.

Medical Policy Panel, June 2018

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

Medical Policy Panel, June 2019

Medical Policy Group, July 2019 (6): Updates to Key Points. No change to policy statement.

Medical Policy Panel, September 2020

Medical Policy Group, September 2020 (6): Updates to Key Points, Coding and References.

Medical Policy Panel, June 2021

Medical Policy Group, June 2021 (6): Updates to Description, Policy statement, Key Points, Practice Guidelines and References. Policy statement updated to remove “investigational” no change to policy intent.

Medical Policy Panel, June 2022

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

Medical Policy Panel, June 2023

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

Medical Policy Group, July 2023 (6): Updates to Policy statement to expand non-covered indications to include “Infertility”, Key Words and References.

Medical Policy Panel, June 2024

Medical Policy Group, June 2024 (6): Updates to Key Points.  Policy statements updated to replace “not medically necessary” verbiage with “investigational”.  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.