Highmark Medicare Services

00363

Fiscal Intermediary

L12904

Sleep Disorders Testing

06-019

CPT codes, descriptions and other data only are copyright 2007 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Pennsylvania

Region III

For services performed on or after 06/20/2003

For services performed on or after 06/15/2006

06/14/2006

This Local Coverage Determination addresses diagnostic testing of sleep disorders in adults and does not address pediatric patients.

Normal nocturnal sleep in adults is a cyclic phenomenon consisting of two (2) distinct states: rapid eye movement (REM), also called dream sleep since most dreaming occurs in this state, and non-rapid eye movement (NREM), which is divided into four (4) stages. Stages 1 and 2 are referred to as light sleep and stages 3 and 4 as deep or slow-wave sleep.

Sleep studies refer to the continuous and simultaneous monitoring and recording of various physiological and pathophysiological parameters of sleep for 6 or more hours with physician review, interpretation and report. Less than 6 hours of recording may be utilized if a definitive diagnosis can be made prior to that time. The studies are performed to diagnose sleep disorders and/or evaluate a patient's response to therapies such as nasal continuous positive airway pressure (CPAP).

Polysomnography(PSG) is a sleep study that includes a sleep staging which requires the use of a 1-4 lead electroencephalogram (EEG), an electrooculogram (EOG), and nasal and/or oral airflow, ventilation and respiratory effort. Other tests which may be included as part of PSG are: electrocardiogram (ECG); submental electromyogram (EMG); gas exchange by oximetry, transcutaneous monitoring or end tidal gas analysis; extremity muscle activity, motor activity movement; extended EEG monitoring; gastroesophageal reflux; blood pressure monitoring; snoring; body positions, etc.

The Multiple Sleep Latency Test (MSLT) is a validated, objective measure of the ability or tendency to fall asleep and is considered the standard for this measurement.The same parameters as for basic polysomnography are monitored, (usually two eye movements and two EEG [central and occipital] channels, in addition to EKG, airflow, and submental EMG). The MSLT consists of 4-5 twenty-minute nap opportunities offered at two-hour intervals on the morning following an overnight sleep study. The MSLT is designed to 1) quantitate sleepiness to determine need for treatment, and 2) to determine the premature occurrence of REM sleep. Mean sleep latency ( time to sleep onset) is influenced by quantity of prior sleep, sleep fragmentation, age, circadian phase, clinical sleep disorders such as obstructive sleep apnea (OSA) and narcolepsy, and medications known to influence sleep and wakefulness. For these reasons PSG should be performed immediately before the MSLT. Pathological ranges of sleep latency have been carefully defined. For each nap, the latency between "lights out" and sleep onset is determined. A mean latency of <5 minutes indicates excessive sleepiness, while a mean sleep latency of 10 minutes or more is normal. A mean sleep latency of 5-10 minutes is consistent with mild sleepiness. MSLT is also useful for identification of sleep-onset REM periods (defined as first epoch of REM sleep at any time during nap trial). The number of naps during which REM sleep appears is recorded.

Normally, sleep studies are performed in a sleep disorder laboratory or center (either free-standing or hospital-affiliated) in which sleep related breathing disorders are diagnosed by a sleep specialist team. The centers may also provide therapeutic services for some sleep-related conditions.

Treatments for sleep disorders include sleep hygiene, sleep position training, psychological counseling and/or behavior modification, weight loss, medication, oral appliances, continuous or bilevel positive airway pressure (CPAP), light therapy, and/or surgery.

Covered Indications
All reasonable and necessary diagnostic tests given for the medical conditions listed in the following section may be covered when the following criteria are met:

• The center is under the direction and control of physicians. Diagnostic testing routinely performed in sleep disorder laboratories may be covered even in the absence of direct supervision by a physician when data is interpreted by a physician.
• Patients are referred to the sleep disorder center by a physician, and the center maintains a record of the physician's orders.
• The need for diagnostic testing is confirmed by medical evidence, e.g., medical history (including a thorough sleep history), physician examinations ( which include respiratory, cardiovascular, and neurologic systems) and possible laboratory tests.

Diagnostic testing may be covered only if the patient has the symptoms or complaints of one of the conditions listed below. Most of the patients who undergo the diagnostic testing are not considered inpatients, although they may come to the facility in the evening for testing and then leave after their tests are over. The overnight stay is considered an integral part of these tests.

Diagnostic sleep testing is appropriate only when the patient is in a baseline or "steady state". Testing performed during the acute phase of an illness or injury is not appropriate.

Generally, sleep studies require at least 6 hours of recording to achieve a diagnosis. Occasionally, a definitive diagnosis can be made prior to that time. Medical record documentation must accompany claims for sleep testing with less than 6 hours of recording.

1. Narcolepsy. -- Narcolepsy is a neurologic disorder of unknown etiology characterized predominantly by abnormalities of REM sleep, some abnormalities of NREM sleep and the presence of excessive daytime sleepiness often with involuntary daytime sleep episodes. Other associated symptoms of narcolepsy include cataplexy, automatic behavior and other REM sleep phenomena, such as sleep paralysis and hypnogogic hallucinations.

Related diagnostic testing is covered if the patient has inappropriate sleep episodes or attacks (e.g., while driving, in the middle of a meal, in the middle of a conversation), amnesiac episodes or continuous disabling drowsiness. The sleep disorder clinic must submit documentation that this condition is severe enough to interfere with the patient's well-being and health before Medicare benefits may be provided for diagnostic testing.

The diagnosis of narcolepsy is usually confirmed by an overnight sleep study (Polysomnography) followed by a multiple sleep latency test (MSLT) the next day. The following measurements are normally required to diagnose narcolepsy: (1) Polysomnographic assessment of the quality and quantity of night-time sleep; (2) determination of the latencies to REM episodes; and (3) the presence of REM-sleep episodes. The minimum electrophysiological channels that are required for this diagnosis include EEG, chin EMG and EOG.

Initial polysomnography and multiple sleep latency testing occasionally fail to identify narcolepsy. Repeat testing is necessary when the initial results are ambiguous and the clinical history strongly indicates a diagnosis of narcolepsy.

2. Sleep Apnea. -- Sleep Apnea is a respiratory dysfunction resulting in cessation or near cessation of respiration for a minimum of 10 seconds. These cessations of breathing may be due to either an occlusion of the airway (obstructive sleep apnea), absence of respiratory effort (central sleep apnea), or a combination of these factors (mixed sleep apnea). Central sleep apnea is a relatively rare entity. Obstructive sleep apnea (OSA) is worsened by one of the following: (1) reduced upper airway caliber due to obesity, adenotonsillar hypertrophy, mandibular deficiency, macroglossia, or upper airway tumor; (2) excessive pressure across the collapsible segment of the upper airway; or (3) activity of the muscles of the upper airway insufficient to maintain patency.

The most common nocturnal (during sleep) symptoms of sleep apnea are severe snoring, breathing pauses, choking and abnormal motor activity (i.e., patients flail extremities). Symptoms while awake are excessive daytime sleepiness due to sleep disruption and cognitive impairment, including poor memory and personality changes.

Polysomnography is the test of choice and is diagnostic if more than 5 observed apneas or hypopneas occur per hour of sleep during at least 6 hours of sleep. Normally, the polysomnography measurements used to diagnose Sleep Apnea are: the electrophysiologic indices of sleep staging (EEG, EOG, EMG); electromechanical indices contrasting respiratory effort with actual ventilation (chest and/or abdomen movement; airflow at the nose and mouth); and consequences of apneic events, including electrocardiograms and pulse oximetry. Ordinarily, sleep apnea can be diagnosed by a single polysomnogram. If more than one such testing session is claimed, documentation justifying the medical necessity for the additional tests must be provided. (Example: No REM sleep in 6 or more hours of recording.)

Polysomnography, including video recording and additional EEG channels in an extended bilateral montage, is routinely indicated to assist with the diagnosis of paroxysmal arousals or other sleep disruptions that are thought to be seizure related when the initial clinical evaluation and results of a standard EEG are inconclusive. Polysomnography is not routinely indicated for patients with a history of epilepsy who have no specific symptoms consistent with a sleep disorder.

Polysomnography may be indicated to provide a diagnostic classification or prognosis when both of the following exist: the clinical evaluation and results of standard EEG have ruled out a seizure disorder; and there is a history of repeated violent or injurious episodes during sleep. Normally when polysomnography is performed for the diagnosis of parasomnias, the following measurements are obtained: sleep-scoring channels (EEG, EOG, chin EMG); EEG using an expanded bilateral montage; EMG for body movements; and audiovideo recording and documented technologist observations.

Polysomnography for Snoring
Polysomnography may be indicated for severe snoring when other evidence of sleep disordered breathing is present.

Snoring and nasal obstructive signs and symptoms are not, in and of themselves, indications for polysomnography, however, they may be indications of sleep apnea when other findings are also present.

Follow up polysomnography may be indicated for any of the following:

• to re-evaluate worsening or lack of improvement in a patient who has received the above therapies;
• after substantial weight loss (e.g., 10% of body weight) has occurred in patients on CPAP for treatment of sleep-related breathing disorders to ascertain whether CPAP is still needed at the previously titrated pressure;
• after substantial weight gain (e.g., 10% of 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;
• when clinical response is insufficient or when symptoms return despite a good initial response to treatment with CPAP; or
• when there has been a significant change in cardiorespiratory status, such as the development or worsening of CHF or LV dysfunction;
• after good clinical response to oral appliance treatment with moderate to severe OSA, to ensure therapeutic benefit;
• after surgical treatment of patients with moderate to severe OSA, to ensure satisfactory response;
• after surgical or dental treatment of patients with OSA whose symptoms return despite a good initial response to treatment.

Follow up polysomnography is not routinely indicated in patients treated with CPAP whose symptoms continue to be resolved with CPAP treatment.

Polysomnography with CPAP titration may be appropriate for patients with any of the following:

• An apnea index (AI) of at least 20 per hour or an apnea-hypopnea (AHI) of at least 30 per hour, regardless of the patient's symptoms;
• AHI of at least 10 per hour in a patient with excessive daytime sleepiness
• A respiratory arousal index of at least 10 per hour in a patient with excessive daytime sleepiness.
• A clinical change, such as a significant change in body weight or the development of CHF or LV dysfunction, indicating that the CPAP dose may need to be changed.

For CPAP titration, a split-night study (initial diagnostic polysomnogram followed by CPAP titration during polysomnography on the same night) is an alternative to one full night of diagnostic polysomnography followed by a second night of titration if all of the following criteria are met:

• a) An AHI of at least 40 is documented during a minimum of 2 hours of diagnostic polysomnography; May be considered for an AHI of 20-40 based on clinical judgement (e.g. if there are also repetitive long obstructions and major desaturations)
• b) CPAP titration is carried out for more than 3 hours;
• c) Evidence of OSA is documented during a minimum of two hours of diagnostic polysomnography.
• d) Polysomnography documents the CPAP eliminates or nearly eliminates the respiratory events during REM and non-REM sleep
• e) A second full night of polysomnography for CPAP titration is performed if the diagnosis of a sleep-related breathing disorder is confirmed but the criteria b and d are not met.

A multiple sleep latency test is not routinely indicated for most patients with sleep-related breathing disorders. A subjective assessment of excessive daytime sleepiness should be obtained routinely. A MSLT may be indicated in patients with excessive daytime somnolence despite the cessation of apnea or a significant decrease in AHI.

Electroencephalogram (EEG), sleep only (CPT code 95822)

This test may be indicated to assist in the diagnoses of narcolepsy and/or sleep apnea and seizures. It may also be indicated to assist in the diagnosis of paroxysmal arousals, other sleep disruptions that are thought to be seizure related, and other parasomnias, when the initial clinical evaluation and standard EEG are inconclusive.

Sleep EEG is not routinely indicated for patients with a history of epilepsy who have no specific complaints consistent with a sleep disorder.

Coverage of THERAPEUTIC services in a sleep disorder clinic.

Sleep disorder centers may at times render therapeutic as well as diagnostic services. Therapeutic services may be covered in a hospital outpatient setting or in a freestanding facility provided they meet the pertinent requirements for the particular type of services, are reasonable and necessary for the patient, and are performed under the direct supervision of a physician.

Coverage Limitations
Diagnostic testing that is duplicative of previous sleep testing, to the extent the results are still pertinent, is not covered if there have been no significant clinical changes in medical history since the previous study.

Polysomnography, cardiorespiratory sleep studies, and MSLTs are not covered in the following situations:

• For the diagnosis of patients with chronic insomnia;
• To preoperatively evaluate a patient undergoing a laser assisted uvulopalato-pharyngoplasty without clinical evidence that obstructive sleep apnea is suspected;
• To diagnose chronic lung disease (Nocturnal hypoxemia in patients with chronic, obstructive, restrictive, or reactive lung disease is usually adequately evaluated by oximetry. However, if the patient's symptoms suggest a diagnosis of obstructive sleep apnea, polysomnography may be considered medically necessary);
• In cases of typical, uncomplicated, and noninjurious parasomnia when the diagnosis is clearly delineated;
• For patients with epilepsy who have no specific complaints consistent with a sleep disorder;
• For patients with symptoms suggestive of the periodic limb movement disorder or restless leg syndrome unless symptoms are suspected to be related to a covered indication;
• Unattended sleep studies are not indicated.

Polysomnography for Chronic Insomnia
Evidence at the present time is not convincing that polysomnography in a sleep disorder clinic for chronic insomnia provides definitive diagnostic data or that such information is useful in patient treatment or is associated with improved clinical outcome. The use of polysomnography for the diagnosis of patients with chronic insomnia is not covered under Medicare because it is not reasonable and necessary.

Parasomnia -- Parasomnias are a group of disorders during sleep that are associated with brief or partial arousals but not with marked sleep disruption or impaired daytime alertness. The presenting complaint is usually related to the behavior itself. Most parasomnias are more common in children, but may persist into adulthood when their occurrence may have more pathologic significance. Behavior during these times can often lead to damage to the patient's surroundings and injury to the patient or to others.

Parasomnias include the following conditions: confusion arousals, sleepwalking (Somnambulism), sleep terrors, REM sleep behavior disorder, sleep-related epilepsy, sleep bruxism, sleep enuresis, and miscellaneous (nocturnal headbanging, sleep talking, restless leg syndrome, periodic limb movement disorder, and nocturnal leg cramps).

Some of the more common, uncomplicated, noninjurious parasomnias, such as typical disorders of arousal, nightmares, enuresis, somniloquy, and bruxism can usually be diagnosed by clinical evaluation alone. A clinical history, neurologic exam and routine EEG obtained while the patient is awake and asleep are often sufficient to establish the diagnosis and permit the appropriate treatment of sleep related epilepsy.

Unattended Sleep Studies (95806)
Sleep studies that are unattended are generally performed outside of a sleep disorder clinic or a hospital affiliated facility, and as such, will be denied as not medically necessary.

Screening tests, in the absence of associated signs, symptoms or complaints will be denied.

Training and Accreditation

The accuracy of sleep disorder testing depends on the knowledge, skill and experience of the technician or physician. Sleep lab accreditation (for example, by the American Academy of Sleep Medicine (formerly the American Sleep Disorders Association)) also helps to ensure that sleep studies are performed in accordance with the highest standards of care.

Technicians or physicians who perform or supervise sleep studies must be capable of demonstrating training and experience specific to the study performed and maintain documentation for postpayment audit. Physicians who perform, supervise, and/or interpret the studies must be capable of demonstrating training and experience specific to the study performed or interpreted and maintain documentation for postpayment audit.

The performance of these studies is limited to technicians or physicians who are highly skilled in sleep disorder testing. The accuracy and utility of the results are dependent on the skill of the performing provider; therefore, the provider may be subject to a postpayment peer review in order to verify his/her qualifications.

A physician may personally perform sleep disorder testing. When a physician employs auxiliary personnel to assist him/her in rendering sleep testing procedures, the services of such personnel are considered "incident to" the physician's service. All guidelines set forth in CMS Internet On-line Manual Publication 100-2, Chapter 15, Section 60, regarding "incident to" must be met.

Diagnostic Tests and X-Rays, Outpatient Hospital Services

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

Italicized and/or quoted material is excerpted from the American Medical Association, Current Procedural Terminology (CPT) codes.

Note: CPT code 95806 will not be reimburseable by this Medicare contractor.

Note: It is the provider's responsibility to select codes carried out to the highest level of specificity and selected from the ICD-9-CM code book appropriate to the year in which the service is rendered for the claim(s) submitted.

Note:
Regarding morbid obesity, ICD-9-CM codes 278.01 and 278.8, while it is permissible to have these codes on the claim, they are insufficient when used alone. Please refer to the additional listing of diagnoses in this section.

(Applicable to procedure codes 95805, 95807, 95808, 95810, 95811)

N/A

Any ICD-9 codes not listed under the "ICD-9 Codes that Support Medical Necessity" section of this policy will be denied.

Conditions that are not listed in the "ICD-9-CM Codes that Support Medical Necessity" section of this policy.

The clinic must maintain a record of the attending physician's order/referral.

The medical record must document signs and symptoms to support reasonable and necessary indications for performing a sleep study and must be available to Medicare upon request. These signs or symptoms include, but are not limited to:

• daytime somnolence
• witnessed apneic episodes
• reports of sleeping/napping during the day
• falling asleep at work or when driving
• witnessed nocturnal motor activity (flailing)

The necessity for diagnostic testing should be confirmed by medical evidence, e.g., physical examinations and laboratory tests.

Medical record documentation must be supplied to the contractor as indicated in the "Indications and Limitations of Coverage" section of this policy and/or as requested.

For a study reported as a polysomnogram, sleep must be recorded and staged.

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

Most patients who undergo diagnostic sleep testing are not considered inpatients, although they may come to the facility in the evening for testing and then leave after their tests are over. The overnight stay is considered an integral part of these tests.

Expected utilization of sleep testing is provided in the "Indications and Limitations and/or Medical Necessity" section of this policy. If additional nights of testing are claimed, documentation to support the medical necessity of the additional tests should accompany the claims.

AARC-APT (American Association of Respiratory Care-Association of Polysomnography Technologists) clinical practice guideline. Polysomnography. Respir Care. 1995 Dec;40(12):1336-43.

Boehlecke B. Controversies in monitoring and testing for sleep-disordered breathing. Curr Opin Pulm Med. 2001 Nov;7(6):372-80.

Chesson AL Jr, Ferber RA, Fry JM, Grigg-Damberger M, Hartse KM, Hurwitz TD, Johnson S, Kader GA, Littner M, Rosen G, Sangal RB, Schmidt-Nowara W, Sher A. The indications for polysomnography and related procedures. Sleep. 1997 Jun;20(6):423-87. (Endorsed by American Academy of Sleep Medicine www.aasmnet.org/practiceparameters.htm)

Littner M, Johnson SF, McCall WV, Anderson WM, Davila D, Hartse SK, Kushida CA, Wise MS, Hirshkowitz M, Woodson BT. Practice parameters for the treatment of narcolepsy: an update for 2000. Sleep. 2001 Jun 15;24(4):451-66. (Endorsed by American Academy of Sleep Medicine www.aasmnet.org/practiceparameters.htm)

Manser RL, Rochford P, Pierce RJ, Byrnes GB, Campbell DA. Impact of different criteria for defining hypopneas in the apnea-hypopnea index. Chest. 2001 Sep;120(3):909-14.

(No authors listed) Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force. Sleep.1999 Aug 1;22(5):667-89.

Thorpy MJ. et al. The Clinical Use of the Multiple Sleep Latency Test. Sleep. 1992 Jun;15(3):268-76. (Endorsed by American Academy of Sleep Medicine www.aasmnet.org/practiceparameters.htm)

Watanabe T, Kumano-Go T, Suganuma N, Shigedo Y, Motonishi M, Honda H, Kyotani K, Uruha S, Terashima K, Teshima Y, Takeda M, Sugita Y. The relationship between esophageal pressure and apnea hypopnea index in obstructive sleep apnea-hypopnea syndrome. Sleep Res Online. 2000;3(4):169-72.

Other contractors policies: HGSAdministrators, BC/BS Alabama, Cahaba GBA, BC/BS Arkansas, Empire, BC/BS Georgia.

03/08/2006

04/27/2006

06-019

01/30/2006