Local Coverage Determination CPT Code/Search Topic 95805, 95806, 95807, 95808, 95810, 95811 LMRP/LCD ID L5234 LMRP/LCD Title Sleep Studies- F-43B-R4 Indications and Limitations of Coverage and/or Medical Necessity Sleep disorder clinics are facilities in which certain conditions are diagnosed through the study of sleep. Such clinics are for diagnosis, therapy and research. Sleep disorder clinics may provide diagnostic or therapeutic services covered under Medicare. These clinics may be affiliated either with a hospital or a freestanding facility. Whether a clinic is hospital-affiliated or freestanding, coverage for diagnostic services under some circumstances is covered under provisions of the law different from those for coverage of therapeutic services. Criteria for Coverage of Diagnostic Tests When the following criteria are met, all reasonable and necessary diagnostic tests given for the medical conditions listed in “Medical Conditions for which Testing is Covered” are covered. - The clinic is either affiliated with a hospital or is under the direction and control of physicians. Diagnostic testing routinely performed in sleep disorder clinics may be covered even in the absence of direct supervision by a physician; - Patients are referred to the sleep disorder clinic by their attending physicians and the clinic maintains a record of the attending physician's orders; and - The need for diagnostic testing is confirmed by medical evidence (e.g., physician examinations and laboratory tests). Diagnostic testing that is duplicative of previous testing performed by the attending physician, to the extent the results are still pertinent, is not covered, because it is not reasonable and necessary under 1862(a)(1)(A) of the Act. Medical Conditions for which Testing is Covered Diagnostic testing is covered only if the patient has symptoms or complaints of one of the conditions listed below. Most patients that undergo diagnostic testing are not considered inpatients, although they may come to the facility in the evening for testing, then leave after tests are over. The overnight stay is considered an integral part of these tests. Narcolepsy: Narcolepsy is a neurologic disorder of unknown etiology characterized predominantly by abnormalities of REM, some abnormalities of NREM sleep, and the presence of excessive daytime sleepiness often with involuntary daytime sleep episodes (e.g., while driving, in the middle of a meal and amnesiac episodes). Other associated symptoms of narcolepsy including cataplexy and other REM sleep phenomena, such as sleep paralysis and hypnogogic hallucinations. The diagnosis of narcolepsy is usually confirmed by an overnight sleep study (polysomnography) followed by a multiple sleep latency test (MSLT). The following measurements are normally required to diagnose narcolepsy: - Polysomnographic assessment of the quality and quantity of night-time sleep; - Determination of the latency to the first REM episode; - MSLT; and - The presence of REM-sleep episodes. The minimum electrophysiological channels that are required for this diagnosis include EEG, EOG and chin EMG. Initial polysomnography and multiple sleep latency testing occasionally fail to identify narcolepsy. Repeat testing is necessary when initial results are negative or ambiguous, and the clinical history strongly indicates a diagnosis of narcolepsy. The diagnosis of narcolepsy requires documentation of the absence of other untreated significant disorders that cause excessive daytime sleepiness (e.g., sleep apnea, mental depression, insomnia, et cetera). Treatment for narcolepsy is usually focused around the symptom of sleepiness, and primarily consists of prescribing and taking of stimulant medication 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 is caused by one of the following: - Reduced upper airway caliber due to obesity, adenotonsillar hypertrophy, mandibular deficiency macroglossia, upper airway tumor, nasal airway obstruction, tongue base hypertrophy, tracheal obstruction or other skeletal deformity; - Excessive pressure across the collapsible segment of the upper airway; or - Activity of the muscles of the upper airway insufficient to maintain patency. The most common nocturnal (during sleep) symptoms of sleep apnea are snoring, abnormal motor activity (e.g., patients flail out and throw the bedcovers off, and may sit up or get out of bed) and nocturia. Diurnal (during wakefulness) symptoms associated with sleep apnea are excessive daytime sleepiness, due to sleep disruption from hypoxemia and cognitive impairment, including poor memory and personality changes. Polysomnography is the test of choice and is diagnostic if more than five observed apneas or hypopneas occur per hour of sleep during at least six hours of nocturnal sleep. Normally, polysomnography measurements used to diagnose sleep apnea are the electrophysiologic indices of sleep staging (EEG, EOG and EMG), electromechanical indices contrasting respiratory effort with actual ventilation (chest and/or abdomen movement, and airflow at the nose and mouth), and consequences of apneic events, including electrocardiograms and pulse oximetry. Treatment for sleep apnea is generally recommended for any patient with an AHI (apneahypopnea index), number of apneas per hour of sleep, > 15 or AHI > 5 and < 15, with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia or documented hypertension, ischemic heart disease of history of smoking. Continuous positive airway pressure (CPAP) is effective, non-surgical treatment for obstructive sleep apnea; however, long-term tolerance and compliance are difficult to assess. Other possible treatment options include oral appliances, a variety of surgical procedures, medications that suppress REM sleep, weight reduction and sleep position training. Polysomnography with CPAP titration is appropriate for patients with any of the following polysomnographic results: The use of CPAP devices are covered under Medicare when ordered and prescribed by the licensed treating physician to be used in adult patients with OSA if either of the following criteria using the AHI are met: AHI = 15 events per hour, or AHI = 5 and = 14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease or history of stroke. The AHI is equal to the average number of episodes of apnea and hypopnea per hour and must be based on a minimum of two hours of sleep recorded by polysomnography using actual recorded hours of sleep (e.g., the AHI may not be extrapolated or projected). Apnea is defined as a cessation of airflow for at least 10 seconds. Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds with at least a 30 percent reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4 percent oxygen desaturation. The polysomnography must be performed in a facility-based sleep study laboratory, and not in the home or in a mobile facility. Initial claims for CPAP devices must be supported by information contained in the medical record indicating that the patient meets Medicare's stated coverage criteria. 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 the following criteria are met: - An AHI = 15 or AH1 = 5 and < 15, but must be based on a minimum of two hours of sleep recorded by polysomnography using actual recorded hours of sleep. It is known that a split study may underestimate the severity of sleep apnea. However, an AHI of 40 is considered severe obstructive sleep apnea with a known mortality and further testing throughout the rest of the night most likely would not change treatment needs; - CPAP titration is carried out for more than three hours; and - Polysomnography documents that CPAP eliminates, or nearly eliminates, the respiratory events during REM and NREM sleep. - Judgment on the part of the attending technologist is needed to determine the timing of split and subsequent accuracy of the CPAP trail. Inappropriate timing of the change from diagnostic to therapeutic portions of the study could result in effective or erroneous date being obtained on the therapeutic portion of the study. Follow-up polysomnography or a cardiorespiratory sleep study is indicated for the following conditions: - To evaluate the response to treatment (CPAP, oral appliances or surgical intervention); - After substantial weight loss has occurred in patients on CPAP for treatment of sleeprelated breathing disorders to ascertain whether CPAP is still needed at the previously titrated pressure; - After substantial weight gain has occurred in patients previously treated with CPAP successfully, who are, again, symptomatic, despite continued use of CPAP, to ascertain whether pressure adjustments are needed; or - When clinical response is insufficient or when symptoms return despite a good initial response to treatment with CPAP. Unattended portable polysomnography studies are not indicated for the routine assessment of obstructive sleep apnea or other sleep disorders. When trained personnel are not physically present throughout a recording session (data observation via modem link is still considered “unattended”), the polysomnogram is considered “unattended.” Unattended portable sleep studies would be considered for payment only: - For patients with severe clinical symptoms that are indicative of a diagnosis, and when initiation of treatment is urgent and standard, polysomnography is not readily available. - For patients unable to be studied in the sleep laboratory. - For follow-up studies when a diagnosis has been established by standard polysomnography and therapy initiated. The intent is most often to evaluate response to therapy. - When all of the following technical recommendations are met: -- If portable studies are indicated, only level II and level III studies are acceptable for the diagnosis and assessment of therapy of OSA; -- Body position must be documented during recordings to assess the presence of OSA; and -- Portable sleep apnea device must record raw (unprocessed) data and stored data must be reproducible. Computer analysis of data is acceptable only if used as an aid to interpretation, in conjunction with visual inspection of the entire raw data record. Medicare has determined there is not sufficient evidence to conclude that unattended portable multi-channel sleep study testing is reasonable and necessary in the diagnosis of OSA for CPAP therapy, and these tests are non-covered for this purpose. Polysomnography (95811) must be performed in a facility based sleep study laboratory, not in the home or in a mobile facility. In order to substantiate medical necessity for portable polysomnography, documentation should be included with the claim. Parasomnias: Parasomnias are a group of behavioral disorders during sleep 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. Parasomnias include the following conditions: sleepwalking (somnambulism), sleep terrors, REM sleep behavior disorder, sleep bruxism, sleep enuresis and miscellaneous (e.g., nocturnal headbanging, sleep talking and nocturnal leg cramps). Normally, 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 appropriate treatment of sleep related epilepsy. In addition, common, uncomplicated, non-injurious parasomnias, such as typical disorders of arousal, nightmares, enuresis, somniloquy and bruxism, can usually be diagnosed by clinical evaluation alone. Polysomnography is indicated to provide a diagnostic classification or prognosis when both of the following exists: (1) when the clinical evaluation and results of standard EEG have ruled out a seizure disorder; and (2) in cases that present a history of repeated violence 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 - Audiovisual recording and documented technologist observations. Impotence: Diagnostic nocturnal penile tumescence testing may be covered under limited circumstances to determine whether erectile impotence in men is organic or psychogenic. Although impotence is not a sleep disorder, the nature of testing requires that it be performed during sleep. Tests ordinarily are covered only where necessary to confirm the treatment to be given (e.g., surgical, medical or psychotherapeutic). Generally, a diagnosis may be determined by two nights of diagnostic testing. If more than two nights of testing are claimed, a provider must require persuasive medical evidence justifying the medical necessity for the additional tests. A provider's medical staff should review questionable cases to ensure the tests are reasonable and necessary for the individual. Use HCPCS procedure code 54250. (See 35-24 of the CIM and TrailBlazer Local Medical Review Policy on Erectile Dysfunction (M-1AB-R4) for policies on coverage of diagnosis and treatment of impotence.) 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 diagnosis of patients with chronic insomnia is not covered under Medicare, because it is not reasonable and necessary under 1862(a)(1)(A) of the Act. Coverage of Therapeutic Services Sleep disorder clinics 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. This is provided that they meet pertinent requirements for the particular type of services, are reasonable and necessary for the patient, and are performed under the direct personal supervision of a physician. Other Indications and Limitations A physician or doctoral level professional with satisfactory training in sleep medicine and significant experience in interpretation of standard polysomnograms must interpret these recordings. Unattended portable recording for the assessment of OSA not meeting the guidelines of this policy are not reimbursable by Medicare Part B. Levels Types of studies for sleep apnea evaluation (6-hour overnight recording minimum): - Level I: Standard Polysomnography Minimal requirements include recording of electroencephalogram (EEG), electrooculogram (EOG), chin electromyogram (EMG), electrocardiogram (ECG), airflow, respiratory effort and oxygen saturation. Body position must be documented or objectively measured. Trained personnel must be in constant attendance and able to intervene. Leg movement recording (EMG or motion sensor) is desirable but optional. - Level II: Comprehensive Portable Polysomnography Same as for level I, except heart rate, instead of ECG, is acceptable, and having trained personnel present and able to intervene is not required for all studies. - Level III: Modified Portable Sleep Apnea Testing Minimum requirements include recording of ventilation (at least two channels of respiratory movement, or respiratory movement and airflow), ECG or heart rate and oxygen saturation. Personnel are needed for preparation, but the ability to intervene is not required for all studies. - Level IV: Continuous (Single or Dual) Bioparameter Recording Only one or two physiologic variables need be recorded. The ability to intervene is not required. Coverage Topic Diagnostic Tests and X-Rays CPT/HCPCS Codes Note: Providers are reminded to refer to the long descriptors of the CPT Codes in their CPT Book. The AMA and CMS require the use of short CPT descriptors in policies published on the Web. 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, SIMULTANEOUS RECORDING OF VENTILATION, RESPIRATORY EFFORT, ECG OR HEART RATE, AND OXYGEN SATURATION, UNATTENDED BY A TECHNOLOGIST 95807 SLEEP STUDY, SIMULTANEOUS RECORDING OF VENTILATION, RESPIRATORY EFFORT, ECG OR HEART RATE, AND OXYGEN SATURATION, ATTENDED BY A TECHNOLOGIST 95808 POLYSOMNOGRAPHY; SLEEP STAGING WITH 1-3 ADDITIONAL PARAMETERS OF SLEEP, ATTENDED BY A TECHNOLOGIST 95810 POLYSOMNOGRAPHY; SLEEP STAGING WITH 4 OR MORE ADDITIONAL PARAMETERS OF SLEEP, ATTENDED BY A TECHNOLOGIST 95811 POLYSOMNOGRAPHY; 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 ICD-9 Codes that Support Medical Necessity Medicare is establishing the following limited coverage for CPT/HCPCS code 95805: Covered for: 347.00 NARCOLEPSY, WITHOUT CATAPLEXY 347.01 NARCOLEPSY, WITH CATAPLEXY 347.10 NARCOLEPSY IN CONDITIONS CLASSIFIED ELSEWHERE, WITHOUT CATAPLEXY 347.11 NARCOLEPSY IN CONDITIONS CLASSIFIED ELSEWHERE, WITH CATAPLEXY 780.53 HYPERSOMNIA WITH SLEEP APNEA 780.54 OTHER HYPERSOMNIA Medicare's is establishing the following limited coverage for CPT/HCPCS codes 95806, 95807, 95808 and 95810: Covered for: 333.2 MYOCLONUS 347.00 NARCOLEPSY, WITHOUT CATAPLEXY 347.01 NARCOLEPSY, WITH CATAPLEXY 347.10 NARCOLEPSY IN CONDITIONS CLASSIFIED ELSEWHERE, WITHOUT CATAPLEXY 347.11 NARCOLEPSY IN CONDITIONS CLASSIFIED ELSEWHERE, WITH CATAPLEXY 518.81 ACUTE RESPIRATORY FAILURE 780.50 UNSPECIFIED SLEEP DISTURBANCE 780.51 INSOMNIA WITH SLEEP APNEA 780.53 HYPERSOMNIA WITH SLEEP APNEA 780.54 OTHER HYPERSOMNIA 780.55 DISRUPTIONS OF 24-HOUR SLEEP-WAKE CYCLE 780.56 DYSFUNCTIONS ASSOCIATED WITH SLEEP STAGES OR AROUSAL FROM SLEEP 780.57 OTHER AND UNSPECIFIED SLEEP APNEA 780.58 SLEEP RELATED MOVEMENT DISORDER Unattended portable sleep studies (95806) would be considered for payment only: - For patients with severe clinical symptoms that are indicative of a diagnosis, and when initiation of treatment is urgent and standard, polysomnography is not readily available. - For patients unable to be studied in the sleep laboratory. - For follow-up studies when a diagnosis has been established by standard polysomnography and therapy initiated. The intent is most often to evaluate response to therapy. - When all of the following technical recommendations are met: -- If portable studies are indicated, only level II and level III studies are acceptable for the diagnosis and assessment of therapy of OSA; -- Body position must be documented during recordings to assess the presence of OSA; and -- Portable sleep apnea device must record raw (unprocessed) data and stored data must be reproducible. Computer analysis of data is acceptable only if used as an aid to interpretation, in conjunction with visual inspection of the entire raw data record. Polysomnography (95811) used in the diagnosis of OSA for CPAP therapy are noncovered when performed in the home or mobile facility. Medicare's is establishing the following limited coverage for CPT/HCPCS code 95811: Covered for: 780.51 INSOMNIA WITH SLEEP APNEA 780.53 HYPERSOMNIA WITH SLEEP APNEA 780.57 OTHER AND UNSPECIFIED SLEEP APNEA 780.58 SLEEP RELATED MOVEMENT DISORDER Documentation Requirements If Medicare is billed for the service, medical records maintained by the provider must clearly and unequivocally document medical necessity for the sleep study. Medical records must document the name of the technician who attended the sleep study. Medicare would not expect to see an evaluation and management (E&M) service performed on the same day as a sleep study, unless significant and separately identifiable medical services were rendered and clearly documented in the patient's medical record. Use modifier -25 appended to the appropriate visit code to indicate the patient's condition required a significant, separately identifiable visit service unrelated to the procedure that was performed. Documentation supporting the medical necessity should be legible, maintained in the patient's medical record, and must be made available to Medicare upon request.