Contractor Name
HealthNow UMD

Contract Number
00801

Contractor Type
Carrier

LCD Database ID Number
L4057

LCD Title
Sleep Disorder Test - Polysomnography

Contractor's Determination Number
M-93-7 End Dated

AMA CPT Copyright Statement
CPT codes, descriptions, and other data only are copyright 2004 American Medical Association (or such other data of publication of CPT). All Rights Reserved. Applicable FARS/DFARS clauses apply. CDT-4 codes and descriptions are copyright 2002, 2004 American Dental Association. All rights reserved.

CMS National Coverage Policy

   -   Title XVIII of the Social Security Act, Section 1862 (a)(7)

       This section excludes routine physical examinations.

   -   Title XVIII of the Social Security Act, Section 1862 (a)(1)(A)

       This section allows coverage and payment for only those services
       considered medically reasonable and necessary.

   -   Title XVIII of the Social Security Act, Section 1833 (e)

       This section prohibits Medicare payment for any claim which lacks the
       necessary information to process the claim.

   -   Code of Federal Regulations, 43 CFR 410.32

       Diagnostic tests may only be ordered by a treating physician (or other
       treating practitioner acting within the scope of their license and
       Medicare requirements).

   -   CMS Manual System, Pub 100-4, Chapter 23, Section 20.9

       This section deals with various medical services included in the sleep
       testing procedure.

   -   CMS Manual System, Pub 100-2, Chapter 15, Section 70

       This section provides coverage for sleep testing for certain
       conditions.

   -   Medicare National Coverage Determinations Manual, Section 240.4

       This section addresses continuous positive airway pressure (CPAP).

Oversight Region
Region II

CMS Consortium
Northeast

Original Determination Effective Date
For services performed on or after 10/18/1993

Original Determination Ending Date
For services performed on or after 08/08/2005

Revision Effective Date
For services performed on or after 04/14/2005

Indications and Limitations of Coverage and/or Medical Necessity
Polysomnography is a test that records a variety of body functions during sleep, such as the electrical activity of the brain, eye movement, muscle activity, heart rate, respiratory effort, air flow, and blood oxygen levels. These tests are used both to diagnose sleep apnea and to determine its severity.

The specific variables monitored during center-based polysomnographic evaluation of sleep-related respiratory disturbances include, but are not limited to, the following:

   1.  Global neural encephalographic activity (EEG) from electrodes placed
       on the patient's scalp;

   2.  Eye movements (electro-oculogram, or EOG) from electrodes placed near
       the outer canthus of each eye;

   3.  Submental electromyographic activity (EMG) from electrodes placed over
       the mentalis, submentalis muscle, and/or masseter regions;

   4.  Rhythm electrocardiogram (ECG) with two or three chest leads;

   5.  Respiratory effort, by chest-wall and abdominal movement via strain
       gauges, piezoelectric belts, inductive plethysmography, impedance or
       inductance pneumography, endoesophageal pressure, or by intercostal
       EMG;

   6.  Nasal and/or oral airflow via thermistor or pneumotachograph;

   7.  Oxygen saturation (SpO2) via pulse oximetry;

   8.  Body position via mercury switches or by direct observation;

   9.  Limb movements (arms and legs) via EMG;

   10. Recordings of or vibration (frequency and/or volume) may be recorded;

   11. End-tidal CO2, transcutaneous CO2, esophageal pH, penile tumescence,
       and bipolar EEG.

CPT codes 95805, 95807, 95808, or 95810
Narcolepsy (ICD-9-CM code 347)

   1.  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, amnesiac episodes).  Other associated symptoms of
       narcolepsy include cataplexy and other REM sleep phenomena, such as
       sleep paralysis and hypnogogic hallucinations.

   2.  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
            nighttime sleep

       -    Determination of the latency to the first REM episode

       -    MSLT

       -    The presence of REM-sleep episodes.

   3.  The minimum electrophysiological channels that are required for this
       diagnosis include EEG, EOG, and chin EMG.

   4.  The most widely used objective test for the diagnostic evaluation of
       patients with excessive sleepiness in the multiple sleep latency test
       (MSLT).  The MSLT is a four or five "nap opportunity" test in which
       the subject rests in a quiet darkened room and the latency to sleep is
       determined by standard electrophysiological means.  Sleep latency is
       defined as the elapsed time from lights-out to the first epoch of any
       sleep stage.

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

   6.  The diagnosis of narcolepsy requires documentation of the absence of
       other untreated significant disorders that cause excessive daytime
       sleepiness, i.e., sleep apnea, mental depression, insomnia, etc.

   1.  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 apnea), absence of respiratory effort (central
       sleep apnea), or a combination of these factors (mixed sleep apnea).

       Central sleep apnea is caused by one of the following:

       a.   Reduced upper airway caliber due to obesity

       b.   Adenotonsillar hypertrophy

       c.   Mandibular deficiency

       d.   Macroglossia

       e.   Upper airway tumor

       f.   Excessive pressure across the collapsible segment of the upper
            airway

       g.   Activity of the muscles of the upper airway insufficient to
            maintain patency.

   2.  Diagnosis of obstructive sleep apnea (OSA) requires documentation of
       at least 30 episodes of apnea, each lasting a minimum of 10 seconds,
       during 6 to 7 hours of recorded sleep.  If OSA is diagnosed, the
       physician will typically prescribe a continuous positive airway
       pressure (CPAP) device.  Usually, a second night of sleep study is
       necessary to titrate the CPAP device (determine the air pressure
       setting of the device).  As the patient sleeps through the second
       night, the CPAP pressure is gradually adjusted (titrated) by the
       technician.

   3.  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 (apnea/hypopnea index) of at least 40 is documented during
            a minimum of 2 hours of diagnostic polysomnography

       -    CPAP titration is carried out for more than 3 hours

       -    Polysomnography documents that CPAP eliminates or nearly
            eliminates the respiratory events during REM and NREM sleep.

       Follow up polysomnography or a cardiorespiratory sleep study is
       indicated for the following conditions:

       1.   To evaluate the response to treatment (CPAP, oral appliances,
            surgical intervention).

       2.   After substantial weight loss has occurred in patients on CPAP to
            determine appropriate titration for CPAP.

       3.   After substantial weight gain 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.

       4.   When clinical response is insufficient or when symptoms return
            despite a good initial response to treatment with CPAP.

CPT codes 95807, 95808, 95810, 95922
Parasomnias (ICD-9-CM codes 307.46-307.48)
Parasomnias are a group of behavioral 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.

Parasomnias include the following conditions: sleepwalking (somnambulism), sleep terrors, REM sleep behavior disorder, sleep bruxism, sleep enuresis, and miscellaneous (nocturnal head banging, sleep talking, and nocturnal leg cramps).

Normally, a clinical history, neurologic examination 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. In addition, common, uncomplicated, noninjurious 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:

   a.  When the clinical evaluation and results of standard EEG have ruled
       out a seizure disorder; and

   b.  In cases that present 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 audiovisual recording
       and documented technologist observations.

   1.  Center-based polysomnography is performed within specialized hospital
       sleep laboratories, appropriately equipped hospital rooms, or
       stand-alone sleep centers with a qualified technician in constant
       attendance.

   2.  New technology now available may allow some sleep studies to be
       conducted in the patient's home or be conducted in a mobile sleep
       testing facility.  Tests billed with these places of service will be
       denied by Medicare at this time.

   3.  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 considered reasonable and
       necessary under Section 1862(a)(1)(A) of the Social Security Act.

   1.  It is this carrier's interpretation of national policy (see Medicare
       Carriers Manual, Section 2055A), that attendance by a technologist is
       required in order to obtain a reliable study.  Therefore, CPT code
       95806 (Sleep study, simultaneous recording of ventilation, respiratory
       effort, ECG or heart rate, and oxygen saturation, unattended by a
       technologist), will not be paid by Medicare because it is not
       reasonable and necessary.

   2.  Mobile sleep testing is considered investigational by Medicare at this
       time.

CPT/HCPCS Codes

    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 (will not be paid by Medicare -- not
                   reasonable and necessary)

    95807          Sleep study, simultaneous recording of
                   ventilation, respiratory effort, ECG, or heart
                   rate, and oxygen saturation, attended by a
                   technologist

    95808          ; sleep staging with 1-3 additional parameters of
                   sleep, attended by a technologist

    95810          ; sleep staging with 4 or more additional
                   parameters of sleep, attended by a technologist

    95811          ; 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

Does the CPT 30% Coding Rule Apply?
No

ICD-9-CM Codes That Support Medical Necessity
TRUNCATED DIAGNOSIS CODES ARE NOT ACCEPTABLE.

ICD-9-CM code listings may cover a range and include truncated codes. It is the provider's responsibility to avoid truncated codes by selecting a code(s) carried out to the highest level of specificity and selected from the ICD-9-CM book appropriate to the year in which the service was performed.

It is not enough to link the procedure code to a correct, payable ICD-9-CM code. The diagnosis or clinical signs/symptoms must be present for the procedure to be paid. Further, these ICD-9-CM codes can be used only with the conditions listed in the "Indications" and "Limitations" section of this LCD.

    307.46         Somnambulism or night terrors

    307.47         Other dysfunctions of sleep stages or arousal
                   from sleep

    307.48         Repetitive intrusion of sleep

    333.2          Myoclonus

    333.99         Other and unspecified extrapyramidal disease and
                   abnormal movement disorders; other (restless leg
                   syndrome)

    347            Cataplexy and narcolepsy (Truncated as of
                   10/01/2004)

    347.00         Narcolepsy without cataplexy

    347.01         Narcolepsy with cataplexy

    518.81         Acute respiratory failure

    780.51         Insomnia with sleep apnea

    780.52         Other insomnia

    780.53         Hypersomnia with sleep apnea

    780.56         Dysfunction associated with sleep stages or
                   arousal from sleep

    780.57         Other and unspecified sleep apnea

ICD-9-CM Codes That DO NOT Support Medical Necessity:
Use of any ICD-9-CM code not listed in the "ICD-9-CM Codes That Support Medical Necessity" section of this LCD will be denied.

Documentation Requirements

   1.  Each claim must be submitted with ICD-9-CM codes that reflect the
       condition of the patient, and indicate the reason(s) for which the
       service was performed.  Claims submitted without ICD-9-CM codes will
       be returned.

   2.  The clinic must be affiliated with a hospital or be under the
       direction and control of a physician, even though the test may be
       covered in the absence of direct physician supervision.  This
       information must be documented and available upon request.

   3.  The patient is to be referred to the clinic by their attending
       physician.  The physician's order must be kept on record.

   4.  The sleep disorder clinic must maintain and provide to Medicare, when
       requested, sufficient documentation that narcolepsy is severe enough
       to interfere with the patient's well being and health before Medicare
       benefits are provided for diagnostic testing.

   5.  Claims for an unusual number of services may require additional
       documentation in the event of a pre or postpayment review.

   6.  If more than two nights of testing are claimed, documentation must be
       available justifying the medical necessity for the additional test(s).

   7.  Certification Requirements for Free-Standing Facilities:

       If the above tests are performed in a free-standing facility, the
       facility must have on file, with the carrier, evidence that they are
       in compliance with the criteria set by the American Sleep Disorders
       Association.  Failure to do so may result in a delay in processing or
       may result in a denial of the claim.

       Some of the criteria that the facility must meet are:

       1.   An accredited clinical polysomnographer (A.C.P.) must be on
            staff, or there must be documented evidence that a staff doctor
            has been accepted for the upcoming exam.

       2.   A chart for each patient which contains records, physicians'
            notes, test results and treatment recommendations must be kept in
            the facility.

       3.   An interpretation report performed and signed by the A.C.P. for
            each separate polysomnographic procedure must be maintained in
            the patient record.

       4.   Technical and professional staff must be trained in CPR.

   1.  "Clinical Practice Guidelines" published by AARC (American Association
       for Respiratory Care) and APT (Association of Polysomnography
       Technologists).

   2.  Indications and Standards for Cardiopulmonary Sleep Studies.

   3.  Thoracic Society consensus statement.  Am Rev Respir Dis 1989; 139:
       559-568.

   4.  National Heart, Lung, and Blood Institute of the National Institutes
       of Health:  National Center on Sleep Disorders Research.

   5.  "Aiming for Higher Standards in Sleep Medicine" published by the
       American Sleep Disorders Association (ASDA).

   6.  American Sleep Disorder Association Review; "The Use of
       Polysomnography in the Evaluation of Insomnia."

   7.  Report from the American Sleep Disorders Association, "The Clinical
       Use of the Multiple Sleep Latency Test."  Sleep 15(3): 58-70.

   8.  An American Sleep Disorders Association Review.  "The Indications for
       Polysomnography and Related Procedures."  Sleep 20(6): 423-487.

   9.  Other carriers local medical review policies:  Nationwide (Ohio, West
       Virginia); Wisconsin, Louisiana, Florida.

   1.  The original version of M-93-7 was presented to the Carrier Advisory
       Committee on December 15, 1993.

   2.  This policy was presented at the September 9, 1998, Carrier Advisory
       Committee meeting by Group Health Incorporated (GHI).  It was adopted
       by the Upstate Medicare Division as M-93-7(3A, 05/30/2002) to
       coordinate policy among the New York State Part B carriers.

   3.  Formal comments received, including additional payable ICD-9-CM
       diagnosis codes, were incorporated into this policy.

   4.  This policy does not reflect the sole opinion of the contractor or
       Contractor Medical Director.  Although the final decision rests with
       the contractor, this policy was developed in cooperation with the
       Advisory Groups, which includes representatives from the specialty
       societies and the Medical Society of the State of New York.

End Date of Comment Period
11/01/1998

Start Date of Notice Period
12/01/1993

Revision History Number
End Date

Revision History Explanation

    End Dated:          This policy is end dated effective 08/08/2005 to
                        prevent conflict with National Policy.

    Revision #4:        Converted LMRP to a LCD.  Added 347.00 and 347.01
                        as payable to replace truncated code 347.  Moved
                        "Documentation Requirement" #4 to Coding
                        Guidelines article.

    Correction:         On 08/26/02, policy #M-93-7 (3A, 05/3032002) was
                        corrected.  Under the "Indications and
                        Limitations of Coverage and/or Medical Necessity,
                        Indications" section for CPT codes 95807, 95808,
                        95810, 95811, 95822, Sleep Apnea:  ICD-9-CM code
                        780.75 should read:  780.57

    Revision #3:        This policy was revised on 05/30/2002 to
                        coordinate with Empire New York and Group Health
                        Incorporated.  The following ICD-9-CM codes will
                        no longer be payable:  307.41-307.45, 307.49,
                        780.55, and 607.84.  The following ICD-9-CM codes
                        will now be payable with this revision:  333.2,
                        333.99, 518.81, and 780.52.  Also added CPT code
                        95806 and 95811 to policy and removed 54250,
                        95822, and unlisted code 94799.  The policy was
                        also put into the new required format.

    Revision #2:        Policy revised on 12/17/1998 with additional
                        changes to verbiage under "Indications " #2,
                        paragraph 3.

    Revision #1:        Policy revised on 09/28/1998 to change verbiage
                        under "Indications" #2, paragraph 3.

Does this LCD contain a "Least Costly Alternative" provision?
Indicate yes, no, or undefined.