This is a limited coverage policy that requires accreditation for all sleep
disorder clinics providing Medicare services.  
  
Sleep studies and polysomnography (PSG) 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. The studies are performed to diagnose a
variety of sleep disorders and to evaluate a patient's response to therapies
such as continuous positive airway pressure (CPAP). PSG is distinguished from
sleep studies by the inclusion of sleep staging.  
  
 **Criteria for coverage of Diagnostic Tests**  
  
All reasonable and necessary diagnostic tests performed by sleep disorder
clinics (Sleep Disorder Centers or Laboratories for Sleep Related Breathing
Disorders) given for the medical conditions listed under **Medical Conditions
for Which Testing is Covered** are covered, when all of the following criteria
are met:

  * The documentation should be retained in the patient's medical record.
  * For a study to be reported as a polysomnogram, sleep must be recorded and staged.

PSG is defined to include, but is not limited to, the following:

  * A 1-4 lead electroencephalogram (EEG) to measure global neural encephalographic activity using electrodes placed on the scalp
  * Electrooculogram (EOG) to measure eye movements using electrodes placed near the outer canthus of each eye
  * A submental electromyogram (EMG) to measure submental electromyographic activity using electrodes placed over the mentalis, submentalis muscle, and/or masseter regions
  * Rhythm electrocardiogram (ECG) with 2 or 3 chest leads
  * Nasal and/or oral airflow
  * Ventilation and respiratory effort by chest-wall and abdominal movement measured using strain gauges, piezoelectric belts, inductive plethysmography, impedance or inductance pneumography, endoesophageal pressure, or by intercostal EMG
  * Gas exchange (oxygen saturation (SpO2)) by oximetry, transcutaneous monitoring, or end-tidal gas analysis
  * Extremity muscle activity, motor activity-movement using EMG
  * Body positions via mercury switches or by direct observation
  * Recordings of vibration (frequency and/or volume) may be recorded
  * Transcutaneous CO2, esophageal pH, penile tumescence, and bipolar EEG

  
Sleep studies are performed in a hospital, sleep laboratory or by an
Independent Diagnostic Treatment Facility (IDTF) that is supervised by a
physician (MD/DO) trained in analyzing and interpreting the recordings and
should be attended by a trained technologist. (For exception to the attendance
requirement, see the section on sleep apnea below).  
  
 **Medical Conditions for Which Testing is Covered**

Diagnostic testing will only be covered if the patient demonstrates clinical
evidence of 1 or more of the following conditions:  
  
 **1\. NARCOLEPSY:**  
  
The diagnosis of narcolepsy is usually confirmed by an overnight sleep study
(PSG) followed by a multiple sleep latency test (MSLT). MSLT involves several
20-minute nap opportunities offered at 2-hour intervals. MSLT objectively
assesses sleep tendency by measuring the number of minutes it takes the
patient to fall asleep. Conversely, the maintenance of wakefulness test (MWT)
requires the patient to try to stay awake. MSLT is the better test for
demonstration of sleep-onset rapid eye movement (REM) periods, a determination
that is important in establishing the diagnosis of narcolepsy. To insure
validity, proper interpretation of the MSLT can only be made following a PSG
performed on the preceding night.  
  
The following measurements are normally required to diagnose narcolepsy:  
  
 Polysomnographic assessment of the quality and quantity of nighttime sleep;  
 Determination of the latency of the first rapid eye movement (REM) episode;  
 MSLT; and  
 The presence of REM-sleep episodes.  
  
Initial PSG and MSLT occasionally fail to identify narcolepsy. Repeat PSG may
be indicated:  
  
 if the first study is technically inadequate due to equipment failure;  
 if the subject could not sleep or slept for an insufficient amount of time
to allow a clinical diagnosis;  
 if initiation of therapy or confirmation of the efficacy of prescribed
therapy is needed; or  
 if the results were inconclusive or ambiguous.  
  
 **2\. SLEEP APNEA:**  
  
The diagnosis of sleep apnea may be made using the following modalities:  
  
a. PSG performed in a sleep laboratory; or  
b. Unattended home sleep monitoring device of Type II; or  
c. Unattended home sleep monitoring device of Type III; or  
d. Unattended home sleep monitoring device of Type IV, measuring at least 3
channels.  
  
Sleep apnea may be due to an occlusion of the airway (obstructive apnea),
absence of respiratory effort (central sleep apnea) or a combination of these
factors (mixed sleep apnea).  
  
Obstructive sleep apnea (OSA) may be caused by 1 of the following:  
  
 Reduced upper airway caliber due to obesity;  
 Adenotonsillar hypertrophy;  
 Mandibular deficiency;  
 Macroglossia;  
 Upper airway tumor;  
 Excessive pressure across the collapsible segment of the upper airway;  
 Activity of the muscles of the upper airway insufficient to maintain
patency.  
  
For patients with severe and unambiguous OSA, the initiation of treatment with
nasal CPAP may be incorporated into the diagnostic study night. A "split-
night" study (initial diagnostic polysomnogram confirming the diagnosis of OSA
followed by CPAP titration during PSG on the same night) may be an alternative
to 1 full night of diagnostic PSG followed by a second night of titration as
long as:  
  
 CPAP titration is carried out for more than 3 hours; and  
 PSG or home sleep study (HST) documents that CPAP eliminates or nearly
eliminates the respiratory events during REM and non-rapid eye movement (NREM)
sleep.  
  
Repeat PSG or HST for diagnosing sleep apnea requires documentation justifying
the medical necessity for the repeated test. Repeat PSG may be indicated:  
  
 if the first study is technically inadequate due to equipment failure;  
 if the subject could not sleep or slept for an insufficient amount of time
to allow a clinical diagnosis;  
 if the results were inconclusive or ambiguous; or  
 if initiation of therapy or confirmation of the efficacy of prescribed
therapy is needed.  
  
Follow-up PSG or HST is not routinely indicated for patients treated with
CPAP, whose symptoms continue to be resolved with CPAP treatment. Follow-up
PSG may be indicated; however, under the following circumstances:  
  
 After substantial weight loss 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 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; or  
 When clinical response is insufficient or when symptoms return despite a
good initial response to treatment with CPAP.  
  
 **3\. PARASOMNIA:**  
  
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, non-injurious parasomnias, such as typical
disorders of arousal, nightmares, enuresis, somniloquy, and bruxism can
usually be diagnosed by clinical evaluation alone.  
  
PSG is indicated to provide a diagnostic classification or prognosis when both
of the following exist:  
  
 When the clinical evaluation and results of standard EEG have ruled out a
seizure disorder; and  
 In cases that present a history of episodes during sleep that result in harm
to the patient or others.  
  
When PSG 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;  
 Audiovisual recording; and  
 Documented technologist observations.  
  
 **4\. Other Respiratory Disorders:** This diagnostic category includes
breathing disorders that are not principally defined by obstructive or central
apnea/hypopnea or the upper airways resistance syndrome (UARS).  
  
PSG is indicated for patients with neuromuscular disorder and sleep-related
symptoms to evaluate symptoms of sleep disorder that are not adequately
diagnosed by obtaining a sleep history, assessing sleep hygiene, and reviewing
sleep diaries.  
  
PSG and HST are not indicated to diagnose chronic lung disease. Nocturnal
hypoxemia in patients with chronic obstructive, restrictive, or reactive lung
disease is usually adequately evaluated by oximetry and does not require PSG
or HST. However, if the patient's symptoms suggest a diagnosis of OSA or
periodic limb movement disorder (PLMD), indications for PSG are the same as
for those disorders in patients without chronic lung disease.  
  
**5\. Restless Legs Syndrome (RLS) and PLMD:** RLS is a neurologic disorder
characterized by disagreeable leg sensations that usually occur at rest or
before sleep and are alleviated by motor activity. Periodic limb movements are
involuntary, stereotypic, repetitive limb movements that may occur during
sleep and usually involve the legs and, occasionally, the arms. Periodic limb
movements during sleep often accompany RLS. PLMD is a sleep disorder
characterized by periodic limb movements that cause frequent arousals and lead
to insomnia or excessive daytime sleepiness. The results of PSG studies from
patients with severe RLS often show prolonged sleep latencies, decreased sleep
efficiency, increased number of awakenings, significant reductions in total
sleep time, and decreased amounts of slow-wave sleep. Patients with PLMD often
have frequent periodic limb movements that are associated with arousals and
awakenings, reduced total sleep time, and decreased sleep efficiency.  
  
PSG is indicated when a diagnosis of PLMD is considered because of complaints
by the patient or an observer of repetitive limb movements during sleep and
frequent awakenings, fragmented sleep, difficulty maintaining sleep, or
excessive daytime sleepiness.  
  
 **Limitation of Coverage:**  
  
Sleep testing performed using an unattended portable monitor (HST) for the
diagnosis of OSA must adhere to the guidelines specified in "Clinical
Guidelines for the Use of Unattended Portable Monitors in the Diagnosis of OSA
in Adult Patients". If discrepancies exist between these guidelines and this
LCD, the parameters in this LCD take precedence. HST is covered only for the
diagnostic study of OSA and for no other indications.  
  
HSTs may be used in addition to a face to face clinical assessment by the
treating physician, Epworth Sleepiness Scale, and physical examination to
diagnose OSA; specifically, it is intended only for those patients who exhibit
clinical signs and symptoms of OSA.  
  
HST is not covered for patients with certain medical comorbidities, including:  
  
 Moderate to severe pulmonary disease (e.g., patients on oxygen or regular
bronchodilator use)  
 Neuromuscular disease affecting muscles of respiration  
 Congestive heart failure  
 Suspicion of the presence of other sleep disorders, i.e., narcolepsy,
parasomnia, or periodic limb movements of sleep  
 other respiratory disorders, impotence, RLS

HST scoring must be performed by an individual certified by the Board of
Registered Polysomnographic Technologists as a Registered Polysomnographic
Technologist (RPSGT), or equivalent, or by a polysomnographic technician under
the supervision of a RPSGT, or equivalent. RPSGTs and polysomnographic
technicians must meet the standards for such individuals promulgated by the
American Academy of Sleep Medicine Standards for Accreditation of Laboratories
for Sleep Related Breathing Disorders, and be licensed or certified by the
state in which they practice, if such licensure or certification exists. The
laboratory physician must review the entire raw data recording for every
patient studied.  
  
 **PSG, HST and MSLT are not covered in the following situations:**  
  
1\. For the diagnosis of patients with chronic insomnia.  
  
Snoring and nasal obstructive signs and symptoms are not, in and of
themselves, indications for PSG; however, they may be indications of sleep
apnea when other findings are also present. Other causes of sleepiness should
be ruled out via a sleepiness scale before performing a sleep study.  
  
2\. To preoperatively evaluate a patient for laser-assisted
uvulopalatopharyngoplasty without clinical evidence that OSA is suspected;  
  
3\. 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 sign/symptoms
suggest a diagnosis of OSA, PSG may be considered medically necessary);  
  
4\. In cases where seizure disorders have not been ruled out;  
  
5\. In cases of typical, uncomplicated, and non-injurious parasomnias when the
diagnosis is clearly delineated;  
  
6\. For patients with epilepsy, who have no specific complaints consistent
with a sleep disorder;  
  
7\. For patients with symptoms suggestive of PLMD or RLS unless symptoms are
suspected of being related to a covered indication;  
  
8\. For the diagnosis of insomnia related to depression;  
  
9\. For the diagnosis of circadian rhythm sleep disorders, (i.e. rapid time-
zone change [jet lag], shift-work sleep disorder, delayed sleep phase
syndrome, advanced sleep phase syndrome, and non-24 hour sleep/wake disorder);  
  
10\. MLST is not routinely indicated for most patients with sleep apnea;  
  
11\. Actigraphy measures the movement of a limb. It can be measured as part of
a sleep test, but will not be paid for separately. Actigraphy is a non-covered
service when it is not done as part of a sleep test or when it is used for
monitoring.  
  
 **Accreditation**  
  
In order to perform the technical component (TC) of PSG and sleep testing
(including HST), the following must be met:  
  
The sleep center or laboratory must maintain documentation on file that
indicates it is accredited by either:

  * the American Academy of Sleep Medicine (AASM), OR
  * the Accreditation Commission for Health Care (ACHC), 
  * the Ambulatory Care Accreditation Program of the Joint Commission.

This documentation must be available on request. The AASM, ACHC, or Joint
Commission accreditation applies to the hospital and freestanding facilities
(including sleep clinics that are part of a physician's office, and all other
non-hospital-based facilities where sleep studies are performed). **Diagnostic
testing performed in an Independent Diagnostic Testing Facility (IDTF) must
follow the supervision and credentialing guidelines set forth by CMS and/or
Palmetto GBA.**  
  
The sleep laboratory or testing facility must be affiliated with a hospital or
be under the direction and control of a physician (MD/DO) who meets 1 of the
following requirements, even though the diagnostic test may be performed in
the absence of direct physician supervision. The raw data from all sleep tests
must be reviewed and the tests must be interpreted by a physician who meets at
least 1 of the following requirements:

  * Certification in Sleep Medicine by the American Board of Sleep Medicine (ABSM) or by a board member of either the American Board of Medical Specialties (ABMS) or the American Osteopathic Association (AOA).
  * A completed fellowship in sleep medicine through an Accreditation Council for Graduate Medical Education (ACGME)-accredited program. Following the completed fellowship, certification in sleep medicine is completed within 2 examination cycles through the ABSM or a member board of either the ABMS or the AOA.

The globally billed professional/technical (PC/TC) components for services
related to home sleep testing are covered for the purpose of testing a patient
for the diagnosis of OSA if the home sleep testing is reasonable and necessary
for the diagnosis of the patient's condition, meets all other requirements,
and the physician who performs the service meets the physician
training/certification requirement.  
  
 **Technologist/Technician Credentials/Training**  
  
 Sleep technicians or technologists attending PSG or sleep studies affiliated
with HST must have appropriate personnel certification. Examples of
certification in PSG and sleep technology for technologists are:  
  
1\. Registered Polysomnography Technologist (RPSGT)  
2\. Registered Electroencephalographic technologist (R. EEG T.) - PSG  
3\. Certified Respiratory Therapist -Sleep Disorders Specialist (CRT-SDS)  
4\. Registered Respiratory Therapist Sleep Disorders Specialist (RRT-SDS)  
5\. ABSM Registered Sleep Technologist (RST)  
  
Credentialing must be provided by nationally recognized credentialing
organizations such as:  
  
 Board of Registered Polysomnographic Technologists (BRPT) that provides
(RPSGT) credential; OR  
 American Board of Registration of Electroencephalographic and Evoked
Potential Technologists (ABRET) that provides R. EEG T. - PSG credential; OR  
 Performed in a sleep center or laboratory accredited by the AASM, or ACHC,
or Joint Commission; OR  
 ABSM that provides credentialing in sleep technology; OR  
 National Board for Respiratory Care, Inc. (NBRC) that provides specialty
examination for respiratory therapists performing sleep disorders testing and
therapeutic intervention (CRT-SDS and RRT-SDS).  
  
All technologists and technicians conducting sleep testing, who are not
registered by the BRPT, ABRET, ABSM, NBRC or other accepted certification
body, must be affiliated with an AASM or ACHC accredited sleep facility or
Joint Commission accredited sleep facility (a Joint Commission accredited
sleep laboratory). Unregistered technologists and technicians must maintain
appropriate training and supervision, and be supervised by a registered and
licensed technologist, where license is required by state law.  
  
Technologist staffing must be adequate to address the workload of the sleep
facility and assure the safety of patients.  
  
 **Unattended Sleep Testing**  
  
The TC of HST and unattended sleep studies must be provided by an accredited
sleep center or laboratory as noted above and meet the requirements of the LCD
for coverage. The only exception would be the global billing
(professional/technical components [PC/TC]) of HST by an office based
physician who meets the requirements under the Physician
Training/Certification as noted earlier. In this case, the PC/TC for HST can
be covered for the purpose of testing a patient for the diagnosis of OSA if
the home sleep testing is reasonable and necessary for the diagnosis of the
patient's condition as outlined in the LCD; and the office-based technician
doing the patient instruction and HST scoring meet the training/credentialing
requirements as outlined above. Under this circumstance, the physician would
be the interpreter of the test and bill globally.