Download Local Coverage Determination

Local Coverage Determination
CPT Code/Search Topic
95805, 95806, 95807, 95808, 95810, 95811
LMRP/LCD ID
L5647
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 an 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
Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals
on their claim forms and electronic claims.
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.