CMS National Coverage Policy
Medicare Benefit Policy Manual– Pub. 100-02:
    Chapter 15, Section 70.
    Chapter 6, Section 50.
 Medicare National Coverage Determinations Manual – Pub. 100-03, Sections 30.4, 240.4, 240.4.1.
 Correct Coding Initiative – Medicare Contractor Beneficiary and Provider Communications Manual – Pub. 100-09, Chapter 5.
 Social Security Act (Title XVIII) Standard References, Sections:
    1862 (a)(1)(A) Medically Reasonable & Necessary.
    1862 (a)(1)(D) Investigational or Experimental.
    1862 (a)(7) Screening (Routine Physical Checkups).
    1833 (e) Incomplete Claim

 Primary Geographic Jurisdiction
    CO – 04101.
    NM – 04201.
    OK – 04301.
    TX – 04401:
        Indian Health Service.
        End Stage Renal Disease (ESRD) facilities.
        Skilled Nursing Facilities (SNFs).
        Rural Health Clinics (RHCs).
    CO – 04102.
    NM – 04202.
    OK – 04302.
    TX – 04402:
    Indian Health Service

Oversight Region
   Region IV

Original Determination Effective Date
04/14/2009
Original Determination Ending Date
N/A
Revision Effective Date
12/21/2009
Revision Ending Date
N/A
Indications and Limitations of Coverage and/or Medical Necessity

Diagnostic Services

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 in the “Indications” section below are covered when the following criteria are met:

     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 physician and the clinic maintains a record of the attending physician’s orders.

     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 of the earlier test are still pertinent to the patient’s condition is not covered because it is not reasonable and necessary under Section 1862(a)(1)(A) of the Social Security Act (the Act). Documentation of the results of the previous test should be retained in the patient’s medical record.

Therapeutic Services

Therapeutic services may be covered if they are standard and accepted services, are reasonable and necessary for the patient, are performed in a hospital inpatient or outpatient setting or freestanding facility, and are performed under the direct personal supervision of a physician.

Certification Requirements

If the above tests are performed in a freestanding facility (includes sleep clinics that are a part of a physician’s office, Independent Diagnostic Testing Facilities (IDTFs) and all other non-hospital-based facilities where sleep studies are performed), the facility must have on file, and make available to Medicare upon request, evidence that:

     They are fully or provisionally certified by either the American Academy of Sleep Medicine (AASM) as a sleep disorders center or as a laboratory for sleep-related breathing disorders or by the Joint Commission as a free-standing sleep center.

     A facility certification is required when the global, professional or technical components are billed by a physician’s office, an IDTF and all other non-hospital-based facilities.

     Effective date of this requirement: January 1, 2011.

Indications

Diagnostic testing will be covered only if the patient has the symptoms or complaints of one of the following conditions:

     Narcolepsy: Related diagnostic testing is covered if the patient has inappropriate sleep episodes or attacks, amnesic episodes or continuous disabling drowsiness.

     Sleep Apnea: The nature of the apnea episodes can be documented by the appropriate diagnostic testing.

     Parasomnia: Suspected seizure disorders as a possible cause of the parasomnia are appropriately evaluated by standard or prolonged sleep EEG studies. In cases where seizure disorders have been ruled out and in cases that present a history of repeated violent or injurious episodes during sleep, polysomnography may be useful in providing a diagnostic classification or prognosis.

Polysomnography is indicated to provide a diagnostic classification or prognosis when all the following exist:

     When the clinical evaluation and results of standard EEG (when indicated) have not established that the nocturnal events are due to a seizure disorder.

     In cases that present a history of repeated violence or injurious episodes during sleep.

     Patients are evaluated for sleep behaviors suggestive of parasomnias that are unusual or atypical because of:

           The patient’s age at onset.

           The time, duration or frequency of occurrence of the behavior.

           The specifics of the particular motor patterns are in question (e.g., stereotypical, repetitive or focal).

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.

     Audiovisual recording and documented technologist observations.

Diagnosis of Obstructive Sleep Apnea (OSA), in anticipation of prescribing Continuous Positive Airway Pressure (CPAP), is covered when accomplished with a Medicare-approved device (see NCD 240.4.1).

Other Indications and Limitations

Split-Night Studies

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 Respiratory Disturbance Index (RDI) ≥ 15 or RDI ≥ 5 and < 15, but must be based on a minimum of two hours of sleep recorded by polysomongraphy 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 OSA 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.

     The entire split-night study must cover six or more hours of recording the parameters of sleep and should be billed with a single unit of 95811.

Follow-Up Studies

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 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 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.

Home Sleep Testing

The physician services related to home sleep testing (G0398, G0399 and G0400) are covered for the purpose of testing a patient for the diagnosis of obstructive sleep apnea if the home sleep testing is reasonable and necessary for the diagnosis of the patient’s condition, meets all other Medicare requirements, including use of an approved device, and the physician who performs the service has sufficient training and experience to reliably perform the service.

The physician performing the service must meet one of the following:

     The physician is a diplomate of the American Board of Sleep Medicine (ABSM).

     The physician is a diplomate in sleep medicine by a member board of the American Board of Medical Specialties (ABMS).

     The physician is an active staff member of a sleep center or laboratory accredited by the American Academy of Sleep Medicine (AASM) or The Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).

A home sleep test is covered only when it is performed in conjunction with a comprehensive sleep evaluation and in patients with a high pretest probability of moderate to severe obstructive sleep apnea. Home sleep testing is not covered for persons with comorbidities (moderate to severe pulmonary disease, neuromuscular disease or congestive heart failure), other sleep disorders (central sleep apnea, periodic limb movement disorder, insomnia, parasomnias, circadian rhythm disorders or narcolepsy) or for screening asymptomatic persons.

Interpretations

A physician or doctoral level professional with satisfactory training in sleep medicine and significant experience in interpretation of standard polysomnograms must interpret these recordings.

Type of Bill Codes

12X, 13X, 18X, 85X