Sleep Disorders Coverage Criteria Medicare Coverage and Payment Rules SUBJECT:  Continuous Positive Airway Pressure (CPAP) Devices (E0601)                                                Initial Coverage of E0601 (First 3 Months) A single level (CPAP) or auto-titrating continuous positive airway pressure (APAP) device (E0601) is covered if the patient has a diagnosis of Obstructive Sleep Apnea (OSA) documented by an attended, facility-based polysomnogram AND meets either of the following criteria (1 or 2): 1)  The Apnea-Hypopnea Index (AHI) is > or = 15 events/hour, OR 2)  The Apnea-Hypopnea Index (AHI) is 5-14 events/hour w/documented symptoms of:      (a)  Excessive daytime sleepiness, impaired cognition, mood disorders, or  insomnia, OR      (b)  Hypertension, ischemic heart disease, or history of stroke. NOTE:  The AHI must be calculated based on a minimum of 2 hours of recorded sleep and must be calculated using actual recorded hours of sleep (i.e. the AHI may not be an extrapolated or a projected calculation). If a CPAP device (E0601) is provided and the criteria above have not been met, it will be denied as not medically necessary. Continued Coverage of E0601 (Beyond The First 3 Months) Continued coverage of a CPAP device (E0601) beyond the first three months of therapy requires that, no sooner than the 61st day after initiating therapy, the supplier ascertain from either the beneficiary or the treating physician that the beneficiary is continuing to use the CPAP device. If the above criterion is not met, continued coverage of a CPAP device (E0601) and related accessories will be denied as not medically necessary. SUBJECT:   Respiratory Assist Devices (RAD)        Bi-Level Positive Airway Pressure (BiPAP) Device, w/o backup rate (E0470)                                  Bi-Level Positive Airway Pressure (BiPAP ST) Device, w/backup rate (E0471)                                General The "treating physician" must be one who is qualified by virtue of experience and training in non-invasive respiratory assistance, to order and monitor the use of respiratory assist devices.  Physicians who treat patients for other medical conditions may or may not be so qualified, and if not, though they may be the treating physician of the beneficiary for other conditions, they are not considered the "treating physician" for the administration of noninvasive positive pressure respiratory assistance (NPPRA) therapy. For the purpose of this policy, polysomnographic studies must be performed in a sleep study laboratory, and not in the home or in a mobile facility.  It must comply with all applicable state regulatory requirements. For the purpose of this policy, arterial blood gas, sleep oximetry and polysomnographic studies may not be performed by a DME supplier.  A DME supplier is not considered a qualified provider or supplier of these tests for purposes of this policy's coverage and payment guidelines.  This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests. Initial Coverage of E0470 and E0471 Devices (First 3 Months) For an E0470 or E0471 respiratory assist device to be covered, the treating physician must fully document in the patient's medical record, symptoms characteristic of sleep-associated hypoventilation, such as daytime hypersomnolence, excessive fatigue, morning headache, cognitive dysfunction, dyspnea, etc. A respiratory assist device (E0470, E0471) used to administer NPPRA therapy is covered for those patients with clinical disorder groups characterized as (I) restrictive thoracic disorders (i.e., progressive neuromuscular diseases or severe thoracic cage abnormalities), (II) severe chronic obstructive pulmonary disease (COPD), (III) central sleep apnea (CSA), or (IV) obstructive sleep apnea (OSA) (E0470 only) and who also meet the following criteria: I.     Restrictive Thoracic Disorders: A.  There is documentation in the patient's medical record of a progressive neuromuscular disease (for example, amyotrophic lateral sclerosis) or a severe thoracic cage abnormality (for example, post-thoracoplasty for TB), AND B.  1)  An ABG PaCO2, done while awake and breathing the patient's usual FIO2 is greater than or equal to 45 mm Hg, OR       2)  Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for at least five continuous minutes, done while breathing the patient's usual FIO2, OR       3)  For a progressive neuromuscular disease (only), maximal inspiratory pressure is less than 60 cm H2O or forced vital capacity is less than 50% predicted, AND   C.  COPD does not contribute significantly to the patient's pulmonary limitation. If all the above criteria are met, either an E0470 or E0471 device (based on the judgment of the treating physician) will be covered for patients within this group of conditions for the first three months of NPPRA therapy. SUBJECT:      CPAP and BiPAP Accessories Accessories used with a CPAP device (E0601), BiPAP device (E0470) or BiPAP ST device (E0471) are covered when the coverage criteria for the device are met.  Accessories are separately reimburseable at the time of initial issue and when replaced. The following table represents the usual maximum amount of accessories expected to be medically necessary: A7030          Full Face Mask, each                       1 per 3 months A7033          Nasal pillows, pair                            1 per 1 month A7034          Nasal Mask or Nasal Aire, each       1 per 3 months A7035          Headgear, each                                1 per 6 months A7036          Chinstrap, each                                1 per 6 months A7037          Tubing, each                                     1 per 1 month A7038          Filter, disposable, each                      2 per 1 month A7039          Filter, non-disposable, each               1 per 6 months A7044          Oral interface, each                           1 per 3 months Either a non-heated (E0561) or heated (E0562) humidifier is covered when ordered by the treating physician for use with a covered CPAP device (E0601).