Oscar Noninvasive Positive Pressure Ventilation (CG003) Form

Noninvasive Positive Pressure Ventilation (NPPV) may be used to treat a number of conditions, including sleep-related breathing disorders and chronic lung disease. Sleep-related breathing disorders, such as obstructive sleep apnea, are conditions in which abnormal breathing events during sleep are associated with negative impacts on a person’s health. Chronic lung diseases, such as chronic obstructive pulmonary disease (COPD), affect the ability of a person to breathe in oxygen and breathe out carbon dioxide. When needed to treat these conditions, NPPV is accomplished by using Positive Airway Pressure (PAP) devices. PAP devices are non-invasive and improve oxygenation and gas exchange in the lungs by producing airflow through oral, nasal, or combination oronasal masks. Prior to initiation of PAP therapy, a sleep study (e.g. home sleep test, attended nocturnal polysomnography) coupled with the clinically appropriate lung testing (e.g. arterial blood gas, pulmonary function testing) is required to confirm the diagnosis, level of severity, and most appropriate treatment. The device must also be prescribed by a board-certified pulmonary specialist or board-certified sleep medicine practitioner. Definitions “Sleep-Related Breathing Disorders” are conditions in which abnormal breathing events occur during sleep include: 1 1. Obstructive Sleep Apnea (OSA)- sleep-related breathing disorder that occurs when the muscles relax during sleep, causing soft tissue in the back of the throat to collapse and block the upper airway. This causes reduced or complete halt in airflow despite an ongoing effort to breathe. 2. Central Sleep Apnea (CSA) syndromes are caused by post-hyperventilation central apnea, which may be triggered by a variety of clinical conditions, and central apnea secondary to hypoventilation, which has been described with opioid use as per American Academy of Sleep Medicine. These types include but not limited to: a. Primary Central Sleep Apnea b. CSA due to Cheyne-Stokes breathing pattern c. CSA due to Medical Condition Not Cheyne-Stokes d. CSA due to Drug or Substance e. Primary Sleep Apnea of Infancy 3. Complex Sleep Apnea (i.e., Treatment-Emergent Central Sleep Apnea) - defined by Centers for Medicare and Medicaid Services as central apnea specifically identified by the persistence or emergence of central apneas or hypopneas during the initiation of CPAP or an E0470 device despite obstructive respiratory events have been significantly reduced. Complex sleep apnea is distinct as obstructive or mixed apnea is present without treatment and can be worsened during positive airway treatment. 4. Sleep-Related Hypoventilation Syndrome (SRHS) - is a syndrome with the presence of elevated PaCO2 levels either directly (by arterial blood gas measurement) or indirectly (by end-tidal CO2 or transcutaneous CO2 measurements) and includes the following disorders: a. Obesity hypoventilation syndrome b. Congenital central alveolar hypoventilation syndrome c. d. Late-onset central hypoventilation with hypothalamic dysfunction Idiopathic central alveolar hypoventilation e. Sleep-related hypoventilation due to a medication or substance f. Sleep-related hypoventilation due to a medical disorder “Sleep-Study Testing” is a diagnostic test that is used to diagnose sleep-related disorders by recording a person’s brain waves, blood oxygen levels, heart rate and breathing during sleep. Two types of sleep-study tests are recognized in the diagnosis of sleep disordered breathing: 1. “Unattended (Home) Polysomnography (PSG)”/Home Sleep Apnea Test (HSAT) is a portable sleep study that can be done at home without the need for a technician on-site to monitor data. 2. “Attended (Facility or Laboratory) Nocturnal Polysomnography” is a test performed overnight in a sleep lab or facility that is administered and overseen by a technician. “Apnea-Hypopnea Index (AHI)” is the number of apneas and hypopneas per hour of sleep recorded during a sleep study. The AHI is commonly used to determine the severity of sleep apnea. An apnea is defined by the cessation of airflow at the nose and mouth for a minimum of 10 seconds. A hypopnea is an abnormal respiratory event lasting ≥10 seconds with ≥ 30% reduction/signal excursion in 2 thoracoabdominal movement or airflow as compared to baseline, and with at least a ≥4% oxygen desaturation from pre-event baseline. “Respiratory Disturbance Index (RDI)” is the number of apneas, hypopneas and respiratory effort-related arousals (RERAs) per hour of sleep recorded during a sleep study. “Respiratory-Event Index (REI)” is a measurement of sleep disordered breathing on home sleep apnea testing defined as the number of apneas plus hypopneas during the sleep test divided by the total sleep or recording time reported in hours. “Pulmonary Function Testing” is non-invasive testing that measures lung capacity, airflow and chest wall mechanics. “Positive Airway Pressure Devices” are non-invasive equipment that assist in ventilation by delivering variable pressures of airflow during inspiration and expiration via an oral, nasal, or oronasal mask. They include: 1. Bi-level Positive Airway Pressure Devices (BPAP) 2. Continuous Positive Airway Pressure (CPAP) 3. Adaptive Servo-Ventilation devices (ASV) Clinical Indications Continuous Positive Airway Pressure (CPAP) / Bi-level Positive Airway Pressure Devices (BPAP - spontaneous mode, spontaneous/timed mode) / Adaptive Servo-Ventilation devices (ASV) The Plan considers CPAP or BPAP devices provided by a network (durable medical equipment) DME provider medically necessary if the following criteria are met: 1. Initiation of Therapy or Short-Term Therapy (up to 90 days) a. Prescription from treating licensed provider; and b. Meets the diagnostic and severity criteria for a sleep-related breathing disorder or other pulmonary disease as outlined: i. MCG criteria A-0431 for [Continuous Positive Airway Pressure (CPAP) Device] (HCPCS E0601); or ii. MCG criteria A-0337 for [CPAP Titration, Home Auto-titrating PAP (APAP)] (HCPCS E0601); or iii. iv. MCG criteria A-0338 for [CPAP Titration, Sleep Center] (HCPCS E0601); or MCG criteria A-0994 [Bilevel Positive Airway Pressure (BPAP) Device] for 1. BPAP without a backup respiratory rate (HCPCS E0470); or 2. BPAP with a back-up respiratory rate (HCPCS E0471, E0472); or v. Adaptive Servo-Ventilation devices (ASV) (e.g., BPAP Auto Servo-Ventilation) (HCPCS codes E0471) is considered medically necessary when ALL of the following criteria are met: 3 1. Member is diagnosed with complex sleep apnea, i.e., treatment-emergent central sleep apnea; and 2. Member does not have symptomatic chronic heart failure between Class II-IV in New York Heart Association (NYHA) Functional Classification;and 3. Cardiac assessment prior to initiation of treatment, member does not have left ventricular ejection fraction ≤45% and moderate to severe predominant central sleep apnea;and 4. Member has diagnostic polysomnography (PSG) that shows five or more predominantly obstructive respiratory events (obstructive or mixed apneas, hypopneas or respiratory effort related arousals [RERAs]) per hour of sleep; and 5. PSG during use of positive airway pressure (HCPCS code E0470) without a backup rate shows significant resolution of obstructive events and emergence or persistence of central apnea or central hypopnea with both of the following: a. b. central apneas and central hypopneas ≥ 5/hour; and total number of central apneas and central hypopneas is >50% of total number of apneas and hypopneas. 2. Authorization for purchase or Long-Term Therapy (more than 90 days) a. Documented symptom and/or AHI/RDI/REI improvement with PAP therapy; and b. Documented follow up with prescribing provider within 90 days of initiation; and c. Documented compliance with use of PAP device, defined as usage on at least 70% of nights for an average of 4 hours per 24-hour period during a period of 30 consecutive days during the first 90 days after initiation. 3. Replacement device a. Device is consistently used on at least 70% of nights for an average of 4 hours per 24-hour period; and b. Device is not functioning appropriately; and c. Device has been evaluated by the supplying DME provider and has been deemed unable to be repaired; and d. The device is no longer covered under the manufacturer’s warranty. Note: e. Replacement due to misuse or abuse is NOT covered. f. Duplicate equipment for traveling is NOT medically necessary and considered a convenience item. Home Ventilators For home ventilators that perform noninvasive ventilation (e.g., E0466,E0467), please see MCG criteria. PAP Treatment Supplies The Plan considers the following PAP treatment supplies medically necessary when: 4 1. They are provided by a network DME provider; and 2. Ordered via signed prescription by licensed treating practitioners dated within one year of request; and 3. Either a CPAP or BiPAP device has been approved based on the criteria above. Masks The Plan considers ONE of the four mask types below medically necessary for a given member. In cases where a member is unable to tolerate the initially provided mask type, eligibility for an alternative mask type will be considered provided documentation is submitted supporting the member is compliant with the PAP device, but unable to tolerate the mask type. ● Combination oral/nasal mask (A7027) - 1 per 3 months ○ Oral cushion used with combination oral/nasal mask (A7028) - 2 per month ○ Nasal pillows used with combination oral/nasal mask (A7029) - 2 per month ● Full face mask (A7030) - 1 per 3 months ○ Full face mask interface replacement (A7031)- 2 per month ● Nasal interface (mask or cannula type) (A7034) - 1 per 3 months ○ Cushion for nasal mask interface (A7032) - 2 per month ○ Nasal pillow for nasal cannula interface (A7033) - 2 per month ● Oral interface (A7044) - 1 per 6 months Tubing The Plan considers ONE of the following tubing types below medically necessary for a given member. ● Tubing with integrated heating element (A4604) - 1 per 3 months ● Tubing used with PAP devices (A7037) - 1 per 3 months Filters The Plan considers the following filter types below medically necessary for a given member. ● Disposable filter (A7038) - 2 per month ● Non-disposable filter (A7039) - 1 per 6 months Heated(E0562)andNon-heated(E0561)Humidifier ● Medically necessary if no previous humidifier has been provided OtherPAPEquipment ● Headgear (A7035) - 1 per 6 months ● Chinstrap (A7036) - 1 per 6 months ● Exhalation port with or without swivel (A7045, bundled with mask interfaces) - 1 per 6 months ● Water chamber for humidifier (A7046, bundled at the time of initial supply) - 1 per 6 months Experimental or Investigational / Not Medically Necessary 5 The following items are considered comfort or convenience items, are available over-the-counter, or are considered not medically necessary: ● Batteries, SD cards, modems, or other feature components for positive airway pressure devices ● DC adapters for positive airway pressure devices ● Electrical devices (e.g., Night ShiftTM Sleep Positioner) as therapy for positional obstructive sleep apnea ● Electrosleep therapy ● Cleaning equipment for automatic or manual cleaning of interfaces, tubing, or other related supplies ● Duplicate equipment for traveling is not medically necessary and considered a convenience item. ● Non-PAP related home humidifiers ● Positive airway pressure bed pillows ● ProventTM Professional Sleep Apnea Therapy Device ● The treatment of snoring alone by any method is considered not medically necessary. ● Use of the miscellaneous durable medical equipment code (HCPCS code E1399)