Medical Affairs Policy

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1 Medical Affairs Policy Service: Sleep Disorder Treatment: Positive Airway Pressure Devices and Oral Appliances (CPAP, BPAP, BiPAP, BiPAP ST, BiPAP with backup, BiPAP -Auto SV, VPAP, VPAP Adapt, VPAP adapt SV, APAP, Adaptive Servo- Ventilation, ASV, oral device, mandibular advancement device) PUM Medical Policy Committee Approval 09/21/18 Effective Date 01/01/19 Prior Authorization Needed Yes Disclaimer: This policy is for informational purposes only and does not constitute medical advice, plan authorization, an explanation of benefits, or a guarantee of payment. Benefit plans vary in coverage and some plans may not provide coverage for all services listed in this policy. Coverage decisions are subject to all terms and conditions of the applicable benefit plan, including specific exclusions and limitations, and to applicable state and federal law. Some benefit plans administered by the organization may not utilize Medical Affairs medical policy in all their coverage determinations. Contact customer services as listed on the member card for specific plan, benefit, and network status information. Medical policies are based on constantly changing medical science and are reviewed annually and subject to change. The organization uses tools developed by third parties, such as the evidence-based clinical guidelines developed by MCG to assist in administering health benefits. This medical policy and MCG guidelines are intended to be used in conjunction with the independent professional medical judgment of a qualified health care provider. To obtain additional information about MCG, medical.policies@wpsic.com. Note: Coverage for Positive Airway Pressure (PAP) and related devices are subject to the individual s health plan language for Durable Medical Equipment (DME) Description: This policy addresses the following treatments: An Oral Appliance, also called: mandibular advancement device (MAD), mandibular advancement appliance (MAA), mandibular repositioning appliances (MRA), or mandibular advancement splint (MAS), is a device used to modify an individual s airway during sleep to decrease the symptoms associated with obstructive sleep apnea (OSA). Positive Airway Pressure (PAP) devices provide respiratory assistance through the administration of positive air pressure through a nasal or oral mask for the treatment of sleep disordered breathing. CPAP (continuous positive airway pressure) provides a continuous set level of airway pressure during both inspiration and expiration. BPAP or BiPAP (bi-level positive airway pressure) provides positive airway pressure at a set level during inspiration, but allows a different level of positive airway pressure to be set during expiration, available with and without back up features. Page 1 of 9

2 ASV (adaptive-servo-ventilation) provides a varying amount of inspiratory pressure superimposed on a low level of CPAP, with a backup respiratory rate. It is used as second-line therapy for patients with hyperventilation-related central sleep apnea who have failed or do not tolerate CPAP. APAP (Automatic Positive Airway Pressure; also called CPAP with auto-titration, autopap, and auto-titrating positive airway pressure) can be used to titrate PAP therapy in the patient s home. VPAP (variable positive airway pressure) devices provide variable levels of airway pressure during inspiration and expiration, responding to the needs of the individual. Definitions: Sleep Medicine Specialist: For purpose of this policy, a sleep medicine specialist is one of the following: o A Diplomate of the American Board of Sleep Medicine or o A certification in sleep medicine and one of the following Board-Certified Specialties: Pulmonologist, Otolaryngologist, Neurologist, Pediatrician, Internist, Family Medicine Physician, Psychiatrist, or Nurse Practitioner or Physician Assistant working in collaboration with one of the listed specialists. Compliance, for the purpose of this policy, is defined as a minimum of four hours of use per night for 70% of the nights of a three-month trial. Several studies have assessed treatment adherence to PAP devices. Estimates for non-compliance, defined as less than or equal to 4 hours per night, range from 29-83%. In general, rates of compliance with the various devices are similar, even when respiratory measures are improved. Early intervention with a BPAP device after poor initial experience with in lab CPAP does not appear to result in improved utilization of the PAP device. Due to the substantial rates of non-compliance, a three-month trial rental of PAP device to allow for time to optimize conditions for compliance and to document compliance is required prior to purchase of a PAP device or approval of an oral appliance. Apnea is defined as >90 percent reduction in peak signal excursion of the airflow sensor for >10 seconds on the recording device. Hypopnea is defined as >30% reduction in excursion of the airflow sensor lasting for >10 seconds and associated with 3 percent oxygen desaturation on the recording device. Severe chronic obstructive pulmonary disease (COPD), for the purpose of this policy, is defined as post bronchodilator FEV1/FVC ratio <0.7, FEV1 <30 percent predicted. Page 2 of 9

3 Indications of Coverage: A. AutoPAP (APAP) or CPAP with or without a humidifier (heated or non-heated) is considered medically necessary for the treatment of any of the following conditions (see section E. for additional APAP indications): 1. Obstructive sleep apnea that has been diagnosed though a Type I, II, or III polysomnogram with an in-lab AHI or home study RDI or REI (as defined above) of 15 or more. 2. Obstructive sleep apnea that has been diagnosed though a Type 1, Type II, or Type III polysomnogram with an in-lab AHI or home study RDI or REI (as defined above) between 5 and 15 and: The individual has at least one of the following co-morbidities or symptoms (a. through j. below): a. Presence of cardiac arrhythmias unstable or refractory to treatment b. Unexplained pulmonary hypertension c. Hypertension (high blood pressure) d. Body mass index (BMI) greater than 40 e. Cerebrovascular disease (Stroke) f. Congestive Heart Failure (CHF) includes New York Heart Association (NYHA) class III or IV, left ventricular ejection fraction (LVEF) less than 45% g. Excessive Daytime Sleepiness defined as an Epworth score over 10 h. Cognitive dysfunction attributed to sleep diagnosed using one of the following clinically recognized cognitive assessment tools: 1) California Verbal Learning Test 2) Digit Span (from the Wechsler Adult Intelligence Scale-Revised) 3) Informant Questionnaire on Cognitive Decline in the Elderly 4) Mini-Mental State Examination (MMSE) 5) Montreal Cognitive Assessment (MoCA) test 6) Trails A or B OR 7) Current use of medication for dementia i. Depression requiring antidepressant therapy Page 3 of 9

4 j. Ischemic Heart Disease B. BPAP (BiPAP) without back up (with or without a humidifier) is considered medically necessary for the treatment of any of the following conditions: 1. Obstructive Sleep Apnea (OSA): Member met the criteria above (A., 1.or 2.) for CPAP and either of the following: a. Documentation from a sleep medicine physician reporting the failure of a onemonth trial of CPAP or AutoPAP due to intolerance to high pressures that exceed 10cm H2O despite adequate changes to headgear and masks. A download from the CPAP device documenting a minimum of four hours of use per night for 70% of the nights of the trial is required. b. Documentation from a laboratory titration study indicating failure to meet therapeutic goals with CPAP or AutoPAP (e.g. BPAP needed due to inadequate reduction of AHI or hypoxia with CPAP). C. BPAP with back up is considered medically necessary when prescribed by a Sleep Medicine Specialist for the treatment of any the following conditions: 1. Neuromuscular disease (for example, amyotrophic lateral sclerosis) or significant thoracic anatomical abnormalities (e.g. post thoracic surgery deformity), when there is documentation from laboratory attended polysomnogram indicating failure of BPAP without back up to meet therapeutic goals, and there is significant improvement of sleep associated hypoventilation on the device prescribed for use at home. 2. Severe COPD: when there is documentation from laboratory attended PSG indicating failure of BPAP without back up to meet therapeutic goals, and there is significant improvement of sleep associated hypoventilation on the device prescribed for use at home. 3. Central Sleep Apnea (CSA) or Complex Sleep Apnea (CompSA) documented by a laboratory attended PSG, when use of CPAP alone has proved ineffective, and there is significant improvement of sleep associated hypoventilation/ hypoxia on the device and setting that will be prescribed for use at home. D. Adaptive Servo Ventilation: (e.g. VPAP Adapt (with Adaptive Servo Ventilation (ASV)) or BiPAP (with auto Servo Ventilation (SV)) are considered medically necessary when the device is prescribed by a Sleep Medicine Specialist and there is documentation that BiPAP with or without backup has failed or is contraindicated, Page 4 of 9

5 and there is significant improvement during laboratory titration on the device that has been prescribed for the treatment of any of the following conditions: 1. Primary Central Sleep Apnea (does not require BPAP trial) 2. Central Sleep Apnea except in patients with symptomatic heart failure with left ventricular ejection fraction (LVEF) less than or equal to 45% 3. Complex Sleep Apnea or treatment-emergent central sleep apnea 4. Sleep Apnea with comorbidity of congestive heart failure (CHF) 5. Hypoventilation Syndrome E. APAP (with or without a humidifier) may also be considered medically necessary for any of the following conditions: 1. When prescribed by a sleep medicine physician for an individual with continued symptoms of obstructive sleep apnea that are documented in the medical record despite a two-month trial of ongoing use of CPAP or BiPAP. A download from the PAP device currently being used that documents a minimum of four hours of use per night for 70% of the nights of the trial, and documentation that issues with mask fit and PAP intolerance have been addressed, is required. (Allow up to 3 months of rental for evaluation and titration changes). 2. When prescribed by a sleep medicine physician following a laboratory polysomnogram that diagnosed obstructive sleep apnea with an AHI of at least 5, but there was insufficient time to complete a split night study for CPAP titration. (Allow up to 3 months of rental for evaluation and titration changes). F. An Oral Appliance for an adult is considered medically necessary when all the following criteria are met: 1. A polysomnogram documented the presence of mild or moderate (e.g. AHI below 30) obstructive sleep apnea sufficient to meet criteria for the use of a Positive Airway Pressure (PAP) device (see this policy, Section A., 1. and 2. for criteria) 2. A two-month trial of the PAP device has failed. Failure of the PAP trial is defined as intolerance of the high pressures needed to maintain airway patency despite documentation of appropriate interventions to improve compliance (e.g. changes to masks and headgear, and support to address side effects and behavioral issues). The documentation must support that the individual has been compliant with recommendations for PAP device use, as evidenced by a download from the PAP Page 5 of 9

6 device that documents a minimum of four hours of use per night for 70% of the nights of the two-month trial. 3. A custom-fitted or prefabricated oral appliance is prescribed in the context of a comprehensive sleep program, after an evaluation by a Sleep Medicine Specialist. The evaluation must include documentation of PAP intolerance or contraindication. 4. The device is provided by a licensed dentist. Note: Aside from one follow up home polysomnogram to insure therapeutic benefit after final fitting/adjustment of the device, all follow up care including (but not limited to) adjustments, modifications, titration studies of a titratable device, and professional services are considered incidental to / included in the oral appliance primary service. Replacement of Oral Appliance: Review member s certificate/plan for replacement purchase versus repair of OA device. Documentation should include the reason replacement is needed (submit repair / replacement estimate when applicable). Medical records should include history, including indications for the original device (for example AHI, Epworth scores when available), recent use history and effectiveness of device (or change in symptoms if the device is not working). Replacement needed due to misuse or abuse or member convenience are not covered. Rental and Purchase of PAP Devices: If the criteria for the specific PAP device (A., B., C., D., or E.) is met: A rental of three months may be approved. For purchase of a device: A separate prior authorization request must be submitted prior to the end of the three-month rental period and include a 60-day (two month) device download that documents a minimum of four hours of use per night for at least 70% of the nights. Continued rental beyond three months will not be approved. Payment of rental charges beyond the purchase price of the device is a limitation of many of our member health plans and provider contracts.. Replacement of PAP Devices: Review member s plan for replacement purchase versus repair of PAP devices. Documentation must include all of the following: 1. The reason PAP device replacement is needed (problem or malfunction of the device; submit repair / replacement estimate when applicable). 2. Medical records including all of the following: history, indications for the original PAP device (for example AHI and Epworth score), a download from the PAP device currently being used that shows a minimum of four hours of use per night for 70% of the nights of the last month, and effectiveness of PAP (or change in symptoms if the device is not working). Page 6 of 9

7 Replacement needed due to misuse, abuse, or member convenience is not covered. Rental of replacement device may be required prior to purchase of the device. Limitations of Coverage: A. Review contract and endorsements for exclusions and prior authorization or benefit requirements (Note: For medical diagnoses, the oral appliance would not process under the dental benefit.) B. If requested/used for a condition/diagnosis other than is listed in the Indications of Coverage, it will be denied as experimental, investigational, and unproven to affect health outcomes. C. If requested/used for a condition/diagnosis that is listed in the Indications of Coverage, but the criteria are not met, it will be denied as not medically necessary D. An oral appliance for the treatment of snoring without documentation of obstructive sleep apnea is not a covered benefit, as snoring is not considered to be an illness or injury E. Only one sleep apnea treatment (either an oral appliance or a PAP device) may be approved for use at the same time. Deny per plan/certificate language. In the absence of specific plan/certificate language, deny as not medically necessary. F. An oral appliance is considered not medically necessary in any of the following situations: 1. When there is no polysomnogram documenting the presence of obstructive sleep apnea 2. In the absence of the failure of a two-month trial of PAP device. Failure of the PAP trial is defined as intolerance of the high pressures needed to maintain airway patency despite documentation of appropriate interventions to improve compliance (e.g. changes to masks and headgear, and support to address side effects and behavioral issues). The documentation must support that the individual has been compliant with recommendations for PAP device use, as evidenced by a download from the PAP device that documents a minimum of four hours of use per night for 70% of the nights of the two-month trial. 3. When the device is obtained over-the-counter without a prescription Page 7 of 9

8 G. ASV to treat central sleep apnea in patients with symptomatic, chronic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF) 45% and moderate to severe predominant central sleep apnea is contraindicated. H. The following are considered experimental, investigational, and unproven to affect health outcomes or not covered per the member health plan: 1. Expiratory Positive Airway Pressure [EPAP] (e.g. Provent nasal dilator) 2. Nasal dilators 3. Oral Pressure Therapy (OPT) or Oral Pressure appliance treatments intended to regulate oral pressure to treat OSA (e.g. Winx Sleep Therapy System) 4. Hypoglossal Nerve Stimulation (inspire Upper Airway Stimulation) 5. Silent Partner noise canceling device to suppress snoring 6. Cleaning supplies and devices for PAP equipment or oral appliances (e.g. SoCLean 2 CPAP Cleaner and Sanitizing Machine) 7. Unilateral Phrenic Nerve Stimulation for Central Sleep Apnea (e.g. remede System) 8. The Morning Repositioner, Sonomed Documentation Required: Sleep study report Medical records documenting comorbidities or other issues relevant to use of the PAP device Respiratory Therapy notes supporting compliance or intolerance issues (if applicable) Prescription or documentation from the physician describing the necessity of the device Page 8 of 9

9 WPS / Arise Review History: Implemented 04/01/15, 04/01/16, 01/01/17, 04/01/18, 01/01/19 Medical Policy 12/13/13, Erratum corrected 03/31/14, 12/12/14, 12/12/15, Committee 12/09/16, 12/01/17, 09/21/18 Approval Reviewed 12/12/14, 12/12/15, 12/09/16, 12/01/17, 09/21/18 Developed Note: For review/revision history prior to 2014 see previous Medical Policy or Coverage Policy Bulletin Approved by the Medical Director Page 9 of 9

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