Humana Obstructive Sleep Apnea and Other Sleep Related Breathing Disorders Nonsurgical Treatments - Medicare Advantage Form

Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals. Type Title ID Number Jurisdiction Medicare Administrative Applicable States/Territories Obstructive Sleep Apnea and Other Sleep Related Breathing Disorders Nonsurgical Treatments Page: 2 of 10 Contractors (MACs) Internet- Only Manuals (IOMs) NCD Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15 §110 Durable Medical Equipment – General Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) 240.4 LCA Billing and Coding: Oral Maxillofacial Prosthesis A53497 LCA Billing and Coding: Independent Diagnostic Testing Facilities (IDTF) A58559 LCD LCA Oral Appliances for Obstructive Sleep Apnea L33611 A52512 Standard Documentation Requirements for All Claims Submitted to DME MACs A55426 JJ - Palmetto GBA (Part A/B MAC) AL, GA, TN JM - Palmetto GBA (Part A/B MAC) JJ - Palmetto GBA (Part A/B MAC) JM - Palmetto GBA (Part A/B MAC) DME A - Noridian Healthcare Solutions, LLC (DME MAC) DME B - CGS Administrators, LLC (DME MAC) DME C - CGS Administrators, LLC (DME MAC) DME D - Noridian Healthcare Solutions, LLC (DME MAC) NC, SC, VA, WV AL, GA, TN NC, SC, VA, WV CT, DE, DC, ME, MD, MA, NH, NJ, NY, PA, RI, VT IL, IN, KY, MI, MN, OH, WI AL, AR, CO, FL, GA, LA, MS, NM, NC, OK, SC, TN, TX, VA, WV, PR, U.S. VI AK, AZ, CA, HI, ID, IA, KS, MO, MT, NE, NV, ND, OR, SD, UT, WA, WY, American Samoa, Guam, Northern Mariana Islands CT, DE, DC, ME, MD, MA, NH, NJ, NY, PA, RI, VT LCD LCA Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea L33718 A52467 DME A - Noridian Healthcare Obstructive Sleep Apnea and Other Sleep Related Breathing Disorders Nonsurgical Treatments Page: 3 of 10 Standard Documentation Requirements for All Claims Submitted to DME MACs A55426 Respiratory Assist Devices LCD LCA Standard Documentation Requirements for All Claims Submitted to DME MACs L33800 A52517 A55426 Solutions, LLC (DME MAC) DME B - CGS Administrators, LLC (DME MAC) DME C - CGS Administrators, LLC (DME MAC) DME D - Noridian Healthcare Solutions, LLC (DME MAC) DME A - Noridian Healthcare Solutions, LLC (DME MAC) DME B - CGS Administrators, LLC (DME MAC) DME C - CGS Administrators, LLC (DME MAC) DME D - Noridian Healthcare Solutions, LLC (DME MAC) IL, IN, KY, MI, MN, OH, WI AL, AR, CO, FL, GA, LA, MS, NM, NC, OK, SC, TN, TX, VA, WV, PR, U.S. VI AK, AZ, CA, HI, ID, IA, KS, MO, MT, NE, NV, ND, OR, SD, UT, WA, WY, American Samoa, Guam, Northern Mariana Islands CT, DE, DC, ME, MD, MA, NH, NJ, NY, PA, RI, VT IL, IN, KY, MI, MN, OH, WI AL, AR, CO, FL, GA, LA, MS, NM, NC, OK, SC, TN, TX, VA, WV, PR, U.S. VI AK, AZ, CA, HI, ID, IA, KS, MO, MT, NE, NV, ND, OR, SD, UT, WA, WY, American Samoa, Guam, Northern Mariana Islands Obstructive Sleep Apnea and Other Sleep Related Breathing Disorders Nonsurgical Treatments Page: 4 of 10 Description Obstructive sleep apnea (OSA) is a common sleep disorder in which the muscles of the soft palate and throat intermittently relax during sleep, creating an obstruction that blocks the upper airway. This causes breathing to become difficult and noisy (snoring). Individuals with OSA experience cessation of breathing from 10 to 60 seconds at a time, which can occur up to 120 times an hour during sleep. As a result, oxygen levels in the bloodstream decrease, which may lead to high blood pressure, stroke, heart attack and/or abnormal heart rhythms. Central sleep apnea (CSA) is a disorder characterized by repetitive cessation or decrease of both airflow and ventilatory effort during sleep. It can be primary (eg, idiopathic CSA) or secondary. Examples of secondary CSA include CSA associated with Cheyne-Stokes breathing, a medical condition, a drug or substance or high- altitude periodic breathing. CSA associated with Cheyne-Stokes breathing is particularly common, especially among individuals who have heart failure or have had a stroke. Depending on which type of sleep study is conducted (facility-based polysomnogram [PSG] or home sleep apnea test [HSAT]), there will be different measurements provided to aid in the diagnosis of OSA, CSA or other sleep related breathing disorders as well as to gauge the severity. Those measurements may include apnea-hypopnea index (AHI), respiratory disturbance index (RDI) and respiratory event index (REI). Nonsurgical treatments for OSA and other sleep related breathing disorders include, but may not be limited to, the following: Positive Airway Pressure (PAP) Therapy There are a number of variations for the devices used to deliver PAP. All devices work similarly by utilizing an air compressor, which forces a flow of air through the nose and into the airway, by way of a light mask worn over the nose during sleep. This prevents collapse of the oropharyngeal passage, which can cause an obstruction of airflow during sleep. Therefore, the goals of PAP therapy are to allow for unobstructed breathing and to improve sleep quality and/or duration. The original and most utilized treatment is continuous positive airway pressure (CPAP). A CPAP device provides the air flow at a constant, preset pressure; however, the settings can be manually changed by a health care professional. A bilevel positive airway pressure (BiPAP) device blows air at a higher pressure for inhaling and a lower pressure for exhaling. This can be used for individuals who cannot tolerate the high constant pressure with CPAP. The settings, like with CPAP, can be manually titrated. An auto-titrating continuous positive airway pressure (AutoPAP or APAP) device continuously modifies the positive pressure level during the night, allowing for a decrease in pressure when spells of apnea and hypopneas disappear and an increase in pressure level when they return. APAP can be used to determine an optimal fixed level of CPAP for long term treatment with conventional CPAP. Claustrophobia, discomfort or other issues may contribute to poor PAP therapy adherence. Pressure relief technology (A-Flex, Bi-Flex, C-Flex and C-Flex +) has been developed for APAP/BiPAP/CPAP devices and Obstructive Sleep Apnea and Other Sleep Related Breathing Disorders Nonsurgical Treatments Page: 5 of 10 provides pressure relief at critical points in the breathing cycle. This technology has become widely used in PAP devices and is purported to increase comfort and compliance with therapy. Some devices have smartcards which can be used to view or verify compliance data of an individual to evaluate the treatment’s overall effectiveness. A demand positive airway pressure (DPAP) device responds to the individual’s changing oxygen demands based on an analysis of each individual breath. It may be used after a trial of CPAP or BiPAP has been ineffective. A variable positive airway pressure device (VPAP) allows bilevel PAP with higher pressure for inhaling and a lower pressure for exhaling, but differs from a regular BiPAP by synchronizing the timing of inspiration and expiration with the individual’s breathing. The amount of pressure does not vary. This may be used for individuals who cannot tolerate the constant pressure of CPAP or who have other sleep related respiratory disorders such as CSA or nocturnal hypoxemia related to severe chronic obstructive pulmonary disease (COPD). The Somnera System, approved by the US Food & Drug Administration (FDA) as a potential alternative to CPAP, uses a proprietary SmartValve which purportedly generates pressure, not airflow. The airbox regulates the back pressure level providing air and back pressure to the individual’s airway in the event of incipient apnea or hypopnea. With hopes of facilitating greater compliance than standard PAP devices, there are some unique features including no humidification, quieter sound while operating, smaller diameter of tubing (9 mm compared to traditional CPAP devices which typically measure 22 mm), various personalization settings and a virtual support program. Regular PAP maintenance and cleaning are important, however currently no home, over-the-counter CPAP cleaning devices that use ozone gas or UV light have been approved by the FDA. The FDA has not determined whether CPAP cleaning devices are safe, nor does it have evidence whether CPAP cleaning devices are effective to clean or disinfect CPAP equipment of germs or allergens. SoClean is an example of this type of device. Oral Appliance Therapy Oral appliances (splints), sometimes called dental appliances, may be a treatment option for mild to moderate OSA and are intended to maintain an open airway. There are two major types of oral appliances: mandibular advancement splints (MAS) and tongue retaining devices. MAS, also referred to as mandibular repositioning appliances or mandibular advancement devices (MAD), push the lower jaw forward and are the most commonly used oral appliance. Tongue retaining devices prevent the tongue from falling back over the airway. Many oral appliances are custom-made, offering individuals the best fit and treatment outcomes. New technology is being introduced for 3D printing of oral appliances. Examples of these devices include, but may not be limited to, Respire Clear and Slow Wave DS8. At this time, there is no evidence that demonstrates these are equivalent to traditional, custom-made appliances. Oral surgical splints are typically fabricated and used to offer perioperative and/or postoperative support to ensure satisfactory surgical outcomes during orthognathic surgery. Obstructive Sleep Apnea and Other Sleep Related Breathing Disorders Nonsurgical Treatments Page: 6 of 10 Some oral appliances have been developed for the treatment of snoring alone. An example of one of these devices is the Snore Guard which resembles an athletic mouthpiece. Suggested as a treatment for snoring, it uses normal body reflexes to maintain an open airway. The device fits snugly on the upper teeth. When the lower jaw closes, the lower teeth close onto the lower ramp of the Snore Guard. This keeps the jaw in a normal position, rather than sagging open and back. In addition, the tongue reflexively seeks the small center orifice between the upper and lower ramp. This reflex keeps it from sagging back into the throat. Another example of such a product is the ZYYPAH Anti-Snoring Mouthpiece. Other Nonsurgical Treatment Devices Daytime oral alignment devices have been introduced to allegedly help an individual perform isometric exercises to return the mandible back to its pretreatment position or help maintain proper mouth alignment after using an overnight sleep apnea device. Some of these devices may require custom fitting and/or other tests may be ordered (eg, laryngeal function studies) to ensure the proper fit. Examples include, but may not be limited to, the SomMorning Repositioner and AM Aligner. Expiratory positive airway pressure (EPAP) is suggested as a treatment for OSA that utilizes the individual’s own breathing to create PAP to prevent obstructed breathing. Bongo Rx, Optipillows EPAP Mask and ULTepap are examples of removable appliances that are placed just inside the nostril and increase pressure inside the nose during exhalation to maintain an open airway during sleep. These appliances may also be referred to as nasal dilators or nasal valve devices. Nonsurgical electric muscular stimulation via the eXciteOSA device, a daytime option for the treatment of mild OSA, delivers electrical stimulation through a mouthpiece that sits around the tongue. The mouthpiece has four electrodes, two located above the tongue and two located below the tongue. It is used for 20 minutes, once a day, for a period of 6 weeks and once each week thereafter. eXciteOSA purportedly works by improving tongue muscle endurance and responsiveness preventing upper airway collapse during sleep. Oral pressure therapy (OPT) is comprised of a bedside console, a soft polymer mouthpiece and a flexible tube connecting the mouthpiece to the console. The console creates a vacuum pulling of the soft palate anteriorly and purportedly stabilizes the tongue to reduce obstruction during sleep. The iNAP One Sleep Therapy System is an example of OPT. Positional sleep therapy devices (eg, NightBalance, Night Shift Positioner, Zzoma) have been developed for individuals who have positional obstructive sleep apnea (POSA). The goal of NightBalance and Night Shift Positioner is to purportedly detect when an individual is sleeping on their back and send a tactile vibration to a strap positioned around the chest or neck in an effort to prompt the individual to change their sleep position. Zzoma is a device that is worn on an individual’s back with adjustable Velcro straps that are secured anteriorly on the upper chest. This device purportedly keeps an individual positioned on their side and prevents the individual from laying in a supine position. Coverage Determination Obstructive Sleep Apnea and Other Sleep Related Breathing Disorders Nonsurgical Treatments Page: 7 of 10 Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare. Please refer to the above CMS guidance for obstructive sleep apnea and other sleep related breathing disorders nonsurgical treatments. In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the criteria contained in the following: Obstructive Sleep Apnea and Other Sleep Related Breathing Disorders Nonsurgical Treatments The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy. Coverage Limitations US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage