Related Medicare Advantage Medical/Pharmacy Coverage Policies

None

Related Documents

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.

Jurisdiction

• Type
• Title
• ID Number
• Medicare Administrative Contractors (MACs)
• Applicable States/Territories

Airway Clearance Devices Page: 2 of 6

1. NCD
2. Intrapulmonary Percussive Ventilator (IPV)
3. 240.5
4. J15 -CGS Administrators, LLC (Part A/B MAC) A
5. | KY, OH

• LCD LCA
• High Frequency Chest Wall Oscillation Devices
• L33785 A52494
• DME C- CGS Administrators, LLC (DME MAC) DME D - Noridian Healthcare Solutions, LLC (DME MAC)
• AL, AR, CO, FL, GA, LA, MS, NM, NC, OK, SC, TN, TX, VA, WV, PR, US VI AK, AZ, CA, HI, ID, 1A, KS, MO, MT, NE, NV, ND, OR, SD, UT, WA, WY, American Samoa, Guam, Northern Mariana Islands

• LCD LCA
• DME A - Noridian Healthcare
• CT, DE, DC, ME, MD, MA, NH, NJ, NY, PA,

LCD LCA Intrapulmonary Percussive Ventilation System L33786 A52495 DME A - Noridian Healthcare Solutions, LLC (DME MAC) DME B - CGS Administrators, LLC (DME MAC) IL, IN, KY, MI, MN, OH, WI AL, AR, CO, FL, GA, LA, MS, NM, NC, OK,

Airway Clearance Devices Page: 3 of 6

• LCD LCA
• Mechanical In-exsufflation Devices
• JN - First Coast Service Options, Inc. (Part A/B MAC)
• FL, PR, US VI

Description

Individuals with impaired ability to cough due to respiratory muscle weakness or pulmonary restriction have difficulty clearing secretions from the lungs. The accumulated secretions may allow growth of pathogens, leading to a higher risk for chronic infections and deterioration of lung function as the bronchial tubes can be occluded. Conditions that can lead to this problem include amyotrophic lateral sclerosis (ALS), bronchiectasis, cystic fibrosis (CF), muscular dystrophy, myasthenia gravis and spinal cord injuries.

Airway clearance devices are an alternative to standard manual chest physiotherapy (CPT), which includes percussion, postural drainage, forced expiratory maneuvers, huffing and coughing. These techniques usually require the aid of another individual. Several types of airway clearance devices have been developed, which include, but may not be limited to:

• High-frequency chest compression vests – These consist of an air generator and an inflatable vest that covers the chest. Increases in air pulses are delivered to the vest with oscillating airflow patterns, causing external manipulations of the chest. Examples of these devices include, but may not be limited to, AffloVest, InCourage System, Monarch Airway Clearance System, SmartVest Airway Clearance System, SmartVest SQL Airway Clearance System and Vest Airway Clearance System.
• Intrapulmonary percussive ventilation (IPV) – IPV utilizes a mouthpiece to deliver mini bursts of oxygen while also delivering therapeutic aerosols through a nebulizer. The intended purpose of this treatment is that through a combination of bursts of oxygen and medication, it loosens secretions, stimulates cough and increases sputum production. An example of this type of device includes, but may not be limited to, the Impulsator.
• Mechanical insufflation-exsufflation (MIE) – This approach utilizes portable devices with a facemask that covers the nose and mouth, delivering alternating positive and negative pressure allowing air to be pumped into the lungs and then rapidly evacuated. This produces a high expiratory flow rate from the lungs and stimulates a cough and increasing secretion clearance.

• BiWaze Cough System
• CoughAssist
• Synclara

Mechanical percussors – These electrical devices provide clapping, percussion and/or vibration to the external chest wall and are used in place of manual chest percussion to assist with secretion clearance. Examples of these types of devices include, but may not be limited to:

• Frequencer
• Vibralung

Positive expiratory pressure (PEP) devices – These devices increase resistance to expiratory airflow which helps improve secretion clearance by creating pressure in the lungs and preventing airway closure. The individual breathes into the device normally, but breathes out harder against resistance. Examples of this device include, but are not be limited to:

• Pari Pep S

TheraPEP is another PEP device; however, this device is available over-the-counter without a prescription.

Oscillating (vibratory) positive expiratory pressure devices (OPEP) – These hand-held devices combine PEP with high-frequency air flow oscillations using a stainless-steel ball or a counterweight plug and magnet. These devices utilize deep breathing and forced exhalation to create a vibration of the airway walls which loosen secretions. Examples of this type of device include, but may not be limited to:

• Flutter

Acapella and Aerobika are examples of other OPEP devices; however, these devices are available over-the-counter without a prescription.

The Volara System and BiWaze Clear System combine several noninvasive therapies into one device. These devices purportedly provide oscillation and lung expansion (OLE) therapy using PEP, oscillation and delivery of aerosol medications.

19 Volara was voluntarily recalled by the manufacturer on April 26, 2022 due to the risk of respiratory distress in ventilated patients during home use with the US Food & Drug Administration (FDA) categorizing it as a Class I recall.50

Coverage Determination

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.

In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the criteria contained in the following:

Airway Clearance Devices

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.

Airway Clearance Devices Page: 5 of 6

Coverage Limitations

US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage