Medical Policy Bulletin Title: Airway-Clearance Devices for Use in the Home Setting

Policy #: 05.00.53d The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service. This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.

Intent

The intent of this policy is to communicate the coverage positions for airway clearance devices for use in the home setting. For information on policies related to this topic, refer to the Cross References section in this policy.

Description:

Individuals with compromised, airway-clearance mechanisms are at risk for pulmonary complications that are a major cause of morbidity and mortality. The ability to loosen and mobilize secretions can be severely impaired due to conditions such as spinal cord injuries, neuromuscular disorders, laryngeal dysfunction, or fatigue secondary to comorbid disease states. Additionally, disease processes such as cystic fibrosis and bronchiectasis affect the amount and viscosity of the sputum produced. The use of nebulized medications followed by chest percussion, vibration, and postural drainage are interventions that are well documented as effective methods of chest physiotherapy (CPT). Pursed-lip breathing, a technique that creates a positive expiratory pressure (PEP), has long been used by individuals with chronic obstructive pulmonary disease (COPD). When performed consistently, the use of nebulized agents followed by CPT assists with keeping the airways open, thereby decreasing the work of breathing and reducing the incidence of airway obstruction and its sequelae. Various devices are available for use as adjunctive tools to promote optimal pulmonary toileting, and these include, but are not limited to, the following: Mechanical chest percussors (eg, G5 Vibracare, G5 Flimm-Fighter, G5 Neocussor [General Physiotherapy Inc., St. Louis, MO]): These are typically electrical devices that are applied to the chest and back during CPT, either independently by the individual or by a caregiver. This type of device provides percussion and/or vibration. PEP devices: Standard PEP devices (eg, TheraPEP® [DHD Healthcare Corp, Wampsville, NY], PariPEP™ [PARI Respiratory Equipment Inc., Monterey, CA]): The use of this type of device requires the individual to exhale through a resistor (mouthpiece or mask) in order to produce PEP during a prolonged period of exhalation. By breathing out with a moderate force through a resistance, a positive pressure is generated in the airways, helping to keep them patent. This pressure allows airflow to get beneath the areas of mucus obstruction and move the mucus toward the larger airways where it can be coughed up. A pressure manometer is sometimes used as an adjunct device in order to help the individual maintain the level of pressure required/desired during exhalation. Oscillating PEP devices (eg, Flutter® [Axcan Scandipharm Inc., Birmingham, AL], Acapella® [DHD Healthcare Corp., Wampsville, NY]): Flutter® PEP device: This hand-held, pipe-shaped device provides vibrating PEP therapy. The mouthpiece is connected to a stem on one end and to a steel ball occupying a plastic circular cone on the other end. When the individual blows into the device, the ball rolls and bounces, thus creating a vibrating PEP. The vibrations loosen the secretions, and the expiratory pressure allows air to reach the smaller airways. The air moves under the secretions, thereby facilitating the movement of the secretions to the larger airways where mucus clearance can be achieved by coughing. Acapella® PEP device: This device consists of a removable mouthpiece or mask. It has a one-way valve that can be adjusted to control frequency and expiratory resistance. Its use during exhalation creates vibrations and a variable flow resistance, which create a positive pressure. The vibrations promote the movement of air into the smaller airways, preventing closure, and assist the air to move underneath the secretions, thus facilitating their removal by coughing. Cough-stimulating devices (CoughAssist® Mechanical in-Exsufflator [also known as the Cofflator] [JH Emerson Co Inc., Cambridge, MA]): This portable device is designed to slowly inflate the lungs with positive pressure during inspiration and simulate cough with rapidly applied negative pressure during expiration. Intrapulmonary percussive ventilation (IPV) system. This device combines internal thoracic percussion through the use of rapid bursts of inhaled air at rates greater than 100 cycles per minute; continuous therapeutic aerosol is also delivered through a nebulizer.

Policy

The following types of airway-clearance devices for use in the home setting are considered medically necessary and, therefore, covered when the medical necessity criteria listed for each individual device are met. MECHANICAL CHEST PERCUSSOR DEVICES (E0480) Mechanical chest percussor devices are considered medically necessary and, therefore, covered when the individual has a diagnosis of chronic obstructive pulmonary disease (COPD), chronic bronchitis, bronchiectasis, or emphysema. STANDARD POSITIVE EXPIRATORY PRESSURE (PEP) DEVICES (E1399) Standard PEP devices are considered medically necessary and, therefore, covered when the individual has both of the following: A diagnosis of cystic fibrosis with pulmonary manifestations such as recurrent or chronic infections evidenced by cough and wheezing, bronchiectasis, or COPD The ability to control breathing and cough OSCILLATING PEP DEVICES (E0484) Oscillating PEP devices are considered medically necessary and, therefore, covered when the individual has both of the following: A diagnosis of cystic fibrosis with pulmonary manifestations such as recurrent or chronic infections evidenced by cough and wheezing, COPD, or bronchiectasis The ability to control breathing and cough COUGH-STIMULATING DEVICES (E0482) Cough-stimulating devices are considered medically necessary and, therefore, covered when an individual has a neuromuscular disease or spinal cord injury that causes a significant impairment of the chest wall and/or diaphragmatic movement that results in either one of the following: An inability to cough spontaneously Ventilator dependence Examples of neuromuscular disease include, but are not limited to, the following: sequela of polio, neuropathies, myopathies, dystrophies, amyotrophic lateral sclerosis, and deformities of the chest wall. NONCOVERED DEVICE THE INTRAPULMONARY PERCUSSIVE VENTILATION (IPV) SYSTEM (E0481) The intrapulmonary percussive ventilation (IPV) system is not considered durable medical equipment (DME) as it is inappropriate for home use and, therefore, a benefit exclusion. The use of this complex device is appropriate only in a facility setting where trained personnel direct its use. REQUIRED DOCUMENTATION The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must reflect the medical necessity of the care and services provided. These medical records may include, but are not limited to: records from the health care professional's office, hospital, nursing home, home health agencies, therapies, and test reports. An order for each item billed must be signed and dated by the health care professional who is treating the member and kept on file by the supplier. Medical record documentation must include a shipment confirmation or member's receipt of supplies and equipment. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

BENEFIT APPLICATION Subject to the terms and conditions of the applicable benefit contract, airway-clearance devices for use in the home setting are covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met. BILLING GUIDELINES When reporting the Flutter® or Acapella® oscillating positive expiratory pressure (PEP) devices, providers should use the Current Procedural Terminology (CPT) code (E0484) or HCPCS code (S8185) specific to the device. All other oscillating PEP devices and all standard PEP devices should be reported with the nonspecific Healthcare Common Procedure Coding System (HCPCS) code. Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply. MEDICARE This policy is consistent with Medicare's coverage determination for the following devices: Mechanical chest percussors Oscillating positive expiratory pressure (PEP) devices Cough-stimulating devices Intrapulmonary percussive ventilation system There is no Medicare coverage determination addressing standard PEP devices; therefore, the Company policy is applicable. US FOOD AND DRUG ADMINISTRATION (FDA) There are numerous devices approved by the FDA that promote airway clearance. Examples include, but are not limited to the following: CoughAssist® Mechanical in-Exsufflator (JH Emerson Co Inc., Cambridge, MA), TheraPEP® (DHD Healthcare Corp, Wampsville, NY), and PariPEP™ (PARI Respiratory Equipment Inc., Monterey, CA).

References

Arens R, Gozal D, Omlin KJ, et al. Comparison of high frequency chest compression and conventional chest physiotherapy in hospitalized patients with cystic fibrosis. Am J Respir Crit Care Med. 1994;150(4):1154–7. App EM, Kieselmann R, Reinhardt D, et al. Sputum rheology changes in cystic fibrosis lung disease following two different types of physiotherapy: flutter vs autogenic drainage. Chest. 1998;114(1):171-7. Bach JR. A comparison of long-term ventilatory support alternatives from the perspective of the patient and care giver. Chest. 1993;104(6):1702-1706. Bach JR. Mechanical insufflation-exsufflation. Comparison of peak expiratory flows with manually assisted and unassisted coughing techniques. Chest. 1993;104(5):1553-1562. Bach JR. Update and perspective on noninvasive respiratory muscle aids. Part 2: The expiratory aids. Chest. 1994;105(5):1538-1544. Bach JR, Baird JS, Plosky D, et al. Spinal muscular atrophy type 1: management and outcomes. Pediatric Pulmonol. 2002;34(1):16-22. Bach JR, Isikawa Y, Kim H. Prevention of pulmonary morbidity for patients with Duchenne muscular dystrophy. Chest. 1997;112(4):1024-1028. Bach JR, Niranjan V, Weaver B. Spinal muscular atrophy type I: A noninvasive respiratory management approach. Chest. 2000;117(4):1100-1105. Bach JR, Wang TG. Noninvasive long-term ventilatory support for individuals with spinal muscular atrophy and functional bulbar musculature. Arch Phys Med Rehabil. 1995;76(3):213-217. Braggion C, Cappelletti LM, Cornacchia M, et al. Short-term effects of three chest physiotherapy regimens in patients hospitalized for pulmonary exacerbations of cystic fibrosis: a cross-over randomized study. Pediatr Pulmonol. 1995;19(1):16–22. Centers for Medicare & Medicaid Services (CMS). A19952: Correct coding Flutter® and ACAPELLA Devices™. [CMS Web site]. 06/01/07. Available at: https://www.cms.hhs.gov/mcd/viewarticle.asp?article_id=19952&article_version=4&show=all. Accessed July 8, 2009. Eaton T, Young P, Zeng I, Kolbe J. A randomized evaluation of the acute efficacy, acceptability and tolerability of flutter and active cycle of breathing with and without postural drainage in non-cystic fibrosis bronchiectasis. Chron Respir Dis. 2007;4(1):23-30. Elkins MR, Jones A, van der Schans C. Positive expiratory pressure physiotherapy for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. 2006;(2):CD003147. Garstang SV, Kirshblum SC, Wood KE. Patient preference for in-exsufflation for secretion management with spinal cord injury. J Spinal Cord Med. 2000;23(2):80-85. Hess DR. The evidence for secretion clearance techniques. Respir Care. 2001;46(11):1276-93. Homnick DN, White F, deCastro C. Comparison of effects of an intrapulmonary percussive ventilator to standard aerosol and chest physiotherapy in treatment of cystic fibrosis. Pediatr Pulmonol. 1995;20(1):50–5. Kempainen RR, Williams CB, Hazelwood A, et al. Comparison of high-frequency chest wall oscillation with differing waveforms for airway clearance in cystic fibrosis. Chest. 2007;32(4):1227-32. Kluft J, Beker L, Castagnino M, et al. A comparison of bronchial drainage treatments in cystic fibrosis. Pediatr Pulmonol. 1996;22(4):271-4. Langenderfer B. Alternatives to percussion and postural drainage. A review of mucus clearance therapies: percussion and postural drainage, autogenic drainage, positive expiratory pressure, flutter valve, intrapulmonary percussive ventilation, and high-frequency chest compression with the ThAIRapy Vest. J Cardiopulm Rehabil. 1998;18(4):283-9. Main E, Prasad A, Schans C. Conventional chest physiotherapy compared to other airway clearance techniques for cystic fibrosis. Cochrane Database Syst Rev. 2005;(1):CD002011. Make BJ, Hill NS, Goldberg AI, et al. Mechanical ventilation beyond the intensive care unit. Report of a consensus conference of the American College of Chest Physicians. Chest. 1998;113(5 suppl):289S-344S. Marks JH. Airway clearance devices in cystic fibrosis. Paediatr Respir Rev. 2007;8(1):17-23. McCool FD, Rosen MJ. Nonpharmacologic airway clearance therapies: ACCP evidence-based clinical practice guidelines. Chest. 2006;129(1 suppl):250S-259S. McIlwaine PM, Wong LT, Peacock D, et al. Long-term comparative trial of positive expiratory pressure versus oscillating positive expiratory pressure (flutter) physiotherapy in the treatment of cystic fibrosis. J Pediatr. 2001;138(6):845-50. Miller RG, Rosenberg JA, Gelinas DF, et al. Practice parameter: the care of the patient with amyotrophic lateral sclerosis (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology: ALS Practice Parameters Task Force. Neurology. 1999;52(7):1311-1323. Newhouse PA, White F, Marks JH, et al. The intrapulmonary percussive ventilator and flutter device compared to standard chest physiotherapy in patients with cystic fibrosis. Clin Pediatr. 1998; 37(7):427-32. Oermann CM, Sockrider MM, Giles D, et al. Comparison of high-frequency chest wall oscillation and oscillating positive expiratory pressure in the home management of cystic fibrosis: a pilot study. Pediatr Pulmonol. 2001;32(5):372-7. Patterson JE, Hewitt O, Kent L, et al. Acapella versus ‘usual airway clearance’ during acute exacerbation in bronchiectasis: a randomized crossover trial. Chron Respir Dis. 2007;4(2):67-74. Patterson JE, Bradley JM, Hewitt O, et al. Airway clearance in bronchiectasis: a randomized crossover trial of active cycle of breathing techniques versus Acapella. Respiration. 2005;72(3):239-42. Thompson CS, Harrison S, Ashley J et al. Randomised crossover study of the Flutter device and the active cycle of breathing technique in non-cystic fibrosis bronchiectasis. Thorax. 2002;57(5):446-8. Tzeng AC, Bach JR. Prevention of pulmonary morbidity for patients with neuromuscular disease. Chest. 2000;118(5):1390-1396. Varekojis SM, Douce FH, Flucke RL, et al. A comparison of the therapeutic effectiveness of and preference for postural drainage and percussion, intrapulmonary percussive ventilation, and high-frequency chest wall compression in hospitalized cystic fibrosis patients. Respir Care. 2003;48(1):24-8. Volsko TA, DeFiore J, Chatburn RL. Performance comparison of two oscillating positive expiratory pressure devices: Acapella versus Flutter. Respir Care. 2003;48(2):124-30.

Coding Table

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply. The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates. In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

Code System Code Number(s) and Narrative(s) CPT N/A ICD Procedure N/A ICD Diagnosis THE DIAGNOSES LISTED BELOW DO NOT COMPRISE AN ALL-INCLUSIVE LIST 011.50: Tuberculous bronchiectasis, confirmation unspecified 011.51: Tuberculous bronchiectasis, bacteriological or histological examination not done 011.52: Tuberculous bronchiectasis, bacteriological or histological examination unknown (at present) 011.53: Tuberculous bronchiectasis, tubercle bacilli found (in sputum) by microscopy 011.54: Tuberculous bronchiectasis, tubercle bacilli not found (in sputum) by microscopy, but found by bacterial culture 011.55: Tuberculous bronchiectasis, tubercle bacilli not found by bacteriological examination, but tuberculosis confirmed histologically 011.56: Tuberculous bronchiectasis, tubercle bacilli not found by bacteriological or histological examination, but tuberculosis confirmed by other methods [inoculation of animals] 138: Late effects of acute poliomyelitis 277.02: Cystic fibrosis with pulmonary manifestations 335.0: Werdnig-Hoffmann disease 335.10: Unspecified spinal muscular atrophy 335.11: Kugelberg-Welander disease 335.19: Other spinal muscular atrophy 335.20: Amyotrophic lateral sclerosis 335.21: Progressive muscular atrophy 335.22: Progressive bulbar palsy 335.23: Pseudobulbar palsy 335.24: Primary lateral sclerosis 335.29: Other motor neuron diseases 335.8: Other anterior horn cell diseases 335.9: Unspecified anterior horn cell disease 340: Multiple sclerosis 344.00: Unspecified quadriplegia 344.01: Quadriplegia and quadriparesis, C1-C4, complete 344.02: Quadriplegia and quadriparesis, C1-C4, incomplete 344.03: Quadriplegia and quadriparesis, C5-C7, complete 344.04: C5-C7, incomplete 344.09: Other quadriplegia and quadriparesis 359.0: Congenital hereditary muscular dystrophy 359.1: Hereditary progressive muscular dystrophy 359.79: Other inflammatory and immune myopathies 491.0: Simple chronic bronchitis 491.1: Mucopurulent chronic bronchitis 491.20: Obstructive chronic bronchitis, without exacerbation 491.21: Obstructive chronic bronchitis, with (acute) exacerbation 491.22: Obstructive chronic bronchitis with acute bronchitis 491.8: Other chronic bronchitis 491.9: Unspecified chronic bronchitis 492.0: Emphysematous bleb 492.8: Other emphysema 494.0: Bronchiectasis without acute exacerbation 494.1: Bronchiectasis with acute exacerbation 496: Chronic airway obstruction, not elsewhere classified 506.4: Chronic respiratory conditions due to fumes and vapors 518.1: Interstitial emphysema 518.2: Compensatory emphysema 748.61: Congenital bronchiectasis 770.2: Interstitial emphysema and related conditions of newborn 780.72: Functional quadriplegia HCPCS Level II E0480: Percussor, electric or pneumatic, home model E0482: Cough stimulating device, alternating positive and negative airway pressure E0484: Oscillatory positive expiratory pressure device, nonelectric, any type, each S8185: Flutter device THE FOLLOWING CODE SHOULD BE USED TO REPORT STANDARD POSITIVE EXPIRATORY PRESSURE (PEP) AIRWAY CLEARANCE DEVICES E1399: Durable medical equipment, miscellaneous THE FOLLOWING INTRAPULMONARY PERCUSSIVE VENTILATION (IPV) SYSTEM DEVICE IS NOT APPROPRIATE FOR HOME USE AND IS A BENEFIT EXCLUSION UNDER DURABLE MEDICAL EQUIPMENT (DME) E0481: Intrapulmonary percussive ventilation system and related accessories Revenue Codes N/A

Cross References

Cross Reference Policies

00.01.25h:PPO Network Rules for Provision of Specialty Services for Durable Medical Equipment and Laboratory, Radiology, and Physical Medicine and Rehabilitative Services 05.00.14e:High-Frequency Chest Wall Oscillation Devices 05.00.21f:Durable Medical Equipment (DME) 05.00.44f:Repair and Replacement of Durable Medical Equipment (DME) 05.00.48d:Durable Medical Equipment (DME) Not Subject to a Rental to Purchase Maximum

Version Effective Date: 10/01/2009

The Policy Bulletins on this web site were developed to assist AmeriHealth and its subsidiaries ("AmeriHealth") in administering the provisions of the respective benefit programs, and do not constitute a contract. If you are an AmeriHealth member, please refer to your specific benefit program for the terms, conditions, limitations and exclusions of your coverage. AmeriHealth does not provide health care services, medical advice or treatment, or guarantee the outcome or results of any medical services/treatments. The facility and professional providers are responsible for providing medical advice and treatment. Facility and professional providers are independent contractors and are not employees or agents of AmeriHealth. If you have a specific medical condition, please consult with your doctor. AmeriHealth reserves the right at any time to change or update its Policy Bulletins. ©2010 AmeriHealth, Inc. All Rights Reserved.  Current Procedural Terminology ©2010 American Medical Association. All Rights Reserved.