120 Form

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Medical Policy Oscillatory Devices for the Treatment of Cystic Fibrosis and Other Respiratory Conditions
Table of Contents • Policy: Commercial • Description • Information Pertaining to All Policies
• Authorization Information • Policy History • Endnotes • Coding Information • References

Policy Number: 120

BCBSA Reference Number: 1.01.15 (For Plan internal use only)

Related Policies
None

Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity

Oscillatory Positive Expiratory Pressure Device Use of an oscillatory positive expiratory pressure device may be considered MEDICALLY NECESSARY in individuals with hypersecretory lung disease (ie, produce excessive mucus) who have difficulty clearing the secretions and recurrent disease exacerbations.

High Frequency Chest Compression Device1 Initial use of a high frequency chest compression device is considered MEDICALLY NECESSARY when ALL of the following are met:

• The device is cleared by the U.S. Food and Drug Administration; and • There is documented need for airway clearance; and • The individual has one of the following diagnoses:
o Cystic fibrosis; or o Chronic bronchiectasis; or o Chronic neuromuscular disorder affecting the ability to cough or clear respiratory secretions with prior history of pneumonia or other significant worsening of pulmonary function; and • There is documentation of i) failure of or ii) inability to use other airway clearance therapies including manual chest physical therapy due to one or more of the following:
o There are 2 or more individuals with cystic fibrosis, chronic bronchiectasis, or chronic neuromuscular disorder (meeting criteria above) in the family; or o The caregiver is unable (physically or mentally) to perform chest physical therapy at the required frequency; or o There is no available parental or partner resource to perform chest physical therapy; and • There is documentation of an initial trial during which the affected individual and the family (when

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applicable) have demonstrated compliance with the high frequency chest compression device (see the following statement for details).

Continued use of a high frequency chest compression device is considered MEDICALLY NECESSARY when ongoing use, (that is, compliance with use) is documented at 6 month to 12 month intervals.
(Note: For high frequency chest compression devices with usage meters, documentation should reflect use, in general, at least 67% of the prescribed time.)

High frequency chest compression devices are considered NOT MEDICALLY NECESSARY when: • The above criteria have not been met; or • Contraindications exist for external manipulation of the thorax, as outlined by the American Association of Respiratory Care and contained in their clinical practice guidelines for Postural Drainage Therapy, which include, but may not be limited to: unstable head or neck injury; active hemorrhage with hemodynamic instability; subcutaneous emphysema; recent epidural, spinal fusion or spinal anesthesia; recent skin grafts or flaps on the thorax; burns, open wounds, and skin infections of the thorax; recently placed transvenous pacemaker or subcutaneous pacemaker; suspected pulmonary tuberculosis; lung contusion; bronchospasm; osteomyelitis of the ribs; osteoporosis; coagulopathy; and complaint of significant chest wall pain.

High frequency chest compression device replacement or upgrade is considered NOT MEDICALLY NECESSARY when requested for convenience or to upgrade to newer technology when the current components remain functional.

All other indications for high frequency chest compression are considered NOT MEDICALLY NECESSARY, including, but not limited to, chronic obstructive pulmonary disease.

Intrapulmonary Percussive Ventilation Device Intrapulmonary percussive ventilation devices may be considered MEDICALLY NECESSARY in individuals with cystic fibrosis or *chronic diffuse bronchiectasis as determined by specific criteria (including chest computed tomography scan) when standard chest physical therapy has failed or standard chest physical therapy is unavailable or not tolerated. In considering the chest wall compression and intrapulmonary percussive ventilation devices, there should be demonstrated need for airway clearance. There should also be documented failure of standard treatments (ie, the patient has frequent severe exacerbations of respiratory distress involving inability to clear mucus despite standard treatment [chest physical therapy and, if appropriate, use of an oscillatory positive expiratory pressure device] or valid reasons why standard treatment cannot be performed, such as inability of the caregiver to perform it.)

*Chronic diffuse bronchiectasis is defined by daily productive cough for at least 6 continuous months or
exacerbations more than 2 times per year requiring antibiotic therapy and confirmed by high-resolution or spiral chest computed tomography scan.

Other applications of high-frequency chest wall compression devices and intrapulmonary percussive ventilation devices, including, but not limited to, their use in individuals with cystic fibrosis, chronic diffuse bronchiectasis or respiratory conditions associated with neuromuscular disorders other than as specified above, their use as an adjunct to chest physical therapy, and their use in chronic obstructive pulmonary disease are considered INVESTIGATIONAL. Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

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Outpatient Commercial Managed Care (HMO and POS) Prior authorization is not required. Commercial PPO and Indemnity Prior authorization is not required. CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list.

The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity:

HCPCS Codes HCPCS codes: Code Description A7025 High frequency chest wall oscillation system vest, replacement for use with patient- owned equipment, each A7026 High frequency chest wall oscillation system hose, replacement for use with patient- owned equipment, each E0483 High frequency chest wall oscillation system, includes all accessories and supplies, each E0484 Oscillatory positive expiratory pressure device, non-electric, any type, each
E0481 Intrapulmonary percussive ventilation system and related accessories
S8185 Flutter device

The following ICD Diagnosis Codes are considered medically necessary when submitted with the CPT codes above if medical necessity criteria are met: ICD-10 Diagnosis Codes ICD-10-CM Diagnosis codes: Code Description A15.0 Tuberculosis of lung E84.0 Cystic fibrosis with pulmonary manifestations E84.11 Meconium ileus in cystic fibrosis E84.19 Cystic fibrosis with other intestinal manifestations E84.8 Cystic fibrosis with other manifestations E84.9 Cystic fibrosis, unspecified G12.0 Infantile spinal muscular atrophy, type I [Werdnig-Hoffman] G12.1 Other inherited spinal muscular atrophy G12.20 Motor neuron disease, unspecified G12.21 Amyotrophic lateral sclerosis G12.22 Progressive bulbar palsy G12.23 Primary lateral sclerosis G12.24 Familial motor neuron disease G12.25 Progressive spinal muscle atrophy

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G12.29 Other motor neuron disease G12.8 Other spinal muscular atrophies and related syndromes G12.9 Spinal muscular atrophy, unspecified G35.A Relapsing-remitting multiple sclerosis G35.B0 Primary progressive multiple sclerosis, unspecified G35.B1 Active primary progressive multiple sclerosis G35.B2 Non-active primary progressive multiple sclerosis G35.C0 Secondary progressive multiple sclerosis, unspecified G35.C1 Active secondary progressive multiple sclerosis G35.C2 Non-active secondary progressive multiple sclerosis G35.D Multiple sclerosis, unspecified G70.80 Lambert-Eaton syndrome, unspecified G70.81 Lambert-Eaton syndrome in disease classified elsewhere G70.89 Other specified myoneural disorders G71.00 Muscular dystrophy, unspecified G71.01 Duchenne or Becker muscular dystrophy G71.02 Facioscapulohumeral muscular dystrophy G71.031 Autosomal dominant limb girdle muscular dystrophy G71.032 Autosomal recessive limb girdle muscular dystrophy due to calpain-3 dysfunction G71.033 Limb girdle muscular dystrophy due to dysferlin dysfunction G71.0340 Limb girdle muscular dystrophy due to sarcoglycan dysfunction, unspecified G71.0341 Limb girdle muscular dystrophy due to alpha sarcoglycan dysfunction G71.0342 Limb girdle muscular dystrophy due to beta sarcoglycan dysfunction G71.0349 Limb girdle muscular dystrophy due to other sarcoglycan dysfunction G71.035 Limb girdle muscular dystrophy due to anoctamin-5 dysfunction G71.036 Limb girdle muscular dystrophy due to fukutin related protein dysfunction G71.038 Other limb girdle muscular dystrophy G71.039 Limb girdle muscular dystrophy, unspecified G71.09 Other specified muscular dystrophies G71.11 Myotonic muscular dystrophy G71.12 Myotonia congenita G71.13 Myotonic chondrodystrophy G71.19 Other specified myotonic disorders G71.2 Congenital myopathies G71.3 Mitochondrial myopathy, not elsewhere classified G71.8 Other primary disorders of muscles G71.9 Primary disorder of muscle, unspecified G72.89 Other specified myopathies G73.7 Myopathy in diseases classified elsewhere J39.8 Other specified diseases of upper respiratory tract J39.9 Disease of upper respiratory tract, unspecified J47.0 Bronchiectasis with acute lower respiratory infection J47.1 Bronchiectasis with (acute) exacerbation J47.9 Bronchiectasis, uncomplicated Q33.4 Congenital bronchiectasis

Description Oscillatory devices are designed to move mucus and clear airways; the oscillatory component can be intra- or extrathoracic. Some devices require the active participation of patients. They include oscillating positive expiratory pressure devices, such as Flutter and Acapella, in which the patient exhales multiple times through a device. The Flutter device is a small pipe-shaped, easily portable handheld device, with a

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mouthpiece at one end. It contains a high-density, stainless steel ball that rests in a plastic circular cone. During exhalation, the steel ball moves up and down, creating oscillations in expiratory pressure and airflow. When the oscillation frequency approximates the resonance frequency of the pulmonary system, the vibration of the airways occurs, resulting in loosening of mucus. The Acapella device is similar in concept but uses a counterweighted plug and magnet to create air flow oscillation.

Other airway clearance techniques also require active patient participation. For example, autogenic drainage and an active cycle breathing technique both involve a combination of breathing exercises performed by the patient. Positive expiratory pressure therapy requires patients to exhale through a resistor to produce positive expiratory pressures during a prolonged period of exhalation. It is hypothesized that the positive pressure supports the small airway such that the expiratory airflow can better mobilize secretions.

High-frequency chest wall oscillation devices (eg, the Vest Airway Clearance System) are passive oscillatory devices designed to provide airway clearance without active patient participation. The Vest Airway Clearance System provides high-frequency chest compression using an inflatable vest and an air- pulse generator. Large-bore tubing connects the vest to the air-pulse generator. The air-pulse generator creates pressure pulses that inflate and deflate the vest against the thorax, creating high-frequency chest wall oscillation and mobilization of pulmonary secretions.

All of these techniques may be alternatives to daily percussion and postural drainage in patients with cystic fibrosis, also known as chest physical therapy. Daily percussion and postural drainage need to be administered by a physical therapist or another trained adult in the home, often a parent if the patient is a child. The necessity for regular therapy can be particularly burdensome for adolescents or adults who lead independent lifestyles. Oscillatory devices can also potentially be used by patients with other respiratory disorders to promote bronchial secretion drainage and clearance, such as diffuse bronchiectasis and chronic obstructive pulmonary disease. Additionally, they could benefit patients with neuromuscular disease who have impaired cough clearance.

This evidence review addresses the outpatient use of oscillatory devices. This review does not address inpatient device use (eg, in the immediate postsurgical period).

Summary Description Oscillatory devices are alternatives to the standard daily percussion and postural drainage method of airway clearance for individuals with cystic fibrosis. There are several types of devices including high- frequency chest compression with an inflatable vest and oscillating positive expiratory pressure devices, such as the Flutter and Acapella devices. Respiratory therapists and other providers may also use oscillatory devices for other respiratory conditions such as diffuse bronchiectasis, chronic obstructive pulmonary disease (COPD), and respiratory conditions associated with neuromuscular disorders. Summary of Evidence For individuals who have cystic fibrosis who receive oscillatory devices, the evidence includes randomized controlled trials (RCTs) and a systematic review. Relevant outcomes are symptoms, quality of life, hospitalizations, and medication use. The RCTs reported mixed findings and limitations such as small sample sizes and large dropout rates. A systematic review identified 39 RCTs comparing oscillatory devices with other recognized airway clearance techniques; some were published only as abstracts. Reviewers could not pool findings due to heterogeneity in study designs and outcome measures and concluded that additional adequately powered RCTs with long-term follow-up would be needed to make conclusions about oscillatory devices for cystic fibrosis. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have bronchiectasis who receive oscillatory devices, the evidence includes RCTs and a systematic review. Relevant outcomes are symptoms, quality of life, hospitalizations, and medication use. A 2015 systematic review identified 7 small RCTs on several types of oscillatory devices; only 1 reported the clinically important outcomes of exacerbations or hospitalizations. Only 3 RCTs reported on

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quality of life, and findings were mixed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have chronic obstructive pulmonary disease (COPD) who receive oscillatory devices, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, quality of life, hospitalizations, and medication use. Only a few controlled studies have evaluated oscillatory devices for the treatment of COPD, and they tend to have small sample sizes, short follow-up periods, and limitations in their analyses (eg, lack of intention-to-treat analysis and between-group comparisons). Moreover, the published studies reported mixed findings and did not consistently support the use of oscillatory devices in this population. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have respiratory conditions related to neuromuscular disorders who receive oscillatory devices, the evidence includes 2 RCTs and a systematic review. Relevant outcomes are symptoms, quality of life, hospitalizations, and medication use. One of the RCTs was not powered to detect statistically significant differences. The other RCT, conducted in patients with amyotrophic lateral sclerosis, did not find significant improvements after high-frequency chest wall compression devices versus usual care in primary outcomes, in pulmonary function measures, or in most secondary outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Policy History Date Action 10/2025 Annual policy review. Policy updated with literature review through July 1, 2025; no references added. Policy statements unchanged. Clarified coding information. 10/2024 Annual policy review. Policy updated with literature review through April 22, 2024; no references added. Policy statements unchanged. 8/2023 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 10/2022 Clarified coding information. 8/2022 Annual policy review. References added. Minor editorial refinements made to policy statements; intent unchanged. 8/2021 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2021 Medicare information removed. See MP #132 Medicare Advantage Management for local coverage determination and national coverage determination reference.
12/2020 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 9/2020 Policy criteria on high frequency chest compression device revised based on expert opinion. New medically necessary indications added for chronic neuromuscular disorder. Clarified coding information. Effective 9/1/2020.
8/2019 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2019 Clarified coding changes. 8/2018 Annual policy review. Policy statements clarified.
1/2018 Clarified coding information. 11/2017 Annual policy review. Not medically necessary statement removed and “patients with cystic fibrosis or chronic diffuse bronchiectasis other than as specified above” added to the investigational statement. Effective 11/1/2017. 11/2016 Annual policy review. Individuals with respiratory conditions associated with neuromuscular disorders added to investigational statement. In title, “disorders” changed to “conditions.” Clarified coding information. Effective 11/1/2016. 9/2015 Clarified coding information. 3/2015 Annual policy review. New references added 7/2014 Changes to medically necessary statement. Effective 7/1/2014.

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6/2014 Updated Coding section with ICD10 procedure and diagnosis codes, effective 10/2015. 5/2014 Annual policy review. New references added 3/2014 Coding information clarified. 1/2014 Updated to add new CPT code 94669.
4/2013 Annual policy review. New references added 11/2011- 4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates. No changes to policy statements.
5/2011 Reviewed - Medical Policy Group - Pediatrics and Endocrinology. No changes to policy statements. 4/2011 Reviewed - Medical Policy Group - Cardiology and Pulmonology. No changes to policy statements. 11/2010
BCBS Association National Policy Review. Changes to policy statement effective 11/2010.
3/2010 Reviewed - Medical Policy Group - Pulmonology, Allergy/Asthma/Immunology, ENT and Otolaryngology. No changes to policy statements. 9/2009 Medical policy describing covered and non-covered indications. Effective 9/1/2009.
Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References

1. Morrison L, Milroy S. Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. Apr 30 2020; 4(4): CD006842. PMID 32352564
2. McIlwaine MP, Alarie N, Davidson GF, et al. Long-term multicentre randomised controlled study of high frequency chest wall oscillation versus positive expiratory pressure mask in cystic fibrosis. Thorax. Aug 2013; 68(8): 746-51. PMID 23407019
3. Sontag MK, Quittner AL, Modi AC, et al. Lessons learned from a randomized trial of airway secretion clearance techniques in cystic fibrosis. Pediatr Pulmonol. Mar 2010; 45(3): 291-300. PMID 20146387
4. Pryor JA, Tannenbaum E, Scott SF, et al. Beyond postural drainage and percussion: Airway clearance in people with cystic fibrosis. J Cyst Fibros. May 2010; 9(3): 187-92. PMID 20153269
5. Radtke T, Böni L, Bohnacker P, et al. Acute effects of combined exercise and oscillatory positive expiratory pressure therapy on sputum properties and lung diffusing capacity in cystic fibrosis: a randomized, controlled, crossover trial. BMC Pulm Med. Jun 14 2018; 18(1): 99. PMID 29898704
6. Lee AL, Burge AT, Holland AE. Airway clearance techniques for bronchiectasis. Cochrane Database Syst Rev. Nov 23 2015; 2015(11): CD008351. PMID 26591003
7. Murray MP, Pentland JL, Hill AT. A randomised crossover trial of chest physiotherapy in non-cystic fibrosis bronchiectasis. Eur Respir J. Nov 2009; 34(5): 1086-92. PMID 19541717
8. Herrero-Cortina B, Vilaró J, Martí D, et al. Short-term effects of three slow expiratory airway clearance techniques in patients with bronchiectasis: a randomised crossover trial. Physiotherapy. Dec 2016; 102(4): 357-364. PMID 26712530
9. Livnat G, Yaari N, Stein N, et al. 4-week daily airway clearance using oscillating positive-end expiratory pressure versus autogenic drainage in bronchiectasis patients: a randomised controlled trial. ERJ Open Res. Oct 2021; 7(4). PMID 34760994
10. Ides K, Vissers D, De Backer L, et al. Airway clearance in COPD: need for a breath of fresh air? A systematic review. COPD. Jun 2011; 8(3): 196-205. PMID 21513439
11. Osadnik CR, McDonald CF, Jones AP, et al. Airway clearance techniques for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. Mar 14 2012; (3): CD008328. PMID 22419331
12. Alghamdi SM, Barker RE, Alsulayyim ASS, et al. Use of oscillatory positive expiratory pressure (OPEP) devices to augment sputum clearance in COPD: a systematic review and meta-analysis. Thorax. Oct 2020; 75(10): 855-863. PMID 32788259

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13. Alghamdi SM, Alsulayyim AS, Alasmari AM, et al. Oscillatory positive expiratory pressure therapy in COPD (O-COPD): a randomised controlled trial. Thorax. Feb 2023; 78(2): 136-143. PMID 35948418
14. Chakravorty I, Chahal K, Austin G. A pilot study of the impact of high-frequency chest wall oscillation in chronic obstructive pulmonary disease patients with mucus hypersecretion. Int J Chron Obstruct Pulmon Dis. 2011; 6: 693-9. PMID 22259246
15. Svenningsen S, Paulin GA, Sheikh K, et al. Oscillatory Positive Expiratory Pressure in Chronic Obstructive Pulmonary Disease. COPD. 2016; 13(1): 66-74. PMID 26430763
16. Goktalay T, Akdemir SE, Alpaydin AO, et al. Does high-frequency chest wall oscillation therapy have any impact on the infective exacerbations of chronic obstructive pulmonary disease? A randomized controlled single-blind study. Clin Rehabil. Aug 2013; 27(8): 710-8. PMID 23503735
17. Winfield NR, Barker NJ, Turner ER, et al. Non-pharmaceutical management of respiratory morbidity in children with severe global developmental delay. Cochrane Database Syst Rev. Oct 19 2014; 2014(10): CD010382. PMID 25326792
18. Yuan N, Kane P, Shelton K, et al. Safety, tolerability, and efficacy of high-frequency chest wall oscillation in pediatric patients with cerebral palsy and neuromuscular diseases: an exploratory randomized controlled trial. J Child Neurol. Jul 2010; 25(7): 815-21. PMID 20357238
19. Lange DJ, Lechtzin N, Davey C, et al. High-frequency chest wall oscillation in ALS: an exploratory randomized, controlled trial. Neurology. Sep 26 2006; 67(6): 991-7. PMID 17000967
20. McCool FD, Rosen MJ. Nonpharmacologic airway clearance therapies: ACCP evidence-based clinical practice guidelines. Chest. Jan 2006; 129(1 Suppl): 250S-259S. PMID 16428718
21. Hill AT, Barker AF, Bolser DC, et al. Treating Cough Due to Non-CF and CF Bronchiectasis With Nonpharmacological Airway Clearance: CHEST Expert Panel Report. Chest. Apr 2018; 153(4): 986-
22. PMID 29355548

23. Flume PA, Robinson KA, O'Sullivan BP, et al. Cystic fibrosis pulmonary guidelines: airway clearance therapies. Respir Care. Apr 2009; 54(4): 522-37. PMID 19327189

    Endnotes

    1 Based on expert opinion A