18
Airway Clearance Systems Aug 13 1 National Medical Policy Subject: Airway Clearance Devices Policy Number: NMP214 Effective Date*: March 2005 Updated: February 2007, April 2009, April 2011, September 2011, August 2012, August 2013 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate Medicaid Manuals for coverage guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link National Coverage Determination (NCD) National Coverage Manual Citation x Local Coverage Determination (LCD)* High Frequency Chest Wall Oscillation Devices: http://www.cms.gov/medicare-coverage- database/search/advanced-search.aspx X Article (Local)* High Frequency Chest Wall Oscillation Devices: LCD and Policy Article Revisions - Summary for September 2008: LCD and Policy Article Revisions - Summary for March 3, 2011: http://www.cms.gov/medicare-coverage- database/search/advanced-search.aspx X Other MLN Matters Number: MM8304 Revised Related Change Request CR 8304. May 31, 2013. “The Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program: Traveling Beneficiary: http://www.cms.gov/Outreach-and- Education/Medicare-Learning-Network-

Airway Clearance Devices

Embed Size (px)

DESCRIPTION

Airway Clearance Devices

Citation preview

Page 1: Airway Clearance Devices

Airway Clearance Systems Aug 13 1

National Medical Policy Subject: Airway Clearance Devices

Policy Number: NMP214

Effective Date*: March 2005

Updated: February 2007, April 2009, April 2011,

September 2011, August 2012, August 2013

This National Medical Policy is subject to the terms in the

IMPORTANT NOTICE

at the end of this document

For Medicaid Plans: Please refer to the appropriate Medicaid Manuals for

coverage guidelines prior to applying Health Net Medical Policies

The Centers for Medicare & Medicaid Services (CMS)

For Medicare Advantage members please refer to the following for coverage

guidelines first:

Use Source Reference/Website Link

National Coverage Determination (NCD)

National Coverage Manual Citation

x Local Coverage Determination (LCD)* High Frequency Chest Wall Oscillation Devices:

http://www.cms.gov/medicare-coverage-

database/search/advanced-search.aspx X Article (Local)* High Frequency Chest Wall Oscillation Devices:

LCD and Policy Article Revisions - Summary for

September 2008:

LCD and Policy Article Revisions - Summary for

March 3, 2011:

http://www.cms.gov/medicare-coverage-

database/search/advanced-search.aspx X Other MLN Matters Number: MM8304 Revised

Related Change Request CR 8304. May 31,

2013. “The Durable Medical Equipment,

Prosthetics, Orthotics, and Supplies (DMEPOS)

Competitive Bidding Program: Traveling

Beneficiary: http://www.cms.gov/Outreach-and-

Education/Medicare-Learning-Network-

Page 2: Airway Clearance Devices

Airway Clearance Systems Aug 13 2

MLN/MLNMattersArticles/Downloads/MM8304.pd

f

None Use Health Net Policy

Instructions

Medicare NCDs and National Coverage Manuals apply to ALL Medicare members

in ALL regions.

Medicare LCDs and Articles apply to members in specific regions. To access your

specific region, select the link provided under “Reference/Website” and follow the

search instructions. Enter the topic and your specific state to find the coverage

determinations for your region. *Note: Health Net must follow local coverage

determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their

service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2)

If more than one source is checked, you need to access all sources as, on

occasion, an LCD or article contains additional coverage information than

contained in the NCD or National Coverage Manual.

If there is no NCD, National Coverage Manual or region specific LCD/Article,

follow the Health Net Hierarchy of Medical Resources for guidance.

Current Policy Statement (Update August 2013 – A Medline search failed to

reveal any studies that would cause Health Net, Inc. to change its current position)

Health Net, Inc. considers any of the following airway clearance devices medically

necessary durable medical equipment (DME) to assist in mobilizing secretions of the

respiratory tract:

Mechanical Percussors Health Net, Inc. considers mechanical percussors medically necessary for any of the

following when the patient or operator of the powered percussor has received

appropriate training by a physician or therapist:

Cystic fibrosis

Chronic bronchitis

Bronchiectasis

Asthma

Immotile cilia syndrome

FLUTTER Health Net, Inc. considers small hand-held positive expiratory pressure devices, such

as the FLUTTER mucous clearance device and the Acapella device, medically

necessary as an adjunct to airway clearance in patients when other methods have

proven inadequate or ineffective in mobilizing pulmonary secretions, who can

demonstrate effective use of the device and who have any of the following:

Cystic fibrosis

Bronchiectasis and conditions that produce increased sputum or secretions

Alpha-1-antitrypsin deficiency

Positive Expiratory Pressure Health Net, Inc. considers positive expiratory pressure (PEP) masks medically

necessary for any of the following:

Page 3: Airway Clearance Devices

Airway Clearance Systems Aug 13 3

Cystic fibrosis

Chronic obstructive pulmonary disease (COPD)

Vest Airway Clearance System Health Net, Inc. considers high-frequency chest compression systems (The Vest

Airway Clearance System, formerly known as the ThAIRapy Bronchial Drainage

System, ABI Vest) medically necessary as an alternative to chest physiotherapy in

patients age 2 years or older or 20-inch chest size, whichever comes first for any of

the following:

Cystic fibrosis in whom home chest physiotherapy (CPT) has been found to

be ineffective to adequately mobilize retained secretions or cannot be

provided; or

Lung transplant recipients within the first six months postoperatively who

are unable to tolerate standard chest physiotherapy; or

Bronchiectasis, characterized by daily productive cough for at least 6

continuous, months or, frequent (i.e. more than 2/year) exacerbations

requiring antibiotic therapy, and confirmed by high resolution, spiral, or

standard CT scan and well-documented failure of standard treatments to

adequately mobilize retained secretions; or

Neuromuscular disease (i.e., Post-polio, Acid maltase deficiency, Anterior

horn cell diseases, Multiple sclerosis, Quadriplegia, Hereditary muscular

dystrophy, myotonic disorders, other myopathies or paralysis of the

diaphragm) for patients with well-documented failure of routine chest

physiotherapy to adequately mobilize retained secretions as evidenced by

recurrent pneumonia

Medical records documentation to support medical necessity must include all of the

following:

Excessive sputum production combined with the member’s inability

to clear the sputum without assistance

A well-documented failure of standard treatments to mobilize

secretions

Frequent exacerbations requiring antibiotic therapy more than two

times per year

Diagnosis confirmed by high resolution or spiral computed

tomography (CT)

Documentation of need for at least daily chest physiotherapy (CPT)

by provider with specialty in pulmonary disease

Significant worsening of pulmonary function*

Specific documentation why this therapy is superior to other most

cost-effective therapy methods, including at least one of the

following:

The patient’s family or other resources cannot adequately perform

the required chest physiotherapy (CPT); or

Allows independent living for university of college attendarnce for

the member; or

Provides health stabilization in single adults or emancipated

individuals without able partners to assist with CPT

Page 4: Airway Clearance Devices

Airway Clearance Systems Aug 13 4

* A significant worsening of pulmonary function exists when at least two of the

following are met:

Forced expiratory capacity (FEC) of less than 80% predicted

Forced vital capacity (FVC) of less than 50% predicted

Small airway score (FEP 25-75%) decrease in one year of 25% or more

Pattern of annual or more often hospitalizations from acute pulmonary

exacerbations

Demonstration of reduction of pulmonary function while on steroids for a

year

Note: Rental of a high frequency chest compression system for three months is

required before purchase of the equipment will be considered. Patient compliance

and tolerance will determine medical necessity for purchase of the system.

Note: Intolerance to the device or failure to comply with usage meter checks is a

basis for the use of alternative methods of airway clearance.

Insufflator-Exsufflator Device Health Net, Inc. considers a mechanical insufflator-exsufflator device, such as the

CoughAssist, medically necessary in a small subset of patients with neuromuscular

disease (e.g., amyotrophic lateral sclerosis, high spinal cord injury with quadriplegia)

associated with a significant impairment of chest wall and/or diaphragmatic

movement when there is an inability to adequately clear secretions in the airways

using standard mechanisms (e.g., chest percussion, postural drainage, etc.). There

should be evidence of significantly low forced expiratory flow of less than 80%

predicted and vital capacity not associated with obstructive disease.

Note: It is not medically necessary for a patient to use both an HFCWO device and a

mechanical in-exsufflation device.

Contraindications Contraindications for high-frequency chest compression systems (The Vest Airway

Clearance System, formerly known as the ThAIRapy Bronchial Drainage System, ABI

Vest):

Unstable head injury

Unstable neck injury

Active Hemorrhage with hemodynamic instability

Subcutaneous emphysema

Recent epidural spinal infusion/anesthesia

Recent skin grafts or flaps on the thorax

Osteoporosis

Burns, open wounds and/or skin infections of the thorax

Recently placed transvenous pacemaker or subcutaneous pacemaker

Suspected pulmonary tuberculosis

Lung contusion

Bronchospasm

Complaint of chest wall pain

Osteomyelitis of ribs

History of pneumothorax, hemoptysis, or cardiac arrest in the past 30 days.

Page 5: Airway Clearance Devices

Airway Clearance Systems Aug 13 5

Note: Intrapulmonary percussive ventilation (IPV) systems, e.g., Percussionaire

device, and IPPB devices as an alternative to chest physiotherapy are not medically

necessary because there are inadequate scientifically controlled studies in the

medical literature to validate their effectiveness. There is insufficient evidence

supporting their effectiveness in the home setting.

Codes Related To This Policy NOTE:

The codes listed in this policy are for reference purposes only. Listing of a code in

this policy does not imply that the service described by this code is a covered or non-

covered health service. Coverage is determined by the benefit documents and

medical necessity criteria. This list of codes may not be all inclusive.

On October 1, 2014, the ICD-9 code sets used to report medical diagnoses and

inpatient procedures will be replaced by ICD-10 code sets. Health Net National

Medical Policies will now include the preliminary ICD-10 codes in preparation for this

transition. Please note that these may not be the final versions of the codes and

that will not be accepted for billing or payment purposes until the October 1, 2014

implementation date.

ICD-9 Codes 277.02 Cystic fibrosis with pulmonary manifestations

335.20 Amyotrophic lateral sclerosis

340 Multiple sclerosis

359.0 Congenital hereditary muscular dystrophy

359.1 Hereditary progressive muscular dystrophy

359.2 Myotonic disorders

466.11 Acute bronchiolitis due to respiratory syncytial virus (RSV)

466.19 Acute bronchiolitis due to other infectious organisms

487.1 Influenza with other respiratory manifestations

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

491.8 Other chronic bronchitis

494.0 Bronchiectasis without acute exacerbation

494.1 Bronchiectasis with acute exacerbation

506.0 Bronchitis and pneumonitis due to fumes and vapors

506.4 Chronic respiratory conditions due to fumes and vapors

516.8 Other specified alveolar and parietoalveolar pneumonopathies

518.0 Pulmonary collapse

748.61 Congenital bronchiectasis

996.84 Complications of transplanted lung

V46.0 Dependence on aspirator

V46.1 Dependence on respirator (ventilator)

V46.8 Dependence on other enabling machines

ICD-10 Codes E84.0-

E84.9 Cystic fibrosis

G12.20-

G12.9 Motor neuron disease

Page 6: Airway Clearance Devices

Airway Clearance Systems Aug 13 6

G35 Multiple sclerosis

G71.0-

G71.9 Primary disorder of muscles

J1Ø.1 Influenza due to other identified influenza virus with other respiratory

manifestations

J11.1 Influenza due to unidentified influenza virus with other respiratory

manifestations

J21.0-

J12.9 Acute bronchiolitis

J41.0-

J41.8 Simple and mucopurulent chronic bronchitis

J42 Unspecified chronic bronchitis

J47.0-

J47.9 Bronchiectasis

J68.0-

J68.9 Respiratory conditions due to inhalation of chemicals, gases, fumes and

vapors

J84.01-

J84.09 Alveolar and parieto-alveolar conditions

Q33.0-

Q33.9 Congenital malformations of lung

T86.81Ø Lung transplant rejection

T86.811 Lung transplant failure

T86.819 Unspecified complication of lung transplant

Z99.0-

Z99.12 Dependence on respirator

CPT Codes 94667 Manipulation chest wall, e.g., cupping, percussing, and vibration to

facilitate lung function; initial demonstration and /or evaluation

94668 Manipulation chest wall, e.g., cupping, percussing, and vibration to

facilitate lung function; subsequent demonstration.

HCPCS Codes 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

E0480 Percussor, electric or pneumatic, home model

E0482 Cough stimulating device, alternating positive and negative airway

pressure

E0483 High frequency chest wall oscillation air-pulse generator system, (includes

hoses and vest), each

E0484 Oscillatory positive expiratory pressure device, non-electric, any type,

each

S8185 Flutter device

Scientific Rational Update – August 2013 At this time, there is insufficient peer reviewed published literature to evaluate the

safety and efficacy of intrapulmonary percussive ventilation. Its effect on health

outcomes or patient management in patients with cystic fibrosis is undefined.

Page 7: Airway Clearance Devices

Airway Clearance Systems Aug 13 7

There is a Clinical Trial on ‘Effects of IPV Assessed With Functional Imaging’ which is

currently recruiting participants. The ClinicalTrials.gov Identifier is NCT01671540 and

it was last updated on June 27, 2013. The investigators are trying to find what the

long term effects of an IPV treatment would be evaluated with classical outcome

parameters, (i.e., FEV1, Raw). The authors are also questioning if the possible effect

noticeable on this technique is comparable with the classical outcome parameters?

The estimated primary completion date is December 2013.

Scientific Rationale Update - September 2011 Additional contraindications to high-frequency chest compression systems include a

history of pneumothorax, hemoptysis, or cardiac arrest in the past 30 days. These

were added to the current list of contraindications.

Scientific Rationale Update- April 2009 Bronchiectasis is a syndrome of chronic cough and daily viscid sputum production

associated with airway dilatation and bronchial wall thickening. Multiple conditions

are associated with the development of bronchiectasis, but all require an infectious

insult plus impairment of drainage, airway obstruction, and/or a defect in host

defense. There are numerous etiologies that can induce or contribute to the

pathophysiologic processes that result in bronchiectasis, including primary infection,

bronchial obstruction, foreign body aspiration), cystic fibrosis, Young's syndrome,

primary ciliary dyskinesa, allergic bronchopulmonary aspergillosis (ABPA ),

immunodeficiency states, and autoimmune diseases.

The high frequency chest wall compressor (HFCWC), a vest worn over the thorax

that is connected to an air compressor, delivers mechanical percussions at rates and

pressures that can be varied by the patient to target different caliber airways, also

sets to patient comfort. Examples of high frequency chest wall oscillation systems

include the Vest airway clearance system (Advanced Respiratory) and Medpulse

SmartVest (ElectroMed Co). There is no published comparison study available that

has demonstrated superiority of one device over another.

A Cochrane review reported by Morrison and Agnew (2009) found no clear evidence

that oscillation was a more or less effective intervention overall than other forms of

physiotherapy. They recommended that more adequately-powered long-term

randomised controlled trials are needed. The authors identified two hundred and

sixty-five studies; thirty studies (total of 708 participants) that compared oscillating

devices with any other form of physiotherapy in people with Cystic Fibrosis (CF).

Single treatment interventions (therapy technique used only once in the comparison)

were excluded. Studies varied in duration from up to one week to one year in

duration. Nineteen of the studies were cross-over in design. Data were not published

in sufficient detail in most of these studies to perform meta-analysis. Forced

expiratory volume in one second (FEV (1) was the most frequently measured

outcome. Results did not show significant difference in effect between oscillating

devices and other methods of airway clearance on FEV (1) or other lung function

parameters. Where there has been a small but significant change in secondary

outcome variables such as sputum volume or weight this has not been wholly in

favour of oscillating devices. Participant satisfaction was reported in eleven studies,

but this was not specifically in favor of an oscillating device as some participants

preferred breathing techniques or techniques used prior to the study interventions.

The results for the remaining outcome measures were not examined or reported in

sufficient detail to provide any high level evidence.

Page 8: Airway Clearance Devices

Airway Clearance Systems Aug 13 8

Lange et al (2006) reported the results of a randomized controlled trial of HFCWC in

a group of 46 patients with ineffective airway clearance due to ALS. Patients who

received HFCWC therapy in addition to usual care reported less breathlessness,

compared with usual care alone. These patients also experienced increased nighttime

coughing, which the authors suggested may have been due to increased mobilization

of secretions.

Although the evidence regarding the efficacy of HFCWC vest therapy in patients with

non–CF-related disorders of clearance is very limited, when conventional PDT and

other devices have failed or are contraindicated, high-frequency chest wall

compression may be indicated.

Scientific Rationale Initial Respiratory health depends on consistent clearance of airway secretions. Normal

airway clearance is accomplished by two important mechanisms: the mucociliary

clearance (MCC) system and the ability to cough. Impaired MCC is linked to poor

lung function in a broad range of diseases and disabilities. When mucus secretion

and mucus clearance are not in balance, excessive, often sticky, airway mucus may

accumulate in the airways and cause serious problems. At-risk individuals are prone

to recurrent episodes of respiratory inflammation, infection and, eventually,

irreversible lung damage, and even death. Improvement of MCC is a vital treatment

goal - one that can be accomplished with an individualized plan of chest

physiotherapy. The aims are to reduce airway obstruction by improving the clearance

of secretions, to reduce the severity of the infection by clearing infected material and

to maintain optimal respiratory function and exercise tolerance.

There are individuals whose MCC and cough are not in balance due to their specific

disease or condition, such as: cystic fibrosis (CF), chronic obstructive pulmonary

disease (COPD), primary ciliary dyskinesia (PCD). These are often identified as

impaired airway clearance conditions. These individuals require external assistance

for their airway clearance needs through some sort of airway clearance therapy to

avoid retention of mucus in their lungs. Without effective airway clearance, such

patients risk gaining stagnate mucus in their lungs creating a site prone to infection.

Repeated infections typically lead to frequent hospitalizations and progressive

pulmonary deterioration, which can result in death. Passive interventions include

nebulized bronchodilating medication, postural drainage combined with chest

percussion and/or vibration, and diaphragmatic (or "quad") coughing maneuvers.

Active interventions consist of autogenic drainage or breathing and coughing

techniques such as forced expiratory technique ("huff" coughing), active cycle

breathing (deep breathing or breath stacking), and pursed lip breathing (creates

positive expiratory pressure). Usually, several of these mechanisms are utilized in an

effective pulmonary toilet program.

Pulmonary complications are major causes of morbidity and mortality for patients

with compromised airway clearance mechanisms. This is particularly true in patients

with cystic fibrosis (CF), an autosomal recessive disease characterized by a chronic

progressive course with acute exacerbations. Neuromuscular diseases (NMDs) are

characterized by progressive atrophy and weakness of skeletal muscle, skeletal-

spinal deformities, limb contractures, and restrictive lung disease leading to poor

respiratory function. Among inherited NMDs, the most prevalent include muscular

dystrophies (Duchenne, Becker, facioscapulohumeral, limb girdle), the myotonias,

and the spinal muscular atrophies. Acquired NMDs include amyotrophic lateral

Page 9: Airway Clearance Devices

Airway Clearance Systems Aug 13 9

sclerosis, multiple sclerosis, Guillain Barré Syndrome, and poliomyelitis. The principal

cause of the morbidity and mortality associated with these diseases is the production

of excessively thick and tenacious tracheobronchial mucus, which leads to airway

obstruction and secondary infection. CF patients require routine maintenance chest

physiotherapy to clear their airways (i.e., manual percussion and postural drainage)

every day to assist in the removal of mucous secretions from the lung. These

treatments may be administered one to three times a day for 20 to 30 minutes per

session by a physical therapist or another trained adult in the home, typically a

parent if the patient is a child. Conditions such as high spinal cord injuries, neuro-

muscular deficits, or severe fatigue associated with intrinsic lung disease can

diminish the effectiveness of a cough, or eliminate the ability to cough altogether.

Other conditions such as bronchiectasis and pneumonia can affect the ability of the

lungs to manage secretions and influence the viscosity and amount of sputum

produced.

Several devices have been developed as an adjunct or alternative to one or more of

the mechanisms described above when the individual is unable to clear pulmonary

secretions effectively. The Vest Airway Clearance System (formerly known as the ABI

Vest or the ThAIRapy Bronchial Drainage System) and the Percussionaire device are

oscillatory devices designed to provide self-administered airway clearance. The Vest

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 cause the vest to inflate and deflate

against the thorax, creating high-frequency chest wall oscillation and mobilization of

secretions. There are no studies with final health outcomes that demonstrate that

the ThAIRapy Vest System is equivalent or superior to other techniques designed to

improve pulmonary clearance in patients with cystic fibrosis. However, in some

situations, other methods of therapy, such as chest PT by a family member, are not

available.

The published literature includes a number of small, randomized studies that

compared different mucus clearance techniques, typically in crossover studies that

do not include final health outcomes regarding long-term stabilization or

improvement of lung function or a decrease in pulmonary exacerbations resulting in

hospitalization. Pulmonary function and weight of expectorated sputum are typically

analyzed immediately after treatment. The reliability and validity of sputum weight

as a proxy for health outcome is still unresolved. The sparse data that are available

do not suggest that any one alternative, including the various oscillatory devices,

autogenic drainage, or positive expiratory pressure, is superior to another.

Kluft and colleagues (1996) at Children’s Hospital, Washington, DC, looked at 29 CF

patients and compared traditional chest physiotherapy (CPT) with the Vest system.

Each patient received two days of each form of therapy over a four-day period.

Expectorated secretions were collected during and after treatment. The results

indicated significantly more pulmonary secretions were expectorated during

treatment with the Vest system as compared with CPT. Mechanical percussors are

typically electrical devices used in lieu of a caretaker's hands for chest percussion

and/or vibration. This method of CPT creates an internal percussion effect on the

lungs as they are held in a state of partial inspiration.

The FLUTTER mucous clearance device and Acapella device are small handheld

devices that provide positive expiratory pressure (PEP.) Exhaling through the device

creates oscillations, or "flutter" in pressures in the airway resulting in loosening of

Page 10: Airway Clearance Devices

Airway Clearance Systems Aug 13 10

mucous. Other PEP devices are used with a small volume nebulizer, and function in

conjunction with medication delivery. Mechanical Insufflator-Exsufflator

(CoughAssist) is a portable electric device which utilizes a blower and a valve to

alternately apply a positive and then a negative pressure to a patient's airway in

order to assist the patient in clearing retained bronchopulmonary secretions. Air is

delivered to and from the patient via a breathing circuit incorporating a flexible tube,

a bacterial filter and either a facemask, a mouthpiece, or an adapter to a

tracheostomy or endotracheal tube.

The published data suggest that mechanical insufflation-exsufflation (MI-E) can

improve the intermediate outcome of peak cough expiratory flow. Data regarding its

role in the clinical management of the patient consist of case series. In some studies,

patients have served as their own control, with a decreased incidence of hospitaliza-

tion among patients who switch from tracheostomy to a noninvasive approach, which

may include MI-E as one component. While controlled trials would ideally further

delineate who is most likely to benefit from MI-E, particularly those who would

benefit from having a device in the home, such trials are logistically difficult. The

heterogeneous nature of the patients, even among those with similar diseases,

almost mandates a case by case approach for these patients. For example, the

clinical utility of MI-E would not only depend on the physiologic parameters of lung

function, but also on the tempo of the disease course, the availability of home

caregivers, and patient preference and motivation. The non-investigational status for

the MI-E device is based on these considerations.

Intrapulmonary percussive ventilation (IPV) is an aerosol machine that delivers high

frequency, low-volume, positive-pressure jets of air to the airways by a pneumatic

flow interrupter at a rate of 100-300 cycles/minute via a mouthpiece. The patient is

able to control variables such as inspiratory time, peak pressure, and delivery rates.

Aerosolized medications can be delivered under pressure and with oscillations that

vibrate the chest. The patient controls variables such as inspiratory time, peak

pressure and delivery rates. The clinical data regarding the Percussionaire device are

sparse. Two small short-term studies have found IPV as effective as standard aerosol

and chest physiotherapy in preserving lung function and no advantage of IPV over

that achieved with good pulmonary care in the hospital environment. There are no

studies in the home setting. Intermittent positive pressure breathing (IPPB) devices

use pressure to passively fill the lungs when a breath is initiated. An incorporated

manometer and mechanical valves serve to terminate the flow of inspired air when a

predetermined pressure is reached on inhalation. IPPB breathing circuits are

designed to nebulize inhaled medication. Most IPPB devices are powered by

compressed air and are not suitable for home use.

Review History March 22, 2005 Medical Advisory Council Initial Approval

April 26, 2005 Medical Advisory Council Final Approval

February 2007 Update – No revisions

October 2008 Removed statement regarding endorsement of vest system by

AARC from scientific rationale

April 2009 Added High frequency chest wall oscillation devices (vest airway

clearance system) as medically necessary for bronchiectasis

and neuromuscular disease when specific criteria is met.

April 2011 Update – no revisions

Page 11: Airway Clearance Devices

Airway Clearance Systems Aug 13 11

September 2011 Update. Added Revised Medicare Table with link to LCD. Added

history of pneumothorax, hemoptysis, or cardiac arrest in the

past 30 days under contraindications.

August 2012 Update – no revisions

August 2013 Update – no revisions. Codes updated.

Patient Education Websites English

1. National Institutes of Health (NIH), National Heart Lung and Blood Institute.

Facts about cystic fibrosis. Information for Patients and the Public. NIH Pub. No.

95-3650. Bethesda, MD: NIH; November 1995.

2. Cystic Fibrosis Trust. Physiotherapy. Living with CF. London, UK: Cystic Fibrosis

Trust; 2004.

3. Cystic Fibrosis Trust. Physiotherapy for cystic fibrosis. Treatment Information.

London, UK: Cystic Fibrosis Trust; 1998.

4. International Cystic Fibrosis Support Group. Physiotherapy in cystic fibrosis.

Physiotherapy. New London, CT: International Cystic Fibrosis Support Group;

2003.

5. Medical College of Wisconsin. The facts about cystic fibrosis. Medical College of

Wisconsin Healthlink. Milwaukee, WI: Medical College of Wisconsin; April 4, 2003.

6. Merck & Co., Inc. Cystic fibrosis. In: Merck Manual of Medical Information --

Home Edition. 2nd Home ed. MH Beers, ed. Ch. 43, Section 4, Lung and airway

disorders. Whitehouse Station, NJ: Merck; 2003.

7. American Association of Respiratory Care (AARC). Suctioning of the patient in the

home. AARC Clinical Practice Guideline. Respir Care. 1999:44(1):99-104.

Accessed at: http://www.rcjournal.com/cpgs/sotpithcpg.html

8. AARC Clinical Practice Guideline. Postural Drainage Therapy. Respir Care

1991;36:1418-1426. Accessed at:

http://www.rcjournal.com/cpgs/pdtcpg.html

Spanish

1. MedlinePlus. Fibrosis Quística. Acceso en:

http://www.nlm.nih.gov/medlineplus/cysticfibrosis.html

2. Federación Española Contra La Fibrosis Quística. Acceso en:

http://www.fibrosis.org/fibrosis/marcfq.htm

3. March of Dimes. Fibrosis Quística. Acceso en:

http://www.nacersano.org/centro/9259_9971.asp

This policy is based on the following evidence-based guidelines: 1. No authors listed. AARC (American Association for Respiratory Care) clinical

practice guidelines. Postural drainage therapy. Respir Care. 1991;36(12):1418-

1426.

2. No authors listed. AARC (American Association for Respiratory Care) clinical

practice guidelines. Directed cough. Respir Care. 1993;38(5):495-499.

3. No authors listed. AARC (American Association for Respiratory Care) clinical

practice guidelines. Suctioning of the Patient in the Home. Respir Care

1999;44(1):99-104.

4. The Veterans Health Administration Clinical Practice Guideline for the

Management of Persons with Chronic Obstructive Pulmonary Disease (COPD) or

Asthma.

5. Hayes Medical Technology Directory. High-Frequency Chest Wall Compression

for Cystic Fibrosis. May 3, 2012. Updated May 20, 2013.

Page 12: Airway Clearance Devices

Airway Clearance Systems Aug 13 12

6. Hayes Medical Technology Directory. High-Frequency Chest Wall Compression

for Diseases Other than Cystic Fibrosis. June 2004. Updated Sept 2008.

Updated September 2, 2011. Updated September 20, 2012.

7. Hayes. Search & Summary. Intrapulmonary Percussive Ventilation (IPV) for

Treatment of Cystic Fibrosis in Children and Adolescents. May 20, 2013.

References – Update August 2013 1. Clinicaltrials.gov. Effects of IPV Assessed With Functional Imaging.

ClinicalTrials.gov Identifier:NCT01671540. June 2013. Available at:

http://clinicaltrials.gov/ct2/show/NCT01671540?term=NCT01671540&rank=1

2. Clinkscale D, Spihlman K, Watts P, et al. A randomized trial of conventional

chest physical therapy versus high frequency chest wall compressions in

intubated and non-intubated adults. Respir Care. 2012 Feb;57(2):221-8. 3. Cochrane Database Syst Rev. 2012 Dec 12;12:CD007862. doi:

10.1002/14651858.CD007862.pub3.Active cycle of breathing technique for

cystic fibrosis.

4. 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. 2013 Feb 13. doi:

10.1136/thoraxjnl-2012-202915. [Epub ahead of print]. References – Update August 2012 1. Atkeson AD, RoyChoudhury A, Harrington-Moroney G, et al. Patient-ventilator

asynchrony with nocturnal noninvasive ventilation in ALS. Neurology 2011;

77:549.

2. Janssens JP, Borel JC, Pépin JL, et al. Nocturnal monitoring of home non-

invasive ventilation: the contribution of simple tools such as pulse oximetry,

capnography, built-in ventilator software and autonomic markers of sleep

fragmentation. Thorax 2011; 66:438.

3. Hill NS, Kramer NR. Practical aspects of nocturnal noninvasive ventilation in

neuromuscular and chest wall disease. UpToDate. February 23, 2012.

4. Hill NS, Kramer NR. Types of noninvasive nocturnal ventilatory support in

neuromuscular and chest wall disease. UpToDate. May 14, 2012.

5. Tsolaki V, Pastaka C, Kostikas K, et al. Noninvasive ventilation in chronic

respiratory failure: effects on quality of life. Respiration 2011; 81:402.

References – Update September 2011 1. Crescimanno G, Marrone O. High frequency chest wall oscillation plus mechanical

in-exsufflation in Duchenne muscular dystrophy with respiratory complications

related to pandemic Influenza A/H1N1. Rev Port Pneumol. 2010;16(6):912-916.

2. Nowobilski R, Włoch T, Płaszewski M, et al. Efficacy of physical therapy methods

in airway clearance in patients with chronic obstructive pulmonary disease: a

critical review. Pol Arch Med Wewn. 2010;120(11):468-477.

3. Stafler P, Carr SB. Non-cystic fibrosis bronchiectasis: its diagnosis and

management. Arch Dis Child Educ Pract Ed. 2010;95(3):73-82.

4. Texas Tech University Health Sciences Center. Use of High Frequency Chest

Compression in Pediatric Status Asthmaticus. National Library of Medicine (NLM)

Identifier: NCT00552448. Updated December 29, 2010. ClinicalTrials.gov

Available at: http://www.clinicaltrials.gov/ct2/show/NCT00552448

5. 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

Page 13: Airway Clearance Devices

Airway Clearance Systems Aug 13 13

neuromuscular diseases: an exploratory randomized controlled trial. J Child

Neurol. 2010;25(7):815-821.

References – Update April 2011 1. Kempainen RR, Milla C, Dunitz J, et al. Comparison of settings used for high-

frequency chest-wall compression in cystic fibrosis. Respir Care. 2010

Jun;55(6):695-701.

2. Robinson KA, McKoy N, Saldanha I, Odelola OA. Active cycle of breathing

technique for cystic fibrosis. Cochrane Database Syst Rev. 2010 Nov

10;(11):CD007862

3. Wang QX, Zhang XY, Li Q. Effects of a flutter mucus-clearance device on

pulmonary function test results in healthy people 85 years and older in China.

Respir Care. 2010 Nov;55(11):1449-52.

References – Update April 2009 1. McCool FD, Rosen MJ. Nonpharmacologic airway clearance therapies: ACCP

evidence-based clinical practice guidelines. Chest 2006 Jan; 129(1 Suppl):

250S-9S.

2. Centers for Medicare & Medicaid Services. LCD for High Frequency Chest Wall

Oscillation Devices (L12739). Noridian Administrative Services.

3. Centers for Medicare & Medicaid Services. LCD for High Frequency Chest Wall

Oscillation Devices

4. Morrison L, Agnew J. Oscillating devices for airway clearance in people with

cystic fibrosis. Cochrane Database Syst Rev. 2009 Jan 21;(1)

5. Hristara-Papadopoulou A, Tsanakas J, Diomou G, Papadopoulou O. Current

devices of respiratory physiotherapy. Hippokratia. 2008 Oct; 12(4): 211-20.

6. Lange DJ, Lechtzin N, Davey C et al. High-frequency chest wall oscillation in

ALS: an exploratory randomized, controlled trial. Neurology. 2006 Sep

26;67(6):991-7.

References 1. Main E, Prasad A, Schans C. Conventional chest physiotherapy compared to other

airway clearance techniques for cystic fibrosis. Cochrane Database Syst Rev.

2005 Jan 25;(1):CD002011.

2. Yoo Y, Koh YY. Current treatment for primary ciliary dyskinesia conditions. Expert

Opin Pharmacother. 2004 Feb;5(2):369-77.

3. Elkins MR, Jones A, Schans C. Positive expiratory pressure physiotherapy for

airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev.

2004;(1):CD003147.

4. Boucher RC. New concepts of the pathogenesis of cystic fibrosis lung disease.

Eur Respir J. 2004 Jan;23(1):146-58.

5. Doring G, Hoiby N; Consensus Study Group. Early intervention and prevention of

lung disease in cystic fibrosis: A European consensus. J Cyst Fibros.

2004;3(2):67-91.

6. Phillips GE, Pike SE, Jaffe A, Bush A. Comparison of active cycle of breathing and

high-frequency oscillation jacket in children with cystic fibrosis. Pediatr Pulmonol.

2004;37(1):71-75.

7. Button BM, Heine RG, Catto-Smith AG, et al. Chest physiotherapy in infants with

cystic fibrosis: To tip or not? A five-year study. Pediatr Pulmonol.

2003;35(3):208-213.

Page 14: Airway Clearance Devices

Airway Clearance Systems Aug 13 14

8. Jones AP, Rowe BH. Bronchopulmonary hygiene physical therapy for chronic

obstructive pulmonary disease and bronchiectasis (Cochrane Review). In: The

Cochrane Library, Issue 1, 2003. Oxford, UK: Update Software.

9. Goss CH. Airway clearance in cystic fibrosis. Respir Care. 2003;48(1):20-21.

10. van der Schans C, Prasad A, Main E. Chest physiotherapy compared to no chest

physiotherapy for cystic fibrosis (Cochrane Review). In: The Cochrane Library,

Issue 3, 2003. Oxford, UK: Update Software.

11. Main E, Prasad A, van der Schans C. Conventional chest physiotherapy compared

to other forms of chest physiotherapy for cystic fibrosis (Protocol for a Cochrane

Review). In: The Cochrane Library, Issue 3, 2003. Oxford, UK: Update Software.

12. Dosman CF, Zuberbuhler PC, Tabak JI, Jones RL. Effects of positive end-

expiratory pressure on oscillated volume during high frequency chest

compression in children with cystic fibrosis. Can Respir J. 2003;10(2):94-98.

13. Silverman E, Ebright L, Kwiatkowski M, Cullina J. Current management of

bronchiectasis: Review and 3 case studies. Heart Lung. 2003;32(1):59-64

14. 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-

28.

15. Volsko TA, DiFiore J, Chatburn RL. Performance comparison of two oscillating

positive expiratory pressure devices: Acapella versus Flutter. Respir Care.

2003;48(2):124-130.

16. Toussaint M, De Win H, Steens M, Soudon P. Effect of intrapulmonary percussive

ventilation on mucus clearance in duchenne muscular dystrophy patients: A

preliminary report. Respir Care. 2003;48(10):940-947.

17. Miyata T. Novel approach to respiratory pharmacology--pharmacological basis of

cough, sputum and airway clearance. Yakugaku Zasshi. 2003 Dec;123(12):987-

1006.

18. Donaldson SH, Boucher RC. Update on pathogenesis of cystic fibrosis lung

disease. Curr Opin Pulm Med. 2003 Nov;9(6):486-91.

19. Hess DR. The evidence for secretion clearance techniques. Respir Care.

2002;46(11):1276-1293.

20. Plioplys AV, Lewis S, Kasnicka I. Pulmonary vest therapy in pediatric long-term

care. J Am Med Dir Assoc. 2002;3(5):318-321.

21. Braverman JM. Increasing the quantity of lungs for transplantation using high-

frequency chest wall oscillation: A proposal. Prog Transplant. 2002;12(4):266-

274.

22. Davidson KL. Airway clearance strategies for the pediatric patient. Respir Care.

2002;47(7):823-828.

23. Fink JB, Mahlmeister MJ. High-frequency oscillation of the airway and chest wall.

Respir Care. 2002;47(7):797-807.

24. Deakins K, Chatburn RL. A comparison of intrapulmonary percussive ventilation

and conventional chest physiotherapy for the treatment of atelectasis in the

pediatric patient. Respir Care. 2002;47(10):1162-1167.

25. Fink JB, Mahlmeister MJ. High-frequency oscillation of the airway and chest wall.

Respir Care. 2002;47(7):797-807.

26. 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):446-448.

27. Wolkove N, Kamel H, Rotaple M, Baltzan MA Jr. Use of a mucus clearance device

enhances the bronchodilator response in patients with stable COPD. Chest.

2002;121(3):702-707.

Page 15: Airway Clearance Devices

Airway Clearance Systems Aug 13 15

28. 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-

377.

29. Scholz SE, Sticher J, Haufler G, et al. Combination of external chest wall

oscillation with continuous positive airway pressure. Br J Anaesth.

2001;87(3):441-446.

30. McIlwaine PM, Wong LT, Peacock D, Davidson AG. 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):845-850.

31. Bellone A, Lascioli R, Raschi S, et al. Chest physical therapy in patients with acute

exacerbation of chronic bronchitis: Effectiveness of three methods. Arch Phys

Med Rehabil. 2000;81(5):558-560.

32. Bach JR, Niranjan V, Weaver B. Spinal muscular atrophy type 1. Noninvasive

respiratory management approach. Chest. 2000;117(4):1100-1105.

33. Kang SW, Bach JR. Maximum insufflation capacity: vital capacity and cough flows

in neuromuscular disease. Am J Phys Med Rehab. 2000;79(3):222-227.

34. Bach JR, Kang SW. Disorders of ventilation: weakness, stiffness, and mobilization

[editorial]. Chest. 2000;117(2):301-303.

35. Houtmeyers E, Gosselink R, Gayan-Ramirez G, et al. Regulation of mucociliary

clearance in health and disease. Eur Respir J. 1999;13(5):1177-1188.

36. Pryor JA. Physiotherapy for airway clearance in adults. Eur Respir J.

1999;14(6):1418-1424.

37. Gondor M, Nixon PA, Mutich R, et al. Comparison of flutter device and chest

physical therapy in the treatment of cystic fibrosis pulmonary exacerbation.

Pediatr Pulmonol. 1999;28(4):255-260.

38. Padman R, Geuouque DM, Engelhardt MT. Effects of the flutter device on

pulmonary function studies among pediatric cystic fibrosis patients. Del Med J.

1999;71(1):13-18.

39. 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):283-289.

40. Scherer TA, Barandun J, Martinez E, et al. Effect of high-frequency oral airway

and chest wall oscillation and conventional chest physical therapy on

expectoration in patients with stable cystic fibrosis. Chest. 1998;113(4):1019-

1027.

41. Homnick DN, Anderson K, Marks JH. Comparison of the flutter device to standard

chest physiotherapy in hospitalized patients with cystic fibrosis: A pilot study.

Chest. 1998:114(4):993-997.

42. Burioka N, Sugimoto Y, Suyama H, et al. Clinical efficacy of the FLUTTER device

for airway mucus clearance in patients with diffuse panbronchiolitis. Respirology.

1998;3(3):183-186.

43. 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):171-177.

44. 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 (Phila). 1998;37(7):427-432.

Page 16: Airway Clearance Devices

Airway Clearance Systems Aug 13 16

45. Van Winden CM, Visser A, Hop W, et al. Effects of flutter and PEP mask

physiotherapy on symptoms and lung function in children with cystic fibrosis. Eur

Respir J. 1998;12(1):143-147.

46. Hanayama K, Ishikawa Y, Bach JR. Amyotrophic lateral sclerosis. Successful

treatment of mucous plugging by mechanical insufflation-exsufflation. Am J Phys

Med Rehabil. 1997;76(4):338-339.

47. Bach JR, Ishikawa Y, Kim H. Prevention of pulmonary morbidity for patients with

Duchenne muscular dystrophy. Chest. 1997;112(4):1024-1028.

48. Hardy KA, Anderson BD. Noninvasive clearance of airway secretions. Respir Care

Clin N Am. 1996;2(2):323-345.

49. Kluft J, Beker L, Castagnino M, et al. A comparison of bronchial drainage

treatments in cystic fibrosis. Pediatr Pulmonol. 1996;22(4):271-274.

50. Birnkrant DJ, Pope JF, Lewarski J, et al. Persistent pulmonary consolidation

treated with intrapulmonary percussive ventilation: A preliminary report. Pediatr

Pulmonol. 1996;21(4):246-249.

51. Thomas J, Cook DJ, Brooks D. Chest physical therapy management of patients

with cystic fibrosis. A meta-analysis. Am J Respir Crit Care Med. 1995;151(3 Pt

1):846-850.

52. Butler S, O'Neill B. High frequency chest compression therapy: A case study.

Pediatr Pulmonol. 1995;19(1):56-59.

53. 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.

54. Homnick DN, White F, de Castro 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):50-55.

55. Bach JR. Update and perspective on noninvasive respiratory muscle aids, part 2:

Expiratory aids. Chest. 1995;105(5):1538-1542.

56. 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):1154-1157.

57. Natale JE, Pfeifle J, Homnick DN. Comparison of intrapulmonary percussive

ventilation and chest physiotherapy. A pilot study in patients with cystic fibrosis.

Chest. 1994;105(6):1789-1793.

58. Konstan M. Efficacy of the Flutter device for airway clearance in patients with

cystic fibrosis. J Pediatr. 1994;124(5 Pt 1):689-693.

59. Pryor JA, Webber BA, Hodson ME, et al. The Flutter VRP1 as an adjunct to chest

physiotherapy in cystic fibrosis. Respir Med. 1994;88(9):677-681.

60. Girard JP, Terki N. The Flutter VRP1: a new personal pocket therapeutic device

used as an adjunct to drug therapy in the management of bronchial asthma. J

Investig Allergol Clin Immunol. 1994;4(1):23-27.

61. Swift GL, Rainer T, Saran R, et al. Use of flutter VRP1 in the management of

patients with steroid-dependent asthma. Respiration. 1994;61(3):126-129.

62. Leru P, Bistriceanu G, Ibraim E, Stoicescu P. Flutter-VRP1 Desitin--a new

physiotherapeutic device for the treatment of chronic obstructive bronchitis. Rom

J Intern Med. 1994;32(4):315-320.

63. Bach JR. Update and perspectives on noninvasive respiratory muscle aids, part 1:

The inspiratory aids. Chest. 1994;105(4):1230-1240.

64. Bach JR. Update and perspective on noninvasive respiratory muscle aids. Part 2:

The expiratory aids. Chest. 1994;105(5):1538-1544.

Page 17: Airway Clearance Devices

Airway Clearance Systems Aug 13 17

65. Bach JR, Smith WH, Michaels J, et al. Airway secretion clearance by mechanical

exsufflation for post-poliomyelitis ventilator-assisted individuals. Arch Phys Med

Rehabil. 1993;74(2):170-177.

66. Bach JR. Mechanical insufflation-exsufflation. Comparison of peak expiratory

flows with manually assisted and unassisted coughing techniques. Chest.

1993;104(5):1553-62.

67. Whitman J, Van Beusekom R, Olson S, et al. Preliminary evaluation of high-

frequency chest compression for secretion clearance in mechanically ventilated

patients. Respir Care. 1992;38(10):1081-1087.

68. Bach JR. Mechanical exsufflation, noninvasive ventilation and new strategies for

pulmonary rehabilitation and sleep disordered breathing. Bull NY Acad Med.

1992;68(2):321-340.

69. Warwick WJ, Hansen LG. The long-term effect of high-frequency chest

compression therapy on pulmonary complications of cystic fibrosis. Pediatr

Pulmonol. 1991;11(3):265-271.

70. Hansen LG, Warwick WJ. High-frequency chest compression system to aid in

clearance of mucus from the lung. Biomed Instrum Technol. 1990;24(4):289-

294.

71. Reisman JJ, Rivington-Law B, Corey M, et al. Role of conventional physiotherapy

in cystic fibrosis. J Pediatr. 1988;113(4):632-636.

Important Notice

General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered,

excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net’s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this " Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member’s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice.

Page 18: Airway Clearance Devices

Airway Clearance Systems Aug 13 18

The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member’s Contract Controls Coverage Determinations. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member’s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member’s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member’s contract shall govern. Coverage decisions are the result of the terms and conditions of the Member’s benefit contract. The Policies do not replace or amend the Member’s contract. If there is a discrepancy between the Policies and the Member’s contract, the Member’s contract shall govern. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal

mandates and regulatory requirements, the requirements of law and regulation shall govern. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation.