High Frequency Chest Wall Oscillation Devices

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HIGH FREQUENCY CHEST WALL OSCILLATION DEVICES HS-036

Clinical Coverage Guideline page 1 Original Effective Date: 8/7/2008 - Revised: 8/31/2009, 8/20/2010, 8/2/2011, 8/2/2012, 6/6/2013, 6/5/2014, 5/7/2015, 7/7/2016, 6/1/2017

Care1st Health Plan Arizona, Inc.

Easy Choice Health Plan Harmony Health Plan of Illinois Missouri Care

‘Ohana Health Plan, a plan offered by WellCare Health Insurance of Arizona

OneCare (Care1st Health Plan Arizona, Inc.) Staywell of Florida

WellCare (Arkansas, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Mississippi, Nebraska, New Jersey, New York, South Carolina, Tennessee, Texas)

WellCare Prescription Insurance

High Frequency Chest Wall Oscillation Devices

Policy Number: HS-036 Original Effective Date: 8/7/2008

Revised Date(s): 8/31/2009; 8/20/2010;

8/2/2011; 8/2/2012; 6/6/2013; 6/5/2014;

5/7/2015; 7/7/2016; 6/1/2017

APPLICATION STATEMENT

The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any.

DISCLAIMER

The Clinical Coverage Guideline (CCG) is intended to supplement certain standard WellCare benefit plans and aid in administering benefits. Federal and state law, contract language, etc. take precedence over the CCG (e.g., Centers for Medicare and Medicaid Services [CMS] National Coverage Determinations [NCDs], Local Coverage Determinations [LCDs] or other published documents). The terms of a member’s particular Benefit Plan, Evidence of Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member’s benefit plan may contain specific exclusions related to the topic addressed in this CCG. Additionally, CCGs relate exclusively to the administration of health benefit plans and are NOT recommendations for treatment, nor should they be used as treatment guidelines. Providers are responsible for the treatment and recommendations provided to the member. The application of the CCG is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. All links are current at time of approval by the Medical Policy Committee (MPC) and are subject to change prior to the annual review date. Lines of business (LOB) are subject to change without notice; current LOBs can be found at www.wellcare.com. All guidelines can be found at this site as well but selecting the Provider tab, then “Tools” and “Clinical Guidelines”.

BACKGROUND

In normal, healthy individuals, clearance of secretions from the respiratory tract is accomplished primarily through ciliary action and the slight bias in respiratory action toward exhalation, with sighs and occasional coughs

stimulated by ciliary irritation. A number of conditions such as cystic fibrosis (CF) and bronchiectasis can result in inadequate airway clearance. These secretions accumulate in the bronchial tree, occluding small passages and interfering with adequate gas exchange in the lungs. They also serve as a culture medium for pathogens, leading to a higher risk for chronic infections and deterioration of lung function. Standard therapy to enhance mucus clearance

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HIGH FREQUENCY CHEST WALL OSCILLATION DEVICES HS-036

consists of chest physical therapy (CPT), including percussion of the thorax and postural drainage, forced expiratory maneuvers, huffing, and coughing. Standard CPT is a time-consuming process requiring frequent sessions and strict patient compliance to ensure effectiveness. CPT has been shown to result in improved respiratory function and has been an important part of treatment regimens for patients with inadequate airway clearance for more than 40 years. Postural drainage and percussion is usually taught to family members so that patients with chronic disease can continue to receive the therapy at home when needed. For hospitalized patients, two or three 20- to 30-minute treatments are provided by respiratory therapists each day. Since this highly labor- intensive activity requires the daily intervention of a trained caregiver, additional methods of enhancing airway clearance have been studied since the 1990s.

In recent years, it has been noted that vibration of the air column in the conducting airways can aid in the removal of secretions in vulnerable patients. One way in which this may be accomplished is to directly vibrate the chest wall at frequencies higher than the normal respiratory rate during deep breathing and coughing exercises. The vibratory and shearing forces are thought to lower mucus viscosity. High-frequency chest wall compression (HFCWC) can be delivered using a device that fits over the patient’s chest and back. The device consists of an inflatable vest

connected by two tubes to a small air-pulse generator. The air-pulse generator rapidly inflates and deflates the vest, compressing and releasing the chest wall up to 20 times per second (Hayes, 2004). High-frequency chest wall compression devices include but are not limited to the following: The Vest™ Airway Clearance System formally known as ThAIRapy® Vest or ABI vest (Hill-Rom Services, Inc.), The Medpulse™ Respiratory Vest System and The Smartvest® Airway Clearance System (Electromed Inc., Minnetonka, MN), The Incourage ™ System (RespirTech, Inc.).

POSITION STATEMENT Applicable To:

Medicaid – All Markets Medicare – All Markets Exclusions

Use of high frequency chest wall oscillation devices is contraindicated and NOT a covered benefit in members:

 With unstable head and neck injury; OR

 With active hemorrhage with hemodynamic instability; OR

 With a history of Pneumothorax, Hemoptysis, or Cardiac Arrest in the past 30 days; OR

 With cystic fibrosis (CF) and ≤ 7 years of age or for CF patients with specific contraindications, such as unstable head or neck injury, active hemorrhage with hemodynamic instability, or a history of

pneumothorax, hemoptysis, or cardiac arrest in the past 30 days; OR

 Undergoing high frequency chest wall compression (HFCWC) vest therapy and who have specific contraindications (e.g., such as unstable head or neck injury; active hemorrhage with hemodynamic instability; or history of pneumothorax, hemoptysis, or cardiac arrest in the past 30 days).

Coverage

The use of high frequency chest wall oscillation devices is considered medically necessary when the member has one of the diagnoses:

 For non-cystic fibrosis-related disorders of airway clearance; OR

 Cystic Fibrosis; OR,

 Bronchiectasis.

NOTE: Medically necessary for the treatment of cystic fibrosis (CF) members ≥ 7 years of age when conventional chest physical therapy is not feasible, not available, or does not provide adequate airway clearance.

For members with cystic fibrosis or bronchiectasis, the diagnoses must be:

 Characterized by daily productive cough for at least 6 continuous months or frequent (more than two a

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HIGH FREQUENCY CHEST WALL OSCILLATION DEVICES HS-036

year) exacerbations requiring antibiotic therapy; AND

 Confirmed by high resolution, spiral, or standard CT scan; AND

 Documentation of failure of standard treatments to adequately mobilize retained secretions.

In addition to the above items, the member should have ONE of the following neuromuscular disease diagnoses:

 Post-poliomyelitis

 Acid maltase deficiency; Pompe’s Disease; Glycogenosis Type II

 Anterior horn cell diseases ;

 Multiple sclerosis;

 Quadriplegia;

 Hereditary muscular dystrophy;

 Myotonic disorders;

 Other myopathies;

 Paralysis of the diaphragm CODING

CPT®*Codes

94669 Mechanical chest wall oscillation to facilitate lung function, per session

Covered 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 E0483+ High frequency chest wall oscillation air-pulse generator system, includes hoses and vest, each

+Note: Coverage is limited to those specific indications outlined in the Coverage Policy section of this document.

Covered ICD-10-CM Diagnosis Codes –This list may not be all inclusive

Primary Diagnosis

A15.0 Tuberculosis of lung (Tuberculous bronchiectasis) 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

J47.0 Bronchiectasis with acute lower respiratory infection J47.1 Bronchiectasis, with (acute) exacerbation

J47.9 Bronchiectasis, uncomplicated Q33.4 Congenital bronchiectasis

Secondary Diagnosis

B91 Sequelae of poliomyelisti E74.02 Pompe disease

G12.8 Other spinal muscular atrophies and related syndromes G14 Post-polio sequelae

G35 Multiple sclerosis G71.0 Muscular dystrophy G71.2 Congenital myopathies G71.11 Myotonic muscular dystrophy G71.12 Myotonia congenita

G71.13 Myotonic chondrodystrophy G71.14 Drug induced myotonia

G71.19 Other specified myotonic disorders G71.2 Congenital myopathies

G71.3 Mitochondrial myopathy, not elsewhere classified G71.8 Other primary disorders of muscles

G72.89 Other specified myopathies

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HIGH FREQUENCY CHEST WALL OSCILLATION DEVICES HS-036

G82.50 Quadriplegia, unspecified G82.51 Quadriplegia, C1-C4 complete G82.52 Quadriplegia, C1-C4 incomplete G82.53 Quadriplegia, C5-C7, complete G82.54 Quadriplegia, C5-C7, incomplete

J44.9 Chronic obstructive pulmonary disease, unspecified J98.6 Disorders of diaphragm

Z86.12 Personal history of poliomyelitis

Non Covered ICD-10-CM Diagnosis Codes –This list may not be all inclusive J93.11- J39.12 Other spontaneous pneumothorax

J93.81 Chronic pneumothorax J93.82 Other air leak

J93.83 Other pneumothorax J39.9 Pneumothorax, unspecified

R04.81 Acute idiopathic pulmonary hemorrhage in infants R04.89 Hemorrhage from other sites in respiratory passages 04.2 Hemoptysis

R04.89 Hemorrhage from other sites in respiratory passages R04.9 Hemorrhage from respiratory passages, unspecified R58 Hemorrhage, not elsewhere classified

S09.10XA-S09.19XS Injury of muscle and tendon of head

S09.8XXA-S09.8XXS Other specified injuries of head, initial encounter S09.90XA-S09.93XS Unspecified injury of face and head

S16.8XXA-S16.8XXS Other specified injury of muscle, fascia and tendon at neck level, initial encounter S16.9XXA-S16.9XXS Unspecified injury of muscle, fascia and tendon at neck level, initial encounter S19.80XA-S19.9XXS Other specified injuries of unspecified part of neck, initial encounter

Z86.74 Personal history of sudden cardiac arrest (successfully resuscitated)

REFERENCES

1. High-frequency chest wall compression for diseases other than cystic fibrosis. Hayes Directory Web site. http://www.hayesinc.com Published March 28, 2014 [Reviewed March 15, 2017]. Accessed May 8, 2017.

2. High-frequency chest wall compression for cystic fibrosis. Hayes Directory Web site. http://www.hayesinc.com. Published December 22, 2016. Accessed May 8, 2017.

3. Local coverage determination for high frequency chest wall oscillation devices (L12934). Centers for Medicare and Medicaid Services Web site. http://www.cms.hhs.gov/mcd/search.asp. Published August 5, 2011 (retired September 30, 2015). Accessed May 8, 2017.

MEDICAL POLICY COMMITTEE HISTORY AND REVISIONS

Date Action

6/1/2017, 7/7/2016, 5/7/2015, 6/5/2014, 6/6/2013, 8/2/2012  Approved by MPC. No changes.

12/1/2011  New template design approved by MPC.

8/2/2011  Approved by MPC. No changes