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Date Printed: December 17, 2017: 10:13 PM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-E0000-28

Original Effective Date: 09/01/01

Reviewed: 03/26/15

Revised: 10/01/16

Subject: Oscillatory Devices for the Treatment of Cystic Fibrosis and Other Respiratory Disorders

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates  
           

DESCRIPTION:

Oscillatory devices are designed to mobilize pulmonary secretions to promote effective airway clearance; the oscillatory component can be intra- or extra-thoracic. Some of the devices require the active participation of the patient. These include oscillating positive expiratory pressure devices, in which the patient exhales multiple times through a device. The Flutter® Mucus Clearance device is a small pipe-shaped, easily portable handheld device, with a 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, 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 require active patient participation. For example, autogenic drainage and active cycle of breathing technique both involve a combination of breathing exercises performed by the patient. Positive expiratory pressure (PEP) 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.

In contrast, high-frequency chest wall oscillation (HFCWO) devices are passive oscillatory devices designed to provide airway clearance without the active participation of the patient. These devices provide high-frequency chest compression using an inflatable vest and an air-pulse generator. 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 pulmonary secretions.

The Percussionaire device delivers intrapulmonary percussive ventilation (IPV) and is another type of passive oscillatory device. This device combines internal thoracic percussion through rapid minibursts of inhaled air and continuous therapeutic aerosol delivered through a nebulizer.

All of the above techniques can be used as alternatives to daily percussion and postural drainage (P/PD), also known as chest physical therapy or chest physiotherapy, in patients with cystic fibrosis and other respiratory disorders. P/PD needs to be administered by a physical therapist or another trained adult in the home, typically a parent if the patient is a child. The necessity for regular therapy can be particularly burdensome for adolescents or adults who wish to 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.

POSITION STATEMENT:

Oscillatory devices meet the definition of medical necessity when criteria 1 and 3 OR criteria 2 and 3 are met:

  1. The patient has a diagnosis of cystic fibrosis; OR
  2. The patient has a diagnosis of bronchiectasis confirmed by a high resolution, spiral, or standard CT scan and is characterized by the following:
  1. There is documentation in the patient’s medical record that standard chest physiotherapy (any of the following: postural drainage, daily percussion, turning deep breathing exercises) to adequately mobilize secretions have failed (e.g., physician history and physical, progress notes, respiratory therapy progress notes) or is not available or tolerated.

The Flutter® valve and Acapella® device meets the definition of medical necessity when used on a daily basis for persons with hypersecretory lung disorders and when the individuals are required to do daily pulmonary drainage or compression physiotherapy to help loosen secretions from the respiratory tract (e.g., bronchial drainage).

Percussors used for mobilizing respiratory tract secretions in patients with chronic obstructive lung disease, chronic bronchitis, or emphysema, meet the definition of medical necessity when the patient or operator of the powered percussor receives appropriate training by a physician or therapist, and there is no competent caregiver available to administer manual therapy.

Other applications of oscillatory devices are considered experimental or investigational, as there is insufficient published scientific evidence to permit conclusions regarding the effect on health outcomes, specifically for use as an adjunct to chest physical therapy or for conditions other than cystic fibrosis or bronchiectasis.

Intrapulmonary percussive ventilation (IPV) is considered experimental or investigational, as there is insufficient published clinical data to permit conclusions regarding the effect on health outcomes.

BILLING/CODING INFORMATION:

The following HCPCS codes may be used to describe devices used for high frequency chest compression or chest wall oscillation:

HCPCS Coding:

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

E0481

Intrapulmonary percussive ventilation system and related accessories (Investigational)

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

LOINC Codes:

The following information may be required documentation to support medical necessity: Treating physician history and physical; treatment notes including established diagnosis; respiratory therapy treatment notes and progress notes.

Documentation Table

LOINC Codes

LOINC
Time Frame
Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician visit note or treatment notes

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Respiratory therapy treatment plan

27726-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Respiratory therapy treatment, progress

27721-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

REIMBURSEMENT INFORMATION:

Replacement supplies (A7025 and A7026) used with member owned equipment are reimbursable if the member meets the criteria listed above for the base device (E0483).

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Intrapulmonary Percussive Ventilator (240.5) and Durable Medical Equipment Reference List (280.1) located at cms.gov.

The following Durable Medical Equipment Regional Carrier (DMERC) Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: High Frequency Chest Wall Oscillation Devices (L12934) located at cgsmedicare.com.

DEFINITIONS:

Bronchiectasis: dilation of the bronchi due to infection or chronic conditions, causing decreased lung capacity and recurrent infections of lungs.

Chest percussion: the act or technique of massage consisting of the striking of the back with light rapid blows to loosen secretions in the lungs.

Cystic fibrosis (CF): a genetic condition that results in excessive and difficult-to-clear mucous secretions in the lungs, leading to airway obstruction, infection, hypoxemia, and bronchiectasis; requires routine maintenance chest physical therapy on a daily basis; symptoms are eventually fatal.

Hypersecretory: The production of excessive amounts of mucus. Hypersecretion occurs during infections in an attempt to rid the body of the microorganisms causing the infection.

Oscillation: the action or state of oscillating; something that moves or travels back and forth between two points.

Postural drainage: drainage of the lungs by placing the patient in an inverted position so that fluids are drawn by gravity toward the trachea.

RELATED GUIDELINES:

None applicable.

OTHER:

Other names and terms used to report Oscillatory Devices:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of
one product over another, and is not intended to represent a complete listing of all products available.

• ABI Vest

• Acapella® device (DHD Healthcare)

• Bird IPV® Noncontinuous Ventilator (Percussionaire Corp)

• Flutter® Mucus Clearance Device (Axcan)

• Frequencer

• High frequency chest compression (HFCC)

• High frequency chest wall oscillation (HFCWO)

• InCourage Vest/System

• Intrapulmonary Percussive Ventilation (IPV)

• Intrapulmonary percussive ventilatory

• MedPulse Respiratory Vest System

• Oscillatory devices

• Percussionaire

• RC Cornet™ Mucus Clearing Device (PARI Respiratory Equipment)

• Respin11 Bronchial Clearance System (MedInnovation/RespInnovation)

• SmartVest

• ThAIRapy Vest System®

• Vest™ Airway System

The ThAIRapy Bronchial Drainage System. Since 1998, updated versions of the device were cleared by the FDA—most recently a fifth generation device. The device is now known as the Vest™ Airway Clearance System, and it is manufactured by Hill-Rom.

REFERENCES:

  1. American Association of Respiratory Care (AARC). Policy statement on the definition and appropriate applications of postural drainage therapy (PDT), (1991).
  2. American College of Chest Physicians. McCool FD, Rosen MJ. Nonpharmacologic airway clearance therapies: ACCP evidence-based clinical practice guidelines. [Chest 2006 Jan; 129(1 Suppl): 250S-9S].
  3. American Medical Association CPT (current edition).
  4. Blue Cross Blue Shield Association Medical Policy Reference Manual – 1.01.15 Oscillatory Devices for the Treatment of Cystic Fibrosis and Other Respiratory Disorders, 02/15.
  5. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Intrapulmonary Percussive Ventilator (IPV) (240.5), 07/97; accessed at cms.gov 02/13/15.
  6. Centers for Medicare and Medicaid Services (CMS) DMERC Local Coverage Determination (LCD): High Frequency Chest Wall Oscillation Devices (L12934), 07/13; accessed at cgsmedicare.com 02/13/15.
  7. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) for Durable Medical Equipment Reference List (280.1), 07/05; accessed at cms.gov 02/13/15.
  8. Cystic Fibrosis Foundation (CFF). Airway clearance techniques. Accessed 06/11/08 at CFF Website.
  9. ECRI Target Report; “High Frequency Chest Compression for COPD”, (03/03).
  10. ECRI Windows on Technology; “High-Frequency Chest Compression for Cystic Fibrosis”, (06/22/05 updated 03/12/08).
  11. HAYES Medical Technology Directory, “High-Frequency Chest Wall Compression” (03/03/00; Updated 08/01/03; updated 06/18/05).
  12. HAYES Medical Technology Directory, “High-Frequency Chest Wall Compression for Diseases Other Than Cystic Fibrosis” (04/14/05; updated 04/08/08).
  13. HAYES Medical Technology Directory, “High-Frequency Chest Wall Compression for Cystic Fibrosis” (06/22/04; updated 06/05/07).
  14. Kempainen RR, Milla C, Dunitz J, Savik K, Hazelwood A, Williams C, Rubin BK, Billings JL. Comparison of settings used for high-frequency chest-wall compression in cystic fibrosis. Respir Care. 2010 Jun;55(6):695-701.
  15. Morrison L, Agnew J. Oscillating devices for airway clearance in people with cystic fibrosis. (Protocol) Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No.: CD006842. DOI: 10.1002/14651858.CD006842.
  16. Pryor JA, Tannenbaum E, Scott SF, Burgess J, Cramer D, Gyi K, Hodson ME. Beyond postural drainage and percussion: Airway clearance in people with cystic fibrosis. J Cyst Fibros. 2010 May;9(3):187-92. Epub 2010 Feb 12.
  17. The Vest™ Airway Clearance System (home page). Hill-Rom Services, Inc. Accessed 05/14/09.
  18. Wagener, JS and Headley, AA. “Cystic Fibrosis: Current Trends in Respiratory Care”; Respiratory Care, March 2003, 48:3 (pp. 234-247).

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 03/26/15.

GUIDELINE UPDATE INFORMATION:

09/01/01

Medical Coverage Guideline Reformatted.

01/01/02

HCPCS coding changes.

10/24/02

Reviewed for investigational; some information revised using BCA policy (MPCC).

12/15/02

Changed guideline name to oscillatory devices, and added flutter device in the guideline title. Added coverage criteria for children with cystic fibrosis. The coverage criteria are based on coverage of other plans (Care First Blue Minnesota, California).

09/15/03

Reviewed; removed references to age requirement.

06/15/04

Unscheduled review; revised to include Program Exception for Medicare & More.

06/15/05

Scheduled review and revision, consisting of inclusion of an additional covered indication.

07/15/06

Scheduled review; added DME code E0480; no change in coverage statement.

07/15/07

Scheduled review; added position statement regarding percussors; added reimbursement statement for associated supplies; reformatted guidelines; updated references.

07/15/08

Annual review; no change in position statement; references updated.

07/15/09

Scheduled review; position statement revised with additional criteria; updated ICD-9 diagnosis coding; added Program Exception for Medicare Advantage; updated references; formatting changes.

12/15/10

Revisions: related ICD-10 codes added, formatting changes.

02/15/11

Review; Position Statement revised; references updated; formatting changes.

09/15/11

Revision; formatting changes.

06/15/13

Revision: Title revised; Description section updated; Program Exceptions section updated; additional brand names added.

04/15/15

Revision; Position statement, description, and references updated; formatting changes.

11/01/15

Revision: ICD-9 Codes deleted.

10/01/16

Revision; coding section updated.

Date Printed: December 17, 2017: 10:13 PM