johns hopkins healthcare llc policy number cms01.02 ......exsufflation devices experimental and...

6
Version 0.0.136 Policy Number CMS01.02 Effective Date 07/01/2019 Johns Hopkins HealthCare LLC Medical Policy Medical Policy Review Date 05/21/2019 Revision Date 05/21/2019 Subject Airway Clearance Devices Page 1 of 6 This document applies to the following Participating Organizations: EHP Johns Hopkins Advantage MD Priority Partners US Family Health Plan Keywords : Chest compression systems, Cystic fibrosis, SmartVest Table of Contents Page Number I. ACTION 1 II. POLICY DISCLAIMER 1 III. POLICY 1 IV. POLICY CRITERIA 2 V. DEFINITIONS 2 VI. BACKGROUND 3 VII. CODING DISCLAIMER 3 VIII. CODING INFORMATION 4 IX. REFERENCE STATEMENT 5 X. REFERENCES 5 XI. APPROVALS 6 I. ACTION New Policy x Revising Policy Number CMS01.02 Superseding Policy Number Archiving Policy Number Retiring Policy Number II. POLICY DISCLAIMER Johns Hopkins HealthCare LLC (JHHC) provides a full spectrum of health care products and services for Employer Health Programs, Priority Partners, Advantage MD, and US Family Health Plan. Each line of business possesses its own unique contract and guidelines which, for benefit and payment purposes, should be consulted first to know what benefits are available for coverage. Specific contract benefits, guidelines or policies supersede the information outlined in this policy. III. POLICY For Advantage MD, see Medicare Coverage Database : Local Coverage Determination (LCD) L33785, High Frequency Chest Wall Oscillation Devices Local Coverage Determination (LCD) L33795, Mechanical In-exsufflation Devices Medicare does not have a National Coverage Determination (NCD) for Airway Clearance Devices © Copyright 2019 by The Johns Hopkins Health System Corporation and/or The Johns Hopkins University

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Page 1: Johns Hopkins HealthCare LLC Policy Number CMS01.02 ......exsufflation devices experimental and investigational for all other indications, as they do not meet Technology Evaluation

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 1 of 6

This document applies to the following Participating Organizations

EHP Johns Hopkins Advantage MD Priority Partners US Family Health Plan

Keywords Chest compression systems Cystic fibrosis SmartVest

Table of Contents Page Number

I ACTION 1II POLICY DISCLAIMER 1III POLICY 1IV POLICY CRITERIA 2V DEFINITIONS 2VI BACKGROUND 3VII CODING DISCLAIMER 3VIII CODING INFORMATION 4IX REFERENCE STATEMENT 5X REFERENCES 5XI APPROVALS 6

I ACTION New Policy

x Revising Policy Number CMS0102

Superseding Policy Number

Archiving Policy Number

Retiring Policy Number

II POLICY DISCLAIMERJohns Hopkins HealthCare LLC (JHHC) provides a full spectrum of health care products and services for Employer HealthPrograms Priority Partners Advantage MD and US Family Health Plan Each line of business possesses its own uniquecontract and guidelines which for benefit and payment purposes should be consulted first to know what benefits are availablefor coverage

Specific contract benefits guidelines or policies supersede the information outlined in this policy

III POLICYFor Advantage MD see Medicare Coverage Database

bull Local Coverage Determination (LCD) L33785 High Frequency Chest Wall Oscillation Devicesbull Local Coverage Determination (LCD) L33795 Mechanical In-exsufflation Devicesbull Medicare does not have a National Coverage Determination (NCD) for Airway Clearance Devices

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 2 of 6

For USFHP see

bull TRICARE Policy Manual 601060-M April 1 2015 Mucus Clearance Devices Chapter 8 Section 161

IV POLICY CRITERIAA When benefits are provided under the memberrsquos contract JHHC considers the use of high-frequency chest compression

systems medically necessary for documented failure of standard treatment to adequately mobilize retained secretions forthe following indications1 Bronchiectasis which has been confirmed by CT scan and is characterized by

a Daily productive cough for at least 6 continuous months ORb More than two exacerbations in a 12 month period requiring antibiotic treatment OR

2 Cystic fibrosis or immotile cilia syndrome OR3 The member has one of the following neuromuscular pulmonary or respiratory disease diagnoses

a Acid maltase deficiencyb Anterior horn cell diseases including amyotrophic lateral sclerosisc Hereditary muscular dystrophyd Multiple sclerosise Myotonic disordersf Other myopathiesg Paralysis of the diaphragmh Post-polio i Quadriplegiaj Chronic Obstructive Pulmonary Disease (COPD)k Lung transplant recipient

B The following are examples of systems that may be used if medical necessity requirements are met and ordered byprovider This list is not all-inclusive1 SmartVestreg2 MedPulsereg Respiratory Vest System3 The Vestreg Airway Clearance System4 ABI Vest5 Incouragetrade VestSystem

C Unless specific benefits are provided under the memberrsquos contract JHHC considers the use of high-frequency chestcompression systems experimental and investigational for all other indications as they do not meet TechnologyEvaluation Criteria (TEC)

D When benefits are provided under the memberrsquos contract JHHC considers the use of mechanical insufflation-exsufflationdevices (eg VitalCoughtrade) medically necessary for patients with neuromuscular disease (eg spinal cord injuryquadriplegia amyotrophic lateral sclerosis) that is causing a significant impairment of chest wall andor diaphragmaticmovement and for whom standard treatments (eg chest percussion and postural drainage etc) have not been successfulin adequately mobilizing retained secretions

E Unless specific benefits are provided under the members contract JHHC considers the use of mechanical insufflation-exsufflation devices experimental and investigational for all other indications as they do not meet Technology EvaluationCriteria (TEC)

V DEFINITIONSBronchiectasis is a condition in which damage to the airways causes them to widen and become flabby and scarred Theairways are tubes that carry air in and out of the lungs It is usually the result of an infection or other condition that injures

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 3 of 6

the walls of the airways or prevents the airways from clearing mucus Mucus is a slimy substance that the airways produce tohelp remove inhaled dust bacteria and other small particles In bronchiectasis the airways slowly lose their ability to clearout mucus When mucus cant be cleared it builds up and creates an environment in which bacteria can grow This leads torepeated serious lung infections Each infection causes more damage to the airways Over time the airways lose their ability tomove air in and out This can prevent enough oxygen from reaching your vital organs Bronchiectasis can lead to serious healthproblems such as respiratory failure atelectasis and heart failure It can effect one section of a personrsquos lungs or many sectionsof both lungs (National Heart Lung and Blood Institute 2018)

Chest Physical Therapy (CPT or Chest PT) is an airway clearance technique (ACT) to drain the lungs and may includepercussion (clapping) vibration deep breathing and huffing or coughing (Cystic Fibrosis Foundation 2018)

Cystic Fibrosis (CF) is an inherited disease caused by mutations in a gene called the cystic fibrosis transmembraneconductance regulator (CFTR) gene The CFTR gene provides instructions for the CFTR protein The CFTR protein is locatedin every organ of the body that makes mucus including the lungs liver pancreas and intestines as well as sweat glands TheCFTR protein has also been found in other cells in the body such as cells of the heart and the immune system The mutationsin the CFTR gene cause the CFTR protein to not work properly This causes thick sticky mucus and blockages in the lungsand digestive system Normally mucus coats tiny hair-like structures called cilia in the airways of your lungs which sweep themucus particles up to the nose and mouth where your body can get rid of them In people who have cystic fibrosis this processdoes not work properly (National Heart Lung and Blood Institute 2018)

High-frequency Chest Wall Compression Systems (HFCWC) is a mechanical form of chest physiotherapy (CPT) used as analternative to conventional chest physical therapy in patients with impaired ability to clear pulmonary secretions The purposeof HFCWC is to promote effective airway clearance and pulmonary function by adjusting airflow patterns and reducing sputumviscosity which aids in mucociliary clearance The HFCWC may also be called High Frequency Chest Wall Oscillation(HFCWO) (Hayes 2019)

VI BACKGROUNDThe administration and utilization of airway clearance devices has increased over the years particularly in patients diagnosedwith respiratory diseases such as cystic fibrosis Respiratory physiotherapy devices are designed to help improve pulmonaryfunction through techniques such as mucus removal Patients with neuromuscular disorders (NMDs) may have weakrespiratory (breathing) muscles which makes it difficult for them to effectively cough and clear mucus from the lungs Thisplaces them at risk of recurrent chest infections and chronic lung disease Mechanical insufflation-exsufflation (MI-E) is one ofa number of techniques available to improve cough efficacy and mucus clearance MI-E is given through a mask mouthpieceor via a tracheostomy (an opening in the neck into the windpipe) MI-E acts like a cough first pushing air into the lungs whenthe person breathes in (insufflation) then sucking it out again (exsufflation) (Morrow 2013)

VII CODING DISCLAIMERCPT Copyright 2018 American Medical Association All rights reserved CPT is a registered trademark of the AmericanMedical Association

Note The following CPTHCPCS codes are included below for informational purposes and may not be all inclusive Inclusionor exclusion of a CPTHCPCS code(s) below does not signify or imply that the service described by the code is a coveredor non-covered health service Benefit coverage for health services is determined by the memberrsquos specific benefit plandocument and applicable laws that require coverage for a specific service The inclusion of a code does not imply any right toreimbursement or guarantee of payment Other policies and coverage determination guidelines may apply

Note All inpatient admissions require pre-authorization

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 4 of 6

Compliance with the provision in this policy may be monitored andaddressed through post payment data analysis andor medical review audits

Employer Health Programs(EHP) refer to specificSummary Plan Description(SPD) If there is no criteriain the SPD apply the MedicalPolicy criteria

Priority Partners (PPMCO)refer to COMAR guidelinesthen apply the Medical Policycriteria

US Family Health Plan(USFHP) TRICARE MedicalPolicy supersedes JHHCMedical Policy If there is noPolicy in TRICARE applythe Medical Policy Criteria

Advantage MD LCDand NCD Medical Policysupersedes JHHC MedicalPolicy If there is no LCDor NCD apply the MedicalPolicy Criteria

VIII CODING INFORMATION

HCPCSCODES

DESCRIPTION

A7020 Interface for cough stimulating device includes all components replacement only

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

E0482 Cough stimulating device alternating positive and negative airway pressure

E0483 High frequency chest wall oscillation system includes all accessories and supplies each

E0484 Oscillatory positive expiratory pressure device nonelectric any type each

ICD10 CODES DESCRIPTION

A150 Tuberculosis of lung [tuberculous bronchiectasis]

E840- E849 Cystic fibrosis

G14 Postpolio syndrome

G1220 Motor neuron disease unspecified

G1221 Amyotrophic lateral sclerosis

G35 Multiple sclerosis

G7102 Facioscapulohumeral muscular dystrophy

G7111 ndashG7119

Myotonic disorders

G720 ndash G729 Other and unspecified myopathies

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 5 of 6

G8250 -G8254

Quadriplegia

J470-J479 Bronchiectasis

J986 Disorders of diaphragm [paralysis of the diaphragm]

Q334 Congenital bronchiectasis

Q348 Otherspecified congenital malformations of respiratory system

Z942 Lung transplant status

IX REFERENCE STATEMENTAnalyses of the scientific and clinical references cited below were conducted and utilized by the Johns Hopkins HealthCareLLC (JHHC) Medical Policy Team during the development and implementation of this medical policy The Medical PolicyTeam will continue to monitor and review any newly published clinical evidence and revise the policy and adjust the referencesbelow accordingly if deemed necessary

X REFERENCESAetna (2019) Clinical Policy Bulletin Chest Physiotherapy and Airway Clearance Devices Medical Policy Number 0067Retrieved httpwwwaetnacom

Bach JR (2019) Continuous noninvasive ventilatory support for patients with neuromuscular or chest wall diseaseUpToDate Retrieved httpwwwuptodatecom

Blue Cross Blue Shield Regence (2019) Medical Policy Manual Oscillatory Devices for the Treatment of Cystic Fibrosis andOther Respiratory Conditions Durable Medical Equipment Policy Number 45 Retrieved httpblueregencecomtrgmedpoldmedme45pdf

Centers for Medicare and Medicaid Services (CMS) (2016) Local Coverage Determination (LCD) Mechanical In-exsufflation Devices (L33795) Retrieved httpswwwcmsgovmedicare-coverage-databasedetailslcd-detailsaspxLCDId=33795ampver=24ampDate=052f312f2019ampDocID=L33795ampbc=iAAAABAAAAAAamp

Centers for Medicare and Medicaid Services (CMS) (2008) Local Coverage Determination (LCD) High Frequency ChestWall Oscillation Devices (L12870) Retrieved httpwwwcmsgov

Centers for Medicare and Medicaid Services (CMS) (2019) Local Coverage Determination (LCD) Intrapulmonary PercussiveVentilation System (L33786) Retrieved httpswwwcmsgovmedicare-coverage-databasedetailslcd-detailsaspxLCDId=33786ampver=7ampDocID=L33786ampbc=gAAAABAAAAAA

Cigna (2018) Medical Policy Airway Clearance Devices in the Ambulatory Setting Medical Policy Number 0069 Retrievedhttpscignaforhcpcignacom

COMAR Regulations Online Table of Rare and Expensive Disease List Cystic Fibrosis Pulmonary ManifestationsRetrieved httpwwwdsdstatemdus

Cystic Fibrosis Foundation (2018) Airway Clearance Retrieved httpwwwcfforg

Hayes Inc ( 2017) Medical Technology Directory CoughAssistreg Mechanical InsufflationExsufflation (MI-E) Device (J HEmerson Co) for Respiratory Insufficiency Retrieved httpwwwhayesinccom

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 6 of 6

Hayes Inc (2018) Medical Technology Directory High-Frequency Chest Wall Compression for Diseases Other Than CysticFibrosis Retrieved httpwwwhayesinccom

Hayes Inc (2019) Medical Technology Directory High-Frequency Chest Wall Compression for Cystic Fibrosis RetrievedhttpswwwhayesinccomsubscribersdisplaySubscriberArticledoarticleId=56406

Homnick DN (2011) Mechanical insufflation-exsufflation for airway mucus clearance Journal of Respiratory Care Vol52(10) p 1296-305 Retrieved httpswwwncbinlmnihgovpubmed17894900

Hristara-Papadopoulou A Tsanakas J Diomou G et al (2008) Current devices of respiratory physiotherapy HippokratiaQuarterly Medical Journal Vol 12(4) p 211-220 Retrieved httpswwwncbinlmnihgovpmcarticlesPMC2580042

Humana (2019) Medical Coverage Policy Airway Clearance Devices Medical Policy Number HCS-0310-015Retrievedhttpappshumanacom

Katkin JP (2018) Cystic Fibrosis Clinical Manifestations and Diagnosis UpToDate Retrieved httpswwwuptodatecomcontentscystic-fibrosis-clinical-manifestations-and-diagnosissearch=Cystic20Fibrosis20Clinical20Manifestations20and20Diagnosis20Katkinampsource=search_resultampselectedTitle=3~150ampusage_type=defaultampdisplay_rank=3

Mahede T Davis G Rutkay A et al (2015) Use of mechanical airway clearance devices in the home by people withneuromuscular disorders effects on health service use and lifestyle benefits Orphanet Journal of Rare Diseases Vol 10 epubRetrieved httpswwwncbinlmnihgovpubmed25943355

Morrow B Zampoli M et al (2013) Mechanical insufflation-exsufflation for people with neuromuscular disordersCochrane Library Retrieved httpswwwcochranelibrarycomcdsrdoi10100214651858CD010044pub2full

National Heart Lung and Blood Institute (NIH) (2018) Bronchiectasis US Department of Health amp Human ServicesRetrieved httpswwwnhlbinihgovhealth-topicsbronchiectasis

National Heart Lung and Blood Institute (NIH) (2018) Cystic Fibrosis US Department of Health amp Human ServicesRetrieved httpswwwnhlbinihgovhealth-topicscystic-fibrosis

Oermann CM Sockrider MM Giles D et al (2001) Comparison of High-Frequency Chest Wall Oscillation andOscillating Positive Expiratory Pressure in the Home Management of Cystic Fibrosis A Pilot Study Pediatric PulmonologyVol 32(5) p 372-7 Retrieved httpswwwncbinlmnihgovpubmed11596162

The Vest Airwayreg Clearance System (2019) Retrieved httpwwwthevestcom

TRICARE Policy Manual 601060-M April 1 2015 Chapter 8 Section 161 Mucus Clearance Devices Retrieved httpmanualstricareosdmil

XI APPROVALS Historical Effective Dates 10222003 10222004 10192005 10202006 10222007 09082008 1204200901072011 02282012 03032017 07012019

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University

Page 2: Johns Hopkins HealthCare LLC Policy Number CMS01.02 ......exsufflation devices experimental and investigational for all other indications, as they do not meet Technology Evaluation

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 2 of 6

For USFHP see

bull TRICARE Policy Manual 601060-M April 1 2015 Mucus Clearance Devices Chapter 8 Section 161

IV POLICY CRITERIAA When benefits are provided under the memberrsquos contract JHHC considers the use of high-frequency chest compression

systems medically necessary for documented failure of standard treatment to adequately mobilize retained secretions forthe following indications1 Bronchiectasis which has been confirmed by CT scan and is characterized by

a Daily productive cough for at least 6 continuous months ORb More than two exacerbations in a 12 month period requiring antibiotic treatment OR

2 Cystic fibrosis or immotile cilia syndrome OR3 The member has one of the following neuromuscular pulmonary or respiratory disease diagnoses

a Acid maltase deficiencyb Anterior horn cell diseases including amyotrophic lateral sclerosisc Hereditary muscular dystrophyd Multiple sclerosise Myotonic disordersf Other myopathiesg Paralysis of the diaphragmh Post-polio i Quadriplegiaj Chronic Obstructive Pulmonary Disease (COPD)k Lung transplant recipient

B The following are examples of systems that may be used if medical necessity requirements are met and ordered byprovider This list is not all-inclusive1 SmartVestreg2 MedPulsereg Respiratory Vest System3 The Vestreg Airway Clearance System4 ABI Vest5 Incouragetrade VestSystem

C Unless specific benefits are provided under the memberrsquos contract JHHC considers the use of high-frequency chestcompression systems experimental and investigational for all other indications as they do not meet TechnologyEvaluation Criteria (TEC)

D When benefits are provided under the memberrsquos contract JHHC considers the use of mechanical insufflation-exsufflationdevices (eg VitalCoughtrade) medically necessary for patients with neuromuscular disease (eg spinal cord injuryquadriplegia amyotrophic lateral sclerosis) that is causing a significant impairment of chest wall andor diaphragmaticmovement and for whom standard treatments (eg chest percussion and postural drainage etc) have not been successfulin adequately mobilizing retained secretions

E Unless specific benefits are provided under the members contract JHHC considers the use of mechanical insufflation-exsufflation devices experimental and investigational for all other indications as they do not meet Technology EvaluationCriteria (TEC)

V DEFINITIONSBronchiectasis is a condition in which damage to the airways causes them to widen and become flabby and scarred Theairways are tubes that carry air in and out of the lungs It is usually the result of an infection or other condition that injures

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 3 of 6

the walls of the airways or prevents the airways from clearing mucus Mucus is a slimy substance that the airways produce tohelp remove inhaled dust bacteria and other small particles In bronchiectasis the airways slowly lose their ability to clearout mucus When mucus cant be cleared it builds up and creates an environment in which bacteria can grow This leads torepeated serious lung infections Each infection causes more damage to the airways Over time the airways lose their ability tomove air in and out This can prevent enough oxygen from reaching your vital organs Bronchiectasis can lead to serious healthproblems such as respiratory failure atelectasis and heart failure It can effect one section of a personrsquos lungs or many sectionsof both lungs (National Heart Lung and Blood Institute 2018)

Chest Physical Therapy (CPT or Chest PT) is an airway clearance technique (ACT) to drain the lungs and may includepercussion (clapping) vibration deep breathing and huffing or coughing (Cystic Fibrosis Foundation 2018)

Cystic Fibrosis (CF) is an inherited disease caused by mutations in a gene called the cystic fibrosis transmembraneconductance regulator (CFTR) gene The CFTR gene provides instructions for the CFTR protein The CFTR protein is locatedin every organ of the body that makes mucus including the lungs liver pancreas and intestines as well as sweat glands TheCFTR protein has also been found in other cells in the body such as cells of the heart and the immune system The mutationsin the CFTR gene cause the CFTR protein to not work properly This causes thick sticky mucus and blockages in the lungsand digestive system Normally mucus coats tiny hair-like structures called cilia in the airways of your lungs which sweep themucus particles up to the nose and mouth where your body can get rid of them In people who have cystic fibrosis this processdoes not work properly (National Heart Lung and Blood Institute 2018)

High-frequency Chest Wall Compression Systems (HFCWC) is a mechanical form of chest physiotherapy (CPT) used as analternative to conventional chest physical therapy in patients with impaired ability to clear pulmonary secretions The purposeof HFCWC is to promote effective airway clearance and pulmonary function by adjusting airflow patterns and reducing sputumviscosity which aids in mucociliary clearance The HFCWC may also be called High Frequency Chest Wall Oscillation(HFCWO) (Hayes 2019)

VI BACKGROUNDThe administration and utilization of airway clearance devices has increased over the years particularly in patients diagnosedwith respiratory diseases such as cystic fibrosis Respiratory physiotherapy devices are designed to help improve pulmonaryfunction through techniques such as mucus removal Patients with neuromuscular disorders (NMDs) may have weakrespiratory (breathing) muscles which makes it difficult for them to effectively cough and clear mucus from the lungs Thisplaces them at risk of recurrent chest infections and chronic lung disease Mechanical insufflation-exsufflation (MI-E) is one ofa number of techniques available to improve cough efficacy and mucus clearance MI-E is given through a mask mouthpieceor via a tracheostomy (an opening in the neck into the windpipe) MI-E acts like a cough first pushing air into the lungs whenthe person breathes in (insufflation) then sucking it out again (exsufflation) (Morrow 2013)

VII CODING DISCLAIMERCPT Copyright 2018 American Medical Association All rights reserved CPT is a registered trademark of the AmericanMedical Association

Note The following CPTHCPCS codes are included below for informational purposes and may not be all inclusive Inclusionor exclusion of a CPTHCPCS code(s) below does not signify or imply that the service described by the code is a coveredor non-covered health service Benefit coverage for health services is determined by the memberrsquos specific benefit plandocument and applicable laws that require coverage for a specific service The inclusion of a code does not imply any right toreimbursement or guarantee of payment Other policies and coverage determination guidelines may apply

Note All inpatient admissions require pre-authorization

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 4 of 6

Compliance with the provision in this policy may be monitored andaddressed through post payment data analysis andor medical review audits

Employer Health Programs(EHP) refer to specificSummary Plan Description(SPD) If there is no criteriain the SPD apply the MedicalPolicy criteria

Priority Partners (PPMCO)refer to COMAR guidelinesthen apply the Medical Policycriteria

US Family Health Plan(USFHP) TRICARE MedicalPolicy supersedes JHHCMedical Policy If there is noPolicy in TRICARE applythe Medical Policy Criteria

Advantage MD LCDand NCD Medical Policysupersedes JHHC MedicalPolicy If there is no LCDor NCD apply the MedicalPolicy Criteria

VIII CODING INFORMATION

HCPCSCODES

DESCRIPTION

A7020 Interface for cough stimulating device includes all components replacement only

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

E0482 Cough stimulating device alternating positive and negative airway pressure

E0483 High frequency chest wall oscillation system includes all accessories and supplies each

E0484 Oscillatory positive expiratory pressure device nonelectric any type each

ICD10 CODES DESCRIPTION

A150 Tuberculosis of lung [tuberculous bronchiectasis]

E840- E849 Cystic fibrosis

G14 Postpolio syndrome

G1220 Motor neuron disease unspecified

G1221 Amyotrophic lateral sclerosis

G35 Multiple sclerosis

G7102 Facioscapulohumeral muscular dystrophy

G7111 ndashG7119

Myotonic disorders

G720 ndash G729 Other and unspecified myopathies

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 5 of 6

G8250 -G8254

Quadriplegia

J470-J479 Bronchiectasis

J986 Disorders of diaphragm [paralysis of the diaphragm]

Q334 Congenital bronchiectasis

Q348 Otherspecified congenital malformations of respiratory system

Z942 Lung transplant status

IX REFERENCE STATEMENTAnalyses of the scientific and clinical references cited below were conducted and utilized by the Johns Hopkins HealthCareLLC (JHHC) Medical Policy Team during the development and implementation of this medical policy The Medical PolicyTeam will continue to monitor and review any newly published clinical evidence and revise the policy and adjust the referencesbelow accordingly if deemed necessary

X REFERENCESAetna (2019) Clinical Policy Bulletin Chest Physiotherapy and Airway Clearance Devices Medical Policy Number 0067Retrieved httpwwwaetnacom

Bach JR (2019) Continuous noninvasive ventilatory support for patients with neuromuscular or chest wall diseaseUpToDate Retrieved httpwwwuptodatecom

Blue Cross Blue Shield Regence (2019) Medical Policy Manual Oscillatory Devices for the Treatment of Cystic Fibrosis andOther Respiratory Conditions Durable Medical Equipment Policy Number 45 Retrieved httpblueregencecomtrgmedpoldmedme45pdf

Centers for Medicare and Medicaid Services (CMS) (2016) Local Coverage Determination (LCD) Mechanical In-exsufflation Devices (L33795) Retrieved httpswwwcmsgovmedicare-coverage-databasedetailslcd-detailsaspxLCDId=33795ampver=24ampDate=052f312f2019ampDocID=L33795ampbc=iAAAABAAAAAAamp

Centers for Medicare and Medicaid Services (CMS) (2008) Local Coverage Determination (LCD) High Frequency ChestWall Oscillation Devices (L12870) Retrieved httpwwwcmsgov

Centers for Medicare and Medicaid Services (CMS) (2019) Local Coverage Determination (LCD) Intrapulmonary PercussiveVentilation System (L33786) Retrieved httpswwwcmsgovmedicare-coverage-databasedetailslcd-detailsaspxLCDId=33786ampver=7ampDocID=L33786ampbc=gAAAABAAAAAA

Cigna (2018) Medical Policy Airway Clearance Devices in the Ambulatory Setting Medical Policy Number 0069 Retrievedhttpscignaforhcpcignacom

COMAR Regulations Online Table of Rare and Expensive Disease List Cystic Fibrosis Pulmonary ManifestationsRetrieved httpwwwdsdstatemdus

Cystic Fibrosis Foundation (2018) Airway Clearance Retrieved httpwwwcfforg

Hayes Inc ( 2017) Medical Technology Directory CoughAssistreg Mechanical InsufflationExsufflation (MI-E) Device (J HEmerson Co) for Respiratory Insufficiency Retrieved httpwwwhayesinccom

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 6 of 6

Hayes Inc (2018) Medical Technology Directory High-Frequency Chest Wall Compression for Diseases Other Than CysticFibrosis Retrieved httpwwwhayesinccom

Hayes Inc (2019) Medical Technology Directory High-Frequency Chest Wall Compression for Cystic Fibrosis RetrievedhttpswwwhayesinccomsubscribersdisplaySubscriberArticledoarticleId=56406

Homnick DN (2011) Mechanical insufflation-exsufflation for airway mucus clearance Journal of Respiratory Care Vol52(10) p 1296-305 Retrieved httpswwwncbinlmnihgovpubmed17894900

Hristara-Papadopoulou A Tsanakas J Diomou G et al (2008) Current devices of respiratory physiotherapy HippokratiaQuarterly Medical Journal Vol 12(4) p 211-220 Retrieved httpswwwncbinlmnihgovpmcarticlesPMC2580042

Humana (2019) Medical Coverage Policy Airway Clearance Devices Medical Policy Number HCS-0310-015Retrievedhttpappshumanacom

Katkin JP (2018) Cystic Fibrosis Clinical Manifestations and Diagnosis UpToDate Retrieved httpswwwuptodatecomcontentscystic-fibrosis-clinical-manifestations-and-diagnosissearch=Cystic20Fibrosis20Clinical20Manifestations20and20Diagnosis20Katkinampsource=search_resultampselectedTitle=3~150ampusage_type=defaultampdisplay_rank=3

Mahede T Davis G Rutkay A et al (2015) Use of mechanical airway clearance devices in the home by people withneuromuscular disorders effects on health service use and lifestyle benefits Orphanet Journal of Rare Diseases Vol 10 epubRetrieved httpswwwncbinlmnihgovpubmed25943355

Morrow B Zampoli M et al (2013) Mechanical insufflation-exsufflation for people with neuromuscular disordersCochrane Library Retrieved httpswwwcochranelibrarycomcdsrdoi10100214651858CD010044pub2full

National Heart Lung and Blood Institute (NIH) (2018) Bronchiectasis US Department of Health amp Human ServicesRetrieved httpswwwnhlbinihgovhealth-topicsbronchiectasis

National Heart Lung and Blood Institute (NIH) (2018) Cystic Fibrosis US Department of Health amp Human ServicesRetrieved httpswwwnhlbinihgovhealth-topicscystic-fibrosis

Oermann CM Sockrider MM Giles D et al (2001) Comparison of High-Frequency Chest Wall Oscillation andOscillating Positive Expiratory Pressure in the Home Management of Cystic Fibrosis A Pilot Study Pediatric PulmonologyVol 32(5) p 372-7 Retrieved httpswwwncbinlmnihgovpubmed11596162

The Vest Airwayreg Clearance System (2019) Retrieved httpwwwthevestcom

TRICARE Policy Manual 601060-M April 1 2015 Chapter 8 Section 161 Mucus Clearance Devices Retrieved httpmanualstricareosdmil

XI APPROVALS Historical Effective Dates 10222003 10222004 10192005 10202006 10222007 09082008 1204200901072011 02282012 03032017 07012019

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University

Page 3: Johns Hopkins HealthCare LLC Policy Number CMS01.02 ......exsufflation devices experimental and investigational for all other indications, as they do not meet Technology Evaluation

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 3 of 6

the walls of the airways or prevents the airways from clearing mucus Mucus is a slimy substance that the airways produce tohelp remove inhaled dust bacteria and other small particles In bronchiectasis the airways slowly lose their ability to clearout mucus When mucus cant be cleared it builds up and creates an environment in which bacteria can grow This leads torepeated serious lung infections Each infection causes more damage to the airways Over time the airways lose their ability tomove air in and out This can prevent enough oxygen from reaching your vital organs Bronchiectasis can lead to serious healthproblems such as respiratory failure atelectasis and heart failure It can effect one section of a personrsquos lungs or many sectionsof both lungs (National Heart Lung and Blood Institute 2018)

Chest Physical Therapy (CPT or Chest PT) is an airway clearance technique (ACT) to drain the lungs and may includepercussion (clapping) vibration deep breathing and huffing or coughing (Cystic Fibrosis Foundation 2018)

Cystic Fibrosis (CF) is an inherited disease caused by mutations in a gene called the cystic fibrosis transmembraneconductance regulator (CFTR) gene The CFTR gene provides instructions for the CFTR protein The CFTR protein is locatedin every organ of the body that makes mucus including the lungs liver pancreas and intestines as well as sweat glands TheCFTR protein has also been found in other cells in the body such as cells of the heart and the immune system The mutationsin the CFTR gene cause the CFTR protein to not work properly This causes thick sticky mucus and blockages in the lungsand digestive system Normally mucus coats tiny hair-like structures called cilia in the airways of your lungs which sweep themucus particles up to the nose and mouth where your body can get rid of them In people who have cystic fibrosis this processdoes not work properly (National Heart Lung and Blood Institute 2018)

High-frequency Chest Wall Compression Systems (HFCWC) is a mechanical form of chest physiotherapy (CPT) used as analternative to conventional chest physical therapy in patients with impaired ability to clear pulmonary secretions The purposeof HFCWC is to promote effective airway clearance and pulmonary function by adjusting airflow patterns and reducing sputumviscosity which aids in mucociliary clearance The HFCWC may also be called High Frequency Chest Wall Oscillation(HFCWO) (Hayes 2019)

VI BACKGROUNDThe administration and utilization of airway clearance devices has increased over the years particularly in patients diagnosedwith respiratory diseases such as cystic fibrosis Respiratory physiotherapy devices are designed to help improve pulmonaryfunction through techniques such as mucus removal Patients with neuromuscular disorders (NMDs) may have weakrespiratory (breathing) muscles which makes it difficult for them to effectively cough and clear mucus from the lungs Thisplaces them at risk of recurrent chest infections and chronic lung disease Mechanical insufflation-exsufflation (MI-E) is one ofa number of techniques available to improve cough efficacy and mucus clearance MI-E is given through a mask mouthpieceor via a tracheostomy (an opening in the neck into the windpipe) MI-E acts like a cough first pushing air into the lungs whenthe person breathes in (insufflation) then sucking it out again (exsufflation) (Morrow 2013)

VII CODING DISCLAIMERCPT Copyright 2018 American Medical Association All rights reserved CPT is a registered trademark of the AmericanMedical Association

Note The following CPTHCPCS codes are included below for informational purposes and may not be all inclusive Inclusionor exclusion of a CPTHCPCS code(s) below does not signify or imply that the service described by the code is a coveredor non-covered health service Benefit coverage for health services is determined by the memberrsquos specific benefit plandocument and applicable laws that require coverage for a specific service The inclusion of a code does not imply any right toreimbursement or guarantee of payment Other policies and coverage determination guidelines may apply

Note All inpatient admissions require pre-authorization

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 4 of 6

Compliance with the provision in this policy may be monitored andaddressed through post payment data analysis andor medical review audits

Employer Health Programs(EHP) refer to specificSummary Plan Description(SPD) If there is no criteriain the SPD apply the MedicalPolicy criteria

Priority Partners (PPMCO)refer to COMAR guidelinesthen apply the Medical Policycriteria

US Family Health Plan(USFHP) TRICARE MedicalPolicy supersedes JHHCMedical Policy If there is noPolicy in TRICARE applythe Medical Policy Criteria

Advantage MD LCDand NCD Medical Policysupersedes JHHC MedicalPolicy If there is no LCDor NCD apply the MedicalPolicy Criteria

VIII CODING INFORMATION

HCPCSCODES

DESCRIPTION

A7020 Interface for cough stimulating device includes all components replacement only

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

E0482 Cough stimulating device alternating positive and negative airway pressure

E0483 High frequency chest wall oscillation system includes all accessories and supplies each

E0484 Oscillatory positive expiratory pressure device nonelectric any type each

ICD10 CODES DESCRIPTION

A150 Tuberculosis of lung [tuberculous bronchiectasis]

E840- E849 Cystic fibrosis

G14 Postpolio syndrome

G1220 Motor neuron disease unspecified

G1221 Amyotrophic lateral sclerosis

G35 Multiple sclerosis

G7102 Facioscapulohumeral muscular dystrophy

G7111 ndashG7119

Myotonic disorders

G720 ndash G729 Other and unspecified myopathies

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 5 of 6

G8250 -G8254

Quadriplegia

J470-J479 Bronchiectasis

J986 Disorders of diaphragm [paralysis of the diaphragm]

Q334 Congenital bronchiectasis

Q348 Otherspecified congenital malformations of respiratory system

Z942 Lung transplant status

IX REFERENCE STATEMENTAnalyses of the scientific and clinical references cited below were conducted and utilized by the Johns Hopkins HealthCareLLC (JHHC) Medical Policy Team during the development and implementation of this medical policy The Medical PolicyTeam will continue to monitor and review any newly published clinical evidence and revise the policy and adjust the referencesbelow accordingly if deemed necessary

X REFERENCESAetna (2019) Clinical Policy Bulletin Chest Physiotherapy and Airway Clearance Devices Medical Policy Number 0067Retrieved httpwwwaetnacom

Bach JR (2019) Continuous noninvasive ventilatory support for patients with neuromuscular or chest wall diseaseUpToDate Retrieved httpwwwuptodatecom

Blue Cross Blue Shield Regence (2019) Medical Policy Manual Oscillatory Devices for the Treatment of Cystic Fibrosis andOther Respiratory Conditions Durable Medical Equipment Policy Number 45 Retrieved httpblueregencecomtrgmedpoldmedme45pdf

Centers for Medicare and Medicaid Services (CMS) (2016) Local Coverage Determination (LCD) Mechanical In-exsufflation Devices (L33795) Retrieved httpswwwcmsgovmedicare-coverage-databasedetailslcd-detailsaspxLCDId=33795ampver=24ampDate=052f312f2019ampDocID=L33795ampbc=iAAAABAAAAAAamp

Centers for Medicare and Medicaid Services (CMS) (2008) Local Coverage Determination (LCD) High Frequency ChestWall Oscillation Devices (L12870) Retrieved httpwwwcmsgov

Centers for Medicare and Medicaid Services (CMS) (2019) Local Coverage Determination (LCD) Intrapulmonary PercussiveVentilation System (L33786) Retrieved httpswwwcmsgovmedicare-coverage-databasedetailslcd-detailsaspxLCDId=33786ampver=7ampDocID=L33786ampbc=gAAAABAAAAAA

Cigna (2018) Medical Policy Airway Clearance Devices in the Ambulatory Setting Medical Policy Number 0069 Retrievedhttpscignaforhcpcignacom

COMAR Regulations Online Table of Rare and Expensive Disease List Cystic Fibrosis Pulmonary ManifestationsRetrieved httpwwwdsdstatemdus

Cystic Fibrosis Foundation (2018) Airway Clearance Retrieved httpwwwcfforg

Hayes Inc ( 2017) Medical Technology Directory CoughAssistreg Mechanical InsufflationExsufflation (MI-E) Device (J HEmerson Co) for Respiratory Insufficiency Retrieved httpwwwhayesinccom

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 6 of 6

Hayes Inc (2018) Medical Technology Directory High-Frequency Chest Wall Compression for Diseases Other Than CysticFibrosis Retrieved httpwwwhayesinccom

Hayes Inc (2019) Medical Technology Directory High-Frequency Chest Wall Compression for Cystic Fibrosis RetrievedhttpswwwhayesinccomsubscribersdisplaySubscriberArticledoarticleId=56406

Homnick DN (2011) Mechanical insufflation-exsufflation for airway mucus clearance Journal of Respiratory Care Vol52(10) p 1296-305 Retrieved httpswwwncbinlmnihgovpubmed17894900

Hristara-Papadopoulou A Tsanakas J Diomou G et al (2008) Current devices of respiratory physiotherapy HippokratiaQuarterly Medical Journal Vol 12(4) p 211-220 Retrieved httpswwwncbinlmnihgovpmcarticlesPMC2580042

Humana (2019) Medical Coverage Policy Airway Clearance Devices Medical Policy Number HCS-0310-015Retrievedhttpappshumanacom

Katkin JP (2018) Cystic Fibrosis Clinical Manifestations and Diagnosis UpToDate Retrieved httpswwwuptodatecomcontentscystic-fibrosis-clinical-manifestations-and-diagnosissearch=Cystic20Fibrosis20Clinical20Manifestations20and20Diagnosis20Katkinampsource=search_resultampselectedTitle=3~150ampusage_type=defaultampdisplay_rank=3

Mahede T Davis G Rutkay A et al (2015) Use of mechanical airway clearance devices in the home by people withneuromuscular disorders effects on health service use and lifestyle benefits Orphanet Journal of Rare Diseases Vol 10 epubRetrieved httpswwwncbinlmnihgovpubmed25943355

Morrow B Zampoli M et al (2013) Mechanical insufflation-exsufflation for people with neuromuscular disordersCochrane Library Retrieved httpswwwcochranelibrarycomcdsrdoi10100214651858CD010044pub2full

National Heart Lung and Blood Institute (NIH) (2018) Bronchiectasis US Department of Health amp Human ServicesRetrieved httpswwwnhlbinihgovhealth-topicsbronchiectasis

National Heart Lung and Blood Institute (NIH) (2018) Cystic Fibrosis US Department of Health amp Human ServicesRetrieved httpswwwnhlbinihgovhealth-topicscystic-fibrosis

Oermann CM Sockrider MM Giles D et al (2001) Comparison of High-Frequency Chest Wall Oscillation andOscillating Positive Expiratory Pressure in the Home Management of Cystic Fibrosis A Pilot Study Pediatric PulmonologyVol 32(5) p 372-7 Retrieved httpswwwncbinlmnihgovpubmed11596162

The Vest Airwayreg Clearance System (2019) Retrieved httpwwwthevestcom

TRICARE Policy Manual 601060-M April 1 2015 Chapter 8 Section 161 Mucus Clearance Devices Retrieved httpmanualstricareosdmil

XI APPROVALS Historical Effective Dates 10222003 10222004 10192005 10202006 10222007 09082008 1204200901072011 02282012 03032017 07012019

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University

Page 4: Johns Hopkins HealthCare LLC Policy Number CMS01.02 ......exsufflation devices experimental and investigational for all other indications, as they do not meet Technology Evaluation

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 4 of 6

Compliance with the provision in this policy may be monitored andaddressed through post payment data analysis andor medical review audits

Employer Health Programs(EHP) refer to specificSummary Plan Description(SPD) If there is no criteriain the SPD apply the MedicalPolicy criteria

Priority Partners (PPMCO)refer to COMAR guidelinesthen apply the Medical Policycriteria

US Family Health Plan(USFHP) TRICARE MedicalPolicy supersedes JHHCMedical Policy If there is noPolicy in TRICARE applythe Medical Policy Criteria

Advantage MD LCDand NCD Medical Policysupersedes JHHC MedicalPolicy If there is no LCDor NCD apply the MedicalPolicy Criteria

VIII CODING INFORMATION

HCPCSCODES

DESCRIPTION

A7020 Interface for cough stimulating device includes all components replacement only

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

E0482 Cough stimulating device alternating positive and negative airway pressure

E0483 High frequency chest wall oscillation system includes all accessories and supplies each

E0484 Oscillatory positive expiratory pressure device nonelectric any type each

ICD10 CODES DESCRIPTION

A150 Tuberculosis of lung [tuberculous bronchiectasis]

E840- E849 Cystic fibrosis

G14 Postpolio syndrome

G1220 Motor neuron disease unspecified

G1221 Amyotrophic lateral sclerosis

G35 Multiple sclerosis

G7102 Facioscapulohumeral muscular dystrophy

G7111 ndashG7119

Myotonic disorders

G720 ndash G729 Other and unspecified myopathies

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 5 of 6

G8250 -G8254

Quadriplegia

J470-J479 Bronchiectasis

J986 Disorders of diaphragm [paralysis of the diaphragm]

Q334 Congenital bronchiectasis

Q348 Otherspecified congenital malformations of respiratory system

Z942 Lung transplant status

IX REFERENCE STATEMENTAnalyses of the scientific and clinical references cited below were conducted and utilized by the Johns Hopkins HealthCareLLC (JHHC) Medical Policy Team during the development and implementation of this medical policy The Medical PolicyTeam will continue to monitor and review any newly published clinical evidence and revise the policy and adjust the referencesbelow accordingly if deemed necessary

X REFERENCESAetna (2019) Clinical Policy Bulletin Chest Physiotherapy and Airway Clearance Devices Medical Policy Number 0067Retrieved httpwwwaetnacom

Bach JR (2019) Continuous noninvasive ventilatory support for patients with neuromuscular or chest wall diseaseUpToDate Retrieved httpwwwuptodatecom

Blue Cross Blue Shield Regence (2019) Medical Policy Manual Oscillatory Devices for the Treatment of Cystic Fibrosis andOther Respiratory Conditions Durable Medical Equipment Policy Number 45 Retrieved httpblueregencecomtrgmedpoldmedme45pdf

Centers for Medicare and Medicaid Services (CMS) (2016) Local Coverage Determination (LCD) Mechanical In-exsufflation Devices (L33795) Retrieved httpswwwcmsgovmedicare-coverage-databasedetailslcd-detailsaspxLCDId=33795ampver=24ampDate=052f312f2019ampDocID=L33795ampbc=iAAAABAAAAAAamp

Centers for Medicare and Medicaid Services (CMS) (2008) Local Coverage Determination (LCD) High Frequency ChestWall Oscillation Devices (L12870) Retrieved httpwwwcmsgov

Centers for Medicare and Medicaid Services (CMS) (2019) Local Coverage Determination (LCD) Intrapulmonary PercussiveVentilation System (L33786) Retrieved httpswwwcmsgovmedicare-coverage-databasedetailslcd-detailsaspxLCDId=33786ampver=7ampDocID=L33786ampbc=gAAAABAAAAAA

Cigna (2018) Medical Policy Airway Clearance Devices in the Ambulatory Setting Medical Policy Number 0069 Retrievedhttpscignaforhcpcignacom

COMAR Regulations Online Table of Rare and Expensive Disease List Cystic Fibrosis Pulmonary ManifestationsRetrieved httpwwwdsdstatemdus

Cystic Fibrosis Foundation (2018) Airway Clearance Retrieved httpwwwcfforg

Hayes Inc ( 2017) Medical Technology Directory CoughAssistreg Mechanical InsufflationExsufflation (MI-E) Device (J HEmerson Co) for Respiratory Insufficiency Retrieved httpwwwhayesinccom

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 6 of 6

Hayes Inc (2018) Medical Technology Directory High-Frequency Chest Wall Compression for Diseases Other Than CysticFibrosis Retrieved httpwwwhayesinccom

Hayes Inc (2019) Medical Technology Directory High-Frequency Chest Wall Compression for Cystic Fibrosis RetrievedhttpswwwhayesinccomsubscribersdisplaySubscriberArticledoarticleId=56406

Homnick DN (2011) Mechanical insufflation-exsufflation for airway mucus clearance Journal of Respiratory Care Vol52(10) p 1296-305 Retrieved httpswwwncbinlmnihgovpubmed17894900

Hristara-Papadopoulou A Tsanakas J Diomou G et al (2008) Current devices of respiratory physiotherapy HippokratiaQuarterly Medical Journal Vol 12(4) p 211-220 Retrieved httpswwwncbinlmnihgovpmcarticlesPMC2580042

Humana (2019) Medical Coverage Policy Airway Clearance Devices Medical Policy Number HCS-0310-015Retrievedhttpappshumanacom

Katkin JP (2018) Cystic Fibrosis Clinical Manifestations and Diagnosis UpToDate Retrieved httpswwwuptodatecomcontentscystic-fibrosis-clinical-manifestations-and-diagnosissearch=Cystic20Fibrosis20Clinical20Manifestations20and20Diagnosis20Katkinampsource=search_resultampselectedTitle=3~150ampusage_type=defaultampdisplay_rank=3

Mahede T Davis G Rutkay A et al (2015) Use of mechanical airway clearance devices in the home by people withneuromuscular disorders effects on health service use and lifestyle benefits Orphanet Journal of Rare Diseases Vol 10 epubRetrieved httpswwwncbinlmnihgovpubmed25943355

Morrow B Zampoli M et al (2013) Mechanical insufflation-exsufflation for people with neuromuscular disordersCochrane Library Retrieved httpswwwcochranelibrarycomcdsrdoi10100214651858CD010044pub2full

National Heart Lung and Blood Institute (NIH) (2018) Bronchiectasis US Department of Health amp Human ServicesRetrieved httpswwwnhlbinihgovhealth-topicsbronchiectasis

National Heart Lung and Blood Institute (NIH) (2018) Cystic Fibrosis US Department of Health amp Human ServicesRetrieved httpswwwnhlbinihgovhealth-topicscystic-fibrosis

Oermann CM Sockrider MM Giles D et al (2001) Comparison of High-Frequency Chest Wall Oscillation andOscillating Positive Expiratory Pressure in the Home Management of Cystic Fibrosis A Pilot Study Pediatric PulmonologyVol 32(5) p 372-7 Retrieved httpswwwncbinlmnihgovpubmed11596162

The Vest Airwayreg Clearance System (2019) Retrieved httpwwwthevestcom

TRICARE Policy Manual 601060-M April 1 2015 Chapter 8 Section 161 Mucus Clearance Devices Retrieved httpmanualstricareosdmil

XI APPROVALS Historical Effective Dates 10222003 10222004 10192005 10202006 10222007 09082008 1204200901072011 02282012 03032017 07012019

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University

Page 5: Johns Hopkins HealthCare LLC Policy Number CMS01.02 ......exsufflation devices experimental and investigational for all other indications, as they do not meet Technology Evaluation

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 5 of 6

G8250 -G8254

Quadriplegia

J470-J479 Bronchiectasis

J986 Disorders of diaphragm [paralysis of the diaphragm]

Q334 Congenital bronchiectasis

Q348 Otherspecified congenital malformations of respiratory system

Z942 Lung transplant status

IX REFERENCE STATEMENTAnalyses of the scientific and clinical references cited below were conducted and utilized by the Johns Hopkins HealthCareLLC (JHHC) Medical Policy Team during the development and implementation of this medical policy The Medical PolicyTeam will continue to monitor and review any newly published clinical evidence and revise the policy and adjust the referencesbelow accordingly if deemed necessary

X REFERENCESAetna (2019) Clinical Policy Bulletin Chest Physiotherapy and Airway Clearance Devices Medical Policy Number 0067Retrieved httpwwwaetnacom

Bach JR (2019) Continuous noninvasive ventilatory support for patients with neuromuscular or chest wall diseaseUpToDate Retrieved httpwwwuptodatecom

Blue Cross Blue Shield Regence (2019) Medical Policy Manual Oscillatory Devices for the Treatment of Cystic Fibrosis andOther Respiratory Conditions Durable Medical Equipment Policy Number 45 Retrieved httpblueregencecomtrgmedpoldmedme45pdf

Centers for Medicare and Medicaid Services (CMS) (2016) Local Coverage Determination (LCD) Mechanical In-exsufflation Devices (L33795) Retrieved httpswwwcmsgovmedicare-coverage-databasedetailslcd-detailsaspxLCDId=33795ampver=24ampDate=052f312f2019ampDocID=L33795ampbc=iAAAABAAAAAAamp

Centers for Medicare and Medicaid Services (CMS) (2008) Local Coverage Determination (LCD) High Frequency ChestWall Oscillation Devices (L12870) Retrieved httpwwwcmsgov

Centers for Medicare and Medicaid Services (CMS) (2019) Local Coverage Determination (LCD) Intrapulmonary PercussiveVentilation System (L33786) Retrieved httpswwwcmsgovmedicare-coverage-databasedetailslcd-detailsaspxLCDId=33786ampver=7ampDocID=L33786ampbc=gAAAABAAAAAA

Cigna (2018) Medical Policy Airway Clearance Devices in the Ambulatory Setting Medical Policy Number 0069 Retrievedhttpscignaforhcpcignacom

COMAR Regulations Online Table of Rare and Expensive Disease List Cystic Fibrosis Pulmonary ManifestationsRetrieved httpwwwdsdstatemdus

Cystic Fibrosis Foundation (2018) Airway Clearance Retrieved httpwwwcfforg

Hayes Inc ( 2017) Medical Technology Directory CoughAssistreg Mechanical InsufflationExsufflation (MI-E) Device (J HEmerson Co) for Respiratory Insufficiency Retrieved httpwwwhayesinccom

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 6 of 6

Hayes Inc (2018) Medical Technology Directory High-Frequency Chest Wall Compression for Diseases Other Than CysticFibrosis Retrieved httpwwwhayesinccom

Hayes Inc (2019) Medical Technology Directory High-Frequency Chest Wall Compression for Cystic Fibrosis RetrievedhttpswwwhayesinccomsubscribersdisplaySubscriberArticledoarticleId=56406

Homnick DN (2011) Mechanical insufflation-exsufflation for airway mucus clearance Journal of Respiratory Care Vol52(10) p 1296-305 Retrieved httpswwwncbinlmnihgovpubmed17894900

Hristara-Papadopoulou A Tsanakas J Diomou G et al (2008) Current devices of respiratory physiotherapy HippokratiaQuarterly Medical Journal Vol 12(4) p 211-220 Retrieved httpswwwncbinlmnihgovpmcarticlesPMC2580042

Humana (2019) Medical Coverage Policy Airway Clearance Devices Medical Policy Number HCS-0310-015Retrievedhttpappshumanacom

Katkin JP (2018) Cystic Fibrosis Clinical Manifestations and Diagnosis UpToDate Retrieved httpswwwuptodatecomcontentscystic-fibrosis-clinical-manifestations-and-diagnosissearch=Cystic20Fibrosis20Clinical20Manifestations20and20Diagnosis20Katkinampsource=search_resultampselectedTitle=3~150ampusage_type=defaultampdisplay_rank=3

Mahede T Davis G Rutkay A et al (2015) Use of mechanical airway clearance devices in the home by people withneuromuscular disorders effects on health service use and lifestyle benefits Orphanet Journal of Rare Diseases Vol 10 epubRetrieved httpswwwncbinlmnihgovpubmed25943355

Morrow B Zampoli M et al (2013) Mechanical insufflation-exsufflation for people with neuromuscular disordersCochrane Library Retrieved httpswwwcochranelibrarycomcdsrdoi10100214651858CD010044pub2full

National Heart Lung and Blood Institute (NIH) (2018) Bronchiectasis US Department of Health amp Human ServicesRetrieved httpswwwnhlbinihgovhealth-topicsbronchiectasis

National Heart Lung and Blood Institute (NIH) (2018) Cystic Fibrosis US Department of Health amp Human ServicesRetrieved httpswwwnhlbinihgovhealth-topicscystic-fibrosis

Oermann CM Sockrider MM Giles D et al (2001) Comparison of High-Frequency Chest Wall Oscillation andOscillating Positive Expiratory Pressure in the Home Management of Cystic Fibrosis A Pilot Study Pediatric PulmonologyVol 32(5) p 372-7 Retrieved httpswwwncbinlmnihgovpubmed11596162

The Vest Airwayreg Clearance System (2019) Retrieved httpwwwthevestcom

TRICARE Policy Manual 601060-M April 1 2015 Chapter 8 Section 161 Mucus Clearance Devices Retrieved httpmanualstricareosdmil

XI APPROVALS Historical Effective Dates 10222003 10222004 10192005 10202006 10222007 09082008 1204200901072011 02282012 03032017 07012019

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University

Page 6: Johns Hopkins HealthCare LLC Policy Number CMS01.02 ......exsufflation devices experimental and investigational for all other indications, as they do not meet Technology Evaluation

Version 00136

Policy Number CMS0102

Effective Date 07012019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05212019

Revision Date 05212019Subject

Airway Clearance DevicesPage 6 of 6

Hayes Inc (2018) Medical Technology Directory High-Frequency Chest Wall Compression for Diseases Other Than CysticFibrosis Retrieved httpwwwhayesinccom

Hayes Inc (2019) Medical Technology Directory High-Frequency Chest Wall Compression for Cystic Fibrosis RetrievedhttpswwwhayesinccomsubscribersdisplaySubscriberArticledoarticleId=56406

Homnick DN (2011) Mechanical insufflation-exsufflation for airway mucus clearance Journal of Respiratory Care Vol52(10) p 1296-305 Retrieved httpswwwncbinlmnihgovpubmed17894900

Hristara-Papadopoulou A Tsanakas J Diomou G et al (2008) Current devices of respiratory physiotherapy HippokratiaQuarterly Medical Journal Vol 12(4) p 211-220 Retrieved httpswwwncbinlmnihgovpmcarticlesPMC2580042

Humana (2019) Medical Coverage Policy Airway Clearance Devices Medical Policy Number HCS-0310-015Retrievedhttpappshumanacom

Katkin JP (2018) Cystic Fibrosis Clinical Manifestations and Diagnosis UpToDate Retrieved httpswwwuptodatecomcontentscystic-fibrosis-clinical-manifestations-and-diagnosissearch=Cystic20Fibrosis20Clinical20Manifestations20and20Diagnosis20Katkinampsource=search_resultampselectedTitle=3~150ampusage_type=defaultampdisplay_rank=3

Mahede T Davis G Rutkay A et al (2015) Use of mechanical airway clearance devices in the home by people withneuromuscular disorders effects on health service use and lifestyle benefits Orphanet Journal of Rare Diseases Vol 10 epubRetrieved httpswwwncbinlmnihgovpubmed25943355

Morrow B Zampoli M et al (2013) Mechanical insufflation-exsufflation for people with neuromuscular disordersCochrane Library Retrieved httpswwwcochranelibrarycomcdsrdoi10100214651858CD010044pub2full

National Heart Lung and Blood Institute (NIH) (2018) Bronchiectasis US Department of Health amp Human ServicesRetrieved httpswwwnhlbinihgovhealth-topicsbronchiectasis

National Heart Lung and Blood Institute (NIH) (2018) Cystic Fibrosis US Department of Health amp Human ServicesRetrieved httpswwwnhlbinihgovhealth-topicscystic-fibrosis

Oermann CM Sockrider MM Giles D et al (2001) Comparison of High-Frequency Chest Wall Oscillation andOscillating Positive Expiratory Pressure in the Home Management of Cystic Fibrosis A Pilot Study Pediatric PulmonologyVol 32(5) p 372-7 Retrieved httpswwwncbinlmnihgovpubmed11596162

The Vest Airwayreg Clearance System (2019) Retrieved httpwwwthevestcom

TRICARE Policy Manual 601060-M April 1 2015 Chapter 8 Section 161 Mucus Clearance Devices Retrieved httpmanualstricareosdmil

XI APPROVALS Historical Effective Dates 10222003 10222004 10192005 10202006 10222007 09082008 1204200901072011 02282012 03032017 07012019

copy Copyright 2019 by The Johns Hopkins Health System Corporation andor The Johns Hopkins University