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Date Printed: December 18, 2017: 03:18 PM

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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.

02-30000-12

Original Effective Date: 08/15/10

Reviewed: 07/27/17

Revised: 11/15/17

Subject: Bronchial Thermoplasty

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:

Bronchial thermoplasty (BT) is a procedure that delivers thermal energy to the airways via a flexible bronchoscope to ablate and reduce the mass of airway smooth muscle. Bronchial thermoplasty is intended as a supplemental treatment for patients with severe persistent asthma (i.e., steps 5 and 6 in the stepwise approach to care).

Bronchial thermoplasty procedures are performed on an outpatient basis with moderate sedation, and last approximately one hour each. During the procedure, a standard flexible bronchoscope is placed through the patient’s mouth or nose into the most distal targeted airway and a catheter is inserted into the working channel of the bronchoscope. After placement, the electrode array in the top of the catheter is expanded and radiofrequency energy is delivered from a proprietary controller and used to heat tissue to 65 degrees Centigrade over a 5 mm area. The positioning of the catheter and application of thermal energy is repeated several times in contiguous areas along the accessible length of the airway. At the end of the treatment session, the catheter and bronchoscope are removed. A course of treatment consists of 3 separate procedures in different regions of the lung, scheduled approximately 3 weeks apart.

In April 2010, the Alair Bronchial Thermoplasty System (Asthmatx, Inc., Sunnyvale, CA) was approved by the FDA through the premarket approval (PMA) process for use in adults with severe and persistent asthma whose symptoms are not adequately controlled with inhaled corticosteroids and long-acting beta agonists. Use of the treatment is contraindicated in patients with implantable devices and those with sensitivities to lidocaine, atropine or benzodiazepines. It should also not be used while patients are experiencing an asthma exacerbation, active respiratory infection, bleeding disorder, or within 2 weeks of making changes in their corticosteroid regimen. The same area of the lung should not be treated more than once with bronchial thermoplasty.

POSITION STATEMENT:

Bronchial thermoplasty for the treatment of asthma and all indications is considered experimental or investigational due to insufficient clinical evidence published in the peer-reviewed literature regarding safety and long-term efficacy of this technology on health outcomes.

BILLING/CODING INFORMATION:

CPT Coding:

31660

Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial thermoplasty, 1 lobe (investigational)

31661

Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial thermoplasty, 2 or more lobes (investigational)

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

Stepwise approach to care: Guidelines from the National Heart, Lung and Blood Institute (NHLBI) define 6 pharmacologic steps for the treatment of asthma (step 1 for intermittent asthma, and steps 2 – 6 for persistent asthma) for individual’s ≥ 12 years of age.

The preferred daily medications:

Step 1: short-acting beta-agonists as needed;

Step 2: low-dose inhaled corticosteroids (ICS);

Step 3: ICS and long-acting beta-agonists (LABA) or medium-dose ICS;

Step 4: medium dose ICS and LABA;

Step 5: high-dose ICS and LABA; AND

Step 6: high-dose ICS and LABA, and oral corticosteroids.

RELATED GUIDELINES:

None applicable.

OTHER:

None applicable.

REFERENCES:

  1. American College of Allergy, Asthma & Immunology Statement on bronchial thermoplasty, 01/01/15.
  2. American College of Chest Physicians. Coverage and Payment for Bronchial Thermoplasty for Severe Persistent Asthma. May 2014.
  3. Arrigo R, Failla G, Scichilone N, et al. How effective and safe is bronchial thermoplasty in "real life" asthmatics compared to those enrolled in randomized clinical trials? Biomed Research International. 2016; 2016: 9132198.
  4. Asthma and Allergy Foundation of America. Letter to FDA re: Alair Bronchial Thermoplasty System (10/18/2009). Assessed 07/16/14.
  5. Bezzi M, Solidoro P, Patella V et al. Bronchial thermoplasty in severe asthma: food for thoughts. Minerva Medica 2014; 105 (3 Suppl. 2): 7-13.
  6. Blue Cross Blue Shield Association Medical Policy Reference Manual 7.01.127 Bronchial Thermoplasty, 06/17.
  7. Bicknell S, Chaudhuri R, Lee N, et al. Effectiveness of bronchial thermoplasty in severe asthma in 'real life' patients compared with those recruited to clinical trials in the same centre. Therapeutic Advances in Respiratory Disease 2015; 9(6):267-271.
  8. Boulet LP , Laviolette M. Is there a role for bronchial thermoplasty in the treatment of asthma? Can Respir J. 2012 May-Jun;19 ( 3):191-2.
  9. Brown R, Wizeman W, Danek, C, Mitzner W. Effect of Bronchial Thermoplasty on Airway Closure. Clin Med Circ Respirat Pulm Med. 2007 October 12; 1:1-6.
  10. Burn J, Sims AJ, Keltie K, et al. Procedural and short-term safety of bronchial thermoplasty in clinical practice: evidence from a national registry and Hospital Episode Statistics. Journal of Asthma 2016 Dec 1.
  11. Cangelosi MJ, Ortendahi JD, Meckley LM et al. Cost-effectiveness of bronchial thermoplasty in commercially-insured patients with poorly controlled severe, persistent asthma. Expert Review of Pharmacoeconomics & Outcomes Research 2015; 15(2): 357-64.
  12. Castro M, Rubin AS, Laviolette M et al. Effectiveness and safety of bronchial thermoplasty in the treatment of severe asthma: a multicenter, randomized, double-blind, sham-controlled clinical trial. American Journal of Respiratory and Critical Care Medicine 2010; 181(2): 116-124.
  13. Castro M, Rubin A, Laviolette ML et al. Persistence of effectiveness of bronchial thermoplasty in patients with severe asthma. Annals of Allergy, Asthma & Immunology 2011; 107(1): 65-70.
  14. Chakir J, Haj-Salem I, Gras D et al. Effects of Bronchial Thermoplasty on Airway Smooth Muscle and Collagen Deposition in Asthma. Annals of American Thoracic Society 2015; 12(11): 1612-1618.
  15. Chung KF, Wenzel SE, Brozek JL et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. European Respiratory Journal 2014; 43(2):343-373.
  16. Cox G, Thomson NC, Rubin AS et al. Asthma control during the year after bronchial thermoplasty. New England Journal of Medicine 2007; 356(13): 1327-1337.
  17. Dheda K, Koegelenberg CFN, Esmail A et al. Recommendations for the use of bronchial thermoplasty in the management of severe asthma. South African Medical Journal 2015; 150(9): 726-732.
  18. Du Rand IA, Barber PV, Goldring J, Lewis RA, Mandal S, Munavvar M, Rintoul RC, Shah PL, Singh S, Slade MG, Woolley A, British Thoracic Society Interventional Bronchoscopy Guideline Group. British Thoracic Society guideline for advanced diagnostic and therapeutic flexible bronchoscopy in adults. Thorax 2011; 66 (11): 1014-1015.
  19. ECRI Emerging Technology Evidence Report. Bronchial Thermoplasty for Treating Adult Patients with Severe Persistent Asthma. January 2013.
  20. ECRI Product Brief: Alair Bronchial Thermoplasty System (Boston Scientific, Inc.) for Treating Asthma. January 2014.
  21. Folch E, Mehta AC. Airway Interventions in the Tracheobronchial Tree. Semin Respir Crit Care Med. 2008; 29(4):441-452.
  22. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. Global Initiative for Asthma (GINA); Updated 2016.
  23. Gildea TR, Khatri SB, Castro M. Bronchial thermoplasty: a new treatment for severe refractory asthma. Cleve Clin J Med. 2011 Jul; 78(7):477-85.
  24. Krmisky W, Sobieszczyk MJ, Sarkar S. Thermal ablation for asthma: current status and technique. Journal of Thoracic Disease 2017 2017; 9 (Suppl 2): S104-S109.
  25. Mayse ML, et al. Clinical Pearls for Bronchial Thermplasty. J Bronchol 2007; 14:115-123.
  26. National Guideline Clearinghouse. Institute for Clinical Systems Improvement (ICSI). Diagnosis and management of asthma. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2008 Jan. 69 p. [83 references].
  27. National Heart Lung and Blood Institute. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma, Revised Sept 2012.
  28. National Institute for Health and Clinical Excellence (NICE). Bronchial thermoplasty for severe asthma. London (UK): National Institute for Health and Clinical Excellence (NICE); 2012 Jan. 9 p. (Interventional procedure guidance; no. 419).
  29. Pavord ID, Cox G, Thomson C et al. Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma. American Journal of Respiratory and Critical Care Medicine 2007; 176(12): 1185-1191.
  30. Pavord ID, Thomson NC, Niven RM, et al. Safety of bronchial thermoplasty in patients with severe refractory asthma. Ann Allergy Asthma Immunol. 2013 ; 111(5):402-407.
  31. Thomson NC, Rubin AS, Niven RM, Corris PA, Siersted HC, Olivenstein R, Pavord ID, McCormack D, Laviolette M, Shargill NS, Cox G, the AIR Trial Study Group. Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial. BMC Pulm Med 2011;11(1):8.
  32. Thomson NC, Chaudhuri R, Spears M. Emerging therapies for severe asthma. BMC Med. 2011 Sep 6; 9:102.
  33. Torrego A, Sola I, Munoz AM et al. Bronchial thermoplasty for moderate or severe persistent asthma in adults. Cochrane Database Systematic Review 2014 Mar 3; (3): CD009910. doi: 10.1002/14651858.CD009910.pub2.
  34. U.S. Food and Drug Administration. Asthmatx, Inc. Alair Bronchial Thermoplasty System – P080032, 04/27/10.
  35. Wahidi NM, Kraft M. Bronchial thermoplasty for severe asthma. American Journal of Respiratory and Critical Care 2012; 185(7): 709-14.
  36. Wechsler ME, Laviolette M, Rubin A et al. Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma. Journal of Allergy and Immunology 2013; 132(6): 1295-1302.
  37. Zafari Z, Sadatsafavi M, Marra CA et al. Cost-effectiveness of bronchial thermoplasty, Omalizumab, and standard therapy for moderate-to-severe allergic asthma. PLoS One 2016; 11(1): e0146003.
  38. Zein JG, Menegay MC, Singer ME et al. Cost effectiveness of bronchial thermoplasty in patients with severe uncontrolled asthma. Journal of Asthma 2016; 53(2): 194-200.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 07/27/17.

GUIDELINE UPDATE INFORMATION:

08/15/10

New Medical Coverage Guideline.

08/15/11

Annual review; position statement unchanged; references updated.

01/01/12

Annual HCPCS coding update: added 0276T and 0277T.

09/15/12

Annual review; position statement unchanged; references updated.

01/01/13

Annual HCPCS coding update: added 31660 and 31661; removed 0276T and 0277T.

09/15/13

Scheduled review; position statement unchanged; Program Exceptions section updated; references updated.

09/15/14

Annual review; position statement unchanged; Program Exceptions section updated; references updated.

11/01/15

Revision: ICD-9 Codes deleted.

09/15/16

Review; no change in position statement. Updated description and references.

03/06/17

Updated program exceptions.

08/15/17

Review; no change in position statement. Updated references.

11/15/17

Revised position statement; added and all indications.

Date Printed: December 18, 2017: 03:18 PM