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Date Printed: May 27, 2018: 07:38 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.

02-31000-01

Original Effective Date: 03/15/07

Reviewed: 04/26/18

Revised: 05/15/18

Subject: Balloon Ostial Dilation (Balloon Sinuplasty) and Implantable Devices

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:

Balloon sinuplasty is proposed as an alternative to endoscopic sinus surgery for individuals with chronic sinusitis who fail medical management (e.g., mucolytic, decongestant (oral and topical), antibiotic therapy). Balloon sinuplasty involves placing a balloon in the sinus ostium and inflating the balloon to stretch the opening.

The U.S. Food and Drug Administration (FDA) have cleared through the 510(k) process several devices (e.g., Relieva™ and Relieva Acella™ Sinus Balloon Catheter [Acclarent, Inc.] and Entellus Medical FinESS Sinus Treatment [Entellus Medical, Inc.], Xpress™ Balloon Device [Entellus Medical, Inc.]) for the catheterization and dilation of the sinus. Balloon sinuplasty can be performed as a stand-alone procedure or as an adjunctive procedure to endoscopic sinus surgery.

The U.S. Food and Drug Administration (FDA) have cleared through the 510(k) process the Vent-OS™ Sinus System, an instrument intended to provide a means to access the sinus space and to dilate the axillary sinus ostia and associated spaces in adults for diagnostic and therapeutic procedures.

Sinus stents and spacers are devices that are used postoperatively following endoscopic sinus surgery (ESS). The intent of these devices is to maintain patency of the sinus openings in the postoperative period, and/or to serve as a local drug delivery vehicle. The U.S. Food and Drug Administration (FDA) have cleared through the 510(k) process several devices (e.g., Propel™, Propel™ mini, PROPEL Contour [Intersect ENT]).

The Propel™ device is indicated for use following ethmoid sinus surgery to maintain patency. The device is a self-expanding, bioabsorbable steroid-eluting stent.

The MicroFlow Spacer is indicated for use as a postoperative spacer to maintain an opening to the frontal sinuses within the first 14 days following surgery. The device is temporary and requires manual removal.

POSITION STATEMENT:

The use of a catheter-based inflatable device (e.g., balloon sinuplasty, balloon sinus dilation) in the treatment of sinusitis is considered integral to the traditional nasal/sinus endoscopic surgery or functional endoscopic sinus surgery (FESS) and is not separately reimbursable.

The use of implantable sinus stents and spacers (e.g., Propel™, MicroFlow Spacer) for postoperative treatment following endoscopic sinus surgery is considered experimental or investigational for all indications. There is insufficient published evidence in the peer-reviewed literature regarding long-term improved health outcomes of sinus spacers and stents postoperatively following endoscopic sinus surgery

BILLING/CODING INFORMATION:

CPT Coding:

0406T

Nasal endoscopy, surgical, ethmoid sinus, placement of drug eluting implant (Investigational)

0407T

Nasal endoscopy, surgical, ethmoid sinus, placement of drug eluting implant; with biopsy, polypectomy or debridement (Investigational)

31295

Nasal/sinus endoscopy, surgical; with dilation of maxillary sinus ostium (e.g., balloon dilation), transnasal or via canine fossa

31296

Nasal/sinus endoscopy, surgical; with dilation of frontal sinus ostium (e.g., balloon dilation)

31297

Nasal/sinus endoscopy, surgical; with dilation of sphenoid sinus ostium (e.g., balloon dilation)

31298

Nasal/sinus endoscopy, surgical; with dilation of frontal and sphenoid sinus ostia (e.g., balloon dilation)

HCPCS Coding:

S1090

Mometasone furoate sinus implant, 370 micrograms (Investigational)

LOINC Codes:

The following information may be required documentation to support medical necessity: physician history and physical, physician progress notes, plan of treatment and reason for catheter-based inflatable device (e.g., balloon sinuplasty, balloon sinus dilation).

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 progress note

18741-9

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

Plan of treatment

18776-5

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

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

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:

No guideline specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

Other names used to report balloon sinuplasty:

Balloon catheter sinuplasty
Balloon sinus dilation (BSD)
Functional Endoscopic Dilation of the Sinuses (FEDS)
Functional Endoscopic Sinus Surgery (FESS)
Hybrid procedure (balloon sinuplasty performed in conjunction with functional endoscopic sinus surgery (FESS))
Sinus balloon dilation

REFERENCES:

  1. American Academy of Otolaryngology Head and Neck Surgery (ASO-HNS) Position Statement: Dilation of Sinuses, Any Method (e.g., balloon, etc.), 03/12/17.
  2. Albritton FD, Casiano RR, Sillers MJ. Feasibility of in-office endoscopic sinus surgery with balloon sinus dilation. American Journal of Rhinology & Allergy 2012; 26(3): 243-248.
  3. American Rhinologic Society (ARS). Ostial Balloon Dilation Position Statement, 03/14/17.
  4. American Rhinologic Society (ARS): ARS Position Statement on Biomaterials, 01/24/14.
  5. Bikhazi N, Light J, Truitt T et al. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial with 1-year follow-up. American Journal of Rhinology & Allergy 2014; 28(4): 323-329.
  6. Blue Cross Blue Shield Association Balloon Ostial Dilation for Treatment of Chronic Sinusitis Medical Policy 7.01.105, 02/18.
  7. Blue Cross Blue Shield Association Implantable Sinus Stents for Postoperative Use Following Endoscopic Sinus Surgery Medical Policy 7.01.134, 02/18.
  8. Blue Cross Blue Association TEC Assessment: Balloon Sinus Ostial Dilation for Treatment of Chronic Rhinosinusitis, Vol. 27, No.9, April 2013.
  9. Bolger WE, Brown CL, Church CA et al. Safety and outcomes of balloon catheter sinusotomy: a multicenter 24-week analysis in 115 patients. Otolaryngology Head Neck Surgery 2007; 137(1): 10-20.
  10. Brown CL, Bolger WE. Safety and Feasibility of Balloon Catheter Dilation of Paranasal Sinus Ostia: A Preliminary Investigation. Annals of Otology, Rhinology & Laryngology 2006; 115(4): 293-301.
  11. Bury S, Singh A. Evaluation of a steroid releasing sinus implant for the treatment of patients undergoing frontal sinus surgery for chronic rhinosinusitis. Expert Review of Medical Devices 2017; 14(2):93-101.
  12. Campbell, RG, Kennedy DW. What is new and promising with drug-eluting stents in sinus surgery? Current Opinion in Otolaryngology Head & Neck Surgery 2014 Feb; 22(1): 2-7.Catalano PJ, Payne SC. Balloon dilation of the frontal recess in patients with chronic frontal sinusitis and advanced sinus disease: an initial report. Annals of Otology, Rhinology, and Laryngology 2009; 118(2): 107-112.
  13. Catalona PJ, Thong M, Weiss R et al. The MicroFlow Spacer: a drug-eluting stent for the ethmoid sinus. Indian Journal of Otolaryngology abd Head & Neck Surgery 2011; 63(3):279-284.
  14. Chandra RK, Kern RC, Cutler JL, et al. REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. Laryngoscope. Jan 2016;126(1):44-50.
  15. Cho KS, Zajac AE, Rashan AR et al. State-of-the-art biomaterials in the nasal cavity: hemostats and spacers following sinus surgery. Otorinolaringologia 2013; 63-111-121.Church CA, Kuhn FA, Mikhail J et al. Patient and surgeon radiation exposure in balloon catheter sinus ostial dilation. Otolaryngology-Head and Neck Surgery 2008; 138: 187-191.
  16. Cutler J, Truitt T, Atkins J et al. First clinic experience: patient selection and outcomes for ostial dilation for chronic rhinosinusitis. International Forum of Allergy & Rhinology 2011; 1(6): 460-465.
  17. Engle RD, Neel GS, Rosen J et al. DRAF IIB and III frontal sinusotomy in cystic fibrosis patients. Journal of Neurological Surgery B 2014; 75-A193.
  18. Forwith KD, Chandra RK, Yun PT et al. ADVANCE: a multisite trial of bioabsorbable steroid-eluting sinus implants. Laryngoscope 2011 Nov; 121(22): 2473-2480.
  19. Forwith KD, Han JK, Stolovitzky JP et al. RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6- outcomes from a randomized, controlled, blinded study. International month Forum of Allergy & Rhinology 2016; 6(6): 573-81.
  20. Gould J, Alexander I, Tomkin E et al. In-office, multisinus balloon dilation: 1-Year outcomes from a prospective, multicenter, open label trial. American Journal of Rhinology & Allergy 2014; 28(2): 156-163.
  21. Han JK, Forwith KD, Smith TL et al. RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. International Forum of Allergy & Rhinology 2014 Nov; 4(11): 861-870.
  22. Han JK, Marple BF, Smith TL et al. Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions: an efficacy meta-analysis. International Forum of Allergy & Rhinology 2012 Jul-Aug; 2(4): 271-279.
  23. Hopkins C, Noon E, Bray D, Roberts D. Balloon sinuplasty: our first year. The Journal of Laryngology & Otology 2010; 24:1-10.
  24. Hopkins C, Noon E, Roberts D. Balloon sinuplasty in acute frontal sinusitis. Rhinology 2009; 47(4): 375-378.
  25. Huang Z, Hwang P, Sun Y et al. Steroid-eluting sinus stents for improving symptoms in chronic rhinosinusitis patients undergoing functional endoscopic sinus surgery. Cochrane Database of Systematic Reviews 2015 Jun 10; (6): CD010436.
  26. Janisiewicz A, Lee JT. In-office use of a steroid-eluting implant for maintenance of frontal ostial patency after revision sinus surgery. Allergy & Rhinology 2015 Jan; 6(1): 68-75.
  27. Kennedy DW. The PROPEL™ steroid-releasing bioabsorbable implant to improve outcomes of sinus surgery. Expert Reviews Respiratory Medicine 2012; 6(5).
  28. Koskinen A, Penttila M, Myller J et al. Endoscopic sinus surgery might reduce exacerbations and symptoms more than balloon sinuplasty. American Journal of Rhinology & Allergy 2012; 26(6): e150-e156.
  29. Kuhn FA, Church CA, Goldberg AN et al. Balloon catheter sinusotomy: one-year follow-up—outcomes and role in functional endoscopic sinus surgery. Otolaryngology-Head and Neck Surgery 2008; 139: S27-S37.
  30. Kutluhan a, Bozdemir K, Cetin H et al. Endoscopic balloon dilation sinuplasty including ethmoidal air cells in chronic sinuplastyitis. Annals of Otology, Rhinology, and Laryngology 2009; 118(12): 881-886.
  31. Lavigne F, Miller SK, Gould AR. Steroid-eluting sinus implant for in-office treatment of recurrent nasal polyposis: a prospective, multicenter study. International Forum of Allergy & Rhinology 2014 May; 4(5): 381-9.
  32. Lee JT, Han JK. Sinus implants for chronic rhinosinusitis: technology evaluation. Expert Opinion on Drug Delivery 2013 Dec; 10(12): 1735-48.
  33. Levine H, Rabago D. Balloon sinuplasty: a minimally invasive option for patients with chronic rhinosinusitis. Post Graduate Medicine 2011; 123(2): 112-118.
  34. Levine HL, Sertich AP, Hoisington DR et al. Multicenter registry of balloon catheter sinusotomy outcomes for 1,036 patients. The Annals of Otology, Rhinology, and Laryngology 2008 April; 117(4): 263-270.
  35. Levy JM, Marino MJ, McCoul ED. Paranasal Sinus Balloon Catheter Dilation for Treatment of Chronic Rhinosinusitis: A Systematic Review and Meta-analysis. Otolaryngology Head and Neck Surgery 2016; 154 (1): 33-40.
  36. Li PF, Downie D, Hwang PH. Controlled steroid delivery via bioabsorbable stent: safety and performance in a rabbit model. American Journal of Rhinology and Allergy 2009 Nov-Dec; 23(6): 591- 596.
  37. Luong A, Ow RA, Singh A et al. Safety and Effectiveness of a Bioabsorbable Steroid-Releasing Implant for the Paranasal Sinus Ostia: A Randomized Clinical Trial. JAMA Otolaryngooogy-Head & Neck Surgery 2018 Jan; 144(1): 28–35.
  38. Marple BF, Smith TL, Han JK et al. Advance II: a prospective, randomized study assessing safety and efficacy of bioabsorbable steroid-releasing sinus implants.
  39. Marzetti A, Tedaldi M, Passali FM. The role of balloon sinuplasty in the treatment of sinus headache. Otolaryngologia Polska 2014; 68(1): 15-19.
  40. Massey CJ, Suh JD, Tessema B et al. Biomaterials in rhinology. Otolaryngology-Head and Neck Surgery 2016 Apr; 154(4): 606-17.
  41. Matheny KE, Carter KB, Tseng EY et al. Safety, feasibility, and efficacy of placement of steroid-eluting bioabsorbable sinus implants in the office setting: a prospective case series. International Forum of Allergy & Rhinology 2014 Oct; 4(10): 808-815.
  42. Matheny KE. Bioabsorbable steroid-releasing sinus implants in the frontal and maxillary sinuses: 2-year follow-up. Allergy & Rhinology 2015 Jan; 6(2): e118-e121.
  43. Murr AH, Smith TL, Hwang PH et al. Safety and efficacy of a novel bioabsorbable, steroid-eluting sinus stent. International Forum of Allergy & Rhinology 2014 Jan-Feb; 1(1): 23-32.
  44. National Institute for Health and Clinical Excellence-Balloon catheter dilation of paranasal sinus ostia for chronic sinusitis, 09/08.
  45. Nayak DR, Balakrishnan R, Murty KD. Endoscopic physiologic approach to allergy-associated chronic rhinosinusitis: A preliminary study. ENT-Ear, Nose & Throat Journal 2001; 80(6): 390-403.
  46. Orlandi RR, Kingdom TT, Hwang PH et al. International Consensus Statement on Allergy and Rhinology: Rhinosinusitis. International Forum of Allergy & Rhinology 2016 Feb;6 Suppl 1:S22-209.
  47. Osguthorpe JD. Adult Rhinosinusitis: Diagnosis and Management. American Family Physician 2001; 63(1): 69-76.
  48. Ow R, Groppo E, Clutter D et al. Steroid-eluting sinus implant for in-office treatment of recurrent polyposis: a pharmacokinetic study. International Forum of Allergy & Rhinology 2014 Oct; 4(10): 816-22.
  49. Parikh A, Anand U, Ugwu MC et al. Drug-eluting nasal implants: formulation, characterization, clinical applications and challenges. Pharmaceutics 2014 May; 6(2): 249-64.
  50. Plaza F, Eisenberg G, Montojo J et al. Balloon dilatation of the frontal recess: a randomized clinical trial. Annals of Otology, Rhinology & Laryngology 2011; 120(8): 511-518.
  51. Pou JD, Riley CA, Tipirneni KE et al. Eosinophilia and quality of life in patients receiving a bioabsorbable steroid-eluting implant during endoscopic sinus surgery. Sinusitis 2017.
  52. Raghunandhan S, Bansal T, Natarajan K et al. Efficacy & outcomes of balloon sinuplasty in chronic rhinosinusitis: a prospective study. Indian Journal of Otolaryngology and Head and Neck Surgery 2013; 65(Suppl 2): S314-S317.
  53. Ramadan HH, McLaughlin K, Josephson G et al. Balloon catheter sinuplasty in young children. American Journal of Rhinology & Allergy 2010; 24(1): e54-e56.
  54. Ramadan HH, Terrall Am. Balloon catheter sinuplasty and adenoidectomy in children with chronic rhinosinusitis. Annals of Otology, Rhinology, and Laryngology 2010;119(9):578-582.
  55. Ramadan HH. Safety and feasibility of balloon sinuplasty for treatment of chronic sinuplastytis in children. Annals of Otology, Rhinology, and Laryngology 2009; 118(3): 161-165.
  56. Ramakrishnan VR, Kennedy DW. Advances in the surgical management of chronic sinusitis and nasal polyps. Current Allergy and Asthma Reports 2011 June; 11(3): 220-9.L, Smith TL. Postoperative care in endoscopic sinus surgery. Otolaryngology Clinics North America 2012; 1019-1032.
  57. Rizzo JA, Rudmik L, Mallow PJ et al. Budget impact analysis of bioabsorbable drug-eluting sinus implants following endoscopic sinus surgery. Journal of Medical Economics 2016 Sept; 19(9): 829-35.
  58. Rudmik L, Smith TL. Economic Evaluation of a Steroid-Eluting Sinus Implant following Endoscopic Sinus Surgery for Chronic Rhinosinusitis. Otolaryngology-Head and Neck Surgery 2014 Aug; 151(2):359-66.Salvin RG, Spector SL, Bernstein IL et al. The diagnosis and management of sinusitis: A practice parameter update. Journal of Allergy and Clinical Immunology 2005; 116(6): S13-47
  59. Sikand A. Introduction to an office-based sinus surgery technique. Operative Techniques in Otolaryngology 2011; 22: 246-252.
  60. Smith TL, Singh A, Luong A et al. Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope. 2016 Dec; 126(12):2659-2664.
  61. Stankiewicz J, Tami T, Truitt T et al. Impact of chronic rhinosinusitis on work productivity through one-year follow-up after balloon dilation of the ethmoid infundibulum. International Forum of Allergy & Rhinology 2011; 1(1): 38-45.
  62. Stankiewicz J, Tami T, Truitt T et al. Transantral endoscopically guided balloon dilation of the ostiomeatal complex for chronic rhinosinusitis under local anesthesia. American Journal of Rhinology & Allergy 2009; 23(3): 331-7.
  63. Stankiewicz J, Truitt T, Atkins J et al. Two-year results: transantral balloon dilation of the ethmoid infundibulum. International Forum of Allergy & Rhinology 2012; 2(3): 199-206.
  64. Stankiewicz J, Truitt T, Atkins J. One-year results: Transantral balloon dilation of the ethmoid infundibulum. ENT Ear, Nose & Throat 2010; 89(2): 72-77.
  65. Stewart AE, Vaughan WC. Balloon sinuplasty versus surgical management of chronic sinuplastyitis. Current Allergy Asthma Respiratory 2010; 10: 181-187.
  66. Vaughan WC. Review of balloon sinuplasty. Current Opinion in Otolaryngology & Head and Neck Surgery 2008 Feb; 16(1): 2-9.
  67. Wei CC, Kennedy DW. Mometasone implant for chronic rhinosinusitis. Medical Devices 2012; 5: 75-80.
  68. Weiss RL, Church CA, Kuhn FA et al. Long-term outcome analysis of balloon catheter sinusotomy: two-year follow-up. Otolaryngology-Head and Neck Surgery 2008 Sept 139 (3 Suppl 3): S38-S46.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 04/26/18.

GUIDELINE UPDATE INFORMATION:

03/15/07

New Medical Coverage Guideline.

06/15/07

Reformatted guideline; updated references.

03/15/08

Scheduled review; no change in position statement. Updated description section, updated references.

03/15/09

Scheduled review. No change in position statement (experimental or investigational). Updated references.

03/15/10

Scheduled review. No change in position statement (experimental or investigational). Updated references.

01/01/11

Annual HCPCS coding update: added 31295, 31296, and 31297. Added program exception for Medicare Advantage products.

02/15/11

Guideline reviewed; added position statement for catheter-based inflatable device (e.g. balloon sinuplasty). Revised experimental or investigational position statement for catheter-based inflatable device (e.g. balloon sinuplasty).

04/01/11

First quarter HCPCS update; deleted S2344.

10/01/11

Revision; formatting changes.

12/15/11

Guideline reviewed; revised description and experimental and investigational statement for clarity. Updated references.

10/15/12

Scheduled reviewed; Deleted experimental or investigational position statement for catheter-based inflatable device (e.g., balloon sinuplasty, balloon sinus dilation) as a stand-alone procedure.

12/15/13

Scheduled review. No change in position statement. Added FDA cleared devices (Relieva Acella™ and Xpress™ Balloon Device [Entellus Medical, Inc.]). Added Medicare Advantage products program exception. Updated references.

09/15/14

Added position statement for implantable sinus stents and spacers. Added S1090. Updated references.

09/15/15

Guideline reviewed; no change in position statements. Revised name of guideline; added “balloon ostial dilation. Updated references.

01/01/16

Annual HCPCS code update. Added 0406T and 0407T.

07/15/17

Guideline reviewed. Revised position statement (added long-term and health).

01/01/18

Annual HCPCS code update. Added 31298.

05/15/18

Review; no change to position statement. Updated description, reimbursement information section and references.

Date Printed: May 27, 2018: 07:38 PM