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Date Printed: August 22, 2017: 07:00 AM

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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: 06/22/17

Revised: 07/15/17

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™ [Intersect ENT], Relieva Stratus™ MicroFlow Spacer (Frontal)).

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)

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 balloon sinuplasty, sinus stents and spacers.

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.

Coding guidelines:

Do not report 31295 with nasal/sinus endoscopy code 31233, 31256, or 31267 when performed on the same sinus.
Do not report 31296 with nasal/sinus endoscopy code 31276 when performed on the same sinus.
Do not report 31297 with nasal/sinus endoscopy code 31235, 31287, or 31288 on the same sinus.

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.), 12/12.
  2. American Academy of Otolaryngology Head and Neck Surgery (ASO-HNS) Statement on Reimbursement of Balloon Sinus Ostial Dilation, 09/14.
  3. 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.
  4. American Rhinologic Society (ARS): Ostial Balloon Dilation Position Statement, 01/08/15.
  5. American Rhinologic Society Position Statement on Balloon Dilation Technology (Balloon Sinuplasty, 07/06/06, revised 12/10/09.
  6. American Rhinologic Society (ARS): ARS Position Statement on Biomaterials, 01/24/14.
  7. 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.
  8. Blue Cross Blue Shield Association Balloon Ostial Dilation for Treatment of Chronic Sinusitis Medical Policy 7.01.105, 05/17.
  9. Blue Cross Blue Shield Association Implantable Sinus Stents for Postoperative Use Following Endoscopic Sinus Surgery Medical Policy 7.01.134, 02/17.
  10. Blue Cross Blue Association TEC Assessment: Balloon Sinus Ostial Dilation for Treatment of Chronic Rhinosinusitis, Vol. 27, No.9, April 2013.
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. 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. ECRI Emerging Technology Evidence Report: Balloon Catheter Dilation for Treating Chronic Rhinosinusitis, August 2012.
  18. ECRI Emerging Technology Evidence Report: Steroid-Eluting Implant (Propel for Maintaining Sinus Patency after Ethmoid Sinus Surgery, 12/12.
  19. 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.
  20. Hopkins C, Noon E, Bray D, Roberts D. Balloon sinuplasty: our first year. The Journal of Laryngology & Otology 2010; 24:1-10.
  21. Hopkins C, Noon E, Roberts D. Balloon sinuplasty in acute frontal sinusitis. Rhinology 2009; 47(4): 375-378.
  22. 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.
  23. 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.
  24. 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.
  25. Levine H, Rabago D. Balloon sinuplasty: a minimally invasive option for patients with chronic rhinosinusitis. Post Graduate Medicine 2011; 123(2): 112-118.
  26. 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.
  27. 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.
  28. Marzetti A, Tedaldi M, Passali FM. The role of balloon sinuplasty in the treatment of sinus headache. Otolaryngologia Polska 2014; 68(1): 15-19.
  29. National Institute for Health and Clinical Excellence-Balloon catheter dilation of paranasal sinus ostia for chronic sinusitis, 09/08.
  30. 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.
  31. Osguthorpe JD. Adult Rhinosinusitis: Diagnosis and Management. American Family Physician 2001; 63(1): 69-76.
  32. 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.
  33. 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.
  34. Ramadan HH, McLaughlin K, Josephson G et al. Balloon catheter sinuplasty in young children. American Journal of Rhinology & Allergy 2010; 24(1): e54-e56.
  35. 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.
  36. 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.
  37. 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
  38. Sikand A. Introduction to an office-based sinus surgery technique. Operative Techniques in Otolaryngology 2011; 22: 246-252.
  39. 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.
  40. 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.
  41. 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.
  42. 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.
  43. Stewart AE, Vaughan WC. Balloon sinuplasty versus surgical management of chronic sinuplastyitis. Current Allergy Asthma Respiratory 2010; 10: 181-187.
  44. Vaughan WC. Review of balloon sinuplasty. Current Opinion in Otolaryngology & Head and Neck Surgery 2008 Feb; 16(1): 2-9.
  45. 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 06/22/17.

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).

Date Printed: August 22, 2017: 07:00 AM