Medical Policy: 07.01.31 
Original Effective Date: May 2006 
Reviewed: October 2015 
Revised: October 2015 


Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.


Description:

Functional endoscopic dilation of the sinuses, also referred to as Balloon SinuplastyTM describes a procedure intended to clear sinus cavities using a balloon rather than invasive surgery. During this endoscopic procedure, a catheter-based device is advanced into the sinus under fluoroscopic guidance. Once positioned the balloon is gradually inflated to open the sinus thereby allowing drainage.

 

In a typical FESS (functional endoscopic sinus surgery), the physician first identifies the middle turbinate and removes the uncinate process to expose the ethmoid bulla. The anterior ethmoid air cells are opened, leaving the bone covered with mucosa. This allows for better ventilation of the anterior ethmoid sinuses. The maxillary ostium is examined and, if it is obstructed, a middle meatal antrostomy is performed. This minimal surgery is often sufficient to improve the function of the osteomeatal complex, which improves the ventilation of the maxillary, ethmoid, and frontal sinuses.

 

Balloon sinuplasty is frequently used within the FESS procedure as a tool to open the sinuses, enabling the surgeon better access with the endoscope. Balloon sinuplasty alone fails to address the underlying issues of sinusitis.


Prior Approval:

 

Not applicable


Policy:

Functional endoscopic dilatation of the sinuses or Balloon Sinuplasty™ is considered investigational as a  procedure when done outside of the FESS procedure.

 

There is insufficient evidence on the impact and duration of balloon sinuplasty on health outcomes. Small randomized, controlled trials do not report significant improvements on clinically relevant outcome measures. A large number of non-comparative single-arm series report high success rates, but are not sufficient to determine comparative efficacy with alternative treatments. Prospective comparative studies with larger patient populations are needed to determine the clinical outcomes for this treatment compared with standard surgical or medical approaches. This information is important to determine symptom improvement as well as the durability of the procedure and the need for subsequent revision.  In addition, more information is needed to determine which patients and which sinuses benefit from the balloon technique as an adjunct to traditional endoscopic sinus surgery, and which patients should get standard approaches. Given the limitations of the available data, the uncertain impact on clinical outcomes, and questions about which patients might be candidates for this procedure, this approach is considered investigational when performed as a stand-alone (outside of the FESS) procedure.

 

The evidence related to the use of balloon ostial dilation, as a stand-alone procedure or an adjunct to functional endoscopic sinus surgery (FESS), has been reviewed in several systematic reviews, including a Cochrane review and a Blue Cross and Blue Shield Association TEC Assessment. These reviews have concluded that, although nonrandomized evidence suggests that balloon ostial dilation has similar outcomes to endoscopic sinus surgery (ESS), evidence from randomized trials is needed to demonstrate an improvement in outcomes for patients treated with balloon ostial dilation.  Comparative long-term data on ostial patency and health outcomes is lacking.  There is a need for higher-quality, longer-term data to fully evaluate balloon sinus procedures and to draw conclusions as to whether the results produced using balloon sinus approaches are as good as or better than those achieved by medical management or surgical approaches, such as FESS alone.



Procedure Codes and Billing Guidelines:

  • To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
  • 31295 Nasal/sinus endoscopy, surgical; with dilation of maxillary sinus ostium (eg, balloon dilation), transnasal or via canine fossa
  • 31296 Nasal/sinus endoscopy, surgical; with dilation of frontal sinus ostium (eg, balloon dilation)
  • 31297 Nasal/sinus endoscopy, surgical; with dilation of sphenoid sinus ostium (eg, balloon dilation)
  • 31299; Unlisted procedure, accessory sinuses   

Selected References:

  • ECRI Technology Target Database. Endoscopic Balloon Dilatation of Paranasal Sinuses for Sinusitis. January 2007.
  • Weiss RL, Church CA, Kuhn FA et al. Long-term outcomes analysis of balloon catheter sinusotomy: two-year follow-up. Otolaryngol Head neck Surg 2008 Sep; 139(3 Suppl 3): S38-46.
  • Kuhn FA, Church, Goldberg AN et al. Balloon catheter sinusotomy: one-year follow-up - Outcomes and role in functional endoscopic surgery. Otolaryngol Head Neck Surg 2008 Sep; 139(3 Suppl 3); S27-37.
  • Vaughan WC, Review of balloon sinuplasty. Curr Opin Otolaryngol Head Neck Surg. 2008 Feb; 16(1): 2-9.
  • TARGET [database online]. Plymouth Meeting (PA): ECRI InstituteExternal Site 2008 Dec 19; Balloon catheter dilation for chronic sinusitis.
  • Levine HL, Sertich AP 2nd, Hoisington DR et al. Multicenter registry of balloon catheter sinusotomy outcomes for 1,036 patients. Ann Otol Rhinol Laryngol. 2008 Apr;117(4):263-70.
  • Wittkopf  ML, Becker SS, Duncavage JA et al. Balloon sinuplasty for the surgical management of immunocompromised and critically ill patients with acute rhinosinusitis. Otolaryngol Head Neck Surg. 2009 Apr; 140(4):596-8.
  • Batra PS, Ryan MW, Sindwani R et al. Balloon catheter technology in rhinology: Reviewing the evidence. Laryngoscope. 2011 Jan; 121(1):226-32. doi: 10.1002/lary.21114. Epub 2010 Sep 7.
  • TARGET [database online]. Plymouth Meeting (PA): ECRI InstituteExternal Site 2010 May 3; Balloon catheter dilation for chronic sinusitis.
  • Plaza G, Eisenberg G, Montojo J, Onrubia T, Urbasos M, O'Connor C. Balloon dilation of the frontal recess: A randomized clinical trial. Ann Otol Rhinol Laryngol. 2011 Aug;120(8):511-8.
  • Ahmed J, Pal S, Hopkins C, Jayaraj S. Functional endoscopic balloon dilation of sinus ostia for chronic rhinosinusitis. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD008515.
  • Fokkens WJ, Lund VJ, Mullol J, Bachert C, et al. EPOS 2012: European Position Paper on Rhinosinusitis and Nasal Polyps 2012. Rhinology. 2012 Mar;50(1):1-12.
  • ECRI. Balloon Catheter Dilation for Treating Chronic Sinusitis. Plymouth Meeting (PA): ECRI InstituteExternal Site 2012 June 13. [Hotline Response].
  • ECRI. Balloon Catheter Dilation for Treating Chronic Rhinosinusitis. Plymouth Meeting (PA): ECRI InstituteExternal Site 2012 August 20. [Emerging Technology Evidence Report].
  • Koskinen A, Penttila M, Myller J, et al. Endoscopic sinus surgery might reduce exacerbations and symptoms more than balloon sinuplasty. Am J Rhinol Allergy 26, e150-e156, 2012, doi: 10.2500/ajra.2012.26.3828.
  • Karanfilov B, Silvers S, Pasha R, et al. Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients. Int Forum Allergy Rhinol. 2013; 3(5):404-411.
  • Cutler J, Bikhazi N, Light J, et al.; REMODEL Study Investigators. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial. Am J Rhinol Allergy. 2013; 27(5):416-422
  • ECRI Standalone balloon sinus dilation for treating chronic rhinosinusitis in adults. Health technology assessment/Emerging technology evidence report. August 2015.
  • Gould J, Alexander I, Tomkin E, et al. In-office, multisinus balloon dilation: 1-Year outcomes from a prospective, multicenter, open label trial. Am J Rhinol Allergy. Mar-Apr 2014;28(2):156-163. PMID 24598043
  • Marzetti A, Tedaldi M, Passali FM. The role of balloon sinuplasty in the treatment of sinus headache. Otolaryngol Pol. Jan-Feb 2014;68(1):15-19. PMID 24484944
  • 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. Am J Rhinol Allergy. Jul 2014;28(4):323-329. PMID 24823902
  • Tomazic PV, Stammberger H, Braun H, et al. Feasibility of balloon sinuplasty in patients with chronic rhinosinusitis: the Graz experience. Rhinology. Jun 2013;51(2):120-127. PMID 23671892
  • Levine SB, Truitt T, Schwartz M, et al. In-office stand-alone balloon dilation of maxillary sinus ostia and ethmoid infundibula in adults with chronic or recurrent acute rhinosinusitis: a prospective, multi-institutional study with-1-year follow-up. Ann Otol Rhinol Laryngol. Nov 2013;122(11):665-671. PMID 24358625
  • Weiss RL, Church CA, Kuhn FA, et al. Long-term outcome analysis of balloon catheter sinusotomy: two-year follow-up. Otolaryngol Head Neck Surg 2008; 139:S38.

Policy History:

  • October 2015 - Annual Review, Policy Revised
  • December 2014 - Annual Review, Policy Revised
  • April 2014 - Interim Review, Policy Revised
  • January 2014 - Annual Review, Policy Renewed
  • January 2013 - Annual Review, Policy Renewed
  • January 2012 - Annual Review, Policy Renewed
  • January 2011 - Annual Review, Policy Renewed

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.