Medical Policy: 07.01.31
Original Effective Date: May 2006
Reviewed: December 2014
Revised: December 2014
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.
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.
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. Since the publication of the systematic reviews, an additional randomized controlled trial has been published, the REMODEL study. This study, which included 105 patients, reported short-term improvement in symptoms that are similar to those seen with FESS, and potential advantages for balloon ostial dilation on postoperative recovery time and pain medication use. Limitations of the REMODEL study include the unblinded design, lack of blinded outcome assessment across the range of outcome measures, and differential dropout between groups. Other trials are either very small, or nonrandomized comparisons.
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
- 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 Institute; 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 Institute; 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 Institute. 2012 June 13. [Hotline Response].
- ECRI. Balloon Catheter Dilation for Treating Chronic Rhinosinusitis. Plymouth Meeting (PA): ECRI Institute. 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
Date Reason Action
January 2011 Annual review Policy renewed
January 2012 Annual review Policy renewed
January 2013 Annual review Policy renewed
January 2014 Annual review Policy renewed
April 2014 Interim review Policy revised
December 2014 Annual review Policy revised
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.