Medical Policy: 07.01.31 

Original Effective Date: May 2006 

Reviewed: October 2017 

Revised: October 2016 

 

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:

Balloon Sinuplasty

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.

Sinus Stents

Sinus stents are devices used postoperatively following endoscopic sinus surgery (ESS). These devices are used to maintain patency of the sinus openings in the postoperative period, and/or to serve as a local drug delivery vehicle. Reducing postoperative inflammation and maintaining patency of the sinuses may be important in achieving optimal sinus drainage and may impact recovery from surgery.

 

Sinus stents are defined as implantable devices specifically designed to improve patency and/or deliver local medication. These devices are inserted under endoscopic guidance and are distinguished from sinus packing and variations on packing devices routinely employed after sinus surgery.

 

Middle meatal spacers are related but separate devices intended to maintain sinus patency post-ESS. They are splint-like devices inserted directly rather than under endoscopic guidance, and do not have the capability of delivering local medication.

 

There are a number of postoperative treatment regimens, and the optimal regimen is uncertain. Options include saline irrigation, nasal packs, topical steroids, systemic steroids, topical decongestants, oral antibiotics, and/or sinus cavity debridement. A number of RCTs have evaluated various treatment options, but all different strategies have not been rigorously evaluated. A systematic review evaluated the evidence for these therapies. The authors of this review concluded that the evidence was not strong for any of these treatments but that some clinical trial evidence supported improvements in outcomes. The strongest evidence was for use of nasal saline irrigation, topical nasal steroid spray, and sinus cavity debridement.

 

A 2015 Cochrane review addressed steroid-eluting sinus stents for improving chronic rhinosinusitis symptoms in individuals undergoing ESS. Study eligibility criteria were RCTs that compared the effects of steroid-eluting sinus stents with non-steroid-eluting sinus stents, nasal packing, or no treatment in adults with chronic rhinosinusitis who underwent ESS. None of the studies met authors’ inclusion criteria. The authors concluded that there is no evidence from high-quality RCTs to demonstrate the benefits of steroid-eluting stents.

 

Guidelines and Position Statements 

American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS)

In a 2015 Clinical Practice Guideline (update) for Adult Sinusitis, the AAO-HNS indicates that clinicians should recommend saline nasal irrigation, topical intranasal corticosteroids, or both for symptom relief of chronic rhinosinusitis (CRS). Surgical management of CRS is not discussed “because of insufficient evidence (e.g., randomized controlled trials) for evidence-based recommendations”.

 

No clinical practice guidelines were identified that recommend the use of sinus stents, including the 2015 update of the 2007 guideline from the American Academy of Otolaryngology-Head and Neck Surgery Foundation.

 

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.

 

The use of implantable sinus stents for postoperative treatment following endoscopic sinus surgery and for treatment of recurrent nasal polyposis is considered investigational.

Rationale

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.

 

Sinus stents may prove to have a role in nasal polyposis; however, additional positive results from well-designed RCTs are needed to confirm the results of the single available RCT.  There is a lack of guidance in national guidelines that recommend the use of sinus stents in any population.

 

The studies available for stents after sinus surgery have limitations, including risk of bias. In addition, because of the comparison group used in these trials primarily evaluate the efficacy of topical steroids when delivered by an implanted device, but do not evaluate the efficacy of the device versus standard care. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

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 
  • 0406T  Nasal endoscopy, surgical, ethmoid sinus, placement of drug eluting implant;
  • 0407T  Nasal endoscopy, surgical, ethmoid sinus, placement of drug eluting implant; with biopsy, polypectomy or debridement
  • S1090  Mometasone furoate sinus implant, 370 micrograms  

 

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 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
  • 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.
  • 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 Syst Rev. 2015;6:CD010436. PMID 26068957
  • Catalona PJ TM, Weiss R, Rimash T. The MicroFlow Spacer: A drug-eluting stent for the ethmoid sinus. Indian J Otolaryngol Head Neck Surg. 2011;63(3):258.
  • Forwith KD, Chandra RK, Yun PT, et al. ADVANCE: a multisite trial of bioabsorbable steroid-eluting sinus implants. Laryngoscope. Nov 2011;121(11):2473-2480. PMID 22020898
  • 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. Int Forum Allergy Rhinol. Nov 2014;4(11):861-870. PMID 25266981
  • Lavigne F, Miller SK, Gould AR, et al. Steroid-eluting sinus implant for in-office treatment of recurrent nasalpolyposis: a prospective, multicenter study. Int Forum Allergy Rhinol. May 2014;4(5):381-389. PMID 24599580
  • Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, Brook I et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015 Apr;152(2 Suppl):S1-S39. doi: 10.1177/0194599815572097.
  • American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) Clinical Indicators for Endoscopic Sinus Surgery for Adults. 2012, updated 2015.
  • American Academy of Otolaryngology – Head & Neck Surgery (2015, September) Position Statement: The use of biomaterials in sinonasal procedures.
  • ECRI Institute. Health Technology Assessment Information Service. Emerging Technology Report. Steroid-eluting Implant (Propel) for Maintaining Sinus Patency after Ethmoid Sinus Surgery. January 2012. Updated March 2015.
  • ECRI Institute. Health Technology Assessment Information Service. Product Brief. Propel (Intersect ENT, Inc.) Steroid-eluting Implant for Maintaining Sinus Patency after Ethmoid Sinus Surgery. January 2015. Archived.
  • Chandra RK, Kern RC, Cutler JL, Welch KC, Russell PT. REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. Laryngoscope. 2016 Jan;126(1):44-50.
  • Forwith, K. D., Han, J. K., Stolovitzky, J. P., Yen, D. M., Chandra, R. K., Karanfilov, B., Matheny, K. E. (2016). RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study. International Forum of Allergy & Rhinology, 6 (6), 573-581.

 

Policy History:

  • October 2017 - Annual Review, Policy Renewed
  • October 2016 - Annual Review, Policy Revised
  • 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.

 

*CPT® is a registered trademark of the American Medical Association.