Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Balloon sinuplasty requires prior authorization to ensure appropriate selection of patients and an adequate trial of more conservative therapy.

The use of a Balloon sinus ostial dilation (balloon sinuplasty: CPT 31295 – 31298) requires prior authorization and is considered as medically necessary in the sinus being considered for dilation (i.e., frontal, maxillary, or sphenoid) for the treatment of chronic rhinosinusitis (CRS) when all of the following criteria are met:

A.   Presence of ≥ 2 of the following signs/symptoms for > 3 months:

·         Nasal obstruction

·         Anterior or posterior mucopurulent drainage

·         Facial pain, pressure, and/or fullness over affected sinus

B.   Decreased sense of smell
Evidence of CRS on computerized tomography (CT) scan in each of the sinuses being considered for treatment, including any of the following:

·         Mucosal thickening > 3 millimeters (mm)

·         Air fluid levels

·         Opacification

C.   Nasal polyposis
Failure of medical management for ≥ 8 weeks, including all of the following:

·         ≥ 2 different full-course antibiotics

·          Steroid nasal spray

·          Antihistamine nasal spray and/or decongestant

·          Nasal saline irrigation

While some clinicians favor the use of endoscopic Balloon Eustachian Tuboplasty (BET) for recurrent ear infections and Chronic Eustachian Tube Dysfunction (CETD), an extensive review of the literature does not support its use (Hayes Rating D2). Based on this, C9745 is considered experimental/investigational and is not covered. Sinus endoscopy and surgery without balloon dilatation (CPT 31231 – 31294) are covered without prior authorization.

Codes Used In This BI:

In some cases of chronic sinusitis, surgical drainage may be necessary.  Endoscopic sinus surgery has become an important aspect for surgical management of chronic sinusitis.  For this procedure, a fiber optic nasal endoscope is used to visualize the sinus Ostia and any obstruction found is corrected.  This restores patency and allows mucous transport through the natural ostium. The procedure may be used when patients fail to respond to aggressive medical management.

Levine reported on results from a registry study of 1,036 patients who received this procedure at 27 sites from December 2005 to May 2007 (Levine et al, 2008). This registry was developed through retrospective chart review of consecutive cases at these institutions. All but 2 patients in this study had treatments while under general anesthesia. An average of 3.2 sinuses was treated per patient. Symptom improvement was reported at 95%. With average follow-up of 40 weeks, the revision rate was 1.3%.

In 2010, Stankiewicz and colleagues reported one-year follow-up data of the Balloon Remodeling Antrostomy Therapy (BREATHE I) study. This multi-center, single-arm study has enrolled 30 patients to receive balloon dilation of the ethmoid infundibulum using the Finesse system, a transantral dilation approached via the canine fossa (Stankiewicz, 2010). Patients were included if they had radiographic evidence of maxillary mucosal thickening despite maximal medical therapy; they were excluded if they had mucosal thickening in other areas or required additional sinus surgery. Primary outcome measure was patient-reported quality of life measure utilizing the SNOT-20. Compliance with all follow-up visits was 29 of 30 subjects (97%). Average overall symptoms scores at baseline were 2.9 + 1.0. At 3, 6, and 12 months following the intervention, average overall symptom scores were 0.7 + 0.8, 0.8 + 0.9, and 0.8 + 0.9, respectively. The authors note the small sample size and lack of comparator groups as limitations of the study. Additional subjects are being enrolled and follow-up data will continue to be collected at 2 years for the cohort.

Tomazic and colleagues reported on a case of ethmoid roof CSF-leak following frontal balloon sinuplasty that was not recognized until 3 weeks post procedure (Tomazic, 2010). This is a known risk factor of any ethmoid manipulation, including endoscopic sinus surgery. The bony defect matched the tip of a standard sinus balloon catheter device. The patient underwent subsequent repair and is reportedly symptom-free. The authors commented that although relatively safe, complications can occur.

A comprehensive review of the literature regarding balloon catheter technology (BCT) in rhinology was published by Batra and colleagues (Batra, 2010). Based on available evidence, they concluded: “The accrued data attests to its safety, whereas the largest published observational cohort studies have demonstrated the ability to achieve Ostia patency for up to 2 years. However, because the selection criteria for these studies were not clearly defined, it is unclear if this data can be extrapolated to the general population with chronic rhino sinusitis (CRS). Is BCT superior or equivalent to the existing devices employed in FESS for the management of CRS? [W]ill the use of BCT translates into improvements in patient outcomes, overall health, and/or quality of life? The many unsettled questions will be best answered by prospective randomized trials that directly compare FESS to BCT, or directly compare medical to surgical treatment.”

In June 2010, the American Academy of Otolaryngology– Head and Neck Surgery offered a statement on balloon ostial dilation.  They stated that “sinus ostial dilation is an appropriate therapeutic option for selected patient with sinusitis. This approach may be used alone or in conjunction with other instruments…”

The American Rhinologic Society has offered a statement that endoscopic balloon catheter sinus dilation technology is acceptable and safe in the management of sinus disease.

1.    American Academy of Otolaryngology-Head and Neck Surgery. Statement on Balloon Dilation. Adopted June 28, 2010. Available online at: http://www.entnet.org/Practice/Balloon-Dilation.cfm.

2.    American Rhino logic Society (ARS). Revised Position Statement on Endoscopic Balloon Catheter Sinus Dilation Technology. Available online at: http://www.american-rhinologic.org/patientadvocacy.balloon.phtml. Last accessed November 30, 2010

3.    Batra PS, Ryan MW, Sindwani R et al. (2010) Balloon catheter technology in rhinology: reviewing the evidence. Laryngoscope 2010

4.    Tomazic PV, Stammberger H, Koele W et al. (2010) Ethmoid roof CSF-leak following frontal sinus balloon sinuplasty. Rhinology 2010; 48(2):247-50.

5.    Chandra RK. (2007) Estimate of radiation dose to the lens in balloon sinuplasty. Otolaryngology Head Neck Surg 2007; 137(6):953-955.

6.    Kuhn FA, Church CA, Goldberg AN et al. (2008) Balloon catheter sinusotomy: one-year follow-up-outcomes and role in functional endoscopic sinus surgery. Otolaryngol Head Neck Surg 2008; 139 (3 suppl 3): 5-15.

7.    Levine HL, Sertich AP, Hoisington DR et al.(2008) Multicenter registry of balloon catheter sinusotomy outcomes for 1,036 patients. Ann Otol Rhinol Laryngol 2008; 117(4):263-270.

8.    Stankiewicz J, Truitt T, Atkins J, Jr. (2010) One-year results: transantral balloon dilation of the ethmoid infundibulum. Ear Nose Throat J 2010; 89(2):72-7.

9.    Cutler J, Bikhazi N, Light J, Truitt T, Schwartz M. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial. Am J Rhinol Allergy.2013; 27(5):416-422

10.    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; 126(1):44-50.

11.    Koskinen A, Myller J, Mattila P, et al. Long-term follow-up after ess and balloon

 sinuplasty: comparison of symptom reduction and patient satisfaction. Acta

 Otolaryngol. 2016; 136(5):532-536.

12.    Koskinen A, Penttila M, Myller J, et al. Endoscopic sinus surgery might reduce

 exacerbations and symptoms more than balloon sinuplasty. Am J Rhinol Allergy.

 2012; 26(6):e150-e156.

13.   Levy JM, Marino MJ, and McCoul ED. Paranasal sinus balloon catheter dilation for  

 treatment of chronic rhinosinusitis: a systematic review and meta-analysis.  Otolaryngol Head Neck Surg. 2016; 154(1):33-40.

14.   Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015; 152(2 Suppl):S1-S39. Sillers MJ, Lay KF, Holy CE. In-office balloon catheter dilation: analysis of 628 patients from an administrative claims database. Laryngoscope. 2015; 125(1):42-48.

15.  Hwang SY, Kok S and Walton J. Balloon dilation for eustachain tube dysfunction:  

 Systematic review. Journal of Laryngology and Otology. 2016; 130(S4):S2-S6.

16.  Schroder S, Lehmann M, Ebmeyer J, Upile T and Sudhoff H. Balloon Eustachian

 tuboplasty: a retrospective cohort study. Clin Otolaryngol. 2015: 40(6):629-638.

17.  Hayes Health Technology Brief. Acclarent Eustachian Tube Balloon Dilation for the

 Treatment of Chronic Eustachian Tube Dysfunction in Adults. July 5, 2018.

Addendum:

1.    Effective 09/01/2017: No longer experimental/investigational based on additional research.

2.    Effective 05/01/2018: Added criteria for balloon dilation of the Eustachian tube.

3.    Effective 02/01/2019: Balloon dilation of Eustachian tube considered experimental/investigational.

4.    Effective 05/01/2019: Sinus endoscopy and surgery without balloon dilatation (CPT 31231-31294) are covered without prior authorization.

5.    Effective 11/01/2019: Updated range of codes.

6.    Effective 01/01/2020: Code update – Revised codes 31233, 31235, 31292, 31293, 31294, 31295, 31296, 31297, 31298 eff 01/01/2020.

7.    Effective 01/01/2021: Code update - C9745 deleted and replaced by 69705 and 69706 and separated code ranges in the search box.

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.