Coverage Policy Manual
Policy #: 2017010
Category: Surgery
Initiated: June 2017
Last Review: December 2018
  Pilot Policy: Balloon Ostial Dilation (Balloon Sinuplasty) for the Treatment of Chronic Sinusitis

Description:
Chronic rhinosinusitis (CRS) is characterized by purulent nasal discharge, usually without fever, that persists for weeks to months. Symptoms of congestion often accompany the nasal discharge. There also may be mild pain and/or headache. Thickening of mucosa may restrict or close natural openings between sinus cavities and the nasal fossae, although symptoms vary considerably because of variation in the location and shape of these sinus ostia.
  
Estimates suggest approximately 30 million individuals in the United States suffer from CRS. Most cases are treated with medical therapy, but surgical drainage is an option for patients who fail to respond to medical therapy. Functional endoscopic sinus surgery (FESS) has become an important aspect for surgical management of CRS, although evidence from randomized controlled trials (RCTs) is limited. FESS has traditionally required general anesthesia. During FESS an endoscope is used to visualize the sinus drainage pathways and any obstruction noted at the time of surgery or on pre-operative imaging is corrected by removing thickened mucosa, bone, or polyps with forceps or motorized debrider instruments. GESS is often performed in conjunction with nasal septoplasty for paranasal sinus access or to relieve concomitant airway obstruction. Fess procedures restore patency and allow air and mucous transport through the natural ostium. Approximately 350,000 FESS procedures are done each year in the United States for CRS.
  
A newer procedure, balloon sinus dilatation (BSD) can be used as an alternative to FESS or in conjunction with FESS for the treatment of CRS. The balloon is directly inserted into the target sinus drainage pathway or ostium. The goal of sinus balloon dilatation includes minimal mucosal damage, minimal intraoperative bleeding, and minimal post-operative discomfort as compared to FESS. FESS techniques may be performed in conjunction with balloon sinus dilatation to remove sinonasal polyps, remove a concha bullosa, or if an ethmoidectomy is needed (as the ethmoid sinuses are not amenable to balloon sinus surgery). When used as an adjunct to FESS, BSD is intended to facilitate and/or increase access to the sinuses. The procedure involves placing a guidewire or stylet into the sinus drainage pathway or sinus ostium, advancing a balloon over the guidewire or stylet, and then stretching the pathway or ostium by inflating the balloon. The guidewire or stylet location is confirmed with CT scan image guidance or with direct transillumination of the targeted sinus cavity(s). General anesthesia may be needed for this procedure to minimize patient movement or because of patient preference, patient age, or sinonasal pathology. However, BSD with/or without FESS, septoplasty, and/or turbinate reduction, may often be performed in a physician’s office using oral sedatives and local anesthesia, bypassing general anesthesia and operating facility expenses. In addition, office based procedures may benefit pregnant patients, patients on blood-thinning/anticoagulant medication, or those patients whose medical conditions put them at higher risk for general anesthesia.
 
The maxillary sinus creates a unique challenge. The maxillary ostia, located within the ethmoid infundibulum, often cannot be accessed transnasally without excising a portion of the uncinate process. An alternative approach to the maxillary ostia is through the sinus, via a canine fossa trocar puncture. With either of these maxillary sinus ostial dilation techniques a balloon can be advanced from within the maxillary sinus to the nasal fossa. The dilating balloon can enlarge the ostia while deflecting the uncinate process.
 
The FDA classifies devices used for balloon catheter dilation for treating chronic sinusitis under product code LRC (instrument, ENT, manual surgical). This is a broad product code category that includes a variety of devices used in ear, nose and throat surgeries (e.g., knives, hooks, injection systems, dilation devices). Additionally, this product code is 510(k)-exempt. Although manufacturers may voluntarily submit product information via the 510(k) process, it is not a requirement. All manufacturers are, however required to register their establishment and submit a “Device Listing” form. These records can be viewed in the Registration and Device Listing Database (search by product code, device, or manufacture name).
  
In March 2008, the Relieva™ Sinus Balloon Catheter (Acclarent, Menlo Park, CA) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. FDA determined that this device was substantially equivalent to existing devices for use in dilating the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children. Subsequent devices developed by Acclarent have also been cleared by FDA through the 510(k) process. These include the Relieva Spin Sinus Dilation System® cleared in August 2011 and the Relieva Seeker Balloon Sinuplasty System® cleared in November 2012.
  
In June 2008, the FinESS™ Sinus Treatment (Entellus Medical, Maple Grove, MN) was cleared for marketing by FDA through the 510(k) process. The indication noted is to access and treat the maxillary ostia/ethmoid infundibulum in adults using a transantral approach (FDA product code: EOB). The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures. Two other balloon sinus ostial dilation devices, the ENTrigue® Sinus Dilation System (ENTrigue Surgical, subsequently acquired by ArthroCare, Austin, TX, acquired by Smith and Nephew, London, UK), and the XprESS™ Multi-Sinus Dilation Tool, also received 510(k) clearance in August 2012.
 
The XprESS Multi-sinus Dilation System (Entellus Medical, Plymouth, MN) was cleared for marketing by the FDA through the 510(k) process in November 2015 to access and treat the maxillary ostia/ethmoid infundibula and frontal ostia/recesses and sphenoid sinus ostia using a trans-nasal approach.  
  
In 2013, a sinus dilation system (Medtronic Xomed, Jacksonville, FL), later named the NuVent™ EM Balloon Sinus Dilation System, was cleared for marketing by the FDA through the 510(k) process for use in conjunction with a Medtronic computer-assisted surgery system when surgical navigation or image-guided surgery may be necessary to locate and move tissue, bone, or cartilaginous tissue surrounding the drainage pathways of the frontal, maxillary, or sphenoid sinuses.
  
Also in 2013, a sinus dilation system (ArthroCare, San Antonio, TX, a division of Smith and Nephew), later named the Ventera™ Sinus Dilation System, was cleared for marketing through the 510(k) process to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid
 
Coding
There are specific category I CPT codes for these procedures (31295-31298). These codes may be used to describe balloon sinus ostial dilation when no other surgical intervention has been performed on the same sinus site.
 
There are HCPCS codes (C1726 and C1727) for use in the Medicare outpatient hospital setting.  These codes are not allowed for billing of balloon sinuplasty under this pilot policy. CMS “C” codes are unique temporary codes established by CMS for use under the Hospital Outpatient Prospective Payment System (OPPS). HCPCS C1726 and C1727 are non-specific for balloon sinuplasty. The specific category I CPT codes should be used to bill for these procedures.

Policy/
Coverage:
Pilot Policy:
  
Effective June 1, 2017 through May 31, 2021 for providers directly contracted with Arkansas Blue Cross and Blue Shield and its affiliates and subsidiaries only, the use of balloon ostial dilation in a facility or office setting is covered under this pilot policy for the treatment of medically refractory chronic rhinosinusitis (as defined by AAO-HNS, 2015) as a minimally invasive alternative to functional endoscopic sinus surgery when ALL of the following criteria are met:
 
    • Age 18 years of age or older, AND
    • Twelve weeks or longer of TWO or more of the following signs and symptoms:
• mucopurulent drainage (anterior, posterior, or both),
• nasal obstruction (congestion),
• facial pain-pressure-fullness, or
• decreased sense of smell; AND
 
    • Inflammation is documented by ONE or more of the following findings:
• purulent (not clear) mucus or edema in the middle meatus or anterior ethmoid region,
• polyps in nasal cavity or the middle meatus, and/or
• radiographic imaging showing inflammation of the paranasal sinuses; AND
 
    • Refractory to > 12 weeks of conservative medical therapy including nasal lavage, steroid nasal spray, decongestant therapy, and the use of antibiotic therapy where appropriate; AND
 
    • Radiographic evidence of chronic sinusitis of the involved sinus(es):
•Sinus opacification
•Sinus air fluid levels
•Mucosal thickening (> 3mm)
 
The use of balloon sinuplasty as an adjunctive procedure during functional endoscopic sinus surgery in the same sinus cavity is considered integral to the primary procedure and not reimbursable separately.
 
The use of balloon ostial dilation for any other reason or in any other circumstance than those listed above is not covered under this pilot policy.
 
The specific Category I CPT codes (31295-31298) should be used to bill for this procedure. The non-specific HCPCS C codes C1726 and C1727 are not covered.   

Rationale:
The REMODEL study was an industry-sponsored RCT that compared balloon ostial dilation as a stand-alone procedure with FESS (Cutler, 2013). A total of 105 patients with recurrent acute sinusitis or chronic sinusitis and failure of medical therapy were randomized to balloon ostial dilation or FESS. Balloon ostial dilation was performed with the Entellus device, which is labeled for a transantral approach. FESS consisted of maxillary antrostomy and uncinectomy with or without anterior ethmoidectomy. Thirteen patients withdrew consent before treatment, 11 (21%) in the FESS group and 2 (4%) in the balloon ostial dilation group. The primary outcomes were the change in the SNOT-20 score at 6-month follow-up and the mean number of debridements performed postoperatively. Secondary outcomes included recovery time, complication rates, and rates of revision surgery. Both superiority and noninferiority analyses were performed on these outcomes.
 
A total of 91 patients were available at 6-month follow-up. The improvement in the SNOT-20 score (SD) was 1.67 (1.10) in the balloon dilation group and 1.60 (0.96) in the FESS arm (p=0.001 for noninferiority). Postoperative debridements were more common in the FESS group than in the balloon dilation group (1.2 [SD=1.0] in the FESS arm vs 0.1 [SD=0.6] in the balloon ostial dilation arm, p<0.001 for superiority in the FESS arm). Patients in the balloon dilation arm returned to normal daily activities faster (1.6 days vs 4.8 days, p=0.002 for superiority) and required fewer days of prescription pain medications (0.9 days vs 2.8 days, p=0.002 for superiority). There were no major complications in either group, and 1 patient in each group required revision surgery.
 
Bikhazi and colleagues reported 1-year follow-up from the REMODEL study (Bikhazi, 2014). Eighty-nine (96.7%) subjects were available for follow-up to 1 year. Improvement in the SNOT-20 score was 1.64 in the balloon dilation arm and 1.65 in the FESS arm (p<0.001 for noninferiority). During the year post-procedure, both groups had fewer self-reported rhinosinusitis episodes (reduction of 4.2 episodes in the balloon arm, reduction of 3.5 episodes in the FESS; p=NS).
 
In 2016, Chandra and colleagues reported results up to 2 years postprocedure for subjects in the REMODEL study, along with an additional 30 subjects treated with either FESS or in-office balloon sinus dilation, for a total of 61 FESS patients or 74 balloon sinus dilation patients (Chandra, 2016). Follow-up data were available for 130, 66, and 25 patients at 12, 18, and 24 months, respectively. Details about group-specific treatment received and loss to follow-up were not reported for the additional 30 patients not described in the 2013 Cutler article. Balloon sinus dilation patients required 0.2 debridements per patient compared with 1.0 per patient in the FESS group (p<0.001). Mean change in SNOT-20 score from baseline to 12-month follow-up was -1.59 (p<0.001) and -1.60 (p<0.001) for the balloon sinus dilation and FESS groups, respectively, which was considered clinically significant. These changes were maintained at 24 months. At 18 months, overall revision rates were 2.7% in the balloon sinus dilation group and 6.9% in the FESS group. In addition to the longer term results of the REMODEL trial, this article includes a meta-analysis of the REMODEL balloon dilation-treated patients and data from 5 manufacturer-sponsored trials, 3 of which had previously been reported in peer-reviewed form (BREATHE: Stankiewicz 2010; Stankiewicz, 2012; RELIEF: Levine, 2013; XprESS Transnasal Maxillary Multi-Sinus: Gould, 2014). Across the 6 studies, 846 patients were treated with balloon sinus dilation, including 121 not described in prior publications. In a random-effects model, overall mean and subscale values for SNOT-20 scores improved compared with baseline at every follow-up time point.
 
 
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed below:
 
Ongoing
(NCT01990820) Study for the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinuplasty; planned enrollment 48; projected completion date Mar 2016
 
(NCT01714687) an industry sponsored or cosponsored trial. Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients (CABERNET); planned enrollment 400; projected completion Apr 2016
 
Unpublished
(NCT01685229) an industry sponsored or cosponsored trial.  Medical Therapy Versus Balloon Sinus Dilation for Patients with Chronic Rhinosinusitis (MERLOT); planned enrollment 198; projected completion date Aug 2015 (completed).
 
2018 Update
A literature search was conducted through November 2018.  There was no new information identified that would prompt a change in the coverage statement.  

CPT/HCPCS:
31295Nasal/sinus endoscopy, surgical; with dilation of maxillary sinus ostium (eg, balloon dilation), transnasal or via canine fossa
31296Nasal/sinus endoscopy, surgical; with dilation of frontal sinus ostium (eg, balloon dilation)
31297Nasal/sinus endoscopy, surgical; with dilation of sphenoid sinus ostium (eg, balloon dilation)
31298Nasal/sinus endoscopy, surgical; with dilation of frontal and sphenoid sinus ostia (eg, balloon dilation)
31299Unlisted procedure, accessory sinuses

References: Bikhazi N, Light J, Truitt T, et al.(2014) 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

Chandra RK, Kern RC, Cutler JL, et al.(2016) REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. Laryngoscope. Jan 2016;126(1):44-50. PMID 26228589

Cutler J, Bikhazi N, Light J, et al.(2013) Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial. Am J Rhinol Allergy. Sep-Oct 2013;27(5):416-422. PMID 23920419

Gould J, Alexander I, Tomkin E, et al.(2014) 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

Levine SB, Truitt T, Schwartz M, et al.(2013) 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

Rosenfeld RM, Picirillo JF, Chandrasekhar SS, et al.(2015) Clinical Practice Guideline: Adult Sinusitis. Otolaryngol Head Neck Surg. April 2015; 152(S3):s1-s39.

Stankiewicz J, Truitt T, Atkins J, et al.(2012) Two-year results: transantral balloon dilation of the ethmoid infundibulum. Int Forum Allergy Rhinol. May-Jun 2012;2(3):199-206. PMID 22337530

Stankiewicz J, Truitt T, Atkins J, Jr.(2010) One-year results: Transantral balloon dilation of the ethmoid infundibulum. Ear Nose Throat J. Feb 2010;89(2):72-77. PMID 20155675


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2019 American Medical Association.