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DESCRIPTIONBalloon ostial dilation (also known as balloon sinuplasty) is proposed as an alternative to traditional endoscopic sinus surgery for patients with chronic sinusitis who fail medical management. The procedure involves placing a balloon in the sinus ostium and inflating the balloon to stretch the opening. It can be performed as a stand-alone procedure or as an adjunctive procedure to functional endoscopic sinus surgery (FESS).
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 US suffer from chronic sinusitis. Most cases are treated with medical therapy, but surgical drainage is an option for patients who fail to respond to medical therapy. FESS has become an important aspect for surgical management of chronic sinusitis, although evidence from randomized controlled trials (RCTs) is limited. For this procedure, a fiberoptic nasal endoscope is used to visualize the sinus ostia, and any obstruction found is corrected. This procedure restores patency and allows air and mucous transport through the natural ostium. About 350,000 FESS procedures are done each year in the US for chronic sinusitis.
A newer procedure, balloon ostial dilation can be used as an alternative to FESS or as an adjunct to FESS for those with chronic sinusitis. The goal of this technique, when used as an alternative to FESS, is to improve sinus drainage using a less invasive approach. When used as an adjunct to FESS, it is intended to facilitate and/or increase access to the sinuses. The procedure involves placing a guidewire in the sinus ostium, advancing a balloon over the guidewire, and then stretching the opening by inflating the balloon. The guidewire location is confirmed with fluoroscopy or with direct transillumination of the targeted sinus cavity. General anesthesia may be needed for this procedure to minimize patient movement.
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 alternate approach to the maxillary ostia is through the sinus, via the canine fossa. A guidewire can be advanced from within the maxillary sinus to the nasal fossa. The dilating balloon can enlarge the ostia while deflecting the uncinate process.
Outcomes in the Evaluation of Chronic Rhinosinusitis
To quantify the severity of chronic sinusitis and to assess treatment response, various outcomes measures can be used, including patient-reported quality of life (QOL) measures, radiologic scores, and endoscopic grading.
The Lund-MacKay scoring system uses radiologist-rated information derived from computed tomography scans regarding opacification of the sinus cavities, generating a score from 0 to 12.
Several disease-specific patient-reported QOL scores have been used. Commonly used is the Sino-Nasal Outcome Test-20 (SNOT-20), which is a validated questionnaire for which patients complete 20 symptom questions on a categorical scale (0 [no bother] to 5 [worst symptoms can be]). Average rankings can be reported over all 20 symptoms, as well as by 4 subclassified symptom domains. The SNOT-22, variation of the SNOT-20, includes two additional questions (“nasal obstruction” and “loss of smell and taste”). The minimal clinically important difference for the SNOT-22 has been estimated to be 8.9 points.
Additionally, QOL may be reported based on overall health-related QOL scores, such as the 36-Item Short-Form Health Survey-36 (SF-36). The SF-36 includes 8 scaled scores on various health domains, which are transformed into a 0-to-100 scale (100 corresponding to best health).
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.
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 infundibula in adults using a transnasal approach.
Use of catheter-based inflatable device (balloon ostial dilation) in the treatment of sinusitis is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY9/28/2006: Policy updated
12/27/2006: Code Reference section updated per the 2007 CPT/HCPCS revisions
8/3/2007: Policy reviewed, no changes
9/11/2008: Policy description amended, policy statement unchanged
6/2/2009: Coding section updated. CPT codes 31256, 31276, 31287 deleted from the non-covered table. These codes should not be used to report the balloon sinuplasty procedure. Note added to code 31299: It is inappropriate to use any of the nasal/sinus endoscopy codes (31231-31294) to report the balloon sinuplasty procedure. The most appropriate code to use to report the balloon sinuplasty procedure is HCPC Level II code S2344. However, we will accept unlisted code 31299 if your system does not support the use of code S2344.
04/21/2010: Policy description updated regarding FDA status of devices. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section.
03/07/2011: Added new CPT codes 31295, 31296, and 31297 to the Code Reference section.
08/11/2011: Policy reviewed; no changes.
07/12/2012: Policy reviewed; no changes.
05/06/2013: Removed ICD-9 diagnosis codes 473.0-473.9 from the Code Reference section.
03/19/2014: Policy reviewed; no changes.
12/05/2014: Policy title changed from "Balloon Sinuplasty for Treatment of Chronic Sinusitis" to "Balloon Ostial Dilation for Treatment of Chronic Sinusitis." Policy description updated regarding balloon ostial dilation, maxillary sinus, and devices. Policy statement updated to add "device" and change "balloon sinuplasty" to "balloon ostial dilation." Intent unchanged.
07/08/2015: Code Reference section updated for ICD-10.
12/18/2015: Policy description updated regarding devices. Policy statement unchanged. Policy guidelines updated to add investigative definition and to remove coding information.
05/31/2016: Policy number A.7.01.105 added.
09/19/2016: Policy description updated regarding outcomes in the evaluation of chronic rhinosinusitis. Policy statement unchanged.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.105
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
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