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DESCRIPTIONBalloon ostial dilation (also known as balloon sinuplasty™) is proposed as an alternative to traditional endoscopic sinus surgery (ESS) 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 are variable because considerable variation exists in the location and shape of these sinus ostia.
Estimates are that about 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. 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 achieve improved 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.
To quantify the severity of chronic sinusitis and to assess treatment response, various outcomes measures can be used. The Lund-McKay scoring system utilizes radiologist-rated information derived from computed tomography scans regarding opacification of the sinus cavities. The Sino-Nasal Outcome Test is a validated questionnaire in 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.
In March 2008, the device “Relieva™ Sinus Balloon Catheter” (Acclarent, Menlo Park, CA) was cleared for marketing by the U.S. Food and Drug Administration 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 granted 510(k) marketing clearance. 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 device, FinESS™ Sinus Treatment (Entellus Medical Inc., 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 by Entellus Medical Inc. also received 510(k) approval in August, 2012. These are the ENTrigue® Sinus Dilation System, and the XprESS® Multi-Sinus Dilation Tool.
POLICYUse 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.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
There is no CPT code that specifically describes the use of this balloon device. It is anticipated that the procedure would be coded using the CPT codes for nasal/sinus endoscopy with maxillary antrostomy (31256), nasal/sinus endoscopy with front sinus exploration (31276), or nasal/sinus endoscopy with sphenoidectomy (31287).
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.
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.