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DESCRIPTIONBalloon sinuplasty is proposed as an alternative to 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.
Chronic sinusitis 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.
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 fiberoptic nasal endoscope is used to visualize the sinus ostia and any obstruction found is corrected. This restores the patency and allows mucous transport through the natural ostium. The procedure may be used when patients fail to respond to aggressive medial management. About 350,000 procedures are done each year in the US for chronic sinusitis. Estimates are that about 30 million individuals in the US suffer from chronic sinusitis.
A new procedure, balloon sinuplasty, is being discussed as an alternative to endoscopic sinus surgery for those with chronic sinusitis. The procedure involves placing a balloon in the sinus ostium and then stretching the opening by inflating the balloon. General anesthesia may be needed for this procedure to minimize patient movement. This technique is said to allow improved sinus drainage.
Of note, surgical interventions are generally not necessary in patients with acute sinusitis.
In March 2008, a balloon sinuplasty device manufactured by Acclarent was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The device is indicated for dilating the sinus ostia and spaces associated with the maxillary sinus in children aged 17 years and younger. In April 2008, another balloon device, the Entellus Medical RS Series System (Entellus Medical, Inc.), was cleared by the FDA through the 510(k) process for the maxillary and ethmoid sinuses. In June 2008, an additional device, the Entellus Medical FinESS Sinus Treatment (Entellus Medical, Inc) was also cleared through the 510(k) process. The indication noted is to access and treat the sinus and its outflow tract with a transantral approach in adults.
POLICYUse of catheter-based inflatable (balloon sinuplasty) 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.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.105
CODE REFERENCEThis is not an all-inclusive list of non-covered procedure codes.
All codes billed for this procedure are considered investigational and not eligible for coverage.