Balloon Sinuplasty for Treatment of Chronic Sinusitis
DESCRIPTION
Balloon sinuplasty is being offered as a treatment for individuals with chronic sinusitis as an alternative to endoscopic sinus surgery. The procedure is performed under anesthesia. A guide wire equipped with a balloon is threaded into the nostrils and up to the blockage. Once the balloon is placed, it is inflated approximately a quarter of an inch. The procedure is intended to provide a means to dilate blocked ostia and spaces within the paranasal sinus cavities without removing bone or tissue. The procedure is done in an effort to restore sinus drainage by stretching the opening to the sinus.
The Acclarent Balloon Sinuplasty™ system (previously called Relieva®) is an example of a device used for this procedure.
Note: This policy does not address FESS (functional endoscopic sinus surgery).
POLICY
Balloon sinuplasty for the treatment of chronic sinusitis is considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Well-designed studies in peer-reviewed journals regarding this technology are lacking. Studies to address questions such as whether balloon sinuplasty brings lasting relief and comparison of outcomes to conventional surgery are needed. Therefore, is not known if this technology leads to improved treatment or better health care outcomes.
SOURCES
American Academy of Otolaryngology - Head and Neck Surgery. (2010). Dilation of sinuses, any method (e.g., balloon, etc.). Retrieved October 24, 2011 from http://www.entnet.org/Practice/Balloon-Dilation.cfm.
American Rhinologic Society. (2007, May). Balloon sinuplasty. Retrieved October 21, 2011 from http://www.american-rhinologic.org/position_balloon_sinuplasty.
Batra, P. S., Ryan, M. W., Sindwani, R., & Marple, B. F. (2011). Balloon catheter technology in rhinology: Reviewing the evidence. The Laryngoscope, 121 (1), 226-232.
BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2011). Balloon sinuplasty for treatment of chronic sinusitis (7.01.105). Retrieved October 21, 2011 from BlueWeb. (17 articles and/or guidelines reviewed)
Brown, F., & Bolger, W. (2006). Safety and feasibility of balloon catheter dilation of paranasal sinus ostia: A preliminary investigation. The Annals of Otology, Rhinology, and Laryngology, 115 (4), 293-299. (Level 4 Evidence - Industry sponsored)
Kim, E., & Cutler, J. L. (2009). Balloon dilatation of the paranasal sinuses: A tool in sinus surgery. Otolaryngologic Clinics of North America, 42 (5), 847-856.
National Institute for Health and Clinical Excellence (NICE). (2008, September). Balloon catheter dilation of paranasal sinus ostia for chronic sinusitis. Retrieved October 21, 2011 from http://www.nice.org.uk/nicemedia/pdf/IPG273Guidance.pdf.
Stankiewicz, J., Truitt, T., & Atkins, J. (2010). One-year results: Transantral balloon dilation of the ethmoid infundibulum. Ear, Nose, & Throat Journal, 89 (2), 72-77. (Level 3 Evidence - Industry sponsored)
Stankiewicz, J., Tami, T., Truitt, T., Atkins, J. Liepert, D., & Winegar, B. (2009). Transantral, endoscopically guided balloon dilation of the ostiomeatal complex for chronic rhinosinusitis under local anesthesia. American Journal of Rhinology and Allergy, 23 (3), 321-327. (Level 2 Evidence - Industry sponsored)
U. S. Food and Drug Administration. (2008, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K073041. Retrieved January 20, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/K073041.pdf.
Vaughn, W. (2008). Review of balloon sinuplasty. Current Opinion in Otolaryngology and Head and Neck Surgery, 16 (1), 2-9.
ORIGINAL EFFECTIVE DATE: 10/14/2006
MOST RECENT REVIEW DATE: 12/8/2011
ID_BA
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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