Balloon and Self-Expanding Absorptive Ostial Dilation for Treatment of Rhinosinusitis
DESCRIPTION
Balloon ostial dilation, also known as balloon sinuplasty (e.g. Relieva™, NuVent™, FinESS™, Ventera™) is a minimally invasive endoscopic procedure in which a balloon is inflated within affected sinus ostia in attempts to widen the ostia and restore proper drainage of the sinus. Balloon sinuplasty (BS) is less invasive than the standard functional endoscopic sinus surgery (FESS) and can be performed in-office under local anesthetic. This technique is designed to preserve normal tissues and restore normal sinus anatomy in individuals with chronic recurrent sinusitis who have failed medical management. BS may be performed as a stand-alone procedure or in conjunction with FESS. Standalone BS is limited to the frontal, maxillary and sphenoid sinuses. Since the anatomy of the ethmoidal sinuses prevents access by BS instrumentation, individuals with ethmoidal disease would require FESS; however, hybrid balloon sinuplasty plus FESS procedures can still be performed in the ethmoidal sinuses.
Self-expanding absorptive ostial dilation devices (e.g., SinuSys Vent-OS system™) have also been proposed as a treatment for maxillary sinus ostia. This technique involves the intranasal insertion of the dilation device under local anesthesia. Once inserted, the device absorbs moisture from surrounding tissue, providing gradual, low-pressure osmotic expansion to dilate the sinus ostia and establish patency. The device is in place for about one hour and removed after it has fully expanded.
Note: This policy does not address functional endoscopic sinus surgery. For FESS, please refer to MCG’s Functional Endoscopic Sinus Surgery (FESS) Ambulatory Care Guideline (ACG): A-0185.
POLICY
Balloon ostial dilation (balloon sinuplasty) may be considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below)
Self-expanding absorptive sinus ostial dilation for the treatment of any sinus condition is considered investigational.
MEDICAL APPROPRIATENESS
Balloon ostial dilation (i.e., balloon sinuplasty) may be considered medically appropriate when ALL the following are met:
Sinusitis confined to the paranasal sinuses without adjacent involvement of neurologic, soft tissue, or bony structures
No evidence of sinonasal polyposis
Documentation of ANY ONE of the following:
Four or more acute rhinosinusitis episodes (defined as four weeks or less in duration) within one year
Chronic sinusitis (defined as twelve weeks or more in duration)
Diagnostic work up that includes a computed tomography (CT) scan of each sinus area being considered for treatment that demonstrates ANY ONE of the following:
Mucosal thickening >3 millimeters
Air fluid levels
Opacification
Symptoms persist despite a minimum one month of medical treatment (e.g., nasal steroids, antibiotics)
Documentation of ANY ONE of the following:
Allergy testing (if symptoms are consistent with allergic rhinitis and have not responded to appropriate environmental controls and pharmacotherapy [e.g., antihistamines, intranasal corticosteroids, leukotriene antagonists])
Allergy testing is non-applicable
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
There are no clinical studies in the published literature to determine if self-expanding absorptive devices for ostial dilation improve health outcomes.
SOURCES
American Academy of Otolaryngology - Head and Neck Surgery. (2018, February). Clinical consensus statement: balloon dilation of the sinuses. Retrieved June 9, 2020 from http://www.entnet.org.
American Academy of Otolaryngology - Head and Neck Surgery. (2021, April). Position statement: dilation of sinuses, any method (e.g., balloon, etc.). Retrieved December 29, 2021 from http://www.entnet.org.
American Rhinologic Society. (2023, January). Ostial balloon dilation position statement. Retrieved February 9, 2024 from https://www.american-rhinologic.org.
BlueCross BlueShield Association. Evidence Positioning System. (3:2023). Balloon ostial dilation for treatment of chronic and recurrent acute rhinosinusitis (7.01.105). Retrieved February 22, 2024 from https://www.bcbsaoca.com/eps/. (22 articles and/or guidelines reviewed)
Chandra, R. K., Kern, R. C., Cutler, J. L., Welch, K. C., & Russell, P. T. (2015). REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. The Laryngoscope, 126, 44-50. (Level 1 evidence)
Koskinen, A., Myller, J., Mattila, P., Penttilӓ, M., Silvola, J., Alastalo, I., et al. (2016). Long-term follow-up after ESS and balloon sinuplasty: Comparison of symptom reduction and patient satisfaction. Acta Otolaryngolica, 136 (5), 532-536. Abstract retrieved August 5, 2016 from PubMed database.
National Institute for Health and Care Excellence. (2008). Balloon catheter dilation of paranasal sinus ostia for chronic sinusitis. Retrieved March 19, 2021 from https://www.nice.org.uk/guidance/ipg273/.
Payne, S. C., Stolovitzky, P., Mehendale, N., Matheny, K., Brown, W., Rieder, A., et al. (2016). Medical therapy versus sinus surgery by using balloon sinus dilation technology: A prospective multicenter study. American Journal of Rhinology & Allergy, 30, 279-286. (Level 1 evidence)
Sikand, A., Ehmer, D.R., Stolovitzky, J.P., McDuffie, C.M., Mehendale, N., Albritton 4th, F.D. (2019). In-office balloon sinus dilation versus medical therapy for recurrent acute rhinosinusitis: A randomized, placebo-controlled study. International Forum of Allergy & Rhinology, 9 (2), 140-148. Abstract retrieved June 9, 2020 from PubMed database.
Thottam, P. J., Kieu, M. C., Barazi, R. A., Saraiya, S., Dworkin, J. P., & Belenky, W. M. (2013). FESS versus balloon sinuplasty as long-term treatment for pediatric chronic rhinosinusitis: A 2-year postoperative analysis. Otolaryngology – Head and Neck Surgery, 149 (2), suppl P130. Abstract retrieved August 4, 2016 from PubMed database.
U. S. Food and Drug Administration. (2008, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K073041 (Relieva™). Retrieved January 20, 2010 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2010, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K102003. Retrieved August 6, 2012 from http://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Health Technology Assessment. (2019, October; last update search December 2022). Balloon sinuplasty for chronic sinusitis in pediatric patients. Retrieved January 30, 2023 from www.hayesinc.com/subscribers. (43 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Health Technology Assessment. (2019, September; last update search September 2022). Balloon sinuplasty for treatment of chronic rhinosinusitis in adult patients. Retrieved January 30, 2023 from www.hayesinc.com/subscribers. (53 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 10/14/2006
MOST RECENT REVIEW DATE: 4/11/2024
ID_BT
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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