Medical Policy: 07.01.31
Original Effective Date: May 2006
Reviewed: October 2015
Revised: October 2015
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Functional endoscopic dilation of the sinuses, also referred to as Balloon SinuplastyTM describes a procedure intended to clear sinus cavities using a balloon rather than invasive surgery. During this endoscopic procedure, a catheter-based device is advanced into the sinus under fluoroscopic guidance. Once positioned the balloon is gradually inflated to open the sinus thereby allowing drainage.
In a typical FESS (functional endoscopic sinus surgery), the physician first identifies the middle turbinate and removes the uncinate process to expose the ethmoid bulla. The anterior ethmoid air cells are opened, leaving the bone covered with mucosa. This allows for better ventilation of the anterior ethmoid sinuses. The maxillary ostium is examined and, if it is obstructed, a middle meatal antrostomy is performed. This minimal surgery is often sufficient to improve the function of the osteomeatal complex, which improves the ventilation of the maxillary, ethmoid, and frontal sinuses.
Balloon sinuplasty is frequently used within the FESS procedure as a tool to open the sinuses, enabling the surgeon better access with the endoscope. Balloon sinuplasty alone fails to address the underlying issues of sinusitis.
Functional endoscopic dilatation of the sinuses or Balloon Sinuplasty™ is considered investigational as a procedure when done outside of the FESS procedure.
There is insufficient evidence on the impact and duration of balloon sinuplasty on health outcomes. Small randomized, controlled trials do not report significant improvements on clinically relevant outcome measures. A large number of non-comparative single-arm series report high success rates, but are not sufficient to determine comparative efficacy with alternative treatments. Prospective comparative studies with larger patient populations are needed to determine the clinical outcomes for this treatment compared with standard surgical or medical approaches. This information is important to determine symptom improvement as well as the durability of the procedure and the need for subsequent revision. In addition, more information is needed to determine which patients and which sinuses benefit from the balloon technique as an adjunct to traditional endoscopic sinus surgery, and which patients should get standard approaches. Given the limitations of the available data, the uncertain impact on clinical outcomes, and questions about which patients might be candidates for this procedure, this approach is considered investigational when performed as a stand-alone (outside of the FESS) procedure.
The evidence related to the use of balloon ostial dilation, as a stand-alone procedure or an adjunct to functional endoscopic sinus surgery (FESS), has been reviewed in several systematic reviews, including a Cochrane review and a Blue Cross and Blue Shield Association TEC Assessment. These reviews have concluded that, although nonrandomized evidence suggests that balloon ostial dilation has similar outcomes to endoscopic sinus surgery (ESS), evidence from randomized trials is needed to demonstrate an improvement in outcomes for patients treated with balloon ostial dilation. Comparative long-term data on ostial patency and health outcomes is lacking. There is a need for higher-quality, longer-term data to fully evaluate balloon sinus procedures and to draw conclusions as to whether the results produced using balloon sinus approaches are as good as or better than those achieved by medical management or surgical approaches, such as FESS alone.
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
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and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
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advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.