Medical Policy: 07.01.31
Original Effective Date: May 2006
Reviewed: October 2018
Revised: October 2018
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.
Sinus stents are devices used postoperatively following endoscopic sinus surgery (ESS). These devices are used to maintain patency of the sinus openings in the postoperative period, and/or to serve as a local drug delivery vehicle. Reducing postoperative inflammation and maintaining patency of the sinuses may be important in achieving optimal sinus drainage and may impact recovery from surgery.
Sinus stents are defined as implantable devices specifically designed to improve patency and/or deliver local medication. These devices are inserted under endoscopic guidance and are distinguished from sinus packing and variations on packing devices routinely employed after sinus surgery.
Latera™ Absorbable Nasal Implant: This new device from Spirox,™ Inc. (Menlo Park, CA) obtained FDA clearance via the 510(k) approval process in 2016 and is indicated for, "Supporting nasal upper and lower lateral cartilage." This implantable device is proposed to assist in the surgical correction of collapsed nasal wall tissue and possibly improving nasal obstruction.
The Propel® implant was approved through the premarket approval application (PMA) process. The implant is intended “for use in patients >18 years of age following ethmoid sinus surgery to maintain patency. The Propel separates mucosal tissues, provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces edema.” The implant is manufactured from a synthetic bioabsorbable copolymer, poly (L-lactideco-glycolide) and contains 370 μg mometasone furoate a synthetic corticosteroid. The implant is designed to accommodate the size and variability of the post-surgical ethmoid sinus anatomy. The device is dissolvable over a period of several weeks, and thereby does not require removal.
The Propel Mini® was FDA PMA approved in 2012 as a shortened version of the Propel and is indicated for use in a patient ≥ 18 years of age following ethmoid sinus surgery to maintain patency. The Mini also contains 370 μg mometasone furoate. In 2016, The Propel Mini FDA indication was expanded to include treatment of the frontal sinus. The Propel Contour Sinus Implant was FDA PMA approved in February 2017 as a supplement to the Propel FDA PMA approval. This device is indicated for use in patients ≥ 18 years of age to maintain patency of the frontal and maxillary sinus ostia following sinus surgery. Per Intersect, the Contour has an hourglass shape and is proposed to conform to sinus ostia, propping the sinuses open while delivering the medication. Like the other Propel devices the Contour releases 370 μg mometasone furoate.
Middle meatal spacers are related but separate devices intended to maintain sinus patency post-ESS. They are splint-like devices inserted directly rather than under endoscopic guidance, and do not have the capability of delivering local medication. The products currently include the Relieva Stratus MicroFlow spacer and the Sinu-Foam spacer. Sinu-Foam is an Food and Drug Administration (FDA)-approved mixture, which is commonly mixed with saline and gently placed in the ethmoid cavity following FESS.
In 2017 Sinuva™ (Intersect ENT, Palo Alto, CA) was FDA approved as a drug for implantation for the treatment of nasal polyps in patients who have had ethmoid sinus surgery and have recurrent polyposis. Sinuva contains 1350 mcg of mometasone furoate and is proposed for implantation in the physician’s office and is left in place for 90 days.
There are a number of postoperative treatment regimens, and the optimal regimen is uncertain. Options include saline irrigation, nasal packs, topical steroids, systemic steroids, topical decongestants, oral antibiotics, and/or sinus cavity debridement. A number of RCTs have evaluated various treatment options, but all different strategies have not been rigorously evaluated. A systematic review evaluated the evidence for these therapies. The authors of this review concluded that the evidence was not strong for any of these treatments but that some clinical trial evidence supported improvements in outcomes. The strongest evidence was for use of nasal saline irrigation, topical nasal steroid spray, and sinus cavity debridement.
A 2015 Cochrane review addressed steroid-eluting sinus stents for improving chronic rhinosinusitis symptoms in individuals undergoing ESS. Study eligibility criteria were RCTs that compared the effects of steroid-eluting sinus stents with non-steroid-eluting sinus stents, nasal packing, or no treatment in adults with chronic rhinosinusitis who underwent ESS. None of the studies met authors’ inclusion criteria. The authors concluded that there is no evidence from high-quality RCTs to demonstrate the benefits of steroid-eluting stents.
In a 2015 Clinical Practice Guideline (update) for Adult Sinusitis, the AAO-HNS indicates that clinicians should recommend saline nasal irrigation, topical intranasal corticosteroids, or both for symptom relief of chronic rhinosinusitis (CRS). Surgical management of CRS is not discussed “because of insufficient evidence (e.g., randomized controlled trials) for evidence-based recommendations”.
No clinical practice guidelines were identified that recommend the use of sinus stents, spacers or implants including the 2015 update of the 2007 guideline from the American Academy of Otolaryngology-Head and Neck Surgery Foundation.
Functional endoscopic dilatation of the sinuses or Balloon Sinuplasty™ is considered investigational as a procedure when done outside of the FESS procedure.
The use of implantable sinus stents, sinus implants, and sinus spacers for all indications, including but not limited to postoperative treatment following endoscopic sinus surgery and for treatment of recurrent nasal polyposis is considered investigational.
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.
Sinus stents/implants may prove to have a role in nasal polyposis; however, additional positive results from well-designed RCTs are needed to confirm the results of the single available RCT. There is a lack of guidance in national guidelines that recommend the use of sinus stents in all populations.
The studies available for stents/implants after sinus surgery have limitations, including risk of bias. In addition, because of the comparison group used in these trials primarily evaluate the efficacy of topical steroids when delivered by an implanted device, but do not evaluate the efficacy of the device versus standard care or standard dosing. The evidence is insufficient to determine the effects of the technology on health outcomes.
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