Pending Policies - Surgery
Nasal and Sinus Surgery
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Medical policies are a set of written guidelines that support current standards of practice. They are based on current peer-reviewed scientific literature. A requested therapy must be proven effective for the relevant diagnosis or procedure. For drug therapy, the proposed dose, frequency and duration of therapy must be consistent with recommendations in at least one authoritative source. This medical policy is supported by FDA-approved labeling and nationally recognized authoritative references. These references include, but are not limited to: MCG care guidelines, DrugDex (IIb level of evidence or higher), NCCN Guidelines (IIb level of evidence or higher), NCCN Compendia (IIb level of evidence or higher), professional society guidelines, and CMS coverage policy.
Nasal and sinus surgery for the procedures listed below may be considered medically necessary when the specified criteria are met:
Rhinoplasty may be considered medically necessary when performed to correct any one of the following:
• Nasal deformity secondary to congenital craniofacial deformity (e.g. cleft lip, cleft palate, or maxillonasal dysplasia); OR
• Significant external nasal pyramid collapse following documented trauma or injury; OR
• Significant deformity following removal of a nasal malignancy, an abscess or osteomyelitis.
NOTE 1: Documentation to support medical necessity, as appropriate for the specific procedure being performed, should include all of the following:
• Historical medical record documentation of previous injury or trauma; AND
• Historical medical record documentation of symptoms and interventions; AND
• Results of imaging and diagnostic studies; AND
• Operative, laboratory and procedure reports.
Rhinoplasty to repair an external nasal deformity not causing functional impairment is considered cosmetic.
Nasal Valve Suspension
Nasal valve suspension as a surgical technique for the repair of nasal valve collapse is considered experimental, investigational and/or unproven.
Reconstructive Nasal and Sinus Surgery for Congenital or Acquired Functional Nasal Deformities
Nasal surgery performed on the outside or inside of the nose may be considered medically necessary when performed as a reconstructive procedure to correct congenital or acquired functional nasal deformities that meets any one of the specific medical necessity criteria for Rhinoplasty as listed above.
Endoscopic Sinus Surgery, Functional (FESS)
Functional endoscopic sinus surgery may be considered medically necessary when medical management has failed or is unavailable for the following diagnoses:
• Chronic sinusitis refractory to medical treatment;
• Recurrent sinusitis;
• Nasal polyposis;
• Antrochoanal polyps;
• Sinus mucoceles;
• Excision of selected tumors;
• Cerebrospinal fluid (CSF) leak closure;
• Orbital decompression (e.g., Graves ophthalmopathy);
• Optic nerve decompression;
• Dacryocystorhinostomy (DCR);
• Choanal atresia repair;
• Foreign body removal; OR
• Epistaxis control.
Balloon Ostial Dilation
Balloon ostial dilation using a U. S. Food and Drug Administration (FDA)-approved catheter-based inflatable device performed in accordance with the device’s FDA-approved labeling for the treatment of medically refractory chronic sinusitis in adults may be considered medically necessary as a minimally invasive alternative to functional endoscopic sinus surgery.
The use of a balloon ostial dilation device, with a FDA-approved device specified for children, (children age 17 and under) may be considered medically necessary when treating the maxillary sinus space as a minimally invasive alternative to functional endoscopic sinus surgery for the treatment of medically refractory chronic sinusitis.
The use of a balloon ostial dilation device, with a FDA-approved device specified for children, (children age 17 and under) is considered experimental, investigational and/or unproven in all other sinus spaces but the maxillary sinus space as a minimally invasive alternative to functional endoscopic sinus surgery for the treatment of medically refractory chronic sinusitis.
Drug-Eluting Sinus Implants
Placement of a mometasone furoate sinus implant consistent with the FDA device-approved or FDA drug-approved label for a specific product, may be considered medically necessary in conjunction with an appropriately indicated sinus surgery for that product for patients ≥18 years of age.
Placement of a mometasone furoate sinus implant is considered experimental, investigational and/or unproven in all other situations in which the above criteria are not met.
NOTE 2: See the Regulatory Status section of this medical policy for additional information concerning drug and devices containing mometasone furoate and their indications.
Balloon Dilation of the Eustachian Tube
Balloon dilation of the Eustachian tube for persistent Eustachian tube dysfunction is considered experimental, investigational and/or unproven.
Other Nasal and Sinus Surgical Procedures
Procedures that are performed to reshape the normal structures of the nose and improve the appearance, whether performed separately or in combination with another procedure, are considered cosmetic. These procedures include:
• Changing the size of the nose; or
• Changing the shape of the nose; or
• Narrowing the nostrils; or
• Changing the angle between the nose and lips.
Cosmetic services that are requested or performed because of psychiatric or emotional problems attributed to the actual or perceived defect being treated are considered cosmetic.
Nasal surgery is a grouping term for procedures performed to correct a variety of nasal deformities. A nasal deformity may be external and/or internal. Nasal deformities may be grouped into four categories:
• Congenital: Deformities resulting from developmental anomalies;
• Acquired: Deformities due to trauma, infections, cancer, disease, or previous surgery;
• Aesthetic (Cosmetic): Conditions, exclusive of congenital and/or acquired deformities, for which the patient desires a change in nasal appearance to enhance self-image; and
• Functional: Conditions with impaired nasal breathing unrelated to appearance.
Rhinoplasty is a surgical procedure to alter the appearance of the nose, the width of the nostrils, and/or change the angle between the nose and the upper lip. It is performed alone or in combination with other procedures, such as septoplasty and turbinoplasty, to correct deformities that result from nasal trauma, either acquired or iatrogenic, airway obstruction related to septal and bony deviations, turbinate hypertrophy or congenital defects.
Nasal Valve Suspension
Nasal valve collapse is a common cause of nasal airway obstruction. Nasal valve suspension is a surgical approach for nasal valve repair that involves suspension of the valve to the orbital rim or the use of lateral suture(s) suspension. Nasal valve suspension refers to a surgical approach for nasal valve repair that involves attaching a suture to the orbital rim, which is passed through the collapsed valve, then returned to the anchor site at the orbital rim and tied, thus resulting in a repaired nasal valve that presumably allows for less obstructed airflow.
Reconstructive Nasal and Sinus Surgery for Congenital or Acquired Functional Nasal Deformities
Nasal deformities may be congenital, (e.g., cleft palate) or acquired (e.g., trauma, disease).
Congenital birth defects have a variety of presentations, including cleft nasal deformity, which may be associated with cleft lip and/or cleft palate, where the nasal structures are distorted and abnormally developed. Some congenital abnormalities may not be fully evident until some years later. Surgical correction of congenital birth defects may involve staged procedures, flaps, or grafts. Since the clefts of palate and lip vary considerably in size, shape, and degree of deformity, the planning of the stages of surgery should be individualized. Nasal correction associated with cleft lip/palate may be delayed until adolescence or performed at the time of initial repair. Children with cleft lip and/or palate usually have a deviated nasal septum due to the asymmetric bony base associated with the defect. Initially, the deviation may not cause airway problems due to the facial cleft providing a patent, low-resistance airway passage. As a result of the repair of the facial cleft, the nasal resistance increases and the deviated septum may then cause nasal airway obstruction.
Acquired nasal deformities may include disease (i.e., tumors), trauma (i.e., motor vehicle accidents, sports injuries). These can be repaired with various techniques depending upon presentation.
Endoscopic Sinus Surgery, Functional (FESS)
Endoscopic sinus surgery is accomplished using fiberoptic technology for various diagnoses as it has precision, but is less invasive than previous surgical techniques, and causes less discomfort to the patient. Endoscopic surgery remains the treatment of choice for many diagnoses including medically refractory chronic rhinosinusitis with or without polyps.
FESS is a type of surgical technique to treat medically unresponsive chronic sinusitis and other serious conditions of the nasal sinuses that result in impaired sinus drainage. FESS utilizes a thin optical telescope to access the nasal sinuses, eliminating the need for an external incision to remove diseased tissue and bone, resulting in improved drainage and function. Recently, balloon dilation catheters have been introduced as an alternative to or adjunctive tool during conventional FESS. Prior to FESS, standard treatment involved surgical opening in the upper jaw above the teeth. The use of FESS allows for shorter surgery and healing times, less postoperative discomfort and fewer complications.
Balloon Ostial Dilation
Chronic rhinosinusitis 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. Thickening of mucosa may restrict or close natural openings between sinus cavities and the nasal fossae, although symptoms vary considerably because of the location and shape of these sinus ostia.
A newer procedure, balloon ostial dilation (also known as balloon sinuplasty™) is proposed as an alternative to endoscopic sinus surgery for those with chronic sinusitis who fail medical management. The goal of this technique, when used as an alternative to FESS, is to achieve improved sinus drainage using a less invasive approach. When used as an adjunct to FESS, it is intended to facilitate and/or increase access to the sinuses. The procedure involves placing a guidewire in the sinus ostium, advancing a balloon over the guidewire, and then stretching the opening by inflating the balloon. The guidewire location is confirmed with fluoroscopy or with direct transillumination of the targeted sinus cavity. General anesthesia may be needed for this procedure to minimize patient movement.
Drug-Eluting Sinus Implants
There are a number of postoperative sinus 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 débridement.
Some form of sinus packing is generally performed postoperatively. Simple dressings moistened with saline can be inserted manually following surgery. Foam dressings are polysaccharide substances that form a gel when hydrated and can be used as nasal packs for a variety of indications. (6) Middle meatal spacers are splint-like devices that prop open the sinus cavities post-endoscopic sinus surgery (ESS), but are not designed for drug delivery. There is some Randomized Controlled Trials (RCT) evidence that middle meatal spacers may reduce the formation of synechiae following ESS, although the available studies have significant heterogeneity in this outcome. (7)
Drug-eluting sinus implants are another option for postoperative management following ESS. They are intended to stabilize the sinus openings and the turbinates, reduce edema, and/or prevent obstruction by adhesions. They also have the capability of being infused with medication that can be delivered topically over an extended period of time, and this local delivery of medications may be superior to topical application in the postoperative setting.
Balloon Dilation of the Eustachian Tube
The Aera™ Eustachian Tube Balloon Dilation System by Acclarent, Inc. is a device that treats persistent Eustachian tube dysfunction (ETD). The Eustachian tube equalizes pressure inside the ear by using the Eustachian tube to ventilate the middle ear. Malfunction of the Eustachian tube may cause the following sensations of muffled hearing, pressure, and/or pain, this may also lead to ear infections. The Aera™ system allows a physician to use a flexible catheter to insert a small balloon through the patient’s nose and into the Eustachian tube. When the balloon is inflated, it opens the Eustachian tube allowing mucus and air to flow through the Eustachian tube. Upon completion of the procedure the physician would deflate and remove the balloon from the patient.
Balloon Ostial Dilation
In March 2008, the Relieva™ Sinus Balloon Catheter (Acclarent, Menlo Park, CA) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices for use in dilating the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children. Subsequent devices developed by Acclarent have also been granted 510(k) marketing clearance. These include the Relieva Spin Sinus Dilation System® cleared in August 2011 and the Relieva Seeker Balloon Sinuplasty System® cleared in November 2012.
In June 2008, the FinESS™ Sinus Treatment (Entellus Medical, Maple Grove, MN) was cleared for marketing by the FDA through the 510(k) process. The indications include to access and treat the maxillary ostia/ethmoid infundibulum in adults using a transantral approach (FDA product code: EOB). The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures. Two other balloon sinus ostial dilation devices by Entellus Medical, the ENTrigue® Sinus Dilation System, and the XprESS® Multi-Sinus Dilation Tool, also received 510(k) clearance in August, 2012.
In 2013, a sinus dilation system (ArthroCare Corp., San Antonio, TX, a division of Smith and Nephew), later named the Ventera™ Sinus Dilation System, was cleared for marketing through the 510(k) process to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a transnasal approach. FDA product code: LRC.
Drug-Eluting Sinus Implants
Sinus Implant under FDA Device Approvals
In August 2011, the PROPEL® system (Intersect ENT, Palo Alto, CA) was approved by the U.S. Food and Drug Administration through the premarket approval (PMA) process. This device is a self-expanding, bioabsorbable, steroid-eluting implant intended for use following ethmoid sinus surgery to maintain patency. It is placed via endoscopic guidance using a plunger included with the device. Steroids (mometasone furoate) are embedded in a polyethylene glycol polymer, which allows sustained release of the drug over an approximate duration of 30 days. The device dissolves over several weeks, and therefore does not require removal. In September 2012, a smaller version of the PROPEL device, the PROPEL mini Sinus Implant, was approved for use in patients older than age 18 years following ethmoid sinus surgery. In March 2016, the PROPEL mini sinus implant received a PMA supplement for the following indication: the implant is intended for use in patients ≥ 18 years of age following ethmoid/frontal sinus surgery to maintain patency of the ethmoid sinus or frontal sinus opening. (P100044/S018). In February 2017, a PMA supplement for the PROPEL Contour Sinus Implant was approved by the FDA. 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 and locally deliver steroids to the sinus mucosa. (49) FDA product code: OWO
NOTE 3: Propel, Propel Mini and Propel Contour sinus implants that were approved by the FDA as devices, contain 370 µg of mometasone furoate.
In October 2011, the Relieva Stratus™ MicroFlow spacer, a balloon-based device that acts as a spacer and medication delivery system, was cleared for marketing by the FDA through the 510(k) program for use postoperatively to maintain an opening to the sinuses for the first 14 days postoperatively. It is placed via a catheter under endoscopic guidance. This device is temporary and requires manual removal after 30 days, with implantation of a new device if needed. It is approved for infusion with saline, but not for use with other medications (e.g., steroids). This device is no longer marketed in the United States.
Sinus Implant under FDA Drug Approval
In December 2017, the FDA approved Sinuva (mometasone furoate) Sinus Implant, 1350 mcg (Intersect ENT, Inc.) as a new drug application. This new drug application provides for the use of Sinuva (mometasone furoate) Sinus Implant for the treatment of nasal polyps in patients 18 years of age or older who have had ethmoid sinus surgery. (54) The FDA label contains the following Dosage and Administration information: The Sinuva Sinus Implant is loaded into a delivery system and placed in the ethmoid sinus under endoscopic visualization. The Implant may be left in the sinus to gradually release the corticosteroid over 90 days. The Implant can be removed at Day 90 or earlier at the physician's discretion using standard surgical instruments. To be inserted by physicians trained in otolaryngology. Repeat administration has not been studied. (55) Contraindications noted are patients with known hypersensitivity to mometasone furoate, or to any of the copolymers of the Sinuva Sinus Implant. The FDA label for Sinuva Sinus Implant goes on to include the following Warnings and Precaution concerning local effects, ocular effects, hypersensitivity reactions, immunosuppression, and hypercorticism and adrenal suppression. Common adverse reactions noted in the patients treated with the Sinuva Sinus Implant included: asthma; headache; epistaxis; presyncope; bronchitis; otitis media and nasopharyngitis.
Balloon Dilation of the Eustachian Tube
The FDA cleared the Aera™ device by Acclarent, through the de novo process in September 2016. The Aera™ Eustachian Tube Balloon Dilation System is indicated to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction in adults ages 22 and older. (51) The FDA news release noted the most common adverse events associated with the Aera system were small tears of the lining of the Eustachian tube, minor bleeding and worsening of ETD. Patients under the age of 22, patients who have a carotid artery that protrudes through a gap in the bone surrounding the Eustachian tube, or patients whose Eustachian tube is always open (patulous Eustachian tube) should not use the Aera system. (52)
Nasal surgery may be considered reconstructive when performed to alter structure and restore function. It is considered cosmetic when done only to improve appearance. This policy defines the criteria for making this distinction to allow appropriate benefit coverage determinations. Reconstructive nasal surgery is considered medically necessary and therefore eligible for benefit coverage. Cosmetic surgery may be a specific exclusion from benefits and coverage.
Endoscopic Sinus Surgery, Functional (FESS)
Only a few controlled trials evaluating the use of FESS are available in literature. Blomqvist et al. compared medical treatment versus combined surgical (endoscopy) and medical treatment for nasal polyps in 32 patients with follow-up of 12 months. The authors reported the sense of smell was improved by the combination of local and oral steroids; surgery had no additional effect. Symptom scores improved significantly with medical treatment alone, but surgery had additional beneficial effects on nasal obstruction and secretion. (45) Ragab et al. randomized 90 patients with chronic rhinosinusitis (CRS) to either medical or surgical therapy with FESS. After 12 months, both medical and surgical treatment of CRS significantly improved almost all the subjective and objective parameters with no significant difference except for the total nasal volume in CRS and CRS without polyposis groups. The authors concluded that CRS should initially be treated with antibiotics and topical steroids, with surgical treatment being reserved for cases refractory to medical therapy. (46)
A Cochrane review of FESS for the indication of CRS concluded: “The evidence available does not demonstrate that FESS, as practiced in the included trials, is superior to medical treatment with or without sinus irrigation in patients with chronic rhinosinusitis.” There were no major complications in any of the included trials and FESS appears to be a safe procedure. “More randomized controlled trials comparing FESS with medical and other treatments, with long-term follow up, are required.” (47)
Although the literature-based evidence addressing FESS is limited, the clinical experience over the past decade has demonstrated the safety and efficacy of this procedure compared to more invasive techniques.
Reconstructive surgery is performed on structural abnormalities of the body that are due to congenital or developmental anomalies, trauma, infection, tumors, or disease. The goal is to improve function and restore or approximate normal structure that is necessary to achieve improved function. In many cases the shape of the inside of the nose, mainly the septum which separates the nostrils, prevents adequate air passage, impeding proper breathing. In other cases, the shape of the nose may become deformed due to disease or trauma resulting in blocked nasal passages. Rhinoplasty is medically indicated when these conditions exist. When rhinoplasty is performed primarily to alter the external appearance of the nose (cosmetic purpose), the procedure has no medical benefit and is considered not medically necessary.
Nasal Valve Suspension
Most of the articles that could be located regarding nasal valve suspension were anecdotal in nature. Two small nonrandomized pilot studies reported subjective self-assessment data included in the results and included no long-term outcome data. (41-44)
Balloon Ostial Dilation
Balloon sinus ostial dilation can be performed as a stand-alone procedure or as an adjunct to FESS. When performed in combination with FESS, it is sometimes referred to as a hybrid procedure, because there are elements of both balloon sinus ostial dilation and FESS.
In 2016, Levy et al. reported on a systematic review and meta-analysis of studies of paranasal balloon ostial dilation for CRS. (23) Reviewers included 17 studies, with 3 RCTs (Achar et al. , (24) Bikhazi et al. , (25) Cutler et al.  ). Two RCTs reported on change score differences for the Sino-Nasal Outcome Test-20 (SNOT-20) between patients treated with balloon ostial dilation and with FESS (n=110; standard mean difference, -0.42; 95% confidence interval [CI], -1.39 to 0.55; I2=76%). There were improvements in SNOT-20 scores and sinus opacification after balloon ostial dilation.
Randomized Controlled Trials (RCT)
The REMODEL study was an industry-sponsored RCT (Cutler et al., 2013) that compared balloon ostial dilation as a stand-alone procedure with FESS. (26) A total of 105 patients with recurrent acute sinusitis or chronic sinusitis and failure of medical therapy were randomized to balloon ostial dilation or FESS. Balloon ostial dilation was performed with the Entellus device, which is labeled for a transantral approach. FESS consisted of maxillary antrostomy and uncinectomy with or without anterior ethmoidectomy. Thirteen patients withdrew consent before treatment, 11 in the FESS group (21%) and 2 in the balloon ostial dilation group (4%). The primary outcomes were the change in the Sino-Nasal Outcome Test (SNOT-20) score at 6-month follow-up, and the mean number of débridements performed postoperatively. Secondary outcomes included recovery time, complication rates, and rates of revision surgery. Both superiority and noninferiority analyses were performed on these outcomes.
A total of 91 patients were available at 6-month follow-up. The improvement in the SNOT-20 score was 1.67±1.10 in the balloon dilation group and 1.60±0.96 in the FESS arm (p=0.001 for noninferiority). Postoperative débridements were more common in the FESS group than in the with balloon dilation group (1.2 in the FESS arm vs 0.1 in the balloon ostial dilation arm, p<0.001 for superiority in the FESS arm). Patients in the balloon dilation arm returned to normal daily activities faster (1.6 days vs 4.8 days, p=0.002 for superiority), and required fewer days of prescription pain medications (0.9 days vs 2.8 days, p=0.002 for superiority). There were no major complications in either group, and 1 patient in each group required revision surgery.
Bikhazi et al. reported 1-year follow-up from the REMODEL trial in 2014. (25) A total of 89 subjects (96.7%) were available for follow up at 1 year. The improvement in the SNOT-20 score was 1.64 in the balloon dilation arm and 1.65 in the FESS arm (p<0.001 for noninferiority). During the year postprocedure, both the balloon dilation and FESS groups had fewer self-reported rhinosinusitis episodes (reduction in 4.2 episodes in the balloon arm and reduction in 3.5 episodes in the FESS; not significantly different between groups).
In 2016, Chandra et al. reported results up to 2 years postprocedure for subjects in the REMODEL study, along with an additional 30 subjects treated with either FESS or in-office balloon sinus dilation, for a total of 61 FESS patients and 74 balloon sinus dilation patients. (27) Follow-up data were available for 130, 66, and 25 patients at 12, 18, and 24 months, respectively. Details about group-specific treatment received and loss to follow-up were not reported for the additional 30 patients not described in the REMODEL trial. Balloon sinus dilation patients required 0.2 débridements per patient, compared with 1.0 per patient in the FESS group (p<0.001). Mean change in SNOT-20 score from baseline to 12-month follow-up was -1.59 (p<0.001) and -1.60 (p<0.001) for the balloon sinus dilation and FESS groups, respectively, which was considered clinically significant. These changes were maintained at 24 months. At 18 months, overall revision rates were 2.7% in the balloon dilation group and and 6.9% in the FESS groups. In addition to the longer-term results of the REMODEL trial, this article includes a meta-analysis including the REMODEL balloon dilation-treated patients and data from 5 manufacturer-sponsored trials, 3 of which had previously been reported in peer-reviewed form (BREATHE, Stankiewicz et al.  (28) and Stankiewicz et al.  (29); RELIEF, Levine et al.  (30); XprESS Transnasal Maxillary Multi-Sinus, Gould et al.  (31). Across the 6 studies, 846 patients were treated with balloon sinus dilation, including 121 not described in prior publications. In a random-effects model, overall mean and subscale values for the SNOT-20 score improved compared with baseline at every follow-up time point.
Bizaki et al. (2014) reported results from an RCT that compared balloon ostial dilation to FESS among patients with symptomatic chronic or recurrent rhinosinusitis. (32) The trial enrolled 46 subjects, 4 of whom withdrew; the analysis included 42 patients (n=21 in each group; statistical power calculations reported). Both groups demonstrated significant improvements in SNOT-22 scores from baseline to postprocedure. There were no differences in change in total SNOT-22 scores between groups at 3 months postprocedure. As a follow-up publication, Bizaki et al. reported on nasal airway resistance and sinus symptoms between FESS- and balloon ostial dilation-treated groups. (33) For this analysis, 62 patients were included (32 from the FESS group, 30 from the balloon dilation group). Patients in the balloon ostial dilation group had significant improvements in nasal volume from pre- to postoperative measurements, but there were no significant differences between groups pre- or postoperatively in nasal volume.
Marzetti et al. (2014) reported results from a small RCT that compared balloon ostial dilation with an unspecified device (or devices) with FESS in the treatment of sinus headache. (34) The trial included 83 patients with sinus headache, based on American Academy of Otolaryngology?Head and Neck Surgery, 44 randomized to conventional endoscopic sinus surgery (ESS) and 35 to balloon ostial dilation. In the balloon dilation group, 23 patients were “only frontal sinus balloon” patients, in which balloon catheters were the only tools used for frontal sinus sinusotomy, and 12 were “hybrid,” in which balloon catheters and traditional ESS were used concurrently. It is not specified how patients were selected for these groups. At 6-month follow-up, scores on the SNOT-22 improved from 28.6 at baseline to 7.8 in the ESS group and from 27.3 at baseline to 5.3 in the balloon ostial dilation group, with a statistically significant reduction in both groups (p<0.001).
Another RCT was published by Achar et al. in 2012. (24) This trial enrolled 24 patients with chronic sinusitis who had failed medical therapy and were scheduled for surgery. Patients were randomized to balloon dilation or FESS and followed for a total of 24 weeks. The primary outcome measures were changes in the SNOT-20 score and the saccharine clearance time (SCT) test. Both groups improved significantly on both outcome measures. The degree of improvement was greater for the functional endoscopic dilatation sinus surgery group compared with the FESS group on both the SNOT-20 score (43.8 vs 29.7, p<0.03) and on the SCT score (7.5 vs 3.5, p=0.03). Adverse events were not reported.
Section Summary: Balloon Ostial Dilation
There are a number of randomized studies of balloon ostial dilation as a stand-alone procedure, compared with FESS. These studies generally report that short-term outcomes of balloon ostial dilation are similar to those of FESS. Only 1 RCT, the REMODEL study (n=105 patients randomized), was likely to have adequate power to detect group differences. This study reported noninferiority for the change in the SNOT-20 scores and superiority for balloon ostial dilation on postoperative recovery and pain medication use.
Practice Guidelines and Position Statements for Balloon Ostial Dilation
National Institute for Health and Care Excellence
A 2008 guidance on balloon catheter dilation of paranasal sinus ostia from the National Institute for Health and Care Excellence (NICE) stated: “Current evidence on the short-term efficacy of balloon catheter dilation of paranasal sinus ostia for chronic sinusitis is adequate and raises no major safety concerns. Therefore, this procedure can be used provided that normal arrangements are in place for clinical governance, consent and audit.” (35) In 2016, NICE published a recommendation on the use of the XprESS Multi-Sinus Dilation System for the treatment of chronic rhinosinusitis (36):
1.1 “The case for adopting the XprESS multi-sinus dilation system for treating uncomplicated chronic sinusitis after medical treatment has failed is supported by the evidence. Treatment with XprESS leads to a rapid and sustained improvement in chronic symptoms, fewer acute episodes and improved quality of life which is comparable to functional endoscopic sinus surgery (FESS).
1.2 XprESS should be considered in patients with uncomplicated chronic sinusitis who do not have severe nasal polyposis. In these patients, XprESS works as well as FESS, is associated with faster recovery times, and can more often be done under local anaesthesia.”
American Academy of Otolaryngology – Head and Neck Surgery
In July 2016, the American Academy of Otolaryngology – Head and Neck Surgery (AAO-HNS) Foundation updated its statement on balloon ostial dilation, reaffirming its 2010 position statement: “Sinus ostial dilation … is a therapeutic option for selected patient with chronic rhinosinusitis…. This approach may be used alone ... or in conjunction with other instruments….” (37)
In 2015, the AAO-HNS Foundation updated its 2007 clinical practice guidelines on adult sinusitis, which do not discuss surgical therapy or use of balloon sinuplasty. (38)
American Rhinologic Society
A position statement, revised in 2015, from the American Rhinologic Society, stated that sinus ostial dilation is “an appropriate therapeutic option for selected patients with sinusitis.” (39)
Drug-Eluting Sinus Implants
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 débridement. There have been a number of RCTs that have evaluated various treatment options, but all different strategies have not been rigorously evaluated. (2-5) A systematic review evaluated the evidence for these therapies. (1) 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 débridement.
Randomized controlled trials are important in this area in order to adequately compare sinus implants to alternative treatment regimens and to minimize the effects of confounders on outcomes. Case series and trials without control groups offer little in the way of relevant evidence, as improvement in symptoms is expected after endoscopic sinus surgery (ESS) and because there are multiple clinical and treatment variables which may confound outcomes.
Sinus Implant under FDA Device Approvals
Randomized controlled trials
There are two RCTs of the PROPEL sinus implant. (10, 11) Both trials have similar designs and both were sponsored by the device manufacturer (Intersect ENT™). Both compare an implant that is steroid-eluting versus an identical implant that is not steroid-eluting. Thus these trials test the value of drug delivery via a stent.
The first RCT was published in 2011 by Murr et al. (10) Thirty-eight patients with refractory chronic rhinosinusitis were included in the efficacy evaluation, and an additional 5 patients were enrolled for a safety evaluation. An intra-patient control design was used, meaning that each patient received a drug-eluting stent on one side and a non-drug-eluting stent on the other via random assignment. Patients were not permitted to use topical or oral steroids for 30 days following the procedure. A 14-day course of antibiotics was given to all patients. The primary end point was the degree of inflammation recorded on follow-up endoscopy at day 21 postprocedure, as scored by a 100-mm visual analog scale (VAS). There were also semiquantitative grading performed for polypoid changes, middle turbinate position, and adhesions/synechiae. The clinicians recording the outcomes were the same physicians who were treating the patients. One patient withdrew prior to study completion.
The difference in inflammation scores at 21 days was significant in favor of the steroid-eluting group. The estimated difference in scores from graphical representation was approximately 18 units on the 0 to 100 VAS scale. The percent of patients having polypoid changes was 18.4% in the steroid-eluting group versus 36.8% in the non-steroid-eluting group (p=0.039). Adhesions were also significantly less common in the steroid-eluting group (5.3% vs 21.1%, p=0.03). There were no significant differences in the appearance or position of the middle turbinate.
In 2012, Marple et al. published results of the Advance II trial., an RCT of the PROPEL™ sinus implant for 105 patients with chronic rhinosinusitis refractory to medical management. (11) This study also used an intra-patient control design with each patient receiving a drug-eluting stent on one side and a non-drug-eluting stent on the other via random assignment. Patients were not permitted to use topical or oral steroids for 30 days following the procedure. A 14-day course of antibiotics was given to all patients. The primary efficacy outcome was reduction in the need for postoperative interventions at day 30 following the procedure. A panel of 3 independent experts, who were blinded to treatment assignment and clinical information, viewed the endoscopy results and determined whether an intervention was indicated. The primary safety end point was the absence of clinically significant increased ocular pressure through day 90.
There were 3 patients lost to follow-up (2.9%), and 9 patients (8.6%) could not be evaluated because the video of the endoscopy could not be graded. Two patients had the device removed within 30 days of placement. Of the remaining patients, the need for postoperative intervention by expert judgment was found in 33.3% of patients in the steroid-eluting arm versus 46.9% in the non-steroid-eluting arm (p=0.028). According to the judgments of the clinical investigators who were treating the patients, intervention was required in 21.9% of the steroid-eluting group and 31.4% of the non-steroid-eluting group (p=0.068). The reduction in interventions was primarily driven by a 52% reduction in lysis of adhesions (p=0.005). The primary safety hypothesis was met, as there were no cases of clinically significant increases in ocular pressure recorded over the 90-day period following the procedure.
PROPEL Mini Sinus Implant
The U. S. Food and Drug Administration Summary of Safety and Effectiveness Data (SSED) for PROPEL® Mini Sinus Implant (Premarket approval [PMA] P100044/S018) included information regarding the pivotal trial-PROGRESS Mini Cohort study. This was a prospective, randomized, double-blind, multi-center study which enrolled 80 patients at 11 U. S. sites. The study utilized an intra-patient control design to assess the safety and effectiveness of the PROPEL Mini sinus implant compared to endoscopic sinus surgery alone. Follow-up exams were for a total of 90 days. Primary efficacy endpoint was the reduction in need for post-operative interventions at day 30 (e.g. debridement of obstructive adhesions or scar tissue formation in the frontal sinus opening and/or oral steroid used to resolve inflammation or polypoid edema in the frontal recess/frontal sinus opening) compared to the control. The population studied included adult patients with chronic rhinosinusitis who were scheduled to undergo primary or revision frontal endoscopic sinus surgery. Chronic rhinosinusitis (CRS) diagnosis confirmed by CT scan within 6 months of the FESS procedure and symptoms lasting longer than 12 consecutive weeks’ duration with inflammation. Follow up exams took place prior to hospital discharge or clinic release and at post-operative days 7, 21, 30 and 90. Seventy-nine of the 80 patients completed the ENT follow-up visits through day 30 (98.8%). Safety results noted 80 patients were available for the 90-day evaluation. The effectiveness results were based on the 67 evaluable patients at the 30-day time point. The primary efficacy endpoint was met. Post-operative intervention rate was 62.7% on the control sides compared to 38.8% on the treatment sides. This difference was statistically significant (p=0.0070) and represented a 38% relative reduction in post-operative interventions. No serious adverse events related to the use of the device were noted. Sinusitis and headache were the most frequently reported adverse events. (48)
The ADVANCE (2011) study was a prospective, multicenter single-arm trial of placement of a mometasone-eluting absorbable device in 50 patients who were scheduled to undergo ESS. (14) As reported by Forwith et al. (2011), the end points evaluated on follow-up endoscopies were the degree of inflammation scored on a 100-mm VAS and semiquantitative grading for polypoid changes, middle turbinate position, and adhesions. By day 7 postprocedure, the inflammation scores were in the “minimal” range and remained there for the rest of the time points. At 1 month, polypoid lesions were present in 10% of patients, adhesions in 1.1%, and middle turbinate lateralization in 4.4%. Scores on the Sino-Nasal Outcome Test-22 and the Rhinosinusitis Disability Index improved significantly in the first month postprocedure.
Steroid-Eluting Stents in Recurrent Polyposis
Han et al. (2014) reported results from RESOLVE, a sham-controlled randomized trial evaluating the use of office-based placement of a mometasone-eluting nasal stent for patients with recurrent nasal polyposis after ESS. (16) Eligible patients had CRS, had undergone prior bilateral total ethmoidectomy more than 3 months earlier, had endoscopically confirmed recurrent bilateral ethmoid sinus obstruction due to polyposis that was refractory to medical therapy, and were considered candidates for repeat surgery based on the judgment of the surgeon and patient. Patients and those who administered symptom questionnaires at follow-up visits were blinded to the treatment group. The trial was powered to detect a between-group difference of at least a 0.6-point change in polyp grade from baseline, and at least a 1.0-point change in nasal obstruction/congestion score. One hundred subjects were randomized to treatment (n=53) or control (n=47). For endoscopically measured outcomes, at 90 days of follow-up, the treatment group had a greater reduction in polyp grade than the control group (-1.0 vs -0.1; p=0.016) and a greater reduction in percent ethmoid obstruction on a 100-mm VAS (-21.5 mm vs 1.3 mm; p=0.001), both respectively. For patient-reported outcomes, there were no significant differences in change in nasal obstruction/congestion scores between groups. Compared with controls, fewer treatment-group patients required oral steroids for ethmoid obstruction (11% vs 26%) and fewer treatment-group patients were indicated for sinus surgery at 3 months based on established criteria (47% vs 77%), although statistical comparisons were not reported.
Section Summary: Sinus Implant under FDA Device Approvals
Drug-eluting sinus implants have been used as an adjunct to ESS (endoscopic sinus surgery) with the intent of maintaining patency of the sinuses and delivering local steroids. Two RCTs have compared the PROPEL device with steroids to the same device without steroids and reported that the steroid-eluting device reduced postoperative inflammation, reduced the need for oral steroids, and reduced the need for postoperative reinterventions.
One prospective, randomized, double-blind, multi-center study (PROGRESS) evaluated the PROPEL Mini sinus implant in the frontal sinus and enrolled 80 patients at 11 U.S. sites. Follow-up exams were for a total of 90 days. No serious adverse events related to the use of the device were noted. The difference in post-operative intervention was statistically significant and represented a 38% relative reduction in post-operative interventions.
Sinus Implant under FDA Drug Approval
The Sinuva Sinus Implant was approved as a drug and contains 1350 mcg of mometasone furoate. The FDA label for Sinuva indicates that two clinical studies were involved in the evaluation of Sinuva (55). One had a duration of 6 months (Study 1: NCT01732536) and the other trial had a duration of 90 days (Study 2: NCT02291549). Efficacy for Sinuva sinus implant is based primarily on Study 2 which included 300 patients. Two hundred one patients (treatment group) underwent bilateral placement of Sinuva sinus implants in the ethmoid sinuses. The control group which included 99 patients underwent a placebo (sham) procedure. The placebo procedure involved placement of the delivery system with the Sinuva sinus implant into the ethmoid sinuses without deployment of the sinus implant, followed by the removal of the delivery system. All patients in both the treatment and control groups used a mometasone furoate nasal spray once daily (200mcg of mometasone furoate) through Day 90. Study 2 was a randomized, controlled single-blinded, multicenter study, the study population included adult patients greater than or equal to 18 years of age, diagnosed with chronic sinusitis who had previously undergone bilateral total ethmoidectomy, but were considered for revision endoscopic sinus surgery due to recurrent nasal obstruction/congestion symptoms and recurrent bilateral sinus obstruction due to sinonasal polyposis. Exclusion criteria included grade 3 or grade 4 adhesions/synechiae, grade 4 polyposis, known history of resistant or poor response to oral steroids, acute bacterial or invasive fungal sinusitis, and immune deficiency, including cystic fibrosis.
There were co-primary efficacy measures that compared data in the treatment group to the control group. The treatment group demonstrated a statistically significant difference from baseline to Day 30 in nasal obstruction/congestion score by the patient using a daily diary for 7 days preceding the baseline and Day 30 visits. The treatment group also demonstrated a statistically significant difference from baseline to Day 90 in bilateral polyp grade, based on grading of video-endoscopies by an independent panel of 3 sinus surgeons who were blinded to treatment assignment.
Section Summary: Sinus Implant under FDA Drug Approval
Sinus implant drug (Sinuva) has been evaluated as treatment of nasal polyps in patients 18 years of age or older who have had ethmoid sinus surgery. Sinuva’s efficacy was based primarily on one randomized, controlled, single-blind, multicenter study with 300 patients compared coprimary efficacy measures for nasal obstruction/congestion scores as established by daily diaries and bilateral polyp grade as established by video-endoscopies reviewed by an independent panel of 3 sinus surgeons, masked to treatment assignment. This study reported statistically significant difference in the co-primary efficacy for the treatment group as compare to the control group.
Balloon Dilation of the Eustachian Tube
In 2016 Hwang et al. performed a systematic literature review. (53) Results noted from the authors included nine prospective studies, describing 713 Eustachian tube balloon dilations in 474 patients (aged 18-86 years). Follow-up duration ranged from 1.5 to 18 months. Ability to perform a Valsalva maneuver improved from 20 to 177 out of 245 ears following Eustachian tube balloon dilation and, where data were reported in terms of patient numbers, from 15 to 189 out of 210 patients. Tympanograms were classified as type A in 7 out of 141 ears pre-operatively and in 86 out of 141 ears post-operatively. The authors concluded that prospective case series can confirm the safety of Eustachian tube balloon dilation. As a potential solution for chronic Eustachian tube dysfunction, further investigations are warranted to establish a higher level of evidence of efficacy.
Section Summary: Balloon Dilation of the Eustachian Tube
Eustachian tube balloon dilations is being investigated for a possible solution for persistent chronic Eustachian tube dysfunction. Further long-term trials are needed to draw conclusions on the impact to health outcomes.
Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.
Disclaimer for coding information on Medical Policies
Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.
The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.
Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.
The following codes may be applicable to this Medical policy and may not be all inclusive.
30120, 30150, 30400, 30410, 30420, 30430, 30435, 30450, 30999, 31295, 31296, 31297, 31298, 31299, 0406T, 0407T
C1726, C9745, J3490, S1090
ICD-9 Diagnosis Codes
Refer to the ICD-9-CM manual
ICD-9 Procedure Codes
Refer to the ICD-9-CM manual
ICD-10 Diagnosis Codes
Refer to the ICD-10-CM manual
ICD-10 Procedure Codes
Refer to the ICD-10-CM manual
The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.
The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.
A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.
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24. Achar P, Duvvi S, Kumar BN. Endoscopic dilatation sinus surgery (FEDS) versus functional endoscopic sinus surgery (FESS) for treatment of chronic rhinosinusitis: a pilot study. Acta Otorhinolaryngol Ital. Oct 2012; 32(5):314-319. PMID 23326011
25. Bikhazi N, Light J, Truitt T, et al. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial with 1-year follow-up. Am J Rhinol Allergy. Jul 2014; 28(4):323-329. PMID 24823902
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|1/15/2019||Document updated with literature review. The following changes were made to Coverage: 1) added coverage under Drug-eluting Sinus Implants to address FDA drug approved sinus implant 2) clarification of coverage per the FDA device or FDA drug approved indications for drug-eluting sinus implants and 3) added the following: NOTE 2: See the Regulatory Status section of this medical policy for additional information concerning drug and devices containing mometasone furoate and their indications. Added references: 54-55.|
|5/1/2018||Document updated with literature review. The following coverage criteria for Rhinoplasty was changed: within the previous 12 months, was removed from the following statement: Significant external nasal pyramid collapse following documented trauma or injury within the previous 12 months. PROPEL Contour was added to the coverage statements for Drug-eluting Sinus Implants.|
|7/1/2017||Document updated with literature review. The following coverage statement was added: Balloon dilation of the Eustachian tube for persistent Eustachian tube dysfunction is considered experimental, investigational and/or unproven.|
|11/15/2016||Document updated with literature review. The following changes to coverage were made: 1) Rhinoplasty coverage criteria changed from 5 criteria to the following 3 criteria: Rhinoplasty may be considered medically necessary when performed to correct any one of the following: Nasal deformity secondary to congenital craniofacial deformity (e.g. cleft lip, cleft palate, or maxillonasal dysplasia); OR Significant external nasal pyramid collapse following documented trauma or injury within the previous 12 months; OR Significant deformity following removal of a nasal malignancy, an abscess or osteomyelitis. 2) Balloon Ostial Dilations coverage changed to the following: Balloon ostial dilation using a U. S. Food and Drug Administration (FDA) approved catheter-based inflatable device performed in accordance with the device’s FDA-approved labeling for the treatment of medically refractory chronic sinusitis in adults may be considered medically necessary as a minimally invasive alternative to functional endoscopic sinus surgery. The use of a balloon ostial dilation device, with a FDA approved device specified for children, (children age 17 and under) may be considered medically necessary when treating the maxillary sinus space as a minimally invasive alternative to functional endoscopic sinus surgery for the treatment of medically refractory chronic sinusitis. The use of a balloon ostial dilation device, with a FDA approved device specified for children, (children age 17 and under) is considered experimental, investigational and/or unproven in all other sinus spaces but the maxillary sinus space as a minimally invasive alternative to functional endoscopic sinus surgery for the treatment of medically refractory chronic sinusitis. 3) the following coverage statement was changed under the Drug-eluting Sinus Implants section: Placement of a mometasone furoate sinus implant (Propel®/Propel® mini) may be considered medically necessary in conjunction with ethmoid sinus and/or frontal sinus surgery when criteria are met.|
|5/1/2015||Document updated with literature review. Coverage language clarified for balloon ostial dilation. Coverage for implantable sinus stent has changed to may be considered medically necessary when listed criteria are met.|
|7/1/2012||Document updated with literature review. CPT/HCPCS code(s) updated. The following was added to Sinus Spacers and Other implantable Devices: Bioabsorbable sinus implants (e.g. Propel™) are considered experimental, investigational and unproven for all indications, including delivery of steroids to the sinus cavities.|
|6/1/2012||Document updated with literature review. CPT/HCPCS code(S) updated. The following was added to coverage: Use of a catheter-based inflatable device (balloon sinuplasty) for the treatment of medically refractory chronic sinusitis may be considered medically necessary as a minimally invasive alternative to functional endoscopic sinus surgery. Information regarding catheter –based inflatable balloon device found in the pricing section was removed.|
|12/1/2010||Document updated with literature review. Explained when FESS is medically necessary (not a new indication); Use of a spacer (e.g. Relieva Stratus™ MicroFlow Spacers and Deployment Guides) for all indications, including delivery of steroids to the sinus cavities, is considered experimental, investigational and unproven.|
|4/15/2009||Policy revised with literature search, no coverage change.|
|1/1/2009||Revised/Updated Entire Document|
|3/1/2007||Revised/Updated Entire Document|
|1/1/2005||Revised/Updated Entire Document|
|11/1/1999||Revised/Updated Entire Document|
|5/1/1996||Revised/Updated Entire Document|
|3/1/1996||Revised/Updated Entire Document|
|1/1/1993||Revised/Updated Entire Document|
|5/1/1990||New Medical Document|
|Title:||Effective Date:||End Date:|
|Nasal and Sinus Surgery||05-01-2018||01-14-2019|
|Nasal and Sinus Surgery||07-01-2017||04-30-2018|
|Nasal and Sinus Surgery||11-15-2016||06-30-2017|
|Nasal and Sinus Surgery||05-01-2015||11-14-2016|
|Nasal and Sinus Surgery||07-01-2012||04-30-2015|
|Nasal and Sinus Surgery||06-01-2012||06-30-2012|
|Nasal and Sinus Surgery||12-01-2010||05-31-2012|
|Nasal and Sinus Surgery||04-15-2009||11-30-2010|
|Nasal and Sinus Surgery||01-01-2009||04-14-2009|
|Nasal and Sinus Surgery||04-15-2008||12-31-2008|