Blue Cross Blue shield of Montana (BCBSMT) may consider Nasal and Sinus Surgery for the procedures listed below 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 cleft lip or cleft palate; OR
- Chronic nasal airway obstruction unresponsive to multiple conservative therapies and resulting in recurrent or chronic rhinosinusitis; OR
- Significant deformity caused by specifically documented trauma within the previous 12 months; OR
- Significant deformity following removal of a nasal malignancy, an abscess or osteomyelitis that has caused breathing difficulty; OR
- Significant deformity in individuals with documented sleep apnea or breathing difficulty, and chronic rhinosinusitis as a result of external nasal pyramid deformity following documented trauma or injury.
NOTE: 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 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.
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.
Sinus Spacers and Other Implantable Devices
Sinus spacers and deployment guides used postoperatively for nasal and sinus surgeries, including but not limited to Relieva Stratus™ MicroFlow Spacers and Deployment Guides and bioabsorbable sinus implants (e.g. Propel™), are considered experimental, investigational and unproven for all indications, including delivery of steroids to the sinus cavities.
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 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. 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.
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.”
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.
A search of peer-reviewed literature was conducted through January 2009.
Brown and Bolger conducted a nonrandomized prospective cohort of 10 endoscopic sinus surgery candidates offered treatment with a new technique of balloon catheter dilation of targeted sinus ostia. The frontal, maxillary, and sphenoid sinuses were considered appropriate for this innovative catheter-based technology. The primary study end points were intraoperative procedural success and absence of adverse events. A total of 18 sinus ostial regions were successfully catheterized and dilated, including ten maxillary, five sphenoid, and three frontal recesses. No adverse events occurred. Mucosal trauma and bleeding appeared to be less with catheter dilation than is typically observed with endoscopic sinus surgery techniques. The authors concluded that dilation of sinus ostial regions via balloon catheter-based technology appears to be relatively safe and feasible.
Bolger and colleagues reported on outcomes at 24 weeks from a multicenter study of balloon sinuplasty of 115 patients. In this study, 115 patients, for whom endoscopic sinus surgery was recommended, received treatment with the balloon catheter. Sinusotomy was attempted in 358 sinuses, and cannulation was successful in 347. Successful sinusotomy was performed in 143 maxillary ostia, 75 sphenoid ostia, and 124 frontal recesses. The average number of sinuses treated per patient with the balloon device was 3.1. In 52% of the patients (57 of 109 who were followed up in the study), traditional endoscopic surgery was used on some sinuses and balloon sinuplasty was used on at least one sinus. Ostia patency rates were assessed at weeks 1, 12, and 24; at 24 weeks, 304 of the 347 sinuses were evaluated (88%). While only five were non-patent; the status of 18% was indeterminate. Indeterminate was used if the ostium could not be viewed with rigid endoscopy or if the patient did not tolerate a complete endoscopic examination. The device malfunctioned in 12 of 358 cases (3.4%); the balloon ruptured in seven cases and the catheter tip malfunctioned in four cases. The authors indicated there were no serious adverse events. Patients’ symptoms as measured by the Sino-Nasal Outcome Test (SNOT 20) also improved post-treatment.
Weiss et al. prospectively evaluated patients who had sinus ostia dilated with balloon catheters two years after surgery by SNOT 20 and computed tomographic (CT) scan. Sixty-five patients (195 ballooned sinuses) were followed for two years after surgery including 34 "balloon-only" patients and 31 "hybrid" patients. SNOT 20 symptom scores were significantly improved from baseline (0.87 vs. 2.17 baseline, P < 0.001) and stable compared to six months and one year; this was the case for both balloon-only (1.09 vs. 2.09, P < 0.001) and hybrid (0.64 vs. 2.26, P < 0.001) patients. Lund-MacKay CT scores (staging system for chronic sinusitis) were significantly improved from baseline (2.69 vs. 9.66, P < 0.001) and stable compared to one year, confirmed for both balloon- only (1.75 vs. 5.67, P < 0.015) and hybrid (3.25 vs. 12.05, P < 0.001) subsets of patients. A total of 85% of patients reported improvement of their sinus symptoms, with 15% same and 0% worsened. Revision treatment was required in seven of 195 sinuses (3.6%) in six of 65 patients (9.2%). The authors concluded that patients who receive balloon catheter sinusotomy in endoscopic sinus surgery have significant improvement in symptoms two years after surgery. Radiographic evidence also confirms resolution of disease after two years. This demonstrates durability of clinical results previously reported at 24 weeks and one year after surgery.
A search of peer-reviewed literature through February 2010 identified the following:
No new randomized controlled trials were identified. There were several new empirical studies.
Stankiewicz et al. (BREATHE I study) reported on 30 subjects with chronic rhinosinusitis of the maxillary sinuses alone or maxillary and anterior ethmoid sinuses who received transantral balloon dilation at three institutions between September 2007 and March 2008. The mean overall SNOT score at 1-month, 3-month, and 6-month follow-up were 0.8 ± 0.8, 0.7 ± 0.8, and 0.8 ± 0.9 respectively. Patency at 3-months as confirmed by CT imaging was 95.8%. Long-term data have not been evaluated.
Wittkoph et al. reported on five critically ill patients who received balloon sinuplasty at a single institution between October 2007 and March 2008. The article described patient characteristic outcomes. Due to the small number of patients, no statistical analyses could be performed and no conclusions can be drawn about the effectiveness of this procedure in critically ill patients.
Ramadan reports on 30 children who received balloon sinuplasty under general anesthesia performed by the author. The children were diagnosed with chronic rhinosinusitis using CT scans and all had failed at least six months of medical management. Balloon sinuplasty was feasible in 51 of 56 sinuses scheduled for surgery and not feasible in four hypoplastic sinuses and one frontal sinus. Thirteen children had both balloon sinuplasty and adenoidectomy. The mean time of fluoroscopy exposure was 18 seconds per sinus (range 6 to 60 seconds). The estimated amount of radiation received was 0.18 mGy (range of 0.06 to 0.6 mGy). No complications or side effects were noted. The author did not report on change in sinusitis symptoms after surgery.
Friedman et al. performed a retrospective chart review that compared results in 35 consecutive patients who received balloon sinuplasty and 35 consecutive patients who received functional endoscopic surgery. Study authors reported no financial relationships with the balloon sinuplasty device manufacturers. All patients were at least 18 years old, had been treated between December 2005 and May 2006, and procedures were performed by a single surgeon. During the time period under consideration, patients with Lund-McKay scores of under 13 (scores can range from 0 to 24) without polyps had been given the choice of either procedure. There were no consistent eligibility criteria; patients generally had a history of recurrent rhinosinusitis despite medical management and either a persistently abnormal CT scan after at least four weeks of antibiotic treatment, or an abnormal CT scan during treatment with a normal scan post-treatment but at least three recurrences per year. Surgeries were revisions for 12 patients in the balloon sinuplasty group and 12 patients in the endoscopic surgery group. Individuals who received a combination of the two procedures, or who were missing preoperative Sino-Nasal Outcome Test (SNOT 20) scores were excluded from the analysis. The SNOT 20 score three months after the operation was significantly higher (more symptoms) in the endoscopic surgery group (see table, below).
SNOT 20 Scores (mean ± SD)
2.80 + 0.52
2.70 + 0.85
0.78 + 0.55
1.29 + 0.87
Postoperative pain, as measured by the number of days patients used a narcotic, was significantly lower in the group of patients that underwent balloon sinuplasty (0.8 + 0.7 days) compared to endoscopic sinus surgery (1.3 + 1.0), p=0.011. The patient satisfaction measure also favored the balloon sinuplasty group. The primary complications reported were turbinate lateralization or scarring, which occurred in eight patients who underwent balloon sinuplasty and in three patients who had endoscopic surgery. One or more sinus infections occurred in six balloon sinuplasty patients and nine endoscopic surgery patients during the 3-month follow-up; one patient in the balloon sinuplasty group required revision surgery due to persistent infection. The number of patients in each group is too small to draw conclusions about differences in adverse effects. Limitations of the study are that it was not randomized and there may have been differences between groups that affected outcomes. Additionally, it was not blinded; patients selected their interventions, and as the authors point out, they may have had more positive expectations about a novel minimally invasive procedure that received extensive media coverage. In addition, relatively short-term outcomes are available and sample size was relatively small. Because of these limitations, the Friedman et al. study is not sufficient evidence that balloon sinuplasty is effective.
National Institute for Health and Clinical Evidence (UK):
“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”.
American Rhinologic Society Position Statement 2007:
- Based on currently available scientific medical evidence, endoscopic balloon dilation technology is acceptable and safe for use in the management of sinus disease.
- Endoscopic balloon dilation technology is a tool, not a procedure, available to the operating surgeon at his/her discretion for the surgical management of sinus disease.
- Patients who are treated with this technology may require concurrent conventional endoscopic sinus surgery especially in the ethmoid sinuses much like any surgical instrument that may be used in some parts of the sinus and not others or in combination with other technologies.
- In a group of selected patients, the use of balloon catheter dilation technology alone may eliminate the need for other surgical techniques.
- Endoscopic balloon catheter dilation as a tool for dilating the opening of the maxillary sphenoid, and frontal sinuses is not investigational or experimental and should not be viewed as such.
American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS) 2010:
Sinus ostial dilation (e.g., balloon ostial dilation) is an appropriate therapeutic option for selected patients with sinusitis. This approach may be used alone to dilate a sinus ostium (frontal, maxillary, or sphenoid) or in conjunction with other instruments (e.g., microdebrider, forceps). The final decision regarding use of techniques or instrumentation for sinus surgery is the responsibility of the attending surgeon.
In conclusion, there is insufficient scientific evidence to support coverage of catheter-based inflatable balloon device (balloon sinuplasty) at this time.
One phase III clinical trial in progress was identified to evaluate the safety and efficacy of treating the ethmoid sinuses with the Relieva Stratus Spacer and for local delivery of Kenalog-40. There have been no posted results of the clinical trials of phase I or phase II found in literature to date. There has been no technology assessment or position statement found regarding sinus spacers. In conclusion, there is insufficient evidence to support coverage of sinus spacers with or without delivery of medication at this time.
A search of peer reviewed literature through March 2012 identified the following:
Levine et al. reported on results from a registry study of 1,036 patients who received a balloon sinuplasty procedure at 27 sites from December 2005 to May 2007 (Levine, 2008). This registry was developed through retrospective chart review of consecutive cases at these institutions. All but two patients in this study had treatments while under general anesthesia. An average of 3.2 sinuses was treated per patient. Symptom improvement was reported at 95%. With average follow-up of 40 weeks, the revision rate was 1.3%.
Batra and colleagues performed a comprehensive review of the literature regarding balloon catheter technology in rhinology (Batra, 2010). They concluded that the accrued data attests to its safety, and the largest published observational cohort studies demonstrated the ability to achieve ostia patency for up to two years.
Sinus Spacers and Other Implantable Devices in Sinus Surgery
The Advance II study was the prospective, randomized, controlled, double-blind, multicenter trial using an intrapatient control design. One hundred five patients with chronic sinusitis underwent bilateral ethmoidectomy. Effects of drug-releasing to non-drug-releasing implants were compared. Results indicated drug-releasing implant provided a 29.0% relative reduction in postoperative interventions (P = .028) and a 52% (P = .005) decrease in lysis of adhesions. The relative reduction in frank polyposis was 44.9% (P = .002). The study concluded use of steroid-releasing implants that apply a sustained release of corticosteroid improves surgical outcomes by reducing polyposis, synechiae formation, and the need for postoperative interventions.
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.