BlueCross and BlueShield of Montana Medical Policy/Codes
Aerosolized Antibiotics as a Treatment of Chronic Sinusitis
Chapter: Medicine: Treatments
Current Effective Date: August 27, 2013
Original Effective Date: August 27, 2013
Publish Date: May 27, 2013
Description

Aerosolized antibiotics refer to antibiotics delivered with a nebulizer directly to the sinuses.   It has been proposed as a treatment for patients who have chronic sinusitis or acute exacerbations of chronic sinusitis.

Chronic sinusitis is defined as a group of disorders characterized by inflammation of the mucosa of the nose and paranasal sinuses of at least twelve consecutive weeks duration.  Clinical signs include purulent drainage, and various imaging studies (i.e., computed tomography, magnetic resonance imaging or plain film radiography) may reveal polyps, edema, erythema, or granulation tissue of the sinuses.  Chronic sinusitis may be associated with asthma, allergies, dental disease, polyposis, cystic fibrosis, and immunodeficiency syndromes.  It is assumed that bacteria contribute to the pathophysiology of chronic sinusitis, but their exact contribution is still unclear.  For example, chronic sinusitis probably represents a continuous spectrum of patho-physiologies ranging from a purely infectious etiology to non-infectious or allergic inflammation. In addition, it is possible that the presence of bacteria colonization may aggravate a noninfectious inflammation.

Conventional treatment for chronic sinusitis includes various combinations of oral antibiotics, decongestants, mucolytics, and topical corticosteroids.  Endoscopic sinus surgery to improve the ventilation within the osteo meatal complex may be offered to those patients who fail medical management.  After endoscopic sinus surgery, the sinus ostia are patent and communicate with the nasal cavity, thus offering an opportunity to deliver aerosolized antibiotics topically to the sinus cavities.

In June 2006, the LC® Star Reusable Nebulizer with Nasal Adapter (PARI Innovative Manufacturers, Inc.) 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 the inhalation treatment of aerosolized medications.

Policy

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.

Coverage

Blue Cross and Blue Shield of Montana (BCBSMT) considers aerosolized antibiotics experimental, investigational and unproven as a technique of treating chronic sinusitis or acute exacerbations of chronic sinusitis.

Rationale

Two different patient groups have been studied; those with persistent symptoms of chronic sinusitis, and those with an acute exacerbation of underlying chronic sinusitis.  In this latter group, the presence of a mucopurulent discharge permits culturing and selection of antibiotic based on culture results.  Aerosolized antibiotics as a treatment for chronic sinusitis without prior endoscopic surgery has not been studied.

Chronic Sinusitis after Endoscopic Surgery

Desrosiers and colleagues reported on a trial of 20 patients with chronic sinusitis persisting after endoscopic sinus surgery who were randomized to receive either a tobramycin solution or a saline only solution.  The solutions, aerosolized with a large particle nebulizer, were administered twice daily for four weeks followed by a four-week observation period.  Outcomes measures included a quality of life questionnaire and an assessment of the nasal mucosa using sinonasal endoscopy.  The authors reported that both treatments were associated with equivalent improvements in symptoms, quality of life, and mucosal assessment.  The addition of tobramycin appeared to add no benefit.

In 2008, Videler and colleagues published a small pilot randomized controlled trial.  The trial included 14 patients with chronic staphylococcal sinusitis.  No differences in outcomes (symptom reduction, functional status, or endoscopic findings) were noted in patients receiving oral levofloxacin who underwent nasal irrigation with bacitracin/colimycin compared to those who received saline (placebo) irrigation.  The study suggests no benefit from aerosolized antibiotics; the small sample size limits any conclusions from this study.

Acute Exacerbation of Underlying Chronic Sinusitis after Endoscopic Sinus Surgery

Two case series were identified.  Vaughan and Carvalho reported on 42 patients who were treated with a three-month course of aerosolized antibiotics.  All patients had undergone prior endoscopic sinus surgery and had an acute exacerbation of the underlying chronic sinusitis, as evidenced by a mucopurulent discharge.  The selection of antibiotic was based on the culture results.  No other oral antibiotics were used during the three-week treatment period.  Outcomes were assessed by review of the results of endoscopy and an assessment of patient symptoms using the Rhinosinusitis Outcome Measurement questionnaire.  Based on the presence of purulent discharge, 28 patients were judged to be free of infection at the end of the treatment.  An additional 10 patients responded to the initial course of therapy, but subsequently developed a new infection with a new organism.  These two groups (38 of 44 patients) were considered treatment successes.  Marked improvements were noted for nasal discharge and facial pain and pressure.  However, without a control group, interpretation of the data is limited.  It is not known if these outcomes are equivalent, better, or worse when compared to the standard treatment with oral antibiotics.  The case series of Scheinberg and colleagues has the same limitations.  This study included 41 patients with acute exacerbations of chronic sinusitis, although the report did not indicate how an acute exacerbation was identified.  The patients received one of four different antibiotics, although it is unclear how the choice of antibiotic was made.  Outcomes were based on nasal obstruction, as assessed by endoscopic examination and subjective assessments of facial pain, pressure, rhinorrhea, and malaise.  All assessments were based on a five-point scale, and were recorded before and after treatment.  The lack of a control group limits the interpretation of this data.

Summary

The data on use of aerosolized antibiotics for chronic sinusitis are very limited.  Two small randomized controlled trials with patients who had chronic sinusitis after endoscopic sinus surgery suggest no benefit.  There are no comparative studies of oral antibiotics with aerosolized antibiotics for patients with acute exacerbations of chronic sinusitis after endoscopic sinus surgery.  No published studies were identified that included patients with chronic sinusitis who did not have endoscopic surgery.   Thus, use of aerosolized antibiotics in the treatment of sinusitis is considered experimental, investigational and unproven because its impact on clinical outcomes is not known.

2011 Update

A search of peer-reviewed literature through April 2011 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.  At this time, no published guidelines have been identified on management of sinusitis with nebulized antibiotics from professional societies.

Coding

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. 

ICD-9 Codes

473.0-473.9

ICD-10 Codes

J32.0-J32.9

Procedural Codes: E0575, G0333, J3535, J7624, J7634, J7637, J7638, J7641, J7682, J7685, Q0513, Q0514, S9430
References
  1. Desrosiers, M.Y., and M. Salas-Prato.  Treatment of chronic rhinosinusitis refractory to other treatments with topical antibiotic therapy delivered by means of a large-particle: results of a controlled trial.  Otolaryngology and Head and Neck Surgery (2001 September) 125(3):265-9.
  2. American Academy of Pediatrics: Clinical Practice Guideline: Management of Sinusitis
  3. Subcommittee on Management of Sinusitis and Committee on Quality Improvement.  Pediatrics (2001 September) 108 (3):798-808.  
  4. Vaughan, W.C., and G. Cervalho.  Use of nebulized antibiotics for acute infections in chronic sinusitis.  Otolaryngology and Head and Neck Surgery (2002 December) 127(6):558-68.
  5. Scheinberg, P.A., and A. Otsuji.  Nebulized antibiotics for the treatment of acute exacerbations of chronic rhinosinusitis.  Ear, Nose and Throat Journal (2002 September) 81(9):648-52.
  6. Videler, W. J., Van Drunen, C. M., Reitsma, J. B., et al. Nebulized bacitracin/colimycin: a treatment option in recalcitrant chronic rhinosinusitis with staphylococcus aureus? A double blind, randomized, placebo-controlled, crossover pilot study. Rhinology 2008; 46:92-8.
  7. Aerolized Antibiotics as a Treatment of Chronic Sinusitis. Chicago, Illinois. Blue Cross Blue Shield Association Medical Policy Reference Manual (2009 September) Medicine 201.01.65.
History
May 2013  New 2013 BCBSMT medical policy.  Considered experimental, investigational and unproven. 
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Aerosolized Antibiotics as a Treatment of Chronic Sinusitis