mp-193
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Aerosolized Antibiotics as a Treatment of Chronic Sinusitis

Policy Number: MP-193

Latest Review Date: September 2019

Category: Medicine                                                               

Policy Grade: Effective 02/06/2013: Active Policy but no longer scheduled for regular literature reviews and updates.

POLICY:

Aerosolized antibiotics as a technique of treating chronic sinusitis or acute exacerbations of chronic sinusitis are considered not medically necessary and investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Chronic sinusitis is defined as a group of disorders characterized by inflammation of the mucosa of the nose and paranasal sinuses of at least 12 consecutive weeks duration.  Clinical signs include purulent drainage and various imaging studies (e.g. CT, MRI, or plain film radiographs) 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. Chronic sinusitis represents a continuous spectrum of pathophysiologies ranging from a purely infectious etiology to noninfectious or allergic inflammation.  In addition, it is possible 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. 

Functional endoscopic sinus surgery (FESS) to improve the ventilation within the osteomeatal complex may be offered to those patients who fail medical management. After FESS, the sinus ostia are patent and communicate with the nasal cavity. FESS is successful in approximately 80-90% of patients with recurrent or medically unresponsive chronic sinusitis.  Antibiotics aerosolized for this purpose include tobramycin, gentamicin, ciprofloxacin, levofloxacin and certain cephalosporins. Aerosolized antibiotics are not commercially available, but may be provided by a compounding pharmacy.

The SinuNEB is a device that uses compounded medications that are aerosolized to a particle size small enough to disperse within the sinus cavities. According to the manufacturer of the SinuNEB, administration of antibiotics via nebulization directly to the lining of the sinuses results in a more rapid response, greater effectiveness, reduced reinfection, and fewer side effects than oral or intravenous antibiotic administration.

KEY POINTS:

The most recent literature search was through September 01, 2019 with searches of the MEDLINE database.

Summary of Evidence

The data on use of aerosolized antibiotics for chronic sinusitis are very limited. Thus, use of aerosolized antibiotics in the treatment of sinusitis is considered investigational because its impact on clinical outcomes is not known.

PRACTICE GUIDELINES AND POSITION STATEMENTS

No published guidelines on sinusitis management from leading professional medical organizations discuss any role for nebulized or nasally irrigated antibiotics. Thus, aerosolized or nasally irrigated anti-infectives are considered experimental and investigational for the treatment of sinusitis.

KEY WORDS:

Aerosolized antibiotics, nebulization, sinusitis, chronic sinusitis, functional endoscopic sinus surgery, FESS, nebulizer, compounding pharmacy, NasoNeb®, SinuNEB

APPROVED BY GOVERNING BODIES:

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.  

The SinuNEB (SinusPharmacy) is a device that nebulizes antibiotics, anti-fungals, and medications for the treatment of sinusitis.

The NasoNeb® System (2009) delivers a penetrating aerosol to the nasal and paranasal sinus cavities.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

CODING:

HCPCS                        E0575       Nebulizer, ultrasonic, large volume

REFERENCES:

  1. American Academy of Otolaryngology—Head and Neck Surgery.  Aerosolized antibiotics prove to be safe and effective for treatment of chronic sinusitis, www.entlink.net/ent-press/12-02.cfm.
  2. Blue Cross and Blue Shield Association.  Medical Policy Reference Manual.  Aerosolized antibiotics as a treatment of chronic sinusitis, September 2009.
  3. Centers for Disease Control (CDC).  National Center for Health Statistics.  Chronic sinusitis, www.cdc.gov/nchs/fastats/sinuses/htm.
  4. Desrosiers MY, Salas-Prato M.  Treatment of chronic rhinosinusitis refractor to other treatment with topical antibiotic therapy delivered by means of a large particle nebulizer:  Results of a controlled trial, Otolaryngol Head Neck Surg 2001; 125: 265-269.
  5. Scheinberg PA, Otsuji A.  Nebulized antibiotics for the treatment of acute exacerbations of chronic rhinosinusitis, Ear Nose Throat Journal 2002; 81: 648-652.
  6. Sinus News.  Aerosolized antibiotics safe and effective against sinusitis, 2003, www.sinusnews.com/articles2003/aerosolizedantibioticseffective.html.
  7. Vaughan WC, Carvalho G.  Use of nebulized antibiotics for acute infection in chronic sinusitis, Otolaryngol Head Neck Surg 2002; 127: 55-68.
  8. Videler WJ, van Drunen CM et al.  Nebulized bacitracin/colimycin:  A treatment option in recalcitrant chronic rhinosinusitis with Staphylococcus aureus?  A double-blind, randomized, placebo-controlled, cross-over pilot study.  Rhinology, June 2008; 46(2): 92-9

POLICY HISTORY:

Medical Policy Group, August 2004 (1)

Medical Policy Administration Committee, August 2004

Available for comment August 24-October 7, 2004

Medical Policy Group, August 2006 (1)

Medical Policy Group, August 2008 (1)

Medical Policy Group, August 2010 (1) Key points updated, Governing bodies

Medical Policy Group, February 2013: Effective 02/06/2013: Active Policy but no longer scheduled for regular literature reviews and updates.

Medical Policy Group, September 2019 (6): Updates to Description, Key Points, Governing Bodies, Key Words (NasoNeb®, SinuNEB) and Practice Guidelines. No change in policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.