Subject:
Aerosolized Antibiotics as a Treatment of Chronic Sinusitis
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Aerosolized antibiotics refer to antibiotics delivered with a nebulizer directly to the sinuses. It is 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 12 consecutive weeks’ duration. Clinical signs include purulent drainage, and various imaging studies (i.e., plain film radiography, computed tomography, magnetic resonance imaging) 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 pathophysiologies ranging from a purely infectious etiology to noninfectious or allergic inflammation. In addition, it is possible that the presence of bacterial 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 osteomeatal 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. The use of aerosolized antibiotics has been studied in patients who have had endoscopic sinus surgery, both those with persistent symptoms of chronic sinusitis and those with acute exacerbations of underlying chronic sinusitis. In the 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.
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:
(NOTE:: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
Aerosolized antibiotics are considered investigational as a technique of treating chronic sinusitis or acute exacerbations of chronic sinusitis.
Medicare Coverage:
There is no National Coverage Determination (NCD) for Aerosolized Antibiotics as a Treatment of Chronic Sinusitis. In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy Aerosolized Antibiotics as a Treatment of Chronic Sinusitis.
For information on nebulizers, refer to Local Coverage Determination (LCD):
Nebulizers (L33370) and Local Coverage Article: Nebulizers - Policy Article (A52466). Available to be accessed at Noridian Healthcare Services, LLC, (DME MAC), Local Coverage Determinations (LCDs) search page: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=1&bc=AAgAAAAAAAAA&#aFinal
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
[INFORMATIONAL NOTE: Literature review.
Chronic Sinusitis after Endoscopic Surgery
Two small randomized controlled trials have been published. Desrosiers and Salas-Prato reported in 2001 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 4 weeks followed by a 4-week observational period. Outcomes measures included a quality of life questionnaire and 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 have been published. Vaughan and Carvalho reported in 2002 on 42 patients who were treated with a 3-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 3-week treatment period. Outcomes were assessed by review of the results of endoscopy and 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 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 (2002) 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 1 of 4 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 5-point scale, and were recorded before and after treatment. The lack of a control group limits the interpretation of these data.
In summary, the published data on the 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, the use of aerosolized antibiotics in the treatment of sinusitis is considered investigational because its impact on clinical outcomes is not known.]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Aerosolized Antibiotics as a Treatment of Chronic Sinusitis
Antibiotics, Aerosolized
Chronic Sinusitis, Aerosolized Antibiotics as a Treatment of
Star Reusable Nebulizer
Star Nebulizer
References:
1. Desrosiers MY, Salas-Prato M. Treatment of chronic rhinosinusitis refractory to other treatments with topical antibiotic therapy delivered by means of a large-particle nebulizer: results of a controlled trial. Otolaryngol Head Neck Surg 2001; 125(3):265-9.
2. Vaughan WC, Carvalho G. Use of nebulized antibiotics for acute infections in chronic sinusitis. Otolaryngol Head Neck Surg 2002; 127(6):558-68.
3. Scheinberg PA, Otsuji A. Nebulized antibiotics for the treatment of acute exacerbations of chronic rhinosinusitis. Ear Nose Throat J 2002; 81(9):648-52.
4. Videler WJ, van Drunen CM, Reitsma JB 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 2008; 46(2):92-8.
5. Sarber KM, Dionb Gr, Weitzel EK, et al. Approaching chronic sinusitis. South Med J 2013 Nov;106(11): 642-8.
6. Woodhouse BM, Cleveland KW. Nebulized antibiotics for the treatment of refractory bacterial chronic rhinosinusitis. Ann Pharmacother. 2011 Jun;45(6):798-802.
7. Settipane RA, Peters AT, Chandra R. Chapter 4: Chronic rhinosinusitis. Am J Rhinol Allergy 2013 May-Jun;27 Suppl 1:S11-5.
8. Ocampo CJ, Peters AT. Medical therapy as the primary modality for the management of chronic rhinosinusitis. Allergy Asthma Proc 2013 Mar-Apr;34(2):132-7.
9. UpToDate. Microbiology and antibiotic management of chronic rhinosinusitis. Literature review current through April 2016; topic last updated: April 17, 2015.
10. UpToDate. Chronic rhinosinusitis: Management. Literature review current through April 2016; topic last updated: March 17, 2016.
11. Moller W, Schuschnig U et al. Drug delivery to paranasal sinuses using pulsating aerosols. J Aerosol Med Pulm Drug Deliv. 2014 Aug;27(14):255-63.
12. Brook I. Microbiology and antibiotic management of chronic rhinosinusitis. In: UpToDate, Calderwood SB, Corren J, Bloom A (Eds), UpToDate, Waltham, MA. (Accessed on April 09, 2017.)
13. Hamilos DL, Chronic rhinosinusitis: Management. In: UpToDate, Corren J, Deschler DG, Feldweg AM (Eds), UpToDate, Waltham, MA. (Accessed on April 9, 2017.
14. Hamilos DL, Chronic rhinosinusitis: Management. In: UpToDate, Feldweg AM (Ed), UpToDate, Waltham, MA. (Accessed on February 27, 2018).
15. Brook I. Microbiology and antibiotic management of chronic rhinosinusitis. In: UpToDate, Bloom A (Eds), UpToDate, Waltham, MA. (Accessed on February 27, 2018.)
16. Hamilos DL, Chronic rhinosinusitis: Management. In: UpToDate, Corren J, Deschler DG, Feldweg AM (Eds), UpToDate, Waltham, MA. (Accessed on February 11, 2019).
17. Brook I. Microbiology and antibiotic management of chronic rhinosinusitis. In: UpToDate, Calderwood SB, Corren J, Bloom A (Eds), UpToDate, Waltham, MA. (Accessed on February 11, 2019.)
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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