Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

The patient has requested authorization and coverage for nebulized antibiotics. She has a history of acute chronic sinusitis. In October 2002, the patient was found to have left nasal polyps and mucopus on exam. She was treated medically with several courses of antibiotics, including broad-spectrum antibiotics (Avelox and Levaquin), nasal steroid spray, and saline irrigation. A CT sinus scan in December 2002 demonstrated mild chronic changes in all of the paranasal sinuses, most marked in the left maxillary sinus. Turbinate hypertrophy was noted as well. Septal deviation was reported upon examination.In December 2002, the patient underwent septoplasty, left endoscopic maxillary antrostomy, and bilateral inferior turbinate radiofrequency reduction. The pathology report confirmed chronic inflammatory infiltrate. No further infections were documented until December 2003. During that interval the patient underwent allergy evaluation with skin test positive to grass and negative inhalant RAST. Medical therapy included Clarinex, Flonase, and Astelin. Since December 2003, the patient continues with recurrent sinusitis. Nebulized antibiotic therapy with ceftazidime was recommended by the patients provider who noted that the patient failed Augmentin, Avelox, and Tequin in addition to allergy medications, Clarinex and Flonase.The patient does not wish to have any further sinus surgery since symptoms improved only for a short period of time with her prior surgery. The patient reports dramatic symptom improvement with nebulized ceftazidime and has requested authorization for continuation of the therapy. The Health Plan has denied authorization and coverage for the requested therapy indicating that there is a lack of peer-reviewed literature demonstrating that nebulized ceftazidime is superior to oral or intravenous antibiotics. This particular patient falls within the category of patients with persistent chronic sinusitis despite functional endoscopic sinus surgery. She has a surgically patent maxillary antrostomy but continues to have symptomatic purulent drainage and mucopus. This is a rather difficult group of patients to treat. The patient has failed to respond to medical therapy including saline rinses, intranasal steroids, antihistamines, and multiple courses of broad-spectrum antibiotics. An allergy evaluation has not been helpful.Most otolaryngology literature treatment algorithms recommend consideration of the following options: revision sinus surgery if appropriate based on patients exam and CT findings; culture directed prolonged oral antibiotic therapy (four to six weeks); intravenous antibiotic therapy (usually six weeks); some form of topical antibiotic therapy instilled in to the sinus endoscopically by the physician at regular intervals (usually weekly or biweekly for one to two months); or most recently nebulized culture directed antibiotic therapy (usually for three to four weeks). There are no multicenter, randomized, peer-reviewed studies that systemically support which of these treatment options is most effective. There have been no long-term outcome studies comparing each treatment. There is information regarding revision sinus surgery perioperative risks as well as risks of prolonged intravenous antibiotic therapy with indwelling catheter. As yet, all the data regarding risks of topical nebulized antibiotic therapy have been minor and transient with no discontinuation of treatment due to side effects. Treatment risks of revision sinus surgery or prolonged intravenous antibiotics are far greater than any risks documented for nebulized culture directed antibiotic therapy. Furthermore, the data that is currently available in the otolaryngology literature on nebulized antibiotic therapy demonstrates good safety and efficacy. Current expert opinion recommends nebulized antibiotics for the few patients such as this patient who have failed other therapies and are approaching a course of intravenous antibiotics or revision sinus surgery. Based upon the information set forth above, I have determined that the requested therapy is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Prior to authorization of the requested therapy, there should be documented evidence of sinus culture and sensitivity to the selected antibiotic in order to comply with culture directed nebulized antibiotic therapy.