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

The patient is a 50-year-old male with a history of chronic sinusitis. He had maxillary advancement surgery in 1982. There is a questioned history of Caldwell-Luc sinus surgery in 1990. In 1992, the patient underwent right-sided functional endoscopic sinus surgery. In 2000, he continued with chronic sinusitis symptoms. Medical therapy has included allergy shots, multiple nasal steroid sprays, Atrovent, Astelin, Singulair, multiple oral antihistamines, oral steroids, Kenalog injections, in addition to multiple antibiotics. The patient subsequently underwent revisional functional endoscopic sinus surgery, septoplasty, and turbinate reduction surgery. Despite multiple surgical interventions and aggressive medical therapy he still continues to experience episodes of sinusitis. He was treated with a course of Rocephin in 2002. In 2003, he was treated with nebulized betamethasone and ciprofloxacin. The patient reported good response to this therapy.In January 2005, the patient saw his primary care physician complaining of severe sinusitis. He was treated with oral Ketek since he had responded to oral quinolones in the past. Because the patients symptoms did not improve, his physician prescribed another quinolone antibiotic that could be administered via nebulizer. His physician based this decision on the basis that topical therapy may work better due to poor sinus cavity blood flow, and as well as the fact that similar therapy with nebulized ciprofloxacin in 2003 provided excellent response. In addition, nebulized betamethasone was prescribed to reduce underlying sinus inflammation. The patients provider notes that the patient has been tried on almost all commercially available nasal steroids with poor results. The patients allergist had prescribed nebulized betamethasone in the past with very good response.The patient had also been treated with nebulized amphotericin twice in the past, reportedly with excellent results. The rationale for the treatment was concern that persistent sinusitis may be fungal in nature though they were not successful in culturing any fungus.The patient has requested reimbursement for the nebulized betamethasone, amphotericin B, and Levaquin prescriptions. The Health Plan has denied this request indicating that there is insufficient evidence to conclude that the administration of nebulized antibiotics and antifungals is clinically superior to alternative management of the diseased process. The Health Plan also notes that corticosteroid inhalation has several formulary alternatives.This particular patient falls within the category of patients with persistent chronic sinusitis despite functional endoscopic sinus surgery. He has surgically patent sinus antrostomies having undergone three prior sinus surgeries, but continues to have symptomatic chronic sinusitis. This is a rather difficult group of patients to treat. The patient has failed to respond to conventional medical therapy including saline rinses, intranasal steroids, oral steroids, oral medications, intranasal antihistamines, multiple courses of broad-spectrum antibiotics, and allergy immunotherapy.Most otolaryngology literature treatment algorithms would recommend the following options be considered: revision sinus surgery if appropriate based on the patients exam and CT findings, culture directed prolonged oral antibiotics therapy (usually 4-6 weeks), IV antibiotic therapy (usually 6 weeks), some form of topical antibiotic therapy instilled in to the sinus endoscopically by the physician at regular intervals (usually weekly or biweekly for 1-2 months), or nebulized culture directed antibiotic therapy (usually 3-4 weeks). There are no multicenter, randomized, peer-reviewed studies that systematically demonstrate which of these 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 IV antibiotic therapy with indwelling catheter. The data regarding the risks of topical nebulized antibiotic therapy indicate the risks have been minor and transient with no discontinuation of treatment due to side effects. Results that are currently available in the otologaryngology literature regarding nebulized antibiotic therapy demonstrate both good safety and efficacy. Current expert opinion recommends nebulized antibiotics for the few patients who have failed other therapies and are approaching a course of IV antibiotics or revision sinus surgery.There has also been growing literature support for use of intranasal antifungal treatment, (amphotericin B) for patients with chronic sinusitis. Early pilot studies including a recent randomized, placebo-controlled, double-blind pilot study have demonstrated both safety and efficacy in treating patients with chronic rhinosinusitis refractory to other medical treatment.In light of the available scientific data and the patients clinical history, the nebulized medications at issue were medically reasonable for treatment of the patients condition and more appropriate than other available treatment modalities. Revision sinus surgery is not indicated for this patient. Additionally, the risks of prolonged IV antibiotics are far greater than any risks documented for nebulized culture directed antibiotic therapy. In addition, the patient had demonstrated good response to nebulized antibiotics, steroids and antifungals in the past. As such, I have determined the medications at issue were medically necessary for treatment of the patients medical condition. The Health Plans denial should be overturned.