Appeal type: Medical Necessity
Decision: Overturned

The patient is a 57-year-old female who has requested authorization and coverage for nebulized ciprofloxacin antibiotic therapy. She has a history of acute and chronic sinusitis. She underwent sinus surgery in 1996, and more recently underwent revision sinus surgery in 2001. Despite the revision surgery, the patient continues to have recurrent sinusitis that has required prolonged oral antibiotic therapy guided by repetitive sinus cultures. The patients provider believes further sinus surgery would not be beneficial to the patient. She has developed multiple allergies and adverse reactions to these oral antibiotic including muscle aches and pain with ciprofloxacin, perioral swelling and erythema with Levaquin, rash with Sulfa, Penicillin and Sporonax, fevers and flu-like symptoms with Aztreonam. The patient also has hearing loss documented, so intravenous aminoglycoside use is of concern with known risk of hearing impairment despite close dosing monitoring.Repetitive sinus cultures are positive for heavy mucoid Pseudomonas Aeruginosa. The patients provider has recommended nebulized ciprofloxacin due to the above noted antibiotic concerns and also because it is less invasive and poses a lower risk to the patient than IV antibiotic therapy. The patient previously attempted ciprofloxacin in nebulized form with reported clearing of infection and without any adverse reaction.The Health Plan has denied authorization and coverage for nebulized ciprofloxacin on the basis it is not medically necessary for treatment of the patients condition.This patient falls into the category of patients with persistent chronic sinusitis despite functional endoscopic sinus surgery and revision sinus surgery. She has surgically patent antrosomies, but continues to have symptomatic purulent drainage and infections that are well documented by multiple sinus cultures. This is a rather difficult group of patients to treat. She fails to respond to conventional medical therapy and has developed significant reactions to most of the oral antibiotics that are culture appropriate for this particular patients infections.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 antibiotic 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 most recently nebulized culture directed antibiotic therapy (usually for 3-4 weeks). There are no multi-center randomized peer reviewed studies that systemically support which of these next steps is most effective. There have been no long-term outcome studies comparing the treatments.This patient has already undergone revision sinus surgery and no further surgery revision is felt to be of any benefit. The risks of prolonged IV antibiotic therapy with indwelling catheter are well known, and this patient has had multiple adverse reactions even to oral forms of antibiotics that can treat her infection. Reactions to IV antibiotics are often much more pronounced. To date, all the data regarding risks of topical nebulized antibiotic therapy have been minor and transient with no discontinued treatment due to side effects. Data that is currently available in the relevant literature on nebulized antibiotic therapy demonstrate both good safety and efficacy. There is support in the Otolaryngological community for nebulized antibiotics for the few patients who have failed other therapies and are approaching a course of IV antibiotics or revision sinus surgery. Based upon the information set forth above, I have determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.