Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1The patient is a 22-year-old male diagnosed with cystic fibrosis in January 1985. Since then, he has had multiple hospitalizations and has been treated for ABPA, pulmonary hemorrhage, pancreatic insufficiency and bronchiectasis. The submitted notes indicate the patients FEV1 was 50% in August 2003. The patient was hospitalized in September 2003 because of decreasing pulmonary functions. After hospitalization, his FEV1 improved to 66%. During hospitalization, the patient was given treatments with an IPV device, which appeared to improve the amount of expectorated sputum.Upon discharge, subsequent pulmonary function tests showed incremental decrease in the patients lung functions. Recently, the patients FEV1 was 58%. According to the patients provider, the patient lives alone and works full-time. The patient has requested an intrapulmonary percussive ventilation (IPV) device in order to be able to clear his secretions by himself. The patient indicates that he has been unable to find a physical therapist willing to perform daily chest physiotherapy (CPT). Review of the outpatient progress notes reveal that the patient has utilized various regimens for secretion clearance including the Vest Airway Clearance System, flutter device, rhDNase and inhaled bronchodilators.The clearance of secretions is a necessary and vital component in the management of cystic fibrosis. Various methods have been used in facilitating mucociliary clearance by both affecting the consistency of the secretions (via mucolytics) or by enhancing its transfer through physical means. Chest physiotherapy, postural drainage, nebulizer treatments, airway oscillation devices (such as a flutter device or IPV machine) and external chest wall vibrators (the Vest Airway Clearance System) have all shown to improve mucociliary clearance. Randomized controlled studies making head-to-head comparisons have been few. The patient has been using various methods of secretion clearance including the Vest System, flutter device, rhDNase and nebulizer therapy. The patient works full-time and lives alone so chest physiotherapy is not possible. The circumstances of adult patients with cystic fibrosis differ greatly from children with cystic fibrosis. The use of an IPV device in the treatment of secretion clearance is well established in its efficacy for secretion clearance. Therefore, I have determined that the requested equipment is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 2The patient is a 22-year-old male with cystic fibrosis who is independent and working full-time. The need to help expectorate secretions is noted. Use of the flutter device has not been effective. In addition, all appropriate medications have been utilized. The patient has requested authorization for an intrapulmonary percussive ventilation (IPV) device. The Health Plan has denied the patients request.The patient has attempted several methods of secretion clearance. Use of the flutter device has not been effective and PD-P is not feasible in this case. It has been noted that the patient has tried the Vest Airway Clearance System (the Vest) without success. However, the submitted clinical records do not provide documented evidence of trial and failure of the Vest. Therefore, documented evidence of the use of the Vest should be obtained. If trial of the Vest proves ineffective, then the patients request for the IPV device should be reconsidered. Based upon the information set forth above, I have determined that the requested equipment is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld at this time.Physician 3The patient is a 22-year-old male who has requested authorization and coverage for an intrapulmonary percussive ventilation (IPV) device. The Health Plan has denied this request indicating the requested equipment is considered investigational for treatment of the patients cystic fibrosis.Review of the medical documentation indicates the patient is under the care of a pulmonologist and his most recent pulmonary lung function studies have demonstrated a FEV1 in the 50% range. He has previously tried the Vest Airway Clearance System and a flutter device for mucus clearance without significant success. Documentation indicates he cannot perform standard chest physiotherapy (CPT) on himself. Mucus clearance is an essential part of a daily program for a patient with cystic fibrosis. The IPV device has proven to be the most effective and efficient way to obtain consistent mucus clearance for patients such as this patient. He is able to mobilize a copious amount of mucus with this device and can take his inhaled antibiotic and bronchodilator while using the device to clear mucus. The documentation from the patients pulmonologist indicates the IPV has provided the best results to date. Therefore, I have determined that the requested equipment is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.