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

Nature of Statutory Criteria/Case Summary: The patient has been diagnosed with C5-7 complete quadriplegia. The provider noted the patient was injured in a vehicle versus pedestrian accident. The patient reported decreased trunk control and functional mobility in her manual wheelchair. The patient was using a manual wheelchair with power assist. An addendum report stated that the power add-on system is needed to assist the patient to independently navigate her environment. The provider reported that the patient cannot independently propel the manual wheelchair through her home or the community. The patient has requested authorization and coverage for power assist wheels and a lithium ion battery pack for her approved wheelchair. The Health Plan denied the requests and reported the requested equipment is not medically necessary for the treatment of this patient. At issue in this case is whether power assist wheels and a lithium ion battery pack for her approved wheelchair is medically necessary for the treatment of the patients medical condition. According to the ZX-1 website, the ZX-1 power add-on device received U.S. Food and Drug Administration (FDA) clearance as a class II medical device. The ZX-1 power add- on device comes standard with two 12 Volt Lead Gel Mat Batteries that provide for a minimum range of five miles based upon an occupant weight of 250 pounds. A lithium ion battery powered option extends the range to over 10 miles and reduces the weight of the device down to 75 pounds. The device has the ability to operate on a variety of surfaces, including gravel, rocky terrain, and thick grass. Van Norman noted U.S. FDA Class I or II device approvals are focused on registration, manufacturing, and labeling and often do not require extensive pre-clinical or clinical data. The author also noted, Around three-fourths of class I devices, and a small percentage of class II devices qualify for exempt status, meaning there is no need for proof of safety or efficacy, nor for clinical trials. In this case, the record does not show that the patient has had a sufficient trial with the requested power assist wheels in the community or at home to indicate that she can use this device safely. The documentation does not support that this patient requires the range of her wheelchair to be 10 miles. The documentation does not reveal that the patient requires this device for gravel, rocky terrain, or thick grass. The medical evidence does not support the requested equipment in this clinical setting. Therefore, power assist wheels and a lithium ion battery pack for her approved wheelchair is not medically necessary for the treatment of this patient. Final Result: The reviewer determined that the requested equipment is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in physical medicine and rehabilitation with sub-specialty certification in neuromuscular medicine and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.