Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Myopathy
Treatment: L2999 lower extremity orthoses, right ottobock C-brace
The insurer denied coverage for L2999 lower extremity orthoses, right ottobock C-brace
The denial is overturned

This case involves an adult who was prescribed a custom fabricated knee ankle-foot orthosis (KAFO) due to a condition which adversely affects his extremities. The patient's right lower extremity was described as the most really affected with weakness of the quadriceps, motor paralysis, foot drop, knee instability. The requesting physician stated the patient requires an orthosis that will control him in the sagittal, frontal, and transverse planes and the only orthotic device currently available to meet the needs of the patient is the C-brace with microprocessor control.  

Scientific evidence in peer-reviewed literature supports a result of improvement in health outcomes.

The L2999 lower extremity orthoses, right Ottobock C-brace already has final approval from the Food and Drug Administration (FDA).

This patient is a good candidate for the L2999 lower extremity orthoses, right Ottobock C-Brace.

The L2999 lower extremity orthoses, right Ottobock C-brace is one of the best available treatments for this patient at this time.

The adverse risks are not increased over standard treatment/services.

Current medical literature has noted that the C-Brace is a microprocessor-controlled Stance and Swing Controlled Orthosis (SSCO) developed to overcome the limitations of KAFOs that do not offer stumble recovery and damped knee flexion during weight-bearing or dynamic swing control. Literature has noted that the Ottobock's C-Brace was launched in the United States in 2014 and in 2015 it was placed on sale in Britain. The robotic support, designed to wrap around lower leg, has been developed to help people with disabilities and improve the way they walk or play sports, it is the first exoskeletal brace marketed for leisure activities such as walking, cycling, and even rollerblading. The brace reduces strain in the joint, enabling people with minor movement disabilities, such as those experienced after a stroke, to employ full range of actions by generating the powered needed for movement. While the patient previously received a notice of adverse determination claiming that the device was considered experimental or investigational under the patient's health plan, evidence has shown that the Ottobock C-brace has received approval by the FDA and has been found to improve the walking abilities for individuals who have lower limb mobility issues due to partial paralysis, incomplete spinal cord injury, post-polio syndrome, quadriceps weakness, and post-stroke. The evidence offered in current peer-reviewed medical literature supports a result of improvement in health outcomes as these devices help to prevent falls and can help each individual regain mobility and overall functionality. Based upon the provided information, the current request is supported. As such, the request for L2999 lower extremity orthoses, right Ottobock C-brace is medically necessary.

In summary, the denial of L2999 lower extremity orthoses, right ottobock C-brace and coverage for the requested treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.