Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Numbness and leg weakness. 
Treatment: J1459 Privigen 59 gm (grams) infused over 2-5 days monthly for one year = 120 units per dose for a total of 1416 units. 
The insurer denied coverage for J1459 Privigen 59 gm infused over 2-5 days monthly for one year = 120 units per dose for a total of 1416 units. 
The denial is overturned. 

The patient was seen for numbness and legs weakness. The patient reported significant improvement since starting intravenous immunoglobulin (IVIG). There was mild distal weakness in the legs and diminished to absent reflexes. Assessment noted chronic inflammatory demyelinating polyneuropathy (CIDP). The plan was to continue with IVIG. 

Over one year prior to presentation, the patient complained of numbness and tingling and unsteadiness. Exam showed absent reflexes in the legs, and the plan was to initiate a workup including Electromyography (EMG). Electromyography (EMG) was suggestive of demyelinating neuropathy. The exam showed absent reflexes in the lower extremities. The plan was to start intravenous immunoglobulin (IVIG) for the treatment of possibility of Guillain-Barre syndrome. 

A few months later, EMG of lower extremities was interpreted to be showing demyelinating peripheral neuropathy with secondary axonal features. 

A few months prior to presentation, EMG was interpreted to be consistent with demyelinating motor peripheral neuropathy. 

Per Drug and Biologic Coverage Policy 5026 Immune Globulin, Privigen (immune globulin) is considered medically necessary for chronic inflammatory demyelinating polyneuropathy (CIDP), including Multifocal Acquired Demyelinating Sensory and Motor Neuropathy (MADSAM) (Lewis-Sumner Syndrome) when these criteria are met: 
- progressive or relapsing motor and/or sensory symptoms of more than one limb and hyporeflexia and areflexia (slow reflexes) in affected limbs present and objectively measured for at least 2 months. 
- electrophysiologic (nerve test) results show demyelinating neuropathy (3 of the 4 criteria are met per the American Academy of Neurology): 
- partial conduction block of 1 or more motor nerve. 
- reduced conduction velocity of 2 or more motor nerves. 
- prolonged distal latency of 2 or more motor nerves. 
- prolonged F-wave latencies of 2 or more motor nerves or the absence of F waves. 
- other causes of demyelinating neuropathy have been excluded (from the European Federation of Neurological Societies and the Peripheral Nerve Society). 
- Magnetic Resonance Imaging (MRI) showing gadolinium enhancement and/or hypertrophy (enlargement) of the cauda equina (nerves at the bottom of the spine), lower back or neck nerve roots, or the brachial or lumbosacral plexuses (neck or lower spine nerves). 

Medical records support the diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP). 

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for proposed medication Healthcare Common Procedure Coding System (HCPCS) code J1459 Privigen 59 gm infused over 2-5 days monthly for one year = 120 units per dose for a total of 1416 units is substantiated.