Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Garre's Osteomylitis. 
Treatment: Humira 40mg. 

The insurer denied the Humira 40mg. 
The denial is overturned. 

This patient is a female with history of Garre's osteomyelitis. The patient had fractured a tooth 4 years prior and had a dental implant. Then she noticed swelling on the left side of the jaw and the crown fell out. She had positive cultures from the site that grew actinomyces, and the patient was started on moxifloxacin followed by clindamycin. She continued to have jaw swelling and pain and underwent hyperbaric oxygen therapy. This was followed by 6 weeks of IV (intravenous) antibiotics. 

Yes, the requested Humira is medically necessary. 

Garre's osteomyelitis is an autoimmune inflammatory disorder. It is clinically similar to chronic recurrent osteomyelitis (CRMO) seen in children. Garre's osteomyelitis is a local thickening of the periosteum caused by a slight irritation or infection. The initial presentation is similar to that of osteomyelitis. Presenting symptoms may include bone pain, localized swelling and fever. The optimal treatment for Garre's osteomyelitis is not known. Treatment with glucocorticoids and NSAIDs (nonsteroidal anti-inflammatory drugs) may provide transient relief of symptoms but recurrences are common. Successful treatment also has been described with sulfasalazine (Azulfidine), methotrexate, gamma interferon and tumor necrosis factor (TNF) inhibitors as well as bisphosphonates. Aggressive treatment in Garre's osteomyelitis improves clinical and imaging measures of disease activity and prevents progression of skeletal damage. Although there are not societal guidelines published on how to treat Garre's osteomyelitis, experts do suggest use of TNF (Tumor Necrosis Factor) inhibitors in those with refractory disease and data supports their effectiveness. The patient was started on Humira in the middle of this year and has had good clinical improvement. Therefore, the proposed treatment is medically necessary in order to continue care. 

No, the health plan did not act reasonably with sound medical judgment and in the best interest of the patient. 

The best interest of the patient is to continue on current medication in which the patient has seen good clinical improvement. 

The patient was seen at another facility and had extensive imaging and a bone biopsy. The biopsy did not show microorganisms and showed little inflammation. She was given the diagnosis of Garre's osteomyelitis. She was started on biologic disease modifying anti-rheumatic drug (DMARD) Humira 40mg (milligrams) every 2 weeks and has had significant improvement since starting Humira. 

Coverage for Humira was initially denied due to the patient not having a diagnosis of rheumatoid arthritis, Crohn's disease, plaque psoriasis, ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis, polyarticular juvenile idiopathic arthritis, oligoarticular juvenile idiopathic arthritis, hidradenitis suppurativa, or Behcet's disease, pyoderma gangrenosum or uveitis. The reason the provider is appealing the determination is because the patient has been on Humira since the middle of this year with good clinical results.