Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Raynaud's phenomenon
Treatment is Botox injections
The insurer denied coverage for Botox injections
The denial is overturned

This is the case of an adult female with a history of Raynaud's disease, right index finger ulceration, and scleroderma. She presented to her PCP's (primary care physician) office for a recurring right index finger infection that was bothering her and not getting better with home treatment. She was prescribed topical Kenalog cream and an oral antibiotic for 7 days, Keflex. She was referred to a plastic surgeon and he injected Botox into the right finger. At her follow up visit the patient reported progressive healing of the ulcer, no symptoms of finger pain, and that she believed her index finger was less swollen. He recommended Botox injections every 8 to 10 weeks.

A study of 33 patients with Raynaud's phenomenon by Neumeister found that "Botulinum toxin appears to improve perfusion of the hand after direct injection around the neurovascular bundles." In another study, Neumeister and colleagues found that, "Vascular function is abnormal in patients with Raynaud's phenomenon. Although its mechanism is unknown, Botox yielded a distinct improvement in perfusion and reduction in pain in patients failing conservative management."  A 2009 study from Henry Ford Hospital found that "Botulinum toxin type A significantly improves pain and improves healing in Raynaud's patients with few complications. BTX-A (botulinum toxin type A) was found to be a safe and useful treatment option for vasospastic digital ischemia." Finally, a study by van Beek and colleagues in 2007 concluded that "Hand injection of botulinum toxin A appears to be an effective treatment for intractable digital ulcerations and rest pain in patients with severe vasospastic disorders. Because of the complexity of surgical digital artery sympathectomy along with its associated high risk of persistent symptoms, the authors conclude that the therapeutic use of botulinum toxin A injections represents an attractive alternative therapy."  A 2015 review by Neumeister concluded: "Raynaud phenomenon may be a primary disorder or associated with a variety of other autoimmune processes. Raynaud phenomenon produces digital vasospasm, which can lead to ischemia and ulceration. The treatment of Raynaud phenomenon has been difficult because multiple medical treatments have not provided uniform resolution of symptoms. Many patients have turned to surgery and sympathectomies for the treatment of unrelenting vasospasm. Botulinum toxin has been shown to be an effective alternative to surgery, with a single treatment being capable of resolving pain and healing ulcer."  A 2019 study concluded: "Btx-A injected via a dorsal approach improves symptoms and reduces the number of Raynaud's phenomenon (RP). We have shown an effective non-surgical approach technique to treat RP."  A 2016 meta-analysis of published data concluded: "Botulinum neurotoxin-A injection proved to be a valid approach in both primary and secondary RP. The available evidence shows the achievement of both symptomatic and functional improvements in this debilitating condition."  Multiple peer reviewed studies indicate that Botox is an appropriate treatment for this patient's vasospastic finger pain and ulcerations.

The health plan did not act reasonably. The treatment is medically necessary.

The insurer's denial of coverage for Botox injections is overturned. Medical Necessity is substantiated.