Cervical Dystonia denials in California external review

What the reviewers wrote

Where the denial was overturned

Physician 1The patient is a 56-year-old male with severe depression, chronic daily headaches, and reported blepharospasm and cervical dystonia. The patient has been treated with Botox 100mg three times in the past with excellent results. He has been unresponsive to triptans and has used several anti-migraine preventatives in the past, which have not been successful in controlling his headaches.Review of the submitted records indicates the patient has been diagnosed with cervical dystonia and blepharospasm by his attending physician. The patient sought a second opinion from a neurologist who concurred with the use of Botox in this patient, specifically for chronic headache. Botox has been approved by the Food and Drug Administration as standard medical therapy for treatment of the patient’s medical condition.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Botox 400 IU to be injected every 10 weeks (HCPCS J0585). Cervical dystonia is a movement disorder clinically characterized by involuntary contractions of cervical muscles, which cause abnormal head movements and postures, often associated with head tremor and chronic pain (Evidente and Pappert). Per the American Academy of Neurology (AAN) practice guidelines and U.S. Food and Drug Administration (FDA), Botox is accepted as first-line treatment for cervical dystonia (Simpson, et al.). The peak effect of Botox typically occurs between two to six weeks after the injections, and the effects begin to wear off after 10-12 weeks (Camargo, et al.).

Where the denial was upheld

An enrollee has requested authorization and coverage for Botox injections at a dosage of 600 units every 12 weeks. Cervical dystonia (CD) is a movement disorder that is clinically characterized by involuntary contractions of cervical muscles which cause abnormal head movements and postures. The Highlights of Prescribing Information for Botox recommend a total dose not to exceed 360 units administered every 12–16 weeks, or at longer intervals, with dosing tailored to the individual patient based on head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse effects history. This recommendation is based primarily on the protocol of a pivotal, randomized, double-blind, placebo-controlled phase 3 clinical trial. In this case, the patient has cervical dystonia with torticollis and laterocollis.

SummaryThe patient is a 34-year-old woman with chronic headache associated with neck muscle pain and spasm. She is requesting authorization for Botox therapy. The Health Plan has denied authorization for Botox indicating it is not medically necessary. The physician reviewer concluded that the Health Plan denial should be upheld. Analysis and FindingsClinical Facts: The patient has chronic headache associated with neck muscle pain and spasm. She is requesting authorization for Botox therapy. The patient has consistently refused usual migraine preventive therapy. MRIs of the brain and neck were unremarkable. An EMG reported cervical muscle spasm “consistent with dystonia.” Reviewer’s Findings:The reviewer found that although Botox is beneficial for some patients with intractable migraines, it is not appropriate as a first or second line therapy for this condition.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving cervical dystonia, then check the rights and deadlines that apply to your plan.