Botulinum Toxin Injection denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the cystoscopy chemodenervation with botulinum toxin. Findings: Two physician reviewers found that the procedure at issue was likely to be more beneficial for treatment of the patient’s medical condition than any available standard therapy. Patients with neurogenic bladder can have significant detrusor overactivity leading to urinary incontinence. Anticholinergic medications are first-line therapy, and patients’ refractory to medications can be managed by minimally invasive therapies such as Botox injection and sacral neuromodulation. Botox injections have been shown to improve compliance and reduce detrusor overactivity in patients with neurogenic bladder refractory to medical therapy, such as in this case.

Nature of Statutory Criteria/Case Summary: An enrollee has requested botulinum toxin (Botox) injections for treatment of her medical condition. Three physician reviewers found that based on the documentation submitted for review, the patient has had significant headache freedom from previous Botox injections. After her initial worsening, Botox was effective in treating the patient’s chronic headache disorder. There is a typical latency prior to the establishment of efficacy when Botox is used under these circumstances. Furthermore, there is data supporting efficacy of Botox used for chronic daily headache in the peer-reviewed literature cited above. In this case, botulinum toxin (Botox) injections are likely to be more beneficial for treatment of the patient’s medical condition than any available standard therapy.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for botox injections.Findings: Two out of three physician reviewers found that the requested botox injections are not likely to be more beneficial than any other available standard treatments for the patient’s medical condition.There is not sufficient support for the requested services in this clinical setting. Botulinum toxin injection (botox) is not approved by the U.S. Food & Drug Administration (FDA) for the treatment of gastroparesis. At this time, there is not sufficient scientific evidence to support the safety and efficacy of botox injection for the treatment of gastroparesis in children.

The patient is a 58-year-old man with a three-year history of post-traumatic right head pain. He responded partially to occipital nerve blocks for two weeks, but developed tenderness at the site of injection. He had two weeks of pain relief after a right C2-3 nerve block and partial response to indomethacin. Lyrica was initially helpful at a dose of 50mg. The dose was subsequently increased, but the patient’s response is not documented. He is now seeking authorization and coverage for botulinum toxin injections. The Health Plan has denied his request on the basis that the requested injections are not medically necessaryThe patient has post-traumatic pain syndrome involving the right side of the head. He did respond to a C2-3 block, occipital nerve block and Lyrica, to some degree. The records indicate the patient’s pain is usually mild and not disabling.

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 Botulinum Toxin Injection, then check the rights and deadlines that apply to your plan.