Indications for Serotypes A and B Botulinum Toxins

According to Novitas LCD L27476, the following indications apply:

1. Blepharospasm and strabismus

2. Spastic dystonia or focal dystonias to relieve pain, to assist posturing and walking, to increase range of motion, to assist in the outcome of physical therapy, and/or to reduce spasm thus allowing adequate perineal hygiene.

3. Spasmodic dysphonia

4. Achalasia and cardiospasm when at least one of the following conditions is met:

• Patient has failed conventional therapy or has a contraindication to such therapy
• Patient is at high risk of complications from pneumatic dilation or surgical myotomy
• Prior myotomy or dilation has failed
• Prior dilation-induced esophageal perforation
• Patient has an epiphrenic diverticulum or hiatal hernia

5. Severe primary focal hyperhidrosis in patients who are not adequately managed with topical agents or ionotophoresis (or have a contraindication to such treatment), and who manifest all of the following indications:

• Severe sweating beyond physiological needs
• Focal, visible, severe sweating of at least 6 months duration without apparent cause with at least 2 of the following characteristics:
  
  – Bilateral and relatively symmetric
  – Significant impairment in daily activities
  – Age of onset less than 25 years
  – Positive family history
  – Cessation of focal sweating during sleep

6. Disability from sialorrhea due to conditions such as motor neuron disease or Parkinson’s disease in those patients who have failed to respond to a reasonable trial of traditional therapies (i.e., anticholinergics, speech therapy, surgical therapy), or who have a contraindication to traditional therapy.

7. OnabotulinumtoxinA, serotype A botulinum toxin, can be used to treat urinary incontinence due to neurogenic bladder or bladder over-activity. This treatment will be considered reasonable and necessary if used only after documented failure of medical therapy.

8. OnabotulinumtoxinA, serotype A botulinum toxin is considered reasonable and necessary for prophlaxis/treatment of headaches in adult patients with chronic intractable migraine more than 15 days/month, with headache lasting 4 hours a day or longer.

The determination regarding whether serotypes A or B botulinum toxin is the most appropriate course of treatment should be based on the physician’s judgment, clinical experience, and the patient’s individual history. If the clinical use of the drug is not an FDA approved use for the specific botulinum toxin product, peer-reviewed medical literature supporting that use should be kept on file and the claim should be submitted with a KX modifier. The KX modifier should not be used for diagnoses that are specifically noted as not reasonable and necessary in this drug policy. See the article: “Approved Drugs and Biologicals; Includes Cancer Chemotherapeutic Agents” (A47797) for further details.

Electrical Stimulation for chemodenervation or electromyography procedure(s) may be medically necessary when the proper injection site(s) are difficult to determine.

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