Botulinum Toxin (BT)
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This policy governs medical necessity and coverage criteria for use of botulinum toxin products (various FDA-approved formulations) for neurologic, urologic, gastroenterologic, and other indications, and identifies indications considered experimental/investigational or noncovered. It applies to Blue Cross and Blue Shield of Kansas members and providers billing BCBSKS.
No material clinical or coverage changes in this revision.
Medical Necessity and Coverage Criteria
Chronic migraine (policy guideline reference)
Covered when ALL of the following are met:
ALL of the following
- Initial 6-month trial: adult patient meets International Classification of Headache Disorders (ICHD) diagnostic criteria for chronic migraine headache (see Policy Guidelines).
- Adequate trials of at least 2 agents from different classes of medications used for chronic migraine prophylaxis (e.g., antidepressants, antihypertensives, antiepileptics) have failed to provide adequate symptom control, or the patient has contraindications to preventive medications (patients with contraindications are not required to undergo these trials).
Continuing treatment beyond 6 months — clinical response required
- Migraine headache frequency reduced by at least 7 days per month compared with pretreatment level.
- OR migraine headache duration reduced by at least 100 hours per month compared with pretreatment level.
Codes and Numeric Thresholds
| onabotulinumtoxinA | Botox (drug product referenced) |
| abobotulinumtoxinA | Dysport (drug product referenced) |
| incobotulinumtoxinA | Xeomin (drug product referenced) |
| rimabotulinumtoxinB | Myobloc (drug product referenced) |
| daxibotulinumtoxinA | Daxxify (drug product referenced) |
| 31513 | Laryngoscopy, indirect; with vocal cord injection. |
| 31570 | Laryngoscopy, direct, with injection into vocal cord(s), therapeutic; |
| 31571 | Laryngoscopy, direct, with injection into vocal cord(s), therapeutic; with operating microscope or telescope. |
| 43201 | Esophagoscopy, flexible, transoral; with directed submucosal injection(s), any substance. |
| 43236 | Esophagogastroduodenoscopy, flexible, transoral; with directed submucosal injection(s), any substance. |
| 46505 | Chemodenervation of internal anal sphincter. |
| 52287 | Cystourethroscopy, with injection(s) for chemodenervation of the bladder. |
| 64611 | Chemodenervation of parotid and submandibular salivary glands, bilateral. |
| 64612 | Chemodenervation of muscle(s); muscle(s) innervated by facial nerve, unilateral (e.g., for blepharospasm, hemifacial spasm). |
| 64615 | Chemodenervation of muscles(s); muscles(s) innervated by facial, trigeminal, cervical spinal and accessory nerves, bilateral (e.g., for chronic migraine). |
Prior Authorization, Documentation, and Step Therapy Expectations
No explicit authorization requirements or new rules in references
No explicit prior authorization requirements are stated in the references portion of this document; the references area is informational and does not impose new authorization rules.
- Inclusion or exclusion of codes in the coding section does not by itself guarantee member coverage or provider reimbursement — check the member's contract benefits at time of service.
- Coding listed is medically necessary ONLY if the procedure is performed according to the 'Policy' section of this document.
Follow-up data and outcome monitoring
Follow-up and outcome data used in evidence and guidance generally span 6 months to 1 year depending on indication; clinical follow-up to document treatment response and adverse effects is expected.
- Anal fissure and many procedural indications: follow-up ranges from 6 months to 1 year.
- Some indications (e.g., selected gastrointestinal procedures) include studies with follow-up up to 5 years.
Coding — condition linkage and medical necessity
Codes, procedures, and listed services are linked to clinical policy criteria — coding is informational and is medically necessary only when the underlying service meets the Policy section criteria.
- Providers must document that the procedure was performed per the Policy criteria to support medical necessity for billing.
- Inclusion of a code in the Coding section does not imply coverage without meeting eligibility and medical necessity criteria.
References are bibliographic / informational only
The references section is bibliographic and internal in nature; it summarizes studies, guideline citations, committee meetings, and other source material and does not establish additional provider-facing authorization requirements.
- Use references for clinical context and evidence support only; they are not standalone authorization rules.
- Operational authorization or coverage determinations must be made based on the Policy section and member contract.
No step therapy requirements specified in references
No step therapy requirements are specified in the references portion of the document. Where step therapy or prior-treatment trials are required, those requirements are specified in the Policy section (for example, chronic migraine and some urinary indications require trials of prior therapies).
- If step therapy applies for an indication, the Policy section details required prior medication or therapy trials (e.g., ≥2 preventive medication classes for chronic migraine; failure/intolerance of first- and second-line OAB therapies prior to intradetrusor botulinum toxin).
- References alone do not add step therapy obligations beyond what is stated in Policy.
Clinical Background and Context
Botulinum toxins (types A and B) are neurotoxins that reduce muscle overactivity by inhibiting presynaptic release of acetylcholine at the neuromuscular junction. Multiple FDA‑approved formulations (including products derived from types A and B) are used clinically for focal hyperactivity disorders and for selected non‑muscular indications; the policy reviews several commercially available products and their off‑label applications.
Definitions and Clinical Terms
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