CurrentBlue Cross Blue Shield - KansasPolicy N/A

Botulinum Toxin (BT)

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.

Policy Summary

PayerBlue Cross Blue Shield - Kansas

PolicyBotulinum Toxin (BT)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNovember 17, 2023

Next Review DateNov 26, 2025

Key ActionObtain prior authorization and document that chronic migraine patients meet ICHD-3 criteria and have had trials of at least 2 preventive agents before initiating a 6-month trial of botulinum toxin.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

13+Named medically necessary indications listed

4Botulinum toxin agents in scope

>=7 daysEfficacy thresholds for migraine continuation

Black boxDistant spread warning

79+Primary references listed

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

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

Botulinum toxin products referencedmixed

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)

Procedure and drug codes mentionedmixed

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).

1–10 of 22

1/3

Chronic migraine continuation thresholds

Continuation efficacy — migraine days>=7 fewer migraine days per month compared with pretreatment level

Continuation efficacy — duration>=100 hours reduction in migraine headache duration per month compared with pretreatment level

Authorization period before assessmentInitial 6-month trial required prior to continuation assessment

Clinically meaningful pain response

Clinically meaningful pain response>=50% reduction in VAS (visual analogue scale)

Outcome domains reportedFunctional improvement and mean VAS score changes included in trials/meta-analyses

Prior Authorization, Documentation, and Step Therapy Expectations

Note

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.

Documentation Required

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.

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

Chronic migraine (ICHD-3) diagnostic criteria summary

Core diagnostic frequencyHeadaches >=15 days per month for >3 months

Migraine-feature daysMigraine features present on >=8 days per month

Typical migraine featuresDuration 4–72 hours; at least 2 of unilateral location, pulsating quality, moderate/severe intensity, aggravation by routine activity; associated nausea/vomiting or photophobia/phonophobia

Spasticity — definition

DefinitionSpasticity: a velocity-dependent increase in tonic stretch reflexes with exaggerated tendon jerks

AssociationTypically associated with central nervous system injury (eg, cerebral palsy, stroke)

Policy Summary

PayerBlue Cross Blue Shield - Kansas

PolicyBotulinum Toxin (BT)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNovember 17, 2023

Next Review DateNov 26, 2025

SourceLink

On This Page

Evidence contextUsed as a primary responder definition in chronic low back pain systematic reviews of BT

Essential tremor primary outcome threshold

Primary outcome threshold>=2-point improvement on the Clinical Global Impression of Change (CGI-C) scale

Assessment timingMeasured at week 6 after the second injection (week 18 after randomization)

Trial result contextIn Marques et al (2024) RCT, 31% BT vs 9% placebo met this threshold

Chronic migraine prior medication trials

Prior medication trials requiredTrials of at least 2 preventive agents from different medication classes (e.g., antidepressants, antihypertensives, antiepileptics)

ExceptionPatients with contraindications to preventive medications are not required to trial these agents

Documentation requirementDocument adequate trials of the medications prior to initial 6-month authorization

Repeat injection interval for internal anal sphincter

Repeat injection intervalEvery 3 to 6 months as needed based on symptoms

Repeat frequency guidanceMay be given as many times as necessary depending on symptoms; symptoms often improve with age

ContextRecommendation from American Pediatric Surgical Association for postoperative Hirschsprung obstructive symptoms

Billing Rule

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.

Note

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.

Step Therapy

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 noteSpasticity is a subset of dystonia describing increased stretch reflexes

Botulinum toxin injection (achalasia) — procedural definition

ProcedureEndoscopic injection of commercially available botulinum toxin into/near the lower esophageal sphincter using endoscopic ultrasound localization

PurposeTo reduce lower esophageal sphincter pressure for symptom relief in achalasia

ProductCommercially available botulinum toxin formulations administered via endoscopic technique

Botulinum toxin injection (anal fissure) — intrasphincteric procedural definition

ProcedureIntrasphincteric injection of commercially available botulinum toxin into the internal anal sphincter

IndicationUsed for chronic anal fissure after failure of medical therapy as a sphincter-sparing alternative to lateral internal sphincterotomy

Technique noteInjection targets the internal anal sphincter muscle

Hirschsprung disease — definition

DefinitionHirschsprung disease: congenital absence of enteric ganglion cells in a bowel segment causing failure to relax and functional obstruction

Clinical consequenceAganglionic segment fails to relax, producing obstructive symptoms

PopulationTypically a pediatric congenital disorder diagnosed in infancy/childhood

Intrasphincteric injection — definition

DefinitionIntrasphincteric injection: injection into the internal anal sphincter muscle

ApplicationTechnique used for chronic anal fissure and postoperative Hirschsprung obstructive symptoms

ProductCommercially available botulinum toxin preparations administered into sphincter muscle

Internal anal sphincter achalasia — definition and diagnostic note

DefinitionInternal anal sphincter achalasia: clinical presentation similar to Hirschsprung disease but with presence of ganglion cells on rectal biopsy

Diagnostic testDiagnosed by anorectal manometry demonstrating absence of the rectosphincteric reflex on rectal balloon inflation

Clinical notePresents with obstructive defecation symptoms; differentiated from Hirschsprung by biopsy findings

Essential tremor — definition

DefinitionEssential tremor: an action tremor typically involving the hands, brought out by movement and sustained postures; may affect head and voice and cause disability

Clinical impactCan significantly impair daily activities such as writing and eating

Treatment contextMultiple symptomatic therapies exist; botulinum toxin evaluated for refractory or focal symptoms

Clinical Global Impression of Change — CGI-C definition used in essential tremor RCTs

Scale descriptionClinical Global Impression of Change (CGI-C): clinician-rated scale assessing overall change in patient status

Trial usePrimary outcome in essential tremor RCTs defined as >=2-point improvement on CGI-C

TimingMeasured at week 6 after the second injection in the referenced RCT

GCSI — Gastroparesis Cardinal Symptom Index definition

DefinitionGastroparesis Cardinal Symptom Index (GCSI): a patient-reported instrument measuring severity of gastroparesis symptoms

Use in trialsPrimary endpoint in refractory gastroparesis studies (eg, Gonzalez et al 2024) with clinical efficacy defined by decrease in mean GCSI

Typical endpointA >1-point decrease in mean GCSI at 3 months used as primary efficacy measure in RCTs

Miscellaneous conditions — umbrella definition for multiple evaluated indications

ScopeMiscellaneous conditions: umbrella term for multiple neurological, urological, pain, gastrointestinal, and other indications evaluated for botulinum toxin use

Typical patient profileOften patients who have failed standard of care or for whom standard therapies are contraindicated

Evidence noteEvidence quality and study designs vary widely across conditions; many indications lack robust RCT data

Intrasphincteric BT injection for Hirschsprung postoperative obstructive symptoms — procedural definition and repeat injection guidance

ProcedureInjection of botulinum toxin into the internal anal sphincter for postoperative obstructive symptoms after Hirschsprung pull-through when no mechanical obstruction and rectal biopsy is normal

Repeat injectionsIf significant improvement occurs, injections may be repeated every 3–6 months as needed; symptoms often improve with age

Follow-upClinical follow-up typically recommended; benefit often short-term and may require repeated dosing

Specialty guideline sources — list of guideline sources cited (AUA, ASCRS, etc.)

Guideline sources citedAmerican Urological Association (AUA) / SUFU; American Society for Gastrointestinal Endoscopy (ASGE); American Society of Colon and Rectal Surgeons (ASCRS); American Pediatric Surgical Association

Additional society referencesAmerican Academy of Neurology guidance on dystonia/essential tremor (historical), various specialty society practice parameters cited in references

PurposeGuideline documents inform coverage considerations for indications such as OAB, anal fissure, achalasia, and Hirschsprung postoperative care