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Medical benefit drug policy governing coverage and medical necessity criteria for multiple botulinum toxin products (abobotulinumtoxinA, daxibotulinumtoxinA-lanm, incobotulinumtoxinA, onabotulinumtoxinA, rimabotulinumtoxinB) including general requirements, diagnosis-specific proven/unproven indications, and applicable HCPCS/J-codes and ICD-10 diagnosis pairings.
Added reference link to Medical Benefit Therapeutic Equivalent Medications - Excluded Drugs Coverage Rationale and language indicating Daxxify is typically excluded from coverage.
Added language that coverage for Dysport, Xeomin, Botox, Myobloc is contingent on criteria in the General Requirements and Diagnosis-Specific Requirements sections.
Added explicit medical necessity criteria for Myobloc for cervical dystonia, detrusor overactivity, sialorrhea, and spasticity including required prior failure/intolerance to alternatives and 12-month authorization limits.
Revised list of proven indications: replaced specific etiologies (cerebral palsy, MS, NMOSD, stroke, other injury/disease/tumor) with the single term 'spasticity'.
Added CMS section and Medicare LCD references for Botulinum Toxins.
Policy 2026D0017AN (effective January 1, 2026, last reviewed October 10, 2025) governs medical benefit coverage for multiple botulinum toxin products: Dysport (abobotulinumtoxinA), Xeomin (incobotulinumtoxinA), Botox (onabotulinumtoxinA), Myobloc (rimabotulinumtoxinB), and the product Daxxify (daxibotulinumtoxinA‑lanm) (which is typically excluded from coverage).
Coverage is contingent on meeting the policy's General Requirements and diagnosis‑specific criteria; injections must be administered no more frequent than every 12 weeks. Myobloc has additional prior‑use/step requirements and authorization limits: initial and reauthorization approvals are limited to no more than 12 months when used for specified indications.
General medical necessity requirements
Covered when ALL of the following are met:
ALL of the following
One of the following:
Proven Indications by Product
Covered when diagnosis matches product-specific proven indications and general requirements are met:
Dysport (abobotulinumtoxinA) proven indications
Xeomin (incobotulinumtoxinA) proven indications
Botox (onabotulinumtoxinA) proven indications
Myobloc Additional Medical Necessity Requirements (product-specific) - Initial therapy branches
Myobloc is medically necessary for specified conditions when ALL of the following are met:
Cervical dystonia - initial therapy
Must fail one of listed alternatives
Applies to initial therapy
Detrusor overactivity - initial therapy
Must fail one of listed alternatives
Applies to initial therapy
Sialorrhea - initial therapy
Must fail one of listed alternatives
Applies to initial therapy
Spasticity - initial therapy
Must fail one of listed alternatives
Applies to initial therapy
Myobloc continuation/reauthorization requirements
Reauthorization requirements for Myobloc-related indications:
Unproven / Not Medically Necessary Indications
Not medically necessary when used for the following:
These products are unproven for chronic migraine
Botox, Daxxify, Dysport, Myobloc, Xeomin unproven/not medically necessary for
Note: Cosmetic uses of botulinum toxins are generally excluded by most Certificates of Coverage and SPDs; hyperhidrosis coverage may also be specifically excluded. Member‑specific benefit documents and any applicable state mandates or Medicare guidance may supersede this policy and should be checked when making coverage determinations.
| J0585 | Injection, onabotulinumtoxinA, 1 unit (Botox) |
| J0586 | Injection, abobotulinumtoxinA, 5 units (Dysport) |
| J0587 | Injection, rimabotulinumtoxinB, 100 units (Myobloc) |
| J0588 | Injection, incobotulinumtoxinA, 1 unit (Xeomin) |
| J0589 | Injection, daxibotulinumtoxina-lanm, 1 unit (Daxxify) |
| C71.0 | Malignant neoplasm of cerebrum, except lobes and ventricles |
| C71.1 | Malignant neoplasm of frontal lobe |
| C71.2 | Malignant neoplasm of temporal lobe |
| C71.3 | Malignant neoplasm of parietal lobe |
| C71.4 | Malignant neoplasm of occipital lobe |
| C71.5 | Malignant neoplasm of cerebral ventricle |
| C71.6 | Malignant neoplasm of cerebellum |
| C71.7 | Malignant neoplasm of brain stem |
| C71.8 | Malignant neoplasm of overlapping sites of brain |
| C71.9 | Malignant neoplasm of brain, unspecified |
| J0585 | Mapped to multiple ICD-10 brain and spinal neoplasm codes (see list) |
| J0586 | Mapped to multiple ICD-10 brain and spinal neoplasm codes (see list) |
| J0587 | Mapped to multiple ICD-10 brain and spinal neoplasm codes (see list) |
| J0588 | Mapped to multiple ICD-10 brain and spinal neoplasm codes (see list) |
| J0589 | Not mapped to the listed ICD-10 neoplasm codes in document (Daxxify) |
Essential actionable callouts
Supporting documentation & plan/benefit checks
Key trial and guideline findings summarized: a randomized crossover study comparing Dysport and Botox in cervical dystonia (n=102) demonstrated non‑inferiority of Dysport at a 2.5:1 unit ratio with a non‑significant trend favoring Botox; a randomized placebo‑controlled trial of Daxxify (n=301) showed both 125U and 250U doses significantly improved TWSTRS total score versus placebo.
For chronic migraine, pooled PREEMPT analyses of onabotulinumtoxinA showed significant reductions in headache days (example at 24 weeks -8.4 vs -6.6 days, p < 0.001) and higher ≥50% responder rates at week 56 (example 69.6% vs 62.8%, p = 0.023), with consistent benefit on HIT‑6 and MSQ measures.
Long‑term intradetrusor onabotulinumtoxinA data (open‑label extension up to 3 years) demonstrated sustained reductions in urinary incontinence episodes with median duration of effect ~9.0 months (200U); common adverse events included urinary tract infection and urinary retention.
Spasticity and cerebral palsy studies (abobotulinumtoxinA) showed significant improvements on the Modified Ashworth Scale at week 4 (e.g., mean differences ~-0.38 to -0.49 versus placebo) and improved Physician Global Assessment.
Evidence‑grading recommendations from authoritative reviews (AAN/Toxicon summaries): products with Level A evidence include Dysport, Xeomin (for upper limb spasticity), Botox (upper/lower limb spasticity and chronic migraine), and Myobloc (cervical dystonia); Level B/C/U designations vary by product and indication as cited in the policy.
Background: Botulinum neurotoxins comprise serotypes A–G; type A products (onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA) cleave SNAP‑25, while type B cleaves synaptobrevin. Potency units are specific to each product and assay method and are not interchangeable across preparations.
Benefit considerations: many plans consider botulinum toxin injections cosmetic when used solely for appearance or without demonstrable functional impairment; hyperhidrosis is often excluded by COCs/SPDs. The policy requires that administration intervals adhere to the General Requirements (e.g., no more frequent than every 12 weeks).
Regulatory and payer context: FDA approvals and professional guidelines are summarized for informational use only; Medicare has no NCD for botulinum toxins but multiple LCDs apply and member‑specific benefit documents, state mandates, or Medicare guidance may supersede this policy.
| Term | Definition |
|---|---|
| Chronic migraine | Defined in policy as ≥ 15 headache days per month, ≥ 8 migraine days per month, and headaches lasting 4 hours or longer. |
| Botulinum toxin unit | Potency units are specific to the preparation and assay method; units are not interchangeable across different botulinum toxin products. |
| BoNT-A | Botulinum neurotoxin type A (includes onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA). |
| PREEMPT | Phase III Research Evaluating Migraine Prophylaxis Therapy clinical program for onabotulinumtoxinA (used in pooled trials of chronic migraine). |
| HIT-6 | Headache Impact Test-6, a measure of headache impact/severity used in migraine clinical trial assessments. |
| Level A/B/C/U (Evidence grading) | Level A = established as effective; Level B = probably effective/consider; Level C = may be considered; Level U = insufficient/conflicting evidence (grading per AAN methodology). |
Added reference to Medical Benefit Therapeutic Equivalent Medications - Excluded Drugs and language indicating Daxxify is typically excluded from coverage; coverage reviews may be required by law or benefit plan.
Added language that coverage for Dysport, Xeomin, Botox, and Myobloc is contingent on meeting criteria in the General Requirements and Diagnosis-Specific Requirements sections.
Added explicit Myobloc product-specific medical necessity criteria for cervical dystonia, detrusor overactivity, sialorrhea, and spasticity requiring history of failure, contraindication, or intolerance to specified alternative botulinum toxin products and specifying initial and reauthorization authorizations will be for no more than 12 months.
Specified administration frequency limit: botulinum toxin administration is no more frequent than every 12 weeks (General Requirements).
Revised proven indications lists to replace detailed etiologies of spasticity with the single term 'spasticity', and revised unproven/not medically necessary lists (removed pelvic floor spasticity and stiff-person syndrome from unproven list).
Chronic migraine branch