CurrentUnitedHealthcarePolicy IEXD0017.13

Botulinum toxin products (Botox, Dysport, Daxxify, Xeomin, Myobloc) medical necessity and indications

Defines general and diagnosis-specific medical necessity criteria for botulinum toxin products (multiple brands) including frequency limits and indication-specific requirements (e.g., achalasia, chronic anal fissure, cervical dystonia, detrusor overactivity, chronic migraine excluded for some products). Also lists applicable procedure (J-) and diagnosis (ICD-10) codes for reference.

Policy Summary

PayerUnitedHealthcare

PolicyBotulinum toxin products (Botox, Dysport, Daxxify, Xeomin, Myobloc) medical necessity and indications

Policy CodePolicy IEXD0017.13

Change TypeRevised proven/unproven indications; ICD-10 code additions/removals; references updated

Effective DateMar 1, 2025

Next Review Date

Key ActionPrescriber must document diagnosis and attest dosing is per FDA labeling or supported by published evidence, and injections must not be given more frequently than every 12 weeks.

POLICY UPDATE CHANGES

Revised list of proven indications in Coverage Rationale and Diagnosis-Specific Requirements.

Revised list of unproven and not medically necessary indications for multiple botulinum toxin products.

Added multiple ICD-10 diagnosis codes to Applicable Codes list.

Removed several ICD-10 diagnosis codes from Applicable Codes list.

Updated FDA and References sections to reflect current information.

proven/unprovenIndications updated

ManyICD-10 codes listed for reference

SeveralUnproven/not medically necessary

MultipleProducts covered with criteria

revisedICD-10 codes changed

Coverage Summary

This policy (Policy Number IEXD0017.13; effective March 1, 2025) defines general and diagnosis-specific medical necessity criteria for multiple botulinum toxin products (e.g., Botox, Dysport, Daxxify, Xeomin, Myobloc), lists applicable HCPCS J‑codes and many ICD‑10 diagnosis codes for reference, and specifies documentation and administration requirements. Coverage stance is mixed: some product–indication pairs are identified as proven and may be covered when criteria are met, while many other uses are listed as unproven or not medically necessary. Coverage is conditional on the specific product, the listed indication and diagnosis-specific requirements, adherence to general requirements (including injections no more frequent than every 12 weeks and prescriber attestation about dosing), alignment with FDA indications and evidence-based guideline recommendations, and the member-specific benefit plan terms.

Key thresholds and definitions

Administration intervalNo more frequent than every 12 weeks

Chronic migraine (Botox) - headache days/month>= 15 headache days per month

Chronic migraine (Botox) - migraine days/month>= 8 migraine days per month

Chronic migraine (Botox) - duration criterionHeadaches last 4 hours per day or longer

Botulinum toxin potency unitsUnits are product- and assay-specific and are not interchangeable between products

Medical-Necessity Criteria — General Requirements

General Requirements (Applicable to all Requests)

All of the following:

Diagnosis
Administration interval: Botulinum toxin administration is no more frequent than every 12 weeks, regardless of diagnosisno more frequent than every 12 weeks
Prescriber attestation
- FDA dosing attestation: Prescriber attests dosing is in accordance with the United States Food and Drug Administration (FDA) approved labeling

Medical-Necessity Criteria — Diagnosis-Specific / Proven Indications

Diagnosis-Specific Requirements / Proven Indications (selected from list)

Listed proven indications with any additional criteria shown below:

Dysport (abobotulinumtoxinA) - Achalasia: Diagnosis of achalasia as confirmed by esophageal manometry; Other causes of dysphagia (e.g., peptic stricture, carcinoma, extrinsic compression) ruled out by upper gastrointestinal endoscopy
Dysport - Chronic anal fissures: Diagnosis of chronic anal fissure
Dysport - Blepharospasm: Diagnosis of blepharospasm associated with dystonia

Coverage Rationale — Proven Indications

Coverage Rationale - Proven Indications (Revised list)

Policy revision updated list of proven indications for specific products (see product-specific FDA and evidence sections); coverage is conditional on FDA indication, evidence-based guideline recommendations, and member-specific benefit plan terms.

Rationale point 1: Treatment corresponds to a listed proven indication for the specific botulinum toxin product (e.g., cervical dystonia, adult upper/lower limb spasticity where indicated, chronic migraine for onabotulinumtoxinA, certain pediatric spasticity indications for Dysport and Botox).
Rationale point 2: Member's condition and prior therapies align with guideline recommendations (e.g., botulinum toxin reserved for achalasia patients unfit for definitive therapies; detrusor overactivity after anticholinergic intolerance or inadequate response).
Rationale point 3: Coverage subject to member-specific benefit plan terms and any applicable federal or state mandates.

Unproven / Not Medically Necessary Indications

Unproven / Not Medically Necessary Indications (Revised list)

Policy revision updated the list of conditions considered unproven or not medically necessary for all named botulinum toxin products unless otherwise supported:

Cricopharyngeal dysphagia (excludes achalasia) — listed as unproven/not medically necessary
Tension-type headache — considered unproven/not medically necessary
Head tremor note: Head tremor — removed from the unproven list (no longer listed as unproven)
Other unproven indications: Other previously listed unproven/not medically necessary indications remain unless specifically revised (see policy for full list).

Coding

HCPCS J-codes for botulinum toxin productsHCPCS

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)

ICD-10 referenced (selected examples)ICD-10

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

ICD-10 full list / large diagnosis listICD-10

C72.0	Malignant neoplasm of spinal cord
C72.1	Malignant neoplasm of cauda equina
D33.0	Benign neoplasm of brain, supratentorial
D33.1	Benign neoplasm of brain, infratentorial
D33.2	Benign neoplasm of brain, unspecified
D33.3	Benign neoplasm of spinal cord, cranial nerves, and other parts of central nervous system

ICD-10 added codesICD-10

I63.543	Cerebral infarction due to thrombosis of other cerebral artery, with cerebral edema
I63.549	Cerebral infarction due to thrombosis of unspecified cerebral artery, with other cerebral infarction
I63.59	Other cerebral infarction due to thrombosis
I63.6	Cerebral infarction due to cerebral venous thrombosis, nonpyogenic

ICD-10 removed codesICD-10

No codes listed

Provider Actions

Prior Authorization

Prior authorization & attestation required

Prior authorization and prescriber attestation are required for botulinum toxin requests. Prescriber must document the diagnosis, attest that dosing follows FDA-approved labeling or, for indications without FDA dosing, that published clinical evidence supports the dosing, and confirm administration is no more frequent than every 12 weeks.

Attestation: dosing per FDA labeling or supported by published clinical evidence
Administration interval: no more frequent than every 12 weeks
Required documentation: diagnosis and clinical rationale

Documentation Required

Achalasia documentation required

For achalasia, submit diagnostic confirmation and testing results demonstrating the condition and exclusion of alternative causes.

Background & Evidence Summary

Botulinum neurotoxins act by inhibiting acetylcholine release at the neuromuscular junction; potency units are product‑ and assay‑specific and are not interchangeable. The policy addresses multiple serotypes and commercial preparations and provides general administration and documentation requirements.

Key clinical evidence summarized in the policy includes randomized trials and guideline assessments: PREEMPT pooled phase‑3 studies support onabotulinumtoxinA for chronic migraine with meaningful reductions in headache days; the Daxxify randomized trial showed significant TWSTRS improvement in cervical dystonia versus placebo; the Yun et al. randomized crossover compared Dysport and Botox in cervical dystonia (2.5:1 ratio, non‑inferiority trend); abobotulinumtoxinA RCTs demonstrated benefit for spasticity in cerebral palsy; long‑term extension data support onabotulinumtoxinA for neurogenic detrusor overactivity with durable effect but known urinary AEs; AAN guideline levels and other guideline recommendations are used to classify strength of evidence; and the FDA requires a boxed warning about distant spread of toxin effect for all botulinum products.

Selected evidence & warnings

Daxxify - cervical dystonia (Daxxify trial)Randomized trial: significant TWSTRS improvement for Daxxify 125U and 250U vs placebo

Dysport vs Botox (Yun et al)Randomized crossover non-inferiority at 2.5:1 ratio; trend favoring Botox but not significant

Definitions

Definitions used in the policy include: Botulinum toxin potency units — units are specific to each product and assay method and are not interchangeable between different botulinum toxin products; AAN evidence levels — Level A (established), Level B (probably), Level C (possibly), Level U (data inadequate/conflicting); and NMO SD — the policy uses the replacement term neuromyelitis optica spectrum disorder (NMO SD) for spasticity‑related indications.

Revision History

2025-03-01revisedLatest

Revised list of proven indications in Coverage Rationale and Diagnosis-Specific Requirements — product-specific updates: Dysport and Botox added 'essential tremor', removed 'hand tremor' and 'voice tremor'; replaced 'spasticity associated with neuromyelitis optica (NMO)' with 'spasticity associated with neuromyelitis optica spectrum disorder (NMO SD)'. Xeomin and Myobloc had similar NMO -> NMO SD replacement. (Material change)

2025-03-01revisedLatest

Revised list of unproven and not medically necessary indications for multiple botulinum toxin products — replaced 'cricopharyngeal dysphagia' with 'cricopharyngeal dysphagia (excludes achalasia)'; replaced 'tension headache' with 'tension-type headache'; removed 'head tremor'. (Material change)

Policy Summary

PayerUnitedHealthcare

PolicyBotulinum toxin products (Botox, Dysport, Daxxify, Xeomin, Myobloc) medical necessity and indications

Policy CodePolicy IEXD0017.13

Change TypeRevised proven/unproven indications; ICD-10 code additions/removals; references updated

Effective DateMar 1, 2025

Next Review Date

Key ActionPrescriber must document diagnosis and attest dosing is per FDA labeling or supported by published evidence, and injections must not be given more frequently than every 12 weeks.

On This Page

Non-FDA dosing attestation: For indications without FDA approved dosing, prescriber attests there is published clinical evidence to support the dosing

Dysport - Cervical dystonia:

Diagnosis of cervical dystonia

Dysport - Detrusor overactivity / detrusor-sphincter dyssynergia: One of: Diagnosis of detrusor overactivity; Diagnosis of detrusor-sphincter dyssynergia due to spinal cord injury or disease

Dysport - Other listed proven indications: Essential tremor; Hand dystonia (writer's, musician's, or typist's cramp); Hemifacial spasm; Hyperhidrosis including gustatory sweating (Frey's Syndrome); Oromandibular dystonia; Sialorrhea; Spasmodic dysphonia; Spasticity associated with cerebral palsy, multiple sclerosis, neuromyelitis optica spectrum disorder (NMOSD), stroke, or other brain/spinal cord injury/disease/tumor; Strabismus; Tongue dystonia; Torsion dystonia

Daxxify (daxibotulinumtoxinA-lanm): Daxxify is proven for the treatment of cervical dystonia when diagnosis of cervical dystonia is present

Xeomin (incobotulinumtoxinA): Blepharospasm associated with dystonia; Cervical dystonia (diagnosis required); Sialorrhea; Spasticity associated with cerebral palsy, multiple sclerosis, NMOSD, stroke, or other brain/spinal cord injury/disease/tumor

Botox (onabotulinumtoxinA) - Achalasia: Diagnosis of achalasia as confirmed by esophageal manometry; Other causes of dysphagia ruled out by upper gastrointestinal endoscopy

Botox - Chronic anal fissures: Diagnosis of chronic anal fissure

Botox - Chronic migraine prophylaxis: Diagnosis of chronic migraine; Greater than or equal to 15 headache days per month; Greater than or equal to 8 migraine days per month; Headaches last 4 hours per day or longer>=15 headache days/month; >=8 migraine days/month; >=4 hours duration

Botox - Overactive bladder: Diagnosis of overactive bladder; One of: Urge urinary incontinence; Urgency; Frequency

Myobloc (rimabotulinumtoxinB): Cervical dystonia (spasmodic torticollis); Detrusor overactivity (detrusor hyperreflexia); Sialorrhea; Spasticity associated with cerebral palsy, multiple sclerosis, NMOSD, stroke, or other brain/spinal cord injury/disease/tumor

Unproven / Not Medically Necessary: Daxxify, Dysport, Myobloc, and Xeomin are unproven and not medically necessary for chronic migraine. Botox, Daxxify, Dysport, Myobloc, and Xeomin are unproven and not medically necessary for a list of conditions including: acquired nystagmus; anismus; benign prostatic hyperplasia; brachial plexus palsy; chronic daily headache; chronic low back pain; chronic prostatic pain; cricopharyngeal dysphagia (excludes achalasia); epiphora after salivary gland transplant; esophageal spasm; gastroparesis; gustatory epiphora; lateral epicondylitis; lichen simplex; lower urinary tract voiding dysfunction; motor tics; myofascial pain syndrome; nasal hypersecretion; and others listed in policy

Coverage is conditional: services are considered only when the request aligns with an FDA‑approved indication or with the policy's proven‑indication criteria and guideline recommendations, and when the member's benefit plan permits the service. The policy requires prescriber attestation that dosing follows FDA labeling or, for non‑FDA dosing, that published clinical evidence supports the dosing, and notes that member‑specific Certificate of Coverage/Summary Plan Description and applicable state or federal mandates govern coverage.

The policy lists many additional indications that are considered unproven or not medically necessary for the named botulinum toxin products (examples include cricopharyngeal dysphagia excluding achalasia, many pain and autonomic indications, and others). Product‑specific exceptions may exist only when the evidence supports them and when the member's benefit plan allows coverage.

ICD-10 code example: K22.0 (Achalasia of cardia)
Diagnostic confirmation: esophageal manometry showing achalasia
Exclude other causes of dysphagia: upper gastrointestinal endoscopy results (e.g., rule out peptic stricture, carcinoma, extrinsic compression)

Documentation Required

Chronic migraine documentation (Botox)

For chronic migraine prophylaxis with onabotulinumtoxinA (Botox), document headache frequency and duration meeting the chronic migraine definition prior to approval.

Headache days per month: 315 days/month (>= 15)
Migraine days per month: 38 migraine days/month (>= 8)
Typical headache duration: headaches last 34 hours or longer

Prior Authorization

Prior authorization / coverage determination

Prior authorization or coverage determination may be required by the member's benefit plan. Third-party tools or benefit check systems may be used to determine medical necessity and coverage prior to service.

Confirm PA requirement via payer portals or benefit verification tools
Use third-party utilization management tools where applicable

Denial Risk

Cosmetic exclusion risk

Requests for botulinum toxin for cosmetic purposes or to address appearance-only concerns are at high risk of denial. Document medical necessity when treatment may be construed as cosmetic.

Cosmetic uses and appearance-only claims are typically excluded
Provide clear clinical rationale and supporting documentation when indication borderline

Documentation Required

Review member-specific benefit document

Review the member-specific benefit document to confirm coverage, benefit limits, and any plan exclusions prior to service.

Verify coverage and any quantity or frequency limits in the member's plan document
Benefit documents supersede policy for coverage determinations

Documentation Required

Document prior botulinum toxin timing

Document dates and details of any prior botulinum toxin administrations. This is especially important for evaluation of trials or prior therapy in cervical dystonia and to ensure adherence to the 12-week interval rule.

Record prior botulinum product, dose, administration date, and response
Ensure prior administrations were at least 12 weeks before the current request

Documentation Required

Reference member-specific benefit plan

Reference the member-specific benefit plan to determine if the requested service is a covered benefit and to identify any plan-specific requirements or limitations.

Check member plan for covered indications and required precertification
Consult benefit documents for exclusions and required clinical documentation

Documentation Required

Align with clinical guidelines

Align documentation and clinical decision-making with applicable clinical guidelines and evidence-based criteria for the specific indication being treated.

Follow guideline-recommended diagnostic testing (e.g., manometry for achalasia)
Document adherence to established clinical criteria for the indication

Detrusor overactivity - onabotulinumtoxinA long-term

Open-label (3 yr) reduced UI episodes; median duration ~9 months (200U); common AEs UTI and urinary retention

PREEMPT pooled (Botox - chronic migraine)Phase 3 pooled: reduced headache days vs placebo (e.g., -8.4 vs -6.6 at week 24); improved HRQoL

Cochrane 2018 (chronic migraine)May reduce migraine days by ~2 days/month in chronic migraine; increased adverse events (~60% vs 47%)

FDA boxed warningAll botulinum toxin products carry black box warning about distant spread of toxin effect with potential serious outcomes including death

2025-03-01addedLatest

Added multiple ICD-10 diagnosis codes to Applicable Codes list (e.g., C72.1, D33.3, D33.7, D33.9, D43.3, D43.8, D43.9, G25.0, H49.881, H49.882, H49.883, H49.889, H49.9, H50.21, H50.22, H50.60, H50.69, H50.9, R13.2, Z85.841, Z85.848, Z87.820). (Material change)

2025-03-01removedLatest

Removed several ICD-10 diagnosis codes from Applicable Codes list (e.g., G25.89, K60.2, R13.3, R25.0, R25.1, R25.2, R25.3, R25.8, R25.9, R29.891). (Material change)

2025-03-01revisedLatest

Supporting Information and references updated; previous policy version IEXD0017.12 archived. (Non-material change)