CareSource Botox Coverage & Prior Auth Update

Recommended Authorization and Coverage Criteria

Covered Indications and Dosing

Coverage of Botox is recommended when the specific indication criteria and dosing limits below are met:

Blepharospasm (FDA): Patient is ≥ 12 years of age; approve up to 200 units every ≥ 3 months.age ≥12; max 200 units q≥3 months

Includes blepharospasm associated with dystonia, benign essential blepharospasm, and VII nerve disorders.

Cervical dystonia (FDA): Approve up to a maximum dose of 300 units, administered not more frequently than once every 3 months.max 300 units q≥3 months

Also referred to as spasmodic torticollis.

Primary axillary hyperhidrosis (FDA): Patient is ≥ 18 years; prescriber has excluded secondary causes; hyperhidrosis significantly interferes with age-appropriate activities of daily living; patient has tried at least one prescription topical agent for at least 4–6 weeks with inadequate efficacy or significant intolerance; approve up to 50 units per axilla every ≥ 3 months.age ≥18; topical trial ≥4–6 weeks; max 50 units per axilla q≥3 months

Examples of prescription topical agents are provided in policy (e.g., Xerac AC, Drysol, Qbrexza, Sofdra).

Chronic migraine prophylaxis (FDA): Patient is ≥ 18 years; Botox prescribed by or in consultation with a neurologist or headache specialist; patient has ≥ 15 migraine headache days per month with headaches lasting ≥ 4 hours; if currently receiving Botox, patient must have demonstrated significant clinical benefit; approve up to 155 units every ≤ 12 weeks.age ≥18; migraine ≥15 days/month with ≥4-hour duration; max 155 units q≤12 weeks

Significant clinical benefit examples include reduction in overall migraine days or severe migraine days as determined by prescriber.

Neurogenic detrusor overactivity (pediatric) (FDA): Patient is ≥ 5 years; patient has tried at least one other NDO pharmacologic therapy (e.g., beta-3 agonist or anticholinergic); approve up to 200 units every ≥ 12 weeks.age ≥5; prior trial required; max 200 units q≥12 weeks

Pediatric NDO is a distinct FDA‑approved pediatric indication.

Overactive bladder (adult) (FDA): Patient is ≥ 18 years; patient has tried at least one other OAB pharmacologic therapy (e.g., beta-3 agonist or anticholinergic); approve up to 200 units every ≥ 12 weeks.age ≥18; prior trial required; max 200 units q≥12 weeks

Policy notes AUA guidance and that dosing limitation was increased to 200 units for adult OAB.

Spasticity (FDA): Patient is ≥ 2 years; approve for up to 1 year with dosing options depending on limb involvement and age: e.g., up to 400 units every ≥ 12 weeks OR adult weight-based regimens (examples: 8 units/kg not to exceed 300 units; 10 units/kg not to exceed 340 units) as specified by regimen.varies by regimen; common max 400 units q≥12 weeks or units/kg caps

Separate regimens specified for lower limb, both upper and lower limbs, and adult weight-based dosing.

Strabismus (FDA): Patient is ≥ 12 years; approve up to 25 units in any one muscle every ≥ 3 months.age ≥12; max 25 units/muscle q≥3 months

Common strabismus types (esotropia, exotropia, hypertropia, hypotropia) are noted.

Urinary incontinence due to neurogenic detrusor overactivity (adult) (FDA): Patient is ≥ 18 years; patient has tried at least one other pharmacologic therapy for urinary incontinence (e.g., beta-3 agonist or anticholinergic); approve up to 200 units every ≥ 12 weeks.age ≥18; prior trial required; max 200 units q≥12 weeks

Examples of neurologic conditions (spinal cord injury, MS, spina bifida) are provided.

Achalasia (supportive evidence): Patient is ≥ 18 years; approve up to 100 units every ≥ 3 months.age ≥18; max 100 units q≥3 months

Listed as an other-use with supportive guideline evidence.

Dystonia, focal upper limb (supportive evidence): Patient is ≥ 18 years; approve up to 400 units every ≥ 3 months.age ≥18; max 400 units q≥3 months

Examples include focal hand dystonia.

Essential tremor (supportive evidence): Patient is ≥ 18 years and has tried at least one other pharmacologic therapy for tremor (e.g., primidone, propranolol, atenolol); approve up to 400 units every ≥ 3 months.age ≥18; prior trial required; max 400 units q≥3 months

Policy lists pharmacologic alternatives.

Hemifacial spasm (supportive evidence): Patient is ≥ 18 years; approve up to 400 units every ≥ 3 months.age ≥18; max 400 units q≥3 months

Policy cites guideline evidence.

Hyperhidrosis (palmar/plantar/facial) (supportive evidence): Patient is ≥ 18 years; prescriber has excluded secondary causes; hyperhidrosis significantly interferes with age-appropriate activities of daily living; patient has tried at least one topical agent for at least 4 weeks with inadequate efficacy or significant intolerance; approve up to 400 units every ≥ 3 months (axillary dosing specified separately).age ≥18; topical trial ≥4 weeks; max 400 units q≥3 months

Axillary hyperhidrosis has a distinct lower dosing limit (50 units per axilla).

Laryngeal dystonia (spasmodic dysphonia) (supportive evidence): Patient is ≥ 18 years; approve up to 25 units every ≥ 3 months.age ≥18; max 25 units q≥3 months

Policy references AAO‑HNS guideline.

Oromandibular dystonia (supportive evidence): Patient is ≥ 18 years; approve up to 400 units every ≥ 3 months.age ≥18; max 400 units q≥3 months

Added as an other-use with supportive evidence.

Sialorrhea, chronic (supportive evidence): Patient is ≥ 18 years; approve up to 100 units (50 units per side) every ≥ 16 weeks.age ≥18; max 100 units q≥16 weeks

Dosing and conversion references noted.

Covered when ALL general conditions are met

Coverage is conditional on meeting indication-specific age limits, dosing limitations, and prerequisite trials where specified.

Generic requirements: Patient meets the age requirement specified for the indication (commonly ≥ 18 years; NDO pediatric indication ≥ 5 years); dosing does not exceed the specified limit for the indication; prerequisite conservative therapies have been trialed where required (e.g., topical prescription agent trial for hyperhidrosis or at least one pharmacologic alternative for OAB/NDO).see indication-specific nodes

Detailed per-indication criteria and required trials (duration and examples) are specified in the Covered Indications and Dosing section.

Coverage of onabotulinumtoxinA (Botox) does not include cosmetic applications or other uses explicitly listed as excluded. Cosmetic uses (examples: facial rhytides, frown lines/glabellar wrinkling, horizontal neck rhytides, mid/lower face and neck rejuvenation, and platysmal bands) are not recommended for coverage under the medical benefit. Additionally, injection of botulinum toxin into the pylorus for gastroparesis is not recommended based on clinical guideline conclusions that symptom improvement was not demonstrated versus placebo. Coverage is limited to the indications and criteria specified in the Recommended Authorization Criteria; uses not listed there are not recommended for approval.

Several indications previously categorized as “Other Uses with Supportive Evidence” were removed or revised in the current policy update. Notably, myofascial pain, plantar fasciitis, and certain ophthalmic disorders (other than blepharospasm and strabismus) were removed from the policy’s supportive‑evidence list. The policy history also documents reclassification and dosing changes across multiple supportive‑use entries as part of this revision.

The policy explicitly states that Botox is not recommended for cosmetic indications and that pyloric injection for gastroparesis is not supported. More broadly, the policy directs that coverage is not recommended for any circumstance not included in the Recommended Authorization Criteria; providers should not expect coverage for uses outside the specified indications and criteria.

Uses removed from the “Other Uses with Supportive Evidence” list include examples such as myofascial pain and plantar fasciitis, and ophthalmic disorders other than blepharospasm/strabismus were de‑emphasized. The history also records addition of certain supportive uses (for example, oromandibular dystonia) while removing others, reflecting a narrowing of off‑label support in this policy revision.

Coding, Definitions and Dosing Limits

Referenced products and sourcesmixed

Xeomin prescribing info	Xeomin injection [prescribing information]; Merz; August 2021 (referenced)
Botox	Search term: Botox (Micromedex referenced)

inv-08: Chronic migraine frequency — key definition used for migraine prophylaxis

Definition≥ 15 migraine headache days per month with headache lasting ≥ 4 hours (used as the policy threshold for chronic migraine prophylaxis)

Age requirementPatient is ≥ 18 years of age for chronic migraine prophylaxis

Prescriber requirementBotox must be prescribed by or in consultation with a neurologist or headache specialist for migraine prevention

inv-09: Dosing limits by indication — specific per-indication maximum doses noted

Anal fissureApprove up to a maximum dose of 100 units every ≥3 months

Overactive bladder (adult) / Urinary incontinence due to detrusor overactivity (adult)

Prior Authorization, Documentation and Operational Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for medical benefit coverage of botulinum toxin (Botox) products. Approval is granted only when requests meet the applicable clinical criteria and dosing limits in the policy. Requests for doses outside the documented dosing will be reviewed case-by-case by a clinician (e.g., Medical Director or Pharmacist). All approvals are provided for the duration noted in the policy. Automation: None.

Prior authorization required for all medical benefit Botox requests
Requests outside policy dosing considered case-by-case by clinician
Approvals issued for specified duration in policy

Documentation Required

Prior Authorization and Specialist Involvement

For migraine headache prevention, Botox must be prescribed in consultation with a physician who specializes in the condition (e.g., neurologist or headache specialist). Approvals for specialist-managed indications follow the duration and dosing limits noted in the policy.

Clinical Background

OnabotulinumtoxinA (Botox) is a neuromuscular blocking agent that produces its effect by inhibiting acetylcholine release at the neuromuscular junction. It is FDA‑approved for multiple movement, neuromuscular, and autonomic conditions including blepharospasm, cervical dystonia, axillary hyperhidrosis, chronic migraine prophylaxis, overactive bladder, pediatric neurogenic detrusor overactivity (NDO), spasticity, strabismus, and urinary incontinence due to NDO. The policy also summarizes guideline‑level and supportive evidence for several off‑label or other uses (for example, achalasia, essential tremor, laryngeal dystonia/spasmodic dysphonia, oromandibular dystonia, sialorrhea, hemifacial spasm, and focal upper limb dystonia).

Key Clinical Definitions

inv-19: Chronic migraine — definition used in the policy

Policy definitionChronic migraine is defined as ≥ 15 migraine headache days per month with headache lasting ≥ 4 hours

Age requirementPatient must be ≥ 18 years of age to qualify under the chronic migraine prophylaxis criterion

Dosing limitMaximum approved Botox dose for chronic migraine prophylaxis is 155 units administered not more frequently than once every 12 weeks

inv-20: NDO — Neurogenic Detrusor Overactivity definition and note (pediatric age threshold referenced elsewhere)

TermNeurogenic Detrusor Overactivity (NDO)

Pediatric age thresholdPediatric NDO indication requires patient to be ≥ 5 years of age

OpenPayer

Botulinum Toxins (Botox) — Coverage Criteria for Medical Benefit

Recommended Authorization and Coverage Criteria

Coding, Definitions and Dosing Limits

Prior Authorization, Documentation and Operational Requirements

Clinical Background

Key Clinical Definitions