UnitedHealthcare Botulinum Toxins Coverage Update

Coverage Criteria and Indication-Specific Rules

General Requirements (Initial and Continuation)

Covered when ALL of the following are met

General requirements: For initial therapy: diagnosis AND medical records documenting history & physical and laboratory/diagnostic evidence supporting the indication; botulinum toxin administration no more frequent than every 12 weeks; initial authorization for no more than 6 months. For continuation of therapy: documentation of positive clinical response AND a statement of expected frequency and duration; botulinum toxin administration no more frequent than every 12 weeks; reauthorization for no more than 12 months.

Dysport — Achalasia

Covered when ALL of the following are met

Dysport for achalasia: Diagnosis of achalasia confirmed by esophageal manometry; patient has failed or is not a candidate for pneumatic dilation or myotomy; other causes of dysphagia (e.g., peptic stricture, carcinoma, extrinsic compression) ruled out by upper gastrointestinal endoscopy.

Dysport — Chronic Anal Fissure

Covered when ALL of the following are met

Dysport for chronic anal fissure: Diagnosis of chronic anal fissure; at least 2 months of symptoms including nocturnal pain and bleeding OR post-defecation pain; history of failure, contraindication, or intolerance to one conventional therapy (topical nitrate OR topical calcium channel blocker such as diltiazem or nifedipine).

Dysport — Cervical Dystonia

Covered when ALL of the following are met

Dysport for cervical dystonia: Diagnosis of cervical dystonia; symptoms include sustained head tilt or abnormal posturing resulting in pain and/or functional impairment AND recurrent involuntary contraction of one or more neck muscles (e.g., sternocleidomastoid, splenius, trapezius, posterior cervical).

Dysport — Detrusor Conditions

Covered when ALL of the following are met

Dysport for detrusor overactivity/detrusor-sphincter dyssynergia: Diagnosis of detrusor overactivity OR detrusor-sphincter dyssynergia due to spinal cord injury or disease; history of failure, contraindication, or intolerance to two anticholinergic medications (e.g., oxybutynin, trospium, darifenacin, tolterodine).

Dysport — Other Indications

Covered for the following conditions when general requirements are met

Other Dysport indications: Essential tremor; hand dystonia (writer's/musician's/typist's cramp); hemifacial spasm; hyperhidrosis including gustatory sweating; oromandibular dystonia; sialorrhea; spasmodic dysphonia; spasticity associated with cerebral palsy, multiple sclerosis, neuromyelitis optica spectrum disorder (NMOSD), stroke, or other CNS injury/disease/tumor; strabismus; tongue dystonia; torsion dystonia.

Specific subcriteria may be defined elsewhere in the full policy.

Daxxify — Cervical Dystonia

Covered when ALL of the following are met

Daxxify for cervical dystonia: Diagnosis of cervical dystonia; symptoms include sustained head tilt or abnormal posturing resulting in pain and/or functional impairment AND recurrent involuntary contraction of one or more neck muscles (e.g., sternocleidomastoid, splenius, trapezius, posterior cervical).

Xeomin — Indications

Covered when ALL of the following are met

Xeomin covered indications: Blepharospasm associated with dystonia; cervical dystonia (spasmodic torticollis) meeting symptom criteria; sialorrhea; spasticity associated with cerebral palsy, multiple sclerosis, NMOSD, stroke, or other injury/disease/tumor of the brain or spinal cord.

Specific diagnostic criteria for cervical dystonia mirror those listed for other products.

Botox — Selected Indications

Covered when ALL of the following are met

Botox for achalasia: Diagnosis of achalasia confirmed by esophageal manometry; patient has failed or is not a candidate for pneumatic dilation or myotomy; other causes of dysphagia ruled out by upper gastrointestinal endoscopy.

Botox for chronic anal fissure: Diagnosis of chronic anal fissure; at least 2 months of symptoms including nocturnal pain and bleeding OR post-defecation pain; history of failure, contraindication, or intolerance to one conventional therapy (topical nitrate OR topical calcium channel blocker such as diltiazem or nifedipine).

Botox — Achalasia

Covered when ALL of the following are met

Achalasia: Diagnosis of achalasia as confirmed by esophageal manometry; patient has failed or is not a candidate for pneumatic dilation or myotomy; other causes of dysphagia ruled out by upper gastrointestinal endoscopy.

Botox — Chronic Anal Fissure

Covered when ALL of the following are met

Chronic anal fissure: Diagnosis of chronic anal fissure; at least 2 months of symptoms including nocturnal pain and bleeding or post-defecation pain; history of failure, contraindication, or intolerance to topical nitrates or topical calcium channel blockers (e.g., diltiazem, nifedipine).

Botox — Cervical Dystonia

Covered when ALL of the following are met

Cervical dystonia: Diagnosis of cervical dystonia; symptoms include sustained head tilt or abnormal posturing resulting in pain and/or functional impairment AND recurrent involuntary contraction of one or more neck muscles (e.g., sternocleidomastoid, splenius, trapezius, posterior cervical).

Botox — Detrusor Overactivity / Detrusor-Sphincter Dyssynergia

Covered when ALL of the following are met

Detrusor overactivity / detrusor-sphincter dyssynergia: Diagnosis of detrusor overactivity OR detrusor-sphincter dyssynergia due to spinal cord injury or disease; history of failure, contraindication, or intolerance to two anticholinergic medications (e.g., oxybutynin, trospium, darifenacin, tolterodine).

Botox — Chronic Migraine

Covered when ALL of the following are met

Chronic migraine prophylaxis: Diagnosis of chronic migraine defined as ≥15 headache days/month AND ≥8 migraine days/month with headaches lasting ≥4 hours/day; history of failure, contraindication, or intolerance after trial (≥2 months) of prophylactic therapy with one agent from two therapeutic classes (antidepressant, antiepileptic, beta blocker); Botox dose does not exceed 155 units intramuscularly divided over 31 injection sites across head/neck muscles every 12 weeks.

Botox — Overactive Bladder

Covered when ALL of the following are met

Overactive bladder: Diagnosis of overactive bladder with symptoms of urge urinary incontinence, urgency, or frequency; history of failure, contraindication, or intolerance to two anticholinergic medications (e.g., oxybutynin, trospium, darifenacin, tolterodine); Botox dose does not exceed 100 units divided over 20 intradetrusor injection sites every 12 weeks.

Myobloc — Cervical Dystonia and Neurogenic Detrusor Overactivity

Covered when ALL of the following are met

Myobloc for cervical dystonia: Diagnosis of cervical dystonia; symptoms include sustained head tilt or abnormal posturing resulting in pain and/or functional impairment AND recurrent involuntary contraction of one or more neck muscles.

Myobloc for neurogenic detrusor overactivity: Diagnosis of neurogenic detrusor overactivity; history of failure, contraindication, or intolerance to two anticholinergic medications (e.g., oxybutynin, trospium, darifenacin, tolterodine).

Clinical evidence (informational)

Clinical trial evidence described for specific indications

Cervical dystonia evidence: Randomized trials comparing Dysport vs Botox (non-inferiority, 2.5:1 ratio) and Daxxify vs placebo demonstrated efficacy on validated scales (Tsui, TWSTRS). Daxxify pivotal trial enrolled 301 patients with baseline TWSTRS thresholds; prior botulinum toxin allowed if ≥14 weeks since last dose.

Includes trial sizes and primary endpoints

Detrusor overactivity evidence: Long-term open-label extension of intradetrusor onabotulinumtoxinA (200U or 300U) showed consistent reductions in UI episodes/day, improved I-QOL, and median duration of effect ≈9 months for 200U; retreatment occurred ≥12 weeks since prior treatment; common AEs included UTI and urinary retention.>= 12 weeks

De novo CIC rates varied across treatments and over successive treatments

Evidence-based indication groups (trial-derived)

Evidence-supported indications and typical trial-based eligibility elements (based on reported RCTs and trials in this document excerpt).

Cervical Dystonia (trial-derived): Clinical diagnosis of cervical dystonia meeting baseline TWSTRS thresholds; if previously treated with botulinum toxin, ≥14 weeks since last injection; trials showed significant TWSTRS improvement with Daxxify vs placebo.TWSTRS total >=20; severity >=15; disability >=3; pain >=1

Daxxify trial N=301

Neurogenic Detrusor Overactivity (trial-derived): Patients with UI due to NDO treated intradetrusor with onabotulinumtoxinA (200U or 300U) with retreatment intervals ≥12 weeks; efficacy measured by change in UI episodes/day and I-QOL; median duration of effect ~9 months for 200U in extension study.>= 12 weeks

Long-term open-label data up to 3 years

Chronic Migraine (trial-derived):

Condition-specific coverage implications

Coverage stance and clinical evidence summarized by condition (evidence/guideline-based):

Chronic migraine: FDA approves onabotulinumtoxinA for prophylaxis of chronic migraine (≥15 headache days/month); evidence reviews (Cochrane, RCTs, AAN) support benefit in chronic migraine with modest reductions in headache days and increased nonserious adverse events.

PREEMPT and systematic review data cited

Episodic migraine and tension-type headache: Evidence is insufficient or indicates no benefit; onaBoNT-A should not be offered for episodic migraine (AAN) and is probably ineffective for tension-type headache.

AAN recommendations

Achalasia: ACG guideline recommends pneumatic dilation, laparoscopic Heller myotomy, or POEM as preferred definitive therapies; botulinum toxin injection is reserved for patients who cannot undergo definitive therapies.

Guideline-based sequencing

This policy applies only to members in the state of Louisiana. Other states are not governed by the medical benefit criteria and processes described in this document; refer to the appropriate state- or plan-specific policy for coverage rules outside Louisiana.

Certain product–indication uses are designated unproven/not medically necessary. Specifically, Daxxify, Dysport, Myobloc, and Xeomin are listed as unproven and not medically necessary for the treatment of chronic migraine. In addition, Botox, Daxxify, Dysport, Myobloc, and Xeomin are listed as unproven and not medically necessary for a range of other indications (examples enumerated in the source include benign prostatic hyperplasia, chronic daily headache, chronic low back pain, gastroparesis, lateral epicondylitis, lower urinary tract dysfunction, myofascial pain syndrome, piriformis syndrome, and others).

The document contains extensive lists of applicable diagnosis codes (ICD-10) associated with botulinum toxin HCPCS/J-codes. These code lists are presented without additional explicit coverage rationale in the cited excerpts; use the listed ICD-10 entries when submitting claims or prior authorization requests but consult the full policy for indication-specific coverage criteria.

Within the provided excerpts there are no explicit general exclusions enumerated; some sections list applicable diagnosis codes only. Refer to the full policy for any comprehensive exclusion lists or plan-specific contractual exclusions.

Randomized trial data indicate that botulinum toxin A is unlikely to be effective for lower urinary tract symptoms due to benign prostatic hyperplasia: a placebo-controlled trial found no difference between BoNT‑A and placebo on the primary symptom score (I-PSS) at 12 weeks, leading the authors to conclude BoNT‑A is unlikely to be an effective therapy for LUTS/BPH.

Per the American Academy of Neurology evidence review cited in the policy, onabotulinumtoxinA (onaBoNT‑A, Botox) should not be offered for episodic migraine (AAN recommendation). This recommendation distinguishes episodic migraine from chronic migraine indications supported for onaBoNT‑A.

The safety and effectiveness of Botox for axillary hyperhidrosis have not been established in pediatric patients under age 18; pediatric use for this indication is therefore not supported by the excerpts provided.

The policy explicitly states that Daxxify, Dysport, Myobloc, and Xeomin are not medically necessary for chronic migraine. This entry functions as an inventory-level note identifying these product–indication combinations as unproven/not medically necessary within the excerpts provided.

In the cited excerpts there are no explicit statements using the phrase 'not medically necessary' beyond those already identified for specific product–indication pairs; other sections are informational or list applicable codes without issuing additional not‑medically‑necessary determinations.

Use of botulinum toxin A for tension‑type headache and numerous miscellaneous indications is described in the literature cited as unsupported or insufficient. Small, uncontrolled, or conflicting studies are reported for many of these conditions, and the policy characterizes these uses as unproven pending larger, well‑designed trials.

The American Academy of Neurology assessment summarized in the policy rates botulinum toxin for headache disorders: it is probably ineffective or not established for episodic migraine and for chronic tension‑type headache (AAN grading indicates lack of supportive high‑quality evidence for benefit in these indications).

The policy notes that FDA approval alone is not a basis for coverage. FDA labeling is provided for informational purposes, but payer coverage decisions require evaluation against the policy criteria rather than automatic coverage based solely on regulatory approval.

Applicable Billing and Diagnosis Codes

Applicable HCPCS CodesHCPCS

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)

Applicable ICD-10 Codes (selected list shown in document)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

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Applicable ICD-10 Codes (neoplasms)ICD-10

D33.9	Benign neoplasm of central nervous system, unspecified
D43.0	Neoplasm of uncertain behavior of brain, supratentorial
D43.1	Neoplasm of uncertain behavior of brain, infratentorial
D43.2	Neoplasm of uncertain behavior of brain, unspecified
D43.3	Neoplasm of uncertain behavior of cranial nerves
D43.4	Neoplasm of uncertain behavior of spinal cord
D43.8	Neoplasm of uncertain behavior of other specified parts of central nervous system

Applicable ICD-10 Codes (movement disorders)ICD-10

D43.9	Neoplasm of uncertain behavior of central nervous system, unspecified
D49.6	Neoplasm of unspecified behavior of brain
G04.1	Tropical spastic paraplegia
G11.4	Hereditary spastic paraplegia
G24.09	Other drug induced dystonia
G24.1	Genetic torsion dystonia
G24.2	Idiopathic nonfamilial dystonia
G24.3	Spasmodic torticollis
G24.4	Idiopathic orofacial dystonia
G24.5	Blepharospasm

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Applicable ICD-10 Codes (MS, NMO, migraine)ICD-10

G35.A	Relapsing-remitting multiple sclerosis
G35.B0	Primary progressive multiple sclerosis, unspecified
G35.B1	Active primary progressive multiple sclerosis
G35.B2	Non-active primary progressive multiple sclerosis
G35.C0	Secondary progressive multiple sclerosis, unspecified
G35.C1	Active secondary progressive multiple sclerosis
G35.C2	Non-active secondary progressive multiple sclerosis
G35.D	Multiple sclerosis, unspecified
G36.0	Neuromyelitis optica [Devic]
G43.701	Chronic migraine without aura, not intractable, with status migrainosus

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Applicable ICD-10 Codes (facial nerve disorders)ICD-10

G51.0	Bell's palsy
G51.1	Geniculate ganglionitis
G51.2	Melkersson's syndrome
G51.31	Clonic hemifacial spasm, right
G51.32	Clonic hemifacial spasm, left
G51.33	Clonic hemifacial spasm, bilateral
G51.39	Clonic hemifacial spasm, unspecified
G51.4	Facial myokymia
G51.8	Other disorders of facial nerve
G51.9	Disorder of facial nerve, unspecified

Applicable ICD-10 Codes (cerebral palsy, hemiplegia)ICD-10

G80.0	Spastic quadriplegic cerebral palsy
G80.1	Spastic diplegic cerebral palsy
G80.2	Spastic hemiplegic cerebral palsy
G80.3	Athetoid cerebral palsy
G80.4	Ataxic cerebral palsy
G80.8	Other cerebral palsy
G80.9	Cerebral palsy, unspecified
G81.10	Spastic hemiplegia affecting unspecified side
G81.11	Spastic hemiplegia affecting right dominant side
G81.12	Spastic hemiplegia affecting left dominant side

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Applicable ICD-10 Codes (strabismus, neurologic conditions)ICD-10

G83.4	Cauda equina syndrome
H49.881	Other paralytic strabismus, right eye
H49.882	Other paralytic strabismus, left eye
H49.883	Other paralytic strabismus, bilateral
H49.889	Other paralytic strabismus, unspecified eye
H49.9	Unspecified paralytic strabismus
H50.21	Vertical strabismus, right eye
H50.22	Vertical strabismus, left eye
H50.60	Mechanical strabismus, unspecified
H50.69	Other mechanical strabismus

Applicable ICD-10 Codes (cerebrovascular disease, infarctions, hemorrhage)ICD-10

H50.9	Unspecified strabismus
H50.89	Other specified strabismus
H51.0	Palsy (spasm) of conjugate gaze
I60.10	Nontraumatic subarachnoid hemorrhage from unspecified middle cerebral artery
I60.11	Nontraumatic subarachnoid hemorrhage from right middle cerebral artery
I60.12	Nontraumatic subarachnoid hemorrhage from left middle cerebral artery
I61.0	Nontraumatic intracerebral hemorrhage in hemisphere, subcortical
I61.1	Nontraumatic intracerebral hemorrhage in hemisphere, cortical
I61.2	Nontraumatic intracerebral hemorrhage in hemisphere, unspecified
I61.3	Nontraumatic intracerebral hemorrhage in brain stem

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Applicable ICD-10 Codes (embolic cerebral infarctions)ICD-10

I63.111	Cerebral infarction due to embolism of right vertebral artery
I63.112	Cerebral infarction due to embolism of left vertebral artery
I63.113	Cerebral infarction due to embolism of bilateral vertebral arteries
I63.119	Cerebral infarction due to embolism of unspecified vertebral artery
I63.12	Cerebral infarction due to embolism of basilar artery
I63.131	Cerebral infarction due to embolism of right carotid artery
I63.132	Cerebral infarction due to embolism of left carotid artery
I63.133	Cerebral infarction due to embolism of bilateral carotid arteries
I63.139	Cerebral infarction due to embolism of unspecified carotid artery

Applicable ICD-10 Codes (occlusion/stenosis of precerebral/cerebral arteries)ICD-10

I63.19	Cerebral infarction due to embolism of other precerebral artery
I63.20	Cerebral infarction due to unspecified occlusion or stenosis of unspecified precerebral arteries
I63.211	Cerebral infarction due to unspecified occlusion or stenosis of right vertebral artery
I63.212	Cerebral infarction due to unspecified occlusion or stenosis of left vertebral artery
I63.213	Cerebral infarction due to unspecified occlusion or stenosis of bilateral vertebral arteries
I63.219	Cerebral infarction due to unspecified occlusion or stenosis of unspecified vertebral artery
I63.22	Cerebral infarction due to unspecified occlusion or stenosis of basilar artery
I63.231	Cerebral infarction due to unspecified occlusion or stenosis of right carotid arteries
I63.232	Cerebral infarction due to unspecified occlusion or stenosis of left carotid arteries
I63.233	Cerebral infarction due to unspecified occlusion or stenosis of bilateral carotid arteries

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Applicable ICD-10 and HCPCS/J codes in excerptmixed

I63.212	Cerebral infarction due to unspecified occlusion or stenosis of bilateral vertebral arteries
I63.213	Cerebral infarction due to unspecified occlusion or stenosis of bilateral vertebral arteries
I63.219	Cerebral infarction due to unspecified occlusion or stenosis of unspecified vertebral artery
I63.22	Cerebral infarction due to unspecified occlusion or stenosis of basilar artery
I63.231	Cerebral infarction due to unspecified occlusion or stenosis of right carotid arteries
I63.232	Cerebral infarction due to unspecified occlusion or stenosis of left carotid arteries
I63.233	Cerebral infarction due to unspecified occlusion or stenosis of bilateral carotid arteries
I63.239	Cerebral infarction due to unspecified occlusion or stenosis of unspecified carotid artery
I63.29	Cerebral infarction due to unspecified occlusion or stenosis of other precerebral arteries
I63.30	Cerebral infarction due to thrombosis of unspecified cerebral artery

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Chronic migraine frequency (diagnostic thresholds)

Headache days per month>= 15 days/month

Migraine days per month>= 8 migraine days/month

Minimum headache durationHeadaches last >= 4 hours per day

PlaceholderNo specific threshold or definition provided in brief/source

Prior Authorization, Documentation, and Step Requirements

Prior Authorization

Authorization duration and frequency limits

For initial therapy: diagnosis and medical records documenting history/physical and diagnostic evidence are required. Botulinum toxin administration is limited to no more frequent than every 12 weeks regardless of diagnosis. Initial authorization will be for no more than 6 months. For continuation: documentation of positive clinical response and statement of expected frequency/duration are required; reauthorization will be for no more than 12 months. Requests may be denied if required documentation is incomplete.

Botulinum toxin administration frequency limit: every 12 weeks.
Initial authorization duration: ≤ 6 months.
Reauthorization duration: ≤ 12 months.

Prior Authorization

PA required for botulinum toxin injections

Prior authorization is required for botulinum toxin injections for indications listed in this policy; requirements may be indication- and dose-specific (for example, Botox dosing limits for cervical/head & neck and overactive bladder are specified). Some plans may require prior authorization consistent with their benefit design; check member’s plan.

Background, Evidence, and Definitions

This policy governs the medical‑benefit use of specified botulinum toxin A and B products across neurologic, gastrointestinal, urologic, and other conditions for UnitedHealthcare members in Louisiana. It defines general requirements (diagnosis confirmation, relevant documentation, frequency limits) and product‑ and indication‑specific criteria used to determine medical necessity.

Definitions and Scales

Initial therapy (definition / requirements)

Initial therapy definitionRequests for initiating botulinum toxin therapy require: diagnosis; medical records with history & physical documenting severity; laboratory or diagnostic evidence supporting indication; administration no more frequent than every 12 weeks; initial authorization ≤ 6 months

Documentation requiredHistory & physical and diagnostic/lab evidence must be included with request

Frequency limitAdministration no more frequent than every 12 weeks regardless of diagnosis

Continuation of therapy (definition / requirements)

Continuation therapy definitionRequests for ongoing treatment require documentation of positive clinical response and a statement of expected frequency and duration; administration no more frequent than every 12 weeks; reauthorization ≤ 12 months

Initial Therapy — Medical Necessity Requirements

Initial Therapy — Initial therapy requirements

Covered when ALL of the following are met

Initial therapy: Diagnosis and medical records documenting history & physical and supporting laboratories/diagnostics; botulinum toxin administration no more frequent than every 12 weeks; initial authorization for no more than 6 months.

Initial therapy (trial-based) — Daxxify trial enrollment criteria

Covered when ALL of the following are met (trial-based enrollment criteria)

Daxxify trial enrollment: Single administration of Daxxify 125 U or 250 U (2.5 mL) divided among affected muscles; prior botulinum toxin treatment allowed if at least 14 weeks have passed since the most recent administration.>= 14 weeks since prior botulinum toxin

Primary endpoint in trial: mean change in TWSTRS averaged over weeks 4 and 6.

Continuation and Retreatment Criteria

Continuation Therapy — continuation therapy requirements

Covered when ALL of the following are met

Continuation requirements: Documentation of positive clinical response to botulinum toxin therapy; statement of expected frequency and duration of proposed treatment; botulinum toxin administration no more frequent than every 12 weeks; reauthorization for no more than 12 months.

Continuation/retreatment — Long-term retreatment data for onabotulinumtoxinA in NDO

Informational — long-term retreatment data for onabotulinumtoxinA in NDO

Retreatment timing and effect: Patients in long-term extension received intradetrusor onabotulinumtoxinA (200 U or 300 U) as needed with treatments separated by ≥12 weeks; onabotulinumtoxinA 200 U consistently reduced UI episodes/day with an overall median duration of effect of approximately 9.0 months.>= 12 weeks

Monitor for urinary tract infection and urinary retention; de novo CIC rates varied across early treatments.

Required Prior Trials and Step Requirements

Indication	Required prior trial(s) or alternatives before botulinum toxin
Achalasia	Failure of or not a candidate for pneumatic dilation (PD) or myotomy (e.g., LHM or POEM); other causes of dysphagia ruled out by upper GI endoscopy
Chronic anal fissure	History of failure, contraindication, or intolerance to at least one conventional topical therapy (topical nitrate OR topical calcium channel blocker such as diltiazem or nifedipine)
Detrusor overactivity / detrusor-sphincter dyssynergia (spinal cord injury/disease)	History of failure, contraindication, or intolerance to two anticholinergic medications (e.g., oxybutynin, trospium, darifenacin, tolterodine)
Overactive bladder (idiopathic) with urgency urinary incontinence	Inadequate response to anticholinergic therapy (trial-level enrollment in phase 3 required prior inadequate response to anticholinergics)
Neurogenic detrusor overactivity (Myobloc)	History of failure, contraindication, or intolerance to two anticholinergic medications (e.g., oxybutynin, trospium, darifenacin, tolterodine)

Documentation element	Notes / examples
List of prior therapies tried	Document specific medications/procedures attempted (e.g., names and dates of anticholinergics, topical nitrates or CCBs, pneumatic dilation, myotomy) as applicable to the indication
Reason prior therapy failed or not used	Provide reason(s) for failure, intolerance, contraindication, or ineligibility (e.g., lack of efficacy, adverse effects, surgical risk)
Diagnostic confirmation relevant to indication	Include confirmatory testing where required (e.g., esophageal manometry for achalasia; baseline scores such as TWSTRS for cervical dystonia; voiding and UI episode counts for bladder indications)
Timing since prior botulinum toxin if applicable	If previously treated with botulinum toxin document interval since last dose (e.g., ≥14 weeks for cervical dystonia trials; ≥12 weeks for intradetrusor retreatment)
Clinical records and objective measures	Provide history & physical, relevant labs/diagnostics, baseline symptom frequency (e.g., UI episodes, micturitions, headache days), and validated rating scales when used

Statement	Supporting detail
No explicit step-therapy rules in these trial/excerpt sections	Clinical trial reports (e.g., Dysport vs Botox, Daxxify vs placebo) describe enrollment and comparator arms but do not define payer step-therapy requirements

Indication / context	Required trial-level enrollment condition
Overactive bladder (onabotulinumtoxinA 100 U phase 3 trial)	Patients enrolled were inadequately treated with anticholinergics prior to receiving onabotulinumtoxinA (trial required prior inadequate response to oral anticholinergics)

Condition	Preferred sequencing before botulinum toxin when patient is a candidate
Achalasia	Pneumatic dilation (PD), laparoscopic Heller myotomy (LHM), or peroral endoscopic myotomy (POEM) are preferred definitive therapies; botulinum toxin injection reserved for patients who cannot undergo these definitive therapies

Dose and Quantity Restrictions

Botox (onabotulinumtoxinA) — 155 units (chronic migraine limit)

Chronic migraine Botox limitOnabotulinumtoxinA 155 units per treatment (with optional up to 195 U using follow-the-pain) every 12 weeks; 155 U specified as primary limit

Typical PREEMPT dosing155 U across 31 fixed sites with discretionary 40 U 'follow-the-pain' to 195 U over 39 sites

Use caseApplied for chronic migraine prophylaxis per PREEMPT protocol

Botox (onabotulinumtoxinA) — 100 units (overactive bladder limit)

OAB Botox limitOnabotulinumtoxinA 100 units per treatment (divided over 20 injection sites) every 12 weeks

Phase 3 trial dose100 U delivered as 20 intradetrusor injections in Nitti et al. phase 3 trial

Site-of-Care Notes

Billing Rule

Site of care — office or hospital outpatient for intradetrusor injections

In procedural indications such as intradetrusor injections, the treatments are typically performed in office or hospital outpatient/ambulatory procedure settings; plan billing should reflect the appropriate site of care.

Intradetrusor injections described in trials imply office or hospital outpatient/ambulatory procedure settings

Billing Rule

Site of care — office or infusion center settings

Intradetrusor injections and trial administration were performed in outpatient or infusion‑capable settings (urology clinics/injection suites); document the intended setting if relevant to billing and authorization.

Office or infusion center settings described in trial conduct

Policy Updates and Change Log

2026-04-01retiredLatest

Policy retired for Louisiana plan membership; Louisiana plan membership disenrolled on Apr. 1, 2026.

2025-10-01effective_period_start

Policy effective period began October 1, 2025 for coverage window through March 31, 2026.

2025-??-??code_updates

Applicable ICD-10 diagnosis code list updated to add G35.A, G35.B0, G35.B1, G35.B2, G35.C0, G35.C1, G35.C2, and G35.D and to remove G35 (annual edits).

OpenPayer

Botulinum Toxins A and B (for Louisiana Only)

Coverage Criteria and Indication-Specific Rules

Applicable Billing and Diagnosis Codes

Prior Authorization, Documentation, and Step Requirements

Background, Evidence, and Definitions

Definitions and Scales

Initial Therapy — Medical Necessity Requirements

Continuation and Retreatment Criteria

Required Prior Trials and Step Requirements

Dose and Quantity Restrictions

Site-of-Care Notes

Policy Updates and Change Log