Colorado Rocky Mountain Health Plans Botulinum Coverage Update

Coverage Criteria for Botulinum Toxins

inv-01: Preferred Product Criteria

Treatment with non‑preferred botulinum toxin products is medically necessary when ONE of the following grouped criteria is met:

Non‑preferred product justification: Either: (1) History of a trial of Botox or Xeomin resulting in minimal clinical response with residual disease activity AND physician attestation that the clinical response would be expected to be superior with the non‑preferred product (e.g., Dysport, Daxxify, Myobloc, or other non‑preferred botulinum toxin); OR (2) History of intolerance, contraindication, or serious adverse event to Botox or Xeomin AND physician attestation that the same intolerance/contraindication/serious adverse event would not be expected with the non‑preferred product.

Supports coverage of Dysport, Daxxify, Myobloc, or other non‑preferred botulinum toxin products when met

inv-02: General Requirements (Applicable to all Medical Necessity Requests)

All requests must meet the following for initial and continuation therapy as specified:

Initial therapy requirements: Diagnosis; medical records documenting history and physical examination documenting severity; laboratory results or diagnostic evidence supporting the requested indication; botulinum toxin administration no more frequent than every 12 weeks; initial authorization for no more than 6 months.

Continuation therapy 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.

inv-03: Dysport — Achalasia

Dysport is medically necessary for achalasia 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; and other causes of dysphagia (e.g., peptic stricture, carcinoma, extrinsic compression) have been ruled out by upper gastrointestinal endoscopy.

inv-04: Dysport — Chronic Anal Fissure

Dysport is medically necessary for chronic anal fissure 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; and history of failure, contraindication, or intolerance to one of the following conventional therapies: topical nitrate OR topical calcium channel blocker (e.g., diltiazem, nifedipine).

inv-05: Cervical Dystonia

Botulinum toxins are medically necessary for cervical dystonia when ALL of the following are met:

Cervical dystonia requirements: Diagnosis of cervical dystonia (spasmodic torticollis); and symptoms including 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).

Applies to Dysport, Daxxify, Xeomin, Botox, and Myobloc per product-specific sections

inv-06: Botox — Detrusor Conditions

Botox is medically necessary for detrusor overactivity or detrusor‑sphincter dyssynergia when BOTH of the following are met:

Botox for detrusor conditions: Diagnosis of detrusor overactivity OR detrusor‑sphincter dyssynergia due to spinal cord injury or disease; AND history of failure, contraindication, or intolerance to two anticholinergic medications (examples: oxybutynin, trospium, darifenacin, tolterodine).

inv-07: Botox — Chronic Migraine

Botox is medically necessary for prophylaxis of chronic migraine when ALL of the following are met:

Chronic migraine criteria: Diagnosis of chronic migraine defined as ≥15 headache days per month and ≥8 migraine days per 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 of the following classes: antidepressant, antiepileptic, beta blocker; AND Botox dose does not exceed 155 units administered intramuscularly divided over 31 injection sites across 7 head and neck muscles every 12 weeks.≤155 units per 12 weeks

PREEMPT dosing schema supported by pooled phase 3 trials

inv-08: Cervical dystonia

Covered when ALL of the following are met

Cervical dystonia criteria: Diagnosis of cervical dystonia.

Cervical dystonia symptoms: 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).

inv-09: Detrusor overactivity / Neurogenic detrusor overactivity

Covered when ALL of the following are met

Diagnosis of detrusor overactivity or detrusor‑sphincter dyssynergia due to spinal cord injury or disease (neurogenic detrusor overactivity).

Prior therapy: History of failure, contraindication, or intolerance to two anticholinergic medications (e.g., oxybutynin, trospium, darifenacin, tolterodine).2 failed anticholinergics

inv-10: Chronic migraine prophylaxis

Covered when ALL of the following are met

Diagnosis of chronic migraine meeting policy definition (≥15 headache days/month, ≥8 migraine days/month, headaches ≥4 hours/day).

Prior therapy: History of failure (after trial of ≥2 months), contraindication, or intolerance to prophylactic therapy with one agent from two of the following classes: antidepressant, antiepileptic, beta blocker.trial durations: ≥2 months for agent

examples include amitriptyline, venlafaxine, divalproex/topiramate, atenolol/propranolol/nadolol/timolol/metoprolol

Dose limit: OnabotulinumtoxinA (Botox) dose does not exceed 155 units intramuscularly divided over 31 injection sites across 7 head and neck muscles every 12 weeks.≤155 units per 12 weeks

inv-11: Overactive bladder

Covered when ALL of the following are met

Diagnosis of overactive bladder.

Symptoms: Urge urinary incontinence OR urgency OR frequency.

Prior therapy: History of failure, contraindication, or intolerance to two anticholinergic medications (e.g., oxybutynin, trospium, darifenacin, tolterodine).2 failed anticholinergics

Dose limit: Botox dose does not exceed 100 units divided over 20 intradetrusor injection sites every 12 weeks.≤100 units per 12 weeks

inv-12: Myobloc indications

Covered for listed indications when diagnosis matches

Myobloc indications: Myobloc (rimabotulinumtoxinB) is medically necessary for cervical dystonia, neurogenic detrusor overactivity, chronic sialorrhea, and spasticity associated with cerebral palsy, multiple sclerosis, neuromyelitis optica spectrum disorder, stroke, or other CNS injury/disease/tumor when the diagnosis and product-specific criteria are met.

Specific prior therapy requirements apply for neurogenic detrusor overactivity (two failed anticholinergics)

inv-13: Intradetrusor therapy (NDO/UI)

Covered when ALL of the following clinical trial–based conditions are met (inferred from trial populations):

NDO/Intradetrusor onabotulinumtoxinA (200U or 300U): Patient has urinary incontinence due to neurogenic detrusor overactivity; prior treatments optimized; retreatment interval ≥ 12 weeks since prior onabotulinumtoxinA administration; and treatment is justified by urinary incontinence episode thresholds similar to trials.>=12 weeks since prior treatment

Dose and response data support 200U (median duration ~9 months); document risk of urinary retention and urinary tract infection; de novo CIC rates observed in trials

inv-14: Chronic migraine prophylaxis

Covered when ALL of the following align with the PREEMPT program evidence (chronic migraine prophylaxis):

Chronic migraine — onabotulinumtoxinA: Adults meeting chronic migraine criteria treated with onabotulinumtoxinA per PREEMPT dosing (155 units fixed-site with optional up to 195 units using 'follow-the-pain'); treatment cycles every 12 weeks with demonstrated reductions in headache days and improvements in HIT-6/MSQ; adverse events include neck pain and muscular weakness.155 units per cycle (±40 units) every 12 weeks

Benefit demonstrated across pooled phase 3 trials and long-term analyses

inv-15: Cervical dystonia / focal movement disorders

Covered when ALL of the following clinical trial conditions are met (cervical dystonia / focal dystonia evidence):

Cervical dystonia — multiple products: Adults with clinical cervical dystonia meeting trial inclusion features (disease duration, baseline severity) including those previously treated with botulinum toxin (with required minimum interval since prior dose in trials, e.g., ≥14 weeks) and dosed per product labeling; units are product‑specific and not interchangeable/conversion ratios vary by study/product.For Daxxify: 125U or 250U single administration evaluated; trials required ≥14 weeks since prior botulinum toxin for previously treated patients

Comparative trials used specific conversion ratios; individualize dosing per product labeling

inv-16: Pediatric spasticity (cerebral palsy)

Covered when ALL of the following conditions are met (pediatric spasticity, cerebral palsy):

Spasticity in cerebral palsy (abobotulinumtoxinA): Children with dynamic equinus foot deformity demonstrated on clinical exam; prior exposure to botulinum toxin does not preclude benefit; treatment with abobotulinumtoxinA at evaluated doses (10 U/kg/leg or 15 U/kg/leg) produced improvement in Modified Ashworth Scale and Physician's Global Assessment at week 4.Dose ranges evaluated: 10U/kg/leg and 15U/kg/leg

Most common AE was muscular weakness; prior toxin exposure did not alter safety or effectiveness in subgroup analyses

inv-17: BPH / LUTS

Not covered / unlikely to be supported when trial results show no benefit versus placebo:

Benign prostatic hyperplasia (LUTS/BPH): Randomized trials did not demonstrate benefit of botulinum toxin A over placebo for International Prostate Symptom Score (I-PSS), peak urinary flow (Qmax), total prostate volume (TPV), or post‑void residual (PVR) at 12 or 24 weeks; therefore BoNT‑A is unlikely to be a covered therapy for male LUTS/BPH based on available evidence.N/A

One phase III trial also inconclusive likely due to placebo effect

inv-18: Idiopathic overactive bladder

Covered when ALL of the following align with evidence (idiopathic overactive bladder):

Idiopathic overactive bladder (OAB): Adults with idiopathic OAB who have ≥3 urgency urinary incontinence episodes in a 3‑day period and ≥8 micturitions per day AND are inadequately treated with anticholinergics; onabotulinumtoxinA 100U given as 20 intradetrusor injections demonstrated clinically meaningful benefit versus placebo.>=3 urgency UI episodes in 3 days; >=8 micturitions/day

Monitor for UTI and urinary retention; ~5.4% urinary retention observed in trials

inv-19: Cervical dystonia - supported by RCTs

Covered when evidence supports benefit with criteria from systematic reviews:

Cervical dystonia: Single botulinum toxin type A treatment sessions in RCTs are associated with clinically relevant reductions in TWSTRS total score and pain at week 4 compared with placebo; doses used in trials varied by formulation (e.g., 150–236U onabotulinumtoxinA, 120–240U incobotulinumtoxinA, 250–1000U abobotulinumtoxinA).dose ranges per formulation

Moderate‑certainty evidence supports benefit but RCTs typically evaluated single sessions; repeated‑cycle data are lacking

inv-20: Chronic migraine - conditional benefit

Covered with limited benefit when criteria match trial populations:

Chronic migraine: Botulinum toxin type A may reduce migraine days by approximately 1.9–3.1 days/month in chronic migraine populations versus placebo; trials used up to three rounds at three‑month intervals and reported increased adverse events compared with placebo.treatment protocols up to three rounds at 12‑week intervals

Evidence quality varies; benefit uncertain for episodic migraine

inv-21: Achalasia - reserved indication

Covered only when specific conditions are met:

Achalasia: Botulinum toxin injection is reserved for patients who are not candidates for definitive therapies (pneumatic dilation, laparoscopic Heller myotomy, or peroral endoscopic myotomy); recommend botulinum toxin as first‑line only for patients unfit for definitive therapies due to lower long‑term remission compared with pneumatic dilation or myotomy.use when patient unfit for PD/LHM/POEM

PD has superior long‑term remission rates; botulinum toxin has fewer immediate serious adverse events but worse durability

inv-22: BPH - not supported

Not recommended / lack of benefit:

Benign prostatic hyperplasia: Randomized trial evidence showed no difference in I‑PSS between BoNT‑A and placebo at primary endpoints; BoNT‑A is unlikely to be an effective therapy for male LUTS/BPH based on available data.single intraprostatic injection studies

Subsequent phase III trial inconclusive due to potential placebo effect

inv-23: CDH / Tension headache - unproven

Insufficient or mixed evidence (not routinely covered as proven):

Chronic daily headache / tension-type headache: Trials for chronic daily headache and tension‑type headache show mixed or predominantly negative results; evidence is insufficient to support routine coverage for these indications.multiple RCTs with variable designs and outcomes

Further larger, well‑designed trials recommended

inv-24: Other indications - insufficient evidence

Experimental / insufficient evidence across many other indications:

Miscellaneous indications: Numerous small, uncontrolled, or low‑quality studies exist for conditions including cricopharyngeal dysphagia, gustatory epiphora, sphincter of Oddi dysfunction, pelvic floor spasticity, chronic prostatic pain, severe paradoxical vocal cord movement, trigeminal neuralgia, Tourette's syndrome, stiff‑person syndrome, and many others; larger well‑designed trials are required before routine coverage as proven therapies.small/uncontrolled studies

Some condition‑specific guideline recommendations exist (see guideline sections)

inv-25: Covered and guideline-supported indications

Guideline-based recommendations (grouped by condition) — summarize when BoNT should be offered, considered, or reserved

Movement disorders and dystonias: BoNT should be offered for cervical dystonia and blepharospasm (Level A); may be offered or considered for hemifacial spasm and focal dystonias (Levels B–C); specific products (Dysport, Xeomin, Botox, Myobloc) are recommended depending on indication and FDA labeling.

See referenced guideline recommendations for product‑level guidance

Spasticity: BoNT should be offered for adult spasticity and for localized/segmental spasticity in children with cerebral palsy (Level A for BoNT‑A formulations); product‑specific evidence varies for passive vs active function improvement.

Chronic migraine: OnabotulinumtoxinA (Botox) is established and should be offered for prophylaxis of chronic migraine (defined as ≥15 headache days/month with headaches ≥4 hours/day).

PREEMPT program evidence supports this indication

Any U.S. Food and Drug Administration (FDA)‑approved and launched botulinum toxin product that is not explicitly named in this policy will be treated as non‑preferred pending review by UnitedHealthcare. This means coverage of such products will generally require documentation meeting the policy's Preferred Product Criteria (e.g., prior trial and inadequate response or intolerance to preferred agents or physician attestation of expected superior response) and prior authorization before benefits will be approved.

Daxxify, Dysport, Myobloc, and Xeomin are listed in this policy as unproven and not medically necessary for chronic migraine. More broadly, Botox, Daxxify, Dysport, Myobloc, and Xeomin are identified as unproven and not medically necessary for a substantial list of other indications (for example, tension‑type headache and many miscellaneous neurologic and gastrointestinal conditions); see the policy's unproven/not medically necessary list for the specific conditions enumerated.

This section of the policy does not itself establish additional clinical coverage criteria or exclusions; rather it provides the applicable ICD‑10 diagnosis codes and associated HCPCS/drug indicator mappings used to support coverage adjudication and claims submission for botulinum toxin products. Providers should pair the appropriate diagnosis code from this list with the HCPCS drug code when billing and include supporting documentation per the policy.

Randomized trial evidence for intraprostatic botulinum toxin A in men with benign prostatic hyperplasia (LUTS/BPH) did not demonstrate benefit versus placebo for primary outcomes (I‑PSS) or secondary measures (Qmax, TPV, PVR) at 12 or 24 weeks. Consequently, BoNT‑A is unlikely to be an effective therapy for LUTS/BPH based on available randomized data and is not supported as a covered treatment for this indication.

Use of botulinum toxin A for lower urinary tract symptoms due to benign prostatic hyperplasia is not supported by randomized controlled trial evidence. The randomized trial cited in this policy showed no difference between BoNT‑A and placebo on the International Prostate Symptom Score and related measures, and subsequent phase III data were inconclusive; therefore coverage for LUTS/BPH is unlikely.

Evidence summaries and guideline recommendations in this policy indicate that onabotulinumtoxinA (Botox) should not be offered for episodic migraine (Level A) and should not be considered for tension‑type headache (Level B). These recommendations reflect specialty review conclusions about lack of demonstrated benefit for those migraine subtypes and for tension‑type headache.

During the recent template update documented in Policy History, content and language pertaining specifically to the state of Louisiana were removed from this policy. The revision is reflected in the policy history (effective 04/01/2026).

The policy identifies a range of listed botulinum toxin products and multiple indications for which available evidence is judged unproven. Use of the listed products for those enumerated unproven conditions is classified in this document as not medically necessary.

This portion of the document is an index of diagnosis codes intended to guide billing and adjudication and does not itself define additional specific Not Medically Necessary conditions. It is provided to ensure accurate mapping between the diagnosis code reported on a claim and the HCPCS/drug indicator when assessing medical necessity under the policy.

The policy summarizes evidence for botulinum toxin A in tension‑type headache and chronic tension‑type headache as insufficient or mixed. Multiple randomized controlled trials have not shown consistent benefit; therefore use of BoNT‑A for these headache subtypes is considered unproven and is not supported for routine coverage pending higher‑quality positive trials.

Systematic review and guideline evidence do not support botulinum toxin efficacy for episodic migraine or tension‑type headache. Specialty review conclusions cited in the policy (e.g., AAN guidance and Cochrane analyses) characterize benefit as limited to specific indications (for example, Botox for chronic migraine) and conclude that BoNT is not effective for episodic migraine or for tension‑type headache.

Coding — Diagnosis and Billing Codes

Applicable HCPCS J-codesHCPCS

J0585	Injection, onabotulinumtoxinA, 1 unit. Brand Name = Botox.
J0586	Injection, abobotulinumtoxinA, 5 units. Brand Name = Dysport.
J0587	Injection, rimabotulinumtoxinB, 100 units. Brand Name = Myobloc.
J0588	Injection, incobotulinumtoxinA, 1 unit. Brand Name = Xeomin.
J0589	Injection, daxibotulinumtoxina-lanm, 1 unit. Brand Name = Daxxify.

Selected ICD-10 diagnosis codes referencedICD-10

G43.701	Chronic migraine without aura, not intractable, with status migrainosus.
G43.709	Chronic migraine without aura, not intractable, without status migrainosus.
G43.711	Chronic migraine without aura, intractable, with status migrainosus.
G43.719	Chronic migraine without aura, intractable, without status migrainosus.
G43.E01	Chronic migraine with aura, not intractable, with status migrainosus.
G43.E09	Chronic migraine with aura, not intractable, without status migrainosus.
G43.E11	Chronic migraine with aura, intractable, with status migrainosus.
G43.E19	Chronic migraine with aura, intractable, without status migrainosus.
G24.3	Spasmodic torticollis (cervical dystonia).
G24.2	Idiopathic nonfamilial dystonia.

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Strabismus and ocular motor disorder ICD-10 codesICD-10Covered

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
H50.9	Unspecified strabismus
H50.89	Other specified strabismus
H51.0	Palsy (spasm) of conjugate gaze

Hemorrhagic and ischemic cerebrovascular disease ICD-10 codes (partial list)ICD-10Covered

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
I61.4	Nontraumatic intracerebral hemorrhage in cerebellum
I61.5	Nontraumatic intracerebral hemorrhage, intraventricular
I61.6	Nontraumatic intracerebral hemorrhage, multiple localized

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HCPCS / drug indicators referenced alongside diagnosesHCPCS

J0585
J0586
J0587
J0588
J0589

Applicable ICD-10 Diagnosis Codes mapped to J0585–J0589ICD-10

I63.542	Cerebral infarction due to unspecified occlusion or stenosis of left cerebellar artery
I63.543	Cerebral infarction due to unspecified occlusion or stenosis of bilateral cerebellar arteries
I63.549	Cerebral infarction due to unspecified occlusion or stenosis of unspecified cerebellar artery
I63.59	Cerebral infarction due to unspecified occlusion or stenosis of other cerebral artery
I63.6	Cerebral infarction due to cerebral venous thrombosis, nonpyogenic
I63.81	Other cerebral infarction due to occlusion or stenosis of small artery
I63.89	Other cerebral infarction
I63.9	Cerebral infarction, unspecified
J38.5	Laryngeal spasm
K11.7	Disturbances of salivary secretion

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Chronic migraine diagnostic threshold — inv-43

Diagnostic threshold≥15 headache days per month AND ≥8 migraine days per month; headaches lasting ≥4 hours/day

PopulationAdults meeting chronic migraine criteria as defined above

Support for requirementUsed as the diagnostic definition required for Botox chronic migraine prophylaxis

Chronic migraine dosing limit — inv-44

Maximum dose per cycleOnabotulinumtoxinA (Botox) ≤155 units per 12 weeks

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior Authorization Required and Authorization Durations

Prior authorization is required for botulinum toxin product requests. Initial authorizations are limited to no more than 6 months; reauthorizations (continuation of therapy) are limited to no more than 12 months. Botulinum toxin administration must be no more frequent than every 12 weeks regardless of diagnosis. Prior authorization requests must reference the specific product, the FDA indication when applicable, and acknowledge known product safety risks (including the boxed warning for distant spread of toxin effect).

Initial authorization: ≤ 6 months
Reauthorization/continuation: ≤ 12 months
Minimum interval between administrations: ≥ 12 weeks

Billing Rule

HCPCS–Product to ICD‑10 Diagnosis Code Pairing and Claim Coding

Initial Therapy — Medical Necessity Rules

inv-88: Initial Therapy

Initial therapy requirements and authorization limits

Initial therapy: Diagnosis; medical records documenting history and physical with severity; laboratory or diagnostic evidence supporting indication; botulinum toxin administration no more frequent than every 12 weeks; initial authorization for no more than 6 months.

inv-89: Initial therapy

Initial therapy criteria for specific indications

Chronic migraine init: Diagnosis per policy AND failure/intolerance/contraindication to one agent from two prophylactic classes AND Botox dose ≤155 units every 12 weeks.

trial durations for prior prophylactic agents ≥2 months

Overactive bladder init:

Continuation and Reauthorization Criteria

inv-93: Continuation Therapy

Continuation of therapy requirements and authorization limits

Continuation therapy: Documentation of positive clinical response; 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.

inv-94: Intradetrusor continuation therapy

Long-term retreatment evidence for intradetrusor onabotulinumtoxinA in NDO:

Retreatment criteria for NDO: Patients retreated as‑needed with intradetrusor onabotulinumtoxinA (200U or 300U) at intervals ≥12 weeks with UI episode thresholds; median duration of effect for 200U approximately 9 months; monitor for urinary tract infection and urinary retention including need for intermittent catheterization.>=12 weeks between treatments

De novo CIC rates and other AEs reported across treatments

Step Therapy and Product Preference Rules

Requirement	Details
Physician attestation
Physician documents that a trial of preferred product (Botox or Xeomin) resulted in minimal clinical response OR documents intolerance/contraindication/adverse event to Botox or Xeomin, and attests that the non-preferred product is expected to provide superior clinical response or avoid the prior intolerance/adverse event.

Requirement	Documentation expected
Prior medication trials for chronic migraine
History of failure, contraindication, or intolerance after trial (≥2 months) of prophylactic therapy with one agent from two classes (antidepressant, antiepileptic, beta blocker) is required for Botox chronic migraine criteria.
Prior medication trials for detrusor overactivity/overactive bladder
History of failure, contraindication, or intolerance to two anticholinergic medications (e.g., oxybutynin, trospium, darifenacin, tolterodine) is required before Botox or Myobloc for detrusor/OAB indications.

Evidence point	Relevance to step requirement
Idiopathic OAB phase 3 trial (Nitti et al.)
Adults enrolled had inadequate response to anticholinergics (≥3 urgency UI episodes in 3 days and ≥8 micturitions/day); onabotulinumtoxinA 100U showed benefit compared with placebo, supporting requirement for prior anticholinergic therapy before BoNT-A.
Neurogenic detrusor overactivity long-term study
Open-label extension of phase III trials treated patients 'as needed' after prior treatments; patients were retreated ≥12 weeks after previous treatment—supports that trial populations were inadequately treated with anticholinergics prior to receiving intradetrusor onabotulinumtoxinA.

Step requirement	Policy instruction
Use reserved after evaluation
Botulinum toxin injection for achalasia is reserved for patients who cannot undergo definitive therapies (pneumatic dilation, laparoscopic Heller myotomy, or POEM); recommend botulinum toxin as first-line only for patients unfit for definitive therapies.

Placement	Alternative use guidance
Step placement
Botulinum toxin is reserved for patients unfit for definitive achalasia therapies (PD, LHM, POEM) and is recommended as first-line only in that population; use may be considered as an alternative to less effective pharmacologic therapies in these patients.

Quantity Limits and Dosing Constraints

Botox — quantity limit value 155 (per 12 weeks for chronic migraine) — inv-102

Quantity limit (chronic migraine)155

ContextMaximum Botox units per 12-week treatment cycle for chronic migraine prophylaxis

Associated codeTypically billed using applicable HCPCS J-codes (J0585–J0589) paired with chronic migraine ICD-10 codes

Botox (onabotulinumtoxinA) — 155 units — inv-103

Product/doseBotox (onabotulinumtoxinA) — 155 units

Indication contextDose referenced for chronic migraine PREEMPT regimen per policy

Administration interval

Site of Care Considerations

Note

Background — Botulinum Toxins Overview

Background: Botulinum toxins types A and B are neuromuscular blocking agents with seven serologically distinct neurotoxin forms (A–G). These agents act at presynaptic nerve terminals to inhibit neurotransmitter release and are used therapeutically across a range of spasticity, dystonia, hypersecretory, and other disorders when supported by evidence and product labeling.

Definitions and Key Terms

Initial therapy — inv-78

Initial therapyInitial therapy (definition placeholder) — see General Requirements for documentation and authorization limits

Key elementsDiagnosis, history & physical documenting severity, laboratory/diagnostic evidence, administration no more frequent than every 12 weeks; initial auth ≤6 months

PurposeUsed to distinguish requirements for initial medical necessity requests versus continuation

Continuation of therapy — inv-79

Continuation of therapyContinuation of therapy (definition placeholder) — documentation of positive clinical response and statement of expected frequency/duration required

Frequency limitBotulinum toxin administration no more frequent than every 12 weeks for continuation requests

OpenPayer

Botulinum Toxins A and B Medical Benefit Drug Policy

Coverage Criteria for Botulinum Toxins

Coding — Diagnosis and Billing Codes

Provider Actions, Prior Authorization & Documentation

Initial Therapy — Medical Necessity Rules

Continuation and Reauthorization Criteria

Step Therapy and Product Preference Rules

Quantity Limits and Dosing Constraints

Site of Care Considerations

Background — Botulinum Toxins Overview

Definitions and Key Terms