Currentsierra health and lifePolicy 2026D0017AN

Medical Benefit Drug Policy

Medical benefit drug policy governing coverage and medical necessity criteria for multiple botulinum toxin products (abobotulinumtoxinA, daxibotulinumtoxinA-lanm, incobotulinumtoxinA, onabotulinumtoxinA, rimabotulinumtoxinB) including general requirements, diagnosis-specific proven/unproven indications, and applicable HCPCS/J-codes and ICD-10 diagnosis pairings.

Policy Summary

Payersierra health and life

PolicyMedical Benefit Drug Policy

Policy CodePolicy 2026D0017AN

Change TypeCoverage criteria updateMyobloc requirementsDaxxify exclusion

Effective DateJan 1, 2026

Next Review Date

Key ActionPrescriber must attest dosing is per FDA-approved labeling or, for non‑FDA dosing, that published clinical evidence supports the dosing and document required step/alternative failures for Myobloc prior to authorization.

SourceLink

POLICY UPDATE CHANGES

Added reference link to Medical Benefit Therapeutic Equivalent Medications - Excluded Drugs Coverage Rationale and language indicating Daxxify is typically excluded from coverage.

Added language that coverage for Dysport, Xeomin, Botox, Myobloc is contingent on criteria in the General Requirements and Diagnosis-Specific Requirements sections.

Added explicit medical necessity criteria for Myobloc for cervical dystonia, detrusor overactivity, sialorrhea, and spasticity including required prior failure/intolerance to alternatives and 12-month authorization limits.

Revised list of proven indications: replaced specific etiologies (cerebral palsy, MS, NMOSD, stroke, other injury/disease/tumor) with the single term 'spasticity'.

Added CMS section and Medicare LCD references for Botulinum Toxins.

5Products referenced

MultipleProven indications listed

>=12wMinimum interval between administrations

4Myobloc criteria count

DaxxifyTypically excluded product

Coverage summary

Policy 2026D0017AN (effective January 1, 2026, last reviewed October 10, 2025) governs medical benefit coverage for multiple botulinum toxin products: Dysport (abobotulinumtoxinA), Xeomin (incobotulinumtoxinA), Botox (onabotulinumtoxinA), Myobloc (rimabotulinumtoxinB), and the product Daxxify (daxibotulinumtoxinA‑lanm) (which is typically excluded from coverage).

Coverage is contingent on meeting the policy's General Requirements and diagnosis‑specific criteria; injections must be administered no more frequent than every 12 weeks. Myobloc has additional prior‑use/step requirements and authorization limits: initial and reauthorization approvals are limited to no more than 12 months when used for specified indications.

General medical necessity requirements

Covered when ALL of the following are met:

ALL of the following

Diagnosis; and

Policy Summary

Payersierra health and life

PolicyMedical Benefit Drug Policy

Policy CodePolicy 2026D0017AN

Change TypeCoverage criteria updateMyobloc requirementsDaxxify exclusion

Effective DateJan 1, 2026

Next Review Date

SourceLink

On This Page

Indication-specific proven uses (by product)

Proven Indications by Product

Covered when diagnosis matches product-specific proven indications and general requirements are met:

Dysport (abobotulinumtoxinA) proven indications

Achalasia
Anal fissures, chronic
Blepharospasm associated with dystonia
Cervical dystonia (spasmodic torticollis)
Detrusor overactivity or detrusor-sphincter dyssynergia due to spinal cord injury or disease
Essential tremor
Hand dystonia (writer's, musician's, or typist's cramp)
Hemifacial spasm (seventh cranial nerve disorders)
Hyperhidrosis including gustatory sweating (Frey's syndrome)
Oromandibular dystonia
Sialorrhea
Spasmodic dysphonia (laryngeal dystonia)
Spasticity
Strabismus
Tongue dystonia
Torsion dystonia

Daxxify (daxibotulinumtoxinA-lanm) proven indications: Cervical dystonia (spasmodic torticollis)

Xeomin (incobotulinumtoxinA) proven indications

Blepharospasm associated with dystonia
Cervical dystonia (spasmodic torticollis)
Sialorrhea
Spasticity

Botox (onabotulinumtoxinA) proven indications

Achalasia
Anal fissures, chronic
Blepharospasm associated with dystonia
Cervical dystonia (spasmodic torticollis)
Detrusor overactivity or detrusor-sphincter dyssynergia due to spinal cord injury or disease
Essential tremor
Hand dystonia (writer's, musician's, or typist's cramp)

Myobloc (rimabotulinumtoxinB) proven indications: Cervical dystonia (spasmodic torticollis)

Initial therapy criteria — product-specific

Myobloc Additional Medical Necessity Requirements (product-specific) - Initial therapy branches

Myobloc is medically necessary for specified conditions when ALL of the following are met:

Cervical dystonia - initial therapy

Diagnosis of cervical dystonia
Step/alternative requirement: History of failure, contraindication, or intolerance to one of: Botox, Dysport, Xeomin
Must fail one of listed alternatives
Initial authorization limit: Initial authorization will be for no more than 12 monthsno more than 12 months
Applies to initial therapy

Detrusor overactivity - initial therapy

Diagnosis of detrusor overactivity
Step/alternative requirement: History of failure, contraindication, or intolerance to one of: Botox, Dysport
Must fail one of listed alternatives
Initial authorization limit: Initial authorization will be for no more than 12 monthsno more than 12 months
Applies to initial therapy

Sialorrhea - initial therapy

Diagnosis of sialorrhea
Step/alternative requirement: History of failure, contraindication, or intolerance to one of: Botox, Dysport, Xeomin
Must fail one of listed alternatives
Initial authorization limit: Initial authorization will be for no more than 12 monthsno more than 12 months
Applies to initial therapy

Spasticity - initial therapy

Diagnosis of spasticity
Step/alternative requirement: History of failure, contraindication, or intolerance to one of: Botox, Dysport, Xeomin
Must fail one of listed alternatives
Initial authorization limit: Initial authorization will be for no more than 12 monthsno more than 12 months
Applies to initial therapy

Unproven / Not medically necessary indications

Unproven / Not Medically Necessary Indications

Not medically necessary when used for the following:

Chronic migraine - unproven: Daxxify, Dysport, Myobloc, and Xeomin for chronic migraine headache

These products are unproven for chronic migraine

Botox, Daxxify, Dysport, Myobloc, Xeomin unproven/not medically necessary for

Acquired nystagmus
Anismus (pelvic floor dyssynergia)
Benign prostatic hyperplasia
Brachial plexus palsy
Chronic daily headache
Chronic low back pain
Chronic prostatic pain
Cricopharyngeal dysphagia (excludes achalasia)
Epiphora following salivary gland transplantation
Esophageal spasm
Gastroparesis (including diabetic gastroparesis)
Gustatory epiphora (crocodile tears)
Lateral epicondylitis (tennis elbow)
Lichen simplex
Lower urinary tract (voiding) dysfunction
Motor tics
Myofascial pain syndrome
Nasal hypersecretion
Pain and/or wound healing after hemorrhoidectomy
Pancreas divisum
Piriformis syndrome
Post-parotidectomy sialoceles
Post-thoracotomy pseudoangina
Proctalgia fugax
Severe bruxism
Severe paradoxical vocal cord movement
Sphincter of Oddi dysfunction
Temporomandibular disorders
Tension-type headache
Thyroid associated ophthalmopathy
Tourette's syndrome
Traumatic sixth nerve palsy
Trigeminal neuralgia
Trismus and stridor in ALS: Trismus and stridor in amyotrophic lateral sclerosis

Note: Cosmetic uses of botulinum toxins are generally excluded by most Certificates of Coverage and SPDs; hyperhidrosis coverage may also be specifically excluded. Member‑specific benefit documents and any applicable state mandates or Medicare guidance may supersede this policy and should be checked when making coverage determinations.

Applicable codes (HCPCS / ICD-10 mappings)

HCPCS/J-codes for botulinum toxinsHCPCS

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 diagnosis codes listed (pairings to HCPCS indicated 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

1–10 of 12

1/2

HCPCS referenced in mappings (mapping summary)HCPCS

J0585	Mapped to multiple ICD-10 brain and spinal neoplasm codes (see list)
J0586	Mapped to multiple ICD-10 brain and spinal neoplasm codes (see list)
J0587	Mapped to multiple ICD-10 brain and spinal neoplasm codes (see list)
J0588	Mapped to multiple ICD-10 brain and spinal neoplasm codes (see list)
J0589	Not mapped to the listed ICD-10 neoplasm codes in document (Daxxify)

Clinical evidence and guideline summaries

-8.4 vs -6.6PREEMPT pooled migraine days change at 24 weeks

69.6% vs 62.8%PREEMPT week 56 ≥50% responder (BoNT-A only vs placebo→BoNT-A)

9.0 moNDO median duration of effect for onabotulinumtoxinA (200U)

Key trial and guideline findings summarized: a randomized crossover study comparing Dysport and Botox in cervical dystonia (n=102) demonstrated non‑inferiority of Dysport at a 2.5:1 unit ratio with a non‑significant trend favoring Botox; a randomized placebo‑controlled trial of Daxxify (n=301) showed both 125U and 250U doses significantly improved TWSTRS total score versus placebo.

For chronic migraine, pooled PREEMPT analyses of onabotulinumtoxinA showed significant reductions in headache days (example at 24 weeks -8.4 vs -6.6 days, p < 0.001) and higher ≥50% responder rates at week 56 (example 69.6% vs 62.8%, p = 0.023), with consistent benefit on HIT‑6 and MSQ measures.

Long‑term intradetrusor onabotulinumtoxinA data (open‑label extension up to 3 years) demonstrated sustained reductions in urinary incontinence episodes with median duration of effect ~9.0 months (200U); common adverse events included urinary tract infection and urinary retention.

Spasticity and cerebral palsy studies (abobotulinumtoxinA) showed significant improvements on the Modified Ashworth Scale at week 4 (e.g., mean differences ~-0.38 to -0.49 versus placebo) and improved Physician Global Assessment.

Evidence‑grading recommendations from authoritative reviews (AAN/Toxicon summaries): products with Level A evidence include Dysport, Xeomin (for upper limb spasticity), Botox (upper/lower limb spasticity and chronic migraine), and Myobloc (cervical dystonia); Level B/C/U designations vary by product and indication as cited in the policy.

Background, benefit considerations, and definitions

Background: Botulinum neurotoxins comprise serotypes A–G; type A products (onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA) cleave SNAP‑25, while type B cleaves synaptobrevin. Potency units are specific to each product and assay method and are not interchangeable across preparations.

Benefit considerations: many plans consider botulinum toxin injections cosmetic when used solely for appearance or without demonstrable functional impairment; hyperhidrosis is often excluded by COCs/SPDs. The policy requires that administration intervals adhere to the General Requirements (e.g., no more frequent than every 12 weeks).

Regulatory and payer context: FDA approvals and professional guidelines are summarized for informational use only; Medicare has no NCD for botulinum toxins but multiple LCDs apply and member‑specific benefit documents, state mandates, or Medicare guidance may supersede this policy.

Term	Definition
Chronic migraine	Defined in policy as ≥ 15 headache days per month, ≥ 8 migraine days per month, and headaches lasting 4 hours or longer.
Botulinum toxin unit	Potency units are specific to the preparation and assay method; units are not interchangeable across different botulinum toxin products.
BoNT-A	Botulinum neurotoxin type A (includes onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA).
PREEMPT	Phase III Research Evaluating Migraine Prophylaxis Therapy clinical program for onabotulinumtoxinA (used in pooled trials of chronic migraine).
HIT-6	Headache Impact Test-6, a measure of headache impact/severity used in migraine clinical trial assessments.
Level A/B/C/U (Evidence grading)	Level A = established as effective; Level B = probably effective/consider; Level C = may be considered; Level U = insufficient/conflicting evidence (grading per AAN methodology).

Revision history

2026-01-01policy_effectiveLatest

Added reference to Medical Benefit Therapeutic Equivalent Medications - Excluded Drugs and language indicating Daxxify is typically excluded from coverage; coverage reviews may be required by law or benefit plan.

2026-01-01policy_updateLatest

Added language that coverage for Dysport, Xeomin, Botox, and Myobloc is contingent on meeting criteria in the General Requirements and Diagnosis-Specific Requirements sections.

2026-01-01policy_updateLatest

Added explicit Myobloc product-specific medical necessity criteria for cervical dystonia, detrusor overactivity, sialorrhea, and spasticity requiring history of failure, contraindication, or intolerance to specified alternative botulinum toxin products and specifying initial and reauthorization authorizations will be for no more than 12 months.

2026-01-01policy_updateLatest

Specified administration frequency limit: botulinum toxin administration is no more frequent than every 12 weeks (General Requirements).

2026-01-01policy_updateLatest

Revised proven indications lists to replace detailed etiologies of spasticity with the single term 'spasticity', and revised unproven/not medically necessary lists (removed pelvic floor spasticity and stiff-person syndrome from unproven list).

OpenPayer

Medical Benefit Drug Policy

Coverage summary

General medical necessity requirements

Indication-specific proven uses (by product)

Initial therapy criteria — product-specific

Continuation / reauthorization criteria

Unproven / Not medically necessary indications

Applicable codes (HCPCS / ICD-10 mappings)

Provider actions / prior authorization & documentation

Clinical evidence and guideline summaries

Background, benefit considerations, and definitions

Revision history