EmblemHealth Neurotoxins Coverage Update

Product-specific Coverage Criteria

Product-specific covered indications

Covered when the specific product-age and indication criteria below are met

Botox: covered indications: Botox is covered for multiple indications with age-specific limits including: blepharospasm (≥12 years); cervical dystonia (≥16 years) to reduce abnormal head position and neck pain; strabismus (≥12 years); lower limb spasticity excluding cerebral palsy (≥2 years); upper limb spasticity (≥2 years); severe palmar hyperhidrosis after failure of topical agents/pharmacotherapy and with medical complications or ADL impact; severe primary axillary hyperhidrosis after failure of topical agents/pharmacotherapy and with medical complications or ADL impact; chronic daily headache (migraine or tension-type) meeting chronic migraine criteria (see chronic migraine criteria); esophageal achalasia with high risk or failed dilation/surgery or specified anatomic risks; oromandibular dystonia of isolated nature; laryngeal dystonia; cerebral palsy with equinus gait; sialorrhea after failed oral therapy in presence of specific neurologic conditions; urinary incontinence due to detrusor overactivity failed or intolerant to anticholinergic medication; overactive bladder with inadequate response or intolerance to anticholinergic; focal upper limb dystonia with pain or functional impairment; and a broad set of other spasticity and paralytic syndromes and related indications listed in the policy coding section.

Dysport: covered indications: Dysport (≥18 years) is covered for cervical dystonia to reduce abnormal head position and neck pain (toxin-naïve and previously treated patients), blepharospasm, adult spasticity, hemifacial spasm, and for pediatric lower and upper limb spasticity (≥2 years) with exclusions for CP as noted.

Myobloc: covered indications: Myobloc is covered for adult cervical dystonia to reduce abnormal head position and neck pain, bladder muscle dysfunction, and excessive salivation.

Xeomin: covered indications: Xeomin is covered for adults (≥18 years) for cervical dystonia, blepharospasm, upper limb spasticity, and chronic excessive salivation; and for pediatric patients (≥2 years) for upper limb spasticity excluding spasticity caused by cerebral palsy.

Daxxify: covered indications: Daxxify (≥18 years) is covered for cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.

Utilization/Limitations

Utilization and treatment frequency limits

Injection interval: It is generally not considered medically necessary to administer musculoskeletal agents more frequently than every 90 days; with a positive response the effect generally lasts ~3 months and repeat injections may be warranted at that interval.

Dose/site and site definition: The plan allows coverage for one dose per affected site in accordance with FDA-approved dosing limitations. A site is defined as one eye (including all periocular muscles and lids), one side of the face, the neck, or the trunk and all limbs and associated girdle muscles.

Electromyography guidance: Electromyography or muscle stimulation (rather than site pain/tenderness) may be necessary to determine injection sites, especially for facial, neck, and upper extremity spastic conditions.

Failure rule: Failure of two definitive, consecutive treatment sessions involving a muscle or muscle group with the same serotype may preclude further coverage of that serotype for one year after the second session; switching to a different serotype may be reasonable.

Chronic migraine (initial therapy)

Covered when ALL of the following are met for chronic migraine prophylaxis

Migraine frequency: Patient has clinically diagnosed migraine defined as at least 8 migraine days per month (or 15 headache days per month).>= 8 migraine days/month or >=15 headache days/month

Prior pharmacologic trials: Patient has prior usage of at least TWO standard prophylactic pharmacologic therapies, each from a different pharmacologic class used to prevent migraines or reduce migraine frequency (examples include angiotensin receptor blockers, ACE inhibitors, beta-blockers, calcium-channel blockers, anti-epileptics, or antidepressants).2 different classes tried

Exceptions/composite pathway: Alternatively, coverage is permitted if the patient has inadequate efficacy to one standard prophylactic AND has experienced adverse events severe enough to warrant discontinuation of another standard prophylactic, as documented by the prescriber.

Daxxify — Cervical dystonia

Covered when ALL of the following are met for Daxxify in cervical dystonia

Age: Patient is ≥ 18 years of age.>=18 years

Indication: Diagnosis of cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.

Exclusions include: infection at the proposed injection site, which precludes administration; injections administered more frequently than the Utilization limits (see Utilization/Limitations — generally not more often than every 90 days) are not considered medically necessary; and use of these agents for cosmetic purposes (e.g., treatment of wrinkles) is not considered medically necessary. In addition, treatment of certain conditions is listed as not medically necessary due to insufficient evidence (examples include spastic conditions not listed in the ICD tables, biliary dyskinesia, irritable bowel, pain conditions not associated with spasticity such as myofascial pain and fibromyalgia, plantar hyperhidrosis, and wrinkles).

The policy lists applicable procedure and billing codes without embedding separate medical necessity rules in those code lists. Procedure and HCPCS/J-code groupings included in the document (representative) are CPT procedure codes for chemodenervation and related procedures (e.g., 31571, 43201, 43236, 46505, 52287, 53899) and extensive chemodenervation CPTs (64611–64617, 64642–64647, 64650, 64653, 67345), plus J‑codes for botulinum products (e.g., J0585–J0589, J3590). The presence of these codes supports billing and prior authorization processes but does not, by itself, define clinical coverage criteria.

Historical revisions document that infection at the proposed injection site has previously been added to the policy exclusions. The revision history notes changes to Guidelines and explicitly records the addition of this exclusion under Exclusions in prior updates.

Use of botulinum neurotoxin products for cosmetic purposes (for example, treatment of wrinkles) is identified as not medically necessary. The policy also lists a set of conditions for which evidence is insufficient to support coverage and therefore are considered not medically necessary (see exclusions list for specific examples such as plantar hyperhidrosis and certain non‑spastic pain conditions).

Previous revisions removed certain cosmetic indications for some products (for example, Xeomin glabellar line indications were removed from the Guidelines in a prior update). The revision history advises consultation of product‑specific guidance for cosmetic uses and records such cross‑product changes over time.

Procedure, Drug and Diagnosis Codes

Applicable Procedure Codes (group 1)CPT

31513	Laryngoscopy, indirect; with vocal cord injection.
31570	Laryngoscopy, direct, with injection into vocal cord(s), therapeutic;

Applicable Procedure Codes (group 2)CPT

31571	Laryngoscopy, direct, with injection into vocal cord(s), therapeutic; with operating microscope or telescope.
43201	Esophagoscopy, rigid or flexible, transoral; with directed submucosal injection(s), any substance.
43236	Esophagogastroduodenoscopy, flexible, transoral; with directed submucosal injection(s), any substance.
46505	Chemodenervation of internal anal sphincter.
52287	Cystourethroscopy, with injection(s) for chemodenervation of the bladder
53899	Unlisted procedure, urinary system.
64611	Chemodenervation of parotid and submandibular salivary glands, bilateral.
64612	Chemodenervation of muscle(s); muscle(s) innervated by facial nerve (e.g., for blepharospasm, hemifacial spasm).
64615	Chemodenervation of muscle(s); muscle(s) innervated by facial, trigeminal, cervical spinal and accessory nerves, bilateral (e.g., for chronic migraine).
64616	Chemodenervation of muscle(s); neck muscle(s), excluding muscles of the larynx, unilateral (e.g., for cervical dystonia, spasmodic torticollis).

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Applicable J-codesHCPCS

J0585	Injection, onabotulinumtoxinA, 1 unit.
J0586	Injection, abobotulinumtoxinA, 5 units.
J0587	Injection, rimabotulinumtoxinB, 100 units.
J0588	Injection, incobotulinumtoxin a, 1 unit.
J0589	Injection, daxibotulinumtoxina-lanm, 1 unit.
J3590	Unclassified biologic

Applicable Procedure and HCPCS/J Codesmixed

31571	Laryngoscopy, direct, with injection into vocal cord(s), therapeutic; with operating microscope or telescope.
43201	Esophagoscopy, rigid or flexible, transoral; with directed submucosal injection(s), any substance.
43236	Esophagogastroduodenoscopy, flexible, transoral; with directed submucosal injection(s), any substance.
46505	Chemodenervation of internal anal sphincter.
52287	Cystourethroscopy, with injection(s) for chemodenervation of the bladder
53899	Unlisted procedure, urinary system.
64611	Chemodenervation of parotid and submandibular salivary glands, bilateral.
64612	Chemodenervation of muscle(s); muscle(s) innervated by facial nerve (e.g., for blepharospasm, hemifacial spasm).
64615	Chemodenervation of muscle(s); muscle(s) innervated by facial, trigeminal, cervical spinal and accessory nerves, bilateral (e.g., for chronic migraine).
64616	Chemodenervation of muscle(s); neck muscle(s), excluding muscles of the larynx, unilateral (e.g., for cervical dystonia, spasmodic torticollis).

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Applicable NDCsNDC

00023-1145-xx	BOTOX 100UNIT Solution Reconstituted.
00023-3921-02	BOTOX 200UNIT Solution Reconstituted.
10454-0710-10	MYOBLOC 2500UNIT/0.5ML Solution.
10454-0711-10	MYOBLOC 5000UNIT/ML Solution.
10454-0712-10	MYOBLOC 10000UNIT/2ML Solution.
00299-5962-30	DYSPORT 300UNIT Solution Reconstituted.
15054-0530-06	DYSPORT 300UNIT Solution Reconstituted.
15054-0500-01	DYSPORT 500UNIT Solution Reconstituted.
00259-1605-01	XEOMIN 50UNIT Solution Reconstituted.
46783-0161-01	XEOMIN 50UNIT Solution Reconstituted.

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Applicable ICD-10 Diagnoses (representative subset)ICD-10

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.
G24.5	Blepharospasm.
G35	Multiple sclerosis.
G43.019	Migraine without aura, intractable, without status migrainosus.
G43.711	Chronic migraine without aura, intractable, with status migrainosus.

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Covered ICD-10 Diagnoses (listed in document)ICD-10Covered

I69.965	Other paralytic syndrome following unspecified cerebrovascular disease, bilateral.
I69.969	Other paralytic syndrome following unspecified cerebrovascular disease affecting unspecified side.
J38.5	Laryngeal spasm.
K11.7	Disturbances of salivary secretion.
K22.0	Achalasia of cardia.
K60.0	Acute anal fissure.
K60.1	Chronic anal fissure.
K60.2	Anal fissure, unspecified.
L74.510	Primary focal hyperhidrosis, axilla.
L74.511	Primary focal hyperhidrosis, face.

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inv-17: Minimum interval between injections

Minimum intervalGenerally not more frequently than every 90 days (effect typically lasts ~3 months)

Dose per sitePlan allows coverage for one dose per affected site in accordance with FDA-approved dosing limitations

Failure ruleFailure of two definitive, consecutive treatment sessions for the same muscle/group may preclude further coverage of that serotype for 1 year; switching serotype may be reasonable

inv-18: HCPCS unit definitions

J0585Injection, onabotulinumtoxinA — 1 unit

Prior Authorization, Documentation & Billing Guidance

Documentation Required

Documentation Required for Review

The treating physician or primary care provider must submit clinical evidence that the member meets criteria for treatment. Without the requested documentation, EmblemHealth cannot properly review preauthorization requests or post-payment reviews.

Submit complete clinical records and relevant specialty notes.
Failure to provide supporting documentation may result in denial or delay.

Prior Authorization

Prior Authorization Required for Botulinum Toxins

Prior authorization is required for all botulinum toxin products when billing product-specific J‑codes (e.g., J0585, J0586, J0587, J0588, J0589) or when billing an unclassified biologic (J3590). Prior authorization requests must reflect current policy age and indication rules and any recent updates (e.g., inclusion of Daxxify and updated migraine criteria).

Affected HCPCS/J‑codes: J0585, J0586, J0587, J0588, J0589, J3590.

Clinical Background & Definitions

Botulinum neurotoxins (medicinal serotypes A and B) act by producing a presynaptic neuromuscular blockade through inhibition of acetylcholine release at the neuromuscular junction, resulting in chemical denervation and local paresis. Multiple commercial formulations with distinct pharmacologic profiles are available and are used therapeutically to reduce overactivity of skeletal or smooth muscles and glands in indications such as dystonia, spasticity, hyperhidrosis, sialorrhea, bladder dysfunction, and chronic migraine.

inv-34: Neurotoxins / musculoskeletal agents definition

DefinitionNeurotoxins (musculoskeletal agents) are products produced by Clostridium botulinum; only serotypes A and B are used medicinally

MechanismThey produce presynaptic neuromuscular blockade by preventing acetylcholine release, causing chemical denervation and local paresis

Clinical targetsUsed to treat overactive skeletal muscles, smooth muscles, and glands (e.g., dystonia, spasticity, detrusor overactivity, achalasia, sialorrhea, hyperhidrosis)

inv-35: Site (for injection) definition

OpenPayer

NEUROTOXINS (Botox®, Daxxify, Dysport™, Myobloc® and Xeomin®)

Product-specific Coverage Criteria

Procedure, Drug and Diagnosis Codes

Prior Authorization, Documentation & Billing Guidance

Clinical Background & Definitions