CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Xeomin (incobotulinumtoxinA) coverage and billing policy

Defines clinical coverage criteria, administration, quantity limits, authorization lengths, coding, and billing guidance for incobotulinumtoxinA (Xeomin) across Medicaid (pharmacy), Commercial, and Medicare scopes. Medicaid members' coverage is limited to the Pharmacy Benefit effective 2022-01-01.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyXeomin (incobotulinumtoxinA) coverage and billing policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2022

Next Review Date

Key ActionPrescriber must document age, absence of concurrent botulinum toxin therapy, indication-specific diagnostic evidence, and response/toxicity for renewals.

POLICY UPDATE CHANGES

No material clinical/coverage changes.

9Major covered indications listed

J0588Primary HCPCS code

3NDC presentations (50U/100U/200U)

84Common per-period days used in quantity limits (days)

Coverage Summary

Xeomin (incobotulinumtoxinA) is provided as a covered with criteria therapy across Medicaid (pharmacy), Commercial, and Medicare scopes. The policy defines clinical coverage, administration, quantity limits, authorization lengths, coding, and billing guidance for Xeomin. Medicaid member coverage is limited to the Pharmacy Benefit effective 01/01/2022. Medicare coverage and applicability of these criteria are subject to applicable National Coverage Determinations (NCDs), Local Coverage Determinations/Articles (LCDs/LCAs) and Medicare Administrative Contractor (MAC) jurisdiction guidance.

Initial Approval Criteria

Coverage is provided when ALL applicable universal criteria and the indication-specific criteria are met:

Universal Criteria

Age: Patient is at least 18 years of age (unless otherwise noted)
No concurrent botulinum toxin: Patient is not on concurrent treatment with another botulinum toxin (e.g., abobotulinumtoxinA, onabotulinumtoxinA, rimabotulinumtoxinB, daxibotulinumtoxinA-lanm, etc.)

INDICATION-SPECIFIC (one of)

Cervical dystonia: history of recurrent involuntary contraction of one or more neck muscles; AND (sustained head tilt OR abnormal posturing with limited neck range of motion)
Blepharospasm: covered as an indicated condition per policy (see dosing/renewal criteria)
Upper limb spasticity: includes pediatric upper limb spasticity in patients 2 to 17 years (excluding spasticity caused by cerebral palsy) OR adult upper limb spasticity (e.g., post-stroke)
Chronic migraine prophylaxis: Prophylaxis for chronic migraine: using prophylactic modalities; AND ≥15 headache days/month for ≥3 months; AND at least 5 attacks with migraine features; AND on ≥8 days/month for ≥3 months headaches have migraine characteristics OR are relieved by a triptan or ergot derivative; AND failure of two oral preventive medications each tried for ≥8 weeks
Neurogenic detrusor overactivity: Incontinence due to neurogenic detrusor overactivity: detrusor overactivity associated with neurologic condition confirmed by urodynamic testing; AND failed ≥1 month trial of two medications from antimuscarinic or beta-adrenergic classes
Overactive bladder (OAB): symptoms of urge urinary incontinence, urgency, frequency; AND failed ≥1 month trial of two medications from antimuscarinic or beta-adrenergic classes
Severe primary axillary hyperhidrosis: failed ≥1 month trial of a topical agent (e.g., aluminum chloride, glycopyrronium); AND (history of medical complications such as skin infections OR significant functional impairments OR significant burden of disease impacting ADLs/work/social activities)
Chronic sialorrhea: troublesome sialorrhea ≥3 months; AND (Parkinson's disease, atypical Parkinsonism, stroke, traumatic brain injury, severe developmental delay, cerebral palsy, or other genetic/congenital disorders); AND patient is ≥2 years of age
Ventral hernia (preoperative): Ventral hernia (preoperative use): large ventral hernia with loss of domain or contaminated ventral hernia; used preoperatively in patients scheduled for abdominal wall reconstruction (AWR)
Not renewable

Dosing/Units Info: See administration and max units per indication for dosing and days-per-dose limits

(e.g., per-dose and per-days maxima listed in policy)

Renewal / Continuation Criteria

Renewal Criteria

Coverage may be renewed when ALL of the following are met:

Renewal requirements

Continuation of criteria: Patient continues to meet the universal and indication-specific criteria in Initial Approval
Absence of unacceptable toxicity (examples: symptoms of toxin spread effect such as asthenia, diplopia, ptosis, dysphagia, dysphonia, dysarthria, breathing difficulties; corneal ulceration)
Evidence of disease response (one or more, indication-specific)
- Blepharospasm response: Blepharospasm: improvement in severity and/or frequency of eyelid spasms
- Cervical dystonia response: Cervical dystonia: improvement in severity and frequency of pain AND improvement of abnormal head positioning
- Upper limb spasticity response: Upper limb spasticity: decrease in tone and/or resistance using a validated instrument (e.g., Ashworth Scale, Physician Global Assessment, CGI)
- Axillary hyperhidrosis response: Severe primary axillary hyperhidrosis: significant reduction in spontaneous axillary sweat production AND significant improvement in activities of daily living
- Chronic migraine response: Chronic migraine prophylaxis: significant decrease in number, frequency, and/or intensity of headaches; improvement in function; continued use of prophylactic modalities
- Detrusor overactivity response: Incontinence due to detrusor overactivity: significant improvement in weekly incontinence episode frequency; PVR periodically assessed as medically appropriate
- Overactive bladder response: Overactive bladder: significant improvement in daily urinary incontinence or micturition frequency and/or volume per micturition; PVR periodically assessed as medically appropriate
- Sialorrhea response: Sialorrhea: significant decrease in saliva production

Ventral hernia renewal: Ventral hernia: May not be renewed (preoperative use not renewable)

Provider Actions & Billing

Prior Authorization

Prior authorization required

Authorization required; initial approvals provided for 6 months and renewals for up to 12 months. Ventral hernia preoperative use is authorized but not renewable.

Documentation Required

Indication-specific clinical documentation

Prescriber must document age, absence of concurrent botulinum toxin therapy, indication-specific diagnostic evidence (e.g., urodynamic confirmation for neurogenic detrusor overactivity, migraine frequency and prior medication trials), and response/toxicity for renewals.

Billing Rule

HCPCS and unit billing

Report J0588 per unit (1 billable unit = 1 unit). HCPCS billing should follow units-per-dose and per-days maximums specified in policy.

J0588

Billing Rule

Dual/secondary diagnosis requirement

Primary G and M diagnosis codes require a secondary or additional code in order to be payable as noted in policy.

Documentation Required

Periodic assessments for bladder indications

For detrusor overactivity and overactive bladder (OAB), providers must periodically assess post-void residual (PVR) as medically appropriate and document improvement in incontinence/micturition metrics for renewal.

N32.81
N31.0
N31.1
N31.8
N31.9

Applicable Codes

HCPCS (drug unit)HCPCSCovered

J0588

Injection, incobotulinumtoxinA, 1 unit

NDCsNDCCovered

00259-1605-xx	Xeomin 50 unit Injection
00259-1610-xx	Xeomin 100 unit Injection
00259-1620-xx	Xeomin 200 unit Injection

Covered ICD-10 Diagnosis Codes (Appendix 1)ICD-10Covered

G24.3	Spasmodic torticollis
G24.5	Blepharospasm
G25.89	Other specified extrapyramidal and movement disorders
G35	Multiple sclerosis
G37.0	Diffuse sclerosis of central nervous system
G43.709	Chronic migraine without aura, not intractable, without status migrainosus
G43.701	Chronic migraine without aura, not intractable, with status migrainosus
G43.711	Chronic migraine without aura, intractable, with status migrainosus
G80.0	Spastic quadriplegic cerebral palsy
G80.1	Spastic diplegic cerebral palsy

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Background

This policy was adopted by the Neighborhood Health Plan of Rhode Island Pharmacy & Therapeutics (P&T) Committee to align Xeomin use with FDA labeling and relevant clinical literature and to ensure medically accepted indications and safe, cost-effective use. Coverage details include authorization lengths (initial approval and renewals), quantity limits, administration and billing guidance. For Medicare members, the policy applies only in the absence of applicable NCDs/LCDs; Medicaid member coverage is limited to the Pharmacy Benefit effective 01/01/2022.

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