Neighborhood Health Plan RI Xeomin Coverage Update

Coverage and Medical Necessity Criteria

Prior Authorization

Authorization Duration

Authorization duration: Initial approvals are granted for up to 84 days (12 weeks) unless a different interval is specified in the indication-specific limits (e.g., 112 days for severe primary axillary hyperhidrosis; single perioperative dose allowance for ventral hernia). Renewal authorizations are typically issued for the same interval as the initial approval (commonly 84 days) based on continued benefit and absence of unacceptable toxicity.

Initial approval: up to 84 days by default; where indication-specific longer intervals apply (e.g., 112 days for severe primary axillary hyperhidrosis), use that interval.
Ventral hernia: special single-use allowance (see quantity limits) — not routinely renewable.

Documentation Required

Prior Authorization Renewal Requirements

Prior authorization renewal requirements: To renew coverage the provider must submit documentation that the patient continues to meet the universal and indication-specific criteria (see Initial Approval Criteria) and evidence of clinical response since the prior authorization. Documentation should include objective disease-response measures appropriate to the indication (see renewal disease-response nodes), assessment of adverse events/toxicity, and dosing/coding details from the prior administration.

Document continued fulfillment of universal and indication-specific criteria.
Provide objective evidence of clinical benefit (see indication-specific renewal measures).
Report any unacceptable toxicities; absence of toxin-spread effects should be documented.
Include prior dosing, units administered, and relevant billing codes/NDCs.

Denial Risk

Renewal Denial Triggers

Renewal may be denied when evidence shows lack of clinical benefit, unacceptable toxicity, or failure to supply required documentation. Ventral hernia indication is not renewable.

Failure to demonstrate disease response per indication-specific measures (e.g., no improvement in frequency/severity of headaches for chronic migraine prophylaxis).
Documentation of unacceptable toxicity (e.g., symptoms of toxin spread such as dysphagia, breathing difficulties).
Missing or insufficient clinical documentation to support continued medical necessity.
Ventral hernia: requests for renewal will be denied.

Denial Risk

Non‑Supported Indications

Requests for indications that are not supported by FDA labeling or peer-reviewed literature and for which no valid clinical rationale is provided may be denied. For Medicare members, the plan follows applicable NCDs/LCDs; where an NCD/LCD exists that disallows a requested indication, the request may be denied.

Provide published evidence or clear clinical justification for off-label uses; absence of such support may lead to denial.
Medicare requests: compliance with NCD/LCD/LCA takes precedence; check CMS coverage database.

Documentation Required

Dosing and Coding Documentation

Required documentation to support authorization and billing includes: indication-specific diagnosis codes, administered product name and NDC (or HCPCS/CPT as applicable), number of units per dose, total units billed, injection date(s), anatomic injection sites, and the signed provider notes supporting medical necessity.

Specify product (e.g., Xeomin 50u, 100u, 200u) and NDC where available.
Report exact units administered per visit and total units within the authorization period.
Include CPT/HCPCS codes and ICD-10 diagnosis code(s) that justify the indication.
Document anatomic sites injected and rationale for dosing.
Attach recent clinical assessment showing response and absence of unacceptable toxicity.

Billing Rule

Diagnosis Coding

Diagnosis coding must reflect the treated condition. When multiple related diagnoses are relevant, include primary and secondary ICD-10 codes to justify therapy (for example, primary chronic migraine code plus a secondary code for status/post prior therapies if relevant). For Medicare Part B submissions, include applicable NCD/LCD diagnosis codes when required.

List the primary ICD-10 code matching the covered indication (e.g., cervical dystonia, chronic migraine, OAB).
Include secondary codes when they support medical necessity or capture comorbid conditions influencing treatment.
For Medicare, ensure compliance with any LCD/NCD required code sets.

Documentation Required

Continued Use Requirement for Renewal

Coverage renewals require documented continued use with objective treatment benefit demonstrated since the prior authorization. The provider must show measurable improvement (see indication-specific renewal disease-response criteria) and periodic assessment for safety (e.g., PVR for bladder indications).

Must document sustained clinical benefit compared to baseline.
Provide validated measures where applicable (e.g., Ashworth Scale for spasticity, headache frequency for migraine).
Document safety monitoring performed since last authorization (e.g., PVR for bladder indications).

Step Therapy

Step therapy considerations: Medicare members with documented prior use of the medication within the past 365 days are exempt from step-therapy requirements. For non‑Medicare members, many indications require failure of specified prior therapies (e.g., trials of two oral migraine prophylactic agents for chronic migraine; trials of two antimuscarinic or beta-3 agonists for OAB). Provide documentation of trial duration and response.

Medicare: prior receipt within 365 days exempts from step therapy.
Chronic migraine: document failure of an 8-week trial of at least two oral prophylactic medications.
OAB and neurogenic detrusor overactivity: document failure of ≥1 month trials of two medications from the antimuscarinic or beta-adrenergic classes.

Coding, Billing Codes, and Quantity Limits

Quantity limits by vial size (Medical Benefit / Pharmacy Benefit)NDC | HCPCS | mixed

Xeomin 50 unit Injection	1 vial per 84 day supply
Xeomin 100 unit Injection	1 vial per 84 day supply ( per 112 days for severe primary axillary hyperhidrosis ); 5 vials once (for Ventral Hernia only)
Xeomin 200 unit Injection	2 vials per 84 day supply

Max units by indication (HCPCS Unit)HCPCS

Billable Units - Cervical dystonia	200 units per 84 days
Billable Units - Blepharospasm	100 units per 84 days
Billable Units - Upper limb spasticity	400 units per 84 days
Billable Units - Chronic migraine prophylaxis	200 units per 84 days
Billable Units - Neurogenic detrusor overactivity	200 units per 84 days
Billable Units - Overactive bladder (OAB)	100 units per 84 days
Billable Units - Severe primary axillary hyperhidrosis	100 units per 112 days
Billable Units - Sialorrhea	100 units per 112 days
Billable Units - Ventral Hernia	500 units, one-time (Per days N/A)

Covered HCPCS Codes — incobotulinumtoxinA J0588 (1 unit)HCPCSCovered

J0588

Injection, incobotulinumtoxinA, 1 unit; 1 billable unit = 1 unit

Product NDCs — Xeomin 50/100/200 unit vialsNDC

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

Covered ICD-10 Diagnosis Codes (partial list)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
G43.719	Chronic migraine without aura, 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

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Covered ICD-10 Codes — full appendixICD-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
G43.719	Chronic migraine without aura, 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

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Chronic Migraine Prophylaxis - Thresholds

Migraine days threshold≥15 headache (tension-type-like and/or migraine-like) days per month for at least 3 months

Additional migraine requirementAt least five attacks with features consistent with migraine (with or without aura)

Monthly migraine-characteristic daysOn ≥8 days/month for ≥3 months headaches have migraine characteristics or respond to triptan/ergot

Maximum Cumulative Dose

General maximum cumulative doseRecommended maximum cumulative dose: 400 Units per treatment session

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior authorization required and clinical review

Prior authorization is required for Xeomin and requests will be reviewed to ensure use aligns with FDA-approved labeling and relevant clinical literature; Medicare requests are subject to applicable NCD/LCD/LCA criteria.

Prior Authorization

Authorization duration (initial and renewal)

Initial authorization may be granted for up to six months when initial, universal, and indication-specific criteria are met; renewals may be issued for up to 12 months.

Prior Authorization

Renewal requirements: continued criteria and response

Renewal requests must document that the patient continues to meet universal and indication-specific criteria, has demonstrated disease response per the indication, and has no unacceptable toxicity.

Required Prior Trials and Step Therapy Rules

Indication	Required prior therapy (trial duration & number)	Notes
Patient must have failed at least two oral preventive medications (each an 8-week trial).
Failed a ≥1 month trial of two medications from antimuscarinic or beta-adrenergic classes (e.g., darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine, trospium, mirabegron).
Failed a ≥1 month trial of two medications from antimuscarinic or beta-adrenergic classes (same class examples as above).
Failed ≥1 month trial of a topical agent (e.g., aluminum chloride, glycopyrronium).

Requirement for continuation	Supporting renewal condition	Notes
Renewal requires patient continues to utilize prophylactic intervention modalities.
Renewal requires significant decrease in number, frequency, and/or intensity of headaches and improvement in function.
Renewal requires absence of unacceptable toxicity (e.g., signs of toxin spread).

Policy preference	Implication for prior authorization	Notes
Plan may require use of cost-effective alternatives prior to Xeomin coverage per P&T-developed criteria.

Quantity Limits and Dispensing Rules

Xeomin (by vial/unit strength) — Quantity Limits & Supply Intervals

Xeomin 50 unit vial1 vial per 84 day supply

Xeomin 100 unit vial - standard1 vial per 84 day supply (112 days supply for severe primary axillary hyperhidrosis)

Xeomin 100 unit vial - ventral hernia5 vials (500 units) — one-time provision for preoperative ventral hernia use

Xeomin 200 unit vial2 vials per 84 day supply

IncobotulinumtoxinA (Xeomin) — Maximum Cumulative Dose

Maximum cumulative dose (general)400 Units per treatment session

Background and Drug Information

Xeomin (incobotulinumtoxinA) is a botulinum neurotoxin type A preparation that acts as a neuromuscular blocking agent by inhibiting acetylcholine release at the neuromuscular junction. It is used for multiple neurologic and related indications including cervical dystonia, blepharospasm, upper limb spasticity, chronic migraine prophylaxis, primary axillary hyperhidrosis, neurogenic detrusor overactivity/overactive bladder, and chronic sialorrhea. Clinical trials and the evidence reviewed by the plan demonstrated statistically significant improvements on indication‑appropriate outcome measures (for example, unstimulated salivary flow rate and Global Impression of Change Scale for sialorrhea; Ashworth Scale for spasticity; TWSTRS and pain/position metrics for cervical dystonia). Common adverse events reported include dry mouth, dysphagia, headache, and injection site reactions. Neighborhood's P&T Committee adopted the coverage criteria to align use with FDA labeling and relevant literature and to ensure appropriate, cost‑effective use.

Outcome Measures Used in Sialorrhea Trials

uSFRUnstimulated Salivary Flow Rate — objective outcome measure used in sialorrhea trials

GICSGlobal Impression of Change Scale — patient/global impression outcome used in sialorrhea trials

Evidence useClinical trials for Xeomin reported statistically significant improvements using uSFR and GICS

Site of Care and Medicare Billing Notes

Note

Medicare Part B coverage and CMS/LCD/LCA compliance for infusion centers

For Medicare Part B patients at infusion/administration sites, coverage and billing follow CMS manuals and applicable MAC/LCD/LCA guidance; site‑of‑care and payment are subject to CMS rules.

OpenPayer

Xeomin (incobotulinumtoxinA) coverage

Coverage and Medical Necessity Criteria

Coding, Billing Codes, and Quantity Limits

Prior Authorization, Documentation, and Provider Requirements

Required Prior Trials and Step Therapy Rules

Quantity Limits and Dispensing Rules

Background and Drug Information

Site of Care and Medicare Billing Notes