CurrentHighmark Blueshield NenyPolicy N/A

Outpatient Botulinum Toxin Injectable Request Form — Coverage Criteria

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Form and documentation requirements for outpatient medical benefit requests for botulinum toxin injections (e.g., Botox, Dysport, Myobloc, Xeomin) used by providers submitting to Highmark BlueShield NENY. Affects ordering/requesting physicians, administering providers, and facility billing for members with migraine, hyperhidrosis, or other indications.

Policy Summary

PayerHighmark Blueshield Neny

PolicyOutpatient Botulinum Toxin Injectable Request Form — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form including diagnosis, J‑code for the requested botulinum product, prior therapy history, and documentation of response (e.g., headache diary or HDSS) as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4indication sections

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CurrentHighmark Blueshield NenyPolicy N/A

Outpatient Botulinum Toxin Injectable Request Form — Coverage Criteria

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Policy Summary

PayerHighmark Blueshield Neny

PolicyOutpatient Botulinum Toxin Injectable Request Form — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4indication sections

2response thresholds

Coverage Criteria for Botulinum Toxin Injections

Chronic Migraine — Initial and Continuation

Covered when documentation meets diagnosis, prior therapy, and response criteria:

Chronic migraine diagnosis and documentation: Diagnosis established using ICHD-III and persistent three-month history of recurring debilitating headache documented via headache diary or calendar3 months

Chunk 1

Provider and administration: Request prescribed by or in consultation with a neurologist or headache specialist and administered by a provider trained in botulinum toxin administration

Chunk 1

Exclude secondary causes: Assessment that headaches are not due to medication overuse/rebound or lifestyle issues

Chunk 1

Prior prophylactic therapy: Trials and failures, intolerance, or contraindication to adequate trials from at least two different prophylactic therapy classes (e.g., antiseizure, beta blocker, tricyclic antidepressant) with adequate dose/duration (example: ~6 weeks each)>=2 classes

Chunk 1

Continuation response: Since starting botulinum toxin, member has experienced at least a 50% reduction in migraine frequency OR a 50% reduction in migraine hours from baseline>=50%

Chunk 1

Focal Hyperhidrosis — Initial and Continuation

Covered when documentation demonstrates severe focal hyperhidrosis, prior therapy failure/intolerance, and measurable response for continuation:

Severity and focality: Documentation of severe focal hyperhidrosis and specification of region treated (axillary, palmar, plantar, craniofacial, other)

Chunk 2

Prior topical/systemic therapy: Failure or intolerance of topical products (e.g., 20% aluminum chloride) and/or pharmacotherapy for excessive sweating (e.g., anticholinergics, beta-blockers, benzodiazepines)

Chunk 2

Complications or comorbid skin disease considered: Documentation of recurrent skin maceration with bacterial or fungal infections or history of atopic dermatitis despite treatments when applicable

Chunk 2

Continuation response:

Other Indications — Initial and Continuation

Requests for other diagnoses require documentation of prior therapies and response:

Prior therapies: List of therapies tried and failed, not tolerated, or contraindicated for the diagnosis

Chunk 3

Response documentation: For continuation, documentation of a documented positive clinical response to treatment

Chunk 3

Coverage for outpatient botulinum toxin injections is granted with criteria when the submitted request form documents the required diagnosis-specific elements, prior therapy history, and—for continuation requests—evidence of clinical response. The form contains distinct sections for Chronic Migraine, Focal Hyperhidrosis, and Other Uses, each with targeted questions to confirm diagnosis, prior treatments tried and failed or not tolerated, and objective response where applicable (e.g., headache diary for migraine, HDSS for hyperhidrosis). (See form sections for chronic migraine, hyperhidrosis, and other uses.)

Common reasons a request may be denied include: missing documentation that the diagnosis meets the stated criteria (for chronic migraine, confirmation of ICHD‑III criteria and a persistent three‑month headache history recorded by diary/calendar), absence of documented trials and failures or intolerances of required prior therapies (for migraine, trials from at least two different prophylactic classes; for hyperhidrosis, failure or intolerance to topical 20% aluminum chloride and/or anticholinergic therapies), and lack of documented clinical response on continuation requests (for migraine, failure to show a ≥50% reduction in headache frequency or hours; for hyperhidrosis, absence of objective improvement such as HDSS change).

Coding and Response Thresholds

Listed Botulinum Toxin HCPCS/J-codesHCPCS

J0585	BOTOX
J0586	DYSPORT
J0587	MYBLOC
J0588	XEOMIN

inv-07: Migraine response threshold — >= 50% reduction in headache frequency or hours

Response threshold>= 50% reduction in migraine headache frequency OR >= 50% reduction in migraine headache hours from baseline

Measurement period contextApplies to continuation of therapy since starting botox (documented change vs baseline)

Documentation sourceHeadache diary or calendar documenting baseline and post-treatment frequency/hours over the relevant period

Provider Action Items, Documentation & Prior Authorization

Prior Authorization

Product-specific prior authorization (include J‑code)

Prior authorization requests must identify the exact botulinum toxin product using the applicable HCPCS/J‑code (BOTOX J0585; DYSPORT J0586; MYBLOC J0587; XEOMIN J0588).

Select the J‑code that matches the product being requested (J0585, J0586, J0587, or J0588).

Step Therapy

Document prior therapy trials (≥2 prophylactic classes for chronic migraine)

Document trials and failures (or intolerance/contraindication) of appropriate alternative therapies before approval: for chronic migraine, record trials of at least two different prophylactic medication classes (e.g., antiseizure, beta blocker, tricyclic antidepressant) at adequate dose/duration.

List all prior prophylactic therapies tried and whether they failed, were not tolerated, or contraindicated.
Confirm adequate dosing and duration (example on form: ~6 weeks each).

Background

Botulinum toxin injections are requested for multiple outpatient indications captured on this form, most commonly chronic migraine and focal hyperhidrosis, but also other off‑label or less common uses. The form is designed to collect information needed to verify medical necessity: diagnostic confirmation (for chronic migraine, ICHD‑III and a three‑month headache diary), documentation of prior therapies tried and failed or not tolerated, and objective measures of response for continuation requests (for migraine, a ≥50% reduction in headache frequency or hours; for hyperhidrosis, measurable improvement such as HDSS). The form also identifies the specific botulinum toxin product by J‑code to ensure correct product authorization and billing.

Definitions and Outcome Measures

inv-17: Chronic Migraine — ICHD-III diagnostic requirement implied

Diagnostic standardDiagnosis established using the International Classification of Headache Disorders, Third Edition (ICHD-III)

Required history durationPersistent three-month history of recurring debilitating headache documented via headache diary or calendar

Assessment of secondary causesAssessment that headaches are not due to medication overuse/rebound or lifestyle issues must be documented

inv-18: Objective response for hyperhidrosis — measurable improvement example (HDSS)

Objective response exampleImprovement in Hyperhidrosis Disease Severity Scale (HDSS) as a documented measurable effect since starting botulinum toxin

Continuation documentation

Policy Summary

PayerHighmark Blueshield Neny

PolicyOutpatient Botulinum Toxin Injectable Request Form — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Since starting botulinum toxin, there is a documented objective measurable effect indicating a positive clinical response to treatment (example: improvement in HDSS)

Documentation Required

Submit completed request form with required fields and supporting documentation

Complete and submit the request form with member demographics, ICD‑10 diagnosis code(s), the requested product and corresponding J‑code, requesting physician and facility details, and indication‑specific sections (migraine diary/history, prior prophylactic therapies, hyperhidrosis treatment history).

Include member name, DOB, UMI, requesting physician name and NPI, facility and facility NPI, office contact phone/fax, and date of service.
Indicate whether the drug will be supplied by Alliance Rx Walgreens Specialty Pharmacy, Bill & Buy, or Other on the form.

Documentation Required

Chronic migraine documentation (ICHD‑III, 3‑month diary, prior prophylactics)

For chronic migraine initial and continuation requests, document that diagnosis meets ICHD‑III criteria, provide a persistent three‑month headache history recorded via diary or calendar, document assessment for medication overuse or lifestyle causes, and list trials of at least two prophylactic therapy classes with confirmation of adequate dose/duration.

Confirm ICHD‑III diagnostic criteria was used (form asks: Has the diagnosis ... been established using ICHD‑III?).
Attach a 3‑month headache diary/calendar and date range showing frequency and duration.
Document whether headaches are due to medication rebound or lifestyle issues.
List previous prophylactic medications and verify adequate dosing/duration for each.

Documentation Required

Hyperhidrosis documentation and prior therapy evidence

For focal hyperhidrosis requests, document severe focal hyperhidrosis and specify the region treated, confirm failure or intolerance to topical 20% aluminum chloride or other extra‑strength antiperspirants and/or pharmacotherapy (e.g., anticholinergics), and provide objective measures of response for continuation (e.g., HDSS improvement).

Indicate focal region(s): axillary, palmar, plantar, craniofacial, or other.
Document history of recurrent skin maceration or atopic dermatitis when applicable.
State whether topical 20% aluminum chloride or other antiperspirants were ineffective or caused severe rash, and whether anticholinergic or other pharmacotherapy was unresponsive or not tolerated.
For continuation, include objective measurable effect (example: improvement in HDSS) and describe it on the form.

Billing Rule

Document drug supply source (Alliance Rx Walgreens, Bill & Buy, or Other)

Specify on the form whether the drug supply will be provided by Alliance Rx Walgreens Specialty Pharmacy, by Bill & Buy, or by another source.

Denial Risk

Continuation response required (≥50% reduction)

For continuation of therapy in chronic migraine, provide documentation that since starting botulinum toxin the member has experienced at least a 50% reduction in migraine frequency or migraine hours from baseline; absence of this ≥50% improvement may result in denial.

On the form answer: Since starting Botox has the member's migraine headache frequency reduced by at least 50% from baseline? and/or hours reduced by at least 50% from baseline?
Attach objective data (headache diary/calendar) demonstrating the percentage reduction.

Denial Risk

Prior therapy for hyperhidrosis must be documented or risk denial

For hyperhidrosis, document prior use and failure or intolerance of topical therapies (e.g., 20% aluminum chloride) and systemic therapies (e.g., anticholinergics); failure to document these prior therapies may lead to denial.

Form asks whether topical products such as 20% aluminum chloride were ineffective or caused severe rash and whether pharmacotherapy modalities were unresponsive or not tolerated.
If prior topical/systemic therapy trials are not documented, the request may be considered not medically necessary.

Submit a completed Outpatient Medical Injectables Botulinum Toxin Request Form including member demographics, ICD-10 diagnosis code(s), date of service, ordering/requesting physician name and NPI, facility name and NPI, office contact information, and whether the drug will be supplied by Alliance Rx Walgreens Specialty Pharmacy, Bill & Buy, or other. The form must identify the specific botulinum toxin product requested using the corresponding J-code (J0585, J0586, J0587, or J0588) or indicate another product if applicable. (See form header and product list.)

For chronic migraine requests, include confirmation that the diagnosis meets ICHD-III criteria and a documented persistent three-month history captured via a headache diary or calendar. Indicate whether the request is prescribed by or in consultation with a neurologist/headache specialist and whether a clinician trained in botulinum toxin administration will administer the drug. List all prior prophylactic therapies, confirm trials of at least two different prophylactic therapy classes (for example antiseizure medication, beta blocker, tricyclic antidepressant) with adequate dose/duration (example: ~6 weeks each), and confirm assessment that headaches are not due to medication overuse/rebound or lifestyle causes. For continuation requests, document whether the member has experienced at least a 50% reduction in migraine frequency OR a 50% reduction in migraine hours from baseline.

For focal hyperhidrosis requests, document the focal region(s) treated (axillary, palmar, plantar, craniofacial, or other), presence of severe focal hyperhidrosis, and whether there is a history of recurrent skin maceration with infections or refractory atopic dermatitis when applicable. Provide documentation of prior trials and failure or intolerance of topical therapy (for example 20% aluminum chloride or extra strength antiperspirants) and/or systemic pharmacotherapy (for example anticholinergics). For continuation requests, include objective measurable evidence of response (for example improvement in the Hyperhidrosis Disease Severity Scale—HDSS) or otherwise describe the documented clinical effect.

For all other indications, list all therapies tried and failed, not tolerated, or contraindicated for the diagnosis, and for continuation requests provide documentation of a documented positive clinical response to prior botulinum toxin treatment. Be aware that failure to include required prior therapy trials, diagnostic confirmation, or objective response documentation (for continuation requests) are common grounds for denial—examples include no documentation of prior prophylactic therapies for migraine, no documentation of at least two prophylactic classes, no documented ≥50% response for migraine continuation, or no documentation that topical/systemic hyperhidrosis therapies were tried and failed.

Continuation requires a documented objective measurable effect indicating positive clinical response (describe outcome if yes)

Prior therapy contextObjective response is evaluated after prior failure/intolerance of topical 20% aluminum chloride or antiperspirants and/or pharmacotherapy