CurrentBlue Cross Blue Shield - MassachusettsPolicy 006

Botulinum toxin products (formulary status and coverage criteria)

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This policy governs prior authorization, medical necessity, and formulary placement for botulinum toxin agents for BCBSMA commercial members, including preferred and non-preferred agents, on-label and select off-label indications.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyBotulinum toxin products (formulary status and coverage criteria)

Policy CodePolicy 006

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization for outpatient administration of botulinum toxins for commercial members and document trials of preferred formulary alternatives (Botox and Dysport).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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CurrentBlue Cross Blue Shield - MassachusettsPolicy 006

Botulinum toxin products (formulary status and coverage criteria)

Customize your policy alerts

Sign up for Blue Cross Blue Shield - Massachusetts Policy 006 alerts

Get alerted when Policy 006 changes without checking for updates manually.

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Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyBotulinum toxin products (formulary status and coverage criteria)

Policy CodePolicy 006

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization for outpatient administration of botulinum toxins for commercial members and document trials of preferred formulary alternatives (Botox and Dysport).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2preferred toxins required trial (Botox and Dysport)

6 monthsinitial approval duration (chronic migraine)

≥15 days/moICHD-3 threshold (chronic migraine)

PA requiredoutpatient services (Commercial plans)

Multipleindications with sufficient evidence

Coverage Criteria for Botulinum Toxin Products

Primary Axillary Hyperhidrosis

For patient safety and coverage determination, botulinum toxin treatment for primary axillary hyperhidrosis is considered MEDICALLY NECESSARY when ALL of the following criteria are met:

ALL of the following

Patient is 18 years of age or older.
Clinical diagnosis of primary (idiopathic) axillary hyperhidrosis confirmed by history and examination (focal excessive sweating of the axillae) with social or occupational impairment; AND the Hyperhidrosis Disease Severity Scale (HDSS) or equivalent documented as moderate to severe.
Inadequate response, intolerance, or contraindication to at least a 4-week trial of topical agents (e.g., aluminum chloride) documented in the medical record.
Treatment is prescribed by or in consultation with a dermatologist, neurologist, or other appropriate specialist experienced in management of hyperhidrosis.
Documentation of target anatomic site and proposed dosing regimen consistent with product labeling and specialty guidelines.
Not being treated for cosmetic indication; primary goal is to reduce clinically significant hyperhidrosis symptoms or functional impairment.

Initial authorization duration

Initial approval duration: 6 months.

Continuation criteria

Demonstrated clinical benefit compared with pretreatment level, such as decreased HDSS score by at least 1 point or patient-reported meaningful reduction in sweating and improvement in quality of life; AND
Absence of treatment-limiting adverse events related to botulinum toxin administration.

Product selection and sequencing

Trial and failure of both preferred toxins, onabotulinumtoxinA (Botox) and abobotulinumtoxinA (Dysport), is required before coverage of non-preferred/Nonformulary-Noncovered toxins (e.g., incobotulinumtoxinA [Xeomin], rimabotulinumtoxinB [Myobloc], prabotulinumtoxinA-xvfs [Jeuveau®], or other non-preferred agents).
Jeuveau® is considered cosmetic and out of scope for coverage.

Exclusions / contraindications

Do not cover botulinum toxin injections for patients on aminoglycoside therapy due to increased risk of neuromuscular blockade.
Do not cover for patients with known hypersensitivity to any botulinum toxin product or known high antibody titers to botulinum toxin.
Do not administer to patients with severe laryngeal or respiratory weakness or with retrobulbar hemorrhage compromising retinal circulation.

Operational notes

Prior authorization required with documentation of diagnostic criteria, prior topical therapy trial, provider specialty, proposed dosing, and targeted site(s).
Billing should follow product-specific HCPCS/NDC coding and documented units/doses consistent with records.

Evidence summary

Randomized, placebo-controlled trials and meta-analyses demonstrate that botulinum toxin injections significantly reduce axillary sweating and improve HDSS and quality-of-life measures in primary axillary hyperhidrosis compared with placebo.
Comparative trials of different botulinum toxin formulations suggest similar efficacy with appropriate dose adjustments. The evidence is sufficient to determine an improvement in net health outcome for primary axillary hyperhidrosis.

Initial Therapy and Formulary Preference

Formulary initial therapy requirements

Formulary preference and step‑therapy requirements that must be met before coverage of non‑preferred or non‑formulary botulinum toxin products.

Formulary step requirement: Trial and failure of both preferred toxins (Botox and Dysport) required before coverage of non‑formulary/non‑preferred toxins (e.g., Daxxify, Myobloc, Xeomin); for non‑covered medications, prior treatment failure with or contraindication to at least two covered formulary alternatives when available is required

Member may incur higher cost share if an exception is approved

Step	Requirement	Provider documentation	Coverage impact
1
Trial and failure of BOTH preferred botulinum toxin products: onabotulinumtoxinA (Botox) AND abobotulinumtoxinA (Dysport)
Documentation of prior trials and treatment failure (or contraindication) for each preferred toxin; include product name, strength, dates of therapy, and clinical reason for failure/intolerance
Non-preferred or non-formulary/non-covered toxins (e.g., Daxxify, Myobloc, Xeomin) require step completion before coverage; member may have higher non-preferred cost share if exception approved

Continuation Therapy Requirements

Continuation therapy (chronic migraine)

Continuation of botulinum toxin for chronic migraine beyond the initial authorization requires documented clinical improvement.

Chronic migraine continuation: May be re‑authorized when EITHER: (a) migraine headache frequency is reduced by at least 7 days per month compared with pretreatment; OR (b) migraine headache duration is reduced by at least 100 hours per month compared with pretreatment>=7 days or >=100 hours

Represents requirement for continued coverage after initial 6‑month trial

Coding and Diagnosis Keys

CPT/HCPCS/ICD codes (informational — list appears in full policy)mixed

No codes listed

HCPCS CodesHCPCS

C9160	Injection, daxibotulinumtoxina-lanm, 1 unit (DAXI)
J0585	Injection, onabotulinumtoxin A, 1 unit (Botox)
J0587	Injection, rimabotulinumtoxin B, 100 units (Myobloc)
J0586	Injection, abobotulinumtoxin A, 5 units (Dysport)
J0588	Injection, incobotulinumtoxin A, 1 unit (Xeomin)

Chronic migraine frequency — ICHD-3 threshold

ICHD-3 diagnostic thresholdHeadaches ≥15 days per month for >3 months with migraine features on ≥8 days (migraine features include 4–72 hour attacks with ≥2 of: unilateral, pulsating, moderate/severe pain, aggravated by routine activity; associated nausea/vomiting or photophobia/phonophobia)

Policy-specific frequency criterion for initial approvalMeets ICHD-3 chronic migraine criteria defined as ≥15 days/month with duration ≥4 hours/day

Continuation requirement linked to frequencyContinuation beyond initial 6 months requires migraine frequency reduced by ≥7 days/month compared with pretreatment

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for outpatient administration of botulinum toxin procedures for Commercial members (Managed Care HMO/POS, PPO, and Indemnity) when performed in the outpatient setting.

Commercial Managed Care (HMO and POS), Outpatient = Prior authorization is required
Commercial PPO and Indemnity, Outpatient = Prior authorization is required

Billing Rule

Coding and Prior Authorization Forms

Specific HCPCS/CPT/ICD codes associated with botulinum toxin administration and related procedures must be reported using up-to-date industry-standard codes and may require prior authorization. Inclusion of a code in the policy does not guarantee coverage; medical necessity criteria must be met. Use the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm) or Form #434 to submit requests.

Site of Care and Administration Settings

Prior Authorization

Office (outpatient) botulinum toxin administration requires PA

Prior authorization is required for outpatient administration of botulinum toxin products when performed in an office setting for BCBSMA commercial plans; outpatient settings are explicitly referenced for PA requirements.

Policy applies to Commercial Managed Care (HMO/POS), PPO/EPO, Indemnity, MEDEX with Rx plans, and Managed Blue for Seniors.

Prior Authorization

PA required for outpatient procedures

Prior authorization is required if the botulinum toxin procedure is performed in an outpatient setting for commercial members (Managed Care, PPO/EPO, Indemnity).

Ensure PA is obtained before scheduling outpatient procedures to avoid claim denials.

Background on Botulinum Toxin Agents

Botulinum toxins are neurotoxin preparations from Clostridium botulinum available in multiple FDA‑approved formulations. This policy refers to commonly used products including onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), and rimabotulinumtoxinB (Myobloc). Labeled indications vary by product; some formulations have approved therapeutic uses (for example, movement disorders, spasticity, chronic migraine prevention, overactive bladder, hyperhidrosis, and others) while other uses are off‑label. Certain products approved solely for cosmetic indications (e.g., Jeuveau®) are out of scope for medical coverage. Safety considerations and contraindications — such as concurrent aminoglycoside therapy, severe respiratory or laryngeal weakness, retrobulbar hemorrhage compromising retinal circulation, known allergy, or high antibody titers — inform coverage exclusions and clinical decision making.

Definitions and Included Products

Dystonia vs spasticity — definitions

Dystonia (clinical definition)A general term describing abnormal or disordered tonicity of muscle (examples: achalasia of the lower esophageal sphincter, cervical dystonia/torticollis)

Spasticity (clinical definition)A subset of dystonia characterized by a velocity-dependent increase in tonic‑stretch reflexes with exaggerated tendon jerks, typically associated with central nervous system injury

Clinical relationshipSpasticity is a common feature of cerebral palsy and represents a distinct, velocity‑dependent motor abnormality within the broader dystonia spectrum

Chronic migraine (ICHD-3) diagnostic criteria and features

ICHD-3 chronic migraine diagnostic thresholdHeadaches at least 15 days per month for >3 months with migraine features on at least 8 days

Required migraine attack features

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyBotulinum toxin products (formulary status and coverage criteria)

Policy CodePolicy 006

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization for outpatient administration of botulinum toxins for commercial members and document trials of preferred formulary alternatives (Botox and Dysport).

SourceLink

On This Page

Providers should report all services using the most up-to-date procedure, revenue, and diagnosis codes, including modifiers where applicable.
To request prior authorization using the Massachusetts Standard Form (eForm): https://www.bluecrossma.org/.../023%20E%20Form%20medication%20prior%20auth%20instruction%20prn.pdf
Or print and fax Form #434

Step Therapy

Step Requirement for Non-Preferred Toxins

Trial and failure (step) requirement: Coverage of non-preferred / non-formulary botulinum toxins (e.g., Daxxify, Myobloc, Xeomin) requires prior trial and failure of both preferred toxins — Botox and Dysport — before coverage of an NFNC agent will be considered. For non-covered medications, the member must also have had prior treatment failure with, or contraindication to, at least two covered formulary alternatives when available. A higher non-preferred cost share may apply if an exception is approved.

Preferred toxins: Botox (onabotulinumtoxinA) and Dysport (botulinum toxin A) — Preferred; PA required.
Non-Preferred / NFNC examples: Myobloc (rimabotulinumtoxinB), Xeomin (incobotulinumtoxinA), Daxxify — NFNC; PA required

Documentation Required

Provider Documentation Requirements

Provider must submit documentation to support any request that an alternative could not be tried, including name and strength of alternatives tried and failed (with dates if available), specifics of treatment failure, and clinical rationale preventing switch to formulary alternatives. Prescription claims may be used to establish prior use; additional information may be requested if claims history is incomplete.

Documentation must include name and strength of alternatives tried and dates and specifics regarding treatment failure, when applicable.
Include clinical notes or supporting clinical statements and any relevant literature or guideline references for individual consideration requests.
Blue Cross Blue Shield of Massachusetts Pharmacy Operations Dept — Phone: 1-800-366-7778; Fax: 1-800-583-6289

Note

Prior Authorization and Authorization Criteria (Reference)

Prior authorization is referenced in multiple places in this excerpt; however, explicit authorization/denial clinical criteria are not specified within this section. For requests that do not meet the stated criteria, providers may submit an Individual Consideration (exception) request with supporting documentation as outlined.

Prior authorization is required for outpatient procedures as noted, but specific authorization/denial decision criteria are not provided in this excerpt.
See the Individual Consideration section for steps to request an exception for atypical patients.

Individual attacks last 4–72 hours and have ≥2 of: unilateral location, pulsating quality, moderate/severe intensity, or aggravation by routine physical activity; associated symptoms include nausea/vomiting or photophobia/phonophobia

Policy applicationPolicy requires meeting these ICHD-3 criteria for initial 6‑month authorization of botulinum toxin for chronic migraine (age ≥18 and specialist prescriber also required)

Botulinum toxin products referenced in policy

abobotulinumtoxinADysport (abobotulinumtoxinA)

incobotulinumtoxinAXeomin (incobotulinumtoxinA)

onabotulinumtoxinABotox (onabotulinumtoxinA)

rimabotulinumtoxinBMyobloc (rimabotulinumtoxinB)

prabotulinumtoxinA-xvfsJeuveau (prabotulinumtoxinA-xvfs) — noted as FDA‑approved for cosmetic use and out of scope for this review