Botulinum toxin prior authorization (Botox, Dysport, Xeomin, Myobloc, Daxxify)
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Prior authorization form and clinical criteria used by CVS Caremark/HMSA for coverage determination of botulinum toxin products for various indications; applies to prescribers submitting requests for member drug benefit coverage.
No material clinical or coverage changes in this revision.
Coverage Criteria for Botulinum Toxin
Initial therapy - Chronic migraine
Covered when ALL of the following are met
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Continuation therapy (general)
Covered when ANY of the following continuation conditions are met (per form flow)
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Indication-specific criteria
Covered when ALL indication-specific requirements are met
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Requests for therapy that are prescribed for cosmetic purposes (for example, treatment of wrinkles) are excluded from medical coverage evaluation on this form. The intake question explicitly asks whether therapy is for cosmetic purposes; if answered "Yes," the request is outside the scope of medical coverage consideration.
If an indication is not listed on the form or the request does not meet the specified age, prior therapy, or documented benefit criteria shown for the listed indications, the use may be considered not medically necessary. The form flow distinguishes new starts from continuations and contains indication‑specific questions and continuation checkpoints that must be satisfied for coverage consideration.
Diagnosis, Age, and Clinical Entry Fields
| ICD-10 | ICD-10 code entry requested on form (specific codes not listed) |
Prior Authorization Submission and Provider Requirements
Prior Authorization Required
Prior authorization via fax to CVS Caremark is required for botulinum toxin products. Complete the indication-specific prior authorization form and fax to CVS Caremark Specialty Programs at 1-866-237-5512. For prior authorization questions contact CVS Caremark at 1-808-254-4414. Approvals may be subject to dosing limits in accordance with FDA labeling, accepted compendia, and evidence-based practice guidelines.
- Fax: 1-866-237-5512 (CVS Caremark Specialty Programs)
- Phone (prior auth questions): 1-808-254-4414
- CaremarkConnect (eligibility/copay/delivery): 1-800-237-2767
Step Therapy / Clinical Criteria
For chronic migraine initial requests, the member must meet diagnostic and frequency criteria and have failed appropriate preventive therapy. Specifically, member must be age ≥18, experience headaches ≥15 days per month with headaches lasting ≥4 hours on at least 8 days per month, and meet IHS chronic migraine diagnostic criteria. In addition, the member must have completed an adequate trial (or have a contraindication to) at least two migraine preventive therapies from at least two of the following drug classes, with each trial at least 60 days in duration: antiepileptic drugs, antidepressants, beta-blockers, or CGRP-targeting therapies. For other indications, follow the indication-specific criteria on the PA form and continuation criteria (e.g., documentation of clinical benefit).
- Chronic migraine step therapy: trial of ≥2 preventive therapies from ≥2 classes (each ≥60 days).
- Allowed classes: Antiepileptic drugs (e.g., topiramate, divalproex), Antidepressants (e.g., amitriptyline), Beta-blockers (e.g., propranolol, metoprolol), CGRP-targeting therapies (e.g., fremanezumab, galcanezumab, eptinezumab, rimegepant, atogepant).
Required Documentation
Attach supporting documentation to the prior authorization submission. Include chart notes or medical records confirming diagnosis, headache frequency/duration for chronic migraine, documentation of trials (medication name, dose, dates, and reason for discontinuation) for at least two oral migraine preventive medications, and any prior authorization history (previous approvals). For continuation/re-authorization requests, include documentation that the patient is benefiting from therapy.
- Attach chart notes confirming headache frequency (≥15 days/month) and duration (≥4 hours on ≥8 days/month) for chronic migraine.
- Attach documentation of trials of at least two preventive medications (name, dose, start/end dates, outcome or intolerance).
- For continuation: documentation of clinical benefit from prior botulinum toxin therapy.
Background
Botulinum toxin injections are used for multiple neurologic and non‑neurologic conditions including chronic migraine prophylaxis, spasticity, dystonias (for example, blepharospasm, cervical dystonia), hyperhidrosis, sialorrhea, and select urologic and gastrointestinal disorders. Coverage determinations on this prior authorization form require documentation of diagnosis, applicable age eligibility, prior therapy trials (where specified), and demonstration of clinical benefit for continuation requests.
Definitions and Clinical Thresholds
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