Botulinum Toxin Prior Authorization and Coverage Criteria (HMSA Medicare Advantage)
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Prior authorization form and clinical criteria governing CVS Caremark's approval of botulinum toxin products for HMSA Medicare Advantage, including required documentation, ICD-10 coding rules, preferred-product step therapy, and exclusions.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
General and indication-specific coverage logic
Covered when criteria in the form's flow are satisfied for the specific indication
Top-level
- ICD-10 acceptance: ICD-10 code is either in Appendix C Table 1 (may be used alone) OR in Table 2 with a Table 3 secondary code that also applies.
Form questions #2-#4 determine this
- Approved FDA indications: If prescribed for FDA-approved indications listed (e.g., overactive bladder, urinary incontinence associated with neurologic condition, prophylaxis of chronic migraine, severe primary axillary hyperhidrosis, strabismus), follow indication-specific criteria and product selection questions.
Form questions #5-#15 determine indication-specific path
- Spasticity and other neurologic indications: If prescribed for upper- or lower-limb spasticity, focal dystonia, hemifacial spasm, or other listed neurologic indications, follow the branch for spasticity/neurologic criteria including prior conventional therapy where specified.
Form questions #7-#19 determine this
- Prior product trials and response assessment: For continuation or previous exposure: if prior botulinum toxin treatment occurred, a satisfactory clinical response is documented OR failure is documented per the form (two or more treatments in a row with one product plus one treatment with an alternative product at maximum appropriate dose failed to produce satisfactory response) before denying further coverage.2 or more treatments in a row with one product plus 1 treatment with an alternative product at maximum appropriate dose failed to produce a satisfactory clinical response
Form questions #22-#24 and #25-#27 outline continuation/response requirements
- Preferred-product step therapy/Exceptions: When a non-preferred botulinum product is requested for indications where Dysport/Xeomin (preferred) are available, documentation of inadequate response or intolerance to preferred products is required; attach chart notes documenting failures or adverse events.
See Exception Criteria questions (A–P) and product selection questions
Form question #1 and Appendix D
Paired diagnosis requirement
Coverage depends on correct ICD-10 coding and, for certain primary diagnoses, a paired secondary diagnosis:
See Table 2 (Primary codes) and Table 3 (Secondary codes) for the required lists; form questions #3–#4 guide submission.
Requests for botulinum toxin are evaluated against the form-based clinical flow. The form first asks whether the drug is prescribed for a cosmetic indication or for any ICD‑10 code listed in Appendix D; uses identified as cosmetic or listed in Appendix D are screened as exclusions and may not be considered reasonable and necessary. Coverage otherwise requires submission of an Appendix C/Table 1 code (may be used alone) or an appropriate Table 2 primary code paired with a Table 3 secondary code, plus completion of the prior authorization form and any indication‑specific documentation requested on the form.
An internal annotation in the ICD‑10 Table 1 material notes a discrepancy for several codes (those marked with an asterisk). Providers should verify correct code placement and asterisk explanations on the form prior to submission to avoid coding or pairing errors that could affect payment or processing.
This extract emphasizes the prior authorization submission process (complete the CVS Caremark form and send to Specialty Programs) and the required diagnosis coding; explicit, granular medical‑necessity decision logic for every indication is not included in this excerpt. For approval, follow the form questions, supply supporting chart notes where the form requests prior failures or intolerances, and submit the completed form to CVS Caremark Specialty Programs.
The policy explicitly lists conditions for which botulinum toxin therapy is NOT reasonable and necessary in Appendix D. These include: skin wrinkles (specific ICD‑10 codes listed), strabismus and deviations >50 prism diopters, restrictive strabismus, chronic paralytic strabismus except as specified, Duane's syndrome with lateral rectus weakness, recurrent TMJ disorder, anal spasm, irritable colon, biliary dyskinesia, muscle tension, tension headaches, myofascial pain, other smooth muscle spasm conditions not listed as covered, and any spastic condition not otherwise listed as covered in the policy.
Use of botulinum toxin for cosmetic indications or for any condition specifically named in Appendix D is considered not reasonable and necessary and may be denied. The form begins by asking whether the prescription is for a cosmetic indication or an Appendix D code to identify such requests early in the review process.
Appendix D contains explicit exclusions and examples of indications that will be treated as not medically necessary for botulinum toxin therapy; these exclusions are enforced during prior authorization review and may result in denial if the submitted diagnosis or clinical rationale matches an Appendix D entry.
Billing Codes and Diagnosis Tables
Prior Authorization, Submission, and Documentation Requirements
Prior Authorization Required
Prior authorization is required for botulinum toxin products for HMSA members. Providers must complete the CVS Caremark prior authorization form and fax the completed form to CVS Caremark Specialty Programs for review. Approvals may be subject to dosing limits per FDA labeling, compendia, or evidence-based guidelines.
- Send completed prior authorization form to CVS Caremark Specialty Programs via fax: 1-866-237-5512.
- Questions about prior authorization: Phone 1-808-254-4414; Specialty Customer Care (CaremarkConnect): 1-800-237-2767.
- Provide the most accurate ICD-10 diagnosis on the form to support medical necessity.
- Include supporting clinical documentation and chart notes when requested (e.g., documentation of inadequate response or intolerable adverse events to preferred products).
Prior Authorization Fax Submission
Fax submission routing: all completed prior authorization requests and supporting documentation must be faxed to CVS Caremark Specialty Programs at 1-866-237-5512. Failure to fax the completed form to this destination may result in denial of the request.
- Primary fax for prior authorization: 1-866-237-5512.
- Retain copies of all submitted documentation; the fax transmittal may contain privileged information and should be handled accordingly.
Submission for Prior Authorization
Submission requirements: requests must be submitted using the completed CVS Caremark prior authorization form and include all required supporting documentation (chart notes, prior trial documentation, demographic and administration details).
- Use the CVS Caremark form provided for botulinum toxins; do not substitute other forms.
- Attach relevant chart notes when documenting inadequate responses or intolerable adverse events to preferred products.
- Incomplete submissions or missing required documentation increase the risk of denial.
Preferred-Product Step Therapy
Preferred-product step therapy and documentation of prior trials: Dysport and Xeomin are the plan-preferred botulinum toxin products. Requests for non-preferred products must document prior inadequate response or intolerable adverse events to the preferred products as specified on the form.
- Preferred products: Dysport and Xeomin.
- If requesting a non-preferred product (e.g., Botox, Myobloc, Daxxify), document prior trials and reasons for inability to use preferred products.
- Attach supporting chart notes when the form indicates 'Action required: Attach supporting chart note(s)'.
- Failure to document trials of preferred products may result in denial.
Coding Discrepancies and Pairing Requirements
Coding and pairing requirements: ensure the ICD-10 codes used on the form accurately reflect the patient’s condition. Some diagnoses must be submitted as paired codes (one primary and one secondary) as indicated in the policy; discrepancies or missing required pairings may delay or deny payment.
- Enter accurate ICD-10 codes that support medical necessity (see Appendix C tables referenced on the form).
- Use paired diagnosis codes where required (one primary and one secondary) per the policy instructions.
- Note internal discrepancies flagged in the source for certain codes (e.g., G83.x and N31.x); verify correct coding before submission.
- If the request is for an excluded indication listed in Appendix D (e.g., cosmetic indications, certain strabismus conditions), the request may be denied.
Required Demographic and Administration Details
Required demographic and administration details: the prior authorization form must include patient demographics, administration/site details, and clinical measures that affect dosing and coverage decisions.
- Include patient weight (kg) and height (ft/in) on the form.
- Indicate where the drug will be dispensed and administered (office, outpatient hospital, pharmacy, home, etc.).
- Provide the ICD-10 code(s) supporting the requested treatment.
- Provide prescriber contact information, NPI, and authorized signature and date.
Submission and Supporting Notes
Submission and supporting notes: always attach supporting clinical documentation when the form requests it (for example, documentation of inadequate response or intolerance to preferred therapies). Retain and be prepared to provide documentation for review by CVS Caremark or the benefit plan sponsor.
- Attach chart notes for prior treatment failures or adverse events when requested by the form.
- Document reasons for using a non-FDA-approved product for the indication when the form asks for a valid documented reason.
- Attest on the form that the information is accurate and that supporting documentation is available for review.
Submission Requirement
Submission requirement: emphasize that a completed PA form must be faxed to CVS Caremark Specialty Programs at 1-866-237-5512. Failure to fax the completed form may lead to denial of coverage.
- Fax number for submissions and supporting documentation: 1-866-237-5512.
- Phone inquiries: 1-808-254-4414.
- Ensure the fax includes all pages of the completed CVS Caremark prior authorization form and attachments.
Clinical Background
Botulinum toxin injections are used across a range of neurologic and related indications, including focal dystonia (for example, blepharospasm and cervical dystonia), upper and lower limb spasticity, chronic migraine prophylaxis, treatment of sialorrhea, and certain voice and laryngeal disorders. The prior authorization form aligns requested product and indication with the appropriate ICD‑10 coding and documentation of prior treatments to determine medical necessity.
Definitions and Appendix References
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