Botulinum Toxins — Coverage Criteria (prior authorization to CVS Caremark Specialty Programs)
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Defines clinical and administrative requirements for prior authorization and medical necessity of botulinum toxin products (e.g., Botox, Dysport, Xeomin, Myobloc, Daxxify) for a range of neurologic and other indications under the payer's prescription/specialty benefit; applies to providers submitting authorization to CVS Caremark for HMSA members.
No material clinical or coverage changes in this revision.
Coverage Criteria
Medical necessity and decision logic
Covered when criteria pathways and ICD-10 support are met as defined in the form flow
Clinical Criteria Question 1
Clinical Criteria Questions 1 and 3
Exception Criteria (product pathway questions 10-13 and exception documentation),
Diagnoses_and_Requirements Q14-Q21; Chronic migraine definition
Approval Duration/Continuation Criteria (Q22–Q27)
Table 2 paired-code coverage rule
Covered when BOTH of the following are met:
Primary code must match a Table 2 entry (see Table 2 list)
Secondary code must be chosen from the documented secondary diagnosis codes (see Secondary diagnosis codes list)
Botulinum toxin therapy is not medically necessary when prescribed for a cosmetic indication or for any condition or ICD‑10 code listed in Appendix D. The form's clinical question #1 explicitly directs that if the agent is prescribed for a cosmetic indication or an Appendix D diagnosis, no further questions are required and the request should not proceed for coverage consideration.
There are no additional explicit broad exclusions in this section beyond the Appendix D cosmetic/unsupported uses; however, the document states that certain primary ICD‑10 codes listed in Appendix C, Table 2, must be paired with a specified secondary diagnosis code. Requests submitted with a primary Table 2 code without the required paired secondary diagnosis may be incomplete and at risk for denial.
The policy requires that selected diagnosis codes from Appendix C Table 2 be accompanied by a second diagnosis code from the referenced secondary diagnosis list. The document notes that "The diagnosis codes above require a second code from Table in order to be" complete; missing the required secondary diagnosis code may render the submission ineligible for payment.
Appendix D explicitly lists conditions for which botulinum toxin therapy is NOT reasonable and necessary. These include: strabismus and deviations over 50 prism diopters; restrictive strabismus; chronic paralytic strabismus except in the narrow circumstance to reduce antagonist contracture with surgical repair; Duane's syndrome with lateral rectus weakness; recurrent temporomandibular joint (TMJ) disorder; anal spasm; irritable colon; biliary dyskinesia; muscle tension / tension headaches; myofascial pain; other smooth muscle spasms not listed as covered; and any spastic condition not listed as covered in the policy.
As stated in the clinical criteria, use of botulinum toxin for cosmetic purposes or for any diagnosis contained in Appendix D is considered not medically necessary. Appendix D provides the specific list of diagnoses and clinical scenarios that will not be considered reasonable and necessary for coverage.
Not all sections contain explicit 'not medically necessary' wording; the document repeatedly emphasizes the Appendix D cosmetic/unsupported uses as the primary not‑covered rule and separately documents paired‑diagnosis requirements in Appendix C/Table 2 that may lead to denial if not satisfied.
Reiterating the exclusions: Appendix D enumerates conditions considered not reasonable and necessary for botulinum toxin therapy, including ocular conditions (e.g., strabismus with large deviations, restrictive or chronic paralytic strabismus outside of specific surgical contexts), certain craniofacial and smooth muscle disorders (e.g., recurrent TMJ disorder, anal spasm, irritable colon, biliary dyskinesia), and pain syndromes (e.g., muscle tension, tension headaches, myofascial pain). Requests for these indications are excluded from coverage.
Coding
| 31513 | Laryngoscopy, indirect; with vocal cord injection. |
| 43236 | Esophagogastroduodenoscopy, flexible, transoral; with directed submucosal injection(s), any substance. |
| 43499 | Unlisted procedure, esophagus. |
| 46505 | Chemodenervation of internal anal sphincter. |
| 52287 | Cystourethroscopy, with injection(s) for chemodenervation of the bladder. |
| 64611 | Chemodenervation of parotid and submandibular salivary glands, bilateral. |
| 64612 | Chemodenervation of muscle(s); muscle(s) innervated by facial nerve, unilateral. |
| 64615 | Chemodenervation of muscle(s); muscle(s) innervated by facial trigeminal, cervical spinal and accessory nerves, bilateral. |
| 64616 | Chemodenervation of muscle(s); neck muscle(s), excluding muscles of the larynx, unilateral. |
| 64617 | Spasmodic dysphonia, includes guidance by needle. |
| G11.4 | Hereditary spastic paraplegia |
| G24.1 | Genetic torsion dystonia |
| G24.2 | Idiopathic nonfamilial dystonia |
| G24.3 | Spasmodic torticollis |
| G24.5 | Blepharospasm |
| G43.011 | Migraine without aura, intractable, with status migrainosus |
| G43.709 | Chronic migraine without aura, not intractable, without status migrainosus |
| G80.0 | Spastic quadriplegic cerebral palsy |
| G80.1 | Spastic diplegic cerebral palsy |
| G83.0 | Diplegia of upper limbs |
| H49.23 | Sixth [abducent] nerve palsy bilateral |
| H49.31 | Total (external) ophthalmoplegia right eye |
| H49.32 | Total (external) ophthalmoplegia left eye |
| H49.33 | Total (external) ophthalmoplegia bilateral |
| H49.41 | Progressive external ophthalmoplegia right eye |
| H49.42 | Progressive external ophthalmoplegia left eye |
| H49.43 | Progressive external ophthalmoplegia bilateral |
| H49.881 | Other paralytic strabismus right eye |
| H49.882 | Other paralytic strabismus left eye |
| H49.883 | Other paralytic strabismus bilateral |
| L74.510 | Primary focal hyperhidrosis, axilla |
| L74.511 | Primary focal hyperhidrosis, face |
| L74.512 | Primary focal hyperhidrosis, palms |
| L74.513 | Primary focal hyperhidrosis, soles |
| L74.52 | Secondary focal hyperhidrosis |
| N31.0 | Uninhibited neuropathic bladder, not elsewhere classified |
| N31.8 | Other neuromuscular dysfunction of bladder |
| N32.81 | Overactive bladder |
| N39.41 | Urge incontinence |
| M62.411 | Contracture of muscle, right shoulder |
| G51.31 | Clonic hemifacial spasm, right |
| G51.32 | Clonic hemifacial spasm, left |
| G51.33 | Clonic hemifacial spasm, bilateral |
| G80.3 | Athetoid cerebral palsy |
| G82.51 | Quadriplegia, C1-C4 complete |
| G82.52 | Quadriplegia, C1-C4 incomplete |
| G82.53 | Quadriplegia, C5-C7 complete |
| G83.82 | Anterior cord syndrome |
| G93.40 | Encephalopathy, unspecified |
| G35 | Multiple sclerosis |
| I69.163 | Other paralytic syndrome following nontraumatic intracerebral hemorrhage affecting left dominant side |
| I69.164 | Other paralytic syndrome following nontraumatic intracerebral hemorrhage affecting right non-dominant side |
| I69.165 | Other paralytic syndrome following nontraumatic intracerebral hemorrhage affecting left non-dominant side |
| I69.231 | Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting right dominant side |
| I69.232 | Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting left dominant side |
| I69.233 | Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting right non-dominant side |
| I69.234 | Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting left non-dominant side |
| I69.241 | Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting right dominant side |
| I69.242 | Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting left dominant side |
| I69.243 | Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting right non-dominant side |
| I69.331 | Monoplegia of upper limb following cerebral infarction affecting right dominant side |
| I69.332 | Monoplegia of upper limb following cerebral infarction affecting left dominant side |
| I69.333 | Monoplegia of upper limb following cerebral infarction affecting right non-dominant side |
| I69.334 | Monoplegia of upper limb following cerebral infarction affecting left non-dominant side |
| I69.341 | Monoplegia of lower limb following cerebral infarction affecting right dominant side |
| I69.342 | Monoplegia of lower limb following cerebral infarction affecting left dominant side |
| I69.343 | Monoplegia of lower limb following cerebral infarction affecting right non-dominant side |
| I69.344 | Monoplegia of lower limb following cerebral infarction affecting left non-dominant side |
| I69.351 | Hemiplegia and hemiparesis following cerebral infarction affecting right dominant side |
| I69.352 | Hemiplegia and hemiparesis following cerebral infarction affecting left dominant side |
| I69.361 | Other paralytic syndrome following cerebral infarction affecting right dominant side |
| I69.362 | Other paralytic syndrome following cerebral infarction affecting left dominant side |
| I69.363 | Other paralytic syndrome following cerebral infarction affecting right non-dominant side |
| I69.364 | Other paralytic syndrome following cerebral infarction affecting left non-dominant side |
| I69.365 | Other paralytic syndrome following cerebral infarction, bilateral |
| S14.0XXA | Concussion and edema of cervical spinal cord, initial encounter |
| S14.0XXD | Concussion and edema of cervical spinal cord, subsequent encounter |
| S14.0XXS | Concussion and edema of cervical spinal cord, sequela |
| S14.101A | Unspecified injury at C1 level of cervical spinal cord, initial encounter |
| S14.101D | Unspecified injury at C1 level of cervical spinal cord, subsequent encounter |
| S14.101S | Unspecified injury at C1 level of cervical spinal cord, sequela |
| S14.112A | Complete lesion at C2 level of cervical spinal cord, initial encounter |
| S14.112D | Complete lesion at C2 level of cervical spinal cord, subsequent encounter |
| S14.112S | Complete lesion at C2 level of cervical spinal cord, sequela |
| S14.121A | Central cord syndrome at C1 level of cervical spinal cord, initial encounter |
| S24.133A | Anterior cord syndrome at T7-T10 level of thoracic spinal cord, initial encounter |
| S24.133D | Anterior cord syndrome at T7-T10 level of thoracic spinal cord, subsequent encounter |
| S24.133S | Anterior cord syndrome at T7-T10 level of thoracic spinal cord, sequela |
| S24.134A | Anterior cord syndrome at T11-T12 level of thoracic spinal cord, initial encounter |
| S24.134D | Anterior cord syndrome at T11-T12 level of thoracic spinal cord, subsequent encounter |
| S24.134S | Anterior cord syndrome at T11-T12 level of thoracic spinal cord, sequela |
| S24.141A | Brown-Sequard syndrome at T1 level of thoracic spinal cord, initial encounter |
| S24.141D | Brown-Sequard syndrome at T1 level of thoracic spinal cord, subsequent encounter |
| S24.141S | Brown-Sequard syndrome at T1 level of thoracic spinal cord, sequela |
| S24.142A | Brown-Sequard syndrome at T2-T6 level of thoracic spinal cord, initial encounter |
| Fax: 1-866-237-5512 | CVS Caremark Specialty Programs fax number for submission |
Provider Actions & Submission Instructions
Prior authorization to CVS Caremark required
Prior authorization to CVS Caremark Specialty Programs is required for botulinum toxin products; send the completed specialty prior authorization form via fax to CVS Caremark Specialty Programs (Fax: 1-866-237-5512) or contact CVS Caremark with questions at 1-808-254-4414.
- Approvals may be subject to dosing limits per FDA labeling and accepted guidelines (see form).
- Provide the most accurate diagnosis for the prescribed medication on the form.
Use listed ICD-10 codes to support medical necessity
Use the ICD-10 diagnosis codes listed in the policy (Appendix C and Table 2) to support medical necessity on the CVS Caremark specialty form; the document includes CVS Caremark Specialty Programs contact information for submission and clarification.
- Appendix C and Table 2 ICD-10 codes serve as supporting diagnoses for coverage determinations.
- Provide accurate ICD-10 codes on the faxed prior authorization form.
Submit prior authorization to CVS Caremark Specialty Programs
Submit prior authorization requests and the completed specialty form to CVS Caremark Specialty Programs using the provided fax and address; the preferred submission method is fax to 1-866-237-5512.
- Mailing address for CVS Caremark Specialty Programs: 2969 Mapunapuna Place, Honolulu, HI 96819 (shown on form).
- Phone for questions: 1-808-254-4414.
Include thoracic spinal cord codes and required secondary code
When using thoracic spinal cord diagnosis codes, include the required paired secondary diagnosis code from the referenced table on the submission; incomplete code pairing may render the request incomplete.
- Thoracic spinal cord codes listed (e.g., S24.133A, S24.134A, S24.141A, S24.142A, S24.144A, S24.151A, S24.152A, etc.) must be accompanied by a second code from the Table 2 secondary diagnosis list.
- The policy states: 'The diagnosis codes above require a second code from Table in order to be' complete.
Preferred products (Dysport, Xeomin) required first; document exceptions
If a non-preferred botulinum product is requested, the form requires that preferred products (Dysport and Xeomin) be considered first; exceptions require documentation of inadequate response or intolerable adverse event to the preferred products.
- Question C on the form identifies Dysport and Xeomin as the preferred products and asks if the patient's treatment can be switched to a preferred product.
- Exception logic (Questions F, K, N, P) requires attaching supporting chart note(s) documenting inadequate response or intolerable adverse events to preferred products when requesting a non-preferred product.
Send completed form to CVS Caremark (fax/address)
Send the completed specialty prior authorization form and supporting documentation to CVS Caremark Specialty Programs via fax; the form and confidentiality notice are provided on the document.
- Fax: 1-866-237-5512
- Address: CVS Caremark Specialty Programs, 2969 Mapunapuna Place, Honolulu, HI 96819
Attach chart notes documenting failure/intolerance to preferred products
Ensure the submission includes any required supporting chart notes when exception criteria are invoked; attach documentation of prior inadequate response or intolerable adverse events to preferred products as indicated on the form.
- Action required: If the patient had inadequate response or intolerable adverse events to preferred products, 'Attach supporting chart note(s).' (see Questions F, K, N, P).
- Supporting notes should be included with the faxed prior authorization form.
Use provided CVS Caremark contact and observe confidentiality notice
Use the CVS Caremark Specialty Programs submission contact details shown on the form for all prior authorization communications; the fax may contain privileged information and includes a confidentiality notice.
- Fax: 1-866-237-5512; Phone: 1-808-254-4414; Website: caremark.com
- Confidentiality notice on fax: privileged/ confidential medical information instructions for unintended recipients.
Fax completed prior authorization form to CVS Caremark
Send the completed prior authorization form via fax to CVS Caremark Specialty Programs at 1-866-237-5512; include all supporting documentation and ensure required diagnosis coding is present.
- Include the most accurate diagnosis and required secondary codes where applicable.
- Keep copies of documentation; the fax includes directions for inadvertent receipt.
Include required paired diagnosis coding with submissions
Completed prior authorization form and supporting documentation should be sent to CVS Caremark Specialty Programs (Fax: 1-866-237-5512); ensure that the submission includes paired diagnosis coding when required by the policy.
- The policy explicitly states the diagnosis codes above require a second code from Table 2 to be complete.
- Submissions lacking required secondary diagnosis codes may be considered incomplete.
Denial risk if no prior authorization or if indication is cosmetic/Appendix D
Requests may be denied if prior authorization is not obtained, or if the requested use is for a cosmetic indication or an Appendix D–listed condition; obtain authorization and ensure indication is not excluded.
- Clinical Criteria Question 1 directs denial of further questions if botulinum toxin is prescribed for a cosmetic indication or any condition/ICD-10 listed in Appendix D.
- Appendix D lists multiple conditions for which botulinum toxin therapy is NOT reasonable and necessary.
Use paired primary + secondary ICD-10 codes where specified
Certain ICD-10 diagnosis codes in Table 2 must be used as a paired primary and secondary code on the prior authorization form; confirm both codes are present before submission.
- The form states: 'The following ICD-10 codes must be used in pairs, i.e., one primary diagnosis and one secondary diagnosis.'
- Table 2 lists primary codes that 'Require a Secondary ICD-10 Code for Payment.'
Missing required secondary code may cause denial
Omitting a required secondary diagnosis code for Table 2 primary codes may trigger denial; ensure the secondary code from the specified list is included with the primary code on the submission.
- Policy note: 'The diagnosis codes above require a second code from Table in order to be' complete.
- The submission instructions repeatedly emphasize inclusion of both codes.
Exclusions in Appendix D may trigger denial
Requests for botulinum toxin therapy for conditions listed in Appendix D are considered not reasonable and necessary and may be denied; do not submit authorization requests for these excluded indications.
- Appendix D exclusions include: strabismus and deviations over 50 prism diopters; restrictive strabismus; chronic paralytic strabismus (with limited exceptions); 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 spasms not listed as covered; and spastic conditions not listed as covered.
Background
Botulinum toxin injections are used across a broad range of neurologic and non‑neurologic indications. The policy's intake flow clarifies that coverage is available only when the clinical pathway and supporting ICD‑10 coding requirements are met; conversely, treatment is not covered for cosmetic uses or any diagnosis in Appendix D. Additionally, several primary ICD‑10 entries in Appendix C Table 2 must be paired with a secondary diagnosis code to form a complete, payable diagnosis pair—missing that second code may lead to denial.
Definitions
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