Myobloc (rimabotulinumtoxinB) — Coverage Criteria
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Defines prior authorization, dosing limits, initial and renewal medical necessity criteria for Myobloc (rimabotulinumtoxinB) for multiple indications in adults; applies to providers requesting coverage through EOCCO.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy
Covered when ALL of the following are met
Renewal Therapy
Renewal criteria — prior authorization may be renewed when all apply
Indication-based coverage
Covered when medication is administered within the dosing and clinical response expectations described for the indication
See dosing per indication; documented significant clinical improvement is required for some indications (e.g., reduction in saliva production for sialorrhea; reduction in spontaneous axillary sweat production and improved ADLs for hyperhidrosis; improvement in urinary incontinence frequency/volume for OAB).
Requests for Myobloc (rimabotulinumtoxinB) must confirm absence of FDA‑labeled contraindications. Specifically, coverage is excluded when there is hypersensitivity to any botulinum toxin product or any of its components or an active infection at the proposed injection site. Additionally, concurrent treatment with another botulinum toxin is a contraindication and excludes coverage.
No additional exclusionary conditions are specified in this portion of the policy excerpt. See the universal criteria and contraindications elsewhere in the policy for exclusionary conditions that must be assessed prior to authorization.
Per the policy's dual coding rules, claims using primary G and M diagnosis codes must include the required secondary G or I code to be payable; primary G and M codes submitted without the required secondary code are not payable.
This segment of the document does not list any explicit statements labeled “not medically necessary.” Review other sections of the full policy for any not‑medically‑necessary determinations or exclusions.
Coding and Billing
| HCPCS unit | Max units per dose and over time listed by indication (see policy) |
| J0587 | Injection, rimabotulinumtoxinb, 100 units; 1 billable unit = 100 units |
| 10454-0710-xx | Myobloc 2,500 unit/0.5 mL single-dose vial solution for Injection |
| 10454-0711-xx | Myobloc 5,000 unit/mL single-dose vial solution for Injection |
| 10454-0712-xx | Myobloc 10,000 unit/2mL single-dose vial solution for Injection |
| G24.3 | Spasmodic torticollis |
| G25.89 | Other specified extrapyramidal and movement disorders |
| G35.A | Relapsing-remitting multiple sclerosis |
| G43.701 | Chronic migraine without aura, not intractable, with status migrainosus |
| G80.0 | Spastic quadriplegic cerebral palsy |
| G81.10 | Spastic hemiplegia affecting unspecified side |
| G82.50 | Quadriplegia, unspecified |
| G83.0 | Diplegia of upper limbs |
| G35.C0 | Non-active primary progressive multiple sclerosis = Secondary progressive multiple sclerosis, unspecified. |
| G35.C1 | Non-active primary progressive multiple sclerosis = Active secondary progressive multiple sclerosis. |
| G35.C2 | Non-active primary progressive multiple sclerosis = Non-active secondary progressive multiple sclerosis. |
| G35.D | Non-active primary progressive multiple sclerosis = Multiple sclerosis, unspecified. |
| G37.0 | Diffuse sclerosis of central nervous system. |
| G43.701 | Chronic migraine without aura, not intractable, with status migrainosus. |
| G43.709 | Chronic migraine without aura, not intractable, without status migrainosus. |
| G43.711 | Chronic migraine without aura, intractable, with status migrainosus. |
| G43.719 | Chronic migraine without aura, intractable, without status migrainosus. |
| G43.E01 | Chronic migraine without aura, intractable, without status migrainosus. |
Provider Actions and Documentation
Prior authorization validity
Initial prior authorization approvals are valid for 6 months (180 days) from the date of authorization; renewals may be issued every 12 months (365 days) thereafter.
Prior authorization recommended per NQTL checklist
Prior authorization should be considered for this drug based on the NQTL factors: indication, safety/efficacy, and drug cost; utilization review or prior authorization methods may be applied.
Use covered ICD-10 diagnosis code from Appendix 1
When requesting coverage or authorization, providers must bill using an ICD-10 diagnosis code listed in Appendix 1; one of these covered codes should be used to support medical necessity.
Required prior medication trials (examples)
Documented prior medication trials are required where indicated (example: for overactive bladder, member must have failed a ≥1 month trial of two medications from the antimuscarinic or beta-adrenergic classes).
Step therapy considerations per NQTL
Evaluation and documentation of prior treatment options may be considered in utilization management per the NQTL factor checklist; the policy notes consideration of prior therapies though no additional explicit multi-step algorithm is specified here.
Baseline disease severity assessment required for chronic migraine
For chronic migraine prophylaxis, the physician must document a baseline assessment of disease severity using an objective tool such as HIT-6, monthly headache days (MHD), MIDAS, or MPFID prior to treatment.
Billing and dosing documentation (HCPCS J0587 & NDCs)
Billing for rimabotulinumtoxinB must use HCPCS code J0587 (Injection, rimabotulinumtoxinB, 100 units; 1 billable unit = 100 units); NDCs for Myobloc single‑dose vials are listed in the policy and dosing/administration per indication should be documented with treatment claims.
- HCPCS: J0587 — Injection, rimabotulinumtoxinB, 100 units; 1 billable unit = 100 units
- NDCs: 10454-0710-xx; 10454-0711-xx; 10454-0712-xx
- Document dose administered and indication-specific dosing/retreatment interval with claim
Medicare Part B coverage and documentation requirements
For Medicare Part B claims, providers must follow applicable CMS guidance (Medicare Benefit Policy Manual, relevant NCDs/LCDs/LCAs); compliance with any applicable NCD/LCD/LCA is required when billing Medicare.
Contraindications and concurrent botulinum toxin therapy — denial risk
Requests may be denied if the member has FDA‑labeled contraindications (for example, hypersensitivity to any botulinum toxin product or active infection at the proposed injection site) or is receiving concurrent treatment with another botulinum toxin.
Prior authorization risk based on indication, safety/efficacy, and cost
Prior authorization may be applied because of concerns about indication appropriateness, safety/efficacy, and drug cost as identified in the NQTL factor checklist; utilization review or PA methods may therefore occur.
Dual coding requirement — claims denial risk
Claims using primary G and M diagnosis codes will require an accompanying secondary G or I code to be payable; failure to include the required secondary code may result in denial.
Background
RimabotulinumtoxinB (Myobloc®) is administered intramuscularly, intradermally, or intraglandularly depending on the indication. Dosing and administration examples in the policy include: initial doses for cervical dystonia of 2,500 to 5,000 units divided among affected muscles with re‑treatment up to 2,500 to 10,000 units every 12–16 weeks; up to 15,000 units divided for upper limb spasticity every 12 weeks; chronic migraine prophylaxis up to 8,250 units every 12 weeks; chronic sialorrhea dosing with 250 units per submandibular gland and a maximum of 3,500 units every 12 weeks; severe primary axillary hyperhidrosis up to 4,000 units per axilla every 12 weeks; and overactive bladder up to 15,000 units every 12 weeks.
Definitions
Initial Therapy Criteria
Initial Therapy
Initial approval requires meeting universal criteria plus indication-specific criteria
Initial therapy dosing
Initial dosing guidance per indication
Exact injection sites and division among muscles not detailed in this excerpt.
Continuation and Retreatment Criteria
Continuation Therapy
Renewal is contingent on safety and clinical response
Continuation/Retreatment
Retreatment and continuation dosing guidance
Providers should adhere to dosing ranges and intervals per indication; exact injection sites and division among muscles not detailed in this excerpt.
Step Therapy and Prior Treatment
| Step | Requirement | Duration/Notes |
|---|---|---|
| 1 | Chronic migraine: Patient must have failed at least an 8-week trial of any two oral migraine‑preventive medications OR had previous treatment with a CGRP antagonist. | Each oral medication trial: ≥8 weeks; see policy for examples of oral preventive agents (e.g., antidepressants, beta blockers, ACE/ARB, antiepileptics). |
| 1 | Overactive bladder (OAB): Member must have failed a ≥1 month trial of two medications from antimuscarinic or beta‑adrenergic classes. | Each medication trial: ≥1 month; documented inadequate response or intolerance required. |
| 1 | Severe primary axillary hyperhidrosis: Member must have tried and failed a ≥1 month trial of a topical agent. | Trial duration: ≥1 month; requirement includes failure or intolerance of topical therapy and significant burden/impact on ADLs. |
| Utilization Management Factor | How it may be applied to prior authorization/step therapy |
|---|---|
| Indication | Consideration of clinical indication when determining PA requirement or step edits; factors noted in the NQTL checklist support using indication to guide PA. |
| Safety and efficacy | Safety/efficacy concerns (e.g., contraindications, toxin spread risk) may be used to require documentation or prior authorization before approval. |
| Prior treatments (treatment history) | Documented evaluation of prior therapies (e.g., trials of topical agents for hyperhidrosis, oral preventive agents for migraine, OAB medications) may be required as part of utilization management per the NQTL factors. |
| Cost of drug | Drug cost was identified in the NQTL checklist as a factor to consider for PA; cost considerations may prompt PA or step requirements. |
Quantity Limits
Site of Care
Document site of care per indication-specific dosing guidance
Site of administration is not specified in this excerpt; follow the indication-specific dosing and administration guidance in the policy when documenting site and procedure details for claims.
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