CurrentAvMedPolicy N/A

Botox - Upper Limb Spasticity (ULS) & Lower Limb Spasticity (LLS) (Pharmacy)

Pharmacy prior authorization form and criteria for coverage of botulinum toxin type A (Botox) for treatment of upper limb spasticity (ULS) and lower limb spasticity (LLS), specifying required documentation, dosing limits, injection site/unit guidance, exclusions, and dispensing source.

Policy Summary

PayerAvMed

PolicyBotox - Upper Limb Spasticity (ULS) & Lower Limb Spasticity (LLS) (Pharmacy)

Policy CodePolicy N/A

Change TypeRevised/Updated (5/20/2025)

Effective Date

Next Review Date

Key ActionPrescriber must complete and sign the pharmacy prior authorization/step-edit request form and provide documentation (lab results, diagnostics, chart notes) supporting each checked clinical criterion; fax to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

Approved by Pharmacy and Therapeutics Committee: 5/22/2025 REVISED/UPDATED: 5/20/2025

2Limb categories covered (upper, lower)

400Adult max units per 3 months

10U/kg or 340Pediatric max guidance

muscle-specificNamed injection sites listed

Key dose thresholds

Adult cumulative dose≤ 400 Units per 3-month interval

Pediatric cumulative dose≤ lower of 10 Units/kg or 340 Units per 3-month interval

Biceps Brachii (upper limb)100 - 200 units divided in 4 sites

Gastrocnemius Medial Head (lower limb)75 units

Gastrocnemius Lateral Head (lower limb)75 units

Soleus (lower limb)75 units

Flexor Halluces Longus (lower limb)50 units

Clinical Criteria for Approval (Initial Therapy)

Clinical Criteria for Approval

All criteria must be met for approval. To support each line checked, all documentation, including lab results, diagnostics, and/or chart notes, must be provided or request may be denied.

ALL of the following

Member has ONE of the following diagnoses
- Single Arm Upper Limb Spasticity
- Both Arms Upper Limb Spasticity
- Lower Limb Spasticity300 - 400 units divided among 5 muscles
Provider must identify location of spasticity for upper limb
- Upper limb muscle/location options (select applicable): Anterior Arm
- Upper limb muscle/location options (select applicable): Biceps Brachii100 - 200 units divided in 4 sites
- Upper limb muscle/location options (select applicable): Flexor Carpi Radialis12.5 - 50 units
- Upper limb muscle/location options (select applicable): Flexor Carpi Ulnaris12.5 - 50 units
Provider must identify location of spasticity for lower limb
- Lower limb muscle/location options (select applicable): Gastrocnemius Medial Head75 units
- Lower limb muscle/location options (select applicable): Gastrocnemius Lateral Head75 units
- Lower limb muscle/location options (select applicable): Soleus75 units
- Lower limb muscle/location options (select applicable): Tibialis Posterior
Medication source indicated: physician's office OR specialty pharmacy

Dosage Limits

Maximum cumulative dose limits by population and interval.

ALL of the following

For adult patients: maximum cumulative dose should not exceed 400 Units in a 3-month interval≤ 400 Units per 3-month interval
See thresholds list for exact values
For pediatric patients: total dose should not exceed the lower of 10 Units/kg body weight or 340 Units, in a 3-month interval≤ min(10 Units/kg, 340 Units) per 3-month interval
See thresholds list for exact values

Dosing is evaluated on a 3-month interval basis and cumulative doses across treated limbs are counted toward the interval limits. The PA form requires the provider to identify specific targeted muscles and list the planned units per muscle as shown on the form (muscle-specific unit ranges are required on the PA; see form for the full muscle list and ranges).

Exclusions and Administrative Notes

ALL of the following

Cosmetic indications are EXCLUDED
Definition: Indications considered aesthetic and excluded from coverage under this policy.
Use of samples to initiate therapy does not meet step edit/preauthorization criteria
Samples not acceptable for initiation
Previous therapies will be verified through pharmacy paid claims or submitted chart notes

"Cosmetic indications" are defined as indications considered aesthetic and are expressly excluded from coverage under this policy. Cosmetic uses are not covered.

Provider Actions & Billing Instructions

Prior Authorization

Prior Authorization Required

Prescriber must complete and sign the pharmacy prior authorization/step-edit request form and provide documentation (lab results, diagnostics, chart notes) supporting each checked clinical criterion; fax to 1-305-671-0200.

Documentation Required

Provider must identify spasticity location and dosing

Provider must identify the specific muscle locations for spasticity and the planned units per muscle as listed in the form; failure to provide required documentation may delay or result in denial.

Billing Rule

Medication source must be indicated

Indicate whether medication is provided by physician's office or specialty pharmacy on the PA form.

Denial Risk

Samples not acceptable for initiation

Use of samples to initiate therapy does not meet step edit/preauthorization criteria and may lead to denial.

Documentation Required

Prescriber signature required

Prescribing physician must sign and clearly print name on the request; preprinted stamps are not valid.

Background

This document is a pharmacy prior authorization/step-edit form for botulinum toxin type A (Botox) used to treat upper and lower limb spasticity. The form collects member and prescriber details (member name, ID, DOB, prescriber name, signature, office contact, phone, fax, NPI), drug and dosing information (drug name/form/strength, dosing schedule, length of therapy, diagnosis, ICD code, weight and date), clinical checkboxes for diagnoses and targeted muscles, and medication source (physician's office or specialty pharmacy). The form provides recommended unit ranges for specific muscles, specifies cumulative dosing limits, and lists exclusions (including cosmetic indications and that samples do not meet initiation criteria).

Policy Summary

PayerAvMed

PolicyBotox - Upper Limb Spasticity (ULS) & Lower Limb Spasticity (LLS) (Pharmacy)

Policy CodePolicy N/A

Change TypeRevised/Updated (5/20/2025)

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Botox - Upper Limb Spasticity (ULS) & Lower Limb Spasticity (LLS) (Pharmacy)

Coverage Summary

Clinical Criteria for Approval (Initial Therapy)

Dosage Limits

Exclusions and Administrative Notes

Provider Actions & Billing Instructions

Applicable Codes

Background

Clinical Evidence

Revision History