Updated Botulinum Toxin A Local Coverage Determination Policy

Effective 2/22/2026, there will be some new changes to Medicare coverage guidelines for the use of onabotulinum toxin A for the Medicare patients. This is due to an update to the Local coverage determination policy for botulinum toxin. 

A local coverage determination (LCD) policy is a decision made by a regional Medicare Administrative  Contractor (MAC) that explains whether and when a specific medical service, test, or procedure is covered by Medicare within that contractor’s region.  The Medicare Administrative Contractors are private organizations that process Medicare claims for specific geographic regions. An LCD applies only within a specific contractor’s region while a National Coverage Determination (NCD) applies nationwide and is issued directly by the Centers for Medicare and Medicaid. 

Documentation of diagnosis, prior trials of medications/treatments, ongoing effectiveness with decrease in monthly migraine days or severe monthly migraine days with or without a CGRP will be necessary.  

Documentation of chronic migraine diagnosis: 

• 15 or more headache days per month AND 
• 8 or more migraine days per month AND 
• Each migraine headache lasts 4 or more hours a day 
• Headaches have persisted for a period of at least 3 months 

Documentation of previous trial of medications: 

• 2 month trial of one agent in any of the 2 following classes at a target dose: 
  • Antidepressants 
  • Betablockers 
  • Calcium channel blockers 
  • Antiseizure medications 
• Document intolerances, side effects, contraindications for each and any medication if needed 

CGRP with onabotulinum toxin A - only FDA approved botulinum toxin for CM 

When being on a CGRP, the patient must still fulfill chronic migraine diagnosis with 15 or more headache days and 8 or more migraine days per month in order to qualify for onabotulinum toxin A coverage. The CGRP should on its own have a decrease in overall number of migraine days or reduction in severe migraine days per month. 

When using CGRP with onabotulinum toxin A concurrently, further reduction in monthly migraine days or severe monthly migraine days must be demonstrated in comparison to using either treatment alone. 

Headaches are causing objective functional disability 

One of the key new updates is the objective consistent assessment of functional disability at baseline prior to the initiation of onabotulinum toxin A and after each procedure and each follow up visit. (HIT-6, MIDAS are examples of questionnaires to use for assessment.) 

The other key update is the dose range of 155 to 195 units with the initial dose of 155 units administered. The units above 155 units use the Follow the Pain protocol for additional sites injected. 

Documentation of effectiveness with ongoing treatment with onabotulinum toxin A injections: 

• Documentation of greater than or equal to 50% reduction in monthly migraine days 
• Documentation of greater than or equal to 50% reduction in migraine episodes 
• Documentation of reduction in disability and improvement in functioning 
• Behavioral therapy assessed and implemented- this part is not clear in designating what needs to be documented but CBT, biofeedback, mindfulness training, behavioral therapy should be considered in this category 

Because this is a new LCD policy, we will continue to learn by experience on how the policy will be implemented.

Link to the LCD policy: LCD - Botulinum Toxin Injections (L39832)