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  • 1.  New Botox Rules Effective 2/22/2026

    Posted 01-14-2026 13:31
    On behalf of the Practice Support Committee and the Advocacy Committee, with thank yous to Chantal Boisvert and Barbara Yates, we wanted to send you:
    1) Botulinum Toxin Injection - Dosage Summary (MACs Finalized Coverage effective February 22, 2026), 
    2) A Coverage Policy Comparison Table prepared by Chantal Boisvert, and 
    3) a link to the CMS responses to difference comments about the changes so you can read what the comments were - it gives us more opportunity to make comment to proposed changes in the future. 

    1) BOTULINUM TOXIN INJECTION - DOSING SUMMARY (MACs Finalized Coverage - Effective Feb 22, 2026)

    ------------------------------------------------------------

    BLEPHAROSPASM

    Initial Dose:

    - Onabotulinumtoxin A (Botox) 1.25–2.5 U per site × 3 sites per affected muscle.

    Subsequent Dose:

    - Incobotulinumtoxin A (Xeomin): match prior onabotulinumtoxin A dose OR 1.25–2.5 U/site if new.

    - Onabotulinumtoxin A: may increase up to 2× if inadequate response.

    - Typical max benefit: 5 U/site. Exceptions up to 10 U/site require documentation.

    ------------------------------------------------------------

    BLEPHAROSPASM + OROFACIAL DYSTONIA / MEIGE

    Initial Dose:

    - No standardized dosing. Typical muscles: masseter, temporalis, medial/lateral pterygoids, submentalis, platysma, genioglossus, hyoglossus.

    Subsequent Dose:

    - Adjust based on response. Increase if duration <2 months.

    ------------------------------------------------------------

    HEMIFACIAL SPASM / FACIAL DYSTONIA

    Initial Dose:

    - Onabotulinumtoxin A (Botox) total 25–30 U to affected side:

      orbicularis oculi, procerus, mentalis, platysma, orbicularis oris, depressor anguli oris

    Subsequent Dose:

    - May increase by +5 to +15 U after 1 year.

    ------------------------------------------------------------

    STRABISMUS

    Initial Dose:

    - Onabotulinumtoxin A (Botox) 1.25–2.5 U in one muscle.

    Subsequent Dose:

    - Same as initial: 1.25–2.5 U in one muscle.

    ------------------------------------------------------------

    CHRONIC MIGRAINE

    Initial Dose:

    - Onabotulinumtoxin A (Botox) 155 U (5 U/site × 31 sites across 7 muscles: frontalis, corrugator, procerus, occipitalis, temporalis, trapezius, and cervical paraspinal muscle group).

    - Allowable range: 155–195 U.

    Subsequent Dose:

    - 155–195 U total.

    - Optional +40 U "follow-the-pain" (max 195 U over 39 sites).

    comparison table that I sent to the committee members this AM.

    Thanks,

    Chantal

     

    BOTULINUM TOXIN INJECTION - DOSING SUMMARY

    (MACs Finalized Coverage - Effective Feb 22, 2026)

    ------------------------------------------------------------

    BLEPHAROSPASM

    Initial Dose:

    - Onabotulinumtoxin A (Botox) 1.25–2.5 U per site × 3 sites per affected muscle.

    Subsequent Dose:

    - Incobotulinumtoxin A (Xeomin): match prior onabotulinumtoxin A dose OR 1.25–2.5 U/site if new.

    - Onabotulinumtoxin A: may increase up to 2× if inadequate response.

    - Typical max benefit: 5 U/site. Exceptions up to 10 U/site require documentation.

    ------------------------------------------------------------

    BLEPHAROSPASM + OROFACIAL DYSTONIA / MEIGE

    Initial Dose:

    - No standardized dosing. Typical muscles: masseter, temporalis, medial/lateral pterygoids, submentalis, platysma, genioglossus, hyoglossus.

    Subsequent Dose:

    - Adjust based on response. Increase if duration <2 months.

    ------------------------------------------------------------

    HEMIFACIAL SPASM / FACIAL DYSTONIA

    Initial Dose:

    - Onabotulinumtoxin A (Botox) total 25–30 U to affected side:

      orbicularis oculi, procerus, mentalis, platysma, orbicularis oris, depressor anguli oris

    Subsequent Dose:

    - May increase by +5 to +15 U after 1 year.

    ------------------------------------------------------------

    STRABISMUS

    Initial Dose:

    - Onabotulinumtoxin A (Botox) 1.25–2.5 U in one muscle.

    Subsequent Dose:

    - Same as initial: 1.25–2.5 U in one muscle.

    ------------------------------------------------------------

    CHRONIC MIGRAINE

    Initial Dose:

    - Onabotulinumtoxin A (Botox) 155 U (5 U/site × 31 sites across 7 muscles: frontalis, corrugator, procerus, occipitalis, temporalis, trapezius, and cervical paraspinal muscle group).

    - Allowable range: 155–195 U.

    Subsequent Dose:

    - 155–195 U total.

    - Optional +40 U "follow-the-pain" (max 195 U over 39 sites).

    __________________________________________________________________________________________________________________


    2) Below is a consolidated comparison prepared by Chantal Boisvert. Each row highlights what MACs previously allowed vs. what the finalized 2026 policies now specify.


    Coverage Policy Comparison Table
    Condition
    Before (Prior MAC Policies)
    After (Final MAC Policies – Feb 22, 2026)
    Blepharospasm
    • Dose ranges varied by MAC.
    • Limited clarity on per‑site maximums.
    • No explicit cross‑product substitution rules.
    • Clear per‑site dosing: 1.25–2.5 U/site, typical max 5 U/site.
    • Up to 10 U/site allowed with documentation.
    • OnabotulinumtoxinA may be increased up to 2× if inadequate response.
    • IncobotulinumtoxinA may match prior onabotulinumtoxinA dose.
    Blepharospasm + Orofacial Dystonia (Meige)
    • Often not separately addressed.
    • No standardized muscle list.
    • No duration‑based titration guidance.
    • Condition now explicitly recognized.
    • Typical muscles listed (masseter, temporalis, pterygoids, submentalis, platysma, etc.).
    • Increase dose if duration <2 months.
    Hemifacial Spasm / Facial Dystonia
    • Dose ranges inconsistent across MACs.
    • No time‑based escalation guidance.
    • Standardized total dose: 25–30 U to affected side.
    • After 1 year, may increase by +5 to +15 U.
    Strabismus
    • Minimal or no explicit dosing guidance.
    • Standardized dose: 1.25–2.5 U initial and subsequent.
    Chronic Migraine
    • Most MACs referenced PREEMPT but did not specify allowable ranges.
    • "Follow‑the‑pain" sometimes inconsistently covered.
    • Initial: 155 U (5 U × 31 sites across 7 muscles).
    • Allowable range: 155–195 U.
    • Subsequent: 155–195 U.
    • Optional +40 U follow‑the‑pain, up to 195 U over 39 sites.


    Here's a clinic‑ready side‑by‑side comparison we can use when grading blepharospasm and orofacial dystonia.
     
    Blepharospasm & Orofacial Dystonia Scales - Side‑by‑Side Comparison
    Scale
    What It Measures
    How It's Structured
    When to Use It
    Jankovic Rating Scale (JRS)
    Eyelid spasm severity & frequency
    • Two domains: severity + frequency
    • Each scored 0–4
    • Total = sum of both
    • Pure blepharospasm
    • Quick follow‑ups
    • Tracking botulinum toxin response
    Burke‑Fahn‑Marsden Scale (BFMS)
    Dystonia severity & disability across body regions
    • Two parts: movement + disability
    • Multiple regions scored separately
    • Captures provoking factors
    • Blepharospasm with oromandibular involvement
    • Segmental or generalized dystonia
    • Baseline severity documentation
    Global Dystonia Severity Rating Scale (GDRS)
    Severity by region across cranial–cervical distribution
    • 10 regions, each scored 0–10
    • Total reflects overall burden
    • Mixed cranial/cervical dystonia
    • Meige syndrome
    • When distribution matters
    Craniocervical Dystonia Questionnaire (CDQ)
    Patient‑reported quality‑of‑life impact
    • Self‑reported questionnaire
    • Domains: pain, daily function, emotional/social impact
    • Complement to clinician‑scored scales
    • Pre‑ and post‑treatment QoL tracking
     



    3) a link to the CMS responses


























  • 2.  RE: New Botox Rules Effective 2/22/2026

    Posted 01-14-2026 13:50
    I thank the committee for preparing this for all of us!



    Original Message


  • 3.  RE: New Botox Rules Effective 2/22/2026

    Posted 01-14-2026 20:54
    Yes, thank you to the committee. Is there any information / guidance on patients who are already on treatment at dose higher than these new guidelines (3 sites per side and 5 units per site)?




    Original Message


  • 4.  RE: New Botox Rules Effective 2/22/2026

    Posted 01-14-2026 21:48
    I will defer to Chantal on this, but the document allows for increased dosages so I believe that you would need to justify that and that the individual has been on treatment for a long time



    Original Message


  • 5.  RE: New Botox Rules Effective 2/22/2026

    Posted 01-14-2026 22:14





    Original Message


  • 6.  RE: New Botox Rules Effective 2/22/2026

    Posted 01-15-2026 07:26

    Good morning,

    To answer Drew's question, below is the blepharospasm policy and their answer to similar questions. It looks like we can inject up to 10U into each of 3 sites per affected facial or ocular muscle with documentation. So, I would think that they will approve your prior injection map if well documented in the chart.

    Indications of Coverage

    Initial Botulinum Toxin Injections

    Initial BTIs for blepharospasm will be considered reasonable and necessary when the following requirements are met:

    1. Objective documentation of the clinical features consistent with the diagnosis of blepharospasm; AND
    2. Chronic blepharospasm of at least 30 days duration measured using an objective clinical scale*; AND
    3. BTI therapy is accepted first line treatment for patients with blepharospasm.

    * The objective assessment must be performed and documented at baseline, after each diagnostic procedure, and at each follow-up assessment using the same scale during each assessment. For example, there are several clinical scales to measure severity of blepharospasm, including the JRS and BSDI.

    Initial Dosing Guidelines

    1. The initial treatment with onabotulinumtoxinA dosing for blepharospasm associated with dystonia is 1.25 Units-2.5 Units into each of 3 sites per affected facial or ocular muscle.27

    Subsequent Botulinum Toxin Injections

    Subsequent BTIs for blepharospasm will be considered reasonable and necessary when the following requirements are met:

    1. Documentation of informed clinical decisions regarding repeat BTIs; AND
    2. Reassessment of the severity and frequency of persistent blepharospasm; AND
    3. Persistence or reoccurrence of blepharospasm; AND
    4. The initial treatment is considered sufficient, and administration of same dose is recommended; OR
    5. The initial treatment is considered insufficient (defined as an effect which does not last longer than 2 months) and administration of an increased dose is recommended. Based upon the initial response, the dosage may be increased up to 5 units per site.

    Subsequent Dosing Guidelines

    1. The subsequent treatment with incobotulinumtoxinA  dosing is based on the previous dosing with onabotulinumtoxinA. If previously treated with onabotulinumtoxinA, if not known or not previously treated with onabotulinumtoxinA, the incobotulinumtoxinA starting dose is 1.25 Units-2.5 Units per injection site.28
    2. For onabotulinumtoxinA in blepharospasm, subsequent doses may be increased up to two-fold if the initial response is insufficient. However, injecting more than 5 units per facial or ocular muscle site provides little additional benefit.
    3. Clinical circumstances that necessitate an exception of onabotulinumtoxinA dose up to 10 units per site may be considered on an individual basis and the rationale for the higher dose must be clearly documented in the medical record.

    Response to Comments: Botulinum Toxin Injections

    While the draft guidelines are based on extensive research and literature, providing a foundation for safety and efficacy, they aim to accommodate the core principles of individualized care. It is important that these guidelines are flexible enough to allow healthcare providers to adjust treatment plans based on their clinical judgment and the unique needs of each patient, ensuring the best possible outcomes. Your perspective is valuable in highlighting the balance between standardized guidelines and personalized treatment strategies.

    Thank you for pointing out this discrepancy regarding the dosing of incobotulinumtoxinA for blepharospasm. According to the compendia, the initial recommended dose for treatment-naive patients is 25 units per eye, totaling 50 units per treatment session, with a maximum of 50 units per eye (100 units per session). This supports the efficacy found in research, indicating that 25 units per eye is effective, whereas 12.5 units does not significantly outperform placebo. For patients previously treated with botulinum toxin A, dosing should also consider response to treatment, duration of effect, and any adverse events, aligning with the safety guidelines. The Canadian labeling further supports these doses, suggesting initial doses of 1.25 to 2.5 units per injection site, with dosing adjustments based on individual responses, not to exceed 100 units per session. This data clearly contradicts the proposed 5-unit-per-eye limit, highlighting the need for treatment guidelines to reflect current evidence and clinical effectiveness. Your feedback emphasizes the critical need to align dosing recommendations with established research to ensure optimal patient care and outcomes.

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    Original Message


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