Response to Comments: Botulinum Toxin Injections

Achalasia

1. We received comments noting lack of thyroarytenoid muscle for treating Adductor Spasmodic Dysphonia. The comment also points out there are many patients with Cricopharyngeal Achalasia who benefit from Botox injection.

Thank you for your comments. We agree. The condition known as adductor spasmodic dysphonia involves involuntary spasms of the vocal cords to hyperadduct during speech requiring treatment for injections into the adductor muscles (thyroarytenoid and lateral cricoarytenoid).

Focal Hand Dystonia

1. The comment argues that those in the support group including those with hand dystonia will be affected by limiting dosage of BoNT.
2. We received comments that the LCD had an incomplete list of muscles involved with focal hand dystonia (EG lumbricals, pronator teres, etc.).
3. Commenter argues that clinical scales are useful for research and quantification of symptoms, but longitudinal use clinical practice is not necessary. Comment advocates for the removal of this requirement.
4. Commenter explains how botulinum toxin is necessary to achieve a normal life and urges MACs not to make botulinum toxin difficult to access.
5. The AAN found the requirements reasonable and necessary. They urge MACs to modify requirements mandating use of reassessment using that tool after each diagnostic procedure and at each follow up assessment. The comment cautions against the requirement for indefinite reevaluation at every visit as this may lead to administrative burdens.
6. Commenter argues that the use of ultrasound or electromyography for injection are not appropriate in every situation. They believe it should be excluded unless there is evidence for clinical evidence provided.

1. Thank you for your comments. We appreciate your concerns regarding the coverage guidelines for focal hand dystonia (FHD). The guidelines outlined in the Local Coverage Determination (LCD) are based on a comprehensive review of current medical literature and clinical studies related to the treatment of FHD with botulinum toxin injections. The dosing guidelines and injection sites specified in the LCD reflect the ranges that have been demonstrated to be safe and effective in the studies cited within the policy. We recognize that botulinum toxin injection therapy for FHD is highly individualized due to different activity types, levels, and multiple potential target muscles with varying doses and intervals. The LCD allows for individualized treatment plans within the dosing ranges provided, aiming to ensure patient safety while achieving optimal therapeutic outcomes.
2. Thank you for your comment regarding the muscles involved in the treatment of focal hand dystonia. We acknowledge your concerns and appreciate your feedback. The Local Coverage Determination (LCD) is developed based on a comprehensive review of the available literature and clinical guidelines. If there are additional muscles that should be considered for inclusion, we welcome any detailed information or studies you can provide to ensure the LCD reflects the most accurate and complete coverage criteria. Your input is invaluable in helping us improve and tailor these guidelines for better patient care.
3. Thank you for raising concerns about mandatory reassessment causing unnecessary burdens. Medicare requires that all services must be reasonable and necessary. Objective scales and assessments help to support the service and variations in dosing and frequencies are reasonable and necessary.
4. Thank you for sharing your perspective on the significance of botulinum toxin in managing your condition and its impact on maintaining a normal life. Your input highlights the critical role that individualized treatment plays in ensuring that patients receive care tailored to their specific needs. It is essential that Medicare Administrative Contractors (MACs) recognize the profound effect that treatment accessibility has on the everyday lives and well-being of patients. The guidelines should reflect clinical realities and provide flexibility that allows healthcare professionals to determine the most appropriate dosage and treatment frequency for each patient. We appreciate your contribution to this discussion and will certainly consider your insights as we work towards policies that prioritize effective and accessible care for all patients who rely on botulinum toxin therapy. Thank you for advocating for yourself and others in the community.
5. Thank you for raising concerns about mandatory reassessment causing unnecessary burdens. Medicare requires that all services must be reasonable and necessary. Objective scales and assessments help to support the service and variations in dosing and frequencies are reasonable and necessary.
6. Thank you for your comments. The Local Coverage Determination (LCD) for focal hand dystonia specifies that botulinum toxin injections are to be performed with guidance either by ultrasound or by electromyography with or without electrostimulation. We recognize that ultrasound guidance can be important for accurate needle placement in treating focal hand dystonia. However, CPT code 76942, which describes ultrasonic guidance for needle placement, is not separately reimbursable for this procedure. The literature cited in the LCD supports the use of guidance techniques as integral to the injection procedure but does not provide evidence for separate billing of ultrasound guidance. Therefore, while healthcare professionals may use ultrasound guidance when performing injections, separate coverage for CPT code 76942 is not provided as it would exceed the need requirement per Medicare Program Integrity Manual (MPIM) 3.6.2.2.

Blepharospasm

1. The proposed 5-unit per eye Dosing limitation is seen as inadequate and appears to have been established without input from patients or consideration of individual needs.
2. Blepharospasm is highlighted as a condition with unique manifestations in each patient. Therefore, individualized treatment plans, including Dosing amounts, injection sites, and frequency, are essential for effective management.
3. The commenter warns that if the proposal is finalized as is, it could severely impact individuals with blepharospasm by limiting their access to necessary care and potentially resulting in functional blindness for many patients.
4. The commenter urges the rejection of the proposed changes, arguing that they would leave many individuals with blepharospsm virtually blind and without access to necessary medical care, causing devastating impacts on the community.
5. The proposed restrictions on Dosing, pattern, and frequency are criticized for being based on a single commercial preparation's package insert (specifically Botox™), using initial dosing recommendations as an absolute upper limit. The restrictions are described as non-evidence-based, lacking support from either the package insert or the wider scientific literature. The comment suggests that these limits do not reflect clinical realities.
6. The commenter has experienced acceptable results with alternative methods, such as acupuncture and the use of frankincense oil, suggesting these could be considered before resorting to Botulinum toxin. The commenter finds acupuncture to be a more cost-effective treatment compared to Botulinum and suggests that financial assistance for acupuncture could be beneficial.
7. While clinical rating scales are valuable for research and symptom quantification, the comment suggests that their routine use in ongoing clinical practice should not be mandated. The commenter advocates for removing the requirement for such scales from the LCD.
8. The document's requirement for moderate to severe blepharospasm before subsequent treatment is questioned. Clinicians typically treat as symptoms begin to recur to avoid allowing the condition to reach peak intensity, which can cause functional blindness. Maintaining a steady treatment effect is crucial to prevent visual impairment.
9. Although onabotulinumtoxin is not categorized as Level A in the evidence summary, it is noted as the most commonly used and studied preparation for treating blepharospasm.
10. Despite not being classified as Level A in the evidence summary, onabotulinumtoxin is highlighted as the most commonly used and most studied treatment option for blepharospasm.
11. There is a request for clarification on whether both incobotulinumtoxinA and onabotulinumtoxinA are covered for initial dosing or if the coverage is limited to one type.
12. This comment requests the evaluation of AboBoNT-A (abobotulinumtoxinA) for indications similar to other botulinum toxin A (BoNT-A) products, specifically for the treatment of blepharospasm. The comment provides evidence and references to support this request.
13. The comment highlights that Medicare does not impose similar restrictions on dosages for antibiotics, chemotherapy, or anti-inflammatory therapies for other medical conditions, questioning why Botulinum toxin should be treated differently.
14. The proposed LCD implies that incobotulinumtoxinA should be a second-line treatment, referencing outdated prescribing information from 2018. However, the commenter notes that in 2019, the FDA approved incobotulinumtoxinA as a first-line treatment, eliminating the need for prior treatment with onabotulinumtoxinA. This change is reflected in the most recent prescribing information.
15. For incobotulinumtoxinA, there are typically 6 injection sites per eye, with an initial recommended dose of 25 units and a maximum of 50 units per eye. Research indicates that 12.5 units per eye does not significantly outperform placebo, whereas 25 units per eye is effective. This data contradicts the proposed 5-unit-per-eye limit.
16. Commenter mentions different forms of botulinum toxin (e.g., onabotulinumtoxinA, known as Botox, and abobotulinumtoxinA, known as Dysport) have different potencies. For example, Botox is approximately three times as potent as Dysport, meaning the same clinical effect requires different unit dosages for different toxins.
17. The commenter mentions using Xeomin as an alternative to avoid waste and be more cost-effective, highlighting practical considerations in treatment.
18. The comment highlights discrepancies and seeks clarification in the draft policy regarding dosing for incobotulinumtoxinA and onabotulinumtoxinA for blepharospasm.
19. The proposal is viewed as an attempt to cut Medicare costs, potentially removing access to the only effective treatment for BEB and related conditions like Meige Syndrome.
20. The commenter suggests negotiating lower drug prices with manufacturers, like Allergan, instead of imposing restrictive treatment measures. They advocate for physicians to have the authority to determine appropriate injection sites and dosing.
21. The commenter opposes third-party interference in medical treatment decisions, arguing that medical specialists, such as ophthalmologists and neurologists, are best equipped to determine the appropriate dosage, injection sites, and frequency based on individual patient needs.

1. Thank you for sharing your concerns about the proposed dosing limitations. We understand that the perception of the 5-unit per eye dosing recommendation as inadequate might stem from a desire for more individualized treatment plans. According to the draft, the initial dosing for blepharospasm with onabotulinumtoxinA is set between 1.25 to 2.5 units per injection site, aligning with the compendia's guidance. The dose may be increased up to twice if the initial response is insufficient, but exceeding 5 units per site is typically not seen to provide additional benefits. Additionally, it appears there was an error in the draft regarding the interchange of ""eye"" for ""site,"" which may have contributed to the confusion. It's important to note that the cumulative dose should not exceed 200 units in a 30-day period, as indicated in the US labeling. These guidelines are intended to ensure both safety and efficacy while providing some flexibility based on patient response. We appreciate your feedback, as it highlights the importance of continuing to evaluate whether guidelines appropriately address individual needs and facilitate optimal treatment outcomes.
2. Thank you for emphasizing the unique nature of blepharospasm and the need for individualized treatment plans. We agree that tailoring dosing amounts, injection sites, and frequency to each patient's specific manifestations is crucial for effective management. 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.
3. Thank you for expressing your concerns. We understand the gravity of the situation for individuals with blepharospasm and the vital role that access to necessary medical care plays in their lives. The proposed changes aim to ensure treatments remain effective and safe, but it's crucial that they do not inadvertently limit access to essential care. It's important that we carefully consider the impact of any policy adjustments on patient outcomes, especially for conditions where treatment is crucial to maintaining quality of life and preventing severe consequences like functional blindness. Your feedback is essential in guiding discussions to ensure that treatment decisions prioritize patient needs and well-being.
4. Thank you for expressing your concerns. We understand the gravity of the situation for individuals with blepharospasm and the vital role that access to necessary medical care plays in their lives. The proposed changes aim to ensure treatments remain effective and safe, but it's crucial that they do not inadvertently limit access to essential care. It's important that we carefully consider the impact of any policy adjustments on patient outcomes, especially for conditions where treatment is crucial to maintaining quality of life and preventing severe consequences like functional blindness. Your feedback is essential in guiding discussions to ensure that treatment decisions prioritize patient needs and well-being.
5. Thank you for emphasizing the unique nature of blepharospasm and the need for individualized treatment plans. We agree that tailoring dosing amounts, injection sites, and frequency to each patient's specific manifestations is crucial for effective management. 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.
6. Please provide literature to support these alternative methods.
7. Thank you for raising concerns about mandatory reassessment causing unnecessary burdens. Medicare requires that all services must be reasonable and necessary. Objective scales and assessments help to support the service and variations in dosing and frequencies are reasonable and necessary.
8. The Local Coverage Determination (LCD) is developed based on a comprehensive review of the available literature and clinical guidelines.
9. Thank you for your comment. While onabotulinumtoxinA may not be categorized as Level A in the evidence summary, it is indeed recognized as the most commonly used and extensively studied preparation for treating blepharospasm. Its widespread use reflects a strong foundation of clinical experience and research that demonstrates its efficacy and safety in managing this condition. The familiarity and confidence that practitioners have in using onabotulinumtoxinA play a crucial role in its continued prevalence as a treatment option. Your input underscores the importance of considering both formal evidence ratings and real-world clinical practice when evaluating treatment options.
10. Thank you for your comment. While onabotulinumtoxinA may not be categorized as Level A in the evidence summary, it is indeed recognized as the most commonly used and extensively studied preparation for treating blepharospasm. Its widespread use reflects a strong foundation of clinical experience and research that demonstrates its efficacy and safety in managing this condition. The familiarity and confidence that practitioners have in using onabotulinumtoxinA play a crucial role in its continued prevalence as a treatment option. Your input underscores the importance of considering both formal evidence ratings and real-world clinical practice when evaluating treatment options.
11. Thank you for your inquiry. The document currently does not list incobotulinumtoxinA for initial dosing, which may have raised some questions about coverage limitations. According to the compendia, incobotulinumtoxinA is indeed recognized for use, with treatment-naive patients receiving an initial dose of 25 units per eye (50 units per treatment session), and the ability to adjust based on response or adverse effects, with a maximum of 50 units per eye. It's essential to clarify whether both incobotulinumtoxinA and onabotulinumtoxinA are covered, as both are relevant options with documented effectiveness. Coverage should ideally reflect the evidence and clinical practices by including both options to allow for flexibility based on patient needs and clinical judgment. Your request for clarification is crucial in ensuring transparent and comprehensive coverage policies that facilitate optimal patient care.
12. Thank you for your comment. Requesting the evaluation of AboBoNT-A (abobotulinumtoxinA) for indications similar to other BoNT-A products, particularly for the treatment of blepharospasm, is an important consideration. We agree that the evidence and references provided offer strong support for this request, highlighting the potential effectiveness and benefits of including abobotulinumtoxinA as a treatment option. Evaluating this option in line with existing evidence would allow for a broader range of therapeutic choices, enabling healthcare providers to tailor treatments more precisely to patient needs. Your input is valuable in guiding the expansion of treatment indications to reflect current clinical research and practice.
13. The Local Coverage Determination (LCD) is developed based on a comprehensive review of the available literature and clinical guidelines.
14. Thank you for highlighting this important update. According to the compendia, incobotulinumtoxinA is indeed recognized for use as a viable treatment option for blepharospasm, with treatment-naive patients receiving an initial dose of 25 units per eye (50 units per treatment session), and the dosing can be adjusted based on individual response and adverse effects, with a maximum of 50 units per eye. This reflects the recent FDA approval from 2019 that positions incobotulinumtoxinA as a first-line treatment, eliminating the requirement for prior treatment with onabotulinumtoxinA. It’s important that the proposed LCD is updated to align with this current prescribing information, supporting the most effective and flexible treatment strategies for patients. Your input is valuable in ensuring that guidelines reflect the latest regulatory and clinical developments.
15. 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.
16. Thank you for your comment. You're correct that different forms of botulinum toxin, such as onabotulinumtoxinA (Botox) and abobotulinumtoxinA (Dysport), have varying potencies, and the unit dosages required to achieve the same clinical effect can differ. For instance, Botox is often considered to be approximately three times as potent as Dysport, necessitating adjustments in dosing when switching between these products. Acknowledging these differences is important for ensuring effective treatment outcomes. Additional specifications could indeed be included in the guidelines to address the varying potencies of different serotypes, thereby assisting healthcare providers in tailoring treatments appropriately for each specific product used. Your feedback is valuable in ensuring that guidelines are comprehensive and reflective of the nuanced nature of botulinum toxin treatments.
17. Thank you for your comment. Xeomin, also known as incobotulinumtoxinA, is indeed a viable alternative that can help avoid waste and be more cost-effective in treatment. The compendia supports its use with specific details: For treatment-naive patients, the initial dose is 25 units per eye, totaling 50 units per treatment session. The number and location of injections can be adjusted based on patient response and any adverse reactions, with a maximum of 50 units per eye (100 units per session). Repeat injections should be administered no more frequently than every three months. For those with prior treatment experience, dosing should consider the patient’s previous response, duration of effect, and any adverse events. Incorporating Xeomin into treatment plans can be a practical consideration for both clinicians and patients, ensuring effective management while optimizing resources. Your feedback underscores the importance of integrating cost-effective and flexible options into treatment strategies.
18. Thank you for your inquiry. The document currently does not list incobotulinumtoxinA for initial dosing, which may have raised some questions about coverage limitations. According to the compendia, incobotulinumtoxinA is indeed recognized for use, with treatment-naive patients receiving an initial dose of 25 units per eye (50 units per treatment session), and the ability to adjust based on response or adverse effects, with a maximum of 50 units per eye. It's essential to clarify whether both incobotulinumtoxinA and onabotulinumtoxinA are covered, as both are relevant options with documented effectiveness. Coverage should ideally reflect the evidence and clinical practices by including both options to allow for flexibility based on patient needs and clinical judgment. Your request for clarification is crucial in ensuring transparent and comprehensive coverage policies that facilitate optimal patient care.
19. Thank you for expressing your concerns. We understand the gravity of the situation for individuals with blepharospasm and the vital role that access to necessary medical care plays in their lives. The proposed changes aim to ensure treatments remain effective and safe, but it's crucial that they do not inadvertently limit access to essential care. It's important that we carefully consider the impact of any policy adjustments on patient outcomes, especially for conditions where treatment is crucial to maintaining quality of life and preventing severe consequences like functional blindness. Your feedback is essential in guiding discussions to ensure that treatment decisions prioritize patient needs and well-being.
20. Thank you for your comment. While negotiating lower prices may be beneficial, that goes beyond the scope of this LCD.
21. Thank you for sharing your concerns about third-party involvement in medical treatment decisions. We understand the importance of ensuring that specialists like ophthalmologists and neurologists, who are intimately familiar with patient needs, play a central role in determining appropriate dosage, injection sites, and treatment frequency. The drafting of the guidelines involves physicians and is based on extensive research and literature to ensure that recommendations are grounded in scientific evidence and clinical expertise. The intention is to provide a framework that supports effective and safe treatment while allowing specialists the flexibility to tailor decisions based on the unique needs of each patient. Your feedback emphasizes the critical balance needed between standardized guidelines and personalized medical care.

Blepharospasm Associated with Orofacial Dystonia

1. Commenter argues that clinical scales are useful for research and quantification of symptoms, but longitudinal use clinical practice is not necessary. Comment advocates for the removal of this requirement.
2. The organizations express concern that the proposed LCD would unnecessarily restrict patient access to effective, medically necessary treatments for conditions like blepharospasm, orofacial dystonia, hemifacial spasm, and strabismus. They emphasize the importance of these treatments in maintaining patients' ability to perform daily activities.
3. Blepharospasm is described as a progressive condition requiring ongoing management. The current proposed restrictions, such as limiting initial treatment to three injections per eye and specific muscles based on outdated FDA guidelines, do not align with modern clinical practices, which may involve up to 200 units of botulinum toxin for bilateral blepharospasm.
4. The organizations advocate for Medicare coverage policies that allow physicians the flexibility to modify treatment plans as needed, including changing the type of botulinum toxin used, to best meet patient needs.
5. The comment emphasizes that individuals with oromandibular dystonia, whether it occurs alone or as part of Meige syndrome (which includes both oromandibular dystonia and blepharospasm), require botulinum toxin injections to manage their condition. Without treatment, these individuals face significant disabilities, such as difficulty talking or eating.

1. Thank you for raising concerns about mandatory reassessment causing unnecessary burdens. Medicare requires that all services must be reasonable and necessary. Objective scales and assessments help to support the service and variations in dosing and frequencies are reasonable and necessary.
2. Thank you for sharing your concerns. The guidelines outlined in the Local Coverage Determination (LCD) are based on a comprehensive review of current medical literature and established clinical evidence and do not restrict access to care. We understand that clinical practices can vary, but the policy aims to reflect treatments supported by robust, high-quality evidence deemed reasonable and necessary under Medicare guidelines. It is important to balance access to effective treatments for conditions like blepharospasm, orofacial dystonia, hemifacial spasm, and strabismus, with the need to ensure that these treatments remain medically appropriate and evidence-based, helping patients maintain their ability to perform daily activities.
3. Thank you for highlighting this important issue. Blepharospasm is indeed a progressive condition that requires ongoing management, and it is crucial that treatment protocols align with modern clinical practices. The proposed restrictions based on outdated FDA guidelines may limit the flexibility needed for effective management. Current practices often involve doses of up to 200 units of botulinum toxin for bilateral blepharospasm, recognizing that initial doses typically range from 1.25 to 2.5 units injected into specific muscles. If the response to the initial dose lasts less than two months, the dose may be increased, with a maximum of 5 units per site. It's important to note that while tolerance can develop with more frequent treatments, this effect is generally not permanent. According to US labeling, the cumulative dose should not exceed 200 units in a 30-day period. These dosing strategies provide a more comprehensive approach to managing this condition effectively.
4. Thank you for your comment. The guidelines outlined in the Local Coverage Determination (LCD) are based on a comprehensive review of current medical literature and established clinical evidence. While we understand that clinical practices can vary, the policy reflects treatments supported by robust, high-quality evidence deemed reasonable and necessary under Medicare guidelines. We recognize the importance of providing physicians with the flexibility to modify treatment plans, including the option to change the type of botulinum toxin used, to best meet individual patient needs. Balancing standardized guidelines with the flexibility required for personalized care is essential for achieving optimal patient outcomes.
5. Thank you for highlighting this critical issue. Individuals with oromandibular dystonia, whether occurring alone or as part of Meige syndrome, indeed rely on botulinum toxin injections to manage their condition effectively. Without this treatment, they can experience significant disabilities that impact essential functions like talking and eating. Ensuring access to these necessary treatments is vital for maintaining the quality of life and daily functioning of those affected. It underscores the importance of treatment policies that accommodate the unique needs of patients and provide them with timely and effective care.

Cervical Dystonia

1. Commenters argue the draft LCD's dosing guidelines significantly differ from the established standards of care potentially impacting the treatment of cervical dystonia. The AAPMR encourages reviewing updated labels and literature to align the guidelines with accepted practices.
2. Commenters argue that while clinical rating scales can be beneficial for research and quantifying symptoms, routine use in clinical practice for cervical dystonia is deemed unnecessary. The AAPM&R advocates for removing the requirement to use these scales from the LCD.
3. Commenters argue that cervical dystonia is diagnosed through clinical history and examination. Therefore, the requirement to document an "etiology" of central nervous system impairment as separate from the diagnosis is unnecessary and should be reconsidered.
4. Commenters argue the current draft's limitation on performing multiple procedures in a single visit is seen as a significant barrier, particularly for patients who travel long distances or face financial and logistical challenges. Allowing multiple procedures during the same visit is crucial for providing accessible and efficient care.
5. Commenters argue for patients with long-standing cervical dystonia, the comment suggests that the upper limit for onabotulinumtoxinA (Botox) should be higher than currently proposed, recommending allowances for doses exceeding 400+ units.
6. The commenters criticize the exclusion of conditions like temporomandibular joint disorders (TMD) and severe bruxism as medically necessary indications for botulinum toxin. The AAPMR argues that patients benefit from botulinum toxin injections for hyperfunction of cervical muscles and mastication muscles and should have access to this treatment.
7. Commenters argue that onabotulinumtoxin (Botox) is highlighted as the most commonly used and preferred type of botulinum toxin for treating cervical dystonia, due to its accessibility and efficacy. The comment notes difficulties in obtaining alternatives like abo(Dysport) in the U.S. and mentions Rima(Myobloc)'s notable side effects and shorter duration of action, underscoring Botox as the first-line treatment.
8. Commenters suffer from cervical dystonia and are strongly opposed to botulinum toxin treatments being taken away. The commenter details that botulinum offers relief from pain and spasms and advocates for addition of treatments rather than removal.
9. Comments emphasize the importance of allowing physicians to determine the most suitable injection schedule and dosage for their patients, tailored to individual needs, rather than adhering to restrictive guidelines.
10. Ambrose, on behalf of herself and the dystonia patient community, requests rejection of these proposed changes, highlighting the potential negative impact on those who currently benefit from BoNT treatments.
11. The restriction to only inject on-label muscles in the treatment of cervical dystonia does not align with current medical practice and literature. The comment recommends allowing injections in all potential target muscles for comprehensive treatment.
12. Commenters argue that the proposed changes don't take into consideration the 35 years of successful clinical experience utilizing BoNT for CD (The proposed dosages seem to be based on the dosage used within the initial clinical studies that supported the application for new drug approval submitted to the FDA).
13. The commenter is a neurologist that specializes in treating movement disorders including dystonias (blepharospasm, cervical dystonia, oromandibular dystonia and focal limb dystonia) and finds the dosing guidelines to be inaccurate. They do not give specifics for cervical dystonia but express most concern about cranial dystonia dosing guidelines.
14. Commenters argue that proposed changes mandate excessive documentation and will require additional patient visits and time reducing physicians' ability to take on new patients. Commenter describes there is already a 3-month waiting time to see her and changes may require additional months that will prevent patients from getting treatment immediately with this highly time-sensitive from the date of injury.
15. The proposal stating that guidance for botulinum toxin procedures is unnecessary is heavily criticized. The physician argues that guidance, such as using portable EMG, is crucial for accurately targeting muscles, minimizing medication wastage, and ensuring safe injections by avoiding critical anatomical areas.
16. The draft's exclusion of various on-label diagnosis codes (including cervical dystonia and other focal dystonias) is concerning, as these conditions are FDA-approved for botulinum toxin treatment. The omission makes it challenging to provide necessary care with approved and effective therapies.
17. Physicians stress their commitment to using the safest and most effective treatments available and urge reconsideration of the proposed changes to maintain access to necessary and efficacious medical interventions for patients with cervical dystonia and other debilitating diagnoses.
18. The commenters request the addition of additional muscles for treatment of cervical dystonia: levator scapulae, scalenus, semispinalis capitis, and longissimus muscles.
19. The commenters request the removal of severity as a requirement in the LCD.
20. Commenters request MACs consider moving sub-bullet 7 under sub-section “Initial botulinum toxin injections” to be moved to the “initial dosing guideline” section to avoid misleading users to believe that only onabotulinumtoxinA is approved as first line treatment for cervical dystonia.
21. Commenters argue that the importance of recognizing AboBoNT-A is also approved as first-line use in cervical dystonia and is the only BoNT-A with level A grade recommendations for the treatment of cervical dystonia by the AAN.
22. The commenters advocate for the use of AboBoNT-A as a treatment for pediatric cervical dystonia and cite a study that details its use, efficacy and adverse effects.
23. The proposed LCD relies on outdated 2018 Prescribing Information to set dose guidelines for incobotulinumtoxinA, limiting both initial and subsequent doses to 120 units. This limitation does not reflect current practices.
24. Verduzco-Gutierrez emphasizes the need to include the use of ultrasound guidance (CPT Code 76942) as it is crucial for ensuring safe and accurate injections, a practice supported by clinical literature and essential in her own practice.
25. The document criticizes the exclusion of Onabotulinumtoxin (Botox) as a first-line treatment option, despite it being the most frequently used. Alternatives like abo(Dysport) are difficult to procure in the U.S., and Rima(Myobloc) has notable side effects and a shorter duration of action, making Botox the preferred option.
26. The commenters request for the addition of Daxxify (DaxibotulinumA-lanm)- BoNTA as a treatment for cervical dystonia. They provide documentation as well as have FDA approval. They provide the HCPC CODE JO589.
27. The commenters argue symptoms such as pain might not correlate with the motor symptoms or changes in posture, indicating that mild postures may have significant associated pain.
28. Commenters request that the LCD Replace "AND" with "OR" in the requirements for treatment eligibility to increase flexibility and better align with clinical practice.
29. Commenters argue for broader muscle selection according to FDA-approved labels such as posterior view (semispinalis capitis, trapezius, splenius cervicis, levator scapulae) and lateral view (splenius capitis, longissimus, sternocleidomastoid, scalene complex).
30. Commenters request that the LCD eliminate the requirement for cervical dystonia duration to exceed 6 months before becoming eligible for treatment. They argue that there are no criteria in studies or guidelines that state a minimum time for cervical dystonia diagnosis before treatment.
31. Commenters argue that associated codes for Cervical dystonia (4) are missing in the draft.
    • G24.9 Dystonia, undefined
    • M47.812 Spondylosis without myelopathy or radiculopathy, cervical region
    • M47.892 Other spondylosis, cervical region
    • M54.2 Cervicalgia
32. Commenter argues the proposed relative dosing for rimabotulinum toxin is notably lower compared to other botulinum toxin formulations, which may impact its effectiveness.
33. The concern is raised that coverage guidelines should not differ based on the form of dystonia, such as blepharospasm or cervical dystonia, since they share similarities in their therapeutic approaches.
34. The LCD defines two types of cervical dystonia: idiopathic or primary (linked to genetic or sporadic onset) with no secondary causes, and acquired or secondary (caused by trauma, exposure to certain drugs, neurodegenerative disease, etc.). The comment suggests that the definition already sufficiently describes the condition without needing additional documentation of CNS impairment.

1. Thank you for your comments. The guidelines outlined in the Local Coverage Determination (LCD) are based on a comprehensive review of current medical literature and established clinical evidence. While we understand that clinical practices can vary, the policy reflects treatments that are supported by robust, high-quality evidence deemed reasonable and necessary under Medicare guidelines. Furthermore, the compendia agree with the current dosing guidelines.
2. Thank you for raising concerns about mandatory reassessment causing unnecessary burdens. Medicare requires that all services must be reasonable and necessary. Objective scales and assessments help to support the service and variations in dosing and frequencies are reasonable and necessary.
3. Cervical dystonia (CD), also known as spasmodic torticollis, is a rare neurological disorder caused by an impairment of the central nervous system, particularly the basal ganglia, brainstem, and cerebellum. A thorough neurological examination is crucial in diagnosing the condition. Cervical dystonia is not simply a manifestation of focal muscle pain, muscle spasm, cervical movements and cervical posture. Therefore, it is reasonable to define the pathology in order to treat the condition.
4. Thank you for your comment. We recognize the theoretical possibility, but there was no supporting literature submitted to indicate this is probable occurrence and no supporting literature to support this change as a matter of policy.
5. Thank you for your comment. The current compendia provide dosing guidance for onabotulinumtoxinA (Botox), indicating a mean dose of 236 units, with a range from 198 to 300 units, divided among the affected muscles for those previously treated. This guidance suggests a maximum of 50 units per site, with specific considerations to reduce adverse effects, such as limiting the dose in the sternocleidomastoid muscles to 100 units to decrease the risk of dysphagia. While the Canadian labeling notes an effective range of 200 to 360 units, administered no more frequently than every two months, any recommendations to exceed 400 units would require strong supporting literature to ensure safety and efficacy. We recognize the ongoing need for flexibility in dosing to accommodate the needs of patients with long-standing cervical dystonia, and further research could help inform potential adjustments to these guidelines.
6. Thank you for your comment. There was no supporting literature submitted to support this change and the treatment of muscle specific oro-facial dysfucntion or pain is an area of active research and still requires additional clinical trials to scientifically validate botulinum toxin use for these various conditions which could be labeled as TMD or mastication muscle disorders.
7. Thank you for your comment. OnabotulinumtoxinA (Botox) is indeed the most commonly used and preferred type of botulinum toxin for treating cervical dystonia. Its accessibility and proven efficacy make it a first-line treatment option for many patients. We understand the challenges in obtaining alternatives like abobotulinumtoxinA (Dysport) in the U.S., which can limit treatment options. Additionally, rimabotulinumtoxinB (Myobloc) is noted for having a shorter duration of action and more pronounced side effects, making Botox a more favorable choice in many cases. Ensuring patients have access to this effective treatment is crucial for managing symptoms and improving quality of life. Furthermore, some practice guidelines have noted that serotypes have variable recommendations to treat cervical dystonia. AbobotulinumtoxinA (AboBoNT-A) and rimabotulinumtoxinB (rimaBoNT-B) are established as effective and should be offered (Level A), and onaBoNT-A and incoBoNT-A are probably effective and should be considered (Level B).
8. Thank you for sharing your concerns. We want to assure you that treatments, including Botulinum toxin, are not being taken away. We understand how crucial botulinum toxin is in providing relief from pain and spasms for individuals with cervical dystonia. Your advocacy for the addition of treatment options rather than their removal is important, as it reflects the need for comprehensive care tailored to individual needs. Ensuring continued access to effective treatments like botulinum toxin remains a priority, and your feedback is invaluable in highlighting the importance of maintaining and enhancing treatment options.
9. Thank you for your comments. The guidelines outlined in the Local Coverage Determination (LCD) are based on a comprehensive review of current medical literature and established clinical evidence. While we understand that clinical practices can vary, the policy reflects treatments that are supported by robust, high-quality evidence deemed reasonable and necessary under Medicare guidelines.
10. Thank you for sharing your concerns on behalf of the dystonia patient community. We assure you that our proposal is designed with patient needs in mind and will not have negative impacts on those who currently benefit from BoNT treatments. Our aim is to create guidelines that continue to support effective and safe patient care while being mindful of the diverse needs of individuals with dystonia. We appreciate your advocacy and are committed to ensuring that treatment strategies remain supportive and beneficial.
11. Thank you for your comment. Based on the literature we disagree. Please provide literature that may support your argument.
12. Thank you for your comment. We understand the importance of acknowledging the 35 years of successful clinical experience with BoNT in treating cervical dystonia. While the proposed changes aim to reflect evidence-based practices, we also adhere to strict guidelines like those outlined in the compendia. These guidelines suggest a mean dose of 236 units, with a range from 198 to 300 units, divided among affected muscles for patients previously treated with botulinum toxin. They also emphasize tailoring the sequential dosing based on factors such as head and neck position, pain localization, and patient response. To ensure safety, the total dose for the sternocleidomastoid muscles should not exceed 100 units to minimize the risk of dysphagia. Furthermore, Canadian labeling has a recognized effective range of 200 to 360 units, allowing treatments to be administered as frequently as every two months. These guidelines are designed to ensure both the safety and efficacy of treatment, while also considering the extensive clinical experience and nuanced needs of individual patients. Your feedback on the importance of integrating both historical clinical success and adaptive guidelines is valuable in refining treatment approaches.
13. Thank you for sharing your perspective as a neurologist specializing in movement disorders. We appreciate your expertise and understand your concerns regarding the dosing guidelines, particularly for cranial dystonias like blepharospasm and oromandibular dystonia. It's crucial that dosing guidelines accurately reflect the nuances of treating these conditions to ensure that patients receive the most effective care. Your feedback is valuable as it highlights the need for continuous review and potential adjustment of guidelines to better align with clinical practice and the specific needs of patients with various forms of dystonia. While we are committed to considering such expert insights to enhance treatment protocols, there was no supporting literature to support this change as a matter of policy.
14. Thank you for highlighting these concerns. We understand that the proposed changes could increase documentation and patient visits, affecting the ability to take on new patients and potentially extending wait times. Thank you for raising concerns about mandatory reassessment causing unnecessary burdens. Medicare requires that all services must be reasonable and necessary. Objective scales and assessments help to support the service, and variations in dosing and frequencies are reasonable and necessary. It's essential to balance these requirements with the need for timely patient access and efficient care delivery. Your feedback is crucial for refining these processes.
15. Thank you for your comment. While we understand the importance of precision in administering botulinum toxin injections, current guidelines indicate that the use of portable EMG is not deemed medically necessary for treating cervical dystonia. Although guidance tools can indeed enhance accuracy and potentially minimize medication wastage, the standard practice generally allows for effective targeting of muscles without EMG for this condition. We value your perspective and acknowledge the need to balance clinical efficiency with practical application, ensuring safe and effective treatment delivery.
16. Thank you for your comment. We understand the concern regarding the exclusion of various on-label diagnosis codes for conditions such as cervical dystonia and other focal dystonias. We want to clarify that all on-label conditions approved by the FDA for botulinum toxin treatment are indeed included in the draft. Our aim is to ensure that patients can access necessary and effective therapies without barriers, and we appreciate your attention to these critical details to safeguard comprehensive patient care.
17. Thank you for sharing your dedication to providing the safest and most effective treatments for your patients. We recognize the critical importance of maintaining access to necessary and efficacious medical interventions for conditions such as cervical dystonia and other debilitating diagnoses. Your commitment to patient care is valued, and your feedback regarding the proposed changes will be carefully considered. It is essential that any adjustments to guidelines continue to support the high standards of care that you and your patients rely on. We appreciate your input and advocacy in ensuring that treatment options remain both effective and accessible.
18. Not part of cervical dystonia but are more likely due to other painful conditions of the cervical spine.
19. Thank for your comment, based on literature we disagree, this treatment is reserved for moderate to severe conditions.
20. Thank you for your comment. According the compendia onabotulinumtoxinA is an approved on-label firs line treatment for cervical dystonia.
21. Thank you for your comment. We agree on the importance of recognizing that AbobotulinumtoxinA (AboBoNT-A) is approved as a first-line treatment for cervical dystonia. It is notable that AboBoNT-A holds Level A grade recommendations by the American Academy of Neurology (AAN) for this condition, highlighting its efficacy and acceptance in clinical practice. Acknowledging such treatment options ensures that healthcare providers can choose from a range of effective therapies to best meet the needs of their patients. Your input underscores the need to consider all approved and recommended treatments in cervical dystonia care.
22. Thank you for emphasizing the potential of AboBoNT-A as a treatment for pediatric cervical dystonia and for citing relevant studies. While we have reviewed the literature you mentioned, it's important to note that the study was open-ended with a relatively small sample size of only 28 participants, who were observed for varying durations from 12 to 64 months. To make robust clinical recommendations, stronger and more extensive evidence is necessary. Larger, well-controlled studies would help in better understanding the efficacy and safety profile of AboBoNT-A in pediatric patients. Your input is crucial in guiding where further research and evidence are needed to support treatment decisions.
23. Thank you for bringing attention to this issue. We agree that relying on outdated 2018 prescribing information for incobotulinumtoxinA may not accurately reflect current practices. According to the compendia, the US labeling recommends doses of 120 to 240 units divided among affected muscles, with the dosage and number of injection sites individualized based on factors such as prior treatment, patient response, duration of effect, adverse events, muscle location, and disease severity. In clinical trials, most patients received between 2 to 10 injections total, with a maximum cumulative dose per treatment session of 400 units, administered no more frequently than every three months. These guidelines indicate the need for more flexible dosing to ensure treatments are tailored to each patient's specific needs. Your feedback underscores the necessity of updating guidelines to align with contemporary clinical standards and practices.
24. Thank you, Dr. Verduzco-Gutierrez, for emphasizing the importance of using ultrasound guidance for injections. According to the compendia, while administering botulinum toxin for cervical dystonia, it is essential to use an appropriately sized needle for intramuscular injections and to limit the dose in the sternocleidomastoid muscle to reduce the risk of dysphagia. The compendia also suggest that simultaneous EMG-guided application and/or ultrasound may be beneficial in accurately identifying active muscles that might not be detectable through physical examination alone. This approach is supported by clinical literature and reflects best practices in ensuring safe and effective treatment outcomes. We plan to allow the use of Ultrasound with Doctors providing specific explanations as of why it is necessary. We will modify the draft to ensure this specification is noted. Your advocacy for including ultrasound guidance aligns with these recommendations, highlighting its value in clinical practice for achieving precise and safe injections.
25. Thank you for your comment. We acknowledge the importance of including OnabotulinumtoxinA (Botox) as a first-line treatment option, given its status as the most frequently used botulinum toxin for many conditions. As you pointed out, alternatives like abobotulinumtoxinA (Dysport) can be challenging to procure in the U.S., and rimabotulinumtoxinB (Myobloc) may present notable side effects and have a shorter duration of action, making Botox the preferred option for both physicians and patients. Ensuring Botox's availability as a first-line treatment is crucial for maintaining effective and accessible care. Your feedback highlights the necessity of aligning treatment guidelines with clinical realities and patient needs.
26. Thank you for your comment and for providing detailed documentation regarding Daxxify (DaxibotulinumA-lanm) as a treatment option for cervical dystonia. We acknowledge the FDA approval and the provided HCPC CODE JO589. According to the compendia, Daxxify can be administered in doses of 125 to 250 units, divided among the affected muscles. The dose and number of injection sites should be individualized, considering factors such as prior treatment, patient response, duration of effect, and any adverse events. Dosages may be adjusted in 50- to 75-unit increments based on individual response, with a total recommended dose per session of 125 to 250 units, administered no more frequently than every three months. Your input is valuable in ensuring that treatment options are comprehensive and aligned with current clinical evidence and approvals. Adding Daxxify as an option could provide an important alternative for managing cervical dystonia effectively.
27. Pain is a subjective measure. Policy is developed to address the objective measurements.
28. Thank you for comment. The proposals in this LCD are based on clinical research and published literature. We therefore disagree with this change to the requirements for treatment.
29. Thank you for comment. The proposals in this LCD are based on clinical research and published literature. We therefore disagree with this change to the requirements for treatment.
30. Thank you for your comment. We agree that OnabotulinumtoxinA (Botox) is considered a first-line treatment for cervical dystonia and acknowledge the request to eliminate the requirement that the condition must persist for over six months before becoming eligible for treatment. The absence of such criteria in studies or established guidelines supports the position that patients should have access to effective treatments like Botox as soon as diagnosis occurs, without unnecessary delays. Ensuring timely access to first-line therapies is crucial for managing symptoms and improving quality of life for individuals with cervical dystonia. Your feedback highlights the importance of aligning treatment eligibility criteria with evidence-based practices and clinical realities.
31. Thank you for the comment. These will be addressed in the billing and coding article.
32. Thank you for your comment. We understand your concern regarding the perceived lower relative dosing for rimabotulinumtoxinB compared to other botulinum toxin formulations, which might affect its effectiveness. Our document specifies an initial dose range of 2,500 to 5,000 units divided among affected cervical muscles, consistent with the guidelines in the compendia. For patients previously treated with botulinum toxin, this initial dosing is intended to provide a balance between efficacy and safety, with room for adjustment in subsequent doses based on the patient's response. It's important to ensure that dosing strategies are tailored to meet individual patient needs while maintaining safety standards. We appreciate your input as it underscores the need for careful consideration of dosing efficacy and flexibility in treatment planning. Your feedback helps guide discussions on how best to optimize rimabotulinumtoxinB dosing for effective management of cervical dystonia.
33. Thank you for raising this concern. While it's true that different forms of dystonia, such as blepharospasm and cervical dystonia, may share some therapeutic similarities, there are also important differences in their clinical presentations and treatment needs. The guidelines are designed to address each type of dystonia individually, ensuring that specific characteristics and therapeutic requirements are taken into account rather than applying a one-size-fits-all approach. This tailored strategy aims to optimize treatment effectiveness and patient outcomes by respecting the unique aspects of each condition. Your feedback reinforces the importance of maintaining individualized guidelines that reflect these differences.
34. CD is a neurological disorder and is not just a spasm of the muscle.

Chronic Migraine

1. Multiple comments site a lack of clarity regarding the initial and subsequent dosing guidelines for chronic migraine treatment, as these guidelines lack specific citations to support their criteria. The proposed dosage is primarily between 155-195 Units, but there is advocacy for starting at 150 Units to avoid wastage, considering vial sizes, proposals to increase upper dosage to 400+ units and comments against the two-month trials from the specified drug classes before being eligible for Botox treatment.
2. There is support for the modification of the PREEMPT protocol, which is the standard for Botox injections for chronic migraine, to tailor treatment to individual patient needs. Many clinicians reportedly do not strictly follow the PREEMPT protocol, indicating variability and the need for more flexibility.
3. The criteria for assessing patient response to treatment are in question. The current guideline proposes a 50% reduction in headache days as a measure of success, but this may not account for the individual variations in patient experiences, such as reductions in headache intensity or disability.
4. The requirement to assess and implement biobehavioral therapies (such as cognitive behavioral therapy, biofeedback, etc.) is deemed vague, as the guidelines do not specify how these should be monitored or the frequency needed, and there are concerns these could exacerbate disparities, as these therapies may be inaccessible to some patients.
5. There is concern over restrictions that prevent multiple procedures on the same day, which could impede patient care for those with conditions requiring different injections. Additionally, botulinum toxin is not covered for generalized pain conditions or other specific disorders, which may impact patients with comorbid conditions like fibromyalgia.
6. There is an argument that Botox could be considered effective for certain pain disorders outside of migraine, based on studies indicating its efficacy for conditions like trigeminal neuralgia.
7. The initial dosing guidelines specify that the Botox doses should be distributed among certain muscles such as the frontalis, corrugator, procerus, occipitalis, temporalis, trapezius, and cervical paraspinal muscle group. However, it does not include the masseter muscle, which is commonly treated in practice.
8. We received a comment recommending the addition of AboBoNT-A as treatment for Migraine along with indication of ongoing clinical trials involving the treatment of episodic and chronic migraine with AboBoNT-A.
9. The proposed LCD requires ongoing documentation of migraines using a consistent scale at each visit, which the AAN finds excessive. They suggest that reevaluation during every visit could lead to negative consequences and recommend more flexible assessment guidelines.
10. The proposed LCD mandates that migraines must be "moderate to severe" with typical characteristics, yet the AAN points out that migraines can present with mild pain or other symptoms like nausea and dizziness. They suggest that the guidelines should consider the severity and presence of both headache and accompanying symptoms.
11. The LCD has a proposed definition for chronic migraine that conflates it with migraine in general. The AAN suggests revising this to distinguish between episodic and chronic migraine according to the frequency of headaches.
12. AAN supports the inclusion of both CGRP agents and Botox but urges clarification so that patients who improve but still have chronic migraine symptoms can continue treatment.
13. AAN believes the universal limit of injections every 12 weeks is reasonable generally, but they propose allowing for exceptions based on individual patient needs, as some might benefit from more frequent dosing.
14. The document supports the exclusion of chronic daily headaches from Botox coverage but emphasizes clarifying language to ensure that chronic migraine isn't unnecessarily excluded.
15. Commenter argues there are certain head and neck conditions which have been treated off label but are not included in this document including chronic migraine.
16. The comment suggests adding guidelines to allow combination therapy for patients using Botox and CGRP agents concurrently. This includes detailing conditions under which additional preventive therapy is warranted, such as when migraines continue to cause significant disability.
17. The commenter critiques the rigid criteria for determining the effectiveness of Botox treatment, particularly the requirement to assess benefit after just one injection cycle. Historical trials like PREEMPT show that benefits are more evident after at least two cycles.
18. The policy requires evidence of significant functional disability and migraine severity to qualify for Botox. However, patients might experience relief from other incapacitating symptoms even if the headache itself is mild.
19. With more than ten criteria required for initial treatment approval, the commenter argues this might unnecessarily exclude patients who could benefit from Botox.
20. The lack of clarity around what constitutes a "significant reduction" in disability and improvement in functioning, as well as the use of "MIC" (Minimal Important Change), is criticized, pointing to issues with current questionnaires like MIDAS or HIT-6.
21. There is concern about the accessibility and availability of such therapies, pointing out a potential health equity issue if they are required for continued treatment.
22. The overarching concern is that the proposed criteria are too restrictive, potentially hindering effective patient care and contradicting the strategic goals of improving health outcomes and advancing health equity. The comments advocate for a more flexible, patient-centric approach that considers patient history and individualized responses to treatment rather than overly stringent criteria.

1. Thank you for your comment. We understand the importance of flexible, individualized approaches to accommodate patient variability and improve treatment outcomes while considering economic implications. In the context of chronic migraine prevention, it's essential to strike a balance between effective dosing and minimizing wastage. Current guidelines recommend administering 155 units once every 12 weeks. Additionally, our preference for initial prophylactic pharmacotherapy includes propranolol, amitriptyline, topiramate, CGRP antagonists, and onabotulinumtoxinA. Recognizing the limitations in current approvals, it is indeed reasonable to consider onabotulinumtoxinA and FDA-approved CGRP medications as viable first-line options, especially for older adults.
2. Thank you for your comment. We understand the importance of flexible, individualized approaches to accommodate patient variability and improve treatment outcomes. The draft policy concerning migraine prevention and the PREEMPT protocol is based on a comprehensive review of current medical literature and established clinical evidence. While we acknowledge that clinical practices can vary, the policy reflects treatments that are supported by robust, high-quality evidence and are deemed reasonable and necessary under Medicare guidelines.
3. Thank you for your comments regarding the 50% reduction in migraines. The current guidelines require a minimum of 50% reduction in the frequency of headaches. This range allows for the possibility of placebo improvements up to 50%. Thank you for bringing up the suggestion to consider headache severity as a measure in addition to frequency. While we appreciate this perspective it does not align with the current definitions and guidelines for the treatment of chronic migraine.
4. Thank you for raising concerns about the behavioral therapy requirement. We recognize the importance of clearly defined guidelines and addressing potential barriers to access and feasibility, which can indeed exacerbate health disparities. According to the compendium behavioral therapy is recommended for migraine prevention, offering options like relaxation training, biofeedback, and cognitive-behavioral therapy. However, the choice of intervention should be individualized based on clinician familiarity, local resources, and patient preferences. Access to these therapies can vary widely, and it's crucial to consider the logistics of implementing and monitoring them to ensure they are accessible to all patients who might benefit. We agree that it is necessary to revisit the requirement, focusing on making these therapies more accessible and feasible for diverse populations.
5. Thank you for your comment. We understand the importance of flexible, individualized approaches to accommodate patient variability and improve treatment outcomes. The draft policy concerning migraine prevention and the PREEMPT protocol is based on a comprehensive review of current medical literature and established clinical evidence. While we acknowledge that clinical practices can vary, the policy reflects treatments that are supported by robust, high-quality evidence and are deemed reasonable and necessary under Medicare guidelines. Additionally, we recognize the theoretical possibly, but there was no supporting literature submitted to indicate this is probable occurrence and no supporting literature to support this change as a matter of policy.
6. Thank you for your comment. We acknowledge the growing body of research suggesting that Botox may be effective for certain pain disorders beyond migraines, such as trigeminal neuralgia. The compendia list Clinical Practice Guidelines that reference studies indicating some evidence for botulinum toxin type A's efficacy, showing a potential 50% decrease in pain severity and frequency at 12 weeks when used alongside other systemic drugs. This highlights the need for further exploration and consideration of Botox's broader applications in pain management, ensuring treatments remain aligned with the latest clinical evidence.
7. Current guidelines recommend administering 155 units once every 12 weeks, divided into specific sites, and do not include the masseter muscle as a standard target due to the lack of evidence supporting its efficacy in trials. The masseter was only injected in a limited number of patients in previous studies, without demonstrating significant benefits, potentially due to confounding factors like additional chronic pain conditions.
8. Thank you for your comment regarding the use of AboBoNT-A as a treatment for chronic migraine. The compendium does not include the use of AboBoNT-A as a treatment for chronic migraine. The information provided suggests trials are still undergoing. If new evidence or updated clinical guidelines become available that support the use of AboBoNT-A for chronic migraine, we encourage you to submit this information for consideration in future policy revisions.
9. Thank you for raising concerns about mandatory reassessment causing unnecessary burdens. Medicare requires that all services must be reasonable and necessary. Objective scales and assessments help to support the service and variations in dosing and frequencies are reasonable and necessary.
10. Thank you for sharing these important comments regarding migraine treatment criteria. The definition used in the LCD is based on the international classification of chronic migraine and the diagnostic criteria was extensive providing multiple characteristics besides severity, only two of the 4 characteristics must be met.
11. Thank you for your comments. We have used the international qualification to define chronic migraine in order to prevent any misunderstandings.
12. Our preference for initial prophylactic pharmacotherapy includes propranolol, amitriptyline, topiramate, CGRP antagonists, and onabotulinumtoxinA. Recognizing the limitations in current approvals, it is indeed reasonable to consider onabotulinumtoxinA and FDA-approved CGRP medications as viable first-line options, especially for older adults.
13. The current guidelines for injections every 12 weeks are rooted in the compendia, which provide a structured framework for treatment. These guidelines recommend administering 155 units every 12 weeks, appropriately divided into 31 sites, to ensure consistency in therapeutic outcomes. While this approach serves as a standard benchmark, it also allows for flexibility to make exceptions based on individual patient needs, as highlighted by the AAN. This ensures that while the general protocol is adhered to, patient-specific considerations are not overlooked.
14. Thank you for your comments. We have used the international qualification to define chronic migraine in order to prevent any misunderstandings.
15. Thank you for your comments. Chronic migraine is addressed in the LCD.
16. Thank you for your input supporting the use of both CGRP antagonists and botulinum toxin for chronic migraine treatment. It's crucial to ensure that patients who experience improvement aren't penalized or have their treatment withdrawn prematurely just because their condition has improved but still requires ongoing management. Our recommended first-line agents include propranolol, amitriptyline, topiramate, CGRP antagonists, and onabotulinumtoxinA, with an expectation that up to 50% of patients may achieve a 50% reduction in headache frequency with these treatments. However, it is important to clarify that achieving such improvements should not preclude patients from continuing therapy if it remains necessary for maintaining their quality of life.
17. Thank you for your comment regarding the determination of effectiveness of treatment. The insights from historical trials, such as PREEMPT, support the view that benefits often become more apparent after multiple cycles. These findings underscore the importance of longer-term evaluation to fully assess the treatment's effectiveness, highlighting the need for flexibility in clinical practice to accommodate individual patient responses over time.
18. Thank you for sharing these important comments regarding migraine treatment criteria. The definition used in the LCD is based on the international classification of chronic migraine and the diagnostic criteria was extensive providing multiple characteristics besides severity, only two of the 4 characteristics must be met.
19. Thank you for your comment. We understand the importance of flexible, individualized approaches to accommodate patient variability and improve treatment outcomes. The draft policy concerning migraine prevention and the PREEMPT protocol is based on a comprehensive review of current medical literature and established clinical evidence. While we acknowledge that clinical practices can vary, the policy reflects treatments that are supported by robust, high-quality evidence and are deemed reasonable and necessary under Medicare guidelines.
20. Thank you for your comment. These objective measures address specificity to address "significant reduction" in disability and improvement in functioning.
21. Thank you for raising concerns about the behavioral therapy requirement. We recognize the importance of clearly defined guidelines and addressing potential barriers to access and feasibility, which can indeed exacerbate health disparities. According to the compendium behavioral therapy is recommended for migraine prevention, offering options like relaxation training, biofeedback, and cognitive-behavioral therapy. However, the choice of intervention should be individualized based on clinician familiarity, local resources, and patient preferences. Access to these therapies can vary widely, and it's crucial to consider the logistics of implementing and monitoring them to ensure they are accessible to all patients who might benefit. We agree that it is necessary to revisit the requirement, focusing on making these therapies more accessible and feasible for diverse populations.
22. Thank you for your comment. We understand the importance of flexible, individualized approaches to accommodate patient variability and improve treatment outcomes. The draft policy concerning migraine prevention and the PREEMPT protocol is based on a comprehensive review of current medical literature and established clinical evidence. While we acknowledge that clinical practices can vary, the policy reflects treatments that are supported by robust, high-quality evidence and are deemed reasonable and necessary under Medicare guidelines.

1. The comment points out the difficulty in satisfying the draft's requirement for objective documentation of spasmodic dysphonia/laryngeal dystonia features, suggesting that such objective documentation may not exist.
2. It emphasizes that diagnosis and treatment decisions are made based on comprehensive evaluations by Otolaryngologists, which include patient history, physical examinations, and laryngeal examinations.
3. The draft's initial dosing guidelines are criticized for lacking scientific or research basis, with the author arguing that dosing should be individualized.
4. Concerns are raised over the draft guidelines not aligning with common clinical practices or peer-reviewed research. A specific issue is the mention of injecting the posterior cricoarytenoid muscle instead of the thyroarytenoid muscle for adductor SD, which misaligns with typical treatment practices.
5. The Proposed LCD focuses only on laryngeal dystonia (spasmodic dysphonia) and fails to recognize other laryngeal conditions that are considered medically necessary according to other CMS documents and the AAO-HNS position statement. The commenter emphasizes that the LCD should include these conditions to ensure comprehensive patient care. The treatment of certain conditions such as palatal myoclonus, which are covered under another CMS article, is not addressed in the Proposed LCD. The inclusion of these conditions is requested. The Proposed LCD does not consider refractory cough, a condition that could benefit from botulinum toxin treatment, nor does it refer to other relevant conditions mentioned in the University of Michigan's information sheet.
6. The LCD's coverage limitation states that payment is allowed for one injection per site, but this may be confusing because CPT codes describe injections as unilateral. The comment requests clarification or updates to this statement.
7. The proposal should also consider the use of different neurotoxins, such as abobotulinumtoxin B, for patients who develop resistance to standard treatments.
8. Commenters express concern that proposed changes would have detrimental effects and leave many people sufferingfrom spasmodic dysphonia voiceless.
9. Commenter urges the removal of the phrase "Documentation to rule out non-organic voice disorders", as they believe it is vague and unhelpful. They believe it is redundant and would lead to medical note bloat to have to document this separately.
10. The guideline to allow payment for only one injection per site could lead to inadequate treatment if bilateral injections are not covered. The proposed practice of injecting the contralateral side weeks later is seen as inefficient and uncomfortable for patients, as it deviates from standard treatment practices.
11. The commenter stresses that whoever drafted the document lacks understanding of the condition and its treatment. They advocate for guidelines that don't restrict medical professionals' ability to provide effective care, warning that the current proposal would severely impact patient outcomes by depriving them of necessary treatment.
12. SD requires varied dosing, injection sites, and intervals, tailored to individual patients and their specific form of the condition. The guidelines are seen as overly restrictive, potentially preventing personalized treatment plans.
13. The commenter notes the initial dosing guidelines were incorrect and provides improvements; Unfortunately, under initial dosing guidelines the sentence was incorrect, the correct sentence should read:
    • The initial injection of onabotulinumtoxinA for Adductor Laryngeal Dystonia may be placed unilaterally or bilaterally into the thyroarytenoid and lateral cricoarytenoid muscles
    • For Adductor Laryngeal dystonia a dose ranging from 1/16 of a unit up to 5 units on each side.
    • For abductor dysphonia the posterior cricoarytenoid muscle in one or both sides may be injected with a dose between 1 to 5 units of toxin

Under subsequent Botulinum toxin injections shall be deemed reasonable and necessary when:

• • Documentation of informed clinical decisions regarding repeat botulinum toxin injections and reassessment of the degree of persistent and or recurrent laryngeal dystonia and assessment of previous response to Botulinum toxin is present and documented

Under subsequent dosing guidelines, the sentence should read:

• • Additional injections of onabotulinumtoxinA on one or both sides, subsequent injections are usually given at 12-week intervals but may be given more or less frequently depending on the documented degree of breathiness, what individual patient can manage and the response to the previous does.

14. The term "laryngeal dysphonia" used in the proposal is described as vague and not commonly used. This could lead to misunderstandings about which conditions are being addressed.

15. The comment outlines several conditions treated with BoNT that might be overlooked by the proposal, including:

• Laryngeal dystonia (spasmodic dysphonia): Comes in different forms, each requiring specific treatment strategies. The proposed guidelines focus on the rarer abductor type while neglecting the more common adductor type.
• Laryngeal/vocal tremor: Not mentioned in the proposal, yet patients often need targeted BoNT treatment.
• Cricopharyngeus muscle dysfunction: Also omitted, despite causing severe swallowing issues and requiring BoNT intervention.
• Frey syndrome: Involving gustatory sweating, treated effectively with BoNT but not addressed in the proposal.

16. The guidelines restrict how physicians can tailor treatments due to their lack of alignment with accepted medical practices and literature. Specific criticism is directed at the 12-week injection interval, which may not be suitable for all patients and conditions.

17. The comment questions whether clinical subject matter experts were involved in crafting these guidelines, suggesting a disconnect between the proposal and the reality of clinical practice.
18. Commenter believes that while the proposal focuses on onabotulinumtoxin, it should also accommodate other preparations like incobotulinumtoxin, commonly used based on patient histories and needs.
19. Commenter suggests working with botulinum toxin manufacturers to produce smaller vials to save costs by reducing wastage as some patients receive dosage much lower than vial size.
20. Coverage for the medication should account for unavoidable wastage that occurs during its preparation and administration, and different injection methods (such as endoscopic guidance) may be necessary for some patients. Some patients, especially those with anatomical variations such as obesity, may require alternative injection methods (like endoscopic guidance), which impacts cost considerations.
21. While onabotulinumtoxin is common, other preparations like incobotulinumtoxin (Xeomin) are also used, and their use should be allowed based on patient history and prior treatments.
22. The comment points to letters from leading medical and advocacy organizations, such as the American Academy of Otolaryngology, American Laryngological Association, and Dysphonia International, which detail errors and express concerns over the guidelines.

1. Thank you for your comment. We understand the concern regarding the utility of the Voice Handicap Index (VHI) and Voice Quality Protocol (VPQ) in the context of diagnosis and care. According to the research commissioned by the Movement Disorders Society, the VHI and VPQ are among the recommended scales for assessing laryngeal dystonia. They have been validated, although on a limited number of patients, which may contribute to their perceived utility in clinical assessment rather than direct diagnosis. Medicare requires that all services be reasonable and necessary, and objective scales and assessments like these help support the provision of services. They allow for variations in dosing and frequencies to be measured and justified in a consistent manner. These tools play a role in ensuring that treatment decisions are informed and that patient care is optimized based on validated criteria. Your input is important in evaluating how best to apply these tools in clinical practice.
2. Thank you for highlighting the comprehensive approach taken by otolaryngologists in diagnosing and making treatment decisions. These decisions are indeed based on detailed evaluations that encompass patient history, thorough physical examinations, and laryngeal assessments. This multifaceted evaluation ensures that each patient receives a diagnosis and treatment plan tailored to their specific needs and medical context. While diagnostic tools and scales, such as the Voice Handicap Index (VHI) or Voice Quality Protocol (VPQ), may play a supplemental role, the cornerstone of effective care lies in the clinical expertise and nuanced judgment of healthcare professionals. Your comment underscores the importance of this comprehensive evaluation process in achieving the best patient outcomes.
3. Thank you for emphasizing the importance of personalized approaches in the treatment of spasmodic dysphonia (SD). We agree that successful treatment often depends on open discussions between patients and physicians to tailor dosage, injection sites, and treatment intervals, with adjustments typically made at each session. The draft guidelines are based on extensive literature and research to ensure they provide a safe and effective framework for treatment. However, they are designed to include flexibility within these limits, allowing healthcare providers to make necessary adjustments based on individual patient needs and responses. Your feedback highlights the crucial role of customization in achieving the best patient outcomes while adhering to evidence-based practices.
4. Thank you for your comment. We have adjusted the draft to specify adductor spasmodic dystonia as the target for botulinum toxin treatments.
5. Thank you for your comment. The LCD has been updated to using current literature and specifications.
6. Thank you for your comment. We have adjusted the draft to specify that injections will not be considered reasonable and necessary when administering bilateral injections for TA and LCA.
7. The Local Coverage Determination (LCD) is developed based on a comprehensive review of the available literature and clinical guidelines.
8. Thank you for expressing your concerns. We understand the gravity of the situation for individuals with spasmodic dysphonia and the vital role that access to medical care plays in their lives. The proposed changes aim to ensure treatments remain effective and safe, but it's crucial that they do not inadvertently limit access to essential care. It's important that we carefully consider the impact of any policy adjustments on patient outcomes, particularly for conditions where treatment is critical to maintaining quality of life and communication abilities. Your feedback is essential in guiding discussions to ensure that treatment decisions prioritize patient needs and well-being.
9. Thank you for your comment. The LCD has been updated to using current literature and specifications.
10. Thank you for your comment. We have adjusted the draft to specify that injections will not be considered reasonable and necessary when administering bilateral injections for TA and LCA.
11. Thank you for your comment. It's important that guidelines are developed with input from the practices of physicians who treat conditions like spasmodic dysphonia (SD) and are supported by relevant peer-reviewed research. The literature referenced in the guidelines is intended to focus on laryngeal dystonia and related research to ensure that the treatment approaches are appropriately aligned with the specific needs of SD patients. If some articles cited pertain to conditions such as cervical dystonia, it is crucial to reassess these resources to maintain relevance and accuracy in the guidelines. Your feedback underscores the need for precise alignment between guidelines and the clinical realities faced by treating physicians to ensure they are both applicable and effective.
12. This variability indeed necessitates individualized treatment plans, as a one-size-fits-all approach is unlikely to be effective. Within the limits of the draft, which is based on extensive research and literature, healthcare providers can tailor interventions to each patient's unique needs, ensuring more precise and effective management of symptoms. Your comment underscores the critical importance of flexibility in clinical guidelines, allowing for adjustments based on the specific characteristics and responses of each patient. By prioritizing individualized care, we can optimize outcomes and improve the quality of life for those affected by these conditions.
13. Thank you for your comment. The dosing has been updated in the LCD.
14. Thank you for highlighting this important point. The term "laryngeal dysphonia" may indeed be perceived as vague and not commonly used in the clinical setting, which can lead to potential misunderstandings about the conditions being addressed. According to the compendia, the more precise term is "laryngeal dystonia," which was formerly known as spasmodic dysphonia. This condition is often subject to diagnostic delays and can be confused with other voice disorders like muscle tension dysphonia or essential vocal tremor. Clarity in terminology is crucial for accurate diagnosis and treatment planning, and your feedback underscores the need to use precise language to avoid confusion and ensure that the appropriate conditions are being targeted in any proposal or guideline.
15. Thank you for your comment. The LCD has been updated to clarify injections for adductor spasmodic dystonia. Botulinum Toxin Injection for Treatment of Cricopharyngeal Dysfunction (CP) is not a U.S. Food and Drug Administration approved indication and is considered an off-label use. There is limited medical literature suggesting this as a reasonable treatment and there is no/unclear support in clinical guidelines for the use of botulinum toxin injections for treatment of CP dysfunction.
16. Thank you for your comment. It's important that guidelines are developed with input from the practices of physicians who treat conditions like spasmodic dysphonia (SD) and are supported by relevant peer-reviewed research. The literature referenced in the guidelines is intended to focus on laryngeal dystonia and related research to ensure that the treatment approaches are appropriately aligned with the specific needs of SD patients. If some articles cited pertain to conditions such as cervical dystonia, it is crucial to reassess these resources to maintain relevance and accuracy in the guidelines. Your feedback underscores the need for precise alignment between guidelines and the clinical realities faced by treating physicians to ensure they are both applicable and effective.
17. Thank you for your comment. It's important that guidelines are developed with input from the practices of physicians who treat conditions like spasmodic dysphonia (SD) and are supported by relevant peer-reviewed research. The literature referenced in the guidelines is intended to focus on laryngeal dystonia and related research to ensure that the treatment approaches are appropriately aligned with the specific needs of SD patients. If some articles cited pertain to conditions such as cervical dystonia, it is crucial to reassess these resources to maintain relevance and accuracy in the guidelines. Your feedback underscores the need for precise alignment between guidelines and the clinical realities faced by treating physicians to ensure they are both applicable and effective.
18. Thank you for your comment. While it's important to consider various treatment options to best meet individual patient histories and needs, the focus of the proposal on onabotulinumtoxin reflects its strong evidence base and established use. Currently, there is not enough robust evidence supporting the use of incobotulinumtoxin specifically for laryngeal dystonia. Ensuring that treatments are backed by solid clinical evidence is crucial for maintaining patient safety and efficacy. However, ongoing research and clinical experiences are vital for expanding and updating treatment options where appropriate. Your feedback is valuable in highlighting the need for continued exploration of all potential therapeutic avenues.
19. Thank you for your comment. Negotiating with manufacturers that goes beyond the scope of this LCD.
20. Please provide literature for the use of endoscopic guidance.
21. Thank you for your comment. While it's important to consider various treatment options to best meet individual patient histories and needs, the focus of the proposal on onabotulinumtoxin reflects its strong evidence base and established use. Currently, there is not enough robust evidence supporting the use of incobotulinumtoxin specifically for laryngeal dystonia. Ensuring that treatments are backed by solid clinical evidence is crucial for maintaining patient safety and efficacy. However, ongoing research and clinical experiences are vital for expanding and updating treatment options where appropriate. Your feedback is valuable in highlighting the need for continued exploration of all potential therapeutic avenues.
22. Thank you for bringing attention to the letters from leading medical and advocacy organizations such as the American Academy of Otolaryngology, the American Laryngological Association, and Dysphonia International. These organizations provide critical insights and express valid concerns regarding the guidelines, highlighting potential errors and areas for improvement. Their expertise is invaluable in ensuring that the guidelines are both accurate and reflective of the best practices in the field. We appreciate this feedback and will carefully consider the points raised by these respected organizations to refine the guidelines and better serve the needs of patients and healthcare providers.

Hemifacial Spasm

1. Commenter believes the suggested dosages are reasonable, but points out some patients may need upto 100U of onabotulinum toxin to achieve complete response and that while treatment evaluation is essential but argues against the necessity of re-evaluations at every visit. They recommend reconsidering the mandated frequent use of these scales during diagnostic procedures and follow-up assessments.
2. Commenters believe that clinical rating scales are useful for research and for quantification of symptoms but there is little evidence of utility in longitudinal clinical practice. They believe this requirement should be removed.
3. We received comments recommending the addition of AboBoNT-A as treatment for hemifacial spasm along with a summary of clinical studies that evaluate the efficacy and safety of AboBoNT-A for treating hemifacial spasm.
4. To avoid wastage and be cost-effective, the neurologist tends to use Xeomin for treating most blepharospasm and hemifacial spasm patients.
5. The writer urges consultation with experts when forming policies to ensure practical and efficient treatment approaches. They highlight that while botulinum toxin might be abused in other areas, it is a crucial treatment for benign essential blepharospasm and provides relief for hemifacial spasm patients, who have limited options outside of extensive procedures like facial nerve decompression.
6. The comment underscores the effectiveness of botulinum toxin in helping patients manage hemifacial spasm and return to normal lives. It notes that botulinum toxin offers moderate relief unavailable from oral medications or other non-invasive procedures.
7. Dr. Brown stresses that effective treatment of blepharospasm and hemifacial spasm requires individualized dosing. Each patient needs a different amount of botulinum toxin, and the treatment must be titrated over repeated doses to maintain efficacy.
8. Drawing from nearly 40 years of experience since starting ophthalmology residency in 1986, Dr. Brown highlights her role as possibly the sole provider of these treatments in her rural region, noting that limited practitioner availability and poor reimbursement deter many physicians from offering this specialized care.
9. Botulinum toxin injections are highlighted as a safe, tried, and true treatment compared to higher-risk surgical options. It's implied that depriving patients of such an effective therapy is unjust.
10. Dr. Brown urges for fair treatment of these patients, advocating for the ability to titrate therapy based on individual patient needs, thus maintaining their functional abilities and improving their quality of life.
11. The organizations express concern that the proposed LCD would restrict access to necessary treatments for hemifacial spasm and related conditions, which are critical for maintaining patients' ability to perform daily activities.
12. They argue that the proposed limitation to three injections per eye and using outdated guidelines (from an FDA package insert from 1989) does not reflect current clinical standards or practices.
13. They support policies that allow physicians the flexibility to adjust the type of botulinum toxin and treatment specifics based on individual patient needs and responses over time.
14. A request for understanding and careful consideration of personal impacts when making policy decisions related to Botulinum toxin treatment.
15. Drawing on 34 years of experience and over 100,000 Botulinum toxin injections, Dr. Forman asserts that the proposed policy does not align with effective medical practice and fails to allow adequate treatment of patients.
16. He highlights that the package insert indicates botulinum toxin is effective for 2 to 4 months, yet Medicare reimbursement is only allowed for injections three months apart. This limitation is seen as an arbitrary decision that does not reflect actual patient needs.
17. The commenter indicates that the proposed Local Coverage Determination (LCD) neglects to include synkinesis (identified by ICD-10 code G51.8), a condition for which botulinum toxin is regarded as a safe and effective treatment. The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) supports this position, considering botulinum toxin as a first-line treatment for synkinesis. Furthermore, the Centers for Medicare & Medicaid Services (CMS) Article ID A57474 recognizes synkinesis as a medically necessary condition for botulinum toxin treatment. The commenter recommends that the proposed LCD incorporate synkinesis as a condition where botulinum toxin is designated as a first-line treatment option.

1. Thank you for your comments. Please provide literature to support these higher dosages. Thank you for raising concerns about mandatory reassessment causing unnecessary burdens. Medicare requires that all services must be reasonable and necessary. Objective scales and assessments help to support the service and variations in dosing and frequencies are reasonable and necessary.
2. Thank you for raising concerns about mandatory reassessment causing unnecessary burdens. Medicare requires that all services must be reasonable and necessary. Objective scales and assessments help to support the service and variations in dosing and frequencies are reasonable and necessary.
3. Thank you for your comment regarding the use of AboBoNT-A as a treatment for chronic migraine. The compendium mentions the use of AboBoNT-A as a treatment for hemifacial spasm in selected patients. The information provided evidence of extensive research carried out on the use of AboBoNT-A as a treatment for hemifacial spasm.
4. Thank you for highlighting the neurologist's approach to using Xeomin for treating blepharospasm and hemifacial spasm, aiming to avoid wastage and be cost-effective. According to the compendia, Canadian labeling supports the use of Xeomin for conditions like cervical dystonia and hypertonicity disorders of the seventh nerve, which includes blepharospasm and hemifacial spasm in adults. This aligns well with the practical considerations of managing these conditions efficiently and economically, allowing for targeted treatment that is both effective and resource-conscious. Your comment underscores the importance of selecting treatment options that optimize both clinical outcomes and cost-effectiveness.
5. Thank you for your insightful comment. We agree that consultation with experts is essential when forming policies to ensure that treatment approaches are both practical and efficient. botulinum toxin is indeed a crucial therapeutic option for conditions like benign essential blepharospasm and hemifacial spasm, providing significant relief where other treatment options may be limited or involve more extensive procedures, such as facial nerve decompression. In developing guidelines, experts and extensive literature were consulted to ensure that the recommendations reflect both current clinical practices and the latest research. Your feedback highlights the importance of continuing to shape policies that are informed by expertise and evidence, ensuring that patients have access to the most effective and practical treatments available.
6. Thank you for highlighting the effectiveness of Botulinum Toxin in managing hemifacial spasm. It's clear that botulinum toxin plays a vital role in allowing patients to return to normal lives by offering relief that may not be achievable with oral medications or other non-invasive procedures. This treatment provides a level of symptom control that is essential for improving daily functioning and quality of life. Your comment underscores the importance of ensuring continued access to botulinum toxin for those who may not have effective alternatives, emphasizing its critical place in the therapeutic landscape for hemifacial spasm.
7. Thank you for emphasizing the importance of individualized dosing in the effective treatment of blepharospasm and hemifacial spasm. We agree that each patient requires a tailored amount of botulinum toxin, and that treatment often needs to be titrated over repeated doses to maintain efficacy. Individualizing treatment is crucial for optimizing outcomes, provided it stays within established safety limits. Adhering to these guidelines ensures that while each patient's specific needs are addressed, their safety is also maintained. Your feedback highlights the delicate balance between personalization in care and adherence to proven safety standards.
8. Thank you for sharing Dr. Brown's valuable insights and extensive experience. Her perspective as potentially the sole provider of these treatments in a rural region underscores the challenges faced due to limited practitioner availability and inadequate reimbursement, which indeed deter many physicians from offering this specialized care. The proposal is intended to assist with these challenges by providing extensive detail and guidance, aiming to streamline the process and support practitioners in delivering these essential treatments. We hope that by clarifying the guidelines and improving the reimbursement framework, more healthcare providers will be encouraged and able to offer such crucial care, particularly in underserved areas.
9. Thank you for your comment. We completely agree that Botulinum toxin injections are a safe and well-established treatment option, especially when compared to higher-risk surgical alternatives. It's important to ensure patients have access to such effective therapies. The intention of the proposed guidelines is not to deprive or withhold these essential treatments from patients but rather to streamline the process, making it more efficient and accessible. By refining the guidelines, we aim to support healthcare providers in delivering high-quality care while maintaining patient access to the treatments they rely on for managing their conditions effectively.
10. Thank you for emphasizing the importance of individualized dosing in the effective treatment of blepharospasm and hemifacial spasm. We agree that each patient requires a tailored amount of botulinum toxin, and that treatment often needs to be titrated over repeated doses to maintain efficacy. Individualizing treatment is crucial for optimizing outcomes, provided it stays within established safety limits. Adhering to these guidelines ensures that while each patient's specific needs are addressed, their safety is also maintained. Your feedback highlights the delicate balance between personalization in care and adherence to proven safety standards.
11. Thank you for your comment. We understand and agree on the critical importance of maintaining access to necessary treatments for hemifacial spasm and related conditions, as they are essential for patients to perform their daily activities effectively. The intention of the proposed LCD is not to restrict access to these vital therapies but to streamline the reimbursement process, ensuring that it is more efficient and supportive for both patients and healthcare providers. By optimizing these administrative elements, we aim to enhance access to care without compromising the availability or quality of necessary treatments. Your feedback is invaluable in striving to align our processes with the needs of the community.
12. The Local Coverage Determination (LCD) is developed based on a comprehensive review of the available literature and clinical guidelines.
13. Thank you for emphasizing the importance of individualized dosing in the effective treatment of blepharospasm and hemifacial spasm. We agree that each patient requires a tailored amount of botulinum toxin, and that treatment often needs to be titrated over repeated doses to maintain efficacy. Individualizing treatment is crucial for optimizing outcomes, provided it stays within established safety limits. Adhering to these guidelines ensures that while each patient's specific needs are addressed, their safety is also maintained. Your feedback highlights the delicate balance between personalization in care and adherence to proven safety standards.
14. Thank you for your comment. We understand and agree on the critical importance of maintaining access to necessary treatments for hemifacial spasm and related conditions, as they are essential for patients to perform their daily activities effectively. The intention of the proposed LCD is not to restrict access to these vital therapies but to streamline the reimbursement process, ensuring that it is more efficient and supportive for both patients and healthcare providers. By optimizing these administrative elements, we aim to enhance access to care without compromising the availability or quality of necessary treatments. Your feedback is invaluable in striving to align our processes with the needs of the community.
15. Thank you for sharing Dr. Forman's perspective. With 34 years of experience and over 100,000 botulinum toxin injections administered, her insights into effective medical practice are invaluable. The proposed policy is based on extensive research and literature, with the aim of ensuring adequate and effective treatment for patients. While we strive to align guidelines with the latest evidence, it's crucial to consider the real-world experiences of seasoned practitioners like Dr. Forman to ensure that policies support the practical needs of both patients and providers. Your feedback highlights the importance of continually refining guidelines to better meet the standards of effective clinical practice.
16. The Local Coverage Determination (LCD) is developed based on a comprehensive review of the available literature and clinical guidelines.
17. Hemifacial spasm is characterized by involuntary facial twitching, can be associated with synkinesis, where voluntary movements trigger involuntary contractions in other facial regions, often after facial nerve injury or palsy. This LCD will allow treatment for synkinesis.

Hyperhidrosis

1. Dr. Stauder emphasizes the life-changing benefits of botulinum toxin injections for her patients, which include those with hyperhidrosis, along with other conditions like spasticity, cervical dystonia, and focal dystonia. These treatments help improve patients' functional independence and potentially reduce overall healthcare costs.
2. Commenter claims the proposed requirement for increased documentation could lead to more patient visits and longer wait times, negatively impacting timely care, especially for new patients who already face long waiting periods.
3. Commenter claims the proposals suggest that guidance is not necessary, but Dr. Stauder asserts that guidance is crucial. She uses the portable EMG optimizes treatment by accurately targeting the right muscles, prevents wastage of the medication, and ensures safe administration, avoiding critical anatomical areas.
4. Commenter claims the proposed dosing limits are considered inadequate and lower than what has been proven safe and effective. For conditions like spastic quadriplegia, the lower doses would be insufficient to manage spasticity effectively.
5. Commenter claims the draft leaves out many on-label diagnosis codes such as hyperhidrosis that are FDA-approved for botulinum toxin treatment. Dr. Stauder argues that these treatments should remain accessible to manage these conditions safely and effectively.
6. We received comments that the LCD currently only includes axillary hyperhidrosis (excessive sweating under the arms). The comment calls for the inclusion of Frey Syndrome (auriculotemporal syndrome) as a covered diagnosis. Frey Syndrome is described as a condition that can occur after procedures such as salivary gland surgery, neck dissection, facelift surgeries, or trauma. It is characterized by sweating and flushing in the preauricular area (near the ear) when eating or in response to salivary stimuli. Frey Syndrome is noted to be relatively common after salivary gland surgery, affecting 4% to 62% of post-parotidectomy patients to varying degrees. For those severely affected, treatment can significantly enhance their quality of life.
7. We received comments recommending the addition of AboBoNT-A as treatment for axillary hyperhidrosis along with a summary of clinical studies that evaluate the efficacy and safety of AboBoNT-A for treating axillary hyperhidrosis.

1. Thank you, Dr. Stauder, for highlighting the life-changing benefits of botulinum toxin injections. Your insights into their role in treating conditions like hyperhidrosis, spasticity, and cervical dystonia underscore their importance in enhancing functional independence and potentially reducing healthcare costs. We appreciate your input and will consider it as we work to support the best outcomes for patients.
2. Thank you for your feedback on the proposed requirement for increased documentation. We understand your concern that this could lead to more visits and longer wait times, which might impact timely care for new patients who already experience delays. However, the use of objective scales is supported by the literature as a valuable tool for documenting the medical necessity of botulinum toxin treatments. These scales aid in assessing whether dosing is effective and if the response to treatment is maintained, ensuring that patients receive the most appropriate care. Balancing thorough documentation with timely access to treatment is crucial, and your input will be considered as we strive to refine these guidelines to support efficient and effective patient care. Thank you for sharing your perspective.
3. Thank you, Dr. Stauder, for emphasizing the importance of using guidance like portable EMG in botulinum toxin injections. Your experience highlights how such tools enhance treatment accuracy by targeting the right muscles, minimizing medication wastage, and ensuring safe administration by avoiding critical anatomical areas. While current compendia may not classify EMG guidance as medically necessary, your insights underscore its value in delivering effective and safe care. If cost concerns are at the forefront, investing in guidance aligns with the priorities of careful and efficient medication use and patient safety. We appreciate your perspective and will consider it as we evaluate these guidelines to ensure they reflect both clinical effectiveness and patient safety. Thank you for your dedication to enhancing patient care.
4. Thank you for your comments. The recommended dosages are based upon current FDA guidelines for the approved botulinum toxin, onabotulinumtoxinA and are supported by the literature cited in this LCD. Specifically, in one of the randomized clinical trials cited in the LCD, there was no difference in sweat production in the axilla for patients treated with 200 units versus those treated with 100 units. In addition, the mean rate of sweat production gradually increased after injection of botulinum toxin but after six months was still well below the initial mean rate of sweat production.
5. Thank you for your comments. The only on label on-label code the FDA covers is severe axillary hyperhidrosis and this is covered in the LCD. Please provide any codes you believe have been left out.
6. Frey syndrome, or auriculotemporal syndrome, is due to aberrant re-innervation of post ganglionic parasympathetic fibers of the parotid gland resulting in gustatory sweating. This usually occurs following trauma or surgery to the parotid gland but can also occur after submandibular gland manipulation. Cutaneous vasomotor and sweat functions through acetylcholine neurotransmitter release and so does the post ganglionic parasympathetic system to the salivary glands. When injury to the salivary gland occurs, cross innervation can result in “gustatory sweating” over the region(s) affected especially during mastication of foods. While anticholinergics are the first line therapy, botulinum toxins may be considered. However, the FDA has no approved indications for Frey Syndrome for any of the botulinum toxins at this time and therefore will not be covered by this LCD. The use of a botulinum toxin for “gustatory sweating” would be considered an off-label use per Medicare Benefit Policy Manual, Chapter 15, Section 50.4.2 and per the LCD will require peer review literature to support its use.
7. The compendium included detailed the use of AboBoNT-A as an off-label treatment for Hyperhidrosis, primary, axillary (off-label use): Intradermal (off-label route): 100 to 200 units per axilla; injections should be evenly distributed into multiple sites ~1 to 2 cm apart (10 to 20 injections) (Ref). May repeat when clinical effect diminishes. Mean duration of effect ranges from 5.5 months to 8.5 months.

Neurogenic/Overactive Bladder

1. We received comments recommending the addition of AboBoNT-A as treatment for Neurogenic bladder along with a summary of clinical studies that evaluate the efficacy and safety of AboBoNT-A for treating Neurogenic bladder.
2. The comment suggests removing the "moderate to severe" classification requirement from the policy for both neurogenic detrusor overactivity and OAB. It argues that the FDA-approved label for onabotulinumtoxinA does not specify severity as a criterion.
3. The comment requests reducing the required duration for conservative treatments from 12 weeks to 4-8 weeks based on AUA guidelines. It suggests that shorter trial periods are more reasonable and less burdensome for patients who may experience adverse events during conservative treatment.
4. According to updated AUA guidelines, treatment decisions should be made collaboratively between the patient and provider, allowing for direct access to onabotulinumtoxinA without having to first try other treatments.
5. Acknowledge the flexibility and immediacy in treatment options, emphasizing shared decision-making between patients and healthcare providers.
6. Adjust dosing guidelines for onabotulinumtoxinA, recommending up to 300 Units for neurogenic bladder, based on clinical trials and real-world studies. Include pediatric dosing guidelines for onabotulinumtoxinA and remove outdated restrictions and severity requirements for neurogenic bladder and overactive bladder coverage.
7. Adjusting coverage criteria for various conditions (neurogenic bladder, overactive bladder, cervical dystonia, chronic migraine) to align with FDA indications and clinical guidelines, removing unnecessary severity and treatment history requirements, and acknowledging the benefits of guidance technologies for injection accuracy.
8. Include pediatric dosing guidelines for onabotulinumtoxinA.
9. We received comments recommending the addition of AboBoNT-A as treatment for Overactive Bladder along with a summary of clinical studies that evaluate the efficacy and safety of AboBoNT-A for treating OAB .

1. Thank you for your comments regarding the use of ABoNT-A as a treatment for Neurogenic bladder along with the summary of clinical studies. The studies provided support the use of AboBoNT-A for treating neurogenic detrusor overactivity (NDO) by significantly reducing urinary incontinence and improving quality of life. Approved in the UK, typical doses are 600 U and, if necessary, 800 U. Trials, including those by Kennelly et al. and Denys et al., reported substantial improvements at 6 weeks, with common side effects being urinary tract infections. No serious treatment-related adverse events were noted. Satisfaction with treatment was high, though the studies noted some limitations in data and sample size. The findings underscore the effective use of AboBoNT-A for NDO with substantial patient outcomes.
2. Objective scales and assessments help to support the service and variations in dosing and frequencies are reasonable and necessary.
3. The request to reduce the required duration for conservative treatments from 12 weeks to 4-8 weeks is based on the AUA/SUFU guidelines, which suggests shorter trial periods may be more appropriate and less burdensome for patients. These guidelines recognize that extended conservative treatments can sometimes lead to adverse events, making a shorter duration potentially more advantageous for patient comfort and safety. While LexiDrugs and UpToDate recommend a 12-week period, aligning treatment durations with AUA/SUFU guidelines allows for flexibility and responsiveness to individual patient needs. It may help facilitate timely adjustments in care, especially when patients experience adverse effects during the conservative treatment phase. Balancing these recommendations with a personalized approach could lead to better patient outcomes.
4. Thank you for highlighting the updated AUA guidelines, which emphasize a collaborative approach to treatment decisions between the patient and provider. Allowing direct access to onabotulinumtoxinA aligns with patient-centered care by considering the unique needs and preferences of each individual. This approach can facilitate timely access to effective therapies and improve patient satisfaction by recognizing that a one-size-fits-all model may not suit everyone. Ensuring that patients have the opportunity to discuss these options with their healthcare provider can lead to more personalized and effective treatment plans.
5. Thank you for your comment. We appreciate the importance of having flexible and immediate treatment options, as they empower both patients and healthcare providers to tailor care plans effectively. Shared decision-making is crucial in this context, allowing patients to actively participate in their treatment journey and ensuring that their preferences and unique health needs are central to the decision-making process. This collaborative approach fosters better outcomes and aligns treatment strategies with individual goals and circumstances.
6. Thank you for your comments on dosing. While we support adequate care for pediatric patients, given the restrictions for Medicare, they will not be featured in the LCD.
7. Thank you for highlighting the importance of aligning coverage criteria with FDA indications and clinical guidelines for conditions such as neurogenic bladder, overactive bladder, cervical dystonia, and chronic migraine. We acknowledge the need for revisiting severity and treatment history requirements to ensure they are in line with contemporary practices and patient needs. The proposed criteria are indeed based on literature and extensive research, aiming to uphold rigorous standards of care and treatment efficacy. These guidelines are designed to support decision-making that enhances patient outcomes while maintaining safety and evidence-based practices.
8. Thank you for your comments. While we support adequate care for pediatric patients, given the restrictions for Medicare, they will not be featured in the LCD.
9. Thank you for your comments regarding the use of ABoNT-A as a treatment for Neurogenic bladder along with the summary of clinical studies. The studies provided support the use of AboBoNT-A for treating Interstitial Cytisis including two retrospective studies.While the studies show efficacy of AboBoNT-A, they provide weak evidence for the use of AboNT-A as a treatment for OAB.

Sialorrhea

1. We received a comment recommending the addition of AboBoNT-A as treatment for sialorrhea along with a summary of clinical studies that evaluate the efficacy and safety of AboBoNT-A for treating sialorrhea.
2. We received a comment that suggests the inclusion of dosing of incobotulinumtoxinA for pediatric patients to be included. The comment provides the specific dosing guidelines.
3. Despite mentioning rima and incobotulinum toxin in dosing guidelines, onabotulinum toxin (Botox) is noted as the most commonly used for treating sialorrhea. This preference is particularly important for patients with neurological dysfunctions like cerebral palsy, stroke, or closed head injury, who often have swallowing dysfunction as the cause of their sialorrhea. These patients may also receive botulinum toxin treatments for related conditions, such as trunk or limb spasticity/dystonia, and it is emphasized that treatment for both conditions should be covered and permitted with the same serotype of toxin.
4. The current guidelines do not allow for an increase in dose for subsequent treatments. The comment suggests permitting dose adjustments for continued effectiveness.
5. For incobotulinumtoxin (Xeomin), the comment recommends shortening the interval between doses from 16 weeks to 12 weeks, aligning with practices that might ensure better ongoing management of symptoms.
6. Commenter argues there are certain head and neck conditions which have been treated with abobotulinumtoxin B off label in patients with secondary non-response to A are not included in this document including sialorrhea. He mentions sialorrhea and other disorders like palatal myoclonus, Frey’s syndrome, and chronic migraine headaches as conditions that also require individualized botulinum toxin treatments. This suggests his advocacy for broader acknowledgment and flexibility in treatment protocols for these condition.
7. Commenter argues that The Proposed LCD states that "Image guidance is not considered reasonable and necessary for injection of botulinum toxin." This stance is seen as conflicting with the standard of care since ultrasound guidance is recognized as a valuable tool and is typically allowed to be billed separately. The comment suggests that the LCD's language be revised to accommodate the use of ultrasound guidance, especially for salivary gland injections, to align with clinical practice and ensure safe procedures.

1. The compendium included detailed the use of AboBoNT-A as an off-label treatment for Sialorrhea: Intraglandular (Ventral) (off-label route): 15 to 75 units injected per gland (submandibular, parotid or both) either unilaterally or bilaterally with intervals of 4 to 6 months between treatments.
2. The compendium included detailed the use of incobotulinumtoxinA a treatment for Pediatric Sialorrhea and had identical specifications for dosing: Administer by injection into the parotid and submandibular glands on both sides (ie, 4 injections total). Use a 27- to 30-gauge, 12.5 mm length needle. Locate salivary glands using ultrasound imaging (refer to manufacturer's labeling); administer close to the center of the gland.
3. The compendium included detailed the use of incobotulinumtoxinA a treatment of Sialorrhea and it can be included in treatments: 100 units divided between the parotid and submandibular glands on both sides (ie, 4 injection sites per treatment session); divide dose with a ratio of 3:2 between parotid and submandibular glands. Treatment may be repeated no sooner than every 16 weeks based on clinical need.
4. According to established compendia, the lowest recommended dose should be used when initiating treatment (regardless of indication). In adults treated for 1 or more indications, the maximum cumulative dose should be ≤400 units per 3 months for Botulinum toxin.
5. The compendium states that treatment may be repeated no sooner than every 16 weeks based on clinical need.
6. The compendium included detailed use of RimabotulinumtoxinB for sialorrhea: 1,500 to 3,500 units divided among the parotid (500 to 1,500 units/gland) and submandibular (250 units/gland) glands. Subsequent dosing should be optimized according to patient’s response and should generally be repeated no sooner than every 12 weeks.
7. Thank you for highlighting the importance of ultrasound guidance in botulinum toxin injections. Your comment underscores that this tool is a vital part of the standard of care, particularly for procedures like salivary gland injections where precision is key. The compendia list electromyography, nerve stimulation or ultrasound to help localize the involved muscles. Aligning the LCD with clinical practice is essential and revising it to accommodate the use of ultrasound will help ensure safe and effective treatment. We appreciate your feedback and will consider it carefully as we refine these guidelines to better support healthcare providers and patients. Thank you for your valuable input.

Spasticity

1. Spasticity is not a subset of dystonia. The definition provided is from an outdated reference from 1980 and subsequent learning is showing that these are clinically distinct movement disorders originating from different areas of the central nervous system with different biological pathways. Hence the different treatment options for these disorders with both pharmacologic (See AACPDM care guidelines for treatment of dystonia) and surgical interventions (see selective dorsal rhizotomy and the biological mechanisms underlying spasticity vs dystonia).
2. The proposed dosing for onabotulinum toxin is based on a now old study with limited muscle group selection, since which there has been extensive additional high quality literature demonstrating the safety and efficacy of use in both additional muscle groups and at additional doses, consistent with long term historical use of this agent clinically prior to the publication of that single study, and treatment of thousands of patients in what is currently being called off label use. Errors in the design of that study were improved on in subsequent studies such as abobotulinum toxin, however the muscle groups selected in these study designs are due to study design feasability and not inclusive of all potentially clinically relevant muscles necessary to consider among the multiple etiologies causing hypertonicity and causing functional limitations, and which are supported as targets both by clinical research and knowledge of the underlying biological pathways. Ignoring these will cause harm to patients.
3. There is again extensive high-quality evidence that ultrasound guidance for chemodenervation procedures increases accuracy and reduces adverse events relative to non-imaging guidance, when used by appropriately trained and knowledgeable clinicians. Despite the procedure of botulinum injections having relatively low rates of adverse effects to begin with, this becomes more relevant in high risk, medically complex patients, more of whom are likely to fail other treatment options and require ongoing botulinum toxin injections to improve function, reduce pain, or improve quality of life. By removing this not only is the ability to further clarify how we can improve safety and accuracy of the procedure with appropriate care eliminated, but additional risk is added to patient care, particularly for the most medically vulnerable. Other measures need to be used to ensure that accurate and appropriate use of imaging guidance for chemodenervation is being implemented, not eliminating a means of increasing patient safety.
4. The statement that conscious sedation and anesthesia is not required for botulinum toxin injections ignores the care needs of individuals with intellectual and developmental disabilities, a population heavily represented among adults receiving botulinum toxin treatment and which already suffers from severe barriers to care and poor health outcomes. It is critical that the importance of using safe and well-established guidelines to ensure patients with intellectual and developmental disabilities, including adults with cerebral palsy and adults with comorbid diagnoses of autism spectrum disorders, are able to receive necessary care in as safe and minimally traumatic way as possible. This vulnerable population, a significant percentage of whom have Medicare coverage, will be harmed by the removal of this coverage.
5. The LCD does not take into account spasticity patterns of SCI, CP, MS and TBI, limiting patient coverage.
6. The 400-unit dosing limit for Botox or Xeomin, which is insufficient for many patients needing up to 600 units, especially those with cerebral palsy.
7. The impractical documentation requirements for each procedure, not reflecting the standard follow-up practices and the necessity of capturing patient-reported improvements.
8. Arbitrary botulinum toxin dosage limits compromise individualized care and could be considered malpractice for patients with spasticity, neurological conditions like strokes, brain injuries, and cerebral palsy.
9. Reducing botulinum toxin coverage will increase overall healthcare costs by leading to more ER visits, hospitalizations, surgeries, and joint injections. Effective dosing prevents complications, reduces reliance on caregivers, and minimizes pain medication. This approach will likely result in higher costs and worse patient outcomes.
10. Limiting botulinum toxin to 360 units is impractical, wastes medication, and fails to meet the needs of growing children and effective treatment.
11. Guidance tools should be mandated to ensure injection accuracy and effectiveness.
12. Expand access to botulinum toxin which is vital for improving quality of life.
13. The new CMS ruling will reduce care quality by limiting necessary treatment doses, affecting patients' quality of life. Expert advice should be considered to ensure appropriate coverage and maintain care standards.
14. Dosing for effective relief. For optimal outcomes, maintaining flexibility in dose and muscle targets is crucial.
15. The proposed NGS draft’s restriction to only “moderate and severe spasticity,” which overlooks the need for early intervention in cases of “mild” spasticity. These changes could undermine patient care and quality of life.
16. Oral spasticity agents and other therapies have limited efficacy and side effects, making botulinum toxin injections essential for maintaining patient functionality and preventing complications.
17. Botulinum toxin use for spasticity and cervical dystonia in Medicare patients to FDA-approved labeling mandates patient visits between injections (disrupting the 3-month stable period).
18. Botulinum toxin use for spasticity and cervical dystonia in Medicare patients to FDA-approved labeling prohibits sedation for pediatric patients.
19. Proposed changes will limit Botulinum injections for managing spasticity due to primary lateral sclerosis, which is crucial for the patient’s daily functioning and caregiving. The restriction could significantly impair their quality of life and caregiving efficiency.
20. The current proposed LCD inaccurately defines spasticity; it should be updated to align with the 2024 AAPM&R Consensus Guidance, acknowledging spasticity's diverse etiologies and impacts.
21. The policy fails to include abobotulinumtoxinA for pediatric spasticity and should incorporate FDA-approved dosing guidelines for both upper and lower limb spasticity in children.
22. The main concern is personalized care, including appropriate dosage and muscle targets, is essential for optimal outcomes.
23. The comment letter, submitted by a practicing physician, opposes the proposed changes to botulinum toxin therapies regulations. The author highlights, the requirement for a repeat office visit between each treatment session. The author argues these changes would burden and patients.
24. The comment letter, submitted by a practicing physician, opposes the proposed changes to botulinum toxin therapies regulations. The author highlights the necessity of sedation for pediatric patients. The author argues these changes would burden physicians and patients, limit care, increase costs, and overlook the needs of pediatric patients.
25. Requests include additional ICD-10 diagnosis codes and CPT procedure codes, particularly for spasticity and other neurological conditions.
26. Requests include to consider clinical evidence supporting the use of AboBoNT-A in various off-label indications.
27. A 12-week minimum interval between botulinum toxin injections and inadequate dosing recommendations, which fail to account for individual patient needs and variability in conditions like dystonia and spasticity. Additionally, the policy's documentation requirements significantly burden physicians, potentially reducing patient care access.
28. The LCD does not reflect updated dosing for Cervical Dystonia and pediatric indications, including specific doses for Upper Limb Spasticity and Chronic Sialorrhea in children.
29. Updating the LCD definition of spasticity to align with the 2024 AAPM&R Consensus Guidance, recognizing it as a component of upper motor neuron syndrome with a range of etiologies and impacts.
30. Revising onabotulinumtoxinA dosing guidelines for adult lower limb spasticity to reflect 300-400 Units based on recent clinical trials and real-world studies.
31. Revise onabotulinumtoxinA dosing guidelines for adult lower limb spasticity to reflect pediatric dosing guidelines.
32. For spasticity, the policy should exclude severity from coverage criteria.
33. For spasticity, the policy should update dosing guidelines to accurately reflect both adult and pediatric recommendations, correcting the omission of adult lower limb dosing.
34. The comment raises concerns about the oversimplified understanding of botulinumtoxins' use in neurological disability treatment, emphasizing that they are first-line treatments for spasticity and dystonia per AAN guidelines, superior to oral medications, and should not be restricted.
35. The primary concerns include the restrictive dosing guidelines in the draft LCD, significantly below the standard of care exclusion of over 80 ICD-10-CM codes affecting spasticity patients.
36. The AHA concerns are: The draft LCD limits coverage to "moderate to severe chronic spasticity," excluding cases of mild spasticity that may significantly impair function or cause discomfort.
37. The AHA concerns are: The draft policy restricts coverage to chronic spasticity, not addressing severe spasticity occurring early post-stroke.
38. The AHA concerns are: The draft imposes dosage limits for botulinum toxin that may not meet individual patient needs; AHA recommends allowing flexible, higher dosages based on clinical necessity.
39. The letter raises concerns about proposed LCD changes for Botulinum Toxin Injections: Anesthesia for botulinum injections is sometimes necessary for safety.
40. The omission of critical ICD-10 diagnosis codes, such as G80.x and G82.2x, limits comprehensive care.
41. The proposed LCD uses outdated 2018 Prescribing Information for incobotulinumtoxinA, whereas updated guidelines from September 2023 should be applied, affecting dosing recommendations.
42. The LCD fails to include updated pediatric dosing guidelines for Upper Limb Spasticity and Sialorrhea, which specify up to 8 Units/kg and 200 Units per limb for spasticity, and adjusted body-weight doses for sialorrhea.
43. Update the definition of spasticity in the LCD to align with the 2024 AAPM&R guidelines, highlighting its diverse etiologies and impacts.
44. Adjust dosing guidelines for onabotulinumtoxinA, recommending 300-400 Units for lower limb spasticity based on clinical trials and real-world studies.
45. EMG guidance for spasticity injections is questioned, especially regarding its necessity for each injection and its applicability to facial conditions.
46. The primary concerns include the omission of critical ICD-10 codes (e.g., G80.x, G82.2x, G82.5x), the exclusion of CPT code 76942 for ultrasound-guided injections.
47. The proposed limitation on sedation for botulinum toxin injections should be revised to require justification by the provider.
48. The key concerns in the comment letter include omission of critical ICD-10 codes necessary for comprehensive patient treatment.

1. Thank you for your comment. We will clarify the definition in the policy.
2. Spasticity: IM: Individualize dose based on patient size, extent, and location of muscle involvement, degree of spasticity, local muscle weakness, and response to prior treatment. May repeat therapy at ≥3 months with appropriate dosage based upon the clinical condition of patient at time of re-treatment. Single session doses of ≤1,200 units (off-label dose) have been reported; however, safety and efficacy of routine use of doses >500 units has not been evaluated (Ref). Single site doses of ≤400 units (off-label dose) in a lower limb (off-label use) have been reported (Ref).

• Lower limb spasticity: The lowest recommended starting dose should be used and ≤50 units/site should be administered. Note: Dose listed is total dose administered as divided separate intramuscular injection(s):

• • Flexor digitorum longus: 50 units (divided into 2 sites)
  • Flexor hallucis longus: 50 units (divided into 2 sites)
  • Gastrocnemius lateral head: 75 units (divided into 3 sites)
  • Gastrocnemius medial head: 75 units (divided into 3 sites)
  • Soleus: 75 units (divided into 3 sites)
  • Tibialis posterior: 75 units (divided into 3 sites)

• Upper limb spasticity. The lowest recommended starting dose should be used and ≤50 units/site should be administered. Note: Dose listed is total dose administered as individual or separate intramuscular injection(s):

• • Adductor pollicis: 20 units (1 site).
  • Biceps brachii: 60 to 200 units (divided into 2 to 4 sites).
  • Brachialis: 30 to 50 units (divided into 1 to 2 sites).
  • Brachioradialis: 45 to 75 units (divided into 1 to 2 sites).
  • Flexor carpi radialis: 12.5 to 50 units (1 site).
  • Flexor carpi ulnaris: 12.5 to 50 units (1 site).
  • Flexor digitorum profundus: 30 to 50 units (1 site).
  • Flexor digitorum sublimes: 30 to 50 units (1 site).
  • Flexor pollicis brevis/opponens pollicis: 5 to 25 units (1 site).
  • Flexor pollicis longus: 20 units (1 site).
  • Lumbricals/interossei: 5 to 10 units (1 site).
  • Pronator teres: 15 to 25 units (1 site).
  • Pronator quadratus: 10 to 50 units (1 site).

• Suggested guidelines for the treatment of stroke-related upper limb spasticity: Canadian labeling: Note: Dose listed is total dose administered as individual or separate intramuscular injection(s):

• • Adductor pollicis: 20 units (1 to 2 sites)
  • Biceps brachii: 100 to 200 units (up to 4 sites)
  • Flexor digitorum profundus: 15 to 50 units (1 to 2 sites)
  • Flexor digitorum sublimes: 15 to 50 units (1 to 2 sites)
  • Flexor carpi radialis: 15 to 60 units (1 to 2 sites)
  • Flexor carpi ulnaris: 10 to 50 units (1 to 2 sites)
  • Flexor pollicis longus: 20 units (1 to 2 sites)

3. Thank you for your comment highlighting the importance of ultrasound guidance. We agree that it is indeed important for chemodenervation and increases accuracy. The compendia additionally approves of guiding techniques such as electromyography, electrical stimulation and ultrasound. We will address this in the policy.
4. Beyond scope of this policy to address anesthesia.
5. We disagree that the policy will limit patient coverage based on the etiology of the central nervous system (CNS) injury. While it is true that there are differences in spasticity patterns after a central nervous system regarding the timing of onset and the specific mechanisms involved with the development of spasticity depending on the various conditions, since the botulinum toxin works at the presynaptic terminal preventing the release of the neurotransmitter acetylcholine into the synaptic cleft, leading to muscle paralysis, there is nothing in the policy which limits the use of this chemical based on the etiology of the CNS lesion(s).
6. The term "high dosage" typically indicates ≥600 U of obabotulinumtoxinA (obaBTX-A), onabotulinumtoxinA, (onaBTX-A), or incobotulinumtoxinA (incoBTX-A). There is insufficient data to recommend high dose of botulinum dosage in spasticity-related pain. (Intiso D, Centra AM, Gravina M, Chiaramonte A, Bartolo M, Di Rienzo F. Botulinum Toxin-A High-Dosage Effect on Functional Outcome and Spasticity-Related Pain in Subjects with Stroke. Toxins (Basel). 2023 Aug 18;15(8):509. doi: 10.3390/toxins15080509. PMID: 37624266; PMCID: PMC10467116.) There is no scientific evidence that there is a defined therapeutic strategy which unequivocally improves the spasticity-related pain of the limbs treated with high dose botulinum toxin. The term "high dosage" typically indicates ≥600 U of obabotulinumtoxinA (obaBTX-A), onabotulinumtoxinA, (onaBTX-A), or incobotulinumtoxinA (incoBTX-A). There is insufficient data to recommend high dose botulinum toxin dosage in improving the functionality of the limbs. There is no scientific evidence that there is a defined therapeutic strategy which unequivocally improves the functionality of the limbs treated with high dose botulinum toxin. The evidence is insufficient to recommend high dose botulinum toxin use in clinical practice. ( Intiso D, Simone V, Bartolo M, Santamato A, Ranieri M, Gatta MT, Di Rienzo F. High Dosage of Botulinum Toxin Type A in Adult Subjects with Spasticity Following Acquired Central Nervous System Damage: Where Are We at? Toxins (Basel). 2020 May 10;12(5):315. doi: 10.3390/toxins12050315. PMID: 32397674; PMCID: PMC7291232).
7. Thank you for sharing your perspective on the documentation requirements. While we acknowledge the concerns about practicality, it is important to emphasize that thorough documentation is reasonable and necessary to ensure patients receive adequate and effective treatment. Documenting each procedure allows healthcare providers to track patient progress comprehensively and make informed decisions about ongoing care. It also ensures accountability and provides a record that can be evaluated for treatment effectiveness and safety.
8. Thank you for your comments. The guidelines and limits in the LCD are based on extensive research and literature to ensure safety and efficacy.
9. Thank you for your comment regarding botulinum toxin coverage and its potential impact on healthcare costs and patient outcomes. It's crucial to address these concerns with evidence-based insights. The dosage limitations for botulinum toxin are grounded in extensive research and literature. Studies indicate that very high doses, typically defined as 600 units or more of various forms of botulinum toxin, do not consistently offer additional effectiveness in treating conditions like spasticity-related pain or improving limb functionality. This approach is supported by recent studies (e.g., Intiso et al., 2023 and 2020), which found insufficient data to recommend high-dose regimens. While the goal is always to enhance patient outcomes, the current dosage recommendations are designed to maximize treatment efficacy while minimizing unnecessary risk. Limiting dosage helps avoid potential complications associated with excessive botulinum toxin use, aligning with safe and effective medical practice standards.
10. Thank you for your comments. While we support adequate care for pediatric patients, given the restrictions for Medicare, they will not be featured in the LCD.
11. Thank you for your comment highlighting the importance of ultrasound guidance. We agree that it is indeed important for chemodenervation and increases accuracy. The compendia additionally approves of guiding techniques such as electromyography, electrical stimulation and ultrasound. We will address this in the policy.
12. Thank you for advocating for expanded access to botulinum toxin, recognizing its vital role in improving quality of life for many patients. The Local Coverage Determination (LCD) is specifically designed to ensure that all patients who genuinely need botulinum toxin therapy have access to it. By setting clear guidelines, the LCD aims to ensure that eligible patients can benefit from this treatment, thereby enhancing their quality of life while maintaining safe and effective use. We continuously review and refine these guidelines to better meet the needs of the patient community and adapt to new clinical evidence. Your feedback helps support this ongoing effort to balance access with quality care.
13. Thank you for your concern about patient's access to botulinum toxin, recognizing its vital role in improving quality of life for many patients. The Local Coverage Determination (LCD) is specifically designed to ensure that all patients who genuinely need botulinum toxin therapy have access to it. By setting clear guidelines, the LCD aims to ensure that eligible patients can benefit from this treatment, thereby enhancing their quality of life while maintaining safe and effective use. We continuously review and refine these guidelines to better meet the needs of the patient community and adapt to new clinical evidence. Your feedback helps support this ongoing effort to balance access with quality care.
14. Thank you for your comments and concern. The LCD utilizes extensive research and literature to ensure optimal outcomes. The LCD was designed to enhance patient outcomes and to maximize efficacy while minimizing unnecessary risk.
15. Thank you for your comment. The current medical literature does not support the use of Botulinum toxin for mild spasticity to improve pain or function.
16. Thank you for your comment. We agree with your comment that botulinum toxin injections are essential and should be provided.
17. Thank you for your comment. The literature does not support more frequent usage of botulinum toxin injections.
18. Thank you for your comments. While we support adequate care for pediatric patients, given the restrictions for Medicare, they will not be featured in the LCD.
19. Thank you for your comment. We agree with this sentiment and will provide the code in the billing article.
20. Thank you for your comment. We will clarify the definition in the policy.
21. Thank you for your comments. While we support adequate care for pediatric patients, given the restrictions for Medicare, they will not be featured in the LCD.
22. Thank you for emphasizing the importance of personalized care, including appropriate dosage and muscle targets, for achieving optimal outcomes with botulinum toxin treatments. The current guidelines and recommendations are grounded in extensive research and literature, aimed at identifying strategies that provide the best results for the majority of patients. While these guidelines are designed to reflect evidence-based practices that ensure safety and efficacy, they also serve as a foundation upon which individualized treatment plans can be built by healthcare providers. By adhering to these well-researched standards, we aim to address optimal outcomes for most patients while allowing practitioners the flexibility needed to tailor treatments to specific individual needs. Your input is valuable as we continually evaluate and integrate new findings to support both standardized and personalized care approaches.
23. Thank you for sharing the concerns regarding the proposed requirement for a repeat office visit between each botulinum toxin treatment session. While we understand that this may seem burdensome to both physicians and patients, it is important to underscore that these guidelines are intended to ensure patient safety and the efficacy of treatment. Regular follow-up visits are reasonable and necessary to closely monitor patient progress, assess the effectiveness of the treatment, and make any necessary adjustments to the therapy plan. These visits provide an opportunity to evaluate each patient's response and ensure that treatments are administered in the most beneficial and safe manner. While we strive for efficient processes, the primary goal of these guidelines is to maintain a high standard of care that protects the well-being of patients. Your feedback is valuable in ongoing efforts to improve healthcare delivery while ensuring that essential safety measures are upheld.
24. Thank you for your comments. While we support adequate care for pediatric patients, given the restrictions for Medicare, they will not be featured in the LCD.
25. Thank you, that will be placed in consideration for the billing and coding article.
26. Thank you for your comments, we have addressed this in the LCD.
27. Thank you for your comment. The literature does not support more frequent usage of botulinum toxin injections.
28. Thank you for your comments. While we support adequate care for pediatric patients, given the restrictions for Medicare, they will not be featured in the LCD.
29. Thank you for your comment. We will clarify the definition in the policy.
30. Thank you for your comment. The LCD allows upto 360 Units, which is in line with real-world studies.
31. Thank you for your comments. While we support adequate care for pediatric patients, given the restrictions for Medicare, they will not be featured in the LCD.
32. Thank you for your comment. The current medical literature does not support the use of Botulinum toxin for mild spasticity to improve pain or function.
33. Thank you for your comments. While we support adequate care for pediatric patients, given the restrictions for Medicare, they will not be featured in the LCD.
34. Thank you for your comments. We agree that botulinum toxins are first line treatments. The LCD does not aim to restrict usage but provide clear guidelines for use.
35. Thank you, that will be placed in consideration for the billing and coding article.
36. Thank you for your comment. The current medical literature does not support the use of Botulinum toxin for mild spasticity to improve pain or function.
37. Thank you for your comment. That is beyond the scope of the policy. The policy does not address when to initiate botulinum following the temporal onset of injury or any illness that causes spasticity.
38. Thank you for your comments. The guidelines and limits in the LCD are based on extensive research and literature to ensure safety and efficacy.
39. Thank you for your comments. The use of anesthesia and sedation is beyond the scope of this LCD.
40. Thank you, that will be placed in consideration for the billing and coding article.
41. Thank you for your comments. This has been addressed in the LCD.
42. Thank you for your comments. While we support adequate care for pediatric patients, given the restrictions for Medicare, they will not be featured in the LCD.
43. Thank you for your comment. We will clarify the definition in the policy.
44. Thank you for your comment. The LCD has been updated to reflect this with patients receiving upto 360 units.
45. Thank you for your comment highlighting the importance of ultrasound guidance. We agree that it is indeed important for chemodenervation and increases accuracy. The compendia additionally approve of guiding techniques such as electromyography, electrical stimulation and ultrasound. We will address this in the policy.
46. Thank you for your comment highlighting the importance of ultrasound guidance. We agree that it is indeed important for chemodenervation and increases accuracy. The compendia additionally approve of guiding techniques such as electromyography, electrical stimulation and ultrasound. We will address this in the policy.
47. Thank you for your comments. The guidelines and limits in the LCD are based on extensive research and literature to ensure safety and efficacy. Providers may provide justification for extreme cases.
48. Thank you, that will be placed in consideration for the billing and coding article.

Strabismus

1. We write to share our concern that the proposed LCD will unnecessarily restrict patient access to proven, medically necessary treatments for blepharospasm, blepharospasm associated with orofacial dystonia, hemifacial spasm, and strabismus.
2. The proposed LCD restricts botulinum toxin injections for treating blepharospasm, blepharospasm with orofacial dystonia, hemifacial spasm, and strabismus by limiting initial treatments to three injections per eye and 5 units per eye, conflicting with over 30 years of clinical practice. This policy inadequately addresses the need for up to 200 units of botulinum toxin per eye and fails to recognize the necessity of modifying treatment based on patient response and evolving clinical standards. Furthermore, requiring objective clinical scales for disease measurement does not align with current practice.
3. We received comments recommending the addition of AboBoNT-A as treatment for Interstitial Cystitis along with a summary of clinical studies that evaluate the efficacy and safety of AboBoNT-A for treating IC.

1. Thank you for sharing your concerns. I want to assure you that the intention of the proposed LCD is not to restrict access to necessary treatments for conditions such as blepharospasm, blepharospasm associated with orofacial dystonia, hemifacial spasm, and strabismus. Instead, the LCD aims to provide clear guidelines that are firmly based on literature and research. These guidelines are designed to ensure that treatments are administered safely and effectively, enhancing patient care by standardizing practices in line with the latest evidence. Our goal is to support access to these necessary therapies by outlining criteria that reflect current best practices, ultimately benefiting both patients and healthcare providers.
2. Thank you for sharing your concerns regarding the proposed LCD and its impact on treatment practices for blepharospasm, blepharospasm with orofacial dystonia, hemifacial spasm, and strabismus. We recognize the importance of adhering to established clinical practices and the flexibility required to optimize patient care. The guidelines are established to provide a comprehensive framework based on extensive research, aiming to ensure safe and effective treatment. For conditions like strabismus, dosing recommendations are provided to carefully calibrate treatment based on clinical evaluation, allowing for dose adjustment where necessary. Typically, the initial dose ranges reflect safe practices and known efficacy, and re-examinations following injection ensure responses are accurately assessed. While current guidelines aim to maintain safety and efficacy, we understand the need to continuously review these standards to better accommodate evolving clinical practices and patient-specific responses. Your feedback highlights the necessity for guidelines that align with decades of successful treatment practices, recognizing the dynamic nature of patient needs and clinical advancements. Engagement with clinical feedback remains vital in refining these practices to best support the complex requirements of treating these conditions effectively.
3. These revisions are designed to empower healthcare providers to tailor treatments based on individual disease presentations and adjust subsequent therapies as necessary. This flexibility aligns with the goal of delivering personalized care that optimizes outcomes for each patient.

Anal Fissure

1. We received comments recommending the addition of AboBoNT-A as treatment for Anal Fissure along with a summary of clinical studies that evaluate the efficacy and safety of AboBoNT-A for treating anal fissures.

1. Thank you for your comments. We appreciate your concerns regarding the coverage guidelines for anal fissure. The compendium included detailed the use of AboBoNT-A as a treatment for anal fissures: 90 to 150 units in 2 divided doses injected into the internal anal sphincter on each side of the anterior midline. it is indeed reasonable to consider AboBoNT-A as a treatment for anal fissure.

Interstitial Cytisis (IC)/Bladder Pain Syndrome

1. We received comments recommending the addition of AboBoNT-A as treatment for Interstitial Cytitis along with a summary of clinical studies that evaluate the efficacy and safety of AboBoNT-A for treating IC.

1. Thank you for your comments regarding the use of ABoNT-A as a treatment for Neurogenic bladder along with the summary of clinical studies. The studies provided support the use of AboBoNT-A for treating Interstitial Cytisis including a prospective study,a two-center open-label study and a retrospective study. While the studies had limitations, they provide evidence of the efficacy of AboBoNT-A as a treatment for Interstitial cytisis.