Response to Comments: Botulinum Toxins

A comment was submitted offering agreement with the changes made in the proposed LCD.

Thank you for your comment. Novitas appreciates your support.

A comment was submitted suggesting that there are 177 ICD-10-CM codes aligned to the label for onabotulinumtoxinA that are covered in the LCD but omitted in the corresponding draft article. The commenter is requesting that all these ICD-10-CM codes be added to the Billing and Coding Article.

• Cervical dystonia – 5 missing codes
• Overactive bladder – 17 missing codes
• Primary Axillary Hyperhidrosis – 3 missing codes
• Spasticity – 152 missing codes

Thank you for your comment. The Billing and Coding article contains diagnosis codes for cervical dystonia, overactive bladder, and axillary hyperhidrosis as they are FDA approved indications for the use of onobotulinumtoxinA.

We recognize that patients with hemiplegia, diplegia, monoplegia, etc. can exhibit spasticity secondary to these conditions. Spasticity is what is being treated, therefore, the proper diagnosis code to report is one for spasticity. The requested codes for hemiplegia, diplegia, monoplegia, etc. do not align to the recognized use of onobotulinumntoxinA to treat spasticity but may be reported in addition to the spasticity code. Thus, these additional codes will not be added to the Billing and Coding article.

A comment was submitted requesting Botox injections be covered to manage excessive salivation due to a host of causes from cerebral palsy, dystonias, and other neurological deficits or idiopathic causes. Additionally, the commenter indicated that Botox can be used to reduce salivation and control symptoms related to sialadenitis or to reduce salivary flow when it is desired to manage salivary leaks. No literature was submitted.

Thank you for your comment. After review, we identified that ICD-10-CM code K11.7 for disturbances of salivary secretion was inadvertently excluded from ICD-10-CM Code Group 4 in the Draft Billing and Coding Article. Since IncobotulinumtoxinA is FDA approved for sialorrhea, K11.7 has been added to Group 4 in the final Billing and Coding Article.

A comment was received with concerns related to the limitation in the proposed LCD indicating that localization procedures would not be expected for easily targeted muscles. The commenter indicates that there is a critical need for muscle localization during botulinum toxin injections. The unique anatomy coupled with complex variations or torsional changes makes the concept of “easily targeted muscles” unrealistic. The commenter further pointed out that ultrasound image guidance is necessary for patients that are on anticoagulation therapy particularly in difficult-to-target or high-risk areas. The commenter recommends the inclusion of language that acknowledges these complexities and supports the use of ultrasound image guidance as a necessary part of safe practice.

Thank you for your comment. We recognize that there are specific circumstances where localization during the injection is critical. The limitation specifically states easily targeted muscles, and the related billing and coding article includes a documentation requirement indicating that the need for localization must be supported in the medical record. To avoid directing providers on which muscles would or would not require localization, the LCD was written to allow flexibility, recognizing that the provider is the best person to determine the need for localization. The medical records must support the use of the localization techniques.

A comment was received regarding the statement that botulinum toxins are not interchangeable. The commenter indicated that they agree with this statement, but it is important to acknowledge that the 4 botulinum toxin A products (onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, and daxibotulinumtoxinA) are all effective for treating spasticity and cervical dystonia. These treatments, including onabotulinumtoxinA, are widely accepted in both on- and off-label indications within clinical practice. This flexibility in botulinum toxin type is necessary to tailor treatment plans effectively and accommodate individual patient responses, ensuring optimal therapeutic outcomes. It would also be cost saving to use toxins outside of onabotulinumtoxinA, which is the costliest to our patients and practices. No literature was submitted with the comment.

Thank you for your comment. Please note that the related billing and coding article includes spasmodic torticollis as a covered diagnosis in all 5 ICD-10-CM Code groups. Additionally, there are spasticity diagnoses included in the billing and coding article for onabotulinumtoxinA, abobotulinumtoxinA, and incobotulinumtoxinA. At the time of publication, the FDA labeling for daxibotulinumtoxinA does not include spasticity. Medicare Administrative Contractors are required to base their coverage determinations on scientific evidence. We are not permitted to base our coverage determinations on cost.¹ Once the LCD becomes effective, full-text articles supporting the use of daxibotulinumtoxinA for spasticity may be submitted following our reconsideration process.

1. Code of Federal Regulations (CFR), Title 42, Chapter IV, Subchater B, Part 422, Subpart C, Section 422.101 Requirements relating to basic benefits.

A comment was received suggesting that the following diagnosis codes were omitted from the policy and that they are crucial for delivering comprehensive care to patients. No literature was submitted.

• Cerebral palsy (G80.x)
• Paraplegia (G82.2x)
• Quadriplegia (G82.5x)
• Diplegia (G83.X and G82.2X)
• Monoplegia (G83.X or I69.x)
• Hemiplegia (G81.X or I69.x)

Thank you for your comment. Please note that ICD-10-CM codes G80.0, G80.1, G80.2, and G80.8 are included in the billing and coding article for onabotulinumtoxinA, abobotulinumtoxinA, and incobotulinumtoxinA. Regarding G81.X, G82.X, G83.X, and I69.X ‘plegia’ diagnosis codes related to spasticity, please see response to comment #2. Once the LCD becomes effective, full-text articles may be submitted following our reconsideration process.

A comment was received expressing concern that the proposed LCD may further restrict access to care by limiting the ability of providers to see new patients, particularly impacting underserved populations. The commenter indicated that a recent study identified only 566 chemodenervation experts in the US with the worst access being in rural areas and areas with Hispanic populations like Texas. The commenter indicated that it is important to ensure the proposed guidelines align with the accepted standards, as botulinum toxin injections are considered a first-line treatment for focal spasticity by organizations such as the American Academy of Neurology (AAN) and American Academy of Physical Medicine and Rehabilitation (AAPMR). No literature was submitted with the comment.

Thank you for your comment. It is not the intention of the contractor to restrict access to care for any population. Medicare Administrative Contractors are required to base their coverage determinations on scientific evidence. This LCD is based on FDA guidelines as well as scientific evidence. Evidence from the AAN was included in the development of the LCD and is referenced. Please see response to comment #2 for further information regarding billing and coding guidance for spasticity. Once the LCD becomes effective, full-text articles may be submitted following our reconsideration process.

A comment was received from a Physical Medicine and Rehabilitation physician expressing concern over the elimination of over 80 diagnostic codes. The commenter is concerned that the elimination of these diagnostic codes will limit access to botulinum toxin care for a significant number of patients with severe neurologic disabilities. The commenter indicated that consistent with the article, patients with spastic cerebral palsy, paraplegia, quadriplegia, monoplegia, hemiplegia, paralytic syndrome, and other conditions will no longer have access to botulinum toxin. The commenter indicated that there is widespread belief that the elimination of these codes may have been an error since there does not appear to be a logical explanation for the change supported by clinical evidence. The commenter requests that we revert to the list of diagnosis codes included in the previous article.

Thank you for your comment. One of the indications for botulinum toxin injections supported by FDA labeling as well as scientific evidence is spasticity. Please see response to comment #2 for information related to billing and coding guidance for spasticity.

A letter was received representing the physiatrists of the American Academy of Physical Medicine & Rehabilitation (AAPM&R) expressing concerns with the proposed LCD. The letter pointed out that half of all PM&R physiatrists treat spasticity as part of their practice. The letter further noted that spasticity affects a large percentage of patients who have had a stroke, traumatic brain injury, spinal cord injury, cerebral palsy, and multiple sclerosis. The physiatrists pointed out that the AAPM&R recently released a consensus guidance on spasticity assessment and management which is a clinical guideline reflecting the most up-to-date research. While they noted that injection of botulinum toxin in the management of focal upper and lower limb spasticity is a SORT Grade of A, reimbursement for these procedures does not adequately compensate physicians making the use of these procedures unattractive to providers. They are concerned that the draft billing and coding article will further negatively impact patient access to this treatment. The AAPM&R requests that the contractor maintain the list of diagnosis codes that were in the previous version of the article. They also request that ICD-10-CM code G24.8, Other Dystonia be included in the article.

Thank you for your comments. Please refer to the response to comment #2 for information regarding the ICD-10-CM codes and billing guidance for spasticity. Please note that the ICD-10-CM code for spastic cerebral palsy is included in the billing and coding article as a covered diagnosis for onabotulinumtoxinA. After further review, the contractor agrees that G24.8 should be added to ICD-10-CM Code group 2 for AbobotulinumtoxinA. The final article includes G24.8 in ICD-10-CM code groups 1 and 2.

Comments were submitted in a joint letter from the American Academy of Ophthalmology, American Society of Oculofacial Plastic and Reconstructive Surgeons (ASOPRS), North American Neuro-Ophthalmology Society (NANOS).

The commenters first concern indicates that hemifacial spasm in adults (cranial nerve VII disorder) and isolated oromandibular dystonia are FDA on-label indications for Botox. Therefore, they request that these diagnoses be removed from the second bullet point of off-label indications for Botox in the final LCD. Hemifacial spasm in adults and oromandibular dystonia should remain as covered indications in the final billing and coding article.

The commenters' second comment expresses concern that the proposed LCD does not cover Xeomin for the treatment of Meige syndrome and hemifacial spasm. They indicate that their current clinical practice includes treatment with Xeomin for these conditions. It is noted that the widely accepted clinical practice for Xeomin has also evolved well-beyond the 2010 initial FDA approval. The organizations believe that Xeomin is more commonly used than Dysport and as much as Botox for Meige syndrome and hemifacial spasm. They indicate that clinical experience demonstrates that trying different botulinum toxin serums in sequence may be an effective treatment. The commenters submitted 2 studies. One demonstrating that Botox and Xeomin can be exchanged in treatment and another showing that switching from Dysport to Xeomin is effective and well-tolerated when treating focal dystonias and that it reduced the cost of botulinum toxin per patient annually to a mean 76.7% of the cost of Dysport. The commenters believe that the inclusion of coverage of Xeomin for Meige syndrome and hemifacial spasm should be inferred from the FDA indications for Xeomin usage in blepharospasm, and thus Xeomin should be covered for Meige syndrome and hemifacial spasm in the final LCD.

The commenters’ final comment addresses coverage of other botulinum toxin serotypes. The commenters request that due to the fact that patients’ responses to botulinum toxin injections changes over time, the final LCD include language which supports a treating physician’s discretion to modify treatment to administer a different brand of botulinum toxin than the initially selected medication. One example cited is the use of Myobloc for the treatment of blepharospasm. The commenters acknowledge that the contractor indicated the 2015 review article related to this indicates that Myobloc is more painful than Botox. However, the commenters do not feel this is reason enough not to allow coverage. They feel, despite it being more painful, it may be in the patient’s best interest. They point out that the article does acknowledge that the only other option if a patient becomes resistant to botulinum toxin would be to switch to Myobloc. The organizations request that the LCD reflect that alternative botulinum toxins may be covered in exceptional circumstances where other drugs and techniques are unsuccessful.

Thank you for your comments. Hemifacial spasm in adults and oromandibular dystonia are not listed in the current FDA label for Botox. Thus, these maladies will remain covered and listed as off-label indications.

We appreciate the 2 studies that were submitted as evidence related to Xeomin for Meige syndrome and hemifacial spasm. Hellman & Torres-Rusotto, 2015, is a narrative review describing the use of botulinum toxins in the management of blepharospasm. This article is not a systematic review and lacks any methodology description and, therefore, is not reproducible. Additionally, both authors report financial ties to manufacturers and industry. While the authors did identify studies supporting the use of Botox, Xeomin, Dysport, and Myobloc for the treatment of blepharospasm, the lack of reproducibility and the authors’ conflicts of interest mean that the certainty of evidence provided by this review is quite limited. Grossett et al, 2015, is a retrospective study assessing the dose equivalence and comparing costs between Dysport and Xeomin for the treatment of focal dystonias. While the study did report on adverse events and provided information on dosage and frequency it did not directly report on patient outcomes. Without outcome information this study is not sufficient to support changing the determination. Once the LCD becomes effective, full-text articles may be submitted following our reconsideration process.

A commenter is concerned with the elimination of codes related to spasticity and the effect it will have on their patients' function and quality of life. The commenter requests the current list of diagnoses for which toxins are covered remains the same. No literature was submitted.

Thank you for your comments. Please see response to comment #2 for information related to billing and coding guidance for spasticity. Once the LCD becomes effective, full-text articles may be submitted following our reconsideration process.

A comment was submitted indicating that spasticity is completely debilitating for some patients and can take a patient from ambulatory status to bedbound status. With the use of botulinum toxin injections, this treatment is oftentimes the first and only treatment that provides patients with the relief that they truly need. These procedures can be life changing. Not only do these treatments have the ability to alter function, but they also help to minimize future, more expensive complications such as falling, head trauma, fractures, skin ulcers, pressure injuries, and more. To think that providers would be restricted further in our dosing and use of botulinum toxins is almost unfathomable. The commenter requests reconsideration to the policy changes for the sake of their patients. No literature was submitted.

Thank you for your comments. Please review response to comment #2. Once the LCD becomes effective, full-text articles may be submitted following our reconsideration process.

A comment was submitted requesting additional diagnosis codes provided in their comment (plegia codes and salivary code) be added to the article for consistency in patient access and the FDA approved label for Xoemin. No literature was submitted.

Thank you for your comments. Please refer to response to comment #2 for information regarding billing and coding guidance for spasticity. Please refer to response to comment #3 related to billing and coding guidance for salivary conditions. Once the LCD becomes effective, full-text articles may be submitted following our reconsideration process.

A comment was submitted requesting that the current list of covered codes be maintained in the new article. The commenter is concerned that the removal of codes related to spasticity will negatively affect the health and well-being of those affected by neurological conditions.

Thank you for your comments. Please see response to comment #2 for information related to billing and coding guidance for spasticity. Once the LCD becomes effective, full-text articles may be submitted following our reconsideration process.