LCD Reference Article Response To Comments Article

Response to Comments: Botulinum Toxin Type A & Type B (DL34635)

A58907

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A58907
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Article Title
Response to Comments: Botulinum Toxin Type A & Type B (DL34635)
Article Type
Response to Comments
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11/14/2021
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This article includes comments WPS received for Draft Local Coverage Determinations (LCD) Botulinum Toxin Type A & Type B DL34635. Thank you for the comments.

Response To Comments

Number Comment Response
1

For proposed LCD DL34635, it would be important to include the medical treatment of primary axillary hyperhidrosis with Botulinum toxin injections, as supported by multiple studies, included in the following systematic review.

Our LCD includes coverage of hyperhidrosis: “Since the resulting chemical denervation of muscle produces local paresis or paralysis, selected muscles can be treated. Botulinum toxins are used in the treatment of overactive skeletal muscles (e.g., Hemifacial spasm, dystonia and spasticity), smooth muscles (e.g., Detrusor over activity and achalasia), glands (e.g., Sialorrhoea and hyperhidrosis) and additional conditions that are being investigated”. We have added Botulinum toxin is covered for hyperhidrosis that significantly affects one’s quality of life and cannot be managed adequately with topical agents to the LCD.

2

The American Academy of Ophthalmology (Academy) is writing in regard to the proposed LCD: Botulinum Toxin Type A & Type B (DL34635) and draft LCA: Botulinum Toxin Type A & Type B (DA57474). The policies were also reviewed by the North American Neuro-Ophthalmology Society (NANOS). The Academy is the largest association of eye physicians and surgeons in the United States. A nationwide community of nearly 20,000 medical doctors, we protect sight and empower lives by setting the standards for ophthalmic education and advocating for our patients and the public.

The Academy disagrees with coverage indication #1 which states, “In most cases it should be established that the patient has been unresponsive to conventional methods of treatments such as medication, physical therapy and other methods used to control and/or treat spastic condition.” Botulinum toxin is FDA approved for blepharospasm/hemifacial spasms and is clearly the first choice for treatment over the other “conventional” therapies listed by WPS. When the other therapies work, then the condition is not a true blepharospasm or hemifacial spasms.

Coverage indication #2 states coverage of botulinum toxin will be limited to the conditions listed in the LCA A57474; however, other conditions such as oculomotor apraxia can also be helped with Botox type drugs and must be balanced with other treatment decisions. Botox treatment for oculomotor apraxia should be considered medically necessary and covered by Medicare. Additionally, in regards to coverage indication #5 which states, “It is usually considered not medically necessary to give botulinum toxin injections for spastic conditions more frequently than every 12 weeks,” in rare cases, Botox should be used more frequently than every 12 weeks and these situations should be documented for medical indication. In the LCA A57474, the Academy and NANOS recommend ICD-10-CM codes under H55 (Nystagmus and other irregular eye movements) be listed as indications for CPT 67345 Chemodenervation of extraocular muscle in the Group 12 paragraph codes.

We have removed the following information from the LCD since the policy indicates which conditions require prior treatments before administering botulinum toxins:

“Before consideration of coverage may be made:

  1. In most cases it should be established that the patient has been unresponsive to conventional methods of treatments such as medication, physical therapy and other methods used to control and/or treat spastic condition. “

The Diagnosis Index lists oculomotor apraxia under Other specified disorders of binocular movement (H51.8). Diagnosis code H51.8 is listed in Group 12 Paragraph of ICD-10 Codes that Support Medical Necessity in in the Billing and Coding Article.

Literature was not submitted to support coverage of nystagmus and other irregular eye movements. H55 diagnosis codes were not added. Information on requesting an LCD reconsideration can be located on our website at https://www.wpsgha.com/wps/portal/mac/site/policies/guides-and-resources/lcd-nc-reconsideration

Based on the product labels, we will be leaving the frequency at 12 weeks. In the rare case, more frequent injections are necessary, documentation should be noted in the medical record. Claim denials may be appealed.

3

On behalf of Allergan, an AbbVie company, the manufacturer of BOTOX® (onabotulinumtoxinA), thank you for the opportunity to provide comments on the Botulinum Toxin Type A & B draft LCD (DL34635). There are two important issues we would like to address. First, this draft LCD contains a link to the BOTOX® FDA label (Prescribing Information) that lists three dosage forms and strengths for therapeutic use:

“For injection: 50 Units, 100 Units, or 200 Units vacuum-dried powder in a single-dose vial.”5 However, the only commercially available formulations of BOTOX for therapeutic indications are single-use vials in the following sizes:

  • 100 Units NDC 0023-1145-01
  • 200 Units NDC 0023-3921-02

A 50 Unit vial was added to the label in 2005, but it has never been commercially available for therapeutic use in the U.S.

The current BOTOX® prescribing information is attached. Please note, the FDA link
contained in the draft LCD DL34635 for BOTOX® prescribing information is not current. Another resource WPS could consider including is the National Institutes of Health’s DailyMed website, which provides an up to date, in-use label for BOTOX® and BOTOX® Cosmetic.

This clarification is in response to several prescribing physicians experiencing BOTOX® wastage denials with other payers due to confusion regarding the size of commercially available vial sizes. We respectfully ask WPS to confirm that its wastage on BOTOX® (J0585) are calculated based on the lowest commercially available package size for therapeutic indications, which is a 100 Unit vial, consistent with CMS guidance.

Additionally, we would like to recommend a change to the definition of chronic migraine to align with the ICHD-3 criteria and American Headache Society Consensus Statement 2021, which we have included for your reference.

Current Proposed LCD:
9. Chronic migraines are described as headaches occurring on 15 or more days a month for more than three months, which on at least eight days a month, has the features of a migraine headache. Typical characteristics of a migraine headache include nausea and/or vomiting, photophobia, pulsating, with moderate to severe pain intensity that is aggravated by or causing avoidance of routine physical activity.2 The Treatment with botulinum toxin may be given every 12 weeks as multiple injections around the head and neck.

Requested Update to Proposed LCD:
9. Chronic migraine is described as headache occurring on 15 or more days a month for more than three months, which on at least eight days a month, has the features of a migraine headache. Diagnostic criteria of a migraine headache without aura should include at least two out of the following four characteristics: unilateral, pulsating, moderate to severe pain intensity, or aggravated by or causing avoidance of routine physical activity and at least one of the following: nausea and/or vomiting, and/or photophobia and phonophobia. Diagnostic criteria of a migraine headache with aura should include one of the following reversible aura symptoms: visual, sensory, speech and/or language, motor, brainstem, or retinal and at least three of the following six characteristics: at least one aura symptom gradually spreads over ≥ 5 minutes, two or more aura symptoms occur in succession, each individual aura symptom lasts 5-60 minutes, at least one symptom is unilateral, at least one symptom is positive, and/or the aura is followed by headache within 60 minutes.1,4 The treatment with botulinum toxin may be given every 12 weeks as multiple injections around the head and neck.

The FDA label for Botox has been updated in the LCD. Payment for the amount of the discarded drug in a single use vial is based on the lowest commercially available vial size of the drug.

We have updated chronic migraine section to: Chronic migraine is defined as a “headache occurring on 15 or more days a month for more than three months, which, on at least eight days/month has the features of migraine headache.2”. Treatment of chronic migraines will be covered when they meet the following diagnostic criteria: for migraine with aura and /or criteria for migraine without aura. Treatment with botulinum toxin may be given every 12 weeks as multiple injections around the head and neck. Information on migraines with and without an aura was also added to the LCD.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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LCDs
L34635 - Botulinum Toxin Type A & Type B
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