Local Coverage Determination (LCD)

Botulinum Toxin Type A & Type B

L34635

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L34635
Original ICD-9 LCD ID
Not Applicable
LCD Title
Botulinum Toxin Type A & Type B
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL34635
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 10/01/2023
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
09/30/2021
Notice Period End Date
11/13/2021
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Issue

Issue Description

Biannual review was completed with no change in coverage. Minor grammatical changes made throughout. 

Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Title XVIII of the Social Security Act section 1862 (a)(1)(A). This section allows coverage and payment of those services that are considered to be medically reasonable and necessary.

Title XVIII of the Social Security Act section 1862 (a)(7). This section excludes routine physical examinations and services.

Title XVIII of the Social Security Act section 1833 (e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 - Reasonable and Necessary Provisions in an LCD.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Botulinum toxins are potent neuromuscular blocking agents that are useful in treating various focal muscle spastic disorders and excessive muscle contractions, such as dystonia, spasms, and twitches. They produce a presynaptic neuromuscular blockade by preventing the release of acetylcholine from the nerve endings. 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 overactivity and achalasia), glands (e.g., Sialorrhoea and hyperhidrosis) and additional conditions that are being investigated.

There are currently 4 botulinum toxin products commercially available in the United States: onabotulinumtoxinA, rimabotulinumtoxinB, abobotulinumtoxinA, and incobotulinumtoxinA. Each preparation has distinct pharmacological and clinical profiles specified on the product insert. Dosing patterns are specific to the preparation of neurotoxin and varies between different serotypes. Failure to recognize the unique characteristics of each formulation of botulinum toxin can lead to undesired patient outcomes. It is expected that physicians will be familiar with and experienced in the use of these agents and utilize evidence-based medicine to select the appropriate drug and dose regimen for each patient condition. A patient who is not responsive or who ceases to respond to one serotype may respond to the other.

Limitations
Voluntary muscular contraction depends upon the release of acetylcholine from vesicles within a nerve ending following stimulation of the nerve. The acetylcholine is released into the neuromuscular junction, binding to specific proteins called receptors in the membrane of the muscle fiber. The effect of the acetylcholine at these receptors is to cause the muscle to contract. When a sufficient amount of acetylcholine has been released with subsequent binding to the muscle fiber proteins, muscle contraction occurs. Botulinum toxin type A and botulinum toxin type B create a chemical blockade by inhibiting the release of acetylcholine from the nerve ending vesicles thereby preventing the acetylcholine from binding to the proteins in the receptor site on the muscle. Localized weakness or paralysis occurs in the muscle injected with botulinum toxin.

Approved indications for botulinum toxin type A and toxin type B differ. WPS GHA has determined that the separate accepted indications for the botulinum toxin products will be combined into a single list of covered indications in this Local Coverage Determination (LCD). It is the responsibility of providers to use each drug in accordance with approved indications. While this policy contains a single list of covered indications, this is not meant to imply that botulinum toxin products are interchangeable.

  1. Coverage of botulinum toxin for certain spastic conditions (e.g., cerebral palsy, stroke, head trauma, spinal cord injuries, and multiple sclerosis) will be limited to those conditions listed in the Billing and Coding: Botulinum Toxin Type A & B (A57474).  All other uses in the treatment of other types of spasm will be considered as investigational and therefore, non-covered by Medicare.
  2. Since organic writer's cramp is uncommon, Medicare would not expect to see the treatment of this condition to be billed frequently.
  3. The patient who has a spastic or excessive muscular contraction condition is usually started with a low dose of botulinum toxin.  Other spastic or muscular contraction conditions, such as eye muscle disorders, (e.g., blepharospasm) may require lesser amounts of botulinum toxin.  For larger muscle groups, it is generally agreed that once a maximum dose per site has been reached and there is no response, the treatment is discontinued.  The treatments may be resumed at a later date.  With response, the effect of the injections generally lasts for 3 months at which time the patient may require repeat injections to control the spastic or excessive muscular condition. 
  4. It is usually considered not medically necessary to give botulinum toxin injections for spastic conditions more frequently than every 12 weeks.
  5. Coverage of treatments provided may be continued unless any 2 treatments in a row, utilizing an appropriate or maximum dose of botulinum toxin failed to produce satisfactory clinical response. 
  6. Botulinum toxin may be covered in the treatment of achalasia. According to the 2018 ISDE achalasia guidelines, botulinum injections should mainly be used in patient’s age 50 or greater and for patients that are unfit for surgery or as a bridge to more definitive therapies such as surgery or balloon dilatation.1
  7. 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.
    1. Migraine with aura2:

      1. At least two attacks fulfilling the following criteria a and b
        1. One or more of the following fully reversible aura symptoms
          • Visual (aura, changes in vision)
          • sensory (e.g., tingling in hands or face, pins and needles, numbness
          • speech and/or language difficulties)
          • motor (e.g., weakness)
          • brainstem (e.g., vertigo, tinnitus, loss of hearing, diplopia, ataxia not attributable to sensory deficit, and decreased level of consciousness)
          • retinal (visual disturbance, flash of light, blind spot)
        2. At least three of the following six characteristics:
          • at least 1 aura symptom spreads gradually over > 5 minutes
          • 2 or more aura symptoms occur in succession
          • each individual aura symptoms last 5-60 minutes
          • at least 1 aura symptom is unilateral
          • at least 1 aura symptom is positive
          • the aura is accompanied, or followed within 60 minutes, by headache
    2. Migraine without aura2:
      1. At least 5 attacks fulfilling the following criteria
        • Headache attacks lasting 4-72 hours (when untreated or unsuccessfully treated)
        • Headache has at least two of the following:
          • unilateral location
          • pulsating quality
          • moderate or severe pain intensity
          • aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs)
        • During headache at least one of the following:
          • nausea and/or vomiting
          • photophobia and phonophobia
  8. Botulinum toxin for chronic anal fissure may be considered for the patient who has not responded satisfactorily to conservative treatment. Conservative treatment may include the use of bulking agents, sitz baths or topical agents.
  9. Botulinum toxin is covered for hyperhidrosis that significantly affects one’s quality of life and cannot be managed adequately with topical agents.
Summary of Evidence

Migraine
The Health technology assessment for the acute and preventive treatment of migraine: A position statement of the International Headache Society indicates that the frequency of headaches is an important factor of classifying chronic migraines. Chronic migraine is defined as at least 3 months with 15 or more monthly headache days (MHDs), at least eight of which satisfy criteria for migraine.

“It is recommended that HTAs assess migraine frequency by counting days with migraine per month or days with headache per month, and the respective units of measure should be monthly migraine days (MMDs) and monthly headache days (MHDs). A migraine day is defined as any calendar day on which the patient had onset, continuation, or recurrence of a migraine headache.”3

FDA labels indicate that the safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month).

Achalasia
ACG Clinical Guidelines: Diagnosis and Management of Achalasia recommends “botulinum toxin injection as first-line therapy for patients with achalasia that are unfit for definitive therapies compared with other less-effective pharmacological therapies.” “Botulinum toxin is the best studied pharmacotherapy in achalasia, and it is the most effective pharmacological treatment that can be offered; however, its benefits are short lived, and the medication should not be offered as first-line treatment to patients who are fit for myotomy.”4

Anal Fissures
“Lateral internal sphincterotomy is still regarded as the gold standard treatment for chronic fissures, despite known potential for serious morbidity, namely fecal incontinence. Therefore, a search for less invasive procedures has been ongoing, including topical nitrates and botulinum toxin injections. However, nitrates are poorly tolerated due to their association with headaches. This chemical denervation is not permanent, and the clinical efficacy generally lasts for 2-3 months, which is enough time for sphincter resting pressure reduction to allow for healing.”5

Analysis of Evidence (Rationale for Determination)

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Proposed Process Information

Synopsis of Changes
Changes Fields Changed
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Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

N/A

Sources of Information
N/A
Bibliography
  1. Heddle R, Cock C. Role of botulinum toxin injection in treatment of achalasia. Ann. Esophagus. 2020;3:26.
  2. Headache classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition, Cephalalgia. 2018;38:1-211.
  3. Diener HC, Ashina, M, Zaleski, et al. Health technology assessment for the acute and preventive treatment of migraine: A position statement of the International Headache Society. Cephalalgia. 2021; 41(3):279-293.
  4. Vaezi, MF, Pandolifino JE, Yadlapati, RH, et.al. ACG Clinical Guidelines: Diagnosis and Management of Achalasia. Am J Gastroenterol. 2020;115:(9): 1393-1411.
  5. Amorim H, Santoalha, J, Cadilha, R, et.al. Botulinum toxin improves pain in chronic anal fissure, Porto Biomed. J. 2017;2(6):273-276.
  6. Brashear A, McAfee AL, Kuhn ER, Fyffe J. Botulinum toxin type B in upper-limb poststroke spasticity: a double-blind, placebo-controlled trial. Arch Phys Med Rehabil. 2004;.85:705-9.
  7. Delgado M R, Hirtz D., Aisen M, et al. (2010) Practice Parameter: Pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review): Report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society Neurology. 2010; 74(4):336-343.
  8. Kyrmizakis, D.E, Pangalos A, Papadakis, C.E, et al. (2004, July) The use of botulinum toxin type A in the treatment of Frey and crocodile tears syndromes. J Oral Maxillofac Surg. 2004; 62(7):840-844.
  9. Naumann M., So, Y, Argoff, C.E, et al., Assessment: Botulinum neurotoxin in the treatment of autonomic disorders and pain (an evidence-based review). Report from the American Academy of Neurology Therapeutics and Technology Assessment subcommittee. Neurology. 2008;70(19):1707-1714.
  10. Pasricha PJ, Rai R, Ravich WJ, et al. Botulinum toxin for achalasia; long-term outcome and predictors of response, Gastroenterology. 1996;110(5):1410-1415.
  11. Restivo, D.A., Lanza, S., Patti, F. et al. Improvement of diabetic autonomic gustatory sweating by botulinum toxin type A. Neurology. 2002; 59(12):1971-1973.
  12. Saadia D, Voustianiouk A, Wang AK, et al. Botulinum toxin type A in primary palmar hyperhidrosis: randomized, single-blind, two-dose study. Neurology. 2001;57(11):2095-2099.
  13. Simpson DM, Gracies JM, Graham HK, et al. Assessment: Botulinum neurotoxin for the treatment of spasticity (an evidence-based review). Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2008;70:1691-1698.
  14. Stewart DB, Gaertner W, Glasgow S, et.al Clinical Practice Guideline for the management of anal fissures. Dis. Colon Rectum. 2017;60(1):7-14.
  15. R Wade, A Llewellyn, J Jones-Diette, et.al. Interventional management of hyperhidrosis in secondary care: a systematic review. Br. J. Dermatol. 2018;179(3):599-608.
  16. U.S. Food and Drug Administration (FDA) prescribing information for onabotulinumtoxinA
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103000s5318lbl.pdf
  17. U.S. Food and Drug Administration (FDA) prescribing information for onobotulinumtoxinA
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125274s115lbl.pdf
  18. U.S. Food and Drug Administration (FDA) prescribing information for incobotulinumtoxinA
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125360s087s088s089s090s091lbl.pdf
  19. U.S. Food and Drug Administration (FDA) prescribing information for rimabotulinumtoxinB https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103846s5195lbl.pdf
  20. Charles, A. Migraine. NEJM. 2017; 377:553-561. DOI: 10.1056/NEJMcp1605502.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
10/01/2023 R13

Posted 09/28/2023: Biannual review completed 08/14/2023 with no change in coverage. Minor grammatical changes made throughout.

  • Provider Education/Guidance
11/14/2021 R12

09/30/2021- Updated the definition of Chronic migraines 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. Added #9: Botulinum toxin is covered for hyperhidrosis that significantly affects one’s quality of life and cannot be managed adequately with topical agents. Added information on migraine with and without aura to #7. Removed “Before consideration of coverage may be made: 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.” Updated and moved the citations from “Sources of information” to the “Bibliography” section. Moved “Medicare will allow payment for one injection per site regardless of the number of injections made into the site. The site description is included in the CPT code description. Payment will be based on the Medicare Physician Fee Schedule and National Correct Coding Initiative” to the Billing and Coding Article

  • Provider Education/Guidance
11/26/2020 R11

11/26/2020 Documentation Requirement Number 8. “Botulinum toxin type A incobotulinumtoxinA for blepharospasm ONLY if there is a history of the beneficiary having previous history of receiving onabotulinumtoxinA.” removed because current literature does not support the statement. Documentation Requirements relocated to A57474 Billing and Coding: Botulinum Toxin Type A & B. Format revision completed

  • Other
01/30/2020 R10

01/30/2020 Format change to Sentence 2 under Limitations: Added “Billing and Coding: Botulinum Toxin Type A & B (A57474)” and removed “Codes that Support Medical Necessity section of this policy” because it is no longer relevant. No changes in coverage.

  • Other
10/31/2019 R9

10/31/2019 Change Request 10901 Local Coverage Determinations (LCDs): it will no longer be appropriate to include Current Procedure Terminology (CPT)/Health Care Procedure Coding System (HCPCS) codes or International Classification of Diseases Tenth Revision-Clinical Modification (ICD-10-CM) codes in the LCDs. All CPT/HCPCS and ICD-10 codes have been removed from this LCD and placed in Billing and Coding: Botulinum Toxin Type A & Type B. Consistent with Change Request 10901 language from IOMs and/or regulations has been removed and the applicable manual/regulation has been referenced. Review completed 10/08/2019.

  • Other (Changes in response to CMS Change Request 10901. Review completed.

    )
10/01/2018 R8

10/01/2018 ICD-10-CM code update deleted G51.3 and added G51.31, G51.32, and G51.33
to Group 7.

  • Revisions Due To ICD-10-CM Code Changes
09/01/2018 R7

09/01/2018 Annual review completed 08/07/2018 with no changes in coverage. Punctuation errors corrected.

  • Other (Annual Review)
09/01/2017 R6

09/01/2017 Annual review completed 08/09/2017 with no changes in coverage. At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 

  • Other (Annual Review)
10/01/2016 R5 10/01/2016 ICD-10-CM code update Group 10 deleted codes I69.01, I69.11, I69.21, I69.31, I69.81, I69.91 annual review no other changes.
  • Other (annual review)
  • Revisions Due To ICD-10-CM Code Changes
12/01/2015 R4 12/01/2015 Annual review, added clarification under limitations number five: There may be slight variation based on FDA indications for a particular product.
  • Other (Maintenance annual review)
10/01/2015 R3 10/06/2015 - Due to CMS guidance, we have removed the Jurisdiction 8 Notice and corresponding table from the CMS National Coverage Policy section. No other changes to policy or coverage.
  • Other
10/01/2015 R2 02/01/2015 corrected description of codes 64644, 64645 and 64647 added “s” to the word muscle.

  • Other
10/01/2015 R1 12/01/2014 Annual review, removed outdated change request information and updated references, corrected grammatical error, no change to coverage.
  • Other (Maintenance annual review)
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Associated Documents

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Public Versions
Updated On Effective Dates Status
09/19/2023 10/01/2023 - N/A Currently in Effect You are here
09/22/2021 11/14/2021 - 09/30/2023 Superseded View
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