Botulinum Toxin Best Practices

Botulinum toxins are potent neuromuscular blocking agents that are useful in treating various focal muscle spastic disorders and excessive muscle contractions, such as dystonias, 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.

There are currently four Botulinum toxin products commercially available in the United States: Botox® (onabotulinumtoxinA), Myobloc® (rimabotulinumtoxinB), Dysport™ (abobotulinumtoxinA), and Xeomin® (incobotulinumtoxinA). Each preparation has distinct pharmacological and clinical profiles specified on the product insert. Dosing patterns are also specific to the preparation of neurotoxin and are very different between different serotypes.

Documentation Requirements

The patient's medical record must contain documentation that fully supports the medical necessity for services included within the LCD. This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

For coverage of botulinum toxin treatment by Medicare, the medical record should include:

• Documentation of the medical necessity for this treatment. For spastic conditions other than upper or lower limb spasticity, blepharospasm, hemifacial spasm, cervical dystonia or other focal dystonias, documentation should include a statement that the spastic condition has been unresponsive to conventional treatment,
• a covered diagnosis,
• dosage(s), site(s) and frequency(ies) of injection,
• documentation of the medical necessity for associated electromyography when used, and
• description of the effectiveness of this treatment.

Due to the short life span of the drug once it is reconstituted, Medicare will reimburse the unused portions of botulinum toxins. When modifier JW is used to report that a portion of the drug is discarded, the medical record must clearly show the amount administered and the amount discarded.

Best Practice/Documentation Feedback/Tips and Help

Botulinum Toxin Injections for Chronic Headaches - Insufficient documentation causes most improper payments. The medical records must support the medical necessity and documentation requirements per the LCD and Billing and Coding Article for botulinum toxins.

• Missing evaluation: This includes documentation that supports patient is having chronic headaches for a period of at least three months with 15 or more headaches per month who have significant disability due to the headaches and the evaluation also supports conventional treatment has not helped.
  • Many notes do not include a history of the chronic headaches, nor do they identify or link a specific significant disability caused by the headaches, all of which is needed to support the initiation of the treatment.
• Missing notes to support decrease: This is documentation that supports a significant decrease in the number and frequency of headaches and an improvement in function upon receiving the injections.
  • Many notes do not include the current number of headache days the patient is experiencing. Documentation should include current information on headaches as well as any improvement in function.
• Amount of waste: The documentation must indicate the amount of waste billed for the botulinum toxin. Medical Review has identified errors in which injected and/or wasted amounts reported on the claim do not match the injected and/or waste amounts noted in the documentation.
• Missing electronic signature or legible signature: An electronic signature or legible signature is required on medical records.
• Evidence of conservative treatment tried and proven unsuccessful should be documented.
• Continuous treatment of botulinum toxin will be considered medically reasonable and necessary when the following are supported in the documentation:
  • Injections have been administered approximately 12 weeks apart.
  • Injection sites that correlate to the administration CPT code and treatment diagnosis.
  • Evidence of effectiveness for the last two injections.
    • It is not expected that the most recent injection provided will show effectiveness since the patient has not returned for their next appointment.
• Medical Record documentation must be unique to each patient. Cloned Documentation Could Result in Medicare Denials for Payment.
  • Documentation is considered cloned when it is worded exactly like or similar to previous entries. It can also occur when the documentation is exactly the same from patient to patient. Individualized patient notes for each patient encounter are required. Documentation must reflect the patient condition necessitating treatment, the treatment rendered and if applicable the overall progress of the patient to demonstrate medical necessity.
• Key Reasons Services Were Denied
  • Documentation did not support medically necessity due to one or more of the following:
    • The submitted documentation is missing a covered indication; a statement indicating the condition was unresponsive to conventional treatment; dosage, site and frequency of injection; description of treatment effectiveness.
  • Documentation did not indicate a significant disability due to the headache/migraine nor the improvement in function to support the effectiveness of treatment.
  • Administering more units for a condition than what is FDA approved for the condition.
  • Documentation was insufficient or incomplete.

Information Regarding Botulinum Toxin Indications, Utilization and Limitations

Indications

Spasticity

Botulinum toxin can be used to reduce spasticity or excessive muscular contractions, to relieve pain, to assist with posture and walking, to improve range of motion, to enhance the effectiveness of physical therapy, and to reduce severe spasm to allow better perineal hygiene in patients with spasticity secondary to spastic hemiplegia and hemiparesis.

Organic writer’s cramp is uncommon, and so botulinum toxin for the treatment of organic writer’s cramp should be infrequent.

Botulinum toxin is indicated for disorders associated with spastic conditions as above and dystonia.

Please note: covered spastic conditions are listed in Article A52848 under "ICD-10-CM Codes that Support Medical Necessity." The wide range of botulinum toxin dosages used in a treatment session is determined by patient age, degree of spasticity, number of injections made into each muscle and number of muscles treated.

Electromyography or muscle stimulation, rather than site pain or tenderness, to determine injection site(s) for botulinum toxin may be necessary, especially for spastic conditions of the face, neck and upper extremity.

OnabotulinumtoxinA is indicated for the treatment of lower limb spasticity in adult patients to decrease the severity of increased muscle tone in ankle and toe flexors (gastrocnemius, soleus, tibialis posterior, flexor hallucis longus, and flexor digitorum longus).

AbobotulinumtoxinA is indicated for the treatment of lower limb spasticity in adults.

Blepharospasm

Botulinum toxin injection therapy is accepted first line treatment for patients with blepharospasm and/or hemifacial spasm. If the upper and lower lid of the same eye and/or adjacent facial muscles, or brow are injected at the same surgery, the procedure is considered to be unilateral. Bilateral procedures will only be considered when both eyes or both sides of the face are injected.

Achalasia

Botulinum toxin for achalasia may be considered for the patient who has not responded satisfactorily to conventional therapy; is at high risk of complication from pneumatic dilation or surgical myotomy; has had treatment failure with pneumatic dilation or surgical myotomy; had perforation from pneumatic dilation; has an epiphrenic diverticulum or hiatal hernia; or has esophageal varices.

Anal Fissure

Botulinum toxin for chronic anal fissure may be considered for the patient who has not responded satisfactorily to conventional therapy.

Hyperhidrosis

OnabotulinumtoxinA has been approved by the FDA for treatment of severe primary axillary hyperhidrosis (primary focal hyperhidrosis) that is inadequately managed with topical therapy. Compendia list onabotulinumtoxinA and rimabotulinumtoxinB as acceptable off-label agents for this condition. The definition of primary focal hyperhidrosis is severe sweating, beyond physiological needs; focal, visible, severe sweating of at least six (6) months duration without apparent cause with at least two (2) of the following characteristics: bilateral and relatively symmetric, significant impairment in daily activities, age of onset less than 25 years, positive family history, and cessation of focal sweating during sleep.

Sialorrhea

The treatment of sialorrhea due to conditions such as motor neuron disease or Parkinson's disease in those patients who have failed to respond to a reasonable trial of traditional therapies (e.g., anticholinergics and speech therapy) or who have a contraindication to or cannot tolerate anticholinergic therapy, will be allowed for coverage.

Urinary Incontinence

Urinary incontinence due to NDO commonly occurs in patients with SCI or neurological diseases such as MS. Patients with NDO usually use CIC to empty the bladder. When incontinence episodes occur between catheterizations, oral anticholinergic agents are used to decrease bladder contractility and improve incontinence.

OnabotulinumtoxinA is indicated for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and frequency, in adults and patients five years of age and older who have an inadequate response to or are intolerant of an anticholinergic medication.

Headache/Migraine

Coverage will only be allowed for those patients with chronic daily headaches (headache disorders occurring greater than 15 days a month - in many cases daily with a duration of four or more hours - for a period of at least three months) who have significant disability due to the headaches, and have been refractory to standard and usual conventional therapy. The etiology of the chronic daily headache may be chronic tension-type headache or CM. CM is characterized by headache on > 15 days per month, of which at least eight headache days per month meet criteria for migraine without aura or respond to migraine-specific treatment. For continuing Botulism toxin therapy the patient must demonstrate a significant decrease in the number and frequency of headaches and an improvement in function upon receiving Botulinum toxin.

Utilization Guidelines

Dose and frequency should be in accordance with the FDA label. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

Limitations

Medicare will allow payment for one injection per site regardless of the number of injections made into the site. A site is defined as one eye (including all muscles surrounding the eye including both upper and lower lids); one side of the face; the neck; or extremity and/or trunk muscle(s).

Failure of two definitive, consecutive, treatment sessions involving a muscle or group of muscles could preclude further coverage of the serotype used in the treatment for a period of one year after the second session. It may be reasonable, however, to attempt treatment with a different serotype.

Treatment of wrinkles using Botulinum toxins is considered to be cosmetic and is not covered under Medicare.

Payment will not be made for any spastic condition of smooth muscle, such as spastic colon and biliary dyskinesia, or of any spastic condition not listed under “ICD-10-CM Codes That Support Medical Necessity” in Article A52848.

Related Content

• Local Coverage Determination (LCD): Botulinum Toxins (L33646)
• Local Coverage Article: Billing and Coding: Botulinum Toxins (A52848)
• CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 16: General Exclusions From Coverage, Section 10 "General Exclusions from Coverage" and Section 120 "Cosmetic Surgery"

Reviewed 6/18/2024