**Abstract:**  
  
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. The
clinical indications for botulinum toxins have increased exponentially since
first used two decades ago. They are used in the treatment of overactive
skeletal muscles (e.g. hemifacial spasm, dystonia, 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 four botulinum toxin products commercially available in
the United States: Botox (onabotulinumtoxinA), Myobloc
(rimabotulinumtoxinB), DysportTM (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. 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. Physicians may decide which
agent to use in beneficiary care except as noted below. Although botulinum
toxins have only been FDA-approved for limited uses, they are frequently used
off-label as well. A patient who is not responsive or who ceases to respond to
one serotype may respond to the other.  
  
This local coverage determination provides CGS' indications and limitations of
coverage for these pharmaceutical products.  
  
 **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.  
  
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
and dystonia. 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 hand.  
  
 **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 Federal Drug Administration (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 (eg., 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 neurogenic detrusor overactivity (NDO) commonly
occurs in patients with spinal cord injuries (SCI) or neurological diseases
such as multiple sclerosis (MS). Patients with NDO usually use clean
intermittent self-catheterization (CIC) to empty the bladder. When
incontinence episodes occur between catheterizations, oral anticholinergic
agents are used to decrease bladder contractility and improve incontinence.  
  
**Headache/Migraine**  
  
Coverage will only be allowed for those patients 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 3
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 chronic
migraine (CM). CM is characterized by headache on _ > _ 15 days per month, of
which at least 8 headache days per month meet criteria for migraine without
aura or respond to migraine-specific treatment. For continuing Botulism toxin
therapy the patients must demonstrate a significant decrease in the number and
frequency of headaches and an improvement in function upon receiving Botulinum
toxin.  
  
**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; or all muscles of one limb and their associated
girdle muscles.  
  
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.  
  
The cost of special syringes is not separately payable. They are considered
part of the surgical procedure.  
  
When the Botulinum Toxins drug is denied, the related injection code(s) will
also be subject to denial.