Chemodenervation refers to the use of chemical agents to produce neuromuscular
blockade for the purpose of selective weakening of specific muscles, or muscle
groups. This policy applies to the use of neurotoxins, as well as, other
chemical agents used for this purpose.  
  
Botulinum toxin, a neurotoxin produced by clostridium botulinum, produces a
clinical effect by blocking the release of neurotransmitters, principally
acetylcholine, from nerve endings. There are currently 4 botulinum neurotoxins
available in the United States (US) with different Federal Drug Administration
(FDA)-approved indication(s): 3 distinct serotype A botulinum toxin
therapeutic products, [onabotulinumtoxinA
(BOTOX)](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103000s5302lbl.pdf),
[abobotulinumtoxinA
(DYSPORT)](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125274s115lbl.pdf)
and [incobotulinumtoxinA
(XEOMIN](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125360s073lbl.pdf)),
and the serotype B botulinum toxin product, [rimabotulinumtoxinB
(MYOBLOC)](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103846s5190lbl.pdf).  
  
The FDA-approved labeling for each product states that the potency units of
the botulinum toxin products are not interchangeable. Labeling differs from
product to product; dosing units are not comparable. It is the physician's
responsibility to select the appropriate product and dose in accordance with
FDA-approval indications for use, compendia-supported uses, and supported by
peer reviewed specific scientific literature.  
  
Chemodenervation techniques are indicated/covered for:  
  
1\. Chemodenervation of muscle innervated by the facial nerve in the
management of blepharospasm or hemifacial spasm  
  
2\. Chemodenervation of cervical spinal muscles in the management of spasmodic
torticollis  
  
3\. Chemodenervation of extremity muscles in the management of dystonias,
cerebral palsy, upper and lower limb spasticity (see **_Note:_** ) and
multiple sclerosis  
  
4\. Chemodenervation of extraocular muscles in the management of strabismus  
  
5\. Chemodenervation of the lower esophageal sphincter in the management of
achalasia  
  
6\. Chemodenervation of laryngeal muscles in the treatment of adductor
spasmodic dysphonia  
  
7\. Chemodenervation of bilateral frontalis, trapezius, temporalis,
sternocleidomastoid, and splenius capitis muscles for treatment of chronic
tension headache and intractable daily headache  
  
8\. Chemodenervation of procerus and bilateral frontalis, corrugator,
occipitalis, temporalis, trapezius, and cervical paraspinal muscle group for
the prophylaxis of headaches in adult patients with chronic migraine ( 15
days per month with headache lasting 4 hours a day or longer)  
  
 **Note:** Onabotulinamtoxin A (BOTOX), is the only botulinum toxin product
that is FDA-approved for the prophylaxis of headaches in adult patients with
chronic migraine ( 15 days per month with headache lasting 4 hours a day or
longer).  
  
9\. Chemodenervation of sweat glands for the treatment of severe primary
hyperhidrosis that is inadequately managed with topical agents. Severe is
defined for this purpose as level 3 (sweating barely tolerable/frequently
interferes with daily activity) or level 4 (sweating intolerable/always
interferes with daily activities) on the Hyperhidrosis Disease Severity Scale
(HDSS).  
  
10\. Chemodenervation of the internal anal sphincter for the treatment of
chronic anal fissure  
  
11\. Chemodenervation of the detrusor urinae muscle for the treatment of over
activity associated with a neurologic condition in adults with an inadequate
response to anticholinergic treatment and for the treatment of overactive
bladder (OAB) with symptoms of urge urinary incontinence, urgency, and
frequency, in adults who have an inadequate response to or are intolerant of
an anticholinergic medication  
  
12\. Chemodenervation of the parotid and submandibular salivary glands,
bilaterally  
  
 **Limitations**  
  
Chemodenervation for the treatment of headaches is limited to patients who
experience headaches that may result in permanent cerebral dysfunction, or are
intractable because the patient cannot tolerate or does not benefit from
standard therapies. Candidates for this treatment are patients with:  
  
1\. Intractable migraines (with or without aura)  
  
2\. Intractable chronic tension-type headache with moderate to severe pain  
  
3\. Chronic daily headaches defined as patients experiencing more than 15 days
of headache per month (either migraine or tension-type features)  
  
4\. Chronic migraine ( 15 days per month with headache lasting 4 hours a day
or longer) (for the prophylaxis of headaches - in adult patients only)  
  
 **Note:** Intractable headache is defined as a patient meeting 1 of the
following criteria for treatment (applies only to disease states 1-3, listed
above):  
  
1\. Failed trials of at least 3 preventive pharmacologic migraine therapies
(e.g., beta-blockers, anticonvulsants, antidepressants) with or without
concomitant behavioral and physical therapies, after titration to maximal
tolerated doses or have medical contraindications to common therapies or who
cannot tolerate common preventative therapies; or  
  
2\. Experience chronic daily headaches or recurrent headaches at least twice
per month causing disability lasting 3 or more days per month; or  
  
3\. Standard abortive medication is required more than twice per week, or is
contraindicated, ineffective or not tolerated.