This policy addresses the use of botulinum toxin, both Botox® (type A) and Myobloc™ (type B), for the treatment of all health conditions, with the exception of hyperhidrosis and tinnitus.

Note: Please see the following document for the use of botulinum toxin as a treatment of primary axillary hyperhidrosis:  

• MED.00032 Treatment of Hyperhidrosis.

Note: Please see the following document for the use of botulinum toxin as a treatment of tinnitus:

• MED.00073 Treatment of Tinnitus.

Medically Necessary:

The use of botulinum toxin is considered medically necessary for strabismus.

The use of botulinum toxin is considered medically necessary in the treatment of the following disorders if associated with spasticity or dystonia:

• Blepharospasm
• Equinus foot, if related to cerebral palsy
• Hereditary spastic paraplegia
• Infantile cerebral palsy
• Multiple sclerosis
• Neuromyelitis optica
• Schilder’s disease
• Spastic hemiplegia
• Spasticity related to stroke, or spinal cord injury
• Spasmodic torticollis
• Idiopathic torsion dystonia
• Organic writer’s cramp
• Orofacial dyskinesia (i.e., jaw closure dystonia)
• Spasmodic dysphonia or laryngeal dystonia (a disorder of speech due to abnormal control of the laryngeal muscles present only during the specific task of speaking)
• Symptomatic torsion dystonia
• Facial nerve (VII) dystonia
• Cervical dystonia
• Other forms of upper motor neuron spasticity

The use of botulinum toxin is considered medically necessary in the treatment of achalasia.

The use of botulinum toxin is considered medically necessary in the treatment of chronic anal fissures.

The use of botulinum toxin is considered medically necessary in the treatment for significant drooling in patients who are unable to tolerate scopolamine.

The use of botulinum toxin is considered medically necessary as a treatment of incontinence related detrusor overreactivity and incontinence of neurogenic origin (i.e., spinal cord injury, multiple sclerosis) that is inadequately controlled with anticholinergic therapy.

The use of botulinum toxin is also considered medically necessary for bladder detrusor sphincter dyssynergia of neurogenic origin.

Cosmetic/Not Medically Necessary:

Botulinum toxin is considered cosmetic/not medically necessary as a treatment of skin wrinkles or other cosmetic indications.

Investigational/Not Medically Necessary:

Botulinum toxin is considered investigational/not medically necessary for the treatment of headache, including but not limited to tension, migraine or chronic daily headaches.

Botulinum toxin is considered investigational/not medically necessary as a treatment in all other conditions, including, but not limited to, the following indications:

• Anismus
• Chronic motor tic disorder
• Fibromyalgia/fibromyositis
• Gastroparesis
• Low back pain
• Myofascial pain syndrome
• Neck pain not related to conditions mentioned above
• Parkinson’s disease
• Tics associated with Tourette’s Syndrome
• Tourette’s Syndrome
• Tremors
• Urinary and anal sphincter dysfunction
• Stuttering
• Carpal tunnel syndrome
  

Spasticity and Dystonia

The use of botulinum toxin therapy is a well-established, safe and effective treatment for a variety of spasticity related disorders, abnormal muscle tone, including muscle over-activity or spasticity related to upper motor neuron (UMN) syndrome caused by cerebral palsy, multiple sclerosis, stroke, spinal cord injury, or neurodegenerative disease. Controlled clinical trials of botulinum toxin injections for focal muscle spasticity have demonstrated prolonged yet reversible clinical improvements in physical function and patient comfort, as well as improvement in prevention or treatment of musculoskeletal complications. These benefits have been achieved with few side effects.

Botulinum toxin treatment has been demonstrated to be a safe and effective method for decreasing the severity of abnormal head positioning and postures and pain associated with various dystonias such as cervical, spasmodic, and torsion dystonia. Although botulinum toxin therapy has not resulted in complete relief of symptoms for these conditions, clinical trials have demonstrated temporary but significant improvements in the degree of muscle contractility, flexibility, and pain. An added benefit of this treatment is the ability to target specific muscles in a dose-response relationship, allowing a precise amount of muscle weakness to be induced.

Spasticity related to stroke may be a significant functional problem. Plantar flexion spasticity may impede walking. Peripheral neurolysis with phenol injections has been used for many years, but recently botulinum toxin injections have been investigated. Kirazli and colleagues (1998) compared the effects of phenol block and botulinum toxin in a randomized trial of 20 patients with spastic foot after stroke.  The authors reported both injections were associated with significant improvements, with botulinum toxin outperforming phenol injections after the first month of treatment, with equal treatment effects at 2 and 3 months. Possible advantage of the botulinum toxin is the relative ease of the procedure (15 to 30 minutes), while phenol injection may take up to 2 hours to target motor nerve for injection. Smith and colleagues (2000) investigated the use of botulinum toxin in a trial which randomized 21 patients with upper limb spasticity related to stroke or head injury.  There was a significant reduction in spasticity in the wrist and fingers in the botulinum group. The effects were transitory and disappeared at 12 weeks. 
 
Achalasia

Achalasia is a primary esophageal motor disorder characterized by abnormal lower esophageal sphincter relaxation. While prior randomized controlled trials validated the efficacy of botulinum toxin in treating achalasia, until recently there was no randomized trial comparing botulinum toxin with pneumatic dilation, perhaps considered the gold standard non-surgical treatment. In 1999, Vaezi and colleagues reported on a trial which randomized 42 patients with achalasia to receive either botulinum toxin or undergo pneumatic dilation. Pneumatic dilation results in a significantly higher cumulative remission rate. At 12 months, 70% of patients in the dilation group were still in remission, compared to 32% of those in the botulinum toxin group. These results reflect the effects of botulinum toxin are known to be reversible, but also pneumatic dilation can provide durable treatment effects. The authors conclude while botulinum toxin is an effective therapy, pneumatic dilation is the preferred medical treatment option.

Chronic Anal Fissure

Chronic anal fissure is a tear in the lower half of the anal canal that is maintained by contraction of the internal anal sphincter. It is treated surgically with an internal sphincterotomy. Since the anal sphincter contraction could be characterized as a dystonia, botulinum toxin represented a logical medical approach. Maria and colleagues (1998) reported on a randomized study of 30 patients with chronic anal fissure to receive either 2 injections of 20 units of botulinum toxin, on either side of the fissure, or 2 injections of saline. After 2 months, 11 patients in the treatment group reported healing, compared to only 2 in the control group. The 4 patients who still had fissures after 2 months underwent retreatment with botulinum toxin; 2 of these 4 patients reported healing scars and symptomatic relief. These results are consistent with earlier case series that reported a healing rate of 80% (Jost, 1997). Nitroglycerin ointment has also been used to successfully treat anal fissure. Brisinda and colleagues (1999) compared the results of nitroglycerin ointment and botulinum toxin in a randomized trial of 50 patients. After 2 months, 96% of the fissures were healed in the botulinum group compared with 60% in the nitroglycerin group.

Headaches

The interest in using botulinum as a treatment for headache stemmed from the observation patients receiving pericranial injections of botulinum toxin for other reasons reported a decrease in the incidence of migraine. While it may exert its effect by relieving the muscle tension associated with migraine, it may also exert an effect by inhibiting nociceptive mediators such as glutamate, substance P and calcitonin gene related peptide.  Botulinum has now been studied in a variety of headache disorders including episodic migraine headache, tension headache, cluster headache or chronic daily headache. 

Due to inconsistent results in treating episodic migraine, tension and cluster headaches (Silberstein. 2000; Evers, 2004, Rollnik, 2000; Rollnik, 2004; Schmitt, 2001; Smuts, 1999; Ondo, 2004; Padberg, 2004; Relja, 2004; and Schulte-Mattler, 2004), research has now focused on the treatment of chronic daily headaches, defined as 16 or more headaches per month.  The results of two randomized placebo controlled phase II trials have now been published. 

Mathew and colleagues (2005) studied 355 patients with chronic daily headache who were categorized as placebo responders or non-responders based on an initial single blind trial of placebo.  Both placebo responders and non-responders were then randomized to receive either placebo or botulinum toxin every 90 days for 9 months; patients were evaluated every 30 days.  The second trial by Silberstein and colleagues (2005) was similarly designed and enrolled 702 patients.  The difference in the trials were primarily the doses of botulinum toxin used.  The trial reported by Mathew and colleagues (2005) permitted a range of botulinum toxin doses injected into a variable number of injection sites.  In contrast, in the trial reported by Silberstein, patients received one of three different doses of botulinum toxin injected into predetermined sites.  In both studies, the primary outcome measure was the mean change from baseline in the frequency of headache-free days at day 180 for the placebo nonresponder group.  In both studies, there was no statistically significant difference in the primary outcome, although there were several statistically significant differences in some of the secondary outcomes.  However, the trial design, in which placebo non-responders were randomized separately from placebo responders, is not consistent with the actual clinical use of botulinum toxin.

Recently, Anand and colleagues (2006) studied 32 patients receiving pericranial botulinum toxin injections for multiple monthly migraines. They reported 75% of the patients had some relief from migraine pain, but still had migraine associated decreased normal daily functioning.

Evers (2006) reviewed randomized double-blind, placebo-controlled trials and noted no sufficient evidence supporting the use of botulinum toxin for the treatment of tension and migraine headache. Evers specifically noted an increasing number of studies on botulinum toxin A in the treatment of idiopathic and symptomatic headache; however, he felt many of the studies were difficult to compare because of different end points and trial designs. Evers noted: “For the prophylactic treatment of tension-type headache and migraine, no sufficient positive evidence for a treatment with botulinum toxin A is obtained from randomized, double-blind, and placebo-controlled trials to date. “ He further stated: “For the treatment of chronic daily headache (including medication-overuse headache), there is inconsistent positive evidence for subgroups (e.g., patients without other prophylactic treatment). This means that most of the double-blind and placebo-controlled studies do not confirm the assumption that botulinum toxin A is efficacious in the treatment of idiopathic headache disorders; however, it is possible that some subgroups of patients with chronic migraine benefit from a long-term treatment for > or = 6 months.” Further trials are needed to make this last determination.

Low Back Pain

Foster et al. (2001) report a randomized, double-blind study of botulinum toxin A in 31 consecutive patients with chronic low back pain. Study selection criteria included low back pain of at least 6 months' duration with more predominant pain on one side. Patients were excluded if there was a systemic inflammatory disorder, acute pathology on MRI, or involvement in worker’s compensation or litigation among other criteria.

The outcome measures used in this study were a visual analogue scale (VAS) for pain, measured at baseline, 3 weeks and 8 weeks, and a 50% reduction was considered a response. The Oswestry Low Back Pain Questionnaire (OLBPQ) was used to measure functional ability at baseline and at 8 weeks. This measure has 10 different subscales (pain, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and traveling) each rated 0 to 5. Responders were required to show a 2-point reduction on the pain subscore and at least 1 of other subscales. Three patients withdrew or were lost to follow-up over the course of the 8-week study, and these subjects were included in the intent-to-treat analysis as nonresponders. Patients were injected with 40 units of Botox (Allergan, Inc.) at 5 lumbosacral locations for a total of 200 U (treated group) or saline placebo (placebo group). Injections were made on one side of the back only, depending on predominance of pain.

At baseline, pain scores on the VAS in the treated group ranged from 6 to 10, with an average of 7.5; in the placebo group, scores ranged from 5 to 10, with an average of 7. At 3 weeks, 73.3% of treated patients and 25% of placebo showed a response on VAS scores (p=0.012). This difference in VAS scores remained significant at 8 weeks with 60% of treated patients and 12.5% of placebo patients still responding (p=0.009). The OLBPQ assessment at 8 weeks showed that 66.7% of treated patients and 18.8% of placebo patients were responders (p= 0.011). These results show clinically significant and statistically significant improvements in treated patients as compared with placebo on all 3 outcome assessments.

However, this is only 1 suggestive study that included 31 subjects, and replication of these findings would be desirable. The population with chronic low back pain is a heterogeneous population, and results in this small group of selected subjects cannot be used to generalize results for the whole population with chronic low back pain. Furthermore, studies should examine the long-term effectiveness of using repeated courses of botulinum toxin to determine the durability of repeated treatments.

Myofascial Pain

Painful muscles with increased tone and stiffness containing trigger points characterize myofascial pain syndrome. Patients are often treated with injections of the trigger points with saline, dilute anesthetics, or dry needling. These trigger point injections, while considered established therapy, have been controversial since it is unclear whether any treatment effect is due to the injection, dry needling of the trigger point, or a placebo effect. Among 3 studies on cervicothoracic myofascial pain syndrome, Wheeler and colleagues (1998) conducted a randomized trial of 33 patients randomized into 3 groups; 1 group receiving 50 units of botulinum toxin, 1 group receiving 100 units of botulinum toxin, and 1 group receiving normal saline. All 3 groups showed similarly significant treatment effects, based on the Neck Pain and Disability Visual Analogue Scale. These same authors (Wheeler, 2001) later found no differences among 50 patients randomized to high-dose botulinum toxin or placebo. A crossover study of only 6 patients (Cheshire, 1994) found significantly better results for botulinum toxin over placebo at 2 and 4 weeks for 4 of 5 pain outcomes. Together, these 3 studies are insufficient to permit conclusions about the effects of botulinum toxin on cervicothoracic myofascial pain syndrome.

Three studies addressed another form of myofascial pain, piriformis syndrome, characterized by buttock tenderness and sciatica. One study of 9 patients (Childers, 2002) compared botulinum toxin with placebo, finding postinjection pain scores were significantly improved in the treatment group for only 1 of 4 pain domains, while none improved in the placebo group. Another study of 36 patients (Fishman, 2002) had a high loss to follow-up (23%) and found the botulinum toxin group had a significantly higher proportion with 50% or greater reduction in pain on each of the last 2 follow-up visits, compared with placebo. These small and flawed studies do not establish the effects of botulinum toxin exceed those of placebo. A third study (Porta, 2000) comparing botulinum toxin with methylprednisolone found better results for the former, but placebo effects were not considered. The evidence for piriformis myofascial pain syndrome does not support conclusions about the effects of botulinum toxin.

Tremor

Tremor may be defined as alternate or synchronous contractions of antagonistic muscles. Some patients may be disabled by severe or task-specific tremors. Tremors are also a frequent component of dystonias, and successful treatment of dystonias resulted in an improvement in tremors. Botulinum toxin has been investigated in patients with tremors unrelated to dystonias. One randomized study by Pahwa (1995) reported on 10 patients with essential head tremor. Patients were randomized to receive either botulinum injections into the sternocleidomastoid or splenius capitus muscle. Five patients improved in the treatment group compared to 3 in the control group. The lack of statistical significance may be related to the small size of the study. Two randomized, placebo-controlled studies addressed essential hand tremors, enrolling 133 and 25 patients, respectively (Brin, 2001; Jankovic, 1996). In both studies, inconsistent significant advantages for botulinum toxin were found on tremor symptom scales, but none were shown on functional outcomes. Thus, the clinical significance of these findings is unclear.

Drooling

Botulinum toxin has also been investigated as a treatment of significant drooling, primarily in patients with Parkinson’s disease or cerebral palsy.  Several randomized controlled trials have demonstrated botulinum toxin can decrease the volume of saliva compared to placebo, as evidenced by a change in the number of bibs required each day (Ondo, 2004; Mancini, 2003; and Lipp, 2003). However, oral scopolamine is an effective technique of reducing salivary flow.  One study randomized 45 children with cerebral palsy to receive either scopolamine therapy or injections of botulinum toxin (Jongerius, 2004). No significant differences in reduction in saliva volume were noted between the two groups, although those receiving scopolamine had greater side effects.  The results of this study suggest that botulinum injection is a reasonable alternative for those who cannot tolerate scopolamine.

Gastroparesis

Botulinum toxin has been researched as a treatment of gastroparesis. Through upper endoscopy, botulinum toxin has been injected into the pylorus to relax the muscle and speed emptying of gastric contents. The literature consists of several case series ranging in size from 3 to 20 patients. Although the results show some positive effect after treatment with botulinum toxin, larger controlled trials are needed to determine the efficacy of this treatment method for gastroparesis. (Friedenberg, 2004).

Urologic Applications

Botulinum toxin is currently being studied for the management of patients with lower urinary tract dysfunctions including detrusor-sphincter dyssynergia and detrusor overactivity. Botulinum toxin is injected into the external urethral sphincter to treat detrusor sphincter dyssynergia, while intra-detrusal injection of botulinum toxin is employed in treating detrusor overactivity and symptoms of the overactive bladder (OAB). Schurch and colleagues (2005) performed a single treatment, randomized, placebo-controlled study on botulinum therapy in 59 patients with incontinence related to detrusor overactivity secondary to spinal cord injury (n=53) or multiple sclerosis (n=6) that was inadequately controlled with anticholinergic therapy. Patients were randomized to receive either botulinum toxin or placebo injection into the detrusor muscle. The study demonstrated a statistically significant decrease (approximately 50%) in daily incontinence episodes in patients treated with botulinum toxin over the duration of the 24 week trial. Although the study is small, the results showed significant improvement to confirm the efficacy of botulinum toxin as a treatment of neurogenic incontinence.

In a study performed by De Seze and colleagues (2002), 13 patients with chronic urinary retention due to detrusor sphincter dyssynergia from spinal cord injury were randomized to receive perineal botulinum toxin or lidocaine injections into the external urethral sphincter. In the botulinum group, there was a significant decrease in the post-void residual volume (one of the endpoints) compared to no change in the control group receiving a lidocaine injection. Improvements were also seen in the satisfaction scores and other urodynamic outcomes.

Chen and Kuo (2004) showed positive results with Botox when comparing Botox and no treatment in patients with urinary problems due to intracranial lesions or cerebrovascular accidents. Patients who received a urethral injection of Botox showed improved voiding pressure and increased maximum urine flow rates (+3.1 mL/sec) compared to baseline (p<0.05). No adverse effects or withdrawals were reported.

Patki and colleagues (2006) studied 37 patients in the treatment of drug-resistant urinary incontinence due to traumatic spinal cord injury. All patients received botulinum toxin-type A injected cystoscopically into the detrusor muscle. At a mean follow-up of 7 months, maximum cystometric capacity increased from a mean of 259 to 522 mL and maximum detrusor pressure fell from 54 to 24 cm H20. Incontinence was abolished in 82% of patients and neurogenic detrusor overactivity was stopped in 76%. In all, 86% of patients were able to stop or reduce anticholinergics and a similar proportion showed an increase in quality-of-life scores. The mean duration of symptomatic improvement was 9 months, and 12 patients had a mean of 14 months of improvement.  Although the study is nonrandomized, the results showed significant improvement to confirm the efficacy of botulinum toxin as a treatment of drug-resistant urinary incontinence due to traumatic spinal cord injury.

Other 2006 case series tend to support the use of Botulinum toxin in drug-resistant urinary incontinence as well. In a prospective uncontrolled case series performed by Schulte-Baukloh et al (2006), 16 patients with neurogenic detrusor overactivity due to multiple sclerosis (MS) with drug-refractory overactive bladder (OAB) symptoms were given botulinum toxin injections into the bladder. They concluded botulinum toxin detrusor injections are very effective in the treatment of drug-resistant OAB symptoms in MS patients as reflected in urodynamic measurements and in high patient satisfaction. However, it was also noted patients need to be warned of the potential for increased residual volume that may require temporary self-catheterization.

Wrinkles

The use of botulinum toxin for the treatment of facial or other wrinkles does not provide any proven medical benefit. Any improvement in physical appearance is considered cosmetic regarding facial and other wrinkles.

Botulinum is a family of toxins produced by the anaerobic organism Clostridia botulinum. There are 7 distinct serotypes designated as type A, B, C-1, D, E, F, and G. In this country, 2 preparations of botulinum are available, produced by 2 different strains of bacteria: type A (Botox) and type B (Myobloc). When administered intramuscularly, all botulinum toxins reduce muscle tone by interfering with the release of acetylcholine from nerve endings.

The U.S. Food and Drug Administration (FDA)-approved label for Botox states it is indicated for the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain, primary axillary hyperhidrosis that is inadequately managed with topical agents, and strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients older than 12 years. Primary axillary hyperhidrosis is addressed in WellPoint MED.00032-Treatment of Hyperhidrosis.  The FDA- approved label for Myobloc states it is indicated for the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain.

Dystonia is a general term describing a state of abnormal or disordered tonicity of muscle. As an example, achalasia is a dystonia of the lower esophageal sphincter, while cervical dystonia is also known as torticollis. Spasticity is a subset of dystonia, describing a velocity-dependent increase in tonic-stretch reflexes with exaggerated tendon jerks. Spasticity typically is associated with injuries to the central nervous system. Spasticity is a common feature of cerebral palsy. Since its FDA approval in 1991, Botox has been used for a wide variety of off-label indications; all associated with dystonia, ranging from achalasia, spasticity after strokes, cerebral palsy, and anal fissures. In addition to widening indications, Botox has also been used in children under 12, particularly for the treatment of cerebral palsy.

Achalasia:a condition involving the esophagus and the muscle that separates the esophagus from the stomach; in this condition the esophagus is less able to move food toward the stomach and the valve from the esophagus to the stomach does not relax adequately during swallowing to allow the passage of food

Blepharospasm: a condition characterized by abnormal, involuntary blinking or spasm of the eyelids

Botulinum Toxin: a powerful drug that can be used to paralyze the nerves that motivate muscle movement

Cervical Dystonia: a nervous system-related movement disorder characterized by neck muscles contracting involuntarily, causing abnormal movements and postures of the head and neck

Detrusor Sphincteric Dyssynergia: a disturbance of the normal relationship between bladder (detrusor) contraction and sphincter relaxation during voluntary or involuntary voiding efforts

Dystonia: a nervous system related movement disorder characterized by sustained muscle contractions

Equinus Foot: a condition where a patient’s foot is positioned so that their toes touch the ground but the heel does not; this condition is due to inappropriate contraction of the calf muscles caused by a nervous system disorder

Facial Nerve VII Disorders (also known as hemifacial spasm): a condition where the face muscles on one side of a patient’s face contract involuntarily

Hereditary Spastic Paraplegia (also known as familial spastic paralysis): a group of genetic disorders that are characterized by progressive weakness and spasticity (stiffness) of the legs; symptoms may occur alone in combination with a number of other neurological symptoms

Idiopathic Torsion Dystonia (also known as primary dystonia): a group of genetic diseases of the nervous system, which cause involuntary abnormal twisting movements of the body

Infantile Cerebral Palsy: a group of disorders characterized by loss of movement or loss of other nerve functions; these disorders are caused by injuries to the brain that occur during fetal development or near the time of birth

Multiple Sclerosis: a disorder of the brain and spinal cord caused by progressive damage to the outer covering of nerve cells; this results in decreased nerve function leading to a variety of symptoms including muscle spasticity, atrophy, weakness, paralysis, or tremor of the limbs

Neuromyelitis Optica (also known as Devic’s disease): a rare nerve disorder characterized by inflammation and swelling of the nerves in the eyes and spinal cord; affected individuals may also experience loss of visual clarity (acuity), mild paralysis, and loss of bladder and bowel control

Organic Writer’s Cramp: a task-specific focal dystonia of the hand; symptoms usually appear when a person is trying to do a task that requires fine motor movements; symptoms may appear only during a particular type of movement, such as writing or playing the piano, but the dystonia may spread to affect many tasks

Orofacial Dyskinesia (also known as jaw closure dystonia): a condition where a patient’s face or mouth are subject to involuntary movements due to muscle contractions

Schilder’s Disease: a rare progressive disease affecting the brain and nerves; symptoms may include dementia, difficulty speaking, seizures, personality changes, poor attention, and tremors

Spasmodic Dysphonia or Laryngeal Dystonia: a disorder of speech due to abnormal control of the laryngeal muscles present only during the specific task of speaking

Spastic Hemiplegia: a condition where one half of a patient’s body is subject to involuntary muscle contractions leading to paralysis

Spasmodic Torticollis: a congenital condition that is caused by a chronically contracted muscle on one side of the head that pulls the head (ear) down toward one shoulder as the chin tilts to the opposite side

Strabismus: a condition where a patient’s eyes are misaligned and point in different directions due to involuntary contractions of the muscles controlling the eyes

Symptomatic Torsion Dystonia: a group of genetic diseases of the nervous system that cause involuntary abnormal twisting movements of the body

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Medically Necessary:

CPT

HCPCS

ICD-9 Diagnosis

When services are Cosmetic/Not Medically Necessary:

For the procedure codes listed above, with the following diagnosis or when the code describes a procedure indicated in the Policy section as cosmetic/not medically necessary.

ICD-9 Diagnosis

When services are Investigational/Not Medically Necessary:

For the procedure codes listed above, for all other diagnoses not listed, when criteria are not met; or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.

Peer Reviewed Publications:

1. Anand KS, Prasad A, Singh MM, et al. Botulinum toxin type A in prophylactic treatment of migraine. Am J Ther. 2006; 13(3):183-187.
2. Basciani M, Intiso D.  Botulinum toxin type-A and plaster cast treatment in children with upper brachial plexus palsy. Pediatr Rehabil. 2006 ; 9(2):165-170. 
3. Brin MF, Lyons KE, Doucette J, et al. A randomized, double masked, controlled trial of botulinum toxin type A in essential hand tremor. Neurology. 2001; 56(11):1523-1528.
4. Brisinda G, Maria G, Bentivoglio AR, et al. A comparison of injections of botulinum toxin and topical nitroglycerin ointment for the treatment of chronic anal fissure. N Engl J Med. 1999; 341(2):65-69.
5. Chen YH, Kuo HC. Botulinum A toxin treatment of urethral sphincter pseudodyssynergia in patients with cerebrovascular accidents or intracranial lesions. Urol Int. 2004; 73(2):156-161.
6. Cheshire WP, Abashian SW, Mann JD. Botulinum toxin in the treatment of myofascial pain syndrome. Pain. 1994; 59(1):65-69.
7. Childers MK, Wilson DJ, Gnatz SM, et al. Botulinum toxin type A use in piriformis muscle syndrome: a pilot study. Am J Phys Med Rehabil. 2002; 81(10):751-759.
8. DeMatteo C, Bain JR, Galea V, Gjertsen D. Botulinum toxin as an adjunct to motor learning therapy and surgery for obstetrical brachial plexus injury. Dev Med Child Neurol. 2006; 48(4):245-252. 
9. De Seze M, Petit H, Gallien P, et al. Botulinum a toxin and detrusor sphincter dyssynergia: a double-blind lidocaine-controlled study in 13 patients with spinal cord disease. Eur Urol. 2002; 42(1):56-62.
10. Desiato MT, Risina B. The role of botulinum toxin in the neuro-rehabilitation of young patients with brachial plexus birth palsy.  Pediatr Rehabil. 2001; 4(1):29-36.
11. Dodick DW, Mauskop A, Elkind AH, et al.; BOTOX CDH Study Group. Botulinum toxin type A for the prophylaxis of chronic daily headache: subgroup analysis of patients not receiving other prophylactic medications: a randomized double-blind, placebo-controlled study. Headache. 2005; 45(4):315-324.
12. Evers S. Status on the use of botulinum toxin for headache disorders. Curr Opin Neurol. 2006; 19(3):310-315.
13. Evers S.  Investigating prophylactic botulinum toxin type A for chronic headache disorders. Expert Opin Investig Drugs. 2006; 15(10):1161-1166.
14. Evers S, Vollmer-Haase J, Schwaag S, et al. Botulinum toxin A in the prophylactic treatment of migraine – a randomized, double-blind, placebo-controlled study. Cephalalgia .2004; 24(10):838-843.
15. Fishman LM, Anderson C, Rosner B. BOTOX and physical therapy in the treatment of piriformis syndrome. Am J Phys Med Rehabi. 2002; 81(12):936-942.
16. Foster L, Clapp L, Erickson M, et al. Botulinum toxin A and chronic low back pain: a randomized, double-blind study. Neurology. 2001; 56(10):1290-1293.
17. Friedenberg F, Gollamudi S, Parkman HP. The use of botulinum toxin for the treatment of gastrointestinal motility disorders. Digestive Diseases and Sciences. 2004; 49:165-175.
18. Heise CO, Goncalves LR, Barbosa ER, Gherpelli JL. Botulinum toxin for treatment of cocontractions related to obstetrical brachial plexopathy. Arq Neuropsiquiatr. 2005; 63(3A):588-591. 
19. Jankovic J, Schwartz K, Clemence W, et al. A randomized, double-blind, placebo-controlled study to evaluate botulinum toxin type A in essential hand tremor. Mov Disord. 1996; 11(3):250-256.
20. Jongerius PH, van den Hoogen FJ, van Limbeek FJ, et al.  Effect of botulinum toxin in the treatment of drooling: A controlled clinical trial.  Pediatrics. 2004; 114:620-627.
21. Jost WH. One hundred cases of anal fissure treated with botulinum toxin: early and long-term results. Dis Colon Rectum. 1997; 40(9):1029-1032.
22. Kirazli Y, On AY, Kismali B, et al. Comparison of phenol block and botulinus toxin type A in the treatment of spastic foot after stroke: a randomized, double-blind trial. Am J Phys Med Rehabil. 1998; 77(6):510-515.
23. Lipp A, Trottenberg T, Schink T, et al. A randomized trial of botulinum toxin A for treatment of drooling. Neurology .2003; 61(9):1279-1281.
24. Mancini F, Zangaglia R, Cristina S, et al. Double-blind, placebo-controlled study to evaluate the efficacy and safety of botulinum toxin type A in the treatment of drooling in Parkinsonism. Mov Disord. 2003; 18(6):685-688.
25. Maria G, Brisinda G, Civello IM, et al. Relief by botulinum toxin of voiding dysfunction due to benign prostatic hyperplasia: results of a randomized, placebo-controlled study. Urology. 2003; 62(2):259-65.
26. Maria G, Cassetta E, Gui D, et al. A comparison of botulinum toxin and saline for the treatment of chronic anal fissure. N Engl J Med. 1998; 338(4):217-220.
27. Mathew NT, Frishberg BM, Gawel M, et al.  Botulinum toxin type A for the prophylactic treatment of chronic daily headache: A randomized double blind, placebo-controlled trial.  Headache. 2005:293-307.
28. Ondo WG, Hunter C, Moore W. A double-blind placebo-controlled trial of botulinum toxin B for sialorrhea in Parkinson’s disease. Neurology. 2004; 62(1):37-40.
29. Ondo WG, Vuong KD, Derman HS. Botulinum toxin A for chronic daily headache: a randomized, placebo-controlled, parallel design study. Cephalalgia. 2004; 24(1):60-65.
30. Padberg M, de Bruijn, de Haan RJ, et al. Treatment of chronic tension-type headache with botulinum toxin: a double-blind, placebo-controlled clinical trial. Cephalalgia. 2004; 24(8):675-680.
31. Pahwa R, Busenbark K, Swanson-Hyland EF, et al. Botulinum toxin treatment of essential head tremor. Neurology. 1995; 45(4):822-824.
32. Patki PS, Hamid R, Arumugam K, et al.. Botulinum toxin-type A in the treatment of drug-resistant neurogenic detrusor overactivity secondary to traumatic spinal cord injury. BJU Int. 2006; 98(1):77-82. 
33. Porta M. A comparative trial of botulinum toxin type A and methylprednisolone for the treatment of myofascial pain syndrome and pain from chronic muscle spasm. Pain. 2000; 85(1-2):101-105.
34. Price AE, Ditaranto P, Yaylali I, et al.  Botulinum toxin type A as an adjunct to the surgical treatment of the medial rotation deformity of the shoulder in birth injuries of the brachial plexus. J Bone Joint Surg Br. 2007; 89(3):327-329. 
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Government Agency, Medical Society, and Other Authoritative Publications:

1. Blue Cross Blue Shield Assoc. Botulinum toxin for treatment of primary chronic headache disorders. Technology Evaluation Center. 2004. 
2. Costa J, Espírito-Santo C, Borges A, Ferreira JJ, Coelho M, Moore P, Sampaio C. Botulinum toxin type A therapy for cervical dystonia. Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD003633. 
3. Costa J, Espírito-Santo C, Borges A, Ferreira JJ, Coelho M, Moore P, Sampaio C. Botulinum toxin type A therapy for hemifacial spasm. Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD004899.
4. Hayes Medical Technology Directory. Botulinum toxin treatment for dystonias. Winifred S. Hayes, Inc., Lansdale PA. February, 2006. Search updated February 25, 2007.
5. Hayes Medical Technology Directory. Botulinum toxin for the treatment of gastrointestinal disorders. Winifred S. Hayes, Inc., Lansdale PA. December, 2003. Search updated December 2005. Search updated January 6, 2007.
6. Hayes Medical Technology Directory. Botulinum toxin treatment for headache. Winifred S. Hayes, Inc., Lansdale PA. November, 2003. Search updated December 2005.  Search updated December 21, 2006.
7. Hayes Medical Technology Directory. Botulinum toxin treatment for spasticity and essential tremor. Winifred S. Hayes, Inc., Lansdale PA. February, 2006. Search updated February 23, 2007.
8. Hayes Medical Technology Directory. Local Injection Therapy and Neurosurgery for Cervicogenic Headache and Occipital Neuralgia. Winifred S. Hayes, Inc., Lansdale PA. July, 2003. Search updated March 6, 2007.
9. Nelson R. Non surgical therapy for anal fissure. Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.: CD003431.
10. Peloso P, Gross A, Haines T, Trinh K, Goldsmith CH, Aker P, Cervical Overview Group. Medicinal and Injection therapies for mechanical neck disorders. Cochrane Database of Systematic Reviews 2004, Issue 2. Art. No.: CD000319.
    

1. Dystonia Medical Research Foundation. Available at:    http://www.dystonia-foundation.org. Accessed on March 16, 2007.
2. Institute of Neurological Disorders and Stroke. Cerebral Palsy Information Page.  Available at:  http://www.ninds.nih.gov/health_and_medical/disorders/cerebral_palsy.htm. Accessed on March 16, 2007.
3. American Academy of Neurology. Evidence based Guidelines for migraine headaches. Available at:  http://www.neurology.org/cgi/reprint/55/6/754.pdf. Accessed on March 16, 2007.
   

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