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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 01/01/2003 Title: Botulinum Toxin A & B
Revision Date: 09/01/2019 Document: BI079:00
CPT Code(s): J0585-J0588, 64615
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    All utilization of botulinum toxins requires pre-authorization.

2)    Botulinum toxins (commonly referred to as “Botox” – which is the brand name for one form of botulinum toxin) are covered when used to treat medical illnesses for which there is good scientific evidence of effectiveness and safety.

Botulinum toxins are commonly used for cosmetic purposes, and other purposes for which they are not covered. 

Medical Statement

1)    Botulinum Toxin Type A (Botox): QualChoice considers botulinum toxin type A (Botox) medically necessary for the following conditions:

a)    Strabismus, including gaze palsies, in accordance with:

i)     Provided there is vision correctable to 20/50 or better in each eye (separately).

ii)    Botulinum toxin is indicated for use in strabismus as indicated by the following diagnosis codes:

(1)    Esotropia    

(2)    Exotropia

(3)    Intermittent Heterotropia

(4)    Other and unspecified Heterotropia

(5)    Heterotropia

(6)    Paralytic strabismus

(7)    Mechanical strabismus

(8)    Duane’s Syndrome

(9)    Other disorders of binocular eye movements

(10) Other dissociated deviation of eye movements

(11) Unspecified disorders of eye movement

iii)   Except as noted above and below, botulinum toxin is indicated for strabismus accompanying diseases, such as:

(1)  Neuromyelitis optical;

(2)  Schilder’s disease

iv)   Botulinum toxin is not recommended for:

(1)  Strabismus when angles are over 50 prism diopters

(2)  Restrictive strabismus

(3)  Duane’s syndrome with lateral rectus weakness; or

(4)  Secondary strabismus caused by prior surgical over-recession

v)    Botulinum toxin treatment is not indicated for patients with chronic paralytic strabismus, except to reduce antagonist contractor in conjunction with surgical repair.

b)    Blepharospasm, characterized by intermittent or sustained closure of the eyelids caused by involuntary contractions of the orbicularis oculi muscle.

(1)  Blepharospasm

c)    Post-facial (7th cranial) nerve palsy Synkinesis (hemi facial spasms), characterized by sudden, unilateral, synchronous contractions of muscles innervated by the facial nerve.

(1)  Other facial nerve disorders (including hemifacial spasm)

d)    Laryngeal spasm.

(1)  Laryngospasm

(2)  Voice disturbance, unspecified; Aphonia

(3)  Voice disturbance; other (including spasmodic dysphonia)                

e)    Focal dystonia’s, including:

i)     Spasmodic torticollis when all of the following criteria are met:

(1)  There are clonic and/or tonic involuntary contractions of multiple neck muscles (e.g., sternocleidomastoid, splenius, trapezius and/or posterior cervical muscles); and

(2)  There is sustained head torsion and/or tilt with limited range of motion in the neck; and

(3)  The duration of the condition is greater than 6 months; and

(4)  There is no history of chronic neuroleptic treatments; and

(5)  There is no associated ataxia, weakness, spasticity, or reflex change; and

(6)  There are no brain CT abnormalities that would explain the condition;

(a)  And the diagnosis is:

i.  Spasmodic Torticollis; or

ii.Torticollis, unspecified; or

iii.   Congenital sternocleidomastoid torticollis

ii)    Lingual dystonia;

f)     Orofacial dyskinesia 

i)     Laryngeal dystonia (i.e., adductor and abductor spasmodic dysphonia)

(1)  (see laryngeal spasm Section I paragraph D, above);

ii)    Jaw-closing Oromandibular dystonia, characterized by dystonic movements involving the jaw, tongue, and lower facial muscles;

iii)   Hand dystonia (i.e., organic writer’s cramp);

(1) Organic writer’s cramp

iv)   Symptomatic torsion dystonia

(1)  Idiopathic torsion dystonia

(2)  Symptomatic torsion dystonia  

(3)  Fragments of torsion dystonia  

(4)  Fragments of torsion dystonia; other

g)    Limb spasticity, including:

i)     Hereditary spastic paraplegia;

(1)  Hereditary spastic paraplegia

ii)    Limb spasticity due to multiple sclerosis;

(1)  Multiple sclerosis

iii)   Limb spasticity due to other demyelinating diseases of the central nervous system;

(1)  Other demyelinating disease of central nervous system

iv)   Spastic hemiplegia;

(1)  Spastic hemiplegia

v)    Infantile cerebral palsy

h)    Esophageal achalasia, for individuals who have any of the following:

i)     Have failed conventional therapy; or

ii)    Are at high risk of complications of pneumatic dilation or surgical Myotomy; or

iii)   Have failed a prior Myotomy or dilation; or

iv)   Have had a previous dilation-induced perforation; or

v)    Have an Epiphrenic diverticulum or hiatal hernia, both of which increase the risk of dilation-induced perforation.

vi)   With diagnosis code:

(1)  Achalasia & cardiospasm

i)     Chronic anal fissure unresponsive to conservative therapeutic measures (e.g., nitroglycerin ointment).

(1)  Chronic anal fissure

j)     Focal hyperhydrosis, when all of the following are met:

i)     Topical aluminum chloride or other extra-strength antiperspirants are ineffective or result in a severe rash; and

ii)    Member is unresponsive or unable to tolerate pharmacotherapy prescribed for excessive sweating (e.g., anticholinergics, beta-blockers, or benzodiazepines); and

iii)   Significant disruption of professional and/or social life has occurred because of excessive sweating.

iv)   With diagnosis code:

(1)  Focal hyperhidrosis

k)    Ptyalism/Sialorrhea (excessive secretion of saliva, drooling) that is socially debilitating and refractory to pharmacotherapy (including anticholinergics).

(1)  Disturbance of salivary secretion

l)     Facial Myokymia and trismus associated with post-radiation Myokymia.

(1)  Other facial nerve disorders                      

m)  Hirschsprung’s disease with internal sphincter achalasia following endorectal pull-through.

(1)  Hirschsprung’s disease

n)    Medically refractory upper extremity tremor that interferes with activities of daily living (ADLs) (Additional botulinum toxin injections are considered medically necessary if response to a trial of botulinum toxin enables ADLs or communication).

o)    Overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and frequency in adults who have:

i)     Detrusor over activity confirmed by urodynamic testing, AND

ii)    Documentation of an inadequate response to or intolerance to at least two adequately titrated anticholinergic medications

p)    Detrusor-sphincter Dyssynergia after spinal cord injury.

q)    Overactive bladder (detrusor over activity) when all of the following conditions are met:

i)     Detrusor over activity is confirmed by urodynamic testing, AND

ii)    Documentation of failure of an adequate trial (three months) of behavioral therapy (first-line treatment per American Urological Association guidelines), AND

iii)   Documented failure or intolerance to at least two adequately titrated anticholinergic medications (second-line treatment per American Urological Association guidelines), AND

iv)   Documented failure or intolerance to mirabegron, a beta-3 adrenergic agonist (second-line treatment per American Urological Association guidelines).

r)     Migraines -- for prevention of chronic (more than 14 days per month with headaches lasting 4 hours a day or longer) migraine headaches in adults who have tried and failed trials of at least 3 classes of migraine headache prophylaxis medications of at least two months (60 days) duration for each medication:

i)     Beta Blockers (e.g. atenolol, propranolol);

ii)    Anticonvulsants (e.g. topiramate, gabapentin, divalproex);

iii)   Anti-depressants (e.g., amitriptyline, venlafaxine);

iv)   Calcium channel blockers (e.g., verapamil);

v)    Anti-CGRP agents (e.g., Aimovig/erenumab)—not to be used with Botox.

2)    Botulinum Toxin Type B (Myobloc): QualChoice considers botulinum toxin type B (Myobloc) medically necessary for the following indications:

a)    Treatment of individuals with cervical dystonia (spasmodic torticollis) to reduce the severity of abnormal head position and neck pain associated with cervical dystonia;

(1)  See section I Paragraph E1 above.

b)    Treatment of spasticity caused by stroke or brain injury.

3)    AbobotulinumtoxinA A (Dysport): QualChoice considers AbobotulinumtoxinA A (Dysport) medically necessary for the treatment of any of the following indications:

a)    Blepharospasm, characterized by intermittent or sustained closure of the eyelids caused by involuntary contractions of the orbicularis oculi muscle.

b)    Cervical dystonia, (spasmodic torticollis) of moderate or greater severity when all of the following criteria are met:

i)     Alternative causes of the member’s symptoms have been considered and ruled out, including chronic neuroleptic treatment, contractures, or other neuromuscular disorders; and

ii)    There is sustained head torsion and/or tilt with limited range of motion in the neck; and

iii)   The duration of the condition is greater than 6 months; and

iv)   There are clonic and/or tonic involuntary contractions of multiple neck muscles (e.g., sternocleidomastoid, splenius, trapezius, and/or posterior cervical muscles). 

c)    Limb spasticity, including:

i)     Equinus Varus deformity in children with cerebral palsy

ii)    Hereditary spastic paraplegia;

iii)   Limb spasticity due to multiple sclerosis;

iv)   Limb spasticity due to other demyelinating diseases of the central nervous system (including adductor spasticity and pain control in children undergoing adductor-lengthening surgery as well as children with upper extremity spasticity);

v)    Spastic hemiplegia, such as due to stroke or brain injury.

4)     IncobotulinumtoxinA (Xeomin): Considered medically necessary for the following conditions:

a)    Blepharospasm characterized by intermittent or sustained closure of the eyelids caused by involuntary contractions of the orbicularis oculi muscle.

b)    Cervical dystonia, (spasmodic torticollis) of moderate or greater severity when all of the following criteria are met:

i)     Alternative causes of the member’s symptoms have been considered and ruled out, including chronic neuroleptic treatment, contractures, or other neuromuscular disorders; and

ii)    There is sustained head torsion and/or tilt with limited range of motion in the neck; and

iii)   The duration of the condition is greater than 6 months; and

iv)   There are clonic and/or tonic involuntary contractions of multiple neck muscles (e.g., sternocleidomastoid, splenius, trapezius, and/or posterior cervical muscles).

5)    Providers must document the results of and the response to these injections at least after every third session. Failure of two definitive, consecutive, treatment sessions involving a muscle or group of muscles could preclude further coverage for same serotype of botulinum toxin.

Codes Used In This BI:

J0585             Injection, OnabotulinumtoxinA, 1 unit

J0586             Injection, AbobotulinumtoxinA, 5 units

J0587             Injection, RimabotulinumtoxinB, 100 units

J0588             Injection, IncobotulinumtoxinA, 1 unit

64615             Injection/chemodenervation of muscles innervated by facial/trigeminal/cervical  

                      spinal/accessory nerves


Limits

1)    QualChoice reviews and authorizes services and substances. Billing and procedure codes change from time to time and QualChoice medical policies may not always reference the current published codes. This does not change the intent or effect of the policy language, nor does it affect the necessity for appropriate process. The codes are included in Medical Policies as a convenience to the readers of the policy.

2)    Strabismus repair is considered cosmetic and not medically necessary in adults with uncorrected congenital strabismus and amblyopia ex Anopsia (evidenced by best corrected vision worse than 20/50 in one eye).

3)    The cost of special syringes is not separately payable.

4)    Experimental and Investigational Indications: QualChoice considers botulinum toxin (type A or type B) experimental and investigational for all other indications, including any of the following conditions:

a)    Headache, including Cervicogenic or tension headache (Hayes C); or

b)    Fibromyositis; or

c)    Painful cramps; or

d)    Urinary and anal sphincter dysfunction; or

e)    Bell’s palsy; or

f)     Stuttering; or

g)    Irritable colon; or

h)    Biliary dyskinesia; or

i)     Temporomandibular joint disorders; or

j)     Chronic low back pain; or

k)    Chronic neck pain; or

l)     Gastroparesis; or

m)  Clubfoot; or

n)    Cranial/facial pain of unknown etiology; or

o)    Piriformis syndrome.

5)    Cosmetic Indications: QualChoice considers botulinum toxin cosmetic and not medically necessary for the following indications:

a)    Wrinkles, frown lines; or

b)    Aging neck; or

c)    Blepharoplasty (eyelid lift)

6)    Botulinum toxin treatment is not indicated for patients receiving aminoglycosides, which may interfere with neuromuscular transmission.

7)    When criteria are met for botulinum toxin use, authorizations will be limited to specific evidence-based protocols (such as the PREEMPT protocol for migraines: 155 units given in 31 injections every three months).


Background

Local injections of botulinum toxin type A (Botox) have been approved by the FDA for the treatment of strabismus, essential Blepharospasm, and hemifacial spasm. In patients with congenital strabismus who have compromised or absent binocular vision, treatment is cosmetic as ocular realignment is not capable of restoring binocular vision.

Clinical studies indicate that Botox can also provide symptomatic relief in a variety of other conditions characterized by involuntary spasm of certain muscle groups, notably in cervical dystonia (spasmodic torticollis) and spasmodic dysphonia. Ninety percent of spasmodic torticollis patients show some improvement of pain relief, head position, and disability, and Botox is now the treatment of choice for this condition. Botox has been shown to result in normal or near normal voice in patients with adductor type (strained or strangled voice) laryngeal dystonia and to be of considerable benefit in patients with abductor type (breathy, whispery voice) laryngeal dystonia.

Botox has been evaluated in various spastic disorders. Botox can be used to reduce spasticity or excessive muscular contractions to relieve pain; to assist in posturing and walking; to allow better range of motion; to permit better physical therapy; and to reduce severe spasm in order to provide adequate perineal hygiene. It has been shown to improve gait patterns in patients with cerebral palsy with progressive dynamic Equinovarus or Equinovalgus foot deformities. Treatment of children with cerebral palsy during the early years when functional skills in walking are being developed improves the outcome and may help to avoid surgery for contracture and bony torsion. In multiple sclerosis, Botox can relieve contractions of thigh adductors that interfere with sitting, positioning, cleaning, and urethral catheterization.

Treatment with Botox has been shown to be safe and effective in the jaw-closing variant of Oromandibular dystonia. Injections of Botox into the masseter, temporalis, and internal pterygoid muscles result in reduction in the Oromandibular and lingual spasms and an improvement in chewing and speech. Symptoms are reduced in about 70 percent of patients, and treatment may prevent dental complications and temporomandibular joint dysfunction. Treatment with Botox has been shown to be safe and effective for writer`s cramp (local and segmental limb dystonia). This dystonia can be incapacitating and has been exceptionally resistant to treatment with oral medications. Other occupational cramps, such as musician’s cramp, respond less well to injections as they require very sophisticated neuromuscular performance.

Botox has also been shown to be effective in the treatment of achalasia. Two thirds of patients with this condition respond within six months and effectiveness lasts on an average of a little over one year for an initial treatment, although shorter and longer duration have been reported. There is some question whether Botox treatments are as good as or better than conventional therapy, pneumatic dilation, or Myotomy.

Botox has been shown to be a promising alternative to Sphincterotomy in patients with chronic anal fissures.

Some autonomic disorders resulting in hyper secretion of glands such as hyperhidrosis and Sialism (Ptyalism) respond well to Botox.

An assessment on use of botulinum toxin in pain associated with neuromuscular disorders, prepared for the Minnesota Health Technology Advisory Committee (2001), concluded that there is insufficient evidence to support the use of botulinum toxin in the treatment of migraine. A review of the literature on treatments for migraine concluded that "botulinum toxin A ha[s] recently been suggested to be effective [for treatment of migraine]; however, at present, there are insufficient rigorous and reliable controlled data on these drugs for them to be indicated for such use" (Krymchantowski, et al., 2002). A structured evidence review by the BlueCross BlueShield Technology Evaluation Center (2002) concluded “The available evidence does not permit conclusions regarding the prophylactic or abortive effect of [botulinum toxin A] or any other botulinum toxin type on chronic primary headache syndromes”, including migraine, chronic tension, and cluster headache syndromes.

Botox has been shown to reduce muscle tone and increase range of movement in upper extremity spasticity or in spastic foot drop after stroke. However, whether this translates into functional improvement has yet to be substantiated.

The value of Botox in treating conditions other than those listed above is under investigation.

If concomitant neuromuscular disorders, such as myasthenia gravis and certain myopathies exist, Botox may be harmful. Thus, diagnosis is crucial before undertaking botulinum toxin Type A injections.

Botox is not indicated in patients receiving aminoglycosides, which may interfere with neuromuscular transmission.

Botulinum toxin type B (Myobloc) was approved by the Food and Drug Administration for symptomatic treatment of patients with cervical dystonia (i.e., spasmodic torticollis) to reduce the severity of abnormal head position and neck associated with cervical dystonia. Botulinum toxin type B is antigenically distinct and has a different mechanism of action than botulinum toxin type A. The U.S. Pharmacopeial Convention (2004) has stated that treatment spasticity caused by stroke or brain injury is an accepted off-label indication for botulinum toxin type B.

Both Botox and Myobloc are neurotoxins produced by fermentation of the bacterium Clostridium botulinum. They interfere with neuromuscular transmission, temporarily paralyzing the affected muscle. Clostridium botulinum is a gram-positive, spore-forming obligate anaerobe that is widely distributed in nature and frequently found in soil, marine environments, and agricultural products. Each strain produces one of eight antigenically distinct toxins designated A through H. Human disease is caused by types A, B, E, and (rarely) F. After repeated use of high doses, antibodies can develop in some individuals, making further treatment ineffective indefinitely. Because of Myobloc’s unique mechanism of action and antigenicity, Myobloc may be effective in patients with cervical dystonia who have developed antibodies to or who have not responded to Botox.

A number of studies have evaluated the effectiveness of botulinum toxin type A in the treatment of back and neck pain, and the manufacturer is planning on pursuing FDA approval of botulinum toxin for this indication. Two small double blind studies (Foster, et al., 2000; Foster, et al., 2001) of botulinum toxin for back pain have been published, one involving 28 patients, and another involving 31 patients. However, both of these studies were small and from a single investigator, raising questions about the generalization of the findings. In addition, both of the studies were short term, with no comparisons to other treatments for back pain. Thus, there is currently insufficient scientific evidence of the effectiveness of botulinum toxin in the treatment of back pain.

According to a systematic review of the evidence for botulinum toxin for essential tremor (Ferreira & Sampaio, 2003), there is evidence of short-term reduction of tremor but no consistent improvement in disability and function. The review noted that botulinum toxin injections cause hand weakness, resulting in a "trade off" between benefits and harms. The review concluded that "RCTs [randomized controlled clinical trials] comparing botulinum A toxin-hemagglutinin complex versus placebo found short term improvement of clinical rating scales, but no consistent improvement of motor task performance or functional disability. Hand weakness, which is dose dependent and transient, is a frequent adverse effect."

The evidence of botulinum toxin in the treatment of piriformis syndrome is limited to a small, controlled short-term study and a small pilot cross-over study reporting on the impact of botulinum toxin on pain, but not on disability and function (Fishman, et al., 2002; Childers, et al, 2002). In addition, the placebo-controlled study had a significant drop-out rate. The existence of piriformis syndrome as a clinical entity is controversial (NHS, 2002).

 

Multiple trials have evaluated the effectiveness of injections of OnabotulinumtoxinA into the bladder in treatment of overactive bladder (detrusor instability), whether idiopathic or neurogenic in origin.  These studies have consistently shown improvement in quality of life measures and in episodes of incontinence over periods up to 24 weeks. 


Reference

1)    Kalra HK, Magoon EH. Side effects of the use of botulinum toxin for treatment of benign essential Blepharospasm and hemifacial spasm. Ophthalmic Surg. 1990; 21(5):335-338.

2)    Hayes: Botulinum Toxin Treatment for Headache; November 2003.

3)    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; 341:65-69.

4)    Schulte-Mattler WJ, Wieser T, Zierz S. Treatment of tension-type headache with botulinum toxin: A pilot study. Eur J Med Res. 1999; 4(5):183-186.

5)    Sedano MJ, Trejo JM, Macarron JL, et al. Continuous facial Myokymia in multiple sclerosis: Treatment with botulinum toxin. Eur Neurol. 2000; 43(3):137-140.

6)    U.S. Food and Drug Administration. Botulinum Toxin Type B, Elan Pharmaceuticals. Center for Biologics and Evaluation. Product Approval Information web site: Available at: http://www.fda.gov/cber/label/botelan120800lb.pdf.

7)    No authors listed. Botulinum toxin for migraine prevention. Bandolier. 2001; 94-95. Available at: http://www.jr2.ox.ac.uk/bandolier/band94/b94-5.html.

8)    No authors listed. What is the evidence for botulinum toxin for migraine? ATTRACT Database. Gwent, Wales, UK: National Health Service; November 27, 2002. Available at: http://www.attract.wales.nhs.uk/question_answers.cfm?question_id=1029

9)    Brashear A, McAfee AL, Kuhn ER, Ambrosius WT. Treatment with botulinum toxin type B for upper-limb spasticity. Arch Phys Med Rehabil. 2003; 84(1):103-107.

10)   BlueCross BlueShield Association (BCBSA), Technology Evaluation Center (TEC). Botulinum toxin for treatment of primary chronic headache disorders. TEC Assessment Program. Chicago IL: BCBSA; December 2002; 17(6).

11)   Hayes Medical Technology Directory.  Botulinum toxin treatment for detrusor instability.      Accessed online 05-14-2014.

12)   Fowler CJ, et al. OnabotulinumtoxinA improves health-related quality of life in patients with urinary incontinence due to idiopathic overactive bladder:  a 36-week, couble-blind, placebo-controlled, randomized, dost-ranging trial.  Eur Uro 62 (2012):148-157

13)   Dmochowski R, et al.  Efficacy and safety of OnabotulinumtoxinA for idiopathic overactive bladder:  a double-blind, placebo controlled, randomized, dose ranging trial.  J Uro 2010; 184:2416-2422

14)   Nitti VW, et al.  OnabotulinumtoxinA for the treatment of patients with overactive bladder and urinary incontinence: results of a phase 3, randomized, placebo controlled trial.  J Uro 2013; 189:2186-2193.

15)   Chapple C, et al.  OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomized, double-blind, placebo-controlled trial.  Eur Uro 2013; 64:249-256.

16) Gromley, E A, et al. Diagnosis and Treatment of Non-Neurogenic Overactive Bladder (OAB) in Adults: AUA/SUFU Guideline 2014. Accessed at: https://www.auanet.org/guidelines/overactive-bladder-(oab)-(aua/sufu-guideline-2012-amended-2014)

17) Dodick DW, et al. OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, placebo-controlled phases of the PREEMPT clinical program. Headache. 2010; 50:921-936.

18)  Diener HC, et al. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, placebo-controlled phase of the PREEMPT 2 trial.  Cephalgia. 2010; 30:804-814.


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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