Chemodenervation with Botulinum Toxin

Policy ID: I-11-042

Section: Injections

Effective Date: May 01, 2019

Revised Date: May 11, 2021

Revision Effective Date: July 01, 2021

Last Reviewed: May 20, 2021

Description

Chemodenervations (i.e., botulinum toxin injections) are intramuscular injections of neurotoxins.The toxin acts by blocking release of acetylcholine at the neuromuscular junction thus reducing the tone of overactive muscles. There are several commercial products (consisting of either serotype-A or serotype-B) currently available for use. Each differs in its unit potency, side effects, and duration of action. The clinical goals for utilizing neurotoxin injections are to result in a temporary chemodenervation of the effected muscle at the neuromuscular junction thus: reducing pain or increasing comfort, improving function, preventing or treating musculoskeletal complications, facilitating ease of care, and/or for improving the general appearance, mobility and/or phonation in patients presenting with spasticity or dystonia.

Criteria

OnabotulinumtoxinA (Botox^®) may be considered medically necessary when used in the treatment of ANY of the following conditions:

Blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in individuals 12 years of age or older characterized by intermittent or sustained closure of the eyelids caused by involuntary contractions of the orbicularis oculi muscle; or
Dystonia, cervical also known as spasmodic torticollis in individuals age 16 years of age or older to reduce the associated severity of abnormal head position and neck pain, associated with sustained head tilt or abnormal posturing with limited range of motion in the neck and a history of recurrent involuntary contraction of one or more of the muscles of the neck (e.g. sternocleidomastoid, splenius, trapezius or posterior cervical muscles); or
Chronic migraine prevention in individuals 18 years of age or older.
- An initial trial (up to four injection treatments in a 12-month period) may be considered medically necessary when ALL of the following criteria are met:
  - Prescribed by or in consultation with a neurologist or headache specialist; and
  - A healthcare provider trained in administration of onabotulinumtoxinA (Botox) is administering the drug; and
  - A diagnosis of chronic migraine headache defined as greater than or equal to 15 days per month for greater than 3 months with features of migraine headache on at least 8 days per month lasting four hours a day or longer [e.g. has been established using the International Classification of Headache Disorders, Third Edition (ICHD-III)]; and
  - There is a persistent three (3) month history of recurring debilitating headaches as defined above and documented by a headache diary; and
  - The headaches are not caused by medication rebound (the individual is not taking narcotics or triptans exceeding more than 18 doses per month) or lifestyle issues (e.g., sleep patterns, caffeine use, etc.); and
  - Adequate trials of prophylactic therapy from at least two (2) different therapy classes (e.g., antiseizure, beta blockers, tricyclic antidepressants) were either not effective or not tolerated. Documentation of trials and failure should include that these medications have been prescribed at adequate doses and for a reasonable length of time (i.e., six weeks each); and
  - The individual will not use onabotulinumtoxinA (Botox) in combination with a prophylactic calcitonin gene-related peptide (CGRP) agent; or
Chronic migraine continued treatment (up to four injection treatments in a 12-month period) may be considered medically necessary when BOTH of the following criteria are met:
- The individual is not using onabotulinumtoxinA (Botox) in combination with a prophylactic calcitonin gene-related peptide (CGRP) agent; and
- The prescriber has provided documentation that the individual has demonstrated a reduction in monthly migraine frequency since starting therapy with onabotulinumtoxinA (Botox); or
Urinary incontinence due to detrusor overactivity, due to neurologic condition (e.g., spinal cord injury, multiple sclerosis), that has an inadequate response to or intolerant to conservative therapy (e.g., moderation of fluid intake, avoidance of alcohol, caffeine, and medications such as diuretics, control of chronic cough and constipation, smoking cessation, etc.) and medical therapy with an anticholinergic medication; or
Spasticity lower limb in individuals 18 years of age or older to decrease the severity of increased muscle tone in ankle and toe flexors (gastrocnemius, soleus, tibialis posterior, flexor halluces longus, and flexor digitorum longus); or
Spasticity, lower limb in individuals 2 to 17 years of age, excluding spasticity caused by cerebral palsy; or
Overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in individuals 18 years of age or older who have inadequate response to or intolerant of an anticholinergic medication; or
Strabismus associated with dystonia, including benign essential blepharospasm or VII nerve disorders in individuals greater or equal to 12 years of age; or
Spasticity, upper limb in individuals 18 years of age or older, to decrease the severity of increased muscle tone in elbow flexors (biceps), wrist flexors (flexor carpi radialis and flexor carpi ulnaris), finger flexors (flexor digitorum profundus and flexor digitorum sublimis) and thumb flexors (adductor pollicis and flexor pollicis longus); or
Spasticity, upper limb in individual two (2) to 17 years of age.
Neurogenic detrusor overactivity (NDO) in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication.

All other uses of onabotulinumtoxinA (Botox) are not medically necessary.

Injections performed on a more frequent basis than FDA-approved guidelines may be considered not medically necessary.

The use of electrical muscle stimulation or needle electromyography may be considered medically necessary for guidance in conjunction with chemodenervation.

The use of chemodenervation is considered not medically necessary for cosmetic purposes as well as all other indications.

Procedure Codes

52287	53899	64611	64612	64613	64614	64615
64616	64617	64642	64643	64644	64645	64646
64647	64999	67345	92265	95867	95873	95874
J0585

OnabotulinumtoxinA (Botox) and other medically accepted non-FDA approved indications, Class IIB or higher grade recommendation.

OnabotulinumtoxinA (Botox) may be considered medically necessary for the following medically accepted non-FDA approved indications when used in the treatment of ANY of the following conditions:

Anal fissure (chronic) in adult individuals; or
Anismus related to pelvic floor dyssynergia in adult individuals who are refractory to biofeedback training, for a maximum of three (3) treatments during a three (3) month period; or
Auriculotemporal syndrome in adults to reduce severe symptoms including food-induced facial flushing and sweating or gustatory hyperhidrosis post-parotidectomy (e.g., Frey syndrome; or
Benign prostatic hyperplasia in adults who no longer respond to medication and refuse surgical treatment with moderate to severe symptoms of urinary obstruction based on the American Urological Association (AUA) index, mean peak urinary flow rate less than 15 mL/sec with voided volume of at least 150 mL, and an enlarged prostate gland; or
Cerebral palsy in individuals with upper and lower limb spasticity; or
Detrusor and sphincter dyssynergia in adults due to multiple sclerosis; or
Disorders of esophagus – dysphagia in adult individuals due to esophageal motility disorder or nonachalasia esophageal motility disorder (i.e., diffuse esophageal spasm, nonspecific esophageal motility disorders, and lower esophageal sphincter dysfunction); or
Dysphagia in adult individuals due to cricopharyngeus muscle spasm or pure upper esophageal sphincter dysfunction; or
Esotropia, congenital in pediatric individuals age 7 months or younger; or
Epicondylitis (e.g. tennis elbow) in adult individuals who did not respond to conventional treatment; or
Epiphora, functional (e.g. excessive tear production) in adult individuals; or
Esophageal achalasia (failure in relaxation of the lower esophageal sphincter with swallowing and by a lack of esophageal peristalsis) in individuals 18 years of age or older who have not responded to dilation therapy or who are considered poor surgical candidates; or
Exotropia of third nerve palsy – Acute Injury to oculomotor nerve in adult individuals; or
Focal spasticity in pediatric individuals age 2 to 17 years of age with cerebral palsy and concurrent equinus gait (tiptoeing); or
Granuloma of the vocal cords in adult individuals refractory to conventional surgical and medical therapies; or
Hand tremors, severe in adult individuals due to Parkinson disease or essential tremor; or
Headache, cervicogenic (whiplash headache) in adult individuals with chronic headache, unrelieved by other therapies, secondary to a cervical whiplash injury which restricts range of motion in the neck; or
Hemifacial spasms (7th cranial nerve palsy) in adult individuals when failure of oral pharmacological therapies such as carbamazepine, baclofen and benzodiazepine; or
Idiopathic trigeminal neuralgia in adult individuals refractory to three (3) to six (6) months of treatment with antiepileptic medications; or
Laryngeal spasm (laryngeal dystonia or spasmodic dysphonia) in adult individuals; or
Larynx closure as an adjunct to surgical treatment in adult individuals; or
Myofascial pain syndrome in adult individuals with fibromyalgia; or
Oro-facial-lingual-masticatory tardive dyskinesia due to dopamine blocking agents in adult individuals; or
Oromandibular dystonia, Isolated in adult individuals refractory to optimal pharmacological therapy, surgery, or both; or
Pharyngoesophageal segment spasm following total laryngectomy in adult individuals as an adjunct to voice therapy program; or
Stuttering in adult individuals; or
Sialorrhea (excessive salivation, drooling) in adult individuals with amyotrophic lateral sclerosis (ALS) or bulbar ALS; or
Sialorrhea (excessive salivation, drooling) in pediatric (2 to 17 years of age) and adult individuals who are neurologically impaired; or
Sialorrhea (excessive salivation, drooling) in pediatric individuals 2 to 17 years of age with cerebral palsy; or
Sialorrhea (drooling or excessive salivation) in adult individuals with functional impairment originating from spasticity or dystonia (conditions of involuntary sustained muscle contraction) resulting from Parkinson disease who have been refractory to pharmacotherapy (including anticholinergics, such as but not limited to scopolamine); or
Temporomandibular joint disorder, chronic in adult individuals; or
Thoracic outlet syndrome in adult individuals unresponsive to physical therapy and sub optimally managed with anesthetic and steroid injections; or
Tics and associated premonitory symptoms from Gilles de la Tourette’s syndrome in adult individuals; or
Whiplash injury to neck in adult individuals with chronic whiplash-associated neck pain following a motor vehicle accident; or
Voice failure after tracheoesophageal puncture and prosthesis placements after total laryngectomy in adult individuals (this is due to persistent focal constrictor hypertonicity/spasm); or
Voice tremor, essential (organic) in adult individuals.

Note: Adult individual is defined as individuals 18 years of age or older.

All other uses of onabotulinumtoxinA (Botox) are considered not medically necessary.

Procedure Codes

46505	64611	64616	64617	95873	95874	J0585
S2340	S2341

AbobotulinumtoxinA (Dysport^™) may be considered medically necessary for the following FDA approved conditions:

Dystonia, cervical (also known as spasmodic torticollis) in individuals 18 years of age or older; or
Spasticity, upper and lower limb in individuals 2 years of age or older.

All other uses of abobotulinumtoxinA (Dysport) are considered not medically necessary.

Procedure Codes

64615	64616	64642	64643	64644	64645	95873
95874	J0586

IncobotulinumtoxinA (Xeomin^®) may be considered medically necessary for individuals for the treatment of:

Dystonia, cervical (also known as spasmodic torticollis) associated with sustained head tilt or abnormal posturing with limited range of motion in the neck and a history of recurrent involuntary contraction of one or more of the muscles of the neck (e.g. sternocleidomastoid, splenius, trapezius or posterior cervical muscles), to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naive and previously treated individuals 18 years of age or older; or
Blepharospasm characterized by intermittent or sustained closure of the eyelids caused by involuntary contractions of the orbicularis oculi muscle or facial nerve (VII) disorders including hemifacial spasm in individuals 18 years of age or older; or
Spasticity, upper limb, in individuals 18 years of age or older, to decrease the severity of increased muscle tone in elbow flexors, forearm pronators, wrist flexors, thumb, and finger flexors; or
Spasticity, upper limb, in pediatric individuals 2 to 17 years of age, excluding spasticity caused by cerebral palsy; or
Sialorrhea, chronic due to Parkinson’s disease, atypical parkinsonism, stroke, or traumatic brain injury, with at least a three (3) month history of sialorrhea.

All other uses of incobotulinumtoxinA (Xeomin) are considered not medically necessary.

Procedure Codes

64612	64616	64642	64643	64644	64645	95873
95874	J0588

RimabotulinumtoxinB (Myobloc^®) may be considered medically necessary for individuals 18 years of age or older for the treatment of:

Dystonia, cervical (also known as spasmodic torticollis) in individuals 18 years of age or older with a history of recurrent involuntary contraction of one or more of the muscles of the neck (e.g. sternocleidomastoid, splenius, trapezius or posterior cervical muscles); or
Sialorrhea, chronic in individuals 18 years of age or older associated with Parkinson’s disease, ALS, stroke, and other causes with at least a three (3) month history of troublesome sialorrhea refractory to pharmacotherapy (including anticholinergics such as but not limited to scopolamine).

All other uses of rimabotulinumtoxinB (Myobloc) are considered not medically necessary.

Procedure Codes

64611

64616

95873

95874

J0587

Note: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

Covered Diagnosis codes for J0585 when billed with: 46505, 52287, 53899, 64611, 64612, 64615, 64616, 64617, 64642, 64643, 64644, 64645, 64646, 64647, 64999, 67345, 92265, 95873, 95874, S2340, S2341

F80.81	F95.2	F98.5	G04.1	G11.4	G20	G24.01
G24.02	G24.09	G24.1	G24.2	G24.3	G24.4	G24.5
G24.8	G24.9	G25.0	G25.3	G25.89	G35	G36.0
G36.8	G37.0	G37.1	G37.2	G37.4	G37.5	G37.8
G37.9	G43.011	G43.019	G43.111	G43.119	G43.701	G43.709
G43.711	G43.719	G44.301	G50.0	G50.8	G51.0	G51.1
G51.2	G51.31	G51.32	G51.33	G51.39	G51.4	G51.8
G54.0	G56.81	G56.82	G56.83	G57.81	G57.82	G57.83
G80.0	G80.1	G80.2	G80.3	G80.4	G80.8	G80.9
G81.11	G81.12	G81.13	G81.14	G82.20	G82.21	G82.22
G82.50	G82.51	G82.52	G82.53	G82.54	G83.0	G83.10
G83.11	G83.12	G83.13	G83.14	G83.21	G83.22	G83.23
G83.24	G83.31	G83.32	G83.33	G83.34	G83.4	H04.211
H04.212	H04.213	H04.219	H49.00	H49.01	H49.02	H49.03
H49.11	H49.12	H49.13	H49.21	H49.22	H49.23	H49.31
H49.32	H49.33	H49.41	H49.42	H49.43	H49.881	H49.882
H49.883	H50.00	H50.011	H50.012	H50.021	H50.022	H50.031
H50.032	H50.041	H50.042	H50.05	H50.06	H50.07	H50.08
H50.10	H50.111	H50.112	H50.121	H50.122	H50.131	H50.132
H50.141	H50.142	H50.15	H50.16	H50.17	H50.18	H50.21
H50.22	H50.30	H50.311	H50.312	H50.32	H50.331	H50.332
H50.34	H50.40	H50.411	H50.412	H50.43	H50.50	H50.51
H50.52	H50.53	H50.60	H50.611	H50.612	H50.69	H50.89
I69.031	I69.032	I69.033	I69.034	I69.041	I69.042	I69.043
I69.044	I69.049	I69.051	I69.052	I69.053	I69.054	I69.061
I69.062	I69.063	I69.064	I69.065	I69.131	I69.132	I69.133
I69.134	I69.141	I69.142	I69.143	I69.144	I69.149	I69.151
I69.152	I69.153	I69.154	I69.161	I69.162	I69.163	I69.164
I69.165	I69.231	I69.232	I69.233	I69.234	I69.241	I69.242
I69.243	I69.244	I69.251	I69.252	I69.253	I69.254	I69.261
I69.262	I69.263	I69.264	I69.265	I69.331	I69.332	I69.333
I69.334	I69.341	I69.342	I69.343	I69.344	I69.349	I69.351
I69.352	I69.353	I69.354	I69.361	I69.362	I69.363	I69.364
I69.365	I69.831	I69.832	I69.833	I69.834	I69.841	I69.842
I69.843	I69.844	I69.849	I69.851	I69.852	I69.853	I69.854
I69.861	I69.862	I69.863	I69.864	I69.865	I69.869	I69.931
I69.932	I69.933	I69.934	I69.941	I69.942	I69.943	I69.944
I69.949	I69.951	I69.952	I69.953	I69.954	I69.961	I69.962
I69.963	I69.964	I69.965	J38.3	J38.5	J38.7	J39.2
K11.7	K22.0	K22.4	K60.2	L74.511	M26.601	M26.602
M26.603	M26.609	M26.69	M43.6	M77.10	M77.11	M77.12
M79.18	N31.0	N31.1	N31.8	N31.9	N32.81	N36.5
N39.3	N39.41	N39.43	N39.44	N39.45	N39.46	N39.498
N40.1	R13.13	R13.14	R25.0	R25.1	R25.2	R25.3
R25.8	R25.9	R32	R49.0	R49.8	S13.4XXA	S13.4XXD
S13.4XXS

Covered Diagnosis codes for J0586 when billed with: 64615, 64616, 64642, 64643, 64644, 64645, 95873, 95874

G11.4	G24.3	G25.89	G80.0	G80.1	G80.2	G80.8
G80.9	G81.10	G81.11	G81.12	G81.13	G81.14	G82.20
G82.21	G82.22	G82.50	G82.51	G82.52	G82.53	G82.54
G83.0	G83.10	G83.11	G83.12	G83.13	G83.14	G83.20
G83.21	G83.22	G83.23	G83.24	G83.31	G83.32	G83.33
G83.34	I69.031	I69.032	I69.033	I69.034	I69.039	I69.041
I69.042	I69.043	I69.044	I69.051	I69.052	I69.053	I69.054
I69.059	I69.061	I69.062	I69.063	I69.064	I69.065	I69.131
I69.132	I69.133	I69.134	I69.139	I69.141	I69.142	I69.143
I69.144	I69.151	I69.152	I69.153	I69.154	I69.161	I69.162
I69.163	I69.164	I69.165	I69.231	I69.232	I69.233	I69.234
I69.239	I69.241	I69.242	I69.243	I69.244	I69.251	I69.252
I69.253	I69.254	I69.259	I69.261	I69.262	I69.263	I69.264
I69.265	I69.331	I69.332	I69.333	I69.334	I69.339	I69.341
I69.342	I69.343	I69.344	I69.351	I69.352	I69.353	I69.354
I69.359	I69.361	I69.362	I69.363	I69.364	I69.365	I69.831
I69.832	I69.833	I69.834	I69.839	I69.841	I69.842	I69.843
I69.844	I69.851	I69.852	I69.853	I69.854	I69.859	I69.861
I69.862	I69.863	I69.864	I69.865	I69.931	I69.932	I69.933
I69.934	I69.939	I69.941	I69.942	I69.943	I69.944	I69.951
I69.952	I69.953	I69.954	I69.959	I69.961	I69.962	I69.963
I69.964	I69.965	R25.2

Covered Diagnosis codes for J0587 when billed with: 64611, 64616, 95873, 95874

G24.3

K11.7

Covered Diagnosis codes for J0588 when billed with: 64612, 64616, 64642, 64643, 64644, 64645, 95873, 95874

G24.3	G24.5	G56.81	G56.82	G56.83	G80.0	G80.1
G80.2	G80.3	G80.4	G80.8	G80.9	G81.11	G81.12
G81.13	G81.14	G83.21	G83.22	G83.23	G83.24	K11.7
R25.2

Professional Statements and Societal Positions Guidelines

American Academy of Neurology (AAN). Practice Guideline Summary: Botulinum Neurotoxin for the Treatment of Blepharospasm, Cervical Dystonia, Adult Spasticity, and Headache. April 2016.

Botulinum neurotoxin should be offered as a treatment option for the treatment of cervical dystonia, blepharospasm, focal upper extremity dystonia, adductor laryngeal dystonia, upper extremity essential tremor, and may be considered for hemifacial spasm and focal lower limb dystonia.

American Urological Association (AUA). Diagnosis and Treatment of Non-Neurogenic Overactive Bladder (OAB) in Adults: an AUA/SUFU Guideline. April 2019.

Intradetrusor onabotulinumtoxinA should be offered as third-line treatment in the carefully-selected and thoroughly-counseled individual who has been refractory to first and second-line OAB treatments. The individual must be able and willing to return for frequent post-void residual evaluation and able and willing to perform self-catheterization if necessary.

ND Committee Review

Internal Medical Policy Committee 1-22-2020 Change from 3 to 2 trials

Internal Medical Policy Committee 3-16-2020 No clinical change, adding J0585, J0586, J0587 and J0588 to the pre-certification list

Internal Medical Policy Committee 5-19-2020 Added additional Xeomin indication; chronic sialorrhea and removed statement previously treated with onabotulinumtoxinA (Botox) for blepharospasm indication

Internal Medical Policy Committee 7-22-2020 Added statement "The individual will/is not use/using OnabotulinumtoxinA (Botox) in combination with a prophylactic calcitonin gene-related peptide (CGRP) agent;" to the migraine criteria portion of the policy effective 7-1-2020, removed six month from migraine initial criteria and revised initial and reauthorization criteria for migraine headaches effective 7-15-2020

Internal Medical Policy Committee 9-21-2020 Changed "Injections performed on a more frequent basis may be considered not medically necessary. In addition, more than four (4) injections per region per year may be considered not medically necessary." to "Injections performed on a more frequent basis than FDA-approved guidelines may be considered not medically necessary. "; added "Upper limb spasticity in pediatric individuals 2 to 17 years of age, excluding spasticity caused by cerebral palsy;" to Xeomin criteria

Internal Medical Policy Committee 1-19-2021 Updated criteria and diagnosis coding

Internal Medical Policy Committee 5-20-2021 Added new indication for J0585 "Neurogenic detrusor overactivity (NDO) in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication"

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-11-040

Section: Injections

Effective Date: May 01, 2019

Revised Date: August 31, 2020

Revision Effective Date: October 01, 2020

Last Reviewed: September 21, 2020

Archived Date: February 28, 2021

Description

Criteria

OnabotulinumtoxinA (Botox^®) may be considered medically necessary when it's used in the treatment of ANY of the following conditions:

Acute dystonia due to drugs; or
Blepharospasm associated with dystonia in individuals greater than or equal to 12 years of age characterized by intermittent or sustained closure of the eyelids caused by involuntary contractions of the orbicularis oculi muscle; or
Cervical dystonia, also known as spasmodic torticollis in adults and pediatric individuals age equal to or greater than 16 years; (applicable whether congenital or due to child birth injury or traumatic injury), associated with sustained head tilt or abnormal posturing with limited range of motion in the neck and a history of recurrent involuntary contraction of one or more of the muscles of the neck (e.g. sternocleidomastoid, splenius, trapezius or posterior cervical muscles); or
Prevention of chronic migraine headaches in adult individuals. Chronic is defined as greater than or equal to 15 days per month for greater than 3 months with features of migraine headache on at least 8 days per month lasting four hours a day or longer.
- An initial trial (up to four injection treatments in a 12-month period) may be considered medically necessary when ALL of the following criteria are met:
  - Prescribed by or in consultation with a neurologist or headache specialist; and
  - A healthcare provider trained in administration of onabotulinumtoxinA (Botox) is administering the drug; and
  - A diagnosis of chronic migraine headache has been established using the International Classification of Headache Disorders, Third Edition (ICHD-III); and
  - There is a persistent three month history of recurring debilitating headaches as defined above and documented by a headache diary; and
  - The headaches are not caused by medication rebound (the individual is not taking narcotics or triptans exceeding more than 18 doses per month) or lifestyle issues (e.g., sleep patterns, caffeine use, etc.); and
  - Adequate trials of prophylactic therapy from at least two (2) different therapy classes (e.g., antiseizure, beta blockers, tricyclic antidepressants) were either not effective or not tolerated. Documentation of trials and failure should include that these medications have been prescribed at adequate doses and for a reasonable length of time (i.e., six weeks each); and
  - The individual will not use onabotulinumtoxinA (Botox) in combination with a prophylactic calcitonin gene-related peptide (CGRP) agent; or
- Continued treatment (up to four injection treatments in a 12-month period) may be considered medically necessary when BOTH of the following criteria are met:
  - The individual is not using onabotulinumtoxinA (Botox) in combination with a prophylactic calcitonin gene-related peptide (CGRP) agent; and
  - The prescriber has provided documentation that the individual has demonstrated a reduction in monthly migraine frequency since starting therapy with onabotulinumtoxinA (Botox); or
Demyelinating disease of central nervous system, unspecified; or
Diplegia of upper limbs; or
Focal upper-limb dystonia ( e.g., organic writer's cramp) when documentation that abnormal muscle tone is causing persistent pain and/or interfering with functional ability; or
Hemifacial spasms (7th cranial nerve palsy) in the adult individual when failure of oral pharmacological therapies such as carbamazepine, baclofen and benzodiazepine; or
Hereditary spastic paraplegia; or
Idiopathic torsion dystonia; or
Incontinence due to detrusor over reactivity (urge incontinence), either idiopathic or due to neurogenic causes (e.g., spinal cord injury, multiple sclerosis), that is refractory to second line treatment, (e.g. antimuscarinics/anticholinergics); or
Late effects of cerebrovascular disease; or
Lower limb spasticity in adult individuals indicated to decrease the severity of increased muscle tone in ankle and toe flexors; or
Monoplegia of lower limb; or
Monoplegia of upper limb; or
Multiple sclerosis; or
Neuromyelitis optica; or
Orofacial dyskinesia; or
Other acquired torsion dystonia; or
Other demyelinating diseases of central nervous system; or
Overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency that is refractory to second line treatment, (e.g. antimuscarinics/anticholinergics); or
Paraplegia; or
Quadriplegia and quadriparesis; or
Schilder's disease; or
Sequela of spinal cord or traumatic brain injury (e.g. spasticity, intractable headache, etc); or
Spastic hemiplegia; or
Strabismus in individuals greater or equal to 12 years of age; or
Subacute dyskinesia due to drugs; or
Upper limb spasticity in adult individuals, to decrease the severity of increased muscle tone in elbow flexors, wrist flexors, finger flexors and thumb flexors; or
Unspecified monoplegia.

All other uses of onabotulinumtoxinA (Botox) are not medically necessary.

Injections performed on a more frequent basis than FDA-approved guidelines may be considered not medically necessary.

The use of electrical muscle stimulation or needle electromyography may be considered medically necessary for guidance in conjunction with chemodenervation.

The use of chemodenervation is considered not medically necessary for cosmetic purposes as well as all other indications.

Procedure Codes

52287	53899	64611	64612	64613	64614	64615
64616	64617	64642	64643	64644	64645	64646
64647	64999	67345	92265	95867	95873	95874
J0585

OnabotulinumtoxinA (Botox) and other medically accepted non-FDA approved indications, Class IIB or higher grade recommendation.

OnabotulinumtoxinA (Botox) may be considered medically necessary for the following medically accepted non-FDA approved indications when it's used in the treatment of ANY of the following conditions:

Anal fissure (chronic); or
Cerebral palsy with spasticity; or
Esophageal achalasia: in individuals who have not responded to dilation therapy or who are considered poor surgical candidates; or
Laryngeal spasm; or
Sialorrhea (drooling) in individuals with functional impairment originating from spasticity or dystonia (conditions of involuntary sustained muscle contraction) resulting from Parkinson disease who have been refractory to pharmacotherapy (including anticholinergics, such as but not limited to scopolamine); or
Spasmodic dysphonia in the adult individual.

All other uses of onabotulinumtoxinA (Botox) are considered not medically necessary.

Procedure Codes

46505	64611	64616	64617	95873	95874	J0585
S2340	S2341

AbobotulinumtoxinA (Dysport^™) may be considered medically necessary for the following FDA approved conditions:

Cervical dystonia spasmodic torticollis in adult individuals; or
Spasticity in adult individuals (upper and lower limb); or
Lower limb spasticity in pediatric individuals 2 years of age and older

All other uses of abobotulinumtoxinA (Dysport) are considered not medically necessary.

Procedure Codes

64615	64616	64642	64643	64644	64645	95873
95874	J0586

IncobotulinumtoxinA (Xeomin^®) may be considered medically necessary for individuals for the treatment of:

Adult individuals with cervical dystonia, also known as spasmodic torticollis associated with sustained head tilt or abnormal posturing with limited range of motion in the neck and a history of recurrent involuntary contraction of one or more of the muscles of the neck (e.g. sternocleidomastoid, splenius, trapezius or posterior cervical muscles), to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naive and previously treated individuals; or
Blepharospasm characterized by intermittent or sustained closure of the eyelids caused by involuntary contractions of the orbicularis oculi muscle or facial nerve (VII) disorders including hemifacial spasm in adult individuals; or
Upper limb spasticity in adult individuals, to decrease the severity of increased muscle tone in elbow flexors, forearm pronators, wrist flexors, thumb, and finger flexors; or
Upper limb spasticity in pediatric individuals 2 to 17 years of age, excluding spasticity caused by cerebral palsy; or
Chronic sialorrhea (excessive secretion of saliva, drooling) in adult individuals with functional impairment originating from spasticity or dystonia (conditions of involuntary sustained muscle contraction) resulting from Parkinson's disease, atypical Parkinsonism, stroke, or traumatic brain injury who have been refractory to pharmacotherapy (including anticholinergics, such as but not limited to scopolamine).

All other uses of incobotulinumtoxinA (Xeomin) are considered not medically necessary.

Procedure Codes

64612	64616	64642	64643	64644	64645	95873
95874	J0588

RimabotulinumtoxinB (Myobloc^®) may be considered medically necessary for adult individuals for the treatment of:

Adult individuals with cervical dystonia, also known as spasmodic torticollis a neurological movement disorder associated with sustained head tilt or abnormal posturing with limited range of motion in the neck and a history of recurrent involuntary contraction of one or more of the muscles of the neck (e.g. sternocleidomastoid, splenius, trapezius or posterior cervical muscles).

All other uses of rimabotulinumtoxinB (Myobloc) are considered not medically necessary.

RimabotulinumtoxinB (Myobloc) for other medically accepted non-FDA approved indications, Class IIB or higher grade recommendation.

RimabotulinumtoxinB (MYOBLOC®) may be considered medically necessary for adult individuals for the treatment of:

Ptyalism/sialorrhea (excessive secretion of saliva, drooling) that is associated with advancedParkinson’s disease; and
Refractory to pharmacotherapy (including anticholinergics such as but not limited to scopolamine).

All other uses of rimabotulinumtoxinB (Myobloc) are considered not medically necessary.

Procedure Codes

64611

64616

95873

95874

J0587

Diagnosis Codes

G04.1	G11.4	G20	G24.1	G24.2	G24.3	G24.4
G24.5	G24.8	G24.01	G24.02	G24.09	G25.89	G35
G36.0	G36.8	G37.0	G37.1	G37.2	G37.4	G37.5
G37.8	G37.9	G43.011	G43.019	G43.111	G43.119	G43.701
G43.709	G43.711	G43.719	G51.0	G51.1	G51.2	G51.31
G51.32	G51.33	G51.39	G51.4	G51.8	G56.81	G56.82
G56.83	G57.81	G57.82	G57.83	G80.0	G80.1	G80.2
G80.3	G80.4	G80.8	G80.9	G81.11	G81.12	G81.13
G81.14	G82.20	G82.21	G82.22	G82.50	G82.51	G82.52
G82.53	G82.54	G83.0	G83.4	G83.11	G83.12	G83.13
G83.14	G83.21	G83.22	G83.23	G83.24	G83.31	G83.32
G83.33	G83.34	H49.01	H49.02	H49.03	H49.11	H49.12
H49.13	H49.21	H49.22	H49.23	H49.31	H49.32	H49.33
H49.41	H49.42	H49.43	H49.881	H49.882	H49.883	H50.21
H50.22	H50.30	H50.40	H50.50	H50.51	H50.52	H50.53
H50.60	H50.69	H50.89	H50.011	H50.012	H50.111	H50.112
H50.411	H50.412	H50.611	H50.612	I69.031	I69.032	I69.033
I69.034	I69.041	I69.042	I69.043	I69.044	I69.051	I69.052
I69.053	I69.054	I69.061	I69.062	I69.063	I69.064	I69.065
I69.131	I69.132	I69.133	I69.134	I69.141	I69.142	I69.143
I69.144	I69.151	I69.152	I69.153	I69.154	I69.161	I69.162
I69.163	I69.164	I69.165	I69.231	I69.232	I69.233	I69.234
I69.241	I69.242	I69.243	I69.244	I69.251	I69.252	I69.253
I69.254	I69.261	I69.262	I69.263	I69.264	I69.265	I69.331
I69.332	I69.333	I69.334	I69.341	I69.342	I69.343	I69.344
I69.351	I69.352	I69.353	I69.354	I69.361	I69.362	I69.363
I69.364	I69.365	I69.831	I69.832	I69.833	I69.834	I69.841
I69.842	I69.843	I69.844	I69.851	I69.852	I69.853	I69.854
I69.861	I69.862	I69.863	I69.864	I69.865	I69.931	I69.932
I69.933	I69.934	I69.941	I69.942	I69.943	I69.944	I69.951
I69.952	I69.953	I69.954	I69.961	I69.962	I69.963	I69.964
I69.965	J38.5	J38.7	K11.7	K22.0	K60.1	M43.6
N31.0	N31.1	N31.8	N31.9	N32.81	N39.3	N39.41
N39.43	N39.44	N39.45	N39.46	N39.498	R25.0	R25.1
R25.2	R25.3	R25.8	R25.9	R32	R49.0	R49.8

Covered Diagnosis codes for J0586 when billed with: 64615, 64616, 64642, 64643, 64644, 64645, 95873, 95874

G11.4	G24.01	G24.02	G24.09	G24.1	G24.2	G24.3
G24.8	G25.89	G35	G36.8	G37.8	G37.9	G80.0
G80.1	G80.2	G80.3	G80.4	G80.8	G80.9	G81.11
G81.12	G81.13	G81.14	G82.20	G82.21	G82.22	G82.50
G82.51	G82.52	G82.53	G82.54	G83.0	G83.11	G83.12
G83.13	G83.14	G83.21	G83.22	G83.23	G83.24	G83.31
G83.32	G83.33	G83.34	G83.4	I69.031	I69.032	I69.033
I69.034	I69.041	I69.042	I69.043	I69.044	I69.051	I69.052
I69.053	I69.054	I69.061	I69.062	I69.063	I69.064	I69.065
I69.131	I69.132	I69.133	I69.134	I69.141	I69.142	I69.143
I69.144	I69.151	I69.152	I69.153	I69.154	I69.161	I69.162
I69.163	I69.164	I69.165	I69.231	I69.232	I69.233	I69.234
I69.241	I69.242	I69.243	I69.244	I69.251	I69.252	I69.253
I69.254	I69.261	I69.262	I69.263	I69.264	I69.265	I69.331
I69.332	I69.333	I69.334	I69.341	I69.342	I69.343	I69.344
I69.351	I69.352	I69.353	I69.354	I69.361	I69.362	I69.363
I69.364	I69.365	I69.831	I69.832	I69.833	I69.834	I69.841
I69.842	I69.843	I69.844	I69.851	I69.852	I69.853	I69.854
I69.861	I69.862	I69.863	I69.864	I69.865	I69.931	I69.932
I69.933	I69.934	I69.941	I69.942	I69.943	I69.944	I69.951
I69.952	I69.953	I69.954	I69.961	I69.962	I69.963	I69.964
I69.965	R25.2

Covered Diagnosis codes for J0587 when billed with: 64611, 64616, 95873, 95874

G20

G24.3

K11.7

Covered Diagnosis codes for J0588 when billed with: 64612, 64616, 64642, 64643, 64644, 64645, 95873, 95874

G24.3	G24.5	G56.81	G56.82	G56.83	G80.0	G80.1
G80.2	G80.3	G80.4	G80.8	G80.9	G81.11	G81.12
G81.13	G81.14	G83.21	G83.22	G83.23	G83.24	K11.7
R25.2

Professional Statements and Societal Positions Guidelines

American Academy of Neurology (AAN). Botulinum neurotoxin should be offered as a treatment option for the treatment of cervical dystonia, blepharospasm, focal upper extremity dystonia, adductor laryngeal dystonia, upper extremity essential tremor, and may be considered for hemifacial spasm and focal lower limb dystonia.

American Urological Association (AUA). Intradetrusor onabotulinumtoxinA should be offered as third-line treatment in the carefully-selected and thoroughly-counseled individual who has been refractory to first and second-line OAB treatments. The individual must be able and willing to return for frequent post-void residual evaluation and able and willing to perform self-catheterization if necessary.

ND Committee Review

Internal Medical Policy Committee 1-22-2020 Change from 3 to 2 trials

Internal Medical Policy Committee 3-16-2020 No clinical change, adding J0585, J0586, J0587 and J0588 to the pre-certification list

Links

References (PDF)

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