Chemodenervation with Botulinum Toxin

Policy ID: I-11-043

Section: Injections

Effective Date: May 01, 2019

Revised Date: September 22, 2022

Revision Effective Date: November 01, 2022

Last Reviewed: September 28, 2022

Applies To: Commercial and Medicaid Expansion

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:

Neuromuscular system

Auriculotemporal syndrome in adult individuals to reduce severe symptoms including food-induced facial flushing and sweating or gustatory hyperhidrosis post-parotidectomy (e.g., Frey syndrome); or
Blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in individuals 12 years of age or older; or
Cervical Dystonia (also known as spasmodic torticollis) in individuals 16 years of age or older; or
Chronic migraine prevention in adult individuals 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 three (3) months with features of migraine headache on at least eight (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
- 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 (6) weeks each); and
Epicondylitis (e.g., tennis elbow) in adult individuals who did not respond to conventional treatment; or
Esotropia, congenital in pediatric individuals seven (7) months of age or younger; or
Exotropia of third nerve palsy – Acute Injury to oculomotor nerve in adult individuals; or
Focal spasticity in pediatric individuals two (2) to 17 years of age with cerebral palsy and concurrent equinus gait (tiptoeing); 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; or
Idiopathic trigeminal neuralgia in adult individuals refractory to three (3) to six (6) months of treatment with antiepileptic medications; or
Granuloma of the vocal cords in adult individuals refractory to conventional surgical and medical therapies; 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
Spasticity of upper and lower limbs in individuals two (2) years of age or older, related to ANY of the following conditions:
- Cerebral palsy, including use for treatment of equinus foot deformity; or
- Demyelinating diseases of the central nervous system; or
- Brain or spinal cord injury; or
- Hemiplegia or paraplegia; or
- Multiple sclerosis; or
- Stroke; or
Strabismus associated with dystonia, including benign essential blepharospasm or VII nerve disorders in individuals 12 years of age or older; or
Stuttering in adult individuals; or
Temporomandibular joint disorder, chronic in adult individuals; or
Tics and associated premonitory symptoms from Gilles de la Tourette’s syndrome in adult individuals; 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; or
Whiplash injury to neck in adult individuals with chronic whiplash-associated neck pain following a motor vehicle accident; and

Digestive System

Anal fissure (chronic) in adult individuals for initial authorization of one (1) injection treatment for a three (3) month period; or
Anismus related to pelvic floor dyssynergia in adult individuals who are refractory to biofeedback training, for a maximum of up to three (3) injection treatments for a three (3) month period; or
Disorders of esophagus – dysphagia in adult individuals due to esophageal motility disorder or nonachalasia esophageal motility disorder; or
Dysphagia in adult individuals due to cricopharyngeus muscle spasm or pure upper esophageal sphincter dysfunction; or
Esophageal achalasia (failure in relaxation of the lower esophageal sphincter with swallowing and by a lack of esophageal peristalsis) in adult individuals who have not responded to dilation therapy or who are considered poor surgical candidates for initial authorization of one (1) injection for a three (3) month period; or
Sialorrhea (excessive salivation, drooling) when ALL of the following are met:
- Pediatric individuals two (2) to 17 years of age with cerebral palsy; or
- Individuals two (2) years of age or older who are neurologically impaired; or
- Adult individuals with functional impairment originating from spasticity or dystonia resulting from Parkinson disease; and
- Documented failure or contraindication to pharmacotherapy (including anticholinergics, such as but not limited to scopolamine); or

Integumentary System

Primary focal hyperhidrosis in adult individuals when ALL of the following criteria are met:
- Diagnosis of severe hyperhidrosis in the axillary, palmar, plantar or craniofacial region; and
- History of recurrent skin maceration with bacterial or fungal infections, (including but not limited to cutaneous disorders such as dermatophytosis (ringworm), pitted keratolysis, viral warts at the sites of hyperhidrosis); or
- History of atopic dermatitis (atopic eczema) in spite of medical treatments with topical dermatological or systemic anticholinergic agents; and
- Unresponsive to or unable to tolerate pharmacotherapy modalities prescribed for excessive sweating (including but not limited to anti-cholinergics, beta-blockers, or benzodiazepines); and
- Topical 20% aluminum chloride or other extra strength antiperspirants are ineffective or result in a severe rash; and
- Initial authorization will be for one (1) injection treatment per region for a three (3) month period; or

Urinary system

Benign prostatic hyperplasia in adult individuals 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
Neurogenic detrusor overactivity (NDO) in pediatric individuals five (5) years of age or older who have an inadequate response to or are intolerant of anticholinergic medication; or
Overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in adult individuals who have inadequate response to or intolerant of an anticholinergic medication or beta-3 adrenergic agonist; or
Urinary incontinence due to detrusor overactivity due to neurologic condition (e.g., spinal cord injury, multiple sclerosis) adult individuals, who have an inadequate response to or intolerant of 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 beta-3 adrenergic agonist; or

Initial authorization for ALL criteria above will be for up to four (4) injection treatments per region in a 12-month period unless otherwise specified above.

Reauthorization Criteria

For chronic migraine, continuation of therapy beyond six (6) months may be considered medically necessary when ALL of the following criteria are met:
- Prescriber has provided documentation that the individual has demonstrated a reduction in monthly migraine frequency since starting therapy with onabotulinumtoxinA (Botox); and
- Reauthorization will be for up to four (4) injections treatments for a 12-month period; or

For hyperhidrosis, continuation of therapy beyond three (3) months may be considered medically necessary when ALL of the following criteria are met:
- Documentation of an objective measurable effect indicating positive clinical response (i.e., improvement in hyperhidrosis severity scale); and
- Reauthorization will be for up to four (4) injection treatments per region fora 12-month period; or

For chronic anal fissure and achalasia, continuation of therapy beyond three (3) months may be considered medically necessary when ALL of the following criteria are met:
- Documentation of positive clinical response; and
- Reauthorization will be for one (1) injection treatment for a three (3) month period; or

For all other indications listed above (excluding chronic migraine, chronic anal fissure, and achalasia), continuation of therapy may be considered medically necessary when ALL of the following criteria are met:
- Documentation of positive clinical response; and
- Reauthorization will be for up to four (4) injection treatments per region in a 12-month period.

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

46505

52287

64611

64612

64615

64616

64617

64642

64643

64644

64645

64646

64647

64650

64653

67345

92265

95867

95873

95874

J0585

S2340

S2341

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

Blepharospasm in adult individuals; or
Cervical Dystonia (also known as spasmodic torticollis) in individuals 18 years of age or older; or
Hemifacial spasms (7th cranial nerve palsy) in individuals 18 years of age or older; or
Spasticity of upper and lower limbs in individuals two (2) years of age or older, related to ANY of the following conditions:
- Cerebral palsy, including use for treatment of equinus foot deformity; or
- Demyelinating diseases of the central nervous system; or
- Brain or spinal cord injury; or
- Hemiplegia or paraplegia; or
- Multiple sclerosis; or
- Stroke; or

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

Procedure Codes

64612

64615

64616

64642

64643

64644

64645

95873

95874

J0586

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

Blepharospasm in adult individuals; or
Cervical Dystonia (also known as spasmodic torticollis) in adult individuals
Chronic sialorrhea in individuals two (2) years of age or older when ALL of the following are met:
- Sialorrhea resulting from Parkinson’s disease, atypical parkinsonism, amyotrophic lateral sclerosis (ALS), stroke, or traumatic brain injury; and
- At least a three (3) month history of sialorrhea; and
- Documented failure or contraindication to pharmacotherapy (including anticholinergics, such as but not limited to scopolamine); or
Spasticity of upper and lower limbs in individuals two (2) years of age or older, related to ANY of the following conditions:
- Cerebral palsy, including use for treatment of equinus foot deformity; or
- Demyelinating diseases of the central nervous system; or
- Brain or spinal cord injury; or
- Hemiplegia or paraplegia; or
- Multiple sclerosis; or
- Stroke; or

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 when used in the treatment of ANY of the following conditions:

Cervical Dystonia (also known as spasmodic torticollis) in adult individuals; or
Chronic sialorrhea in adult individuals when ALL of the following are met:
- Sialorrhea resulting from Parkinson’s disease, atypical parkinsonism, ALS, stroke, or traumatic brain injury; and
- At least a three (3) month history of sialorrhea; and
- Documented failure or contraindication to pharmacotherapy (including anticholinergics, such as but not limited to scopolamine); or
Overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in adult individuals who have inadequate response to or intolerant of an anticholinergic medication or beta-3 adrenergic agonist; or

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

Procedure Codes

52287

64611

64616

95873

95874

J0587

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

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, 64611, 64612, 64615, 64616, 64617, 64642, 64643, 64644, 64645, 64646, 64647, 67345, 92265, 95873, 95874, S2340, S2341

F80.81

F95.2

F98.5

G04.1

G11.4

G20

G24.01

G24.09

G24.1

G24.2

G24.3

G24.4

G24.5

G24.8

G24.9

G25.0

G25.89

G35

G36.0

G43.701

G43.709

G43.711

G43.719

G44.86

G50.0

G51.0

G51.1

G51.2

G51.31

G51.32

G51.33

G51.4

G51.8

G80.0

G80.1

G80.2

G80.3

G80.4

G80.8

G80.9

G81.11

G81.12

G81.13

G81.14

G82.21

G82.22

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

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

H50.011

H50.012

H50.021

H50.022

H50.031

H50.032

H50.041

H50.042

H50.05

H50.06

H50.07

H50.08

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

H50.611

H50.612

H50.69

H50.89

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

I69.849

I69.851

I69.852

I69.853

I69.854

I69.931

I69.932

I69.933

I69.934

I69.941

I69.942

I69.943

I69.944

I69.951

I69.952

I69.953

I69.954

J38.3

J38.5

J38.7

K11.7

K22.0

K22.4

K60.1

L74.510

L74.511

L74.512

L74.513

M26.601

M26.602

M26.603

M26.609

M26.69

M77.10

M77.11

M77.12

M79.7

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: 64612, 64615, 64616, 64642, 64643, 64644, 64645, 95873, 95874

G11.4

G24.3

G24.5

G25.89

G51.31

G51.32

G51.33

G80.0

G80.1

G80.2

G80.8

G80.9

G81.11

G81.12

G81.13

G81.14

G82.21

G82.22

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

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: 52287, 64611, 64616, 95873, 95874

G24.3

K11.7

N32.81

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

G24.3

G24.5

G80.0

G80.1

G80.2

G80.3

G80.4

G80.8

G80.9

G81.11

G81.12

G81.13

G81.14

G82.21

G82.22

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

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

K11.7

R25.2

Professional Statements and Societal Positions Guidelines

Not Applicable

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,
Added 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 - Effective July 01, 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
Removed six (6) month from migraine initial criteria and
Revised initial and reauthorization criteria for migraine headaches - Effective July 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 two (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
Updated Diagnosis coding

Internal Medical Policy Committee 5-20-2021

Added new indication for J0585 "Neurogenic detrusor overactivity (NDO) in pediatric individuals five (5) years of age and older who have an inadequate response to or are intolerant of anticholinergic medication"

Internal Medical Policy Committee 9-21-2021

Added Diagnosis code G44.86 to the policy and
Updated with some minor wording changes

Internal Medical Policy Committee 1-20-2022

Removed migraine criteria "The individual will not use onabotulinumtoxinA (Botox) in combination with a prophylactic calcitonin gene-related peptide (CGRP) agent."

Internal Medical Policy Committee 7-21-2022

Updated Criteria and
Updated Diagnosis codes for all botulinum toxins

Internal Medical Policy Committee 9-28-2022

Added Integumentary System criteria and
Added Reauthorization criteria for Botox as this was removed from S-178 Treatment of Hyperhidrosis

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-11-042

Section: Injections

Effective Date: May 01, 2019

Revised Date: January 15, 2022

Revision Effective Date: February 01, 2022

Last Reviewed: January 20, 2022

Archived Date: August 31, 2022

Applies To: Commercial and Medicaid Expansion

Description

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 three (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 (6) weeks each); or
- Chronic migraine continued treatment (up to four injection treatments in a 12-month period) may be considered medically necessary when 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 two (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; or
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 seven (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 two (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 (two (2) to 17 years of age) and adult individuals who are neurologically impaired; or
Sialorrhea (excessive salivation, drooling) in pediatric individuals two (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 two (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

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

G44.86

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"

Internal Medical Policy Committee 9-21-2021 Added diagnosis code G44.86 to the policy and some minor wording changes

Internal Medical Policy Committee 1-20-2022 Removed migraine criteria "The individual will not use onabotulinumtoxinA (Botox) in combination with a prophylactic calcitonin gene-related peptide (CGRP) agent."

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