| Printer Friendly Version |
| Medical Policy: | I-11-036 |
| Topic: | Botulinum Toxin (Chemodenervation) |
| Section: | Injections |
| Effective Date: | June 25, 2018 |
| Issue Date: | June 25, 2018 |
| Last Reviewed: | May 2018 |
Chemodenervation is a procedure whereby small amounts of botulinum toxin are injected into excessively contracted muscles. Botulinum toxin prevents the release of the chemical signal, which leads to muscle relaxation. Botulinum toxin type A and B are chemically, pharmacologically, and clinically distinct products and are not interchangeable. |
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
| Policy Position Coverage is subject to the specific terms of the member’s benefit plan. |
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 six month trial 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 three 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
- If an individual’s headaches do not adequately respond to treatment (defined as less than a 30% reduction in headache days per month after two treatment cycles), the botulinum toxin should be discontinued; or
- Chronic migraine continued treatment beyond six (6) months (up to four injection treatments in a 12-month period) may be considered medically necessary when ALL the following criteria are met:
- Migraine headache frequency reduced by at least seven (7) days per month; and
- Migraine headaches duration reduced at least 100 hours per month; 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.
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.
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.
IncobotulinumtoxinA (Xeomin®) may be considered medically necessary for adult individuals for the treatment of:
- Adults 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 adults previously treated with onabotulinumtoxinA (Botox); or
- Upper limb spasticity in adults, to decrease the severity of increased muscle tone in elbow flexors, forearm pronators, wrist flexors, thumb, and finger flexors.
All other uses of incobotulinumtoxinA (Xeomin) are considered not medically necessary.
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 advanced Parkinson’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.
Refer to medical policy S-178, Treatment of Hyperhidrosis, for additional information. Dosage recommendations per the FDA label. Dosage recommendations per DRUGDEX® Evaluations (non-FDA approved indications, Class IIb or higher grade recommendation). |
| Professional Statements and Societal Positions |
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. |
| Place of Service: Outpatient |
Botulinum Toxin (Chemodenervation) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
| The policy position applies to all commercial lines of business |
| Denial Statements |
Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
| Links |
- Link to Provider Resource Center for the Medical Policy Update
11/2016, AbobotulinumtoxinA (DYSPORT™) Now Covered for Lower Limb Spasticity in Pediatric Patients 2 Years of Age and Older.
07/2018, Updated Guidelines for Botulinum Toxin (Chemodenervation).
 |
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
- Provides free aids and services to people with disabilities to communicate effectively with us, such as:
- Qualified sign language interpreters
- Written information in other formats (large print, audio, accessible electronic formats, other formats)
- Provides free language services to people whose primary language is not English, such as:
- Qualified interpreters
- Information written in other languages
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.
Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.
