1. health and fitness
2. disorders

Status
Active
Medical and Behavioral Health Policy
Section: Medicine
Policy Number: II-16
Effective Date: 03/25/2015
Blue Cross and Blue Shield of Minnesota medical policies do not imply that members should not receive specific services
based on the recommendation of their provider. These policies govern coverage and not clinical practice. Providers are
responsible for medical advice and treatment of patients. Members with specific health care needs should consult an
appropriate health care professional.
BOTULINUM TOXIN
Description:
Botulinum toxin is produced by the bacterium Clostridium botulinum
and includes seven distinct serotypes. Type A is the most powerful of
the subtypes and was the first to be developed for clinical use; Type B
is also commercially available. The potency units of botulinum toxin
products are specific to the preparation and assay method utilized.
They are not interchangeable and, therefore, units of biological activity
of one botulinum toxin product cannot be compared or converted into
units of any other botulinum toxin products. Botulinum toxin injections
cause muscle paralysis by acting at the peripheral nerve endings to
block release of the neurotransmitter acetylcholine.
Four botulinum toxin agents are commercially available in the United
States. Three of these, onabotulinumtoxinA (Botox®, Botox®
Cosmetic), abobotulinumtoxinA (Dysport®), and incobotulinumtoxinA
(Xeomin®) are serotype A agents. One agent, rimabotulinumtoxinB
(Myobloc®) is a serotype type B preparation.
OnabotulinumtoxinA (Botox®) has been FDA-approved for the
following:
• Treatment of cervical dystonia in adult patients, to reduce the
severity of abnormal head position and neck pain.
• Treatment of strabismus and blepharospasm associated with
dystonia, including benign essential blepharospasm or VII (facial)
nerve disorders in patients 12 years of age and above.
• Treatment of upper limb spasticity in adult patients.
• Prevention of chronic migraine headache in adult patients with
chronic migraine (≥15 days per month with headache lasting 4 hours
a day or longer).
• Severe primary axillary hyperhidrosis that is inadequately managed
with topical agents in adult patients. Note: This indication is
addressed in a separate policy (II-55 Hyperhidrosis Treatments).
• Treatment of urinary incontinence due to detrusor overactivity
associated with a neurologic condition [e.g., spinal cord injury (SCI),
multiple sclerosis (MS)] in adults who have an inadequate response
to or are intolerant of an anticholinergic medication.
• Treatment of overactive bladder with symptoms of urge urinary
incontinence, urgency, and frequency, in adults who have an
inadequate response to or are intolerant of an anticholinergic
medication.
OnabotulinumtoxinA (Botox® Cosmetic) has been FDA-approved for
the following:
• Temporary improvement in the appearance of moderate to severe
glabellar lines associated with corrugators and/or procerus muscle
activity in adult patients.
• Temporary improvement in the appearance of moderate to severe
lateral canthal lines associated with orbicularis oculi activity in adult
patients.
AbobotulinumtoxinA (Dysport®) has received FDA approval for
treatment of cervical dystonia in adults to reduce the severity of
abnormal head position and neck pain in both toxin-naïve and
previously treated patients. Dysport® is also approved for temporarily
improving the appearance of glabellar lines (wrinkles) in adults less
than 65 years of age.
IncobotulinumtoxinA (Xeomin®) consists of the pure neurotoxin
without complexing proteins and is the only product that is stable at
room temperature for up to 36 months. This agent is FDA-approved
for:
• Treatment of blepharospasm in adults who were previously treated
with onabotulinumtoxinA (Botox®)
• Treatment of adults with cervical dystonia, to decrease the severity
of abnormal head position and neck pain in both botulinum toxinnaïve and previously treated patients; and
• Temporary improvement in the appearance of glabellar lines
associated with corrugator and/or procerus muscle activity in adult
patients.
RimabotulinumtoxinB (Myobloc®) is FDA-approved for treatment of
cervical dystonia, to decrease the severity of abnormal head position
and neck pain associated with cervical dystonia. It is anticipated that
rimabotulinumtoxinB will be used for the same range of off-label
indications as Type A agents.
After successful extended use of botulinum toxin (usually one of the
botulinumtoxinA serotypes), some initial responders become nonresponders. Such secondary non-response may occur for a variety of
reasons; one cause in a small percentage of patients is the
development of antibodies that neutralize the activity of the
administered botulinum toxin. These patients are likely to respond to
another botulinum toxin type. A clinically useful assay for toxin-reactive
antibodies would detect only neutralizing antibodies, as nonneutralizing antibodies can be present in the serum of patients who
have not developed resistance to treatment. Assay formats best suited
to the clinical laboratory, such as immunoprecipitation, western blot, or
enzyme-linked immunosorbent assay, typically do not discriminate
between neutralizing and non-neutralizing antibodies and would thus
generate false-positive results in some patients.
Policy:
I.
The use of botulinum toxin (A or B serotypes) may be considered
MEDICALLY NECESSARY for any of the following:
A. Cervical dystonia (spasmodic torticollis to decrease the
severity of abnormal head position and neck pain.*
B. Strabismus* or blepharospasm including benign essential
blepharospasm or VII (facial) nerve disorders in patients 12
years of age and above*
C. Upper limb spasticity*
D. Dystonia/spasticity in patients with any of the following
diseases of the central nervous system:
1. Focal dystonias:
a. Focal upper limb dystonia (e.g., organic writer’s cramp)
b. Oromandibular dystonia (e.g., orofacial dyskinesia,
Meige syndrome)
c. Laryngeal dystonia (adductor spasmodic dysphonia)
d. Idiopathic (primary or genetic) torsion dystonia
e. Symptomatic (acquired) torsion dystonia
2. Spastic conditions:
a. Cerebral palsy
b. Spasticity related to stroke
c. Acquired spinal cord or traumatic brain injury
d. Hereditary spastic paraplegia
e. Spastic hemiplegia
f. Neuromyelitis optica
g. Multiple sclerosis or Schilder’s disease
E. Esophageal achalasia in patients who have not responded to
dilation therapy or who are considered poor surgical
candidates
F. Sialorrhea (drooling) associated with Parkinson’s disease
G. Chronic anal fissure
H. Prevention (treatment) of chronic migraine headache in the
following situations*
1. Initial 6-month trial in adult patients who
a. Meet International Headache Classification (ICHD-2)
diagnostic criteria for chronic migraine headache:
• migraine headaches lasting at least 4 hours on at
least 15 days per month; and
• migraine headaches for at least 3 months;
AND
b. Have symptoms that persist despite adequate trials of
at least 2 agents from different classes of medications
used in the treatment of chronic migraine headaches,
e.g. antidepressants, antihypertensives and
antiepileptics.
•
Patients who have contraindications to preventive
medications are not required to undergo a trial of
these agents.
2. Continuing treatment beyond 6-months:
a. Migraine headache frequency reduced by at least 7
days per month compared to pre-treatment level;
OR
b. Migraine headache duration reduced at least 100 hours
per month compared to pre-treatment level.
I. Urinary incontinence due to detrusor overactivity associated
with a neurologic condition [e.g., spinal cord injury (SCI),
multiple sclerosis (MS)] in adults who have an inadequate
response to or are intolerant of an anticholinergic medication.*
J. Overactive bladder with symptoms of urge urinary
incontinence, urgency, and frequency, in adults who have an
inadequate response to or are intolerant of an anticholinergic
medication.*
* FDA-approved indication for at least one of the agents.
II.
Retreatment for all indications, including prevention of migraine
headache, is considered NOT MEDICALLY NECESSARY if the
original treatment was determined to be not medically necessary.
III. The use of all botulinum toxin agents is considered COSMETIC for
the treatment of glabellar lines or wrinkles and other indications
solely to improve appearance.
IV. All other uses of botulinum toxin are considered INVESTIGATIVE
including, but not limited to:
A. Bell’s palsy
B. Benign prostatic hyperplasia
C. Chronic low back pain
D. Chronic motor tic disorder, and tics associated with Tourette
syndrome (motor tics)
E. Depressive disorders
F. Detrusor sphincteric dyssynergia
G. Essential tremor
H. Facial wound healing
I. Gastroparesis
J. Headaches, except as noted above for prevention (treatment)
of chronic migraine headache
K. Hirschsprung’s disease
L. Internal anal sphincter (IAS) achalasia
M. Interstitial cystitis
N. Joint pain
O. Lateral epicondylitis
P. Mechanical neck disorders
Q. Myofascial pain syndrome
R. Neuropathic pain after neck dissection
S. Pain after hemorrhoidectomy or lumpectomy
T. Prevention of pain associated with breast reconstruction after
mastectomy
U. Raynaud’s disease/Raynaud’s phenomenon
V. Sialorrhea (drooling), unless secondary to Parkinson’s disease
W. Tinnitus
X. Trigeminal neuralgia
V. The use of assays to detect antibodies to botulinum toxin is
considered INVESTIGATIVE due to a lack of evidence
demonstrating a beneficial impact on health outcomes.
Documentation
Submission:
The following documentation in the medical record is required for
review of botulinum toxin for chronic migraine headache:
A. The patient meets the criteria for migraine headache defined
in section IH1;
B. The agents from two different classes used to treat chronic
migraine or contraindication to one or more of the
medications; and
C. For continued treatment beyond 6-months: Information from
the medical record and or headache diary/log entries
quantifying a reduction in migraine frequency or duration
compared to baseline.
Coverage:
Blue Cross and Blue Shield of Minnesota medical policies apply
generally to all Blue Cross and Blue Plus plans and products. Benefit
plans vary in coverage and some plans may not provide coverage for
certain services addressed in the medical policies.
Medicaid products and some self-insured plans may have additional
policies and prior authorization requirements. Receipt of benefits is
subject to all terms and conditions of the member’s summary plan
description (SPD). As applicable, review the provisions relating to a
specific coverage determination, including exclusions and limitations.
Blue Cross reserves the right to revise, update and/or add to its
medical policies at any time without notice.
For Medicare NCD and/or Medicare LCD, please consult CMS or
National Government Services websites.
Refer to the Pre-Certification/Pre-Authorization section of the Medical
Behavioral Health Policy Manual for the full list of services,
procedures, prescription drugs, and medical devices that require Precertification/Pre-Authorization. Note that services with specific
coverage criteria may be reviewed retrospectively to determine if
criteria are being met. Retrospective denial of claims may result if
criteria are not met.
Coding:
The following codes are included below for informational purposes
only, and are subject to change without notice. Inclusion or exclusion
of a code does not constitute or imply member coverage or provider
reimbursement.
HCPCS:
J0585 Injection, onabotulinumtoxinA, 1 unit
J0586 Injection, abobotulinumtoxinA, 5 units
J0587 Injection, rimabotulinumtoxinB, 100 units
J0588 Injection, incobotulinumtoxinA, 1 unit
Deleted Codes: C9278, Q2040
Policy History:
Developed August 14, 2002
Most recent history:
Revised February 8, 2012
Reviewed/Updated, no policy statement changes February 13, 2013
Revised March 12, 2014
Reviewed/Updated, no policy statement changes March 11, 2015
Cross
Reference:
Hyperhidrosis Treatments, II-55
Current Procedural Terminology (CPT®) is copyright 2014 American Medical
Association. All Rights Reserved. No fee schedules, basic units, relative
values, or related listings are included in CPT. The AMA assumes no liability
for the data contained herein. Applicable FARS/DFARS restrictions apply to
government use.
Copyright 2015 Blue Cross Blue Shield of Minnesota.