Botulinum Toxin

POLICY NUMBER

L.5.01.491

Botox (onabotulinumtoxinA)

Dysport (abobotulinumtoxinA)

Myobloc (rimabotulinumtoxinB)

Xeomin (incobotulinumtoxinA)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum and related species. It prevents the release of the neurotransmitter acetylcholine from axon endings at the neuromuscular junction and thus causes flaccid paralysis. Infection with the bacterium causes the disease botulism. The toxin is also used commercially in medicine, cosmetics, and research. There are seven distinct serotypes designated as type A, B, C-1, D, E, F, and G. However, in the United States four preparations of botulinum are available, produced by two different strains of bacteria.

POLICY

Prior authorization is required.

Upon approval, the Botox medical claim must be filed with the clinically supported ICD-10 diagnosis code in the primary position to be considered medically necessary. See Code Reference section.

The use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review.

Botox (onabotulinumtoxinA) is the only covered preparations of botulinum toxin for non-cosmetic indications. Dysport (abobotulinumtoxinA), Myobloc (rimabotulinumtoxinB), and Xeomin (incobotulinumtoxinA) are currently considered not medically necessary, as a formulary alternative is available.

Before consideration of coverage may be made, it should be established that the patient does not have any FDA labeled contraindications to the requested agent and that Botox administration follows applicable state guidelines (see Policy Guidelines section). 

Botox may be approved for a clinically supported diagnosis listed below when ALL of the criteria are met for a given indication. If a member is being treated with Botox for one or more indications, the maximum cumulative dose in a 3-month (12 week) interval should not exceed 400 units for adults or the lower of 8 units/kg or 300 units for pediatrics.

Overactive Bladder

Botox (onabotulinumtoxinA) may be considered medically necessary for the treatment of overactive bladder when ALL of the following criteria are met:

1. Member is 18 years of age or older

2. Member has documented symptoms of urge urinary incontinence, urgency, and frequency (≥1 urinary urgency incontinence episodes and ≥8 urinations per day);

3. Member has had an inadequate response to conservative therapies (e.g., bladder training, pelvic floor muscle exercises, fluid management) for at least 2-months;

4. Member has failed (see Policy Guidelines section) or is intolerant to an anticholinergic agent (e.g. oxybutynin, tolterodine, trospium, darifenacin, solifenacin or fesoterodine) AND Myrbetriq (mirabegron);

5. Maximum dose of 100 units into the detrusor muscle every 12 weeks will not be exceeded.

Length of Approval: 12 months

Urinary Incontinence (neurogenic bladder)

Botox (onabotulinumtoxinA) may be considered medically necessary for the treatment of urinary incontinence (neurogenic bladder) when ALL of the following criteria are met:

1. Member is 18 years of age or older;

2. Member has documented urinary incontinence with detrusor muscle over-activity associated with neurologic condition (e.g. spinal cord injury, multiple sclerosis) and is either spontaneously voiding or using catheterization;

3. Member has failed (see Policy Guidelines section) or is intolerant to an anticholinergic agent (e.g. oxybutynin, tolterodine, trospium, darifenacin, solifenacin or fesoterodine) AND Myrbetriq (mirabegron);

4. Maximum dose of 200 units into the detrusor muscle every 12 weeks will not be exceeded.

Length of Approval: 12 months

Migraine Prophylaxis

Botox (onabotulinumtoxinA) may be considered medically necessary for the prevention of migraines when ALL of the following criteria are met:

1. Member is 18 years of age or older;

2. Member is experiencing ≥15 days per month with headache lasting 4 hours a day or longer;

3. Member has failed (see Policy Guidelines section) at least TWO medications from different drug classes indicated for and at generally accepted doses for migraine prophylaxis within the past 24 months:

   1. anticonvulsants – divalproex, valproate, topiramate

   2. beta blockers – atenolol, metoprolol, nadolol, propanolol, timolol

   3. antidepressants – amitriptyline, venlafaxine

4. Member has been evaluated for and does not have medication overuse headache;

5. Secondary migraine as a result of an underlying condition or different etiology (e.g.,  hypertension, stress/anxiety, insomnia, environmental factors) has been ruled out;

6. Botox will not be used in conjunction with a CGRP for prophylactic treatment. There is limited data regarding concomitant use of Botox with CGRP therapy at this time;

7. Maximum dose of 155 units divided in 31 sites every 12 weeks will not be exceeded.

Length of Approval: 12 months

Spasticity

Botox (onabotulinumtoxinA) may be considered medically necessary for the treatment of spasticity when ALL of the following criteria are met:

1. Member is 2 years of age or older;

2. Member has had an inadequate response to physical/occupational therapy and/or bracing/splinting;

3. Member has failed (see Policy Guidelines section) at least ONE conventional agent (e.g. benzodiazepines, oral or intrathecal baclofen);

4. ONE of the following:

   1. Adults: Maximum dose of 400 units (no more than 50 units per site) every 12 weeks will not be exceeded.

   2. Pediatrics:

      1. Upper Limb: Maximum dose of 6 units/kg or 200 units, whichever is lower, every 12 weeks.

      2. Lower Limb: Maximum dose of 8 units/kg or 300 units, whichever is lower, every 12 weeks.

      3. Both Lower Limbs OR Combination of Upper and Lower Limbs: Maximum dose 10 units/kg body weight or 340 units, whichever is lower, every 12 weeks.

Length of Approval: 12 months 

Cervical Dystonia (spasmodic torticollis)

Botox (onabotulinumtoxinA) may be considered medically necessary for the treatment of cervical dystonia (spasmodic torticollis) when ALL of the following criteria are met:

1. Member is 18 years of age or older;

2. Member has documented sustained head tilt or abnormal posturing with limited range of motion in the neck;

3. Member has a history of recurrent involuntary contraction of one or more muscles of the neck (e.g. sternocleidomastoid, splenius, trapezius or posterior cervical muscles);

4. Maximum dose of 400 units every 12 weeks will not be exceeded.

Length of Approval: 12 months

Primary Axillary Hyperhidrosis

Botox (onabotulinumtoxinA) may be considered medically necessary for the treatment of primary axillary hyperhidrosis when ALL of the following criteria are met:

1. Member is 18 years of age or older;

2. Secondary hyperhidrosis as a result of an underlying condition (e.g., hyperthyroidism) has been ruled out;

3. Member has focal, visible, excessive sweating of at least 6 months duration with at least TWO of the following characteristics:

   1. Bilateral and relatively symmetric

   2. Impairs daily activities

   3. Frequency of at least one episode per week

   4. Age of onset is less than 25 years

   5. Positive family history

   6. Cessation of focal sweating during sleeping

4. Member has failed (see Policy Guidelines section) aluminum chloride 20% solution;

5. The prescriber is, or has consulted with, a dermatologist;

6. Maximum dose of 50 units per axilla evenly distributed in multiple sites (10-15) every 12 weeks will not be exceeded.

Length of Approval: 12 months

Blepharospasm

Botox (onabotulinumtoxinA) may be considered medically necessary for the treatment of blelpharospasm when ALL of the following criteria are met:

1. Member is 12 years of age or older;

2. Member has documented dystonia, including benign essential blepharospasm and VII nerve disorders;

3. Maximum dose of 30 units (15 units per eye) every 12 weeks will not be exceeded.

Length of Approval: 12 months

Strabismus

Botox (onabotulinumtoxinA) may be considered medically necessary for the treatment of strabismus when ALL of the following criteria are met:

1. Member is 12 years of age or older;

2. Member has had an inadequate response to corrective lenses AND any other additional, patient appropriate, conservative corrective therapies (e.g., exercises, eye patching);

3. Member has good vision in both eyes and there is a potential for binocular vision;

4. Maximum dose of 25 units in any one muscle every 12 weeks will not be exceeded.

Length of Approval: 12 months

Renewal Evaluation

Botox (onabotulinumtoxinA) may be approved for RENEWAL when ALL of the following criteria are met:

1. The member has been previously approved for the requested agent through the BCBSMS PA process and continues to meet all initial criteria;

2. The member has documented clinical response/improvement (i.e., decrease in symptom severity and/or frequency) from baseline;

3. Documentation has been provided to support the requested agent is being administered at the correct dosage into the correct muscles for the indication being treated.

Length of Approval: 12 months

Services related to delivery and/or administration of a medication which have not been approved through BCBSMS PA review process will be considered not medically necessary.

POLICY EXCEPTIONS

For Federal Employee Program (FEP) subscribers only, the use of botulinum toxin may be considered medically necessary for FDA-labeled indications and off-label indications.

State Health Plan (State and School Employees) Participants

Out of State Providers: The criteria for Botox administration by a non-physician practitioner do not apply to out of state providers; however, the prior authorization and medical necessity criteria outlined in the Policy section must be met.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Electromyography (EMG) guidance may be used to direct the Botox (onabotulinumtoxinA) injection. If so, EMG guidance is considered an integral part of the procedure and no additional reimbursement for the EMG is warranted.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary. BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

Botox Administration by a Non-Physician Practitioner in Mississippi

In accordance with the Mississippi State Board of Medical Licensure and the Mississippi State Board of Nursing, the appropriately prepared non-physician practitioner can administer Botox injections provided that all of the following criteria are met:

1. The non-physician practitioner is educated and competent in the use of Botox and the procedure being performed. This education and competence must be documented initially and on an ongoing basis;

2. The collaborative physician is educated in the use of Botox;

3. The non-physician practitioner's protocol addresses the administration of Botox;

4. The collaborative physician has examined the patient and documented the patient’s chart approving the use of Botox; and

5. The non-physician practitioner practices according to the generally accepted standards of practice.

Medication Failure

Medication failure is defined as disease progression at generally accepted doses (for ≥3 months use) as appropriate for the disease state being treated. Dosages below the recommended dose for the specific condition being treated and/or experience of common side effects of medication will not be considered medication failure or lack of response for the purpose of this review.

BCBSMS determines patient medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.

POLICY HISTORY

3/1993: Approved by Medical Policy Advisory Committee (MPAC), CPT code 64612, 64613, 67345 added, HCPCS J0585 added.

8/1999: Comprehensive revision approved by MPAC, cerebral palsy, head trauma, multiple sclerosis, spinal cord injuries and stroke are covered indications when resulting in functional impairment due to spastic conditions, ICD-9 diagnosis code 300.11, 306.0, 333.6, 333.7, 333.81, 333.82, 333.83, 333.84, 333.89, 334.1, 340, 341.0-341.9, 342.11, 342.12, 343.0-343.9, 351.8, 378.00-378.03, 378.10-378.18, 378.20-378.24, 378.30-378.35, 378.40-378.45, 378.50-378.56, 378.60-378.63, 378.71-378.73, 378.81-378.87, 378.9, 478.75, 530.0, 530.3, 723.5, 728.85, 754.1, 767.8, 780.8, 847.0, 952.00-952.9, 959.01 added to covered, CPT code 31513, 31570, 31571, 43243, 64640 added to covered, ICD-9 procedure code 99.29 added to covered.

11/1999: Revisions approved by Pharmacy & Therapeutics Committee.

2/2001: Reviewed by MPAC; Botox® treatment for headache is considered investigational. Botox® treatment for hyperhidrosis changed to investigational. MYOBLOC^® is considered medically necessary for cervical dystonias after failure of Botox®.

2/28/2001: Non-covered effective date ICD-9 diagnosis code 780.8.

4/2/2001: Cervical dystonia in adults, strabismus and blepharospasm in patients 12 years of age and older added as covered indications.

7/13/2001: Code Reference section updated, ICD-9 diagnosis code 436, 575.8 added to covered codes, ICD-9 diagnosis code 307.22, 307.23, 332.0, 564.1, 564.6, 784.0 added to non-covered codes, ICD-9 diagnosis 780.8 moved to non-covered, HCPCS J3490 added to covered.

1/10/2002: J0587 added to code reference section.

1/30/2002: Prior authorization added, Nova Factor statement added.

2/8/2002: Investigational definition added.

4/18/2002: Type of Service and Place of Service deleted.

9/11/2002: Policy reviewed.

11/6/2002: "Prior Authorization is required for Botox and MYOBLOC." and "Nova Factor is our preferred provider of Botox." added. Nova Factor new telephone and fax numbers added. Telephone # 1-800-235-8498 and fax # 1-888-355-6652 deleted.

11/27/2002: Sources updated.

3/6/2003: Code Reference section updated, CPT code 43201, 43236, 45335, 45381, 64614 added to covered codes.

4/15/2003: ICD-9 diagnosis code 728.85 deleted.

4/17/2003: ICD-9 diagnosis code 728.85 added to covered with a "Note" for clarity.

8/19/2003: Policy text reorganized, ICD-9 diagnosis code ranges 341.0-341.9, 343.0-343.9, 378.00-378.03, 378.10-378.18, 378.20-378.24, 378.30-378.35, 378.40-378.45, 378.50-378.56, 378.60-378.63, 378.71-378.73, 378.81-378.87, 952.00-952.9 listed separately, ICD-9 diagnosis codes 754.1, 767.8, 300.11, 306.0 deleted.

11/2003: Reviewed by MPAC, Botulinum Toxin as a treatment for cervicogenic headache and occipital neuralgia (called symmetrical dystonia) is considered investigational.

2/16/2004: Code Reference section updated, CPT code 43243, 64640 deleted, CPT code 45335 moved to non-covered codes, ICD-9 diagnosis 530.3, 575.8 deleted, non-covered codes 307.22, 307.23, 332.0, 564.1, 564.6, 780.8, 784.0 deleted, HCPCS J3490 deleted, ICD-9 procedure code 04.2, 15.29, 31.0, 42.23 added to covered, ICD-9 diagnosis codes 850.0, 850.11, 850.12, 850.2, 850.3, 850.4, 850.5, 850.9, 851.00, 851.01, 851.02, 851.03, 851.04, 851.05, 851.06, 851.09, 851.10, 851.11, 851.12, 851.13, 851.14, 851.15, 851.16, 851.19, 851.20, 851.21, 851.22, 851.23, 851.24, 851.25, 851.26, 851.29, 851.30, 851.31, 851.32, 851.33, 851.34, 851.35, 851.36, 851.39, 851.40, 851.41, 851.42, 851.43, 851.44, 851.45, 851.46, 851.49, 851.50, 851.51, 851.52, 851.53, 851.54, 851.55, 851.56, 851.59, 851.60, 851.61, 851.62, 851.63, 851.64, 851.65, 851.66, 851.69, 851.70, 851.71, 851.72, 851.73, 851.74, 851.75, 851.76, 851.79, 851.80, 851.81, 851.82, 851.83, 851.84, 851.85, 851.86, 851.89, 851.90, 851.91, 851.92, 851.93, 851.94, 851.95, 851.96, 851.99, 852.00, 852.01, 852.02, 852.03, 852.04, 852.05, 852.06, 852.09, 852.10, 852.11, 852.12, 852.13, 852.14, 852.15, 852.16, 852.19, 852.20, 852.21, 852.22, 852.23, 852.24, 852.25, 852.26, 852.29, 852.30, 852.31, 852.32, 852.33, 852.34, 852.35, 852.36, 852.39, 852.40, 852.41, 852.42, 852.43, 852.44, 852.45, 852.46, 852.49, 852.50, 852.51, 852.52, 852.53, 852.54, 852.55, 852.56, 852.59, 853.00, 853.01, 853.02, 853.03, 853.04, 853.05, 853.06, 853.09, 853.10, 853.11, 853.12, 853.13, 853.14, 853.15, 853.16, 853.19, 854.00, 854.01, 854.02, 854.03, 854.04, 854.05, 854.06, 854.09, 854.10, 854.11, 854.12, 854.13, 854.14, 854.15, 854.16, 854.19 added to covered.

3/25/2004: Reviewed by MPAC, The Committee agreed Botulinum Toxin (Type A and Type B) is considered medically necessary for non-cosmetic FDA approved indications only. VII nerve disorders added, Policy section aligned with BCBSA policy #5.01.05, FEP exception added.

5/17/2004: Code Reference section updated, covered ICD-9 diagnosis codes 334.1, 340, 341.0-341.9, 342.11, 342.12, 343.0-343.9, 436, 478.75, 530.0, 723.5, 728.85, 847.0, 850.0, 850.11, 850.12, 850.2, 850.3, 850.4, 850.5, 850.9, 851.00, 851.01, 851.02, 851.03, 851.04, 851.05, 851.06, 851.09, 851.10, 851.11, 851.12, 851.13, 851.14, 851.15, 851.16, 851.19, 851.20, 851.21, 851.22, 851.23, 851.24, 851.25, 851.26, 851.29, 851.30, 851.31, 851.32, 851.33, 851.34, 851.35, 851.36, 851.39, 851.40, 851.41, 851.42, 851.43, 851.44, 851.45, 851.46, 851.49, 851.50, 851.51, 851.52, 851.53, 851.54, 851.55, 851.56, 851.59, 851.60, 851.61, 851.62, 851.63, 851.64, 851.65, 851.66, 851.69, 851.70, 851.71, 851.72, 851.73, 851.74, 851.75, 851.76, 851.79, 851.80, 851.81, 851.82, 851.83, 851.84, 851.85, 851.86, 851.89, 851.90, 851.91, 851.92, 851.93, 851.94, 851.95, 851.96, 851.99, 852.00, 852.01, 852.02, 852.03, 852.04, 852.05, 852.06, 852.09, 852.10, 852.11, 852.12, 852.13, 852.14, 852.15, 852.16, 852.19, 852.20, 852.21, 852.22, 852.23, 852.24, 852.25, 852.26, 852.29, 852.30, 852.31, 852.32, 852.33, 852.34, 852.35, 852.36, 852.39, 852.40, 852.41, 852.42, 852.43, 852.44, 852.45, 852.46, 852.49, 852.50, 852.51, 852.52, 852.53, 852.54, 852.55, 852.56, 852.59, 853.00, 853.01, 853.02, 853.03, 853.04, 853.05, 853.06, 853.09, 853.10, 853.11, 853.12, 853.13, 853.14, 853.15, 853.16, 853.19, 854.00, 854.01, 854.02, 854.03, 854.04, 854.05, 854.06, 854.09, 854.10, 854.11, 854.12, 854.13, 854.14, 854.15, 854.16, 854.19, 952.00-952.9, 959.01 deleted, ICD-9 diagnosis code 351.0, 351.9 added to covered.

9/3/2004: Code Reference section updated, CPT code 31513, 31570, 31571, 43201, 43236, 45381 moved to non-covered, ICD-9 procedure code 31.0, 42.23 moved to non-covered, ICD-9 diagnosis code 333.82, 333.84, 333.89, 351.0, 351.8, 351.9 deleted, ICD-9 diagnosis codes 378.00-378.9 listed in code range format.

5/19/2005: Prior authorization information changed as follows, Nova Factor changed to Accredo, Nova Factor phone # 1-866-591-9075 changed to Accredo phone # 1-800-530-6680, Nova Factor fax # 1-866-591-9094 changed to Accredo fax # 1-877-382-8372.

11/15/2005: Description section updated. Policy section updated; changed phone number for Accredo from 1-800-530-6680 to 1-866-240-3373. Sources updated; Botox® and MYOBLOC® added.

11/18/2005: Code Reference section updated, ICD9 diagnosis code 351.9 added, codes 333.6, 333.7, 378.81-378.9 deleted.

11/2005: Approved by Pharmacy & Therapeutics (P&T) Committee.

03/10/2006: Coding updated. CPT4 2006 revisions added to policy.

10/9/2007: Code reference section reviewed; CPT 46505 moved to non-covered table.

01/01/2009: Accredo and CuraScript preferred provider information removed. BCBSMS information added.

08/04/2009: Policy Title revised to include abobotulinumtoxinA (Dysport®), Policy Description Section updated to add abobotulinumtoxinA (Dysport®) as an FDA approved botulinum, and to provide the new FDA approved names for Botox® and MYOBLOC®. Policy Statement Section revised to add abobotulinumtoxinA (Dysport®) to Prior Authorization requirements and to include abobotulinumtoxinA (Dysport®) medically necessary information, Policy Sources Section updated to add Dysport® Prescribing Information, CPT-4 codes 64650 and 64653 deleted from covered table, HCPCS unclassified drugs code J3490 added to convered table with note to use for abobotulinumtoxinA Dysport®, Revised note to Non-Covered Table procedure codes for clearer understanding.

09/23/2009: Coding section revised to include verbiage, "* Some covered procedure codes have multiple descriptions. Coverage will only be made for covered codes when used for services outlined within the policy statement section." for the Covered Codes Table, and "*This is not an all inclusive list of non-covered procedure codes." for the Non-Covered Codes Table.

06/23/2010: Policy Statement revised to include current (March 9, 2010) FDA approved indications for upper limb spasticity in adults. Code Reference section updated: added ICD-9 code 728.85 to the Covered Codes table, added new HCPCS code J0586 for reporting abobotulinumtoxinA (Dysport®), and revised the descriptions of J0585 and J0587.

04/11/2011: Policy title and description updated regarding the preparations of botulinum that are currently available; added Incobotulinumtoxin A (Xeomin®) to the list. Policy statement revised to state that effective 04/01/2011, OnabotulinumtoxinA (Botox®) is the only covered preparation of botulinum toxin. Abobotulinum Toxin Type A (Dysport®), RimabotulinumtoxinB (Myobloc®), and IncobotulinumtoxinA (Xeomin®) are not covered effective 04/01/11. Added additional coverage criteria for OnabotulinumtoxinA (Botox®) for cervical dystonia, blepharospasm, strabismus, and chronic migraine. State Health Plan verbiage added to the Policy Exceptions section. Moved HCPCS codes J0586 and J0587 to the Non-Covered Codes table. Added new HCPCS code Q2040 to the Non-Covered Codes table. Added Xeomin® Prescribing Information to the Sources section.

11/04/2011: Policy description updated regarding FDA approved indications of Botox®). Added the following policy statement: OnabotulinumtoxinA (Botox®) is approved for treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (eg spinal cord injury, multiple sclerosis) in adults who have an inadequate response to or are intolerant of an anticholinergic medication. Do not exceed a total of 200 units administered every 12 weeks. Deleted the ICD-9 diagnosis codes from the Covered Codes table as botulinum toxin requires prior authorization for the indications outlined in the policy statement.

01/12/2012: Added CPT code 53899 to the Covered Codes table.

09/11/2012: Added the following statement to the Policy Exceptions section: State Health Plan (State and School Employees): OnabotulinumtoxinA (Botox®) does not require prior authorization. However, it will be reviewed for medical necessity based on medical policy guidelines.

12/21/2012: Added the following new 2013 CPT codes to the Code Reference section: 52287 and 64615.

07/10/2013: Revised the policy statement regarding strabismus and blepharospasm to state that Botox is indicated for VII nerve disorders (including hemifacial spasm) per the Prescribing Information for the drug and to add a dosage limit of 15 units every 12 weeks for these indications.

11/15/2013: Overall policy title changed to Botulinum Toxin, with the botulinum toxin names listed as the subtitle. Added the following as a covered indication for Botox®: OnabotulinumtoxinA (Botox®) is approved for treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication. Do not exceed a total of 100 units administered every 12 weeks.

12/15/2014: Added dosage of 1.25 units to 2.5 units in up to eight sites per affected side of the face for hemifacial spasm. Chronic migraine policy statement revised to remove “administered by a board certified neurologist.” Added criteria for coverage of Botox administration by a Mississippi Nurse Practitioner. Policy Exceptions section updated to state that the criteria for Botox® administration by a Nurse Practitioner do not apply to out of state providers; however, the prior authorization and medical necessity criteria outlined in the Policy section must be met. Added Mississippi State Board of Medical Licensure and Mississippi Board of Nursing to the Sources section. Added CPT codes 64616, 64642, 64643, 64644, and 64645 to the Covered Codes table. Added CPT codes 64617, 64646, and 64647 to the Not Medically Necessary Codes table.

12/31/2014: Code Reference section updated to revise the description of the following CPT code: 45381.

05/19/2015: Removed deleted CPT code 64614 from the Covered Codes table. Removed ICD-9 procedure code 42.23 from the Not Medically Necessary Codes table.

08/26/2015: Medical policy revised to add ICD-10 codes. Removed ICD-9 procedure codes 04.2, 15.29, and 99.29 from the Covered Codes table. Removed ICD-9 procedure code 31.0 and deleted HCPCS code Q2040 from the Not Medically Necessary Codes table.

09/03/2015: Medically necessary policy statement updated to increase the maximum dosing units from 360 to 400 for Botox and to add the following muscles as an indication for upper limb spasticity in adult patients: Adductor Pollicis and Flexor Pollicis Longus.

02/02/2016: Approved by Pharmacy & Therapeutics (P&T) Committee. Policy guidelines updated to add medically necessary and investigative definitions.

02/25/2016: Policy description and statement updated to add lower limb spasticity in adult patients as an indication for Botox®.

05/31/2016: Policy number L.5.01.491 added.

08/25/2016: Policy statement updated to add upper and lower limb spasticity in pediatric patients as an indication for Botox®.

12/30/2016: Code Reference section updated to add new 2017 CPT code 31573.

02/07/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

02/06/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

05/23/2018: Medical policy link updated in policy description.

03/26/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added statement to perform a formulary drug search on the patient's member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member's benefit plan. Policy description updated regarding botulinum toxin; removed the FDA approved indications. Policy section updated to add that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Policy updated to add Dysport as covered for non-cosmetic indications when meeting certain criteria. Policy statement criteria updated. Policy statement for botox administration was updated to change "Nurse Practitioner" to "non-physician practitioner." Sources updated. Code Reference section updated to add HCPCS code J0586 as covered (If determined to be medically necessary in patients age 2-18 years old only.) Added J0588 as not medically necessary.

10/01/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added policy statement that botox will not be used in conjunction with CGRP. There is limited data regarding concomitant use of Botox with CGRP therapy at this time. Sources updated.

02/18/2021: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy statement revised to state that Dysport (abobotulinumtoxinA), Myobloc (rimabotulinumtoxinB), and Xeomin (incobotulinumtoxinA) are currently considered not medically necessary as a formulary alternative is available. Policy statement regarding consideration of coverage updated to add that "Botox administration follows applicable state guidelines." Revised statement regarding approval of Botox and treatment if member has one or more indications. Medically necessary criteria updated for overactive bladder, urinary incontinence, migraine prophylaxis, spasticity, cervical dystonia, and blepharospasm. Added medically necessary criteria for primary axillary hyperhidrosis and strabismus. Added renewal evaluation criteria. Added statement that services related to deliver and/or administration of a medication which have not been approved through BCBSMS PA review process will be considered not medically necessary. Information regarding botox administration by a non-physician practitioner in Mississippi was moved from the Policy section to the Policy Guidelines. Policy Guidelines updated regarding BCBSMS request for medical records and to define medication failure. Sources updated. Code Reference section updated to remove HCPCS code J0586 from the Covered Codes table.

03/26/2021: Code Reference section updated to change "Covered Codes" to "Medically Necessary Codes." Added CPT codes 32664 and 64650 to the medically necessary codes table. Added CPT codes 15878, 64653, and 64818 to the not medically necessary codes table.

03/01/2023: Policy section updated to state that upon approval, the Botox medical claim must be filed with the clinically supported ICD-10 diagnosis code in the primary position to be considered medically necessary. Code Reference section updated to add ICD-10 diagnosis codes that must be filed in the primary position on the claim.

07/01/2023: Policy Exceptions updated regarding State Health Plan (State and School Employees) Participants.

09/18/2023: Code Reference section updated to remove deleted CPT code 64613.

07/08/2024: Code Reference section updated to add ICD-10 diagnosis codes G43.E01, G43.E09, G43.E11, G43.E19, G81.10, G83.10, G83.20, and G83.30.

06/03/2025: Policy reviewed by Pharmacy & Therapeutics (P&T) Committee; no changes.

10/01/2025: Code Reference section updated to add new ICD-10 diagnosis codes G35.A, G35.B0, G35.B1, G35.C0, G35.C1, and G35.D.

SOURCE(S)

1. A. Brashear, MD et al. "Safety and efficacy of NeuroBloc* (botulinum toxin type B) in type A -resistant cervical dystonia," in Neurology 1999; 53:1439-1446

2. Botox prescribing information. Allergan, Inc. September 2020. Last accessed December 2020.

3. Blue Cross Blue Shield Association policies # 5.01.05 and # 8.01.19

4. Blue Cross & Blue Shield Association Technology Evaluation Center 1996: Tab 6

5. Dysport prescribing information. Galderma Laboratories, L.P. July 2020. Last accessed December 2020.

6. Elan Pharmaceuticals

7. Hayes Alert, Volume IV, Number 1 – January 2001

8. Hayes Alert, Volume V, Number 4 – April 2002

9. Hayes Alert, Volume V, Number 7 – July 2002

10. Hayes Alert, Volume V, Number 8 – August 2002

11. Hayes Medical Technology Directory

12. M.F. Brin, MD et al. "Safety and efficacy of NeuroBloc* (botulinum toxin type A -resistant cervical dystonias," in Neurology 1999, 53:1431-1438.

13. Mississippi Board of Nursing

14. Mississippi State Board of Medical Licensure

15. MYOBLOC prescribing information. Solstice Neurosciences, LLC. September 2020. Last accessed December 2020.

16. TEC Vol 19, #3, 2002

17. Xeomin prescribing information. Merz North America, Inc. October 2020. Last accessed December 2020.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medical claims for Botox must be filed with the clinically supported ICD-10 diagnosis code from the table below in the primary position for reimbursement. Any Botox claim filed without a clinically supported diagnosis listed below in the primary position will be considered not medically necessary.

Medically Necessary Codes

Not Medically Necessary Codes

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