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FDA APPROVED INDICATIONS

Botox® is indicated for prophylaxis of headaches in adult patients with chronic migraine (> 15 days per month with headache lasting 4 hours a day or longer),upper limb spasticity in adult patients, cervical dystonia in adult patients to reduce the severity of abnormal head position and neck pain, severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients, urinary incontinence due to detrusor overactivity associated with a neurologic condition in adults who have an inadequate response to or are intolerant of an anticholinergic medication, blepharospasm associated with dystonia in patients >12 years of age, and strabismus in patients > 12 years of age.

Dysport® is indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain in both toxin-naïve and previously treated patients.

Myobloc® is indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.

Xeomin® is indicated for the treatment of adults with cervical dystonia, to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naïve and previously treated patients and blepharospasm in adults previously treated with Botox®.

IDENTIFICATION

Generic Name: OnabotulinumtoxinA - Brand Name: Botox®

Generic Name: AbobotulinumtoxinA - Brand Name: Dysport®

Generic Name: RimabotulinumtoxinB - Brand Name: Myobloc®

Generic Name: IncobotulinumtoxinA - Brand Name: Xeomin®

Note: Botulinum toxin as a treatment of hyperhidrosis is considered in a separate medical policy.

Before consideration of coverage may be made, it should be established that the patient has been unresponsive to conventional methods of treatments such as medication, physical therapy and other appropriate methods used to control and/or treat spastic conditions.

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.

OnabotulinumtoxinA(Botox®) is medically necessary for the following non-cosmetic FDA approved indications only:

• OnabotulinumtoxinA (Botox®) is approved for the treatment of cervical dystonia (positional torticollis) in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.

Effective 04/01/11 for new starts, cervical dystonia must be 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 (ex. sternocleidomastoid, splenius, trapezius, or posterior cervical muscles.) Do not exceed a total dose of 360 units administered every 12 to 16 weeks or at longer intervals.

• OnabotulinumtoxinA (Botox®) is approved for the treatment of strabismus and blepharospasm associated with dystonia in patients 12 years of age and above. Effective 04/01/11 for new starts, a dose of 1.25 units to 2.5 units into each of 3 sites per affected eye should be administered for blepharospasm, and for strabismus, a dose of 1.25 units to 2.5 units initially in any one muscle should be administered.
• 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.
• OnabotulinumtoxinA (Botox®) administered by a board certified neurologist is also approved (by FDA on October 15, 2010) for prophylaxis of headaches in adult patients with chronic migraine (>15 days per month with headache lasting >4 hours a day documented in clinical notes) using a maximum total of 155 units divided across seven head and neck muscles every 12 weeks. Documentation of failure (> 3 months) with at least two agents (from different drug classes) used to prevent or reduce frequency of migraines is also required (ex. Inderal®, Blocadren®, Topamax®, Depakote®) before Botox will be considered.
• OnabotulinumtoxinA (Botox®) is also approved (by FDA on March 9, 2010) for upper limb spasticity in adult patients in the following muscles: 

Do not exceed a total dose of 360 units administered every 12 to 16 weeks or at longer intervals.

Documentation requirements for the use of Botox® injections include:

• Support for the medical necessity of the injection;
• A covered FDA approved diagnosis;
• A statement that traditional methods of treatments have been tried and proven unsuccessful;
• Dosage and frequency of the injections;
• Support of the clinical effectiveness of the injections;
• Specify the site(s) injected

State Health Plan (State and School Employees): OnabotulinumtoxinA (Botox®) ) is covered for spasmodic dysphonia (laryngeal spasm).

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.

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

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

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.

Hayes Medical Technology Directory

Blue Cross Blue Shield Association policies # 5.01.05 and # 8.01.19

Elan Pharmaceuticals

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

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

TEC Vol 19, #3, 2002

Hayes Alert, Volume IV, Number 1 – January 2001

Hayes Alert, Volume V, Number 4 – April 2002

Hayes Alert, Volume V, Number 7 – July 2002

Hayes Alert, Volume V, Number 8 – August 2002

Botox® Prescribing Information

MYOBLOC® Prescribing Information

Dysport® Prescribing Information

Xeomin® Prescribing Information

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

Covered Codes

This is not an all-inclusive list of non-covered procedure codes.

The code(s) listed below and ANY code not listed in the previous section are considered non-covered for this procedure. 

Non-Covered Codes 

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