Oxford Health Plans > Medical and Administrative Policies > Botulinum Toxin-A (Botox or BTX-A) and Botulinum Toxin B (Myobloc or BTX-B), Botox Cosmetics for Commercial Plans
Title of Policy

Botulinum Toxin-A (Botox or BTX-A) and Botulinum Toxin B (Myobloc or BTX-B), Botox Cosmetics for Commercial Plans

The services described in Oxford policies are subject to the terms, conditions and limitations of the Member's contract or certificate. Unless otherwise stated, Oxford policies do not apply to Medicare Advantage enrollees. Oxford reserves the right, in its sole discretion, to modify policies as necessary without prior written notice unless otherwise required by Oxford's administrative procedures. The term Oxford includes Oxford Health Plans, LLC and all of its subsidiaries as appropriate for these policies as well as SecureHorizons and Evercare.

Certain policies may not be applicable to Self-Funded Members and certain insured products. Refer to the Member's plan of benefits or Certificate of Coverage to determine whether coverage is provided or if there are any exclusions or benefit limitations applicable to any of these policies. If there is a difference between any policy and the Member’s plan of benefits or Certificate of Coverage, the plan of benefits or Certificate of Coverage will govern.


Policy #: PHARMACY 105.12 T2

Coverage Statement:

Policy is applicable to:

    Commercial plans

For Medicare plans, refer to policy: Botulinum Toxin-A (Botox or BTX-A) and Botulinum Toxin B (Myobloc or BTX-B), Botox Cosmetics for Medicare.

Note: Botox cosmetics are not covered.

Conditions of Coverage
Benefit Type General benefits package
Referral Required
(Does not apply to non-gatekeeper products)
No
Authorization (Precertification always required for inpatient admission) Yes1
Precertification with MD Review No2
Site(s) of Service
(If not listed, MD Review required)
Home, Office
Special Considerations

1Precertification is required for services covered under the Member's General Benefits package when performed in the office of a participating provider. Precertification is not required, but encouraged, for out-of-network services performed in the office that are covered under the Member's General Benefits package. If precertification is not obtained, Oxford may review for medical necessity after the service is rendered.
2Review by a Medical Director or their designee is required for all ICD-9 diagnosis codes not listed in the Payment Guidelines section of this policy.

Description of Service/Assessment/Background Information:
Botulinum Toxin is a powerful neuromuscular blocking agent produced by the Clostridium botulinum, which is used to treat different focal spastic diseases and excessive muscle contractions, such as dystonias and spasticity. This toxin causes a presynaptic neuromuscular blockade, by inhibiting the release of acetylcholine from the nerve endings. Because of this chemical blockade, it causes local paresis or paralysis so that selected muscles can be treated.

Although a single clinical assessment that applies to all situations cannot be offered, in general, Botulinum Toxins have emerged as the therapy of choice for conditions characterized by excessive cholinergic activity.

Policy and Rationale:
Since this treatment is potentially cosmetic, strict clinical criteria must be met before it can be considered for coverage. Oxford will not cover Botox for cosmetic procedures. Refer to Oxford policy: Cosmetic and Reconstructive Procedures for Commercial Plans.

Oxford® covers Botulinum Type A and Botulinum Type B based on the below criteria.

Treatment/Application Guidelines:

Indications for Botulinum Toxin Type A
  1. Botulinum Toxin Type A has been tested or adopted for therapeutic use in five clinical areas:
    1. Ophthalmology
      • Blepharospasm
      • Strabismus
    2. Neurology
      • Focal dystonias, such as writer's cramp and segmental dystonias
      • Idiopathic torsion dystonia
      • Orofacial dyskinesia (i.e., jaw closure dystonia)
      • Cervical dystonia
      • Hemifacial spasm
      • Equines foot, if related to cerebral palsy
      • Hereditary spastic paraplegia
      • Infantile cerebral palsy
      • Spasticity due to multiple sclerosis
      • Neuromyeltis optica
      • Schilder's disease
      • Spastic hemiplegia
      • Spasticity related to stroke or spinal cord injury
      • Facial tics, when recommended by a neurologist. The following must be met:
        • **The Member must have failed a clinically supervised and documented trial of at least 3 anti-tic medications which have been titrated to maximum doses without benefit and/or effect.

        **This requirement does not apply to New Jersey lines of business.

      • Intractable headaches, when recommended by a neurologist. All of the following criteria MUST be met:
        1. Intractable migraine headaches, with or without aura, are occurring at least twice per month and cause a disability lasting three or more days, AND
        2. **Documented failed trials of at least three preventative anti-migraine medications (such as beta-blockers, calcium channel blockers, anticonvulsants, and/or antidepressants) with or without concomitant behavioral and/or physical therapies, after titration to maximum tolerated doses. Should a Member have a contraindication to a specific treatment or medications, this is considered as a treatment failure, and must be documented within the progress notes for submission.
          • Abortive medications being taken more than twice weekly.

        **This requirement does not apply to New Jersey lines of business.

    3. Otolaryngology
      • Spasmodic dysphonia or laryngeal dystonia
    4. Gastroenterology
      • Achalasia and cardiospasm*
      • Anal fissure
    5. Dermatology
      • Management of excessive sweating known as hyperhyirosis.

    *For Members diagnosed with achalasia and/or cardiospasm, Botox should be administered only after one or more of the conditions listed below have been met:

    • **Conventional therapy has failed

        **This requirement does not apply to New Jersey lines of business.

    • There is a high risk of complications from pneumatic dilation or surgical myotomy
    • Failed prior myotomies or dilatations
    • Esophageal perforations caused by a prior dilatation
    • The Member has epiphrenic diverticulum or hiatal hernia, which increases the risk perforation by dilatation.

    The patient who has spasticity is usually started with a low dose of Botulinum Toxin Type A (10 units) and the accepted maximum dosage per site is about 50-100 units. Other spastic or muscular contraction conditions, such as eye muscle disorders, (e.g., blepharospasm) may require lesser amounts such as only 3-5 units. For larger muscle groups, it is generally agreed that once a maximum of 25 units per site has been reached with no response, the treatment should be discontinued. The treatments may be resumed at a later date, if clinically appropriate.

    For patients demonstrating successful response, the effect of the injections generally lasts for 3 months. Therapy may be continued unless two successive injections utilizing appropriate or maximal dosage fail to elicit a satisfactory clinical response.

Indications for Botulinum Toxin Type B

Botulinum Toxin Type B has only been tested or adopted for therapeutic use in the clinical area of neurology for the treatment of cervical dystonia. Based upon the current literature reviews it will not be approved for any other conditions.

Limitations

Coverage of Botulinum Toxin Type A and Type B for certain spastic conditions (e.g., cerebral palsy, stroke, head trauma, spinal cord injuries, and multiple sclerosis) will be limited to those ICD-9 Codes listed in Payment Guidelines. All other uses in the treatment of other types of spasm, related to smooth or skeletal muscle types, will be considered investigational and, therefore, non-covered by Oxford.

Utilization Guidelines
  • It is generally not considered medically necessary to give Botulinum Toxin Type A and Type B injections for spastic or excess muscular contraction conditions more frequently than every 90 days.
  • For migraines, administration of 155 units per treatment cycle (a maximum of 200 total Units of Botulinum Toxin Type A billed for multiple injection sites) will be covered in a single session.
Note: Oxford will NOT cover the following medical conditions for Botox therapy due to insufficient literature to support clinical effectiveness:
  • First line management for migraines
  • Muscle tension headaches
  • Cluster headaches
  • Muscle spasms (strain/sprain of spine)
  • Myofascial pain
  • Fibromyalgia
  • BOTOX is not covered for the treatment of muscles pain, spasm, or tension related to musculoskeletal sprains/strains as there is insufficient evidence that such intervention is any more efficacious than other standard therapies already approved.
  • Management and care of wrinkles, frown lines, or other related cosmetic dermatological procedures
  • Tremors
  • Tics related to Tourette syndrome

Payment Guidelines:
  • If the upper and lower lids of the same eye or brow and/or adjacent facial muscles are injected at the same surgery, the procedure is considered to be unilateral. Bilateral procedures will be considered when both eyes or both sides of the face are injected.

Applicable HCPCS Codes

Code Description
J0585 Injection, onabotulinumtoxinA, 1 unit
J0586 Injection, abobotulinumtoxinA, 5 units
J0587 Injection, rimabotulinumtoxinB, 100 units
Q2040 Injection, incobotulinumtoxinA, 1 unit

ICD-9 Diagnosis Codes

The following ICD-9 diagnosis codes represent clinical indications that do not require Medical Director review:

Code Description
333.6 Genetic torsion dystonia
333.71-333.79 Acquired torsion dystonia
333.81-333.89 Fragments of torsion dystonia
334.1 Hereditary spastic paraplegia
340 Multiple sclerosis
341 Neuromyelitis optica
341.1 Schilder’s disease
341.8 Other demyelinating diseases of central nervous system
341.9 Demyelinating disease of central nervous system, unspecified
342.11 Spastic hemiplegia, affecting dominant side
342.12 Spastic hemiplegia, affecting non-dominant side
343.0-343.9 Infantile cerebral palsy
344.00-344.09 Quadriplegia and quadriparesis
344.1 Paraplegia
344.2 Diplegia of upper limbs
344.30-344.32 Monoplegia of lower limb
344.40-344.42 Monoplegia of upper limb
351.8 Other facial nerve disorders
378.00-378.08 Esotropia
378.10-378.18 Exotropia
378.20-378.24 Intermittent heterotropia
378.30-378.35 Other and unspecified heterotropia
378.40-378.45 Heterophoria
378.50-378.56 Paralytic strabismus
378.60-378.63 Mechanical strabismus
378.71-378.73 Other specified strabismus
378.81-378.87 Other disorders of binocular eye movements
378.9 Unspecified disorder of eye movements
478.75 Laryngeal spasm
530 Achalasia and cardiospasm
564.6 Anal spasm
565 Anal fissure
705.21-705.22 Focal hyperhidrosis
723.5 Torticollis, unspecified
728.85 Spasm of muscle
780.8 Generalized hyperhidrosis

Review by a Medical Director or their designee is required for all ICD-9 diagnosis codes not listed above.

References:

  1. Empire Medicare Services Local Medical Review Policy. DR010E01- New York, I16-E New Jersey. Revision date 1-1-03. Retrieved 5-15-03.
  2. Matthew, NT et al. Headache 2002 May; 42(5): 454 ABS S107. “Disease Modification in chronic migraine with botulinum toxin type A: long term experience".
  3. Barrientos, N., Chana P. Headache 2002 May; 42(5): 452 ABS 106. Efficacy and safety of botulinum toxin type A in the prophylatic treatment of migraine.
  4. J Med Assoc Thai 84 2002: 1199-1203. The First World Report of Botulinum A Toxin Injection for Status Migrainosus.
  5. Empire Medicare New York Policy. DR010E01. “Botulinum Toxin Type A”. Dated December 30, 2001. Retrieved May 23, 2002.
  6. Medicare News Brief – New York. MNB-2001-6. “Botulinum Toxin Type B (Myobloc)”. Dated June 2001. Retrieved May 23, 2002.
  7. Parker-Pope, Tara. Wrinkle Fighter Botox is Being Used to Treat a Variety of Ailments. Health Journal 2002.
  8. American Medical Association. Healthcare Common Procedure Coding System. Medicare’s National Level II Codes: HCPCS.
  9. American Medical Association. ICD-9-CM Code Book.
  10. American Academy of Neurology. Practice parameter: Evidence-based guidelines for migraine headache. Report of the Quality Standards Subcommittee of the American Academy of Neurology. Published in Neurology 2000; 55:754-763.
  11. Botulinum Toxin Type A: A New Paradigm in Headache Therapy: Abstract Review 2001: University of Wisconsin-Madison Medical School and Medical Education Network.

  12. Headache Currents, July/August 2004, American Headache Society, Blackwell Publishing.

  13. Prevention and Management of Headache - New Insights into the Role of Botulinum Toxins, 2004, The Institute for Medical Studies.

  14. ECRI Windows on Medical Technology, Botulinum Toxin for Treatment of Hyperhidrosis, September 2003.

  15. ECRI Hotline Report, Botulinum Toxin for Prevention and Treatment of Migraine, April 20, 2004.

  16. ECRI Health Technology Forecast, Botulinum Toxin for Migraine Pain, June 11, 2004.

  17. Salloway S, Stewart CF, Israeli L, et al. Botulinum toxin for refractory vocal tics. Mov Disord 1996;11:746-8.

  18. Marras C, Andrews D, Sime E, Lang AE. Botulinum toxins for simple motor tics: A randomized, double-blind, controlled clinical trial. Neurology 2001;56:605-10.

Effective Date: July 1, 2011 through Septeber 30, 2011