CMS Botulinum Toxin Types A and B Policy Form

Summary Of Evidence

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Analysis of Evidence

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Botulinum toxin injections are used to treat various focal muscle spastic disorders and excessive muscle contractions such as dystonia, spasms, twitches, etc. These drugs produce a presynaptic neuromuscular blockade by preventing the release of acetylcholine from the nerve endings. The resulting chemical denervation of muscle produces local paresis or paralysis and allows individual muscles to be weakened selectively. Botulinum toxins have the advantage of being potent neuromuscular blocking agents with good selectivity and duration of action.

Botulinum Toxin Type A (Botox-onabotulinumtoxinA, Xeomin -incobotulinumtoxinA and Dysport-abotulinumtoxinA) are derived from a culture of Hall strain Clostridium Botulinum. Botulinum toxin type B (Myobloc – rimabotulinumtoxinB) is derived from the Bean strain of Clostridium Botulinum. Type B has the same action on neuromuscular conduction (blockade) as Type A.

Botulinum toxin type A and botulinum toxin type B have many similarities and as experience has been gained, medical consensus has gradually developed that the two toxins have similar, but not identical, properties. Each botulinum toxin product is pharmacologically and clinically distinct, and therefore, not interchangeable with any other botulinum toxin product. As a result, approved indications for the two toxins differ. This A/B MAC has determined that the separate accepted indications for the four toxins will be combined into a single list of covered indications in this Local Coverage Determination (LCD) policy. However, it is the responsibility of providers to use each drug in accordance with the FDA approved indications unless there are valid and documented reasons stating why the unapproved/off label form is used, “Providers should consult the package insert of each neurotoxin to identify the FDA approved indications for each product."

Please note that the unit dose of one form must not be equated with the unit dose of any of the others, i.e., one unit of Botox does not equal one unit of Dysport, Xeomin or Myobloc.

1. 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. An exception to this general rule is that for certain treatments including focal dystonia, hemifacial spasm, orofacial dyskinesia, blepharospasm, severe writer’s cramp, laryngeal spasm, or dysphonia, botulinum toxin can be an initial mode of therapy, and in these circumstances, it is not necessary to show that other methods of treatment have been tried and proven unsuccessful.

2. Coverage of botulinum toxin for certain spastic conditions (e.g., cerebral palsy, stroke, head trauma, spinal cord injuries and multiple sclerosis) will be limited to those conditions listed in the Covered ICD-10-CM section of the billing and coding article (A57185). This group of codes shall be used only when accompanied by spasticity of central nervous system origin. Recently, there has been approval by the FDA for use in upper limb spasticity. All other uses in the treatment of other types of spasm, including smooth muscle types, will be considered as investigational (not proven effective) and, therefore, noncovered by Medicare. Claims submitted for tension headaches, myofascial pain, irritable colon, biliary dyskinesia, other forms of smooth muscle spasm not specifically addressed in the policy, and any other spastic conditions not listed in the ICD-10 CM Codes That Support Medical Necessity section of the Billing and Coding article (A57185) will be considered investigational, not safe and effective, or not accepted as the standard of practice within the medical community and, therefore, not medically reasonable and necessary.

3. Botulinum toxin can be used to reduce spasticity or excessive muscular contractions to relieve pain, to assist in posturing and walking, to allow better range of motion, to permit better physical therapy, and to reduce severe spasm in order to provide adequate perineal and palmar hygiene.

4. Botulinum toxin has indications for overactive bladder and severe primary axillary hyperhidrosis,

5. Due to the rarity of severe organic writer's cramp, Medicare would not expect to see the treatment of this condition billed frequently.

6. There may be patients who require Electromyography (EMG) in order to determine the proper injection site(s). The electromyography procedure codes specified in the HCPCS section of this policy may be covered if the physician has difficulty in determining the proper injection site(s).

It should be noted that needle electromyographic procedures include the interpretation of electrical waveforms measured by equipment that produces both visible and audible components of electrical signals recorded from the muscle(s) studied by the needle electrode. Electromyography equipment must be capable of showing both visual and auditory components of the electrical activity produced by and recorded from within muscle tissue by the needle electrode for myopathy or neuropathy diagnosis. For purposes of botulinum injection guidance, the EMG tools that have audible output alone are sufficient.

7. For the appropriate initial and total doses of botulinum toxins please consult the FDA manufacturers' recommendations or the AHFS.

8. Coverage of treatments provided may be continued unless any two treatments in a row, utilizing an appropriate or maximum dose of a botulinum toxin, fail to produce a satisfactory clinical response. In such situations it may be appropriate to use an alternative botulinum toxin once in order to determine if a more satisfactory response can be obtained. Providers must also document the results of and response to these injections.

9. Requests may be considered for redetermination (formerly appeal) for continued treatment during a treatment period or for resumption at a later date if satisfactory results have not been obtained and compelling clinical evidence of medical necessity for continued treatment is presented.

10. Medicare will allow payment for one injection per site regardless of the number of injections made into the site. A site is defined as including muscles of a single contiguous body part, such as a single limb, single eyelid, side of the face, side of the neck, both vocal cords, etc.

11. For treatment of achalasia and cardio spasm, botulinum toxin should be used only after one or more of these conditions have been met and documented:

• The patient has failed conventional therapy.
• The patient is at high risk of complications from pneumatic dilation or surgical myotomy.
• The patient who refuses surgical myotomy or balloon dilation, in preference to a less invasive risky procedure.
• A prior myotomy or dilatation has failed.
• A prior dilatation caused an esophageal perforation.
• The patient has an epiphrenic diverticulum or hiatal hernia, both of which increase the risk of dilatation-induced perforation.

12. Botulinum Toxin is covered for prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer). It is also covered for the 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.
    
    13. Treatment of skin wrinkles using botulinum toxin is cosmetic and is not covered by Medicare.
    
    14. Acceptance of botulinum toxin has not been established for the following conditions (USP DI 2006):

• Deviations over 50 prism diopters
• Restrictive strabismus
• Chronic paralytic strabismus except to reduce antagonist contracture in conjunction with surgical repair
• Duane’s syndrome with lateral rectus muscle weakness
• Recurrent temporomandibular joint (TMJ) disorder

15. Anal spasm, irritable colon, biliary dyskinesia, or any treatment of spastic conditions not listed as covered in this policy are considered to be cosmetic, investigational, or not safe and effective.
    
    16. The use of botulinum toxin to treat muscle tension is considered not proven effective.