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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
Medicare may cover the use of an FDA-approved drug or biological if it is safe and effective and otherwise 
reasonable and necessary for the patient. Food and Drug Administration (FDA) approved drugs used for 
indications other than what is indicated on the official label may be covered if the use is determined to be 
medically accepted, taking into consideration the major drug compendia, authoritative medical literature and/or 
accepted standards of medical practice. You can find this rule in the Centers for Medicare and Medicaid 
Services, Internet Only Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Sections 
50.4.1 and 50.4.2. 
 
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. 
 
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 writers 
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). 
 
You can find this information in the Local Coverage Determination (LCD) for Botulinum Toxin Types A and 
B Policy (L35170). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.