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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. 
The rules state that Botulinum toxins are potent neuromuscular blocking agents that are useful in treating 
various focal muscle spastic disorders and excessive muscle contractions, such as dystonia, spasms, and 
twitches. They produce a presynaptic neuromuscular blockade by preventing the release of acetylcholine from 
the nerve endings. Since the resulting chemical denervation of muscle produces local paresis or paralysis, 
selected muscles can be treated. Botulinum toxins are used in the treatment of overactive skeletal muscles (e.g., 
Hemifacial spasm, dystonia and spasticity), smooth muscles (e.g., Detrusor overactivity and achalasia), glands 
(e.g., Sialorrhoea and hyperhidrosis) and additional conditions that are being investigated. 
There are currently four botulinum toxin products commercially available in the United States: 
onabotulinumtoxinA, rimabotulinumtoxinB, abobotulinumtoxinA, and incobotulinumtoxinA. Each preparation 
has distinct pharmacological and clinical profiles specified on the product insert. Dosing patterns are specific to 
the preparation of neurotoxin and varies between different serotypes. Failure to recognize the unique 
characteristics of each formulation of botulinum toxin can lead to undesired patient outcomes. It is expected 
that physicians will be familiar with and experienced in the use of these agents and utilize evidence-based 
medicine to select the appropriate drug and dose regimen for each patient condition. A patient who is not 
responsive or who ceases to respond to one serotype may respond to the other. 
 
Limitations 
Voluntary muscular contraction depends upon the release of acetylcholine from vesicles within a nerve ending 
following stimulation of the nerve. The acetylcholine is released into the neuromuscular junction, binding to 
specific proteins called receptors in the membrane of the muscle fiber. The effect of the acetylcholine at these 
receptors is to cause the muscle to contract. When a sufficient amount of acetylcholine has been released with 
subsequent binding to the muscle fiber proteins, muscle contraction occurs. Botulinum toxin type A and 
botulinum toxin type B create a chemical blockade by inhibiting the release of acetylcholine from the nerve 
ending vesicles thereby preventing the acetylcholine from binding to the proteins in the receptor site on the 
muscle. Localized weakness or paralysis occurs in the muscle injected with botulinum toxin. 
 
Approved indications for botulinum toxin type A and toxin type B differ. WPS GHA has determined that the 
separate accepted indications for the botulinum toxin products will be combined into a single list of covered indications in this Local Coverage Determination (LCD). It is the responsibility of providers to use each drug 
in accordance with approved indications. While this policy contains a single list of covered indications, this is 
not meant to imply that botulinum toxin products are interchangeable. 
1. 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 Billing and 
Coding: Botulinum Toxin Type A & B (A57474).  All other uses in the treatment of other types of 
spasm will be considered as investigational and therefore, non-covered by Medicare. 
2. Since organic writer's cramp is uncommon, Medicare would not expect to see the treatment of this 
condition to be billed frequently. 
3. The patient who has a spastic or excessive muscular contraction condition is usually started with a low 
dose of botulinum toxin.  Other spastic or muscular contraction conditions, such as eye muscle 
disorders, (e.g., blepharospasm) may require lesser amounts of botulinum toxin.  For larger muscle 
groups, it is generally agreed that once a maximum dose per site has been reached and there is no 
response, the treatment is discontinued.  The treatments may be resumed at a later date.  With response, 
the effect of the injections generally lasts for three months at which time the patient may require repeat 
injections to control the spastic or excessive muscular condition.  
4. It is usually considered not medically necessary to give botulinum toxin injections for spastic conditions 
more frequently than every 12 weeks. 
5. Coverage of treatments provided may be continued unless any two treatments in a row, utilizing an 
appropriate or maximum dose of botulinum toxin failed to produce satisfactory clinical response.  
6. Botulinum toxin may be covered in the treatment of achalasia. According to the 2018 ISDE achalasia 
guidelines, botulinum injections should mainly be used in patients age 50 or greater and for patients 
that are unfit for surgery or as a bridge to more definitive therapies such as surgery or balloon dilatation. 
7. Chronic migraine is defined as a headache occurring on 15 or more days a month for more than three 
months, which, on at least eight days/month has the features of migraine headache.. Treatment of 
chronic migraines will be covered when they meet the following diagnostic criteria: for migraine with 
aura and /or criteria for migraine without aura. Treatment with botulinum toxin may be given every 12 
weeks as multiple injections around the head and neck.  
A. Migraine with aura: 
1. At least two attacks fulfilling the following criteria a and b  
a. One or more of the following fully reversible aura symptoms  
i. Visual (aura, changes in vision) 
ii. sensory (e.g., tingling in hands or face, pins and needles, numbness 
iii. speech and/or language difficulties 
iv. motor (e.g., weakness) 
v. brainstem (e.g., vertigo, tinnitus, loss of hearing, diploplia, ataxia not 
attributable to sensory deficit, and decreased level of consciousness) 
vi. retinal (visual disturbance, flash of light, blind spot) 
b. At least three of the following six characteristics:  
i. at least one aura symptom spreads gradually over greater than 5 minutes 
ii. two or more aura symptoms occur in succession 
iii. each individual aura symptoms last 5-60 minutes 
iv. at least one aura symptom is unilateral 
v. at least one aura symptom is positive 
vi. the arura is accompanied, or followed within 60 minutes, by headache 
B. Migraine without aura:  
1. At least five attacks fulfilling the following criteria  
a. Headache attacks lasting 4-72 hours (when untreated or unsuccessfully treated) 
b. Headache has at least two of the following:  
i. unilateral location 
ii. pulsating quality iii. moderate or severe pain intensity 
iv. aggravation by or causing avoidance of routine physical activity (e.g. 
walking or climbing stairs) 
c. During headache at least one of the following:  
i. nausea and/or vomiting 
ii. photophobia and phonophobia 
8. Botulinum toxin for chronic anal fissure may be considered for the patient who has not responded 
satisfactorily to conservative treatment. Conservative treatment may include the use of bulking agents, 
sitz baths or topical agents. 
9. Botulinum toxin is covered for hyperhidrosis that significantly affects ones quality of life and cannot 
be managed adequately with topical agents. 
You can find this rule in the Local Coverage Determination (LCD) for Botulinum Toxin Type A & Type B, 
L34635. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.