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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. 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 Medicare Benefit Policy Manual, Chapter 15, Sections 50.4.1 and 50.4.2. 
 
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. The clinical indications for botulinum toxins have increased exponentially since first used two decades 
ago. They are used in the treatment of overactive skeletal muscles (e.g. Hemifacial spasm, dystonia and 
spasticity), smooth muscles (e.g. Detrusor over activity 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 also 
specific to the preparation of neurotoxin and are very different 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. 
Although botulinum toxins have only been FDA-approved for limited uses, they are frequently used off-label 
as well. 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, however, to use 
each drug in accordance with approved indications unless there are valid and documented reasons stating why 
the unapproved or unaccepted form is used. While this policy contains a single list of covered indications, this 
is not meant to imply that botulinum toxin products are interchangeable. 
 
Before consideration of coverage may be made: 
1. In most cases it should be established that the patient has been unresponsive to conventional methods of 
treatments such as medication, physical therapy and other methods used to control and/or treat spastic 
condition. 
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 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, noncovered by Medicare. 
3. Since organic writer's cramp is uncommon, Medicare would not expect to see the treatment of this 
condition to be billed frequently. 
4. 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.  
5. It is usually considered not medically necessary to give botulinum toxin injections for spastic conditions 
more frequently than every 90 days. There may be slight variation based on FDA indications for a 
particular product. 
6. 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.  
7. Medicare will allow payment for one injection per site regardless of the number of injections made into 
the site. The site description is included in the CPT code description. Payment will be based on the 
Medicare Physician Fee Schedule and National Correct Coding Initiative. 
8. Botulinum toxin may be covered in the treatment of achalasia.  This use appears to be safe and 
effective.  Two-thirds of patients respond within six months of treatment and effectiveness lasts an 
average of more than one year for the initial treatment, although shorter and longer durations have been 
reported.  
The use of botulinum toxin should not be endorsed for all patients, but it can be considered individually 
if: 
A. The patient has failed conventional therapy; 
B. The patient is at high risk of complications of pneumatic dilation or surgical myotomy; 
C. The patient has failed a prior myotomy or dilation; 
D. The patient has had a previous dilation-induced perforation; 
E. The patient has an epiphrenic diverticulum or hiatal hernia, both of which increase the risk of 
dilation-induced perforation. 
Some patients may fail a first injection and respond to a second.  Further therapy should be questioned 
if two treatments in a row fail.  Therapy can be repeated later in those who fail after an initial response. 
9. Migraine headaches are described as an intense pulsing or throbbing pain in one area of the head. The 
headaches are often accompanied by nausea, vomiting, and sensitivity to light and sound. Migraine 
usually begins with intermittent headache attacks 14 days or fewer each month (episodic migraine), but 
some patients go on to develop the more disabling chronic migraine.  To treat chronic migraines, 
botulinum toxin is given approximately every 12 weeks as multiple injections around the head and neck 
to try to dull future headache symptoms. Botulinum toxin has not been shown to work for the treatment 
of migraine headaches that occur 14 days or less per month, or for other forms of headache. 
10. Botulinum toxin for chronic anal fissure may be considered for the patient who has not responded 
satisfactorily to conventional therapy. 
You can find this rule in the Local Coverage Determination (LCD): Botulinum Toxin Type A and Type B 
(L34635) effective January 30, 2020. 
 
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.