Appeal type: unknown
Decision: unknown

 
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 (Botox, Dysport, Xeomin and Myobloc), will be considered 
medically reasonable and necessary when administered for treatment of FDA-labeled indications and Off-label 
indications (as applicable) below: 
1. FDA indications for onabotulinumtoxinA (Botox) as noted on the FDA 
website: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=
103000  
2. Off-Label indications for onabotulinumtoxinA (Botox) may be considered medically reasonable and 
necessary in patients for the following conditions: 
A. Esophageal achalasia in adults who are considered poor surgical candidates 
B. Chronic anal fissure for patients with inadequate response to conservative or pharmacologic 
treatment 
C. Essential hand tremor for patients with a high amplitude tremor that disrupts activities of daily 
living and have had inadequate response to oral pharmacotherapy such as propranolol and 
primidone 
D. Focal limb dystonia 
E. Hemifacial spasm in adults (cranial nerve VII disorder) 
F. Isolated oromandibular dystonia in adults 
G. Laryngeal dystonia (spastic dysphonia) for adductor type (ADSD) 
H. Bothersome simple motor tics in adolescents and adults when the benefits of treatment outweigh 
the risks 
I. Severely disabling or aggressive vocal tics in older adolescents and adults when the benefits of 
treatment outweigh the risks 
3. FDA indications for abobotulinumtoxinA (Dysport) as noted on the FDA 
website: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=
125274 
4. Off-label indications for abobotulinumtoxinA (Dysport) may be considered medically reasonable and 
necessary in patients for the following conditions: 
A. Blepharospasm in adults B. Hemifacial spasm in adults (cranial nerve VII disorder) 
C. Isolated oromandibular dystonia in adults 
5. FDA indications for incobotulinumtoxinA (Xeomin) as noted on the FDA 
website: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=
125360.  
6. FDA
 
indications for rimabotulinumtoxinB (Myobloc) as noted on the FDA 
website: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=
103846  
 
The following are limitations: 
1. Localization procedures would not be expected for easily targeted muscles and, therefore, would not be 
considered medically reasonable and necessary. 
2. Cosmetic procedures are not a covered benefit under Medicare. 
A. Treatment of wrinkles, also referred to as glabellar lines, smokers lines, crows feet, laugh lines 
and aging neck, using botulinum toxins is considered to be a cosmetic procedure, and is not 
covered under Medicare. 
You can find this rule in the Local Coverage Determination (LCD) for Botulinum Toxins, L38809. 
 
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.