Appeal type: Drugs
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve botox treatment of gastroparesis. 
 
You asked the Plan to pre-approve botox treatment. You say that the botox treatment is medically necessary for 
the enrollee. The Plan denied your request. The Plan says the noted diagnosis is not one for which coverage is 
available for the requested service. 
 
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. FDA3 indications for onabotulinumtoxinA (Botox) as noted on the FDA website. 
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 
     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 
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. FDA10 indications for incobotulinumtoxinA (Xeomin) as noted on the FDA website 
6. FDA11 indications for rimabotulinumtoxinB (Myobloc) as noted on the FDA website 
 
Localization procedures would not be expected for easily targeted muscles and, therefore, would not be 
considered medically reasonable and necessary. Cosmetic procedures are not a covered benefit under Medicare. 
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. 
Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in 
this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and 
all existing CMS national coverage determinations, and all Medicare payment rules. You can find this information in the Local Coverage Determination (LCD): Botulinum Toxins (L38809). 
 
We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve botox treatment. Our reviewer says that 
the service is not medically necessary. Our physician reviewer found the enrollee does not meet the coverage 
indication for this procedure. The enrollee does not meet any of the limitations/exclusions for this request. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of botox treatment have not been met. Therefore, we decided that the Plan does 
not have to pre-approve botox treatment of gastroparesis.