Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Gynecological. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied: Botox. 
The denial is overturned. 

The patient is a female with history of chronic and interstitial cystitis and chronic dyspareunia related to the pelvic floor spasticity. She has been evaluated by urogynecology over the period of 2 to 3 years, last year she was seen in office at least 8 times. Her interstitial cystitis had improved significantly with Heparin bladder instillation. Unfortunately, despite multi-modality treatments that has included dilation therapy, pelvic floor physical therapy by a specialist physical therapist (PT), electrical stimulation and medications she has been unable to improve significantly to achieve successful coitus in several years. On most recent pelvic examination, she was found to have spastic and tender levator ani muscles. As she has failed multiple therapy, Botox injection into the pelvic floor musculature was discussed and patient accepted to trial it. The subject under review is the medical necessity for the Botox injections.

Yes, the requested health service or treatment of Botox for pelvic floor injection due to pelvic floor spasticity causing significant dyspareunia and related quality life issue is considered medically necessary for this patient.

Pelvic floor spasticity is a well-known entity and common in patients with chronic pain conditions such as interstitial cystitis as well as history of sexual abuse. Unfortunately, this patient has history both. There are no modalities specifically Food and Drug Administration (FDA) approved for the treatment of this unfortunate condition. Every therapy that are medically used for this condition are off label and not FDA approved. Treatment includes, as this patient has tried and failed, such as pelvic floor therapy particularly pelvic floor relaxation, dilation therapy, electrical stimulation, and medications including Valium suppository for relaxation of pelvic floor musculature. Unfortunately, none of these treatments have been effective enough for this patient to successfully achieve coitus in several years. Botox has been successfully used and this particular situation when other standard treatments have failed. There are articles in peer reviewed journal that have reported various degree of success for this condition. This is most certainly not a cosmetic treatment and has solid scientific basis for it. Unfortunately, outside of this treatment other treatment options for this patients are severely limited. Therefore, it would be reasonable and considered medically necessary for this patient to have trial of Botox injections in pelvic floor musculature for the relief for pelvic floor spasticity and related chronic dyspareunia.

As mentioned above this patient has failed multiple medical therapies that have included physical therapy, dilation therapy, electrical stimulation and medication therapy all of which have failed to improve her pelvic floor spasticity and related dyspareunia. Therefore, Botox which is medically accepted therapy for this condition would be considered standard of treatment and medically necessary for this patient.