Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Hernia repair
Treatment: Outpatient Botox Injection
The insurer denied: Outpatient Botox Injection
The denial is upheld

The patient is an adult male with BMI (body mass index) of 24 and with giant right inguinoscrotal hernia that contains all of the small bowel, ascending colon, and part of the transverse colon within the right hemiscrotum. He is reported to have loss of abdominal domain. He consulted with his surgeon and the surgeon has proposed adjuncts to facilitate hernia repair, including Botox injections into the bilateral abdominal wall muscles for 'chemical component separation.' The surgeon has also proposed progressive pre-operative pneumoperitoneum to allow for reduction of the hernia contents into the abdomen.
Pre-operative abdominal wall Botox performed by interventional radiology has been requested in an effort to relax the lateral abdominal wall to promote hernia repair. The submitted documentation includes the denial letter that states that the Plan will consider approval of Botox when used in certain situations (chronic migraine, overactive bladder/urinary incontinence due to detrusor overactivity, upper and lower limb spasticity, cervical dystonia, severe primary axillary hyperhidrosis, blepharospasms, achalasia, strabismus, anal fissure, and sialorrhea). The letter notes that the submitted clinical information does not support the use of Botox for an approved clinical situation. This denial is being appealed.

The requested Botox is not medically necessary.

This patient has giant right inguinoscrotal hernia. This hernia is reported to contain the entire small bowel and right colon. The submitted clinical documentation indicates that the provider in this case has proposed preoperative Botox injections into the bilateral abdominal wall muscles for 'chemical component separation' due to anticipated difficulty with compliance of the abdominal wall. Based on the current published peer-reviewed literature, it is not known to any degree of medical certainty whether the use of pre-surgical Botox will improve the clinical result over standard treatment in the setting of an inguinal hernia. Consequently, use of pre-surgical abdominal wall Botox injection is not medically necessary. Use of Botox does not require specific FDA (United States Food and Drug Administration) approval for use as an adjunct to surgical treatment of ventral hernia. However, there are no society guidelines that endorse the use of BTA (Botox A) for ventral hernia repair, and there is limited clinical data regarding the use of Botox A in this clinical setting. Existing publications are generally case series, feasibility studies, or retrospective reviews. Also, the existing literature that pertains to the use of 
Botox involves ventral hernia (not inguinal hernia). Botox A (BTA) has not been incorporated into peer reviewed nationally endorsed society guidelines for use in ventral or inguinal hernia repair surgery.
There is preliminary data and short-term results that indicate that BTA (Botox A) may have a role in the treatment of ventral hernia, however, the existing published data uniformly state that further study and long-term results are needed prior to this intervention being considered to be a standard of care and evidence-based therapy [1-4]. There are no publications that definitively support that there are improved clinically meaningful outcomes with BTA (Botox A) as an adjunct to ventral hernia repair at this time. There is no long-term safety or outcomes data pertaining to use of BTA (Botox A) as an adjunct to operative treatment of ventral hernia. There is no data that detail outcomes and efficacy of Botox injections of the lateral abdominal wall musculature for inguinal hernias as in this case.