Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Incisional Hernia without Obstruction or Gangrene.
Treatment: Botox 100 Unit Vial (3), Pre-service.
The insurer denied the Botox 100 Unit Vial (3), Pre-service.
The denial is upheld.

This patient is a woman with BMI (body mass index) of 45.5. She has a complex past medical history that includes gastric bypass performed for morbid obesity, abdominoplasty and subsequent surgery to repair an incarcerated incisional hernia. The emergency ventral hernia repair operation was performed. The hernia recurred approximately one-year later.

The patient presented for surgical evaluation and was seen in consultation. A CT (computed tomography) scan identified a lower abdominal wall rectus diastasis with a fascial defect of approximately 8-cm (centimeter). Repeat CT (computed tomography) scan again showed an 8-cm (centimeter) hernia defect. Surgical consultation has yielded the recommendation for repair of the recurrent 8-cm (centimeter) ventral hernia with bilateral component separation and use of biologic mesh. 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/abdominal wall closure.

The submitted documentation includes the denial letter from the health plan that states that The Plan may consider approval of Botox when used in certain situations (strabismus, achalasia, anal fissures, certain disorders associated with spasticity or dystonia, etc.). The letter states that the submitted clinical information does not support the use of Botox for an approved clinical situation.

No, the requested Botox is not medically necessary.
This patient has an 8-cm (centimeter) lower abdominal wall recurrent hernia. She is morbidly obese with a current body mass index of 45, and she has had prior abdominoplasty. The submitted clinical documentation does not provide any detail regarding the anticipated compliance of the abdominal wall or provide clinical rationale for use of biologic, rather than permanent, mesh prosthesis. Based on the current published peer-reviewed literature it is not known to any degree of medical certainty whether or not use of pre-surgical Botox will improve her clinical result over standard treatment. 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 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. Botox A has not been incorporated into peer reviewed nationally endorsed society guidelines for use in ventral hernia repair surgery. The Update of Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (International Endohernia Society (IEHS)): Part B (Bittner) states that due to the low evidence of available data, no recommendations regarding the use of Botox A, progressive pneumoperitoneum, and tissue expanders as adjunct interventions in ventral hernia repair can be made. The references that resulted in this statement from the International Endohernia Society (IEHS)): Part B are listed on pages 3534 - 3535 of Surgical Endoscopy (11).

There is preliminary data and short-term results that indicate that Botox A may have a role in the treatment of ventral herniae, 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 Botox A as an adjunct to ventral hernia repair at this time. There is not long-term safety or outcomes data pertaining to use of Botox A as an adjunct to operative treatment of ventral hernia.

Yes, the health plan did act reasonably, with sound medical judgment, and in the best interest of the patient.
The health plan acted reasonably and with sound medical judgment with its determination regarding use of Botox injection for this patient.  This treatment is not an evidence-based therapy for the clinical indication in this case.