Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Pelvic pain
Treatment: Ovarian vein embolization
The proposed treatment, ovarian vein embolization, is medically necessary.

The patient is a female with pelvic congestion syndrome requesting gonadal vein embolization.

There are no phase I, II or III clinical trials or determinations of safety in comparison to conventional alternatives or toxicity regarding ovarian and internal iliac vein embolization for pelvic congestion syndrome found by a search at ClinicalTrials.gov. Ovarian and internal iliac vein embolization is a procedure and does not need FDA approval and also does not require institutional review board (IRB) approval.  

A search on PubMed finds many articles concerning the treatment of pelvic congestion syndrome with the overall conclusion that ovarian and internal iliac vein embolization is efficacious, safe, has been performed for many years, and, along with surgery, is standard of care for the treatment of pelvic congestion syndrome (PCS).  A peer-reviewed prospective trial by Kim of 131 patients, published in 2006, found that: "embolotherapy can achieve significant improvement in pain perception levels in patients with chronic pelvic pain caused by pelvic venous congestion."  A prospective study of 56 patients performed by Venbrux, in 2002, found that: "For patients with ovarian/internal iliac varices, transcatheter embolotherapy provides a nonsurgical treatment option. There is a significant decrease in pain based on VAS without any notable impact on menstrual cycle."  A review article from 2006 states that ovarian vein embolization results are "equivalent to those of surgery and better than conventional medical therapy."  Several quotes from other peer-reviewed published review articles state that "[o]varian vein embolization using coils is a safe and effective therapeutic method for treatment of PCS" and "[o]varian and/or internal iliac vein embolization appears to be a safe, well-tolerated, effective treatment for pelvic congestion syndrome."  A retrospective paper of 113 patients by Nasser, in 2014, found that "Transcatheter embolization was safe and effective for PCS." A review paper by Smith, in 2012, states that "Limited clinical evidence supports the use of embolotherapy in the management of pelvic congestion syndrome."

The following definition of medical necessity is fulfilled: Services will be deemed medically necessary only when all the following criteria are met: 
1) They are appropriate and consistent with the diagnosis and treatment of the patient's medical condition; 
2) They are required for the direct care and treatment or management of that condition; 
3) If not provided the patient's medical condition would be adversely affected; 
4) They are provided in accordance with standards of generally accepted medical practice; 
5) They are not primarily for the convenience of the patient, the patient's family, the provider of services, or another provider; 
6) They are the most appropriate service(s), rendered in the most efficient and economical way, and at the most economical level of care which can safely be provided; and 
7) When the patient is an inpatient, the medical symptoms or conditions are such that diagnosis and treatment  cannot safely be provided in any other setting (e.g., outpatient, physician's office or at home).