Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Pelvic Pain.
Treatment: Vein Embolization (procedure 37241 x 1), pre-service.

The insurer denied the Vein Embolization (procedure 37241 x 1), pre-service.  The denial is overturned.

The patient is a female with pelvic congestion syndrome. The request is for ovarian vein embolization.

Yes, the Vein Embolization (procedure 37241 x 1) is medically necessary.

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.

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 (United States Food and Drug Administration) approval and also does not require IRB (institutional review board) 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 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, 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 [Visual Analogue Scale] without any notable impact on menstrual cycle."

A review article 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 [pelvic congestion syndrome]," 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 found that "Transcatheter embolization was safe and effective for PCS [pelvic congestion syndrome]."

A review paper by Smith states that "Limited clinical evidence supports the use of embolotherapy in the management of pelvic congestion syndrome."

A randomized prospective trial by Guirola found that "Embolization for PCS [pelvic congestion syndrome] resulted in pain relief in 90% of patients; clinical success was not affected by embolic device."

A peer-reviewed systematic review paper by Brown states that "PCS [pelvic congestion syndrome] is a prevalent and treatable condition for which percutaneous treatment is safe and effective...Catheter-directed venography demonstrates improved sensitivity in detecting venous insufficiency compared with noninvasive imaging, as well as the benefit of simultaneous diagnosis and treatment, and a high rate of success in improving clinical symptoms."

In this patient's case, the requested Vein Embolization is safe, effective, generally accepted national standard of medical practice; not provided primarily for convenience of the patient or the practitioner, the least intensive and/or most appropriate alternatives among diagnostic and treatment options, provided in the most effective setting, and no other treatment would provide a clinically appropriate benefit at a lower intensity.