Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #3:

Diagnosis: Pelvic congestion syndrome.

Treatment: vascular embolization or occlusion.

The insurer denied coverage for vascular embolization or occlusion.

The denial is upheld.

The patient has a history of migraines, anemia, ovarian cyst, hyperthyroidism, and pelvic congestion syndrome. The patient presented to the Interventional Radiologist's (IR) office for a follow up for pelvic pain in the setting of pelvic congestion syndrome (PCS). The patient reported increasing pelvic pain, pressure, and bleeding with menstruation. The patient presented for a follow up for possible ovarian vein embolization. The patient was amenable to the procedure.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcomes. 

Use of this treatment is not supported by peer reviewed data since it lacks efficacy and safety data from large, prospective studies. It is not standard of care and requires further testing before safety and efficacy can be established.

Below are the most recent and relevant studies applicable to this request:

Per Kolani et al., (2021) "There are few reports on the agenesis of the iliac veins especially as an etiology of pelvic congestion syndrome. They are generally discovered in young subjects with chronic venous insufficiency symptoms or superficial venous circulation. The surgical management of these patients must be carefully planned. Surgical stripping should ensure that the substitute veins are spared, at the risk of worsening the clinical symptoms."

Per O'Brien & Gillespie (2015) "Diagnosis of PCS requires a careful history, physical examination, and noninvasive imaging. Several large case series have demonstrated the efficacy of embolotherapy in the reduction of pelvic pain; thus, it is the most favored treatment option for patients with PCS. For patients with outflow obstruction due to nutcracker syndrome, a limited number of studies have demonstrated remission of symptoms with stenting of the LRV as an alternative to open surgery."

Per Ignacio et al., (2008) "The diagnosis of pelvic congestion syndrome (PCS) continues to challenge all physicians involved especially those in such specialties as anesthesia, gastroenterology, general surgery, obstetrics and gynecology, and interventional radiology. When other pelvic pathology is ruled out, an interventional radiologist may be consulted for additional evaluation and treatment of PCS. A heightened awareness and clinical suspicion for the specific symptomatology and associated findings may bring about a more rapid progression toward treatment. For most interventional radiologists who treat PCS patients, magnetic resonance imaging/MR venography (MRI/MRV), diagnostic venogram, and embolotherapy are at the center of diagnosis and treatment of PCS."

Per Saadat & Singh (2022) "Pelvic congestion syndrome (PCS) is a common cause of chronic pelvic pain in women of reproductive age. Pain that is intermittent or constant lasting for 3-6 months, present in the pelvic or abdominal region, occurring throughout the menstrual cycle, and without any association with pregnancy is chronic pelvic pain."      

Finally, a recent Cochrane review of patients with pelvic pain which included pelvic congestion syndrome found only 4 studies that could be included involving a total of 214 studies. Of note they found no randomized studies dealing with embolization. They noted that "However, the diagnostic criteria for pelvic congestion have not been clearly defined or validated (Amin 2021), and thus the literature in this field remains inconsistent and difficult to interpret."  Also noted that "While there is evidence for the release of potentially pain-producing agents from venous endothelium and perivascular nerve terminals (Stones 2000), the role of pelvic venous congestion in the pathogenesis remains unclear."

Vascular embolization or occlusion does not have final approval from the appropriate regulatory bodies for this diagnosis. 

The patient is not a good candidate for vascular embolization or occlusion as use of this treatment is not supported by peer reviewed data in this setting and in general since efficacy and safety have not been established. It is not standard of care, and it is not supported by professional organizations.     

Vascular embolization or occlusion is not the best available treatment for this patient at this time. Use of this treatment is not the best available. Both physical therapy and medical treatment are better options supported by peer reviewed data.     

Use of this treatment lacks efficacy and safety data and it is not known if the risks are equivalent or worse than for standard treatment.     

Use of this treatment is not likely to be more beneficial than any of the standard of care treatment or procedures. Use of this treatment is not supported by peer reviewed data.

In summary, the denial of vascular embolization or occlusion and coverage for the requested service/treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are substantially increased over standard treatments.