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Pelvic congestion syndrome is characterized by chronic pelvic pain which often is aggravated by standing; diagnostic criteria for this condition are not well-defined. Embolization of the ovarian and internal iliac veins has been proposed as a treatment for patients who fail medical therapy.
Pelvic congestion syndrome is a chronic pelvic pain syndrome of variable location and intensity, which is associated with dyspareunia and postcoital pain and aggravated by standing. The syndrome occurs during the reproductive years, and pain is often greater before or during menses. The underlying etiology is thought to be related to varices of the ovarian veins, leading to pelvic congestion. As there are many etiologies of chronic pelvic pain, the pelvic congestion syndrome is often a diagnosis of exclusion, with the identification of varices using a variety of imaging methods, such as magnetic resonance imaging (MRI), computed tomography (CT) scanning, or contrast venography. However, the syndrome is still not well defined, and it is unclear whether pelvic congestion syndrome causes chronic pelvic pain. Although venous reflux is common, not all women with this condition experience chronic pelvic pain, and conversely, chronic pelvic pain is reported by women without pelvic congestion syndrome.
Initial treatment of pelvic congestion syndrome includes psychotherapy and medical therapy (eg, nonsteroidal anti-inflammatory drugs) and hormonal therapy. For patients who fail initial therapy, surgical ligation of the ovarian vein may be considered. Embolization therapy of the ovarian and internal iliac veins has been proposed as an alternative to surgical ovarian vein ligation. Vein embolization can be performed using a variety of materials including coils, glue and gel foam.
Ovarian and internal iliac vein embolization is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration (FDA).
Various materials (eg, coils, glue, gel foam) would be used to embolize the vein(s), and they would be subject to FDA regulation. Several products have been cleared for marketing by FDA through the 510(k) process for uterine fibroid embolization (eg, Embosphere® Microspheres, Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles) and/or embolization of hypervascular tumors and arteriovenous malformations (eg, Contour® Emboli PVA).
Also, see the Occlusion of Uterine Arteries Using Transcatheter Embolization medical policy.
POLICYEmbolization of the ovarian vein and internal iliac veins is considered investigational as a treatment of pelvic congestion syndrome.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY7/15/2004: Approved by Medical Policy Advisory Committee (MPAC)
10/1/2004: Code Reference section completed
6/8/2009: Policy reviewed, no changes
06/07/2010: Policy description udated regarding material used for vein embolization. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section.
07/29/2011: Policy reviewed; no changes.
07/13/2012: Policy reviewed; no changes.
08/14/2013: Policy reviewed; no changes.
08/06/2014: Policy reviewed; description updated. Policy statement unchanged.
08/27/2015: Code Reference section updated for ICD-10. Added ICD-9 procedure code 39.79 and CPT code 37241.
10/29/2015: Policy reviewed. Policy statement unchanged. Investigative definition updated in policy guidelines section.
05/27/2016: Policy number A.4.01.18 added.
09/22/2016: Policy description updated regarding pelvic congestion syndrome and FDA regulation of surgical procedures and products. Policy statement unchanged.
Blue Cross Blue Shield Association policy # 4.01.18
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.