Ovarian and Internal Iliac Vein Endovascular Occlusion as a Treatment of Pelvic Congestion Syndrome

POLICY NUMBER

A.4.01.18

DESCRIPTION

Pelvic congestion syndrome is characterized by chronic pelvic pain that is often aggravated by standing; diagnostic criteria for this condition are not clearly defined. Endovascular occlusion (eg, embolization, sclerotherapy) of the ovarian and internal iliac veins has been proposed as a treatment for patients who fail medical therapy.

Pelvic Congestion Syndrome

Pelvic congestion syndrome is a chronic pelvic pain syndrome of variable location and intensity, which is associated with dyspareunia (which may be aggravated by standing) and symptoms suggestive of a venous origin, such as postcoital ache and tenderness over the ovarian point. The syndrome usually occurs before menopause, and pain is often greater before or during menses. The underlying etiology is thought to be related to varices of the pelvic veins, leading to pelvic vascular congestion. The lack of clear diagnostic criteria and overlapping clinical presentation of pelvic congestion syndrome with other potentially related pelvic venous disorders has hindered research progress and contributed to underdiagnosis of these disorders as causes of chronic pelvic pain. In 2021, a multidisciplinary, intersociety working group convened by the American Vein and Lymphatic Society published the Symptoms-Varices-Pathophysiology (SVP) classification of pelvic venous disorders which, in conjunction with the established Clinical-Etiologic-Anatomic-Physiologic classification for lower extremity venous disorders when applicable, places patients in homogeneous populations based on standardized definitions of presenting symptoms, involved variceal reservoirs, and underlying pathophysiology (including anatomic, hemodynamic, and etiologic disease features). The term pelvic venous disorder, accompanied by the patient-specific SVP classification, has been proposed to replace pelvic congestion syndrome and other historical nomenclature for related diseases (such as May-Thurner syndrome and nutcracker syndrome). As diagnostic criteria remain lacking, pelvic venous disorder as a cause of chronic pelvic pain amounts to a diagnosis of exclusion; evaluation may involve a variety of physical assessments, laboratory measurements, and/or imaging studies to eliminate other etiologies of chronic pelvic pain, such as cystitis or gynecologic malignancy.

TreatmentAn initial conservative approach to the treatment of pelvic congestion syndrome may involve analgesics (eg, short-term use of nonsteroidal anti-inflammatory drugs) and hormonal therapy, with or without psychotherapy. The evidence base for medical management consists primarily of 5 clinical trials of hormonal therapy (sample sizes ranging from 22 to 102) in which medroxyprogesterone (in combination with psychotherapy), goserelin, and etonogestrel demonstrated significant improvements in pain scores with up to 13 months of follow-up. Longer-term efficacy of these treatments has not been demonstrated, and the largest trial of medroxyprogesterone indicated rapid recurrence of symptoms with discontinuation. Surgical ligation of pelvic veins may be considered, but is also supported by limited evidence and further limited by need for general anesthesia, duration of hospitalization, recovery time, and associated morbidity. Embolization therapy and/or sclerotherapy of the ovarian and internal iliac veins has been proposed as an alternative to surgical vein ligation. Endovascular occlusion can be performed using a variety of materials including coils, vascular plugs, glue, liquid embolic agents, and gelatin sponge or powder (Gelfoam).

Ovarian and internal iliac vein embolization are surgical procedures and, as such, are not subject to regulation by the U.S. Food and Drug Administration (FDA).

Various products (eg, coils, vascular plugs, glue, liquid embolic agents, Gelfoam) and/or delivery-assist devices would be used to embolize the vein(s), and they would be subject to FDA regulation. Several products have been cleared for marketing by the 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™ PVA Embolization particles). Several embolization delivery systems have also been cleared via the 510(k) process for arterial and venous embolization in the peripheral vasculature featuring vascular plugs (eg, ArtVentive Medical Group, Inc. Endoluminal Occlusion System [EOS™]) or coils (eg, Cook Incorporated MReye® Flipper®). FDA product code: KRD.

In November 2004, the sclerosant agent Sotradecol® (sodium tetradecyl sulfate injection) was approved by the U.S. Food and Drug Administration for use in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves (ANDA 040541).

Also, see the  Occlusion of Uterine Arteries Using Transcatheter Embolization medical policy.

POLICY

Endovascular occlusion of the ovarian vein and internal iliac veins is considered investigational as a treatment of pelvic congestion syndrome.

POLICY EXCEPTIONS

Federal 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.

POLICY GUIDELINES

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 HISTORY

7/15/2004: 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 updated 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.

09/01/2017: Policy description updated. Policy statement unchanged.

08/22/2018: Policy description updated. Policy statement unchanged.

09/10/2019: Policy title changed from "Ovarian and Internal Iliac Vein Embolization as a Treatment of Pelvic Congestion Syndrome" to "Ovarian and Internal Iliac Vein Endovascular Occlusion as a Treatment of Pelvic Congestion Syndrome." "Embolization" changed to "endovascular occlusion" throughout the policy to clarify policy inclusion of both embolization and sclerotherapy treatment strategies.

09/09/2020: Policy reviewed; no changes.

12/09/2021: Policy description updated regarding products. Policy statement unchanged.

09/09/2022: Policy reviewed; no changes.

10/16/2023: Policy description updated regarding pelvic congestion syndrome and treatment. Policy statement unchanged.

09/12/2024: Policy reviewed; no changes.

09/17/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 4.01.18

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.