BlueCross and BlueShield of Montana Medical Policy/Codes
Therapeutic Embolization and Vessel Occlusion
Chapter: Maternity/Gyn/Reproduction
Current Effective Date: November 26, 2013
Original Effective Date: January 26, 2013
Publish Date: November 26, 2013
Revised Dates: October 29, 2013
Description

Therapeutic embolization is defined as the intravascular deposition of particulate liquid, mechanical agents, or autologous blood clot to produce intentional vessel occlusion. Embolic vascular occlusion may be performed at any level from large arteries or veins to the capillary beds, and it may be temporary or permanent in nature. Therapeutic embolization has been applied to virtually every vascular territory, to:

  • Arrest hemorrhage,
  • Occlude congenital and acquired vascular abnormalities,
  • Palliate neoplasms, or
  • Ablate tissue.

Occlusion of Uterine Arteries Using Transcatheter Embolization or Laparoscopic Occlusion to Treat Uterine Fibroids

Uterine leiomyomata (i.e., fibroids) are extremely common benign tumors that can be located primarily within the uterine cavity (submucosal fibroids) or on the serosal surface of the uterus. Two techniques, transcatheter uterine artery embolization (UAE) and laparoscopic bipolar occlusion of the uterine vessels have been developed to directly devascularize the uterine fibroid and potentially serve as alternatives to hysterectomy.

Treatment for uterine fibroids is usually sought when they are associated with menorrhagia, pelvic pain, urinary symptoms (i.e., frequency), or are suspected to be the cause of infertility. Treatment options include medical therapy with gonadotropin agonists or gestagen suppression or various types of surgical therapy. Hysterectomy is considered the definitive surgical treatment for those who no longer wish to maintain fertility. Various types of myomectomy, which describes removal of the fibroid with retention of the uterus, have also been described. Hysteroscopic myomectomy involves removal of submucosal fibroids using either a resectoscope or a laser. Subserosal fibroids can be removed via an open abdominal or laparoscopic approach. Laparoscopic laser coagulation of uterine fibroids is a unique approach in that the fibroid is not physically removed, but instead multiple (up to 75) laparoscopic laser punctures of the uterine fibroids are performed in an effort to devascularize the fibroid and induce atrophy. Two techniques have been developed that directly devascularize the uterine fibroid by interrupting the uterine arteries. UAE involves selective catheterization of the uterine arteries with injection of embolization material. More recently, laparoscopic bipolar coagulation of the uterine vessels has been investigated as an alternative to UAE.

Regulatory Status

In April 2000, Embosphere® Microspheres (Biosphere Medical) were cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for hypervascularized tumors and arteriovenous malformations (AVMs). In November 2002, this product was cleared for marketing specifically for use in uterine fibroid embolization. Since that time, several other devices have been cleared for marketing. In 2003, Contour® Emboli PVA (Boston Scientific) was cleared for the embolization of peripheral hypervascular tumors and peripheral AVMs. In March 2004, the Contour SE™ (Boston Scientific) was cleared by the FDA for treatment of uterine fibroids. In December 2008, Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles received FDA marketing clearance for use in uterine fibroid embolization.

No devices have specific clearance or approval from the U.S. Food and Drug Administration (FDA) for laparoscopic bipolar occlusion of the uterine vessels.

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

Pelvic congestion syndrome is a condition of chronic pelvic pain 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. For those who fail medical therapy with analgesics, surgical ligation of the ovarian vein has been considered. More recently, embolization therapy of the ovarian and internal iliac veins has been proposed. Vein embolization can be performed using a variety of materials including coils, glue, and gel foam.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage

Transcatheter therapeutic embolization or vessel occlusion may be considered medically necessary for the following:

  1. Uterine arteries as a treatment of uterine fibroids (leiomyomata) that meet the following criteria:
    • Excessive uterine bleeding as evidenced by either profuse bleeding lasting more than eight days, or anemia due to acute or chronic blood loss; or
    • Pelvic discomfort caused by leiomyomata, either acute severe pain, chronic lower abdominal pain, or low back pressure or bladder pressure with urinary frequency not due to urinary tract infection; or
  2. Uterine arteries as treatment of post-partum hemorrhage; OR
  3. Congenital or acquired vascular anomaly; OR
  4. Acute or recurrent hemorrhage; OR
  5. Devascularization of neoplasms for palliation; OR
  6. Symptomatic varicocele.                                           

One repeat transcatheter therapeutic embolization or vessel occlusion of uterine arteries to treat persistent symptoms of uterine fibroids after an initial uterine artery embolization may be considered medically necessary when there is documentation of continued symptoms such as bleeding or pain, in combination with findings on imaging of an incomplete initial procedure, as evidenced by continued blood flow to the treated regions.

Transcatheter embolization for the management of cervical ectopic pregnancy is considered experimental, investigational and unproven.

Laparoscopic occlusion of the uterine arteries using bipolar coagulation is considered experimental, investigational and unproven.

Embolization of the ovarian vein and internal iliac veins is considered experimental, investigational and unproven as a treatment of pelvic congestion syndrome.

Policy Guidelines

There are no specific CPT codes for ovarian and internal iliac vein embolization. The nonspecific CPT codes 36012 and 37204 might be billed.

Rationale

Occlusion of Uterine Arteries Using Laparoscopic Occlusion to Treat Uterine Fibroids

No random controlled trials (RCTs) were identified that compared laparoscopic uterine artery occlusion (UAO) to surgery. The literature searches retrieved two European cohort studies (n = 21 and n = 114) on laparoscopic occlusion. Both studies are limited due to a lack of appropriate controls. A retrospective evaluation of the complications and recurrence rate from the study of 114 patients found a 7.1% complication rate with a rate of fibroid recurrence of 9%. (2) The recurrence-free survival rate at a median of 23.6 months follow-up was 88.3%.

Two RCTs were identified comparing transcatheter uterine artery embolization (UAE) and laparoscopic UAO.

A small RCT was conducted in India; 20 women with symptomatic fibroids were randomized to UAE (n=10) or laparoscopic UAO (n=10). (5) The primary outcome was symptomatic improvement in blood loss, measured by pictorial blood loss assessment charts. The groups were unbalanced at baseline—the pictorial blood loss was significantly higher in the laparoscopy group compared to the UAE group. The mean reduction in the blood loss score three months and six months postintervention did not differ significantly between groups. At six months, the percent reduction in blood loss scores was 60% in the UAE group and 41% in the laparoscopy group, p=0.44. The subjective pain score at day one after surgery, a secondary measure, was significantly greater in the UAE group compared to the laparoscopy group (mean scores of 6.5 and 2.7, respectively, on a visual analogue scale [VAS]). Although blood loss was similar in the two groups, the sample size was too small to draw accurate conclusions about the comparative efficacy of the procedures.

Occlusion of Uterine Arteries Using Transcatheter Embolization

UAE for treatment of uterine fibroids

UAE compared to surgery

In 2011, van der Kooij and colleagues published a meta-analysis of RCTs comparing UAE and surgery for treating symptomatic uterine fibroids and presented up to 5-year follow-up data. (8) The investigators identified 11 articles reporting on 5 RCTs. The overall intra-procedural and early post-procedural complication rates were similar with the 2 procedures. However, length of hospital stay, need for blood transfusion, and febrile morbidity were significantly lower in the UAE group compared to the surgery group. At 12 months, a pooled analysis of 2 studies found a significantly higher reintervention rate in the UAE group compared to the surgery group (odds ratio [OR]: 5.78, 95% confidence interval [CI]: 2.14 to 15.58). Pooled analyses of quality-of-life variables at 12 months did not find significant differences between groups. Results were similar after 5 years. The reintervention rate was significantly higher at 5 years, according to a pooled analysis of 2 trials (OR: 5.41, 95% CI: 2.48 to 11.81).

A Cochrane review also conducted a meta-analysis of 5 RCTs comparing UAE to surgery in women with symptomatic uterine fibroids. (9) Pooled analyses did not find statistically significant differences in patient satisfaction with UAE or surgery after 2 years (OR: 0.69, 95% CI: 0.40 to 1.21, 5 trials) or 5 years (OR: 0.90, 95% CI: 0.45-1.90, 2 trials). UAE was associated with a lower procedure length, shorter hospital stay, shorter time to resumption of routine activities, and lower likelihood of blood transfusion. There were no significant differences between UAE and surgery in terms of major complications, but there was a higher rate of minor complications and reintervention with UAE.

Two key trials are described below.

The Randomized Trial of Embolization versus Surgical Treatment for Fibroids (REST) multicenter trial assigned patients in a 2:1 ratio to undergo UAE (n=106) or surgery (43 hysterectomies and 8 myomectomies). (10) The embolization group had lower postoperative pain (3.0 vs. 4.6, respectively) and faster recovery (e.g., 1- vs. 5-day median hospitalization, respectively). Of 7 identified pregnancies in the UAE group, 2 resulted in successful live births. Five-year follow-up data from the REST trial were published in 2011. (11) A total of 144 of 157 (92%) randomized patients were included in the 5-year analysis. Quality-of-life and symptom scores were similar in the 2 groups at 5 years. For example, the mean symptom score was 4.5 in the UAE group and 4.8 in the surgery group (scores ranged from 15, markedly worse to 5, markedly better). By the 5-year follow-up, 27 of 106 (25%) in the UAE group and 2 of 51 (4%) in the surgery group had received an additional intervention for continued or recurrent symptoms. The total rate of further intervention for symptoms or adverse events over the 5-year period was 32% in the UAE group and 4% after surgery. In the UAE group, there were 3 technical failures of the procedure, 8 repeat UAEs, and 18 hysterectomies. Note that one woman had both a repeat UAE and a hysterectomy, and 2 women were not embolized after randomization and subsequently underwent surgery.

The Embolization versus hysterectomy (EMMY) trial from the Netherlands included 177 women with uterine fibroids and heavy menstrual bleeding who were scheduled to undergo hysterectomy. They were randomized to receive UAE (n=88) or hysterectomy (n=89). (12, 13) By the 2-year follow-up, 19 of the 81 (23%) women who actually received UAE had undergone a hysterectomy. An analysis of health-related quality of life (HRQOL) outcomes at 2 years found similar improvement in both groups overall. The defecation distress inventory (DDI) score improved significantly in only the UAE group starting at 6 months. A report of 5-year outcome data from the EMMY trial was published in 2010. (14) A total of 70 of the 89 (79%) patients originally randomized to the hysterectomy group and 75 of 88 (85%) in the UAE group completed questionnaires at 60 months. In an intention-to-treat (ITT) analysis, 23 of 81 (28.4%) women who had received UAE underwent hysterectomy during the 5 years. Including the hysterectomies, 58 of 81 (71.6%) women in the UAE group no longer had menorrhagia. There were no significant differences between groups in health-related quality of life at 5 years, as assessed by mental and physical components of the Short Form-36 (SF-36). For example, the mean difference in change scores at 60 months on the physical component summary of the SF-36 was 1.26 (95% CI: 2.16 to 4.70). Within the hysterectomy group, there was a statistically significantly worse physical health score at 5 years (mean of 6.87) compared to 2 years (mean of 7.26), p=0.01. The UAE group did not have a significant change in the mean physical health score, which was 6.87 at 5 years and 5.80 at 2 years, p=0.34. There was also not a statistically significant difference in the rate of reported urinary incontinence. Similar to the 2-year finding, the DDI significantly improved over time in the UAE group but not in the group assigned to initial hysterectomy. There was not, however, a statistically significant difference between groups in defecation function at 5 years. The authors did not discuss their level of statistical power to detect between-group differences.

Several RCTs comparing UAE and surgery have been published since the literature search conducted for the van der Kooij meta-analysis. A study from China reported only 6-month follow-up data. (15) An RCT by Manyonda and colleagues from the U.K. focused on myomectomy. (16) The investigators randomized women with symptomatic fibroids to UAE (n=82) or myomectomy (n=81). Mean hospital stay was significantly shorter after UAE than surgery (2 vs. 4 days, respectively; p<0.0001). There were no significant differences in minor or major complications. A total of 120 of 163 (74%) were available for the analysis of quality of life, the primary outcome measure. There were no significant differences between groups in change in quality-of-life scores from baseline to 1 year. Nine patients (11%) in the UAE group required additional intervention, and 3 patients (4%) in the myomectomy group later underwent hysterectomy.

Repeat UAE to treat recurrent or persistent symptoms

A few retrospective case series on repeat UAE were identified. In 2009, McLucas and colleagues published a study in which the charts of 1,058 women who had undergone initial bilateral UAE at several U.S. centers were reviewed. (17) Forty-two (4%) patients had documentation of persistent symptoms, and they were offered a second bilateral UAE. Thirty-nine patients had repeat procedures, and 34 of these (87%) completed a follow-up questionnaire at least 6 months postembolization. Before the second UAE procedure, 27 of the 34 (79%) women reported severe bleeding, and only 2 (6%) women reported severe bleeding after the procedure. Similarly, the number of women with severe pain decreased from 20 (59%) to 2 (6%), and with severe pressure decreased from 18 (53%) to 2 (6%). A total of 4 individuals experienced severe levels of one or more symptoms after the second UAE. Prospective comparative studies are needed to confirm the findings.

In 2006, Yousefi and colleagues reported on 24 patients who underwent repeat embolization for recurrent or persistent symptoms 6-66 months after the initial procedure. (18) The most common symptoms were pressure and/or bulk symptoms (n=15), recurrent heavy bleeding, (n=12) and pelvic pain or cramping (n=7). Follow-up data were available on 21 of 24 (87.5%) after the second UAE; 19 (90%) reported symptom control.

UAE compared to laparoscopic occlusion

Two RCTs were identified comparing transcatheter UAE and laparoscopic UAO. The larger study with longer follow-up was by Hald and colleagues and was conducted at a university hospital in Norway. (19) The investigators evaluated clinical outcomes in 66 premenopausal women (mean age: 43 years) with symptomatic uterine fibroids who were randomized to treatment with either laparoscopic occlusion of uterine arteries or UAE. Women who wanted to bear children in the future, had a large uterus, had undergone multiple previous open abdominal surgeries, and who had bleeding disorders were excluded. The primary outcome was reduction in blood loss at 6 months’ post-intervention, as measured by a pictorial blood loss assessment chart. Fifty-eight women underwent treatment, 29 with UAE and 29 with laparoscopic occlusion. The proportion of women who had a reduction in blood loss after 6 months did not differ between the treatment groups (52% after UAE and 53% after laparoscopy, respectively; p=0.96). An additional publication reported on follow-up data at a median of 48 months after treatment (range: 8-73 months). (20) The cumulative clinical failure and recurrence rate was significantly lower for patients in the UAE group (17%, n=5) compared to the laparoscopy group (48%, n=17), p=0.02. Moreover, fewer patients in the UAE group (7%, n=2) had a hysterectomy than in the laparoscopy group (28%, n=8), p=0.41. The authors concluded that UAE is superior to laparoscopic UAO for treatment of uterine fibroids.

Impact of UAE treatment of uterine fibroids on fertility and pregnancy outcomes

A 2010 systematic review by Homer and Saridogan identified a total of 227 pregnancies after UAE for uterine fibroids from 8 published reports. (21) Miscarriage rates were compared to a control group of 1,121 pregnancies in women with intramural fibroids from 14 studies. The overall pooled miscarriage rate was 80 of 227 (35.2%) in the UAE group compared to 185 of 1,121 (16.5%) in the fibroid group, p<0.001. In addition, the review compared obstetric outcomes in women with UAE to a control group of 4,454 women from 10 studies on pregnancies complicated by fibroids. The rate of Cesarean section was significantly higher in the UAE group (66%) than in the fibroid group (48.6%), p<0.001. There was also a significantly higher rate of postpartum hemorrhage in the UAE group compared to the fibroid group, 14% versus 2.5%, p<0.001. Rates of preterm delivery, malpresentation, and intra-uterine growth retardation did not differ significantly between groups.

UAE for treatment of postpartum uterine hemorrhage (PPH)

No RCTs or other comparative studies evaluating UAE for treating PPH were identified. Several case series have been published. Representative larger series are described below:

In 2011, Ganguli and colleagues published data on 66 women who underwent UAE for the treatment of PPH. (22) The clinical success rate, defined as obviation of hysterectomy, was 95%. Three of 66 (5%) women had a subsequent hysterectomy. In addition to the 3 clinical failures, there were 3 (5%) major complications after UAE: one case of lower-extremity deep vein thrombosis, one case of postprocedural pancreatitis, and one admission for intravenous antibiotic treatment for presumed endometritis. Nine pregnancies after UAE were identified; there were 2 spontaneous abortions and 7 viable gestations.

In 2009, Kirby and colleagues published a retrospective analysis of data from 43 women who underwent UAE for primary PPH. (23) In this study, clinical success was defined as cessation of bleeding without need for repeat embolization, laparotomy or hysterectomy and without mortality. Eight of 43 (19%) of women had a hysterectomy prior to UAE. Of the remaining 35 women, clinical success was achieved in 29 women (83%). Considering the sample as a whole, the clinical success rate was 29 of 43 (67%). Complications among women who had a UAE without a previous hysterectomy included one case of a groin hematoma, one inadvertent perforation of the left obturator artery during UAE, one bleeding necrotic fibroid tumor, and one case of symptoms consistent with endometritis.

UAE for treatment of cervical ectopic pregnancy

No RCTs or other comparative studies evaluating UAE for treating cervical ectopic pregnancy were identified. The published literature consisted of case series with small numbers of patients. Sample sizes ranged from 2 to 20 patients, and most studies had fewer than 10 patients. The largest prospective series was conducted in China by Xiaolin and colleagues. (24) Patients underwent UAE and in conjunction with methotrexate injections before, during, and after the UAE procedure. Median follow-up was 12 months (range 1 to 50 months). Two of 20 patients (10%) had recurrent vaginal bleeding; the other 18 had no significant bleeding after UAE. Five patients (25%) had an additional curettage procedure due to bleeding and/or high levels of beta (b)-hCG. The uterus was preserved in all patients, and normal menses resumed after 2 to 4 months. Eight of 16 (50%) women who attempted another pregnancy achieved a normal pregnancy within 1 year. There were 2 miscarriages and 6 live births at term.

Ongoing Clinical Trials

The FIRSST: Comparing MRgFUS (MR guided Focused Ultrasound) versus UAE (Uterine Artery Embolization) (NCT00995878) (25): This is an RCT comparing MRgFUS to UAE in premenopausal women at least 25 years of age who have symptomatic uterine fibroids. The study is sponsored by the Mayo Clinic. The expected study completion date is December 2015.

Practice Guidelines and Position Statements

In 2004, the American College of Obstetricians and Gynecologists (ACOG) issued a committee opinion on UAE. (27) The statement offered the following conclusions: “…. There is insufficient evidence in the current literature to ensure safety in women desiring to retain their fertility. Furthermore, pregnancy-related outcomes remain understudied. Therefore, the procedure should be considered investigational or relatively contraindicated in women wishing to retain fertility. The use of uterine artery embolization in postmenopausal women is rarely, if ever, indicated.” In August 2008, ACOG issued a Practice Bulletin titled “Alternatives to Hysterectomy in the Management of Leiomyomas." (28) This Bulletin contained the following statement regarding UAE: “Based on long- and short-term outcomes, uterine artery embolization is a safe and effective option for appropriately selected women who wish to retain their uteri.”

In 2006 (reaffirmed in 2008), ACOG issued a practice bulletin (No. 76) on management of postpartum hemorrhage. (26) The bulletin states that UAE may be indicated under the following circumstances:

“A patient with stable vital signs and persistent bleeding, especially if the rate of loss is not excessive, may be a candidate for arterial embolization. Radiographic identification of bleeding vessels allows embolization with Gelfoam, coils, or glue. Balloon occlusion is also a technique used in such circumstances. Embolization can be used for bleeding that continues after hysterectomy or can be used as an alternative to hysterectomy to preserve fertility.”

2010 Quality Improvement Guidelines from the Society of Interventional Radiology stated that uterine artery embolization is indicated in women with uterine leiomyomas that are causing significant symptoms. (29) Absolute contraindications to UAE are viable pregnancy, active infection, and suspected uterine, cervical, or adnexal malignancy (unless the procedure is being performed for palliation or in conjunction with surgery). A desire to maintain fertility is a relative contraindication.

Summary

Uterine artery embolization involves selective catheterization of the uterine arteries with injection of embolization material. The available evidence suggests that the net health outcome after UAE for uterine fibroids is reasonable compared to surgery, especially for women who do not desire to maintain their fertility; this procedure may be considered medically necessary. Meta-analyses of RCTs have found similar levels of quality of life after 5 years among women receiving UAE or surgery, although there were more reinterventions in the UAE group. Reviews of fertility and pregnancy outcomes after UAE suggest that successful pregnancy is possible but that there are higher rates of miscarriage and postpartum hemorrhage compared to women with intramural fibroids and higher rates of preterm delivery compared to women whose fibroids had been treated by myomectomy. Although there are a lack of controlled studies on repeat UAE, case series found a high rate of success after a second UAE for recurrent or persistent symptoms.

There are no controlled studies evaluating UAE for postpartum hemorrhage or cervical ectopic pregnancy. However, due to available evidence from case series and strong support from clinical reviewers, UAE for postpartum hemorrhage may be considered medically necessary. In the absence of either controlled studies or strong clinical support, UAE for management of cervical ectopic pregnancy is considered investigational.

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

No RCTs have been published comparing embolization therapy for pelvic congestion syndrome to an alternative or sham/placebo treatment. RCTs are especially needed in situations such as this where the primary symptom is pain, a subjective outcome for which a placebo response to treatment is likely. The published studies consist of case series, most of which were retrospective and conducted outside of the United States. A summary table of the largest case series, (31-36, respectively) identified in review articles by Naoum (37) and Kies and Kim (38) is as follows:

Study

Location

No. of Patients

Mean Follow-Up (months)

Clinical Outcome (improvement in symptoms

Maleux et al., 2000 (31) 

Belgium 

41

19.9

Significant: 58.9% 

Venbrux et al., 2002 (32) 

U.S.

56

22.1

Significant or partial: 96% 

Pieri et al., 2003 (33) 

Italy 

33

12

Significant: 100% 

Kim et al., 2006 (34) 

U.S.

127

45

Significant: 83% 

Kwon et al., 2007 (35) 

Korea 

67

~44.8

Significant or partial: 82% 

Gandini et al., 2008 (36) 

Italy

38

12

Significant: 100% 

In addition to the efficacy of embolization for treating pelvic congestion syndrome, the published literature has addressed the issue of diagnosis of pelvic congestion syndrome and whether it causes pelvic pain. In his 2009 review article, Naoum, a U.S.-based vascular surgeon, stated that venography is considered the ‘gold standard’ for diagnosing pelvic congestion syndrome but that other types of diagnostic imaging, e.g., ultrasound, computed tomography (CT) scan, are also used. (37) He added that a diagnostic algorithm to guide patient management still needs to be developed. Similarly, in 2010, Tu and colleagues published a systematic review of literature on the diagnosis and management of pelvic congestion syndrome. (39) The authors commented that studies have rarely specified explicit diagnostic criteria for pelvic congestion syndrome and that definitions of pelvic pain have varied widely among studies. Moreover, most studies have not used objective outcome measures.

A 2012 review article by Ball and colleagues stated that the issue of whether pelvic congestion syndrome causes chronic pelvic pain is still a matter of debate. (40) The authors noted that although venous reflux is common, not all women with this condition experience chronic pelvic pain and, additionally, chronic pelvic pain is reported by women without pelvic congestion syndrome. The authors recommended a systematic review of evidence on the causal link between pelvic congestion syndrome and chronic pelvic pain, and they stated that, if causation is established, well-designed RCTs evaluating embolization therapy may be needed.

Practice Guidelines and Position Statements

American College of Obstetricians and Gynecologists (ACOG) website has no relevant policy positions on embolization for treating pelvic congestion syndrome. The Society of Interventional Radiology (SIR) fact sheet on chronic pelvic pain in women endorses coil embolization as an effective treatment option for pelvic congestion syndrome (41)

Summary

RCTs using well-defined diagnostic criteria are required to establish the safety and efficacy of this procedure. The available literature regarding embolization therapy for the treatment of pelvic congestion syndrome is inadequate to draw clinical conclusions; thus the treatment is considered experimental, investigational and unproven.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

39.72, 39.75, 39.76, 39.79, 44.44, 68.25, 99.29, 218.0-218.9, 417.0, 447.0, 456.4, 625.5, 666.0-666.2, 747.60–747.69, 747.81, 784.7

ICD-10 Codes

I28.0, I28.1, I77.0-I77.9, I86.0, N94.89, D25.0-D25.9, O00.8, O27.1, O27.2, O27.3-O27.9, O28.0, O28.1, O28.2, O28.3, O28.8, O72.0-O72.2,  Q26.5, Q26.6, Q27.33, Q27.8, 3E033GC, 3E043GC, 04LE3DT, 04LE3ZT, 04LF3DU, 04LF3ZU

Procedural Codes: 36012, 36245, 36246, 36247, 37204, 37210, 61624, 61626, 75894, S2095
References

Occlusion of Uterine Arteries Using Laparoscopic Occlusion to Treat Uterine Fibroids (1-6); Occlusion of Uterine Arteries Using Transcatheter Embolization (7-30); Ovarian and Internal Iliac Vein Embolization as a Treatment of Pelvic Congestion Syndrome (31-42)

  1. Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Uterine artery embolization for treatment of symptomatic uterine fibroids. TEC Assessments 2002; Volume 17, Tab 8.
  2. Holub Z, Eim J, Jabor A et al. Complications and myoma recurrence after laparoscopic uterine artery occlusion for symptomatic myomas. J Obstet Gynaecol Res 2006; 32(1):55-62.
  3. Hald K, Klow NE, Qvigstad E et al. Laparoscopic occlusion compared with embolization of uterine vessels: a randomized controlled trial. Obstet Gynecol 2007; 109(1):20-7.
  4. Hald K, Noreng HJ, Istre O et al. Uterine artery embolization versus laparoscopic occlusion of uterine arteries for leiomyomas: Long-term results of a randomized comparative trial. J Vasc Interv Radiol 2009; 20(10):1303-10.
  5. Ambat S, Mittal S, Srivastava DN et al. Uterine artery embolization versus laparoscopic occlusion of uterine vessels for management of symptomatic uterine fibroids. Int J Gynecol Obstet 2009; 105(2):162-5.
  6. Occlusion of Uterine Arteries Using Laparoscopic Occlusion to Treat Uterine Fibroids – Archived. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (February 2011) Surgery 4.01.20.
  7. Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Uterine artery embolization for treatment of symptomatic uterine fibroids. TEC Assessments 2002; Volume 17, Tab 8.
  8. Van der Kooij SM, Bipat S, Hehenkamp WJ et al. Uterine artery embolization versus surgery in the treatment of symptomatic fibroids: a systematic review and meta-analysis. Am J Obstet Gynecol 2011; 205(4):317.e1-8.
  9. Gupta JK, Shinha A, Lumsden MA et al. Uterine artery embolization for symptomatic uterine fibroids. Cochrane Database Syst Rev 2012; CD005073.
  10. Edwards RD, Moss JG, Lumsden MA et al; Committee of the Randomized Trial of Embolization versus Surgical Treatment for Fibroids. Uterine-artery embolization versus surgery for symptomatic uterine fibroids. N Engl J Med 2007; 356(4):360-70.
  11. Moss JG, Cooper CG, Khaund A et al. Randomised comparison of uterine artery embolisation (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): 5-year results. BJOG 2011; 118(8):936-44.
  12. Hehenkamp WJ, Volkers NA, Donderwinkel FJ et al. Uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids (EMMY trial): peri- and postprocedural results from a randomized controlled trial. Am J Obstet Gynecol 2005; 193(5):1618-29
  13. Volkers NA, Hehenkamp WJ, Birnie E et al. Uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids: 2 years' outcome from the randomized EMMY trial. Am J Obstet Gynecol 2007; 196(6):519.
  14. van der Kooij SM, Hehenkamp WJ, Volkers NA et al. Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids: 5-year outcome from the randomized EMMY trial. Am J Obstet Gynecol 2010; 203(2):105.e1-13.
  15. Jun F, Yamin L, Xinli X et al. Uterine artery embolization versus surgery for symptomatic uterine fibroids: a randomized controlled trial and a meta-analysis of the literature. Arch Gynecol Obstet 2012; 285(5):1407-13.
  16. Manyonda IT, Bratby M, Horst JS et al. Uterine artery embolization versus myomectomy: Impact on quality of life-results from the FUME (Fibroids of the Uterus: Myomectomy versus Embolization) trial. Cardiovasc Intervent Radiol 2012; 35(3):530-6.
  17. McLucas B, Reed RA. Repeat uterine artery embolization following poor results. Minim Invasive Ther Allied Technol 2009; 18(2):82-6.
  18. Yousefi S, Czeyda-Pommersheim F, White AM et al. Repeat uterine artery embolization: indications and technical findings. J Vasc Interv Radiol 2006; 17(12):1923-9.
  19. Hald K, Klow NE, Qvigstad E et al. Laparoscopic occlusion compared with embolization of uterine vessels: a randomized controlled trial. Obstet Gynecol 2007; 109(1):20-7.
  20. Hald K, Noreng HJ, Istre O et al. Uterine artery embolization versus laparoscopic occlusion of uterine arteries for leiomyomas: long-term results of a randomized comparative trial. J Vasc Interv Radiol 2009; 20(10):1303-10.
  21. Homer H, Saridogan E. Uterine artery embolization for fibroids is associated with an increased risk of miscarriage. Fertil Steril 2010; 94(1):324-30.
  22. Ganguli S, Stecker MS, Pyne D et al. Uterine artery embolization in the treatment of postpartum uterine hemorrhage. J Vasc Interv Radiol 2011; 22(2):169-76.
  23. Kirby JM, Kachura JR, Rajan DK et al. Arterial embolization for primary postpartum hemorrhage. J Vasc Interv Radiol 2009; 20(8):1036-45.
  24. Xiaolin Z, Ling L, Chengxin Y et al. Transcatheter intraarterial methotrexate infusion combined with selective uterine artery embolization as a treatment option for cervical pregnancy. J Vasc Interv Radiol 2010; 21(6):836-41.
  25. The FIRSST: Comparing MRgFUS (MR guided Focused Ultrasound) versus UAE (Uterine Artery Embolization) (NCT00995878). Last updated November 22, 2011. Available online at: www.ClinicalTrials.gov . Last accessed January 2012.
  26. American College of Obstetricians and Gynecologists (ACOG). Postpartum hemorrhage. 2006; (ACOG Practice Bulletin; no. 76). Available online at: <www.guideline.gov>. Last accessed June 2012.
  27. ACOG Committee Opinion No. 293. Uterine artery embolization. Obstet Gynecol 2004; 103(2):403-4.
  28. ACOG Practice Bulletin. Alternatives to hysterectomy in the management of leiomyomas. Obstet Gynecol 2008; 112(2 pt 1):387-400.
  29. Stokes LS, Wallace MJ, Godwin RB et al. Quality improvement guidelines for uterine artery embolization for symptomatic leiomyomas. J Vasc Interv Radiol 2010; 21(8):1153-63.
  30. Occlusion of Uterine Arteries Using Transcatheter Embolization. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (July 2012) Surgery 4.01.11.
  31. Maleux G, Stockx L, Wilms G et al. Ovarian vein embolization for the treatment of pelvic congestion syndrome: long-term technical and clinical results. J Vasc Interv Radiol 2000; 11(7):859-64.
  32. Venbrux AC, Chang AH, Kim HS et al. Pelvic congestion syndrome (pelvic venous incompetence): impact of ovarian and internal iliac vein embolotherapy on menstrual cycle and chronic pelvic pain. J Vasc Interv Radiol 2002; 13(2 pt 1):171-8.
  33. Pieri S, Agresti P, Morucci M et al. Percutaneous treatment of pelvic congestion syndrome. Radiol Med 2003; 105(1-2):76-82.
  34. Kim HS, Malhotra AD, Rowe PC et al. Embolotherapy for pelvic congestion syndrome: long-term results. J Vasc Interv Radiol 2006; 17(2 pt 1):289-97.
  35. Kwon SH, Oh JH, Ko KR et al. Transcatheter ovarian vein embolization using coils for the treatment of pelvic congestion syndrome. Cardiovasc Intervent Radiol 2007; 30(4):655-61.
  36. Gandini R, Chiocchi M, Konda D et al. Transcatheter foam sclerotherapy of symptomatic female varicocele with sodium-tetradecyl-sulfate foam. Cardiovasc Intervent Radiol 2008; 31(4):778-84.
  37. Naoum JJ. Endovascular therapy for pelvic congestion syndrome. Methodist Debakey Cardiovasc J 2009; 5(4):36-8.
  38. Kies DD, Kim HS. Pelvic congestion syndrome: a review of current diagnostic and minimally invasive treatment modalities. Phlebology 2012; 27(Suppl 1):52-7.
  39. Tu FF, Hahn D, Steege JF. Pelvic congestion syndrome-associated pelvic pain: a systematic review of diagnosis and management. Obstet Gynecol Surv 2010; 65(5):332-40.
  40. Ball E, Khan KS, Meads C. Does pelvic congestion syndrome exist and can it be treated? Acta Obstet Gynecol Scand 2012 [Epub ahead of print].
  41. Society of Interventional Radiology (SIR). Patient Information Sheet on Pelvic Congestion Syndrome. Available online at: www.sirweb.org Last accessed April 2012.
  42. Ovarian and Internal Iliac Vein Embolization as a Treatment of Pelvic Congestion Syndrome. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (May 2012) Surgery 4.01.18.
History
October 2012 New 2012 BCBSMT medical policy based on MEDLINE literature search through May 2012..
November 2013 Policy formatting and language revised.  Title changed from "Occlusion of Uterine Arteries" to "Therapeutic Embolization and Vessel Occlusion".  Added the following indications to the medically necessary statement: 1.) Uterine arteries as treatment of post-partum hemorrhage; OR 2.) Congenital or acquired vascular anomaly; OR 3.) Acute or recurrent hemorrhage; OR 4.) Devascularization of neoplasms for palliation; OR 5.) Symptomatic varicocele.  Added codes 36012, 61624, 61626, 75894, and S2095.
BCBSMT Home
®Registered marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. ®LIVE SMART. LIVE HEALTHY. is a registered mark of BCBSMT, an independent licensee of the Blue Cross and Blue Shield Association, serving the residents and businesses of Montana.
CPT codes, descriptions and material only are copyrighted by the American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS Restrictions Apply to Government Use. CPT only © American Medical Association.
Therapeutic Embolization and Vessel Occlusion