Clinical Policy Title: Uterine artery embolization

Clinical Policy Title: Uterine artery embolization Clinical Policy Number: 12.03.02 Effective Date: Initial Review Date: Most Recent Review Date: Next...
Author: Oswald Horn
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Clinical Policy Title: Uterine artery embolization Clinical Policy Number: 12.03.02 Effective Date: Initial Review Date: Most Recent Review Date: Next Review Date:

April 1, 2015 October 15, 2014 October 21, 2015 October 2016

Related policies: CP# 12.03.03

Policy contains:  Uterine artery embolization.  Leiomyoma.  Fibroids.  Adenomyosis.

Endometrial Ablation

ABOUT THIS POLICY: Keystone First has developed clinical policies to assist with making coverage determinations. Keystone First’s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by Keystone First when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Keystone First’s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Keystone First’s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Keystone First will update its clinical policies as necessary. Keystone First’s clinical policies are not guarantees of payment.

Coverage policy 1. Keystone First considers the use of uterine artery embolization (UAE) for treatment of uterine fibroids to be clinically proven and, therefore, medically necessary when the following criteria are met: Clinical criteria (Criteria A, B and C must be met) A. Presence of one or more persistent symptoms directly attributed to uterine fibroids, including, but not limited to, excessive menstrual bleeding (menorrhagia), bulk-related pelvic pain, pressure or discomfort, urinary symptoms referable to compression of the ureter or bladder, and/or dyspareunia.

B. Any of the following criteria are met:  The use of anesthesia places the individual at high surgical risk.  The individual has medical contraindications to hysterectomy (e.g., morbid obesity).  The use of hormonal therapy is contraindicated, or the individual is intolerant to or has previously failed a course of hormone therapy. 1

Clinical criteria (Criteria A, B and C must be met)  

The individual wishes to avoid a hysterectomy. The individual has hydronephrosis.

C. None of the following contraindications to UAE are present:  Viable pregnancy, active untreated infection, suspicion of leiomyosarcoma or adnexal malignancy (unless uterine artery embolization is performed for palliation or with surgery), and severe vascular disease limiting access.  Contraindications to angiographic procedures (e.g., coagulopathy, severe contrast allergy and renal impairment).  Prior treatment or procedure that alters pelvic arterial anatomy, (e.g., salpingo-oophorectomy, resection of an ectopic pregnancy or pelvic irradiation), which may make selection and embolization of the uterine arteries difficult or impossible.  Future pregnancy is planned, as its effectiveness in this population has not been determined.  Compromised immune system, chronic endometritis or partially treated pelvic infection, extensive endometriosis or diffuse adenomyosis, markedly pedunculated subserosal fibroids (risk of detachment) or submucosal fibroids, and associated gynecological conditions requiring surgery (e.g., uterine prolapse or stress incontinence).  Currently using a gonadotropin-releasing agonist, as it may cause diffuse vasospasm and impact the technical success of the procedure. UAE should be performed no earlier than six weeks after discontinuation of hormone therapy.

2. Keystone First considers the use of repeat UAE to be clinically proven and, therefore, medically necessary to treat symptoms of uterine fibroids that persist after an initial uterine artery embolization. 3. Keystone First considers the use of UAE for treatment of adenomyosis to be not clinically proven and, therefore, not medically necessary. Limitations: All other uses of UAE are not medically necessary. Note: The following CPT/HCPCS code is not listed in the Pennsylvania Medicaid fee schedule: S2095 - Transcatheter occlusion or embolization for tumor destruction, percutaneous, any method, using yttrium-90 microspheres

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Alternative covered services:   

Prescription drug therapy (e.g., gonadotropin-releasing hormone agonist). Hysterectomy. Myomectomy (via hysteroscopy, laparoscopy or laparotomy).

Background Uterine fibroids (also known as leiomyomas or myomas) are benign growths that attach to the muscle tissue of the uterus. They are the most common tumor in women of reproductive age, affecting more than 66 percent of women by 50 years of age. Symptomatic uterine fibroids are the leading cause of hysterectomy in the U.S. (Whiteman 2008). The size, shape and location of uterine fibroids can vary greatly (ACOG 2014). They may be present inside the uterus, on its outer surface or within its wall, or attached to it by a stem-like structure. A woman may have only one fibroid or many of varying sizes. Uterine fibroids may remain very small for a long time and suddenly grow rapidly, or grow slowly over a number of years. Uterine fibroids may or may not be symptomatic. Adenomyosis (also known as adenomyoma or endometriosis interna) is a benign condition in which the inner lining of the uterus (the endometrium) breaks through the outer muscular wall of the uterus. Adenomyosis can cause menstrual cramps, lower abdominal pressure and bloating before menstrual periods and can result in heavy periods (NLM 2014). The condition may be localized or diffusely spread throughout the uterus, and may coincide with endometriosis or leiomyomas. Adenomyosis is diagnosed with increasing frequency in women attending infertility clinics, but its role in infertility independent of these other conditions is not well understood. Symptoms associated with uterine fibroids and adenomyosis include changes in menstruation, abnormal bleeding, anemia from blood loss, abdominal or lower back pain, difficulty urinating or frequent urination, difficult bowel movements, and abdominal cramps. They may cause an enlarged uterus and abdomen, miscarriages, and infertility. Rarely, they can be associated with cancer. Asymptomatic growths may be found incidentally during a routine pelvic exam or during tests for other problems. The differential work up includes laboratory testing, ultrasonography, hysteroscopy, hysterosalpingography, sonohysterography and laparoscopy. Imaging tests, such as magnetic resonance imaging (MRI) and computed tomography, may be used to further differentiate these conditions. Some of these tests may be used to track the growth of these conditions over time (ACOG 2014).

Treatment options Uterine fibroids that are asymptomatic, are small, or occur in a woman who is nearing menopause often do not require treatment. Symptomatic growths may signal the need for treatment. For some women, drug therapy is an option to reduce heavy bleeding and painful periods. Drug treatment includes hormonal birth 3

control methods, gonadotropin-releasing hormone (GnRH) agonists, and a progestin-releasing intrauterine device. However, these agents have several drawbacks. Once the agent is discontinued, the growths quickly return to their previous volume and symptoms typically recur. In addition, chronic use of GnRH agonists results in trabecular bone loss. Drug treatment may not prevent the new tumors. Therefore, these agents are typically used for temporary situations, such as to reduce tumor size prior to surgical therapy (ACOG 2014). The need for surgical treatment is based on the clinical stability of the patient, the severity of bleeding, contraindications to medical management, the patient’s lack of response to medical management, the underlying medical condition of the patient, and the patient’s desire for future fertility (ACOG 2013). Fertility-preserving surgical options include dilation and curettage, myomectomy, hysteroscopy, endometrial ablation, and uterine artery embolization. These options remove the tumor(s) while leaving the uterus in place, enabling the women to bear children, but they do not prevent new tumors from developing (Stokes 2010). If new growths appear, more surgery may be needed. A hysterectomy removes the entire uterus and is done when other treatments have not worked, are not possible or the tumors are very large. The effectiveness of other techniques, such as magnetic resonance imaging-guided ultrasound, is being studied (ACOG 2014, Burke 2012). Uterine artery embolization According to the Society of Interventional Radiology (SIR) Standards of Practice Committee, uterine artery embolization (UAE) is defined as the delivery of an embolic agent, typically tris-acryl gelatin microspheres or spherical polyvinyl alcohol, via a catheter or microcatheter placed in both uterine arteries (Stokes 2010). The U.S. Food and Drug Administration (FDA) has approved a number of embolic agents specifically for UAE (FDA 2014). The goal of UAE is to occlude or markedly reduce the arterial blood flow of all distal uterine artery branches feeding the tumor(s), producing irreversible ischemic injury to the tumor while avoiding permanent damage to the uterus. Since the 1990s, UAE has seen rapid adoption into the standard practice of interventional radiology (Burke 2012). The procedure is performed typically under conscious sedation using either a unilateral or bilateral common femoral artery approach, depending on operator preference. Afterward, the patient is observed and treated for postprocedure pain and/or nausea. The patient is followed closely for the first 24 to 48 hours after discharge for adequacy of pain and nausea control and to assess for potential complications. At three to six months following the procedure, the patient is re-evaluated for treatment efficacy (Stokes 2010). Technical success of UAE is defined as occlusion or marked reduction in blood flow in both uterine arteries. Successful embolization of only one uterine artery is considered a technical failure unless only a single uterine artery is present, as the intention is to reduce blood flow bilaterally. Arterial spasm may prevent successful cannulation or result in premature reduction of blood flow, but the latter situation may be recognized as a true technical failure only retrospectively after infarction of the growth has failed to occur, preferably confirmed by contrast-enhanced MRI. Clinical success is defined as the significant improvement or resolution of presenting symptoms, such as menorrhagia or bulk-related pain, bloating, urinary frequency, or constipation, without additional therapy (Stokes 2010).

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Appropriate patient selection and management are integral to successful outcomes with UAE. Presenting symptoms, clinical history, physical examination, imaging findings, and patient preferences influence candidacy for UAE. However, identification of appropriate candidates for UAE often relies on ill-defined objective criteria (e.g., tumor size) or subjective criteria (e.g., perceived symptom severity). Evidence-based recommendations are needed to assess effectiveness of, and guide appropriate patient selection for, UAE.

While there are a growing number of small case studies on the use of UAE for treatment of adenomyosis, there are no meta-analyses to date (December 6, 2014) demonstrating effectiveness of this modality. ACOG Committee Opinion of April 2013 on “Management of Acute Abnormal Bleeding in Non-Pregnant Reproductive-Aged Women” lists UAE as having a series of case reports only for support. Keystone First considers this level of evidence of interest, but not yet clinically proven.

Searches Keystone First searched PubMed and the databases of:  UK National Health Services Centre for Reviews and Dissemination.  Agency for Healthcare Research and Quality’s National Guideline Clearinghouse and other evidencebased practice centers.  The Centers for Medicare & Medicaid Services (CMS). We conducted searches on September 23, 2015.Search terms were: “uterine artery embolization" [MeSH] and "Leiomyoma" [MeSH] or "fibroma" [MeSH] or “adenomyosis” [MeSH], and also free text terms for “uterine artery embolization” limited to human studies published in English.

We included:  Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies.  Guidelines based on systematic reviews.  Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes — sometimes referred to as efficiency studies — which also rank near the top of evidence hierarchies. Findings For this policy, we identified seven systematic reviews (Mohan 2013, Martin 2013, Toor 2012, Gupta 2012, Maheshwari 2012, Popovic 2011 and Hayes 2009) and five evidence-based guidelines (ACOG 2013, ACOG 2008, ACOG 2004, Burke 2012 and Stokes 2010). For treatment of uterine fibroids with UAE, the evidence consists of randomized comparative studies and observational studies of low to moderate quality. For adenomyosis, the evidence is of low quality, consisting of uncontrolled studies, case-control studies, case reports and expert opinion.

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Patients included in these studies had confirmed uterine fibroids or adenomyosis that caused a variety of problems, including anemia, menorrhagia, pain and bulk-related symptoms. Some patients had elected to undergo UAE in an attempt to preserve fertility, but most studies excluded patients seeking to become pregnant. Outcome measures included symptom relief, resumption of normal menses, resolution of anemia, changes in growth volume, complications, pregnancy and patient satisfaction. Control groups generally consisted of patients who underwent hysterectomy and myomectomy. None of the studies compared UAE with pharmaceutical therapies. While there is insufficient evidence to establish definitive patient selection criteria for UAE, the evidence permits the following conclusions to be made: 

There is sufficient evidence to support UAE as an alternative to hysterectomy or myomectomy in women with symptomatic uterine fibroids who wish to avoid surgical therapies or who are not good surgical candidates, and who are not concerned about preserving their fertility (Martin 2013, Toor 2012, Gupta 2012 and Hayes 2009; Table 1). The evidence suggests UAE is a safe procedure and provides significant symptomatic relief associated with uterine fibroids that was comparable to surgery, although some patients who undergo UAE may require subsequent hysterectomy. Evidence-based guidance recommends consideration of UAE in patients who are not good candidates for myomectomy and in patients who refuse surgery (ACOG 2008, Stokes 2010). Major complications are uncommon and occur at a rate of approximately 3 percent in observational studies and 7 percent in randomized controlled studies for the initial few years after UAE, with this value tapering off over time. When reported, most patients reported high or very high satisfaction with the UAE procedure. Hospital length of stay, recovery time and time to return to work or normal activities were significantly shorter for patients who underwent UAE than for those who underwent hysterectomy or myomectomy. Limited evidence suggests UAE is more cost- effective than hysterectomy in the short term, but hysterectomy becomes more cost-effective in the long term when factoring in the increased risk of reintervention after UAE.



There is insufficient evidence to support UAE as an alternative to hysterectomy or myomectomy in women with adenomyosis (Maheshwari 2012, Popovic 2011). While both systematic reviews acknowledge an increasing interest in using UAE for adenomyosis, the evidence is confined to lowquality, uncontrolled, observational studies with short-term follow-up. In the absence of evidence from randomized controlled studies, Popovic (2011) concluded there was insufficient evidence to establish embolization as a potential first-line treatment for adenomyosis, and Maheshwari (2012) cautioned against using UAE or other treatments for adenomyosis outside of research settings. The Society of Interventional Radiology (SIR) Standards of Practice Committee considered these uncontrolled studies and expert opinion in their recommendation — UAE is a conservative alternative for patients who desire fertility, are at increased risk in the setting of surgery, or absolutely desire uterine preservation (Stokes 2010). While knowledge regarding the safety and efficacy of UAE for treatment of adenomyosis is evolving, at this time the evidence is insufficient to support its use outside of a research setting.

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There is insufficient evidence to support the use of UAE as a first-line treatment in women who are planning future pregnancy (Mohan 2013, Gupta 2012, Maheshwari 2012 and Popovic 2011). The minimally invasive nature of the procedure is attractive to the increasing numbers of patients with symptomatic fibroid tumors or adenomyosis during childbearing age. The issue of fertility following UAE remains a controversial area, as the impact on future fertility and subsequent delivery has been inadequately studied. Advanced age and presence of these growths may affect fertility and complicate assessment of fertility following UAE. The lack of good-quality prospective studies with appropriate control groups and a strong likelihood of publication bias make it difficult to draw definite conclusions about the efficacy of UAE in this population. Large, well-designed RCTs comparing UAE versus other fertility-preserving options (e.g., myomectomy) and large registries for observational data are needed to confirm these findings. For now, myomectomy may be superior to UAE in women planning future pregnancy. Evidence-based guidelines list the desire for future fertility as a relative contraindication to UAE (Burke 2012, Stokes 2010 and ACOG 2008).

 Contraindications: Absolute contraindications include patients with viable pregnancy, active untreated infection, suspicion of leiomyosarcoma or adnexal malignancy (unless UAE is performed for palliation or with surgery) and severe vascular disease limiting access (ACOG 2008, Stokes 2010 and Burke 2012). Relative contraindications to UAE that are the same as those for other angiographic procedures include coagulopathy, severe contrast allergy and renal impairment. Other relative contraindications more specific to UAE include (Stokes 2010, Hayes 2009): o Any prior treatment or procedure that could alter pelvic arterial anatomy, such as salpingooophorectomy, resection of an ectopic pregnancy, or pelvic irradiation, which may make selection and embolization of the uterine arteries difficult or impossible. o A desire to maintain childbearing potential. o Concurrent use of a gonadotropin-releasing agonist, as it may cause diffuse vasospasm and impact the technical success of the procedure. o Patients with diffuse endometriosis or adenomyosis, markedly pedunculated subserosal fibroids (risk of detachment) or submucosal fibroids, and associated gynecological conditions requiring surgery (e.g., adnexal disease, uterine prolapse or stress incontinence).

Table 1. Outcomes of UAE vs. surgery (hysterectomy and/or myomectomy) Minor complications (number of studies)

Major complications (number of studies)

Fertility rates (number of studies)

Martin 2013

NS (5)

Favors UAE (2)

NR

Gupta 2012

Favors surgery (7)

NS (1)

Favors myomectomy (1)

Citation

Reintervention rates (number of studies) Favors surgery (3)

Favors surgery within 2 years follow-up (4) and 5

Patient satisfaction rates (number of studies) NR

NS within 2 years follow-up (5) or 5

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years follow-up (2)

years follow-up (2)

NS, no statistically significant difference NR, not reported UAE, uterine artery embolization

Policy updates: No new evidence. Formatting only. Table 2. Summary of clinical evidence: Citation

Content, Methods, Recommendations

Fibroids Mohan (2013)

Fertility outcomes

Martin (2013)

Key points:  Systematic review of one low-quality RCT, six nonrandomized cohort or follow-up studies, and five poor-quality cohort or case-control studies and case series.  Overall quality: Low.  Cumulative pregnancy rate (58.6%, mean age = 35.9 years), miscarriage rate (28%) and preterm delivery rate (7.3%) following UAE of included study populations were comparable to rates in the general population.  Confounders of fertility assessment following UAE for fibroids are advanced age and presence of the leiomyoma.  Large, well-designed RCTs comparing UAE versus other fertility-preserving options (e.g., myomectomy) and large registries for observational data are needed to confirm these findings. Key points:      



Systematic review of five RCTs, 76 nonrandomized studies. Overall quality assessment: Not reported. Common complications were discharge and fever (4.00%), bilateral uterine artery embolization (UAE) failure (4.00%), and postembolization syndrome (2.86%). Two trials showed a significantly decreased risk in major complications with UAE, with odds ratios (ORs) of 0.07143 (0.009426-0.5413) and 0.5196 (0.279-0.9678). None of the trials showed a significant difference in OR for minor complications of UAE. None of the trials showed a significant difference in risk for overall complications of UAE. Three trials showed a significantly increased risk for reintervention with UAE with ORs of 10.45 (2.654-41.14), 2.679 (1.289-5.564), and 9.096 (1.269-65.18). In 76 nonrandomized studies, common complications were amenorrhea (4.26%), pain (3.59 %), and discharge and fever (3.37 %). In 41 case studies, common complications were discharge and fever (n = 22 cases), repeat UAE (n = 6 cases), and fibroid expulsion (n = 5 cases). Conclusion: Overall, UAE has a significantly lower rate of major complications relative to surgery, but it comes at the cost of increased risk of reintervention in the future. Educating patients about the rate and types of complications of UAE versus surgery, as well as the potential for reintervention, should help the patient and clinician come to a

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Citation

Content, Methods, Recommendations reasoned decision.

Toor (2012)

Key points:    

  

Gupta (2012)

Key points: 

Cochrane review  



Hayes (2009)

Systematic review of seven RCTs and 47 observational studies (total n = 8,159). Overall quality assessment: Low to moderate (mean score = 15.6 ± 3.7 out of 24 points). There were no reported deaths. Major complication rate = 2.9% (95% CI, 2.2% – 3.8%). Hysterectomy rate for resolution of a complication from UAE = 0.7% (0.5% – 0.9%), readmission rate = 2.7% (1.9% – 3.7%), leiomyoma tissue passage = 4.7% (3.9% – 5.7%), deep venous thrombosis or pulmonary embolism = 0.2% (0.2% – 0.4%), and permanent amenorrhea = 3.9% (2.7% – 5.3%). Reintervention rates including repeat UAE, myomectomy or hysterectomy = 5.3% (4.2% – 6.4%) per patient-year with 0.25 to five years follow-up. Clinical symptomatic improvement = 78% to 90%, with follow-up ranging from 0.25 to two years. Conclusion: UAE is an effective procedure with a low rate of major complications supporting its use as an alternative to hysterectomy.

Systematic review of five RCTs (three trials [n = 291] UAE vs. hysterectomy; one RCT [n = 157] UAE vs. surgery (hysterectomy or myomectomy); one RCT [n = 121] UAE vs. myomectomy in women wishing to preserve fertility). Overall quality assessment: Low to moderate. UAE vs. myomectomy: Very low-level evidence from one cohort of women (n = 66) who tried to conceive suggests myomectomy may be associated with better fertility outcomes (live birth: OR 0.33, 95% CI 0.11 to 1.00; pregnancy: OR 0.29, 95% CI 0.10 to 0.85). No significant difference in the rate of major complications. UAE vs. surgery: o Moderate evidence of no significant difference between UAE and surgery in patient satisfaction rates at two years (OR 0.69, 0.40 to 1.21, 516 women, five trials) or at five years (OR 0.90, 95% CI 0.45 to 1.80, 295 women, two trials). o UAE significantly reduced the length of the procedure, length of hospital stay and time to resumption of routine activities and decreased the likelihood of needing a blood transfusion. o UAE was associated with higher rates of minor short-term and long-term complications, more unscheduled readmissions after discharge and an increased surgical reintervention rate. This increase in the surgical reintervention rate may balance out the initial cost advantage of UAE (reinterventions within two years: OR 5.64, 95% CI 2.92 to 10.90, 486 women, four trials; within five years: OR 5.79, 95% CI 2.65 to 12.65. 289 women, two trials). o There was no significant difference in ovarian failure rates at long-term follow-up.

Key points: 

Systematic review of 10 randomized comparative studies; 21 prospective uncontrolled studies, case series, or registry studies; four prospective controlled or comparative studies; and five retrospective or case control studies. Substantial overlap in

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Citation

Content, Methods, Recommendations  

    

populations. Overall quality: Low to moderate. Moderate-quality evidence that UAE can reduce menstrual bleeding, pelvic pain and bulk-related symptoms, and may lead to a reduction in fibroid size and uterine volume in patients with symptomatic uterine fibroids. Short-term symptomatic relief similar to myomectomy or hysterectomy; longer-term studies reported that up to 20% of patients who underwent UAE had recurrence of symptoms and required reintervention. High early patient satisfaction rates for UAE, with significant improvements in several health-related quality of life (HRQOL) measures, shorter hospital stays and faster recovery times compared with surgery. No studies provided a comparison with medical therapy. Limited evidence of UAE effect on ovarian and uterine function, fertility and pregnancy outcomes in women with fibroids who wish to retain childbearing potential. Age may be a contributing factor. Limited evidence that women who become pregnant following UAE may be at increased risk for pregnancy complications compared with the general population and with those who undergo myomectomy. UAE is generally considered to be a safe procedure, with minimal complications, although adequate pain management is essential, and serious adverse events, including infection (sepsis) and pulmonary embolus, have been reported.

Adenomyosis Popovic (2011)

Key points: 

Symptomatic outcomes

Maheshwari (2012)

Fertility outcomes

Systematic review of 15 studies (n = 511). Mostly case series, case reports and uncontrolled studies.  Overall quality: Low. High risk of publication bias, small cohorts lacking controls, variable methodologies, embolic agents and outcomes, the diagnosis of adenomyosis not carried out uniformly across studies.  Patients with pure adenomyosis or mixed adenomyosis and fibroids were included.  No deaths or serious adverse events reported.  Short-term symptom relief after UAE for pure adenomyosis and mixed populations range from 83.3% to 92.9%, respectively.  Long-term symptomatic improvement for pure adenomyosis and mixed populations were 64.9% and 82.4%, respectively. Hysterectomy offers full symptom relief.  Where reported, 37 hysterectomies among 280 patients (13.2%) occurred approximately 12 months after intervention.  Improvements on MRI were prominent in the short term and tend to diminish over time.  Authors’ conclusion: Results are promising but insufficient to establish embolization as a potential first-line treatment for adenomyosis. Larger-scale, randomized trials needed. Key points:    

Systematic review of studies reporting pregnancy as an outcome measure; one case series of UAE found. Overall quality: Low. Limited with high risk of bias. At 35 months follow-up, live birth rate = 83.3% (five of six patients). Authors’ conclusion: No definite treatment can be advocated, due to lack of goodquality prospective studies with appropriate control groups. Therefore, none of these treatments should be offered outside research settings.

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Glossary Adenomyosis — A condition in which the tissue that normally lines the uterus begins to grow in the muscle wall of the uterus. Anemia — Abnormally low levels of blood or red blood cells in the bloodstream. Fibroids — See leiomyoma. Hysterosalpingography — A special X-ray procedure in which a small amount of fluid is injected into the uterus and fallopian tubes to detect abnormal changes in their size and shape or to determine whether the tubes are blocked. Hysteroscopy — A surgical procedure in which a slender, light-transmitting telescope, the hysteroscope, is used to view the inside of the uterus or perform surgery. Leiomyoma — A benign smooth muscle tumor that is very rarely (0.1 percent) premalignant. The most common forms occur in the uterus, where the growth develops from the muscular tissue of the uterus. Magnetic Resonance Imaging (MRI)-guided focused ultrasound ablation — Noninvasive procedure used to treat fibroids by delivering focused ultrasound waves to heat and destroy the fibroids and spare healthy tissue in women who do not desire future pregnancy. Myoma — See leiomyoma. Myolysis — Laparoscopic procedure that uses electrical current, laser, cryoablation (freezing) or radiofrequency ablation to either destroy the fibroid directly or disrupt the blood supply to the blood vessels that feed them. Myomectomy — Surgical removal of fibroids while leaving the uterus in place and preserving fertility. Surgical methods for myomectomy include hysteroscopy, laparoscopy or laparotomy. Resectoscope — A slender telescope with an electrical wire loop or rollerball tip used to remove or destroy tissue inside the uterus. Sonohysterography — A procedure in which fluid is put into the uterus and ultrasonography is used to view the inside of the uterus. Uterine artery embolization (UAE) — Partial blockage of the uterine arteries with microparticles, which decreases blood flow to fibroids. Uterine artery occlusion — Doppler-guided procedure in which the uterine arteries are temporarily clamped (approximately six hours), which stops the flow of blood to the fibroids. The procedure is supposed to cause the excess fibroid tissue to slough off. Uterus — A muscular organ in the female pelvis that contains the developing fetus during pregnancy.

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References Professional society guidelines/other: American College of Obstetricians and Gynecologists (ACOG). Alternatives to hysterectomy in the management of leiomyomas. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); August 2008. [Reaffirmed 2012] 14 p. (ACOG practice bulletin; no. 96). [117 references]. American College of Obstetricians and Gynecologists (ACOG). ACOG Committee on Gynecologic Practice. Committee Opinion. Management of Acute Abnormal Uterine Bleeding in Nonpregnant Reproductive-Aged Women. Number 557. April 2013. URL: http://www.acog.org/Resources-And-Publications/CommitteeOpinions/Committee-on-Gynecologic-Practice/Management-of-Acute-Abnormal-Uterine-Bleeding-inNonpregnant-Reproductive-Aged-Women. (Reaffirmed 2015). Accessed September 23, 2015. American College of Obstetricians and Gynecologists. ACOG Committee on Gynecologic Practice. Committee Opinion. Uterine artery embolization. Obstetrics and gynecology. February 2004; 103(2): 403 – 404. Burke CT, Ray CE Jr, Lorenz JM, et al. Expert Panel on Interventional Radiology. ACR Appropriateness Criteria® radiologic management of uterine leiomyomas. [online publication]. Reston (VA): American College of Radiology (ACR); 2012. 8 p. [62 references]. Available at: http://www.guideline.gov/content.aspx?id=37946&search=uterine+fibroid. Accessed September 23, 2015. Stokes LS, Wallace MJ, Godwin RB, Kundu S, Cardella JF. Quality improvement guidelines for uterine artery embolization for symptomatic leiomyomas. J Vasc Interv Radiol. 2010 Aug;21(8):1153-63. Peer-reviewed references: American Congress of Obstetricians and Gynecologists (ACOG). For Patients. Uterine Fibroids (FAQ074). Available at: http://www.acog.org/Patients/FAQs/Uterine-Fibroids. Accessed September 23,2015. Food and Drug Administration (FDA) [website]. Center for Devices and Radiological Health (CDRH). 510(k) Premarket Notification Database [search: product code NAJ]. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed September 23, 2015. Gupta JK, Sinha A, Lumsden MA, Hickey M. Uterine artery embolization for symptomatic uterine fibroids. Cochrane Database Syst Rev. 2012;5:Cd005073. Hayes Inc., Hayes Medical Technology Report. Uterine artery embolization. Lansdale, PA: HAYES Inc.; 2009. Maheshwari A, Gurunath S, Fatima F, Bhattacharya S. Adenomyosis and subfertility: a systematic review of prevalence, diagnosis, treatment and fertility outcomes. Human reproduction update. Jul 2012;18(4):374392.

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Martin J, Bhanot K, Athreya S. Complications and reinterventions in uterine artery embolization for symptomatic uterine fibroids: a literature review and meta-analysis. Cardiovasc Intervent Radiol. 2013 Apr;36(2):395-402. Mohan PP, Hamblin MH, Vogelzang RL. Uterine artery embolization and its effect on fertility. J Vasc Interv Radiol. 2013 Jul;24(7):925-30. Popovic M, Puchner S, Berzaczy D, Lammer J, Bucek RA. Uterine artery embolization for the treatment of adenomyosis: a review. Journal of vascular and interventional radiology : JVIR. Jul 2011;22(7):901-909; quiz 909. Toor SS, Jaberi A, Macdonald DB, McInnes MD, Schweitzer ME, Rasuli P. Complication rates and effectiveness of uterine artery embolization in the treatment of symptomatic leiomyomas: a systematic review and meta-analysis. AJR Am J Roentgenol. 2012 Nov;199(5):1153-63. Whiteman MK, Hillis SD, Jamieson DJ, et al. Inpatient hysterectomy surveillance in the United States, 20002004. Am J Obstet Gynecol. 2008 Jan;198(1):34 e1-7.

Clinical trials: Searched clinicaltrials.gov on September 23, 2015.using terms |uterine artery embolization" [MeSH] and "Leiomyoma" [MeSH] or "fibroma" [MeSH] or “adenomyosis” [Mesh], and also free text terms for “uterine artery embolization” limited to human studies published in English. Open Studies. 12 studies found, 7 relevant. Searched clinicaltrials.gov on, Accessed September 23, 2015. using terms “ Open Studies | uterine artery embolization. 12 trials found, seven relevant. Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives. Available at: http://ClinicalTrials.gov/show/NCT01852734. Accessed September 23, 2015. This Study has been completed.. Accessed September 23, 2015. . No longer recruiting. Accessed September 23, 2015. Patient-Controlled Epidural Analgesia After Uterine Artery Embolization. Available at: http://ClinicalTrials.gov/show/NCT02236585. Accessed September 23, 2015. Diffusion- and Perfusion-Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization. Available at: http://ClinicalTrials.gov/show/NCT01514617. Accessed September 23, 2015. Post Market TRUST - U.S.A. Study. Symptomatic Uterine Fibroids. Available at: http://ClinicalTrials.gov/show/NCT02163525. Accessed September 23, 2015.

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. The recruitment status of this study is unknown because the information has not been verified recently. Accessed September 23, 2015. CMS National Coverage Determinations (NCDs): No NCDs identified as of the writing of this policy. Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code

Description

37243

Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia or infarction

0336T

Laparoscopy, surgical, ablation of uterine fibroid(s), including intraoperative ultrasound guidance and monitoring, radiofrequency

ICD-9 Code

Description

218.0

Submucosal leiomyoma of uterus ( includes myoma and uterine fibroid)

218.1

Intramural leiomyoma of uterus ( includes myoma and uterine fibroid)

218.2

Subserous leiomyoma of uterus (includes myoma and uterine fibroid)

218.9

Leiomyoma of uterus, unspecified (includes myoma and uterine fibroid)

ICD-10 Code

Description

D25.0

Submucous leiomyoma of uterus

D25.1

Intramural leiomyoma of uterus

D25.2

Subserosal leiomyoma of uterus

Comment

Comment

Comment

14

D25.9

Leiomyoma of uterus, unspecified

HCPCS Level II

Description

S2095

Comment

Transcatheter occlusion or embolization for tumor destruction, percutaneous, any method, using yttrium-90 microspheres

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