dysfunctional uterine bleeding & uterine fibroids - Health Plan of ...

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DYSFUNCTIONAL UTERINE BLEEDING 

& UTERINE FIBROIDS 

Protocol: OBG028 

Effective Date: January 17, 2011 

Table of Contents 

COMMERCIAL, MEDICARE & MEDICAID COVERAGE RATIONALE......................................... 1 

BACKGROUND ...................................................................................................................................... 3 

CLINICAL EVIDENCE........................................................................................................................... 5 

U.S. FOOD AND DRUG ADMINISTRATION (FDA)........................................................................ 15 

APPLICABLE CODES.......................................................................................................................... 17 

REFERENCES ....................................................................................................................................... 18 

PROTOCOL HISTORY/REVISION INFORMATION ........................................................................ 24 

INSTRUCTIONS FOR USE 

This protocol provides assistance in interpreting UnitedHealthcare benefit plans. When deciding 

coverage, the enrollee specific document must be referenced. The terms of an enrollee's document 

(e.g., Certificate of Coverage (COC) or Evidence of Coverage (EOC) may differ greatly. In the event 

of a conflict, the enrollee's specific benefit document supersedes this protocol. All reviewers must first 

identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage 

prior to use of this Protocol. Other Protocols, Policies and Coverage Determination Guidelines may 

apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Protocols, Policies and 

Guidelines as necessary. This protocol is provided for informational purposes. It does not constitute 

medical advice. 

COMMERCIAL, MEDICARE & MEDICAID COVERAGE RATIONALE 

Endometrial Ablation 

Endometrial ablation, using the following techniques, is medically necessary for treating 

menorrhagia in premenopausal women: 

• Cryoablation (HerOption®) 

• Thermal balloon ablation (Gynecare Thermachoice®) 

• Hydrothermal ablation (Hydro ThermAblator®) 

• Radiofrequency ablation (NovaSure®) 

• Microwave ablation (Microsulis® Microwave Endometrial Ablation (MEA) System) 

• Manual endometrial ablation techniques such as resectoscopic ablation or laser ablation 

Magnetic resonance imaging (MRI)-guided cryoablation is not medically necessary for treating 

uterine fibroids. 

The published evidence on MRI-guided cryoablation for uterine fibroids is very limited, as the 

procedure has been evaluated in very few patients. The long-term outcomes and overall health benefits 

Dysfunctional Uterine Bleeding & Uterine Fibroids Page 1 of 24

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remain unknown. Further long-term studies on larger samples published in peerr-eviewed medical 

literature are necessary to demonstrate the safety and efficacy of this technology. 

Magnetic resonance imaging (MRI)-guided focused ultrasound ablation (FUA) is not medically 

necessary for treating uterine fibroids. 

Further studies are needed to determine the long-term efficacy of this procedure and to evaluate the 

efficacy and safety of this procedure relative to other treatments for uterine fibroids. See the Benefit 

Considerations section for potential coverage of unproven services. 

Levonorgestrel-Releasing Intrauterine Device 

The levonorgestrel-releasing intrauterine device (LNG-IUD) is medically necessary for treating 

dysfunctional uterine bleeding in premenopausal women. 

Uterine Artery Embolization 

Uterine artery embolization (UAE) is medically necessary for treating confirmed, symptomatic 

uterine fibroids. 

Uterine artery embolization (UAE) is not medically necessary for women with symptomatic 

uterine fibroids who wish to preserve their childbearing potential. 

The effects of UAE on ovarian and uterine function and on fertility are relatively unknown. Further 

studies of safety and/or efficacy in published, peer-reviewed medical literature are necessary. 

Medicare does not have a National Coverage Determination or a Local Coverage Determination for 

Nevada for Uterine Bleeding and Uterine Fibroids. 

Medicare does have a National Coverage Determination (NCD) for Therapeutic Embolization. The 

NCD is as follows: 

Therapeutic embolization is covered when done for hemorrhage, and for other conditions amenable 

to treatment by the procedure, when reasonable and necessary for the individual patient. 

Renal embolization for the treatment of renal adenocarcinoma continues to be covered, effective 

December 15, 1978, as one type of therapeutic embolization, to: 

1. Reduce tumor vascularity preoperatively, or 

2. Reduce tumor bulk in inoperable cases, or 

3. Palliate specific symptoms. 

See NCD for Therapeutic Embolization (20.28) at: 

http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=20.28&ncd_version=1&basket=ncd:20.28:1:Thera 

peutic+Embolization . 

There is no Local Coverage Determination for Nevada for Therapeutic Embolization. (Accessed June, 

2010) 


Articles exist for uterine artery embolization and compliance with these policies is required where 

applicable available at: http://www.cms.gov/mcd/index_local_alpha.asp?from=alphaarticle&letter=A. 

For Medicare and Medicaid Determinations Related to States Outside of Nevada: 

Please review Local Coverage Determinations that apply to other states outside of Nevada. 

http://www.cms.hhs.gov/mcd/search 

Important Note: Please also review local carrier Web sites in addition to the Medicare Coverage 

database on the Centers for Medicare and Medicaid Services’ Website. 

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BACKGROUND 

Abnormal uterine bleeding in women of childbearing age is defined as any change in menstrual period 

frequency or duration, a change in amount of flow, or any bleeding between cycles. In postmenopausal 

women, abnormal uterine bleeding includes vaginal bleeding 12 months or more after the cessation of 

menstruation, or unpredictable bleeding in patients who have been receiving hormone therapy for 12 

months or more. Abnormal uterine bleeding terms include oligomenorrhea (bleeding occurs at 

intervals of more than 35 days), polymenorrhea (bleeding occurs at intervals of less than 21 days), 

menorrhagia (bleeding occurs at normal intervals but with heavy flow or duration of more than 7 

days), menometrorrhagia (bleeding occurs at irregular, noncyclic intervals and with heavy flow or 

duration more than 7 days), and metrorrhagia (irregular bleeding occurs between ovulatory cycles) 

(Milliman Care Guidelines). Menorrhagia can be idiopathic or can be associated with underlying 

uterine lesions such as fibroids or polyps, pelvic pathology, anatomical abnormalities, systemic illness, 

hormonal imbalance or certain medications. Idiopathic menorrhagia that is not related to a specific 

underlying condition is called dysfunctional uterine bleeding (DUB). All these conditions associated 

with menorrhagia can be referred to as dysfunctional uterine bleeding, although it is also possible to 

have some conditions such as fibroids or an anatomical abnormality with normal menses. The focus in 

this policy is on 

treatment options when the bleeding pattern is abnormal. 

Conservative management of DUB includes watchful waiting and pharmacological therapy. Another 

treatment option is dilation and curettage. Hysterectomy is available when symptoms cannot be 

controlled by conservative treatment. Conservative management of symptomatic fibroids includes 

watchful waiting and hormonal therapy. Hormone therapy causes the fibroids to shrink; however they 

will quickly return to their original mass once therapy has been discontinued. Hysterectomy has been 

the primary treatment for symptomatic or rapidly enlarging fibroids. Hysteroscopic removal of fibroids 

has been the procedure of choice for those women who want to maintain their fertility, but this is a 

demanding and lengthy procedure and sometimes more difficult to perform than a hysterectomy and 

does not prevent the recurrence of fibroids. The resulting endometrial cavity may be problematic for 

fertility. 

Alternate minimally invasive techniques have emerged. An advantage of these procedures over 

hysterectomy is that they do not involve surgical removal of the uterus; therefore, the operative and 

recovery times are shorter and the complication rates seem to be lower. Some may be performed as 

outpatient procedures, avoiding the hospital stay required after hysterectomy. 


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Uterine fibroids (also known as leiomyomata) are benign tumors of the uterus. They have a rich blood 

supply and may cause excessive uterine bleeding, uterine enlargement and mass or bulk related 

symptoms such as pelvic pain and pressure, urinary frequency and abdominal distension. 

Endometrial Cryoablation (ECA): In this procedure, a cryoprobe introduced through the vagina under 

ultrasound guidance delivers extreme cold (below -15° C to -20° C) in freeze-thaw cycles to the 

endometrium. 

Thermal Balloon Endometrial Ablation (TBEA): In this procedure, heat is delivered to the 

endometrial lining of the uterus via a latex balloon is filled with a small volume of sterile dextrose and 

water. The temperature of the fluid is raised by a heating element to 87 degrees C resulting in thermal 

coagulation of 3 to 5 mm of endometrium. A variation of this technique, hydrothermal endometrial 

ablation (HTEA), involves direct exposure of the uterine lining to saline heated to 90 degrees C. 

Radiofrequency Endometrial Ablation (RFA): This procedure uses a radiofrequency signal generator, 

a controller and a probe to generate heat in the uterus in an attempt to destroy the endometrial lining. 

Microwave Endometrial Ablation (MEA): This procedure uses microwave energy to ablate the 

endometrium. 

Manual Endometrial Ablation: This includes procedures that use a resectoscope to surgically remove, 

electrically desiccate or vaporize the endometrium, as well as laser destruction of the endometrium. 

Levonorgestrel-Releasing Intrauterine Device (LNG-IUD): The local administration of the progestin 

levonorgestrel is delivered via an intrauterine device (IUD). The MIRENA© device consists of a T- 

shaped polyethylene frame with a steroid reservoir around the vertical stem. The reservoir contains 52 

mg of levonorgestrel, which is released at a dose of 20 ug per day. The local delivery of this hormone 

causes the endometrium to become insensitive to ovarian estradiol leading to atrophy of the 

endometrial glands, inactivation of the endometrial epithelium and suppression of endometrial growth 

and activity. The effects of this IUD last for approximately 5 years and are reversible upon removal of 

the IUD. 

Magnetic Resonance Imaging (MRI)-Guided Cryoablation: This procedure is also known as 

interventional MRI (I-MRI) cryoablation. It uses a specially designed, i-MRI scanner to locate the 

fibroids and guide their cryosurgical destruction through a transabdominal percutaneous approach. 

Magnetic Resonance Imaging (MRI)-Guided Focused Ultrasound (FUA): This procedure combines 

real-time MRI-guidance with high-intensity focused ultrasound for the noninvasive thermal ablation of 

uterine fibroids. Tumor ablation is performed by focusing a collection of ultrasonic beams to increase 

sonic beam intensity at a point deep within the tissue to cause thermal coagulation while sparing 

normal tissues. The procedure is also referred to as MRgFUS. 

Uterine Artery Embolization (UAE): This procedure attempts to block the blood supply to uterine 

fibroid tumors thus promoting shrinkage through blood deprivation. For UAE to be effective, the 

arteries and their vascular beds must be completely occluded. The resultant ischemia can result in 


postembolization pain, but the abundant collateral blood supply in the pelvis protects against ischemic 

necrosis. 

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CLINICAL EVIDENCE 


A 2009 Cochrane systematic review by Lethaby et al. compared the efficacy, safety and acceptability 

of methods used to destroy the endometrium to reduce heavy menstrual bleeding (HMB) in 

premenopausal women. The evidence base included 21 RCTs comparing different endometrial ablation 

techniques in women (n = 3395, mostly within the age range 30 to 55 years) with HMB. The outcomes 

included reduction of HMB, improvement in quality of life (QOL), operative outcomes, satisfaction 

with the outcome, complications and need for further surgery or hysterectomy. Duration of surgery 

was an average of 15 minutes less, local anesthesia was more likely to be used and equipment 

malfunction was more likely with second-generation ablation. In addition, women who underwent 

more recent ablative procedures compared to those who underwent the more traditional type of 

ablation and resection were less likely to have complications such as fluid overload, uterine 

perforation, cervical lacerations and hematometra. The authors concluded that endometrial ablation 

techniques offer a less invasive surgical alternative to hysterectomy. 

Cryoablation 

A 2003 Hayes directory reported three single-center, prospective case series on the effectiveness of 

endometrial cryoablation (ECA) for menorrhagia. The study populations ranged from 15 to 67 patients. 

Follow-up times ranged from 16 months or less to 22 months (Pittrof, 1994; Rutherford, 1998; Kumar, 

2002). Two additional studies were identified that evaluated outcomes at 1 and 2 years in patients 

participating in a multicenter, randomized controlled trial to compare the efficacy and safety of ECA 

with rollerball electroablation (RBEA) for treatment of menorrhagia. These studies were supported by 

the device manufacturer CryoGen, Inc. The study population consisted of 279 patients who were 

randomized to ECA or RBEA and followed up to 2 years (Duleba, 2003; Corson, 2001). 

Zupi et al. (2005) reported on cryomyolysis with the HerOption Cryoablation Unit for treatment of 

symptomatic uterine myomas in 20 menstruating women. At one year follow-up, all patients reported 

no bleeding and no myoma-related symptoms, comparable with patients who underwent hysterectomy. 

Mean reduction of myoma volume was 60% one year after surgery. No intraoperative or postoperative 

complications occurred. 

Thermal Balloon Endometrial Ablation (TBEA) and Hydrothermal Endometrial Ablation 

(HTEA) 

A 2003 Hayes directory reported on five randomized controlled trials of TBEA. Although none of the 

studies compared TBEA with hysterectomy for treatment of menorrhagia, all of them compared TBEA 

with another minimally invasive treatment. Two of the reviewed studies compared TBEA with 

rollerball endometrial ablation (RBEA), a trial by Meyer et al. (1998) that enrolled 255 patients and a 

trial by Soysal et al. (2001) that enrolled 93 patients. The latter study involved only 1 year of follow-up 

but two subsequent reports have extended follow-up of the Meyer study to 3 years. Both trials 

comparing TBEA with RBEA indicated that these treatments have essentially equal efficacy with 

TBEA completely eliminating menstrual blood loss for 11% to 15% of women. The larger of these two 


trials also found that 3 years after TBEA, 50% of patients had below normal menstrual blood loss and 

another 29% had normal loss. Meyer et al. did not find any statistically significant differences between 

TBEA and RBEA in patient outcomes; however, Soysal et al. reported that there was a 10% rate of 

intraoperative complications during RBEA versus no intraoperative complications during TBEA. 

Although none of the studies that met the criteria for review compared HTEA with hysterectomy for 

menorrhagia treatment, the sole reviewed study of HTEA did compare this treatment with RBEA, a 

minimally invasive technique that uses a heated electrode to ablate the endometrium. In a multicenter, 

randomized controlled trial in which 276 women underwent HTEA or RBEA and 1 year of follow-up, 

no significant differences were found in menstrual blood loss outcomes. After HTEA, 40% of women 

had no menstrual blood loss, 42% had normal or below normal blood loss, and 1% underwent a 

subsequent hysterectomy (Corson, 2001). RBEA did have a small, statistically significant advantage 

over HTEA in postoperative nausea and/or vomiting which occurred in 22% of women after HTEA 

versus 7% of women after RBEA. 

Barrington et al. (2003) reported no significant differences between TBEA and the 

levonorgestrelintrauterine system (LNG-IUS), an intrauterine device that continuously releases a 

hormone. In this study, 50 women were randomized to menorrhagia treatment with TBEA or the LNG- 

IUS and at 6 months follow-up, the two treatments had essentially equal efficacy. After TBEA, 

menstrual blood loss ended for 9% of patients and menstrual blood loss decreased for another 70%. 

A randomized controlled trial by Hawe et al. (2003) enrolled 71 patients and compared TBEA with 

endometrial ablation using a surgical laser. Again, the two minimally invasive techniques for 

endometrial ablation had essentially equal efficacy and 1 year after TBEA, 29% of women had no 

menstrual blood loss, 44% had loss that was less than normal menstrual blood loss, and 12% had 

normal levels of blood loss. 

Three case series studies of women with menorrhagia (total n = 205) treated by thermal balloon 

ablation with a follow-up ranging from 6 months to 3 years had overall improvement rates ranging 

from 65 to 85% with only minor complications (Clark, 2004; Gallinat, 2004; Shaamash, 2004). 

Cooley et al. (2005) determined the medium-term (1-3 years) and long-term (3-5 years) outcome for 44 

women who underwent ablation by uterine balloon technique and 40 women who had ablation by 

VESTA (radiofrequency) technique. Outcome measures were the amenorrhea rate and patient 

satisfaction and were determined by chart review and questionnaire. Combined medium-term followup 

had a success rate of 90%; long-term follow-up had a success rate of 80% and a patient satisfaction 

rate of 73%. 

Two cohort studies evaluated HTEA for the management of menorrhagia in women with myomata. 

One year after treatment, Glasser and Zimmerman (2003) evaluated twenty-two women with myomata 

up to 4 cm. in diameter who were treated for menorrhagia with HTEA. Twelve patients reported 

complete amenorrhea (7 of these women were premenopausal and 5 were postmenopausal), five 

women reported oligomenorrhea and 3 reported eumenorrhea. There were 2 failures which resulted in 

one woman having a repeat HTEA for menorrhagia and another electing to have a vaginal 

hysterectomy. 

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Rosenbaum et al. (2005) evaluated HTEA in 47 premenopausal women with abnormal uterine 

bleeding; 20 of these women had normal endometrial cavities and 27 had had intracavitary pathology, 

most often leiomyomas. Follow-up ranged from 5 to 25 months with a mean of 12.7 months. Baseline 

and follow-up scores were similar for both groups. 

Radiofrequency Endometrial Ablation (RFA) 

In two multicenter, 2-arm, randomized clinical trials, RFA, using the Vesta DUB or NovaSure 

endometrial ablation devices, was compared with resection/rollerball ablation. RFA reduced mean 

pictorial bleeding assessment chart (PBAC) scores from 535 (Corson, 2000) and 652 (Cooper, 2002) at 

baseline to 18 and 27 at 1-year follow-up, respectively. This improvement was similar to that achieved 

with resection/rollerball ablation. PBAC scores were reduced from 445 (Corson, 2000) and 562 

(Cooper, 2002) to 28 and 36, respectively. The treatment was successful in 87% (Corson, 2000) and 

91%of RFA patients compared with 83% (Corson , 2000) and 88% (Cooper , 2002) of 

resection/rollerball ablation patients. Amenorrhea was achieved in 31% of RFA patients and 35% of 

resection/rollerball ablation patients. The complication rate was similar for both procedures (2.2% and 

13% for RFA; 3.5% and 25.3% for resection/rollerball ablation) but differed considerably between 

studies. Differences in the devices, training and experience of the investigators, and the definition of 

what constitutes a complication may account for some of these differences. Nevertheless, additional 

studies may be needed to address the issue of procedure safety. At least one of these studies (Corson , 

2000) had the statistical power to detect a 20% difference in efficacy based on the PBAC scores. The 

results therefore suggest that the efficacy of RFA compares to that of resection/rollerball ablation 

(Hayes, 2004). 

Kleijn et al. (2008) previously reported that NovaSure was more effective than balloon ablation at 12 

months follow up in the treatment of menorrhagia. In this follow-up study, the same authors report 5- 

year outcomes. The objective was to evaluate amenorrhea rates, hysterectomy rate and quality of life 

associated with the bipolar impedance-controlled endometrial ablation technique (NovaSure) in 

comparison with balloon ablation technique (ThermaChoice) at 5 years after administration. A total of 

126 premenopausal women with menorrhagia were randomly allocated to bipolar radio-frequency 

ablation and balloon ablation in a 2:1 ratio. At 5 years of follow up, amenorrhea was reported in the 

bipolar group by 48% of women and in the balloon arm by 32%. There were eight women in the 

bipolar group (9.8%) and five in the balloon group (12.9%) who had undergone a hysterectomy. 

Furthermore, there was a significant equal improvement of health-related QoL over time in both 

groups. The authors concluded that, at 5 years follow up, bipolar thermal ablation was superior over 

balloon ablation in the treatment of menorrhagia. 

Bongers et al. (2004) compared the effectiveness of two second-generation ablation techniques, bipolar 

radio-frequency impedance-controlled endometrial ablation (NovaSure) and balloon ablation 

(ThermaChoice), in the treatment of menorrhagia. One hundred twenty-six women with menorrhagia, 

without intracavitary abnormalities, were randomly allocated to bipolar radiofrequency ablation 

(bipolar group) (n=83) and balloon ablation (balloon group) (n=43) in a 2:1 ratio. At follow up, both 

women and observers were unaware of the type of treatment that had been performed. The main 

outcome measure was amenorrhea at 3, 6 and 12 months after randomization. At the one-year follow 

up stage, amenorrhea rates were 43% (34/83) in the bipolar group and 8% (3/43) in the balloon group. 

At this stage, 90% of the patients in the bipolar group were satisfied with the result of the treatment 

against 79% in the balloon group. 

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Thermal balloon ablation was compared with RFA in 1 randomized, 2-arm clinical trial and in 1 

nonrandomized, multi-center, 2-arm trial (Abbott, 2003; Laberge, 2003). In these studies, treatment 

time was significantly shorter for RFA (3 to 4 minutes) compared with thermal balloon ablation (12 to 

23 minutes). At 12 months follow-up, RFA was effective in 96% of patients; 43% of patients 

developed amenorrhea, 27% hypomenorrhea, and 16% eumenorrhea (Abbott, 2003). 

Thermal balloon ablation was effective in 100% of patients; 12% of patients developed amenorrhea, 

59% hypomenorrhea, and 29% eumenorrhea. RFA caused less intra- and postoperative pain compared 

with thermal balloon ablation (Laberge, 2003). The Abbott study had the statistical power to detect a 

20% difference in efficacy based on the PBAC scores. The results therefore suggest that the efficacy of 

RFA compares to that of thermal balloon ablation. 

A National Institute for Health and Clinical Excellence (NICE) guidance document states that while 

information is lacking about the long-term results of the procedure, current evidence on the safety and 

efficacy of impedance-controlled bipolar radiofrequency ablation for menorrhagia appears adequate to 

support the use of this procedure, provided that the normal arrangements are in place for consent, audit 

and clinical governance (NICE, 2004). 

Microwave Endometrial Ablation (MEA) 

In a systematic review, Garside et al. (2005) compared the effectiveness of microwave and thermal 

balloon endometrial ablation with first generation techniques of endometrial ablation to treat heavy 

menstrual bleeding in women. Two randomized controlled trials of microwave endometrial ablation 

and eight trials (six randomized controlled trials) of thermal balloon endometrial ablation were 

included in the review. No significant differences were found between first and second generation 

techniques in terms of amenorrhoea, bleeding patterns, premenstrual symptoms, patient satisfaction or 

quality of life. Microwave endometrial ablation and thermal balloon endometrial ablation had 

significantly shorter operating times than first generation techniques. Adverse effects were few with all 

techniques, but there were fewer peri-operative adverse effects with second generation techniques. 

Cooper et al. (2004) compared the effectiveness, safety and acceptability of microwave endometrial 

ablation (MEA) with those of rollerball electroablation (REA) for the treatment of menorrhagia. Three 

hundred twenty-two women with documented menorrhagia due to benign causes were randomized to 

either MEA or REA in a 2:1 allocation scheme. Of the 215 patients in the MEA group, 209 were 

treated, with 194 available for evaluation at 1 year. Of the 107 patients in the REA group, 106 were 

treated, with 96 available for evaluation at 1 year. The success rate of MEA at 12 months did not differ 

significantly from that of REA. The amenorrhea rate in evaluable patients after MEA was 61.3% and 

51% after REA. Patient satisfaction with results of treatment was high (98.5% of the MEA and 99.0% 

of the REA group). The authors concluded that MEA is an efficacious and safe procedure for the 

treatment of menorrhagia and is suitable for women with myomas and irregular uterine cavities. 

Cooper, et al. (1999) conducted a randomized controlled trial, comparing microwave endometrial 

ablation (MEA) with transcervical resection of the endometrium (TCRE), for women with heavy 

menstrual loss. Two hundred sixty three women were randomly assigned to MEA (n=129) or TCRE 

(n=134). Questionnaires were completed at recruitment and at 12 months' follow-up. The primary 

outcome measures were patients' satisfaction with and the acceptability of treatment. At 1 year of 


follow-up, 116 of the 129 women in the MEA group and 124 or the 134 women in the TCRE group 

were available for evaluation. At 1 year, 89 (77%) women in the MEA group and 93 (75%) in the 

TCRE group were totally or generally satisfied with their treatment and 109 (94%) versus 112 (90%) 

found it acceptable. Mean operating times were shorter for MEA than for TCRE (11.4 vs 15.0 min) 

and the postoperative stay slightly but not significantly shorter. Of eight health-related quality of life 

dimensions, all were improved after MEA (six significantly) and seven were improved after TCRE (all 

significantly). Both techniques achieved high rates of satisfaction and acceptability and both improved 

quality of life after 1 year. Follow-up after 2, 5 and 10 years reported similar results (Bain, 2002; 

Cooper, 2005; Sambrook, 2009). 

Magnetic Resonance Imaging (MRI)-Guided Cryoablation 

Two feasibility studies representing an ongoing, manufacturer-sponsored clinical trial on this specific 

technique that were conducted at the same study center were identified in the peer-reviewed literature. 

The first study consisted of 2 patients who were included in the second study. The second published 

study is a prospective case series that evaluated the efficacy and safety of MRI-guided cryoablation of 

uterine fibroids in 9 symptomatic women whose disease was confirmed by clinical examination and 

MRI. The outcomes assessed included surgical time, postoperative fibroid volume, postoperative 

hemoglobin level, overall reduction in fibroid size, and complications. Postoperative MRI findings 

were available for the patients for a period of 48 to 334 days after surgery (Sewell, 2001; Cowan, 

2002). 

While the preliminary data from a manufacturer-sponsored pilot study show that MRI-guided 

cryoablation of uterine fibroids can reduce the volume of uterine fibroids by an average of 65% as 

determined by serial MRI and improve patient-reported symptoms over the short term, the procedure 

has been evaluated in very few patients, and the long-term outcomes and overall health benefits remain 

unknown. During this short-term study, none of the fibroids disappeared completely, and it remains 

unclear whether this would eventually occur. In the clinical trial, 3 of 9 (33%) patients experienced 

what the researchers described as important procedure-related complications. One patient developed 

persistent bleeding following laceration of a tumor blood vessel. The patient required emergent 

laparotomy and myomectomy. She recovered without complications but was ineligible for follow-up 

of the cryoablation procedure since her fibroids were removed. Another patient sustained a mild 

peroneal nerve injury that resulted in a mild footdrop, which resolved at 4 months postoperatively. A 

third patient was observed for 24 hours due to nausea. No other serious complications were reported 

during follow-up. 

Dohi et al. (2004) published a study evaluating MRI-guided transvaginal cryotherapy to treat 8 uterine 

fibroids. They assessed the ratio of pre-treatment to post-treatment volume of the uterine fibroids as 

well as symptoms of anemia, abdominal pain and dysfunctional uterine bleeding. The mean ratio of 

reduction in uterine fibroid volume was 31.0% at 9-12 months (0-75.0%). Symptoms caused by uterine 

fibroids improved in seven cases. There were no complications requiring surgical intervention. 

Magnetic Resonance Imaging (MRI)-Guided Focused Ultrasound Ablation (FUA) 

Studies suggest that the ExAblate procedure provides short- and mid-term benefits for most patients 

who have uterine fibroids; however, the long-term efficacy of this procedure is unknown. Further 

studies are needed to determine the long-term efficacy of the ExAblate procedure and to evaluate the 

efficacy and safety of this procedure relative to other treatments for uterine fibroids (Hayes, 2007). 

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Taran et al. (2009) compared women undergoing magnetic resonance-guided focused ultrasound 

(MRgFUS) to a group of contemporaneously recruited women undergoing total abdominal 

hysterectomy. Patient demographics, safety parameters, quality of life outcomes and disability 

measures are reported. One hundred and nine women were recruited in seven centers for MRgFUS 

treatment and 83 women who underwent abdominal hysterectomy were recruited in seven separate 

centers to provide contemporaneous assessment of safety. Overall, the number of significant clinical 

complications and adverse events was lower in women in the MRgFUS group compared to women 

undergoing hysterectomy. MRgFUS was associated with significantly faster recovery, including 

resumption of usual activities. At 6 months of follow-up, there were four (4%) treatment failures in the 

MRgFUS arm. There was improvement in all quality of life scales for both treatment groups at 6 

months. However, scores were significantly better in the hysterectomy group than in the MRgFUS 

group. Women undergoing MRgFUS had steady improvement in all parameters throughout the 6- 

month follow-up period, despite the fact that they continued to have symptomatic myomatous uteri and 

menstruation. The authors concluded that MRgFUS treatment of uterine leiomyomas leads to clinical 

improvement with fewer significant clinical complications and adverse events compared to 

hysterectomy at 6 months' follow-up. Longer follow-up from randomized trials is needed to confirm 

these results. 

Identified studies reported data from the manufacturer sponsored PMA trial (Stewart, 2006; Hindley, 

2004). The PMA trial considered quality of life and recovery of non-randomized patients who received 

either MRI-guided focused ultrasound (FUA) (n=109) or hysterectomy (n=83) to treat uterine fibroids. 

FUA treated patients were followed for 12 months and hysterectomy treated patients were followed for 

6 months. At 12-month follow-up, 42 of 82 FUA treated patients maintained a 10 point score 

improvement. 

The Uterine Fibroid Symptoms and Quality of Life (UFS-QOL) questionnaire was used to assess 

uterine fibroid symptoms. Stewart et al. reported the mean symptom severity scores for the FUA 

patients at 12-months compared to baseline were 38.8 versus 61.1, respectively. By 12- month followup, 

23 of 82 evaluable FUA patients had sought alternative treatment for fibroids (Stewart, 2006). 

Limitations of these studies include short follow-up, no comparison of FUA to other minimally 

invasive technologies intended to treat uterine fibroids and preserve uterine structure and function, the 

subjective nature, measurement, and interpretation of principal outcomes, small sample size and the 

incomplete reporting of results. 

According to an evidence report prepared for the Agency for Healthcare Research and Quality 

(AHRQ), the strength of evidence for MRI-guided ultrasound ablation of fibroids is weak (AHRQ, 

2007). 

A National Institute for Health and Clinical Excellence (NICE) guidance document states that current 

evidence on the safety and efficacy of magnetic resonance image guided focused ultrasound ablation 

for uterine fibroids is such that this procedure should only be used with special arrangements for 

consent and for audit or research. The guidance also indicates that patients should be told about the 

uncertainties of the procedure's safety and efficacy and that future research should look at long-term 

outcomes (NICE, 2007). 


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Levonorgestrel-Releasing Intrauterine Device (LNG-IUD) 

There is evidence from several randomized controlled trials and a few nonrandomized controlled trials 

and prospective case series that the LNG-IUD is a relatively safe and efficacious minimally invasive 

therapy for DUB in premenopausal women with confirmed menorrhagia that is refractory to oral 

medications or for whom surgery has been recommended, who have no benign or malignant pelvic 

pathology that requires another type of therapy, who do not want or are ineligible for surgery, who 

cannot tolerate the drug side effects and/or who wish to retain their childbearing capacity. Overall, 

treatment with the LNG-IUD for 3 to 12 months resulted in significant reductions in menstrual blood 

loss (MBL) (ranging from 67% to 96%), improvement in menstrual bleeding patterns in the majority of 

patients, increases in blood hemoglobin and iron levels, high levels of satisfaction and improved 

quality of life (QOL). Surgery was cancelled or postponed in approximately 70% of patients on 

surgical waiting lists whose menstrual bleeding improved during LNG-IUD therapy. The rates of 

treatment discontinuation or failure varied from 3% to 52% (Hurskainen, 2001; Lahteenmaki, 1998; 

Istre, 2001; Crosignani, 1997; Barrington, 1997; Fedele, 1997; and Romer, 2000). 

The evidence from the randomized controlled trials comparing the LNG-IUD with drug therapy (the 

progestin norethisterone, an NSAID and an antifibrinolytic) showed that the IUD reduced MBL by 

over 90% and induced amenorrhea in 32% to 44% of patients. While patients were more satisfied with 

the LNG-IUD than with oral norethisterone, and no serious side effects were reported, IUD use was 

associated with a higher incidence of spotting and intermenstrual bleeding at 3 months. While spotting 

and intermenstrual bleeding are initially common following insertion of the LNG-IUD, these 

symptoms tend to lessen or disappear. LNG-IUD was significantly more efficacious than the NSAID 

flurbiprofen and the antifibrinolytic tranexamic acid for reducing MBL and improving blood Hb and 

ferritin levels; however, the IUD was removed in 15% of patients due to side effects or persistent 

menorrhagia, and 5% of patients had a hysterectomy after device expulsion. No major side effects 

were associated with the LNG-IUD (Hurskainen, 2001; Lahteenmaki, 1998; Istre, 2001; Crosignani, 

1997; Barrington, 1997; Fedele, 1997; and Romer, 2000). 

Kaunitz et al. (2009) compared the effects of the levonorgestrel intrauterine system and endometrial 

ablation in reducing heavy menstrual bleeding. The systematic review and metaanalysis was restricted 

to randomized controlled trials in which menstrual blood loss was reported using pictorial blood loss 

assessment chart scores. Six randomized controlled trials that included 390 women (levonorgestrel 

intrauterine system, n=196; endometrial ablation, n=194) were reviewed. Three studies pertained to 

first-generation endometrial ablation (manual hysteroscopy) and three to second-generation 

endometrial ablation (thermal balloon). Both treatment modalities were associated with similar 

reductions in menstrual blood loss after 6 months, 12 months and 24 months. In addition, both 

treatments were generally associated with similar improvements in quality of life in five studies that 

reported this as an outcome. No major complications occurred with either treatment modality in these 

small trials. The authors concluded that the efficacy of the levonorgestrel intrauterine system in the 

management of heavy menstrual bleeding appears to have similar therapeutic effects to that of 

endometrial ablation up to 2 years after treatment. 

Lethaby et al. (2005) conducted a meta-analysis of randomized controlled trials of women of 

reproductive age treated for heavy menstrual bleeding with progesterone or progestogen-releasing 

intrauterine devices. One trial compared LNG-IUD with medical therapy, two trials compared it with 


transcervical resection of the endometrium (TCRE), and three trials compared it with balloon ablation. 

There was a significantly greater mean reduction in menstrual bleeding in one trial in women who had 

balloon ablation, a lower score on the pictorial blood loss chart and higher rates of successful treatment 

in 3 trials including both balloon and TCRE. The LNG-IUD was compared to hysterectomy in one trial 

and the LNG-IUD treatment had lower costs than the hysterectomy at one- and at five-year follow-up. 

Busfield et al. (2006) compared LNG-IUD (n=40) to thermal balloon ablation (n=39) in a prospective, 

randomized trial. Both treatments resulted in significant reductions in pictorial bleeding assessment 

chart (PBAC) scores. However at 12 and 24 months, median PBAC scores in women treated by LNG- 

IUD were significantly lower than those of women treated by thermal balloon (11.5 versus 60.0 and 

12.0 versus 56.5, respectively) supporting LNG-IUD as more efficacious. Treatment failed in 11 (28%) 

women using the LNG-IUD and in 10 (26%) women treated with thermal balloon ablation. 

Uterine Artery Embolization (UAE) 

Goodwin et al. (2008) assessed the long-term clinical outcomes of uterine artery embolization across a 

wide variety of practice settings in 2112 patients with symptomatic leiomyomata. At 36 months after 

treatment, 1,916 patients remained in the study, and of these, 1,278 patients completed the survey. The 

primary measures of outcome were the symptom and health-related quality-of-life scores from the 

Uterine Fibroid Symptom and Quality of Life questionnaire. Mean symptom scores improved 41.41 

points (P

Siskin et al. (2006) compared UAE to hysterectomy in 146 women for treatment of fibroids. UAE was 

associated with greater sustained improvements in symptom severity and quality of life scores and with 

fewer complications than myomectomy. MRI at 6-month follow-up demonstrated significant 

reductions in uterine and tumor volumes. (Siskin , 2006) 

Spies et al. (2005) reported a 5-year follow-up in 182 patients treated with UAE for leiomyomata. 73% 

continued to experience symptom control. 13.7% (25) had undergone hysterectomies, 4.4% (8) had 

undergone myomectomies, and 1.6% (3) had repeat embolizations. 

Joffre et al. (2004) concluded that UAE using large microspheres provided good symptom control with 

low post procedural pain and complications. A total of 9% of the study patients required a follow up 

hysterectomy but 72% had a reduction in fibroid size. 

Spies et al. (2004) completed a randomized comparative study to evaluate the differences in response 

to PVA particles and tris-acryl gelatin microspheres used to complete the embolization. Recovery for 

all women was brief and "relatively mild". There were no differences between the two methodologies. 

Complications occurred in 19 of the 100 study participants and included allergic reactions, pain with 

fibroid passage, urinary retention, hematoma, and one person had a pulmonary embolus. 

Pinto et al. (2003) completed a randomized trial comparing UAE with hysterectomy. They concluded 

that UAE reduced abnormal bleeding in 86% of the patients and was associated with significantly 

shorter hospitalization and recovery time compared with hysterectomy. The total complication rate was 

higher for UAE than hysterectomy, although there were few major complications with UAE. Patient 

satisfaction was high for both procedures. 

Pron et al. (2003) completed a multicenter case series involving 555 patients evaluating fibroid uterine 

volume reduction, symptom relief and patient satisfaction following UAE. Their findings indicate that 

UAE reduced symptoms in the majority of patients as menorrhagia (83%), dysmenorrhea (77%) and 

bulk related urinary complaints were decreased (86%). They also noted that complications occurred in 

44 patients (8%) including increased pain (26), eight patients required a hysterectomy, two had post 

procedure infections, one had vaginal bleeding and one had a prolapsed fibroid. The procedure could 

not be completed in 3 patients due to variant anatomy. Patient satisfaction was 91% and nearly half of 

the patients remained amenorrheic three months after the procedure. Hospital stays were 1.3 days and 

recovery time was an average of 10 days. 

Walker and Pelage (2002) concluded in their study of 400 patients that UAE reduced uterine volumes 

and improved symptoms, but 6% of the patients had treatment failure and required a hysterectomy. 

Other complications reported include permanent amenorrhea and chronic vaginal discharge. 

Broder et al. (2002) completed a study of 97 women who had either a myomectomy or UAE. They 

concluded that women who had UAE were more likely than those who had myomectomy to require 

further invasive fibroid procedures 3-5 years post-surgery. Both procedures were effective in symptom 

control (92% for the UAE group and 90% for the myomectomy group). The satisfaction rate was 

higher in the UAE group. 

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Razavi also studied 111 patients who had an UAE or a myomectomy. They concluded that the UAE 

was less invasive and safer than myomectomy with a shorter hospitalization, recovery time and 

duration of pain medication. UAE was also superior for control of menorrhagia, whereas myomectomy 

was superior for correction of mass/bulk effect. Both procedures were equal with respect to pain 

control. Of the patients who had complications, 11% were in the UAE group but 25% of the 

myomectomy patients had complications that were more serious and included blood transfusions, 

wound infections, ileus and adhesions (Razavi, 2003). 

According to an evidence report prepared for the Agency for Healthcare Research and Quality 

(AHRQ), studies comparing uterine artery embolization (UAE) with other procedures reported 

procedure time and length of stay favoring UAE. However, the absence of key information on longerterm 

outcomes suggests that the evidence base is inadequate to comment on the relative risks and 

benefits of UAE versus hysterectomy or myomectomy (AHRQ, 2007). 

Professional Societies 


American College of Obstetricians and Gynecologists (ACOG) 

Endometrial ablation is indicated for the treatment of menorrhagia or patient-perceived heavy 

menstrual bleeding in premenopausal women with normal endometrial cavities who have no desire for 

future fertility. The various techniques appear to be equivalent with respect to successful reduction in 

menstrual flow and patient satisfaction at one year following index surgery (ACOG, 2007). 

American Society for Reproductive Medicine (ASRM) 

An ASRM practice bulletin states that endometrial ablation is an effective therapeutic option for the 

management of menorrhagia in premenopausal women. Hysteroscopic and nonhysteroscopic 

techniques offer similar rates of symptom relief and patient satisfaction. Endometrial ablation is not 

indicated in postmenopausal women, in women with endometrial cancer or hyperplasia or in 

premenopausal women who wish to preserve their fertility (ASRM, 2008). 

Magnetic Resonance Imaging-Guided Focused Ultrasound Ablation 


While short-term studies show safety and efficacy, long-term studies are needed to discern whether the 

minimally invasive advantage of MRI-guided focused ultrasound surgery will lead to durable results 

beyond 24 months (ACOG, 2008). 



An ACOG practice guideline on the use of noncontraceptive uses of hormonal contraceptives states the 

following: 

• Combined oral contraceptives (OC) have been shown to regulate and reduce menstrual bleeding, 

treat dysmenorrhea, reduce premenstrual dysphoric disorder symptoms and ameliorate acne. 

(Evidence Level A – based on good and consistent scientific evidence.) 

• Hormonal contraception should be considered for the treatment of menorrhagia in women who 

may desire further pregnancies. (Evidence Level B – based on limited or inconsistent scientific 

evidence.) (ACOG, 2010) 

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In an updated practice bulletin, ACOG states that the levonorgestrel intrauterine system leads to 

minimal systemic effects, and the localized endometrial effect is beneficial for treatment of 

menorrhagia. Small studies suggest that the levonorgestrel intrauterine system may be effective for 

treatment of heavy uterine bleeding in women with leiomyomas. However, these women may have a 

higher rate of expulsion and vaginal spotting. (ACOG, 2008) 



In a committee opinion on uterine artery embolization (UAE), ACOG makes the following statement. 

Based on current evidence, it appears that uterine artery embolization, when performed by experienced 

physicians, provides good short-term relief of bulk-related symptoms and a reduction in menstrual 

flow. Complication rates associated with the procedure are low, but in rare cases can include 

hysterectomy and death. There is insufficient evidence to ensure its safety in women desiring to retain 

their fertility, and pregnancy-related outcomes remain understudied. ACOG considers the procedure 

investigational or relatively contraindicated in women wishing to retain fertility. The use of uterine 

artery embolization in postmenopausal women is rarely, if ever, indicated (ACOG, 2004). 

In a separate practice bulletin on alternatives to hysterectomy in managing uterine fibroids, ACOG 

states that 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 (ACOG, 2008). 

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U.S. FOOD AND DRUG ADMINISTRATION (FDA) 


Devices for thermal ablation of the endometrium are regulated by the FDA as Class III devices that are 

subject to the most extensive regulations enforced by the FDA. See the following website for more 

information (use product codes MNB or MKN): 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm. Accessed June 30, 2010. 

The HerOption Uterine Cryoblation Therapy System received premarket approval (PMA) on April 20, 

2001. The device is a closed-cycle cryosurgical device intended to ablate the endometrial lining of the 

uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is 

complete. See the following website for more information: 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=p000032. Accessed 

June 30, 2010. 

ThermaChoice received premarket approval (PMA) on December 12, 1997 for the treatment of 

menorrhagia (excessive uterine bleeding) due to benign causes in premenopausal women for whom 

child bearing is complete. See the following website for more information: 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=1088. Accessed June 30, 2010. 

Hydro ThermAblator received premarket approval (PMA) on April 20, 2001 to ablate the endometrial 

lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to 

benign causes for whom child bearing is complete. See the following website for more information: 


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http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=13208. Accessed June 30, 

2010. 

The NovaSure® Impedance Controlled Endometrial Ablation System (Hologic, Inc.) received 

premarket approval (PMA) on September 28, 2001 for ablation of the endometrial lining of the uterus 

in premenopausal women with menorrhagia due to benign conditions for whom childbearing is 

complete. See the following website for more information: 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p010013. Accessed 

June 30, 2010. 

The Microsulis® Microwave Endometrial Ablation (MEA) System received premarket approval 

(PMA) on September 23, 2003 for ablation of the endometrial lining of the uterus in premenopausal 

women with menorrhagia due to benign conditions for whom childbearing is complete. See the 

following website for more information: 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P020031. Accessed 

July 1, 2010. 

The Cryo-Hit System (Galil Medical) first received 510(k) approval from the FDA on July 1, 1998. 

Modified versions of the device received 510(k) approval on July 12, 1999 and October 30, 2001. The 

device is intended for the cryosurgical destruction of tissue during gynecological procedures as well as 

in general, dermatological, neurosurgical, thoracic, oncological, rectal, and urological surgeries. See 

the following website for more information: 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed June 30, 2010. 

Magnetic Resonance Imaging-Guided Focused Ultrasound 

The ExAblate 2000 System received premarket approval (PMA) on October 22, 2004 for ablation of 

uterine fibroid tissue in pre- or perimenopausal women with symptomatic uterine fibroids who desire a 

uterine sparing procedure. See the following website for more information: 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=3720. Accessed June 30, 2010. 


MIRENA© received FDA approval on December 8, 2000 for use as an intrauterine contraceptive. 

Treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception as 

their method of contraception was approved as an additional indication on October 1, 2009. See the 

following Web site for more information: 

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails. 

Accessed June 25, 2010. 


Uterine artery embolization (UAE) is a procedure and, therefore, not subject to FDA regulation. 

However, the embolic agents used are subject to FDA oversight. A number of agents are approved by 

the FDA for embolization procedures of the neurological system, but several have been specifically 

approved for UAE. See the following website for additional information (use product code HCG): 

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails. 

Accessed June 25, 2010. 


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APPLICABLE CODES 

The codes listed in this policy are for reference purposes only. Listing of a service or device code in 

this policy does not imply that the service described by this code is a covered or non-covered health 

service. Coverage is determined by the benefit document. This list of codes may not be all inclusive. 

CPT ® Code Description 

Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total 

0071T 

leiomyomata volume less than 200 cc of tissue 

Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total 

0072T 

leiomyomata volume greater or equal to 200 cc of tissue 

Uterine fibroid embolization (UFE, embolization of the uterine arteries to treat 

uterine fibroids, leiomyomata), percutaneous approach inclusive of vascular access, 

37210 vessel selection, embolization, and all radiological supervision and interpretation, 

intraprocedural roadmapping, and imaging guidance necessary to complete the 

procedure 

58353 Endometrial ablation, thermal, without hysteroscopic guidance 

Endometrial cryoablation with ultrasonic guidance, including endometrial 

58356 

curettage, when performed 

Hysteroscopy, surgical; with endometrial ablation (eg, endometrial resection, 

58563 

electrosurgical ablation, thermoablation) 

CPT ® is a registered trademark of the American Medical Association. 

HCPCS Code 

J7302 

J7306 

S4981 

Description 

Levonorgestrel-releasing intrauterine contraceptive system, 52 mg 

Levonorgestrel (contraceptive) implant system, including implants and supplies 

Insertion of levonorgestrel-releasing intrauterine system 

ICD-9 Codes Description 

617.0 Endometriosis of uterus 

617.9 Endometriosis, site unspecified 

626.0 Absence of menstruation 

626.1 Scanty or infrequent menstruation 

626.2 Excessive or frequent menstruation 

626.3 Puberty bleeding 

626.4 Irregular menstrual cycle 

626.5 Ovulation bleeding 

626.6 Metrorrhagia 

626.7 Postcoital bleeding 

626.8 

Other disorder of menstruation and other abnormal bleeding from 

female genital tract 

626.9 

Unspecified disorder of menstruation and other abnormal bleeding 

from female genital tract 

627.0 Premenopausal menorrhagia 


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627.1 Postmenopausal bleeding 

627.2 Symptomatic menopausal or female climacteric states 

627.4 Symptomatic states associated with artificial menopause 

627.8 Other specified menopausal and postmenopausal disorder 

627.9 Unspecified menopausal and postmenopausal disorder 

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PROTOCOL HISTORY/REVISION INFORMATION 

Date 

11/29/2010 

05/21/2010 

03/20/2009 

Action/Description 

Corporate Medical Affairs Committee 

The foregoing Health Plan of Nevada/Sierra Health & Life Health Healthcare Operations protocol has 

been adopted from an existing UnitedHealthcare coverage determination guideline that was researched, 

developed and approved by the UnitedHealthcare Coverage Determination Committee.

dysfunctional uterine bleeding & uterine fibroids - Health Plan of ...

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