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Transcript of OBG028_Abnormal Uterine Bleeding Uterine Fibroids_12-12.pdf
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ABNORMAL UTERINE BLEEDING
& UTERINE FIBROIDS
Protocol: OBG028Effective Date: December 10, 2012
Table of Contents Page
COMMERCIAL, MEDICARE & MEDICAID COVERAGE RATIONALE ......................................... 1BACKGROUND ...................................................................................................................................... 3
CLINICAL EVIDENCE ........................................................................................................................... 5
U.S. FOOD AND DRUG ADMINISTRATION (FDA) ........................................................................ 15APPLICABLE CODES .......................................................................................................................... 17
REFERENCES ....................................................................................................................................... 18
PROTOCOL HISTORY/REVISION INFORMATION ........................................................................ 23
INSTRUCTIONS FOR USE
This protocol provides assistance in interpreting UnitedHealthcare benefit plans. When decidingcoverage, 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 coverageprior 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.
UnitedHealthcare may also use tools developed by third parties, such as the Milliman CareGuidelines
, to assist us in administering health benefits. The Milliman Care Guidelines are intended
to be used in connection with the independent professional medical judgment of a qualified health care
provider and do not constitute the practice of medicine or medical advice.
COMMERCIAL, MEDICARE & MEDICAID COVERAGE RATIONALE
Endometrial Ablation
Endometrial ablation, using the following techniques, ismedically necessaryfor treatingmenorrhagia 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
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Levonorgestrel-Releasing Intrauterine Device
The levonorgestrel-releasing intrauterine device (LNG-IUD) is medically necessary for treating
dysfunctional uterine bleeding in premenopausal women.
Uterine Fibroids
Uterine Artery Embolization
Uterine artery embolization (UAE) is medically necessary for treating symptomatic uterine fibroids
for women who do NOT wish to preserve their childbearing potential.
Uterine artery embolization (UAE)isnot medically necessaryfor treating 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.
Magnetic resonance imaging (MRI)-guided cryoablation isnot medically necessaryfor treatinguterine 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 remain unknown. Further long-term studies on larger samples published in peer-reviewed medical literature are necessary to demonstrate the safety and efficacy of this technology.
Magnetic resonance imaging (MRI)-guided focused ultrasound ablation (FUA) isnot medically
necessary for treating uterine fibroids. Further studies are needed to determine the long-term efficacyof this procedure and to evaluate the efficacy and safety of this procedure relative to other treatments
for uterine fibroids.
MEDICARE & MEDICAID COVERAGE RATIONALE
Medicare does not have a National Coverage Determination or a Local Coverage Determination for
Nevada for Uterine Bleeding and/or Uterine Fibroids (accessed October 2012). Medicare does have aLocal Coverage Article for Endometrial Hyperplasia Treatment (A51618) and it states the following:
Treatment of endometrial hyperplasia with the insertion of a hormone-containing intrauterine device(IUD) is an accepted method to manage endometrial hyperplasia for patients with abnormal uterine
bleeding and are unable to tolerate or at high risk for complications of oral megestrol. Therefore,
effective for dates of service on and after 02/01/12, Palmetto GBA will reimburse IUD insertion
services for patients who meet these criteria.
Medicare has a National Coverage Determination for Therapeutic Embolization (NCD 20.28). The
National Coverage Determination 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
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Embolization for the treatment of renal adenocarcinoma continues to be covered, effective December15, 1978, as one type of Therapeutic Embolization, to:
Reduce tumor vascularity preoperatively; Reduce tumor bulk in inoperable cases; or Palliate specific symptoms.
There is no Local Coverage Determination for Nevada for Therapeutic Embolization. (AccessedOctober, 2012)
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 Coveragedatabase on the Centers for Medicare and Medicaid Services Website.
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 ofmenstruation, 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 7days), 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 underlyinguterine 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 associatedwith 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 includeswatchful 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 fibroidshas 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 forfertility.
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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 asoutpatient procedures, avoiding the hospital stay required after hysterectomy.
Uterine fibroids (also known as leiomyomata) are benign tumors of the uterus. They have a rich bloodsupply 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 underultrasound 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 thermalcoagulation 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 theendometrium.
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 progestinlevonorgestrel 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 theendometrial 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.
Uterine Artery Embolization (UAE): This procedure attempts to block the blood supply to uterinefibroid tumors thus promoting shrinkage through blood deprivation. For UAE to be effective, thearteries 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 ischemicnecrosis.
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Magnetic Resonance Imaging (MRI)-Guided Cryoablation: This procedure is also known asinterventional 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 ofuterine fibroids. Tumor ablation is performed by focusing a collection of ultrasonic beams to increasesonic 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.
CLINICAL EVIDENCE
In a systematic review, Matteson et al. (2012) compared hysterectomy with less-invasive alternatives
for abnormal uterine bleeding (AUB). Nine randomized controlled trials comparing bleeding, quality
of life, pain, sexual health, satisfaction, need for subsequent surgery and adverse events were included.
Endometrial ablation, levonorgestrel intrauterine system and medications were associated with lowerrisk of adverse events but higher risk of additional treatments than hysterectomy. Compared to
ablation, hysterectomy had superior long-term pain and bleeding control. Compared with thelevonorgestrel intrauterine system, hysterectomy had superior control of bleeding. No other differences
between treatments were found. The review group concluded that less-invasive treatment options for
AUB result in improvement in quality of life but carry significant risk of retreatment caused byunsatisfactory results. Although hysterectomy is the most effective treatment for AUB, it carries the
highest risk for adverse events
Endometrial Ablation
Daniels et al. (2012) conducted a meta-analysis to determine the relative effectiveness of second
generation ablation techniques in the treatment of heavy menstrual bleeding unresponsive to medicaltreatment. Nineteen randomized controlled trials (involving 3287 women) were included. Of the threemost commonly used techniques, the meta-analysis showed that bipolar radiofrequency and microwave
ablation resulted in higher rates of amenorrhoea than thermal balloon ablation at around 12 months.
There was no evidence of a convincing difference among the three techniques in the number of womendissatisfied with treatment or still experiencing heavy bleeding.
A 2009 Cochrane systematic review by Lethaby et al. compared the efficacy, safety and acceptabilityof 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, satisfactionwith 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 underwentmore 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 ablationtechniques offer a less invasive surgical alternative to hysterectomy.
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Cryoablation
A National Institute for Health and Clinical Excellence (NICE) guidance document states that limited
short-term evidence on the safety and efficacy of endometrial cryotherapy for menorrhagia appearsadequate to support the use of this procedure in carefully selected patients provided that normal
arrangements are in place for consent, audit and clinical governance (NICE, 2006).
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 postoperativecomplications occurred.
Thermal Balloon Endometrial Ablation (TBEA) and Hydrothermal Endometrial Ablation
(HTEA)
Barrington et al. (2003) reported no significant differences between TBEA and the levonorgestrel
intrauterine system (LNG-IUS), an intrauterine device that continuously releases a hormone. In thisstudy, 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 nomenstrual 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 balloonablation 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 patientsatisfaction and were determined by chart review and questionnaire. Combined medium-term follow-
up 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 myomataup 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), fivewomen 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 uterinebleeding; 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)Kleijn et al. (2008) previously reported that NovaSure was more effective than balloon ablation at 12months 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 of126 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 thebipolar 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 overballoon ablation in the treatment of menorrhagia.
Bongers et al. (2004) compared the effectiveness of two second-generation ablation techniques, bipolarradio-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, bothwomen 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 treatmentagainst 79% in the balloon group.
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 patientsdeveloped 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 withthermal 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 ofRFA compares to that of thermal balloon ablation.
A National Institute for Health and Clinical Excellence (NICE) guidance document states that whileinformation 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, auditand clinical governance (NICE, 2004).
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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 heavymenstrual bleeding in women. Two randomized controlled trials of microwave endometrial ablation
and eight trials (six randomized controlled trials) of thermal balloon endometrial ablation wereincluded in the review. No significant differences were found between first and second generationtechniques 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. Threehundred 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 weretreated, 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 endometrialablation (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 offollow-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 theTCRE 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 (allsignificantly). 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 CryoablationTwo feasibility studies representing an ongoing, manufacturer-sponsored clinical trial on this specifictechnique 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 publishedstudy 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, postoperativehemoglobin level, overall reduction in fibroid size, and complications. Postoperative MRI findings
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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-guidedcryoablation 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 procedurehas been evaluated in very few patients, and the long-term outcomes and overall health benefits remainunknown. 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 emergentlaparotomy 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. Athird 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 ofreduction 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)
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 MRgFUStreatment and 83 women who underwent abdominal hysterectomy were recruited in seven separate
centers to provide contemporaneous assessment of safety. Overall, the number of significant clinicalcomplications 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 6months. 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 andmenstruation. The authors concluded that MRgFUS treatment of uterine leiomyomas leads to clinical
improvement with fewer significant clinical complications and adverse events compared tohysterectomy at 6 months' follow-up. Longer follow-up from randomized trials is needed to confirmthese 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
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6 months. At 12-month follow-up, 42 of 82 FUA treated patients maintained a 10 point scoreimprovement.
The Uterine Fibroid Symptoms and Quality of Life (UFS-QOL) questionnaire was used to assessuterine 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 follow-up, 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 theincomplete 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 efficacy of magnetic resonance image (MRI)-guided transcutaneous focused
ultrasound for uterine fibroids in the short term is adequate, although further treatment may be requiredand the effect on subsequent pregnancy is uncertain. There are well-recognized complications, but the
evidence on safety is adequate to support the use of this procedure provided that normal arrangements
are in place for clinical governance and audit. NICE encourages further research into the efficacy of
MRI-guided transcutaneous focused ultrasound for uterine fibroids. Research studies should reportlong-term outcomes, including the need for further treatment (NICE, 2011).
Levonorgestrel-Releasing Intrauterine Device (LNG-IUD)
Kaunitz et al. (2010) compared the efficacy and safety of the levonorgestrel-releasing intrauterinesystem and oral medroxyprogesterone acetate in the treatment of idiopathic heavy menstrual bleeding.
In this multicenter, randomized, controlled study, women aged 18 years or older with heavy menstrualbleeding (menstrual blood loss 80 mL or more per cycle) were randomly assigned to six cycles of
treatment with either levonorgestrel-releasing intrauterine system or oral medroxyprogesterone acetate.
Of 807 women screened, 165 were randomly assigned to treatment (levonorgestrel-releasing
intrauterine system n=82, oral medroxyprogesterone acetate n=83). At the end of the study, theabsolute reduction in median menstrual blood loss was significantly greater in the levonorgestrel-
releasing intrauterine system group than in the medroxyprogesterone acetate arm, and the proportion of
women with successful treatment was significantly higher for the levonorgestrel-releasing intrauterinesystem (84.8%) than for medroxyprogesterone acetate (22.2%).
There is evidence from several randomized controlled trials and a few nonrandomized controlled trialsand 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 oralmedications 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
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loss (MBL) (ranging from 67% to 96%), improvement in menstrual bleeding patterns in the majority ofpatients, 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 oftreatment 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 wasassociated 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 NSAIDflurbiprofen 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 effectswere 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 (levonorgestrelintrauterine 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, bothtreatments 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 thesesmall 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 withtranscervical 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 hadballoon ablation, a lower score on the pictorial blood loss chart and higher rates of successful treatmentin 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 assessmentchart (PBAC) scores. However at 12 and 24 months, median PBAC scores in women treated by LNG-
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IUD were significantly lower than those of women treated by thermal balloon (11.5 versus 60.0 and12.0 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)
A National Institute for Health and Clinical Excellence (NICE) guidance document states that currentevidence on uterine artery embolization (UAE) for fibroids shows that the procedure is efficacious forsymptom relief in the short and medium term for a substantial proportion of patients. There are no
major safety concerns. Therefore, this procedure may be used provided that normal arrangements are
in place for clinical governance and audit (NICE, 2010).
van der Kooij et al. (2010) compared clinical outcomes and health related quality of life (HRQOL) 5
years after uterine artery embolization (UAE) or hysterectomy in the treatment of menorrhagia caused
by uterine fibroids. Patients with symptomatic uterine fibroids who were eligible for hysterectomywere assigned randomly 1:1 to hysterectomy (n=89) or UAE (n=88). Endpoints after 5 years were
reintervention rates, menorrhagia and HRQOL measures that were assessed by validated
questionnaires. Five years after treatment 23 of 81 UAE patients (28.4%) had undergone ahysterectomy because of insufficient improvement of complaints (24.7% after successful UAE).
HRQOL measures improved significantly and remained stable until the 5-year follow-up evaluation,
with no differences between the groups. UAE had a positive effect both on urinary and defecationfunction.
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 aftertreatment, 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
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groups were compared to each other, there were no significant differences in bleeding improvementand uterine volume reduction. Patients who received UAE required fewer days off work, fewer
hospital days and experienced fewer adverse events.
Mara et al. (2006) compared UAE to myomectomy in 63 women and followed-up for a mean of 17
months. Both methods were clinically successful in the majority of cases and were without asignificant number of serious complications.
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 significantreductions 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 concludedthat 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 washigher 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 uterinevolume 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 in44 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 couldnot be completed in 3 patients due to variant anatomy. Patient satisfaction was 91% and nearly half ofthe 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.
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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 symptomcontrol (92% for the UAE group and 90% for the myomectomy group). The satisfaction rate was
higher in the UAE group.
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 paincontrol. 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 reportedprocedure time and length of stay favoring UAE. However, the absence of key information on longer-
term 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
Endometrial Ablation
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, reaffirmed2009).
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 notindicated 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
American College of Obstetricians and Gynecologists (ACOG)While short-term studies show safety and efficacy, long-term studies are needed to discern whether theminimally invasive advantage of MRI-guided focused ultrasound surgery will lead to durable results
beyond 24 months (ACOG, 2008, reaffirmed 2010).
Levonorgestrel-Releasing Intrauterine Device
American College of Obstetricians and Gynecologists (ACOG)
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An ACOG practice guideline on the use of noncontraceptive uses of hormonal contraceptives states thefollowing:
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 whomay desire further pregnancies. (Evidence Level B based on limited or inconsistent scientificevidence.) (ACOG, 2010)
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 ofmenorrhagia. 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; reaffirmed 2010)
Uterine Artery Embolization
American College of Obstetricians and Gynecologists (ACOG)In a 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, reaffirmed 2010).
U.S. FOOD AND DRUG ADMINISTRATION (FDA)
Endometrial Ablation
Devices for thermal ablation of the endometrium are regulated by the FDA as Class III devices that aresubject 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 October 2012.
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 theuterus 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. AccessedOctober 2012.
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 whomchild bearing is complete. See the following website for more information:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=1088. Accessed October 2012.
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 October2012.
The NovaSure Impedance Controlled Endometrial Ablation System (Hologic, Inc.) receivedpremarket 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 iscomplete. See the following website for more information:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p010013. Accessed
October 2012.
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
October 2012.
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 asin 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 October 2012.
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 October
2012.
Levonorgestrel-Releasing Intrauterine Device
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 astheir 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 October 2012.
Uterine Artery Embolization
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 bythe 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 October 2012.
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APPLICABLE CODES
The codes listed in this policy are for reference purposes only. Listing of a service or device code inthis 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
0071TFocused ultrasound ablation of uterine leiomyomata, including MR guidance; total
leiomyomata volume less than 200 cc of tissue
0072TFocused ultrasound ablation of uterine leiomyomata, including MR guidance; total
leiomyomata volume greater or equal to 200 cc of tissue
37210
Uterine fibroid embolization (UFE, embolization of the uterine arteries to treat
uterine fibroids, leiomyomata), percutaneous approach inclusive of vascular access,
vessel selection, embolization, and all radiological supervision and interpretation,
intraprocedural roadmapping, and imaging guidance necessary to complete the
procedure58353 Endometrial ablation, thermal, without hysteroscopic guidance
58356Endometrial cryoablation with ultrasonic guidance, including endometrialcurettage, when performed
58563Hysteroscopy, surgical; with endometrial ablation (eg, endometrial resection,
electrosurgical ablation, thermoablation)
58999 Unlisted procedure, female genital system (Medicare)CPT
is a registered trademark of the American Medical Association.
HCPCS Code Description
J7302 Levonorgestrel-releasing intrauterine contraceptive system, 52 mg
J7306 Levonorgestrel (contraceptive) implant system, including implants and suppliesS4981 Insertion of levonorgestrel-releasing intrauterine system
ICD-9 Codes Description
621.30-621.34 Endometrial hyperplasia (Medicare)
626.2 Excessive or frequent menstruation
626.6 Metrorrhagia
627.0 Premenopausal menorrhagia
627.2 Symptomatic menopausal or female climacteric states
627.4 Symptomatic states associated with artificial menopause
218.0 Submucous leiomyoma of uterus
218.1 Intramural leiomyoma of uterus
218.2 Subserous leiomyoma of uterus
218.9 Leiomyoma of uterus, unspecified
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ICD-10
Diagnosis Code
(effective
10/01/14)
Description
N92.3 Excessive and frequent menstruation with regular cycleN92.1 Excessive and frequent menstruation with irregular cycle
N92.4 Excessive bleeding in the premenopausal period
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PROTOCOL HISTORY/REVISION INFORMATION
Date Action/Description
10/25/201210/27/2011
11/29/201005/21/201003/20/2009
Corporate Medical Affairs Committee
The foregoing Health Plan of Nevada/Sierra Health & Life Health Healthcare Operations protocol hasbeen adopted from an existing UnitedHealthcare coverage determination guideline that was researched,
developed and approved by the UnitedHealthcare Coverage Determination Committee.