CurrentColorado Rocky Mountain Health PlansPolicy 2026T0442VV

Abnormal Uterine Bleeding and Uterine Fibroids

Defines clinical coverage stance for endometrial ablation, levonorgestrel-releasing intrauterine devices (LNG-IUD), uterine artery embolization (UAE), and MRgFUS for members under UnitedHealthcare Commercial and Individual Exchange plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyAbnormal Uterine Bleeding and Uterine Fibroids

Policy CodePolicy 2026T0442VV

Change TypeNo material clinical or coverage changes

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain and submit clinical documentation and prior authorization for MRgFUS or UAE requests, including indication, uterine size/volume, prior treatments, and fertility goals.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Medically necessaryEndometrial ablation

Medically necessaryLNG-IUD

Medically necessaryUAE/UFE

Not medically necessaryMRgFUS

0071T/0072TExample codes listed

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ArchivedArchived versions

Coverage Criteria and Evidence Summary

Medically Necessary Treatments

Covered when meeting referenced clinical criteria:

Endometrial ablation is proven and medically necessary for treating abnormal uterine bleeding in premenopausal individuals; medical necessity clinical coverage criteria per InterQual CP: Procedures, Hysteroscopy, Operative.

See InterQual criteria link for detailed clinical requirements.

Levonorgestrel-releasing IUD: LNG-IUDs (e.g., Mirena, Skyla, Liletta, Kyleena) are proven and medically necessary for treating menorrhagia.

Coverage may be subject to preventive care or contraceptive exclusion rules per plan documents; refer to the FDA section for device details.

Uterine artery embolization (UAE/UFE): UAE is proven and medically necessary for treating symptomatic uterine fibroids, postpartum or posthysterectomy bleeding, or uterine arteriovenous malformation (AVM); for clinical criteria refer to InterQual CP: Procedures, Uterine Artery Embolization.

UAE is not considered effective for preserving childbearing potential; see Benefit Considerations.

Not Medically Necessary / Unproven

MRgFUS: Magnetic resonance-guided focused ultrasound ablation (MRgFUS) is unproven and not medically necessary for treating uterine fibroids due to insufficient evidence of efficacy.

UAE to preserve fertility: UAE is unproven and not medically necessary for the purpose of preserving childbearing potential for individuals with symptomatic uterine fibroids due to insufficient evidence of efficacy.

Listed under Benefit Considerations.

Evidence summaries relevant to coverage decisions

Coverage-relevant findings and comparative outcomes (evidence summaries):

LNG-IUS effectiveness for HMB: Multiple systematic reviews and randomized trials show the 52-mg LNG-IUS reduces menstrual blood loss, improves quality of life, and yields higher clinical responder rates versus oral medical therapies in short- and medium-term follow-up.

Cochrane and other systematic reviews support LNG-IUS as preferred first-line medical therapy for non-surgical candidates.

Long-term reintervention after LNG-IUS vs ablation: Long-term follow-up of an RCT found cumulative reintervention rates were similar between initial LNG-IUS and radiofrequency endometrial ablation strategies overall, but surgical reintervention was higher when initial strategy was LNG-IUS (35.3% vs 19.1%).

Most reinterventions occurred within the first 24 months.

LNG-IUS in special populations: Observational studies suggest LNG-IUS reduces bleeding and improves hemoglobin/ferritin in people with inherited bleeding disorders, with amenorrhea rates and hematologic improvement reported in small cohorts.

Data are from small observational studies with limited controls.

Evidence-based coverage considerations

Summary of comparative evidence and limitations

Evidence on MRgFUS efficacy and safety: Systematic reviews and meta-analyses report MRgFUS can reduce fibroid volume and symptoms in short-term follow-up, but overall evidence quality is low (small cohorts, few randomized trials, short follow-up) and findings are inconclusive for long-term benefit.

Includes assessments by Kociuba et al., ECRI, and Hayes reports.

Comparative effectiveness: Compared with surgery or UAE, MRgFUS in some reports is associated with fewer immediate adverse events and shorter hospital stays but may provide less symptom improvement and have higher reintervention rates versus UAE; US-guided HIFU may achieve higher NPVR and better short-term efficacy than MR-guided in pooled analyses.

Meta-analyses and clinical assessments highlight heterogeneity and device/protocol differences.

Procedure limitations and eligibility: MRgFUS treatments are lengthy, have restrictive selection criteria that exclude many patients, and carry procedure-specific risks including pain, skin burns, and rare nerve injury.

Patient eligibility and procedural duration have limited mainstream adoption.

Some plan benefit documents exclude coverage for contraceptive services. In those plans, intrauterine devices (including levonorgestrel-releasing IUDs) are excluded when used for contraceptive purposes. However, when the LNG-IUD is used for a noncontraceptive therapeutic indication (for example, treatment of abnormal uterine bleeding), coverage may exist under the member's benefit. Refer to the Coverage Rationale for the specific medically necessary indications.

The evidence base for magnetic resonance–guided focused ultrasound ablation (MRgFUS) for uterine fibroids is limited by short follow-up, small cohorts, and heterogeneous treatment protocols across studies. Systematic reviews note a paucity of long-term data on symptom durability and fibroid recurrence and emphasize the need for larger randomized trials with standardized protocols to establish safety and efficacy.

Meta-analyses and pooled studies report variable reintervention rates and identify device- and protocol-related differences that affect outcomes; adverse event evaluations also highlight inconsistent reporting and limited follow-up, which collectively constrain confidence in long-term effectiveness.

The American Association of Gynecologic Laparoscopists (AAGL) position statement on submucous leiomyomas indicates that embolic and ablative therapies — including uterine artery embolization and radiofrequency or thermal ablation techniques (such as MRgFUS) — are not appropriate for women with submucous myomas who have current infertility or who wish to conceive. This guidance is based primarily on consensus/expert opinion (Level C) and the AAGL recommends long-term studies on ablation impacts in this population.

Laparoscopic power morcellators carry an FDA safety communication stating they are contraindicated when the tissue to be morcellated is known or suspected to contain malignancy. The FDA also advises against their use for removal of uterine tissue containing suspected fibroids in peri- or post-menopausal patients or in patients who are candidates for en bloc tissue removal. These warnings should inform preoperative planning and may affect coverage and authorization decisions.

Based on current evidence assessments and guideline summaries, MRgFUS is considered not medically necessary / unproven for treatment of uterine fibroids. Major limitations cited include small sample sizes, few randomized trials, high risk of bias in available studies, inconsistent outcome reporting, and insufficient long-term durability data, resulting in inadequate evidence to support routine coverage.

Comparative data indicate that pregnancy rates after uterine artery embolization (UAE) may be lower and miscarriage rates higher compared with myomectomy, although the overall quality of evidence is low and estimates are uncertain. Systematic reviews report variable pregnancy rates and elevated miscarriage proportions after UAE versus myomectomy; therefore, UAE should be used with caution and patients desiring future fertility require counseling and individualized authorization review.

Patient selection for MRgFUS is restrictive: many women are ineligible due to device-specific and procedural exclusion criteria, anatomic considerations, and risk of visceral injury. Procedures are often lengthy and require specialized equipment and trained operators, which further limits eligibility. These selection limitations mean MRgFUS may not be appropriate for a substantial proportion of patients evaluated for uterine-sparing fibroid treatment.

Procedure and Device Codes, Key Procedural Parameters

Uterine fibroids / procedural CPT codesCPT

0071T	Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total leiomyomata volume less than 200 cc of tissue.
0072T	Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total leiomyomata volume greater or equal to 200 cc of tissue.
37243	Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia, or infarction.
58563	Hysteroscopy, surgical; with endometrial ablation (e.g., endometrial resection, electrosurgical ablation, thermoablation).

Levonorgestrel-releasing IUD and device codesHCPCS

J7296	Levonorgestrel-releasing intrauterine contraceptive system, (Kyleena), 19.5 mg.
J7297	Levonorgestrel-releasing intrauterine contraceptive system (Liletta), 52 mg.
J7298	Levonorgestrel-releasing intrauterine contraceptive system (Mirena), 52 mg.
J7301	Levonorgestrel-releasing intrauterine contraceptive system (Skyla), 13.5 mg.
J7306	Levonorgestrel (contraceptive) implant system, including implants and supplies.
S4981	Insertion of levonorgestrel-releasing intrauterine system.

Fibroid volume inclusion — < 300 cm3

Fibroid volume inclusionFibroid volume inclusion criterion: < 300 cm3

Source contextIncluded as an enrollment/inclusion criterion in MR-HIFU studies and meta-analyses

Implication for selectionPatients with total fibroid volume less than 300 cm3 were included in HIFU trials informing outcomes

NPVR success threshold — > 80%

NPVR success threshold> 80% NPVR considered successful

DefinitionNonperfused volume ratio (NPVR) quantifies the proportion of treated fibroid volume that is nonperfused after ablation

Prior Authorization, Documentation, and Clinical Expectations

Prior Authorization

Prior Authorization Recommended for Uterine-Sparing Procedures

Prior authorization is recommended for uterine-sparing procedures when fertility preservation is a goal. Providers should verify plan coverage and submit clinical justification demonstrating fertility-preservation intent and how the selected procedure aligns with the member's reproductive goals.

Procedures commonly requiring review: MRgFUS (0071T/0072T), Uterine Artery Embolization (37243), and myomectomy (various CPT codes).
Document fertility desire, prior fertility-preserving treatments, and counseling about comparative reintervention and pregnancy outcomes.

Note

Special Arrangements and Facility-Level Requirements

Some minimally invasive and novel procedures require special facility arrangements or clinician training. Follow NICE and device manufacturer guidance for clinical governance, audit, and specialized-center requirements.

NICE recommends use of MRgFUS/HIFU and ultrasound‑guided HIFU only with special arrangements for governance, consent, audit, and prospective data collection.

Clinical Background

Abnormal uterine bleeding (AUB) describes changes in menstrual frequency, duration, or flow and includes patterns such as menorrhagia and metrorrhagia. Uterine fibroids (leiomyomata) are benign uterine tumors commonly seen in women aged approximately 30–40 that can cause heavy menstrual bleeding and bulk-related symptoms. Minimally invasive uterine-sparing alternatives to hysterectomy include endometrial ablation, levonorgestrel-releasing IUDs, and uterine artery embolization.

Key Definitions and Device Descriptions

AUB definition — Abnormal uterine bleeding (AUB)

TermAbnormal uterine bleeding (AUB) is any change in menstrual period frequency or duration, amount of flow, or bleeding between cycles

IncludesMenorrhagia, oligomenorrhea, polymenorrhea, metrorrhagia, and menometrorrhagia

Postmenopausal definitionIn postmenopausal women, AUB includes vaginal bleeding 12 months or more after cessation of menstruation or unpredictable bleeding on prolonged hormone therapy

Uterine fibroids / leiomyomata definition

TermUterine fibroids (leiomyomata) are benign tumors of the uterus

Common presentationMay cause excessive uterine bleeding, uterine enlargement, pelvic pain/pressure, urinary frequency, and abdominal distension

Policy Revision History

2026-01-01Template update and archivingLatest

Created shared policy version to support application to Oxford plan membership and archived previous policy versions (2025T0442UU and SURGERY 057.46).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyAbnormal Uterine Bleeding and Uterine Fibroids

Policy CodePolicy 2026T0442VV

Change TypeNo material clinical or coverage changes

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain and submit clinical documentation and prior authorization for MRgFUS or UAE requests, including indication, uterine size/volume, prior treatments, and fertility goals.

SourceLink

On This Page

UAE comparative outcomes: Systematic reviews and meta-analyses indicate UAE has higher reintervention and hysterectomy rates versus myomectomy at mid-term follow-up but lower early complications and readmissions; fertility and pregnancy outcomes after UAE are uncertain, with some analyses showing reduced pregnancy rates and higher risks of postpartum hemorrhage and placenta previa.

Evidence limited by heterogeneity and study quality.

HIFU/MRgFUS outcomes and limitations: HIFU (US-guided and MR-guided) demonstrates fibroid volume reduction and variable reintervention rates (reported 1–29% over 12–60 months depending on modality and NPVR); US-guided HIFU often shows higher NPVR and shorter procedure times than MR-guided, but long-term durability and standardized protocols are lacking.

Device and protocol variability, small cohorts, and short follow-up limit conclusions.

Evidence gaps and recommendation for research: High-quality randomized controlled trials with larger populations, standardized treatment protocols, long-term outcomes, and consistent reporting of patient selection and fertility outcomes are needed before definitive conclusions can be drawn about MRgFUS effectiveness and comparative performance.

Consistent recommendation across ECRI, Hayes, and guideline sources.

Clinical relevanceHigher NPVR positively correlates with clinical success and lower reintervention rates

Uterine size limit for MRgFUS (ExAblate) — uterine size less than 24 weeks

Uterine size limit (ExAblate MRgFUS)Indication: uterine size less than 24 weeks

Device labelingExAblate PMA indicates use in pre- or perimenopausal women with uterine size <24 weeks

Patient selection implicationUterine size must be assessed and documented when considering MRgFUS (ExAblate)

Procedure should be performed in specialized centers by clinicians with specific training in the technique.

Denial Risk

Potential Denial Triggers for UAE Selection

Uterine artery embolization (UAE) may be denied or deprioritized when evidence suggests a higher likelihood of reintervention or hysterectomy compared with alternative uterine‑sparing surgeries; reviewers will consider comparative long‑term outcomes when assessing medical necessity.

Meta-analyses report higher reintervention and hysterectomy rates after UAE versus myomectomy at intermediate follow-up.
Provide rationale if UAE is selected over myomectomy for patients desiring fertility preservation, including discussion of trade-offs and patient preference.

Denial Risk

Power Morcellation Contraindications

Laparoscopic power morcellation is contraindicated when uterine tissue is known or suspected to be malignant and in many peri- or postmenopausal patients; failure to document preoperative malignancy risk assessment may result in noncoverage or denial.

Morcellation contraindicated if tissue is known or suspected to contain malignancy (FDA boxed warning).
Contraindicated for removal of uterine tissue in peri- or postmenopausal persons or when en bloc removal is appropriate.
Preoperative evaluation should include imaging, cervical screening, and endometrial sampling when indicated to stratify malignancy risk.

Documentation Required

Documentation Expectations for LNG-IUS

When requesting coverage for a levonorgestrel-releasing intrauterine system (LNG-IUS) for heavy menstrual bleeding or other non-contraceptive indications, include specific device information and prior treatment documentation.

Document diagnosis (e.g., heavy menstrual bleeding), reason for non-contraceptive use if applicable, and device characteristics (brand and dose — e.g., Mirena/Liletta 52 mg, Skyla 13.5 mg, Kyleena 19.5 mg).
Include prior medical therapies tried (e.g., NSAIDs, tranexamic acid, oral hormonal therapies) and response to those therapies.

Documentation Required

Informed Consent and Counseling

Obtain informed consent that describes uncertainties, procedure risks, possible complications, and the potential need for additional procedures. Counsel patients considering procedures such as MRgFUS, UAE, or myomectomy about fertility, reintervention rates, and recovery expectations.

Disclose risks specific to procedures (e.g., skin burns with HIFU/MRgFUS; potential for disseminating occult malignancy with morcellation).
Inform individuals considering pregnancy that effects on fertility and future pregnancy outcomes may be uncertain for some procedures (e.g., MRgFUS, UAE).
Document shared decision-making and that alternatives were discussed.

Documentation Required

Supporting Documentation for Minimally Invasive Procedures

Supporting documentation is expected for minimally invasive procedures (MRgFUS, UAE, UFE). Submit imaging, prior conservative therapy records, and procedural rationale to support medical necessity determinations.

Include recent pelvic ultrasound and/or MRI documenting fibroid size, number, and location when relevant.
Provide prior conservative therapy trial details (medical management duration and response) and endometrial sampling or biopsy results if performed.
For MRgFUS, document patient eligibility relative to device indications (e.g., uterine size limits, fibroid characteristics) and specialized-center availability.

Billing Rule

Coverage Sequencing and Benefit Limitations

Coverage sequencing and benefit limitations may affect access to devices and procedures. Check member-specific plan language for contraceptive coverage, preventive-care benefits, and any exclusions that apply to LNG‑IUDs or fertility-preserving procedures.

Some plans include LNG-IUDs as preventive care; others exclude contraceptive services—coverage for LNG-IUD may be allowed only when used for non-contraceptive indications such as abnormal uterine bleeding.
Benefit limitations or step therapy requirements may apply before approving more invasive or higher‑cost procedures.

Step Therapy

Step Approach for Heavy Menstrual Bleeding

Follow a stepwise approach for heavy menstrual bleeding (HMB): begin with appropriate first-line medical therapy and reserve invasive or surgical options for those who fail, are unsuitable for, or decline medical management.

NICE and ACR guidance support LNG-IUS as first-line medical therapy for many patients with HMB (including those with small fibroids or no identified pathology).
Surgical options (endometrial ablation, myomectomy, hysterectomy) are considered for patients who fail medical therapy or have severe symptoms; document trials of medical therapy and reasons for escalation.

Note

Conservative Therapy Expectation

Conservative (uterine-sparing) therapy is expected to be considered and documented prior to more invasive procedures when clinically appropriate. LNG-IUDs (Mirena, Liletta, Kyleena, Skyla) are among the recommended uterine‑sparing options.

Document trials of conservative options and the clinical rationale for proceeding to invasive uterine-sparing procedures (e.g., symptom persistence despite medical therapy).
When fertility preservation is desired, document discussion of alternatives (myomectomy, UAE, MRgFUS) and relative risks/benefits.

EpidemiologyMost commonly found in women aged 30–40 but can occur at any age

LNG-IUS (52-mg) — levonorgestrel amount and release rate

Levonorgestrel amountLNG-IUS contains 52 mg levonorgestrel

Release rateApproximately 20 µg/day during the first year (continuous-release intrauterine progesterone system)

Clinical useUsed to reduce menstrual blood loss in heavy menstrual bleeding (HMB)

HIFU / MRgFUS definition and variability

DefinitionHigh-intensity focused ultrasound (HIFU) and MR-guided focused ultrasound (MRgFUS) are noninvasive ablation techniques that concentrate ultrasound energy to thermally ablate uterine fibroid tissue

VariabilityProtocols, devices (e.g., ExAblate, Sonalleve, Chongqing Haifu), NPVR, treatment times, and reported outcomes vary substantially across studies

Evidence limitationsPaucity of long-term data and lack of standardized protocols limit conclusions about durability and comparative effectiveness

UAE definition — uterine artery embolization summary

DefinitionUterine artery embolization (UAE) is a minimally invasive procedure that uses embolic agents to reduce blood flow to uterine fibroids

Regulatory noteProcedure itself is not FDA-regulated, though embolic agents used are subject to FDA oversight

Clinical considerationsAssociated with different reintervention and fertility outcomes compared with myomectomy; preprocedure evaluation (e.g., endometrial biopsy) is recommended

NPVR — Nonperfused volume ratio definition and success threshold

DefinitionNonperfused volume ratio (NPVR) is the proportion of fibroid volume that is nonperfused after ablation and is positively associated with clinical success

Success thresholdAn NPVR > 80% is considered successful

Relation to outcomesHigher NPVR is associated with lower reintervention rates and better symptom relief in HIFU/MRgFUS studies

LNG-IUD — Levonorgestrel-Releasing Intrauterine Device (LNG-IUD) naming

NameLevonorgestrel-Releasing Intrauterine Device (LNG-IUD)

ExamplesCommercial products include Mirena, Liletta, Skyla, and Kyleena as named LNG-IUDs in the policy

IndicationUsed for contraception and for treatment of heavy menstrual bleeding when indicated

MRgFUS / ExAblate device description

DeviceExAblate 2000/2100 System (Insightec)

Indication per PMAPMA indicates ablation of uterine fibroid tissue in pre- or perimenopausal women desiring uterine-sparing treatment (uterine size < 24 weeks)

Regulatory statusExAblate received FDA premarket approval (P040003) with updated labeling; indications were modified in 2015 to remove restriction to women who had completed childbearing

UAE definition (alternate entry)

Definition (alt entry)Uterine artery embolization (UAE) is a minimally invasive embolic procedure that reduces fibroid blood supply to induce shrinkage and symptom relief

Outcomes noteSystematic reviews show UAE has higher mid-term reintervention and hysterectomy rates versus myomectomy but lower early complications and shorter initial recovery

Fertility considerationEvidence is insufficient to conclude UAE preserves childbearing potential; fertility and pregnancy outcomes remain uncertain