Abnormal Uterine Bleeding and Uterine Fibroids (for New Mexico Only)

Coverage Summary

This policy (Policy Number CS002NM.C, effective November 1, 2025) governs medical necessity and coverage positions for treatments of abnormal uterine bleeding (AUB) and uterine fibroids for UnitedHealthcare members in New Mexico. It addresses endometrial ablation, levonorgestrel-releasing intrauterine devices (LNG-IUD), uterine artery embolization (UAE), and magnetic resonance-guided focused ultrasound ablation (MRgFUS).

Procedure-level medical necessity determinations for operative hysteroscopy (endometrial ablation) and UAE reference InterQual® clinical criteria; documentation requirements and examples are listed and medical records must support medical necessity and be legible and available upon request.

Numeric thresholds and notable policy points

ExAblate uterine size indicationuterine size less than 24 weeks

ExAblate approval / label change datesPMA original approval 2004-10-22; childbearing restriction removed 2015-08-31

NPVR success thresholdNPVR > 80% considered successful in cited study

MR-HIFU vs US-HIFU NPVR valuesMR-HIFU NPVR ~58.92%; US-HIFU NPVR ~81.07%

Average MR-HIFU treatment time noteMR-HIFU average treatment time almost double US-HIFU (US mean 96.9 minutes)

Pooled fibroid volume reduction at 6 monthsRFA 70%; UAE 54%; FUS 32%

Focused ultrasound CPT volume-based codes0071T: total leiomyomata volume < 200 cc; 0072T: total leiomyomata volume ≥ 200 cc

Medical Necessity Criteria

Endometrial Ablation - Coverage

Covered when medical necessity is met per referenced criteria:

ALL of the following

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

Levonorgestrel-Releasing Intrauterine Device (LNG-IUD) - Coverage

Covered when used to treat menorrhagia / heavy menstrual bleeding per policy:

ALL of the following

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

Not Medically Necessary / Experimental

Magnetic Resonance-Guided Focused Ultrasound Ablation (MRgFUS) - Not Medically Necessary

Policy position:

ALL of the following

MRgFUS is unproven and not medically necessary for treating uterine fibroids due to insufficient evidence of efficacy.

The evidence summary states there is insufficient evidence to conclude MRgFUS is effective for treating fibroids and that long-term durability of symptom relief and reintervention rates are uncertain. Systematic reviews and comparative analyses highlight limitations including small studies, heterogeneity, and lack of long-term randomized data.

Comparative findings that informed the policy's not-medically-necessary stance include pooled outcomes showing lower fibroid volume reduction with focused ultrasound (FUS) versus other ablation methods (pooled 6-month reductions: FUS 32%, UAE 54%, RFA 70%), higher reintervention rates for MRgFUS versus some alternatives in pooled analyses, and RCT/cohort data reporting longer procedures and selection limitations for MRgFUS with no clear superiority in symptom improvement compared with established treatments.

Relevant Codes

Uterine Fibroids - Relevant Procedure Codes (reference only)CPT

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 Intrauterine Device - Drug and Insertion Codesmixed

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.

Provider Actions & Requirements

Documentation Required

Medical record documentation required

Medical records must fully support medical necessity, be legible, and be made available upon request. Examples of documentation that may be required include relevant medical history, physical examination findings, and results of pertinent diagnostic tests or procedures.

Relevant medical history
Physical examination
Pertinent diagnostic test results or procedure reports
Legible documentation maintained in the patient record
Availability of records upon request

Documentation Required

Medical record documentation for reviews

Background & Evidence Summary

Abnormal uterine bleeding (AUB) is defined as any change in menstrual frequency, duration, flow amount, or bleeding between cycles, and includes terms such as menorrhagia, metrorrhagia, and menometrorrhagia. Uterine fibroids (leiomyomata) are benign uterine tumors that can cause heavy bleeding, bulk symptoms, pelvic pain, and fertility-related issues.

Conservative management options for AUB and fibroids include watchful waiting, pharmacologic therapy (e.g., hormonal contraception, tranexamic acid, NSAIDs), and device-based medical therapy such as the levonorgestrel-releasing intrauterine device (LNG-IUD), which delivers local progestin to induce endometrial atrophy and reduce bleeding.

Surgical and minimally invasive options include endometrial ablation (proven and medically necessary for AUB in premenopausal individuals when criteria are met), uterine artery embolization (UAE) which blocks arterial supply to fibroids to induce shrinkage, and magnetic resonance-guided focused ultrasound (MRgFUS), a noninvasive thermal ablation technique using MR guidance and high-intensity focused ultrasound.

Fertility considerations: LNG-IUD is recommended as a first-line option for many with heavy menstrual bleeding who may desire future pregnancy counseling per guidelines; UAE has mixed and limited evidence regarding fertility preservation and may be associated with altered pregnancy outcomes, so counseling on reproductive risks is required; MRgFUS effects on subsequent pregnancy are uncertain and long-term data are limited. Clinical recommendations and device-specific guidance (including patient selection and counseling) are provided by professional bodies (ACOG, ACR, NICE) and are referenced in the policy.

Evidence	Brief summary
InterQual referenced
InterQual CP criteria used for procedure-level medical necessity determinations for operative hysteroscopy and UAE (policy references InterQual for hysteroscopy and UAE).
Systematic reviews / RCTs summary
Multiple systematic reviews, meta-analyses, RCTs and cohort studies support LNG-IUD efficacy for heavy menstrual bleeding; mixed/insufficient evidence for fertility preservation after UAE; insufficient evidence for MRgFUS efficacy and durability.
MR-HIFU vs US-HIFU treatment time
MR-HIFU average treatment time almost double US-HIFU (US mean 96.9 minutes).
Pooled volume reduction at 6 months
Pooled fibroid volume reductions at 6 months: RFA 70%, UAE 54%, FUS 32%.
Safety evidence for ExAblate
ECRI assessment: evidence inconclusive — suggests symptom reduction and QOL improvement up to 3 years but studies have high risk of bias and limited outcomes.
Barnard 2017 RCT findings
Barnard RCT: focused ultrasound had longer procedure time; UAE associated with higher opioid use, longer time off work and to return to normal activities; no significant differences in incidence or severity of adverse events.

Definitions

Definitions (term → definition)

Abnormal Uterine Bleeding (AUB)Any change in menstrual period frequency or duration, change in amount of flow, or bleeding between cycles; includes oligomenorrhea, polymenorrhea, menorrhagia, menometrorrhagia, metrorrhagia and postmenopausal bleeding as defined in policy.

NPVRNonperfusion volume ratio; NPVR > 80% considered successful in cited study.

MRgFUS / MR-HIFUMagnetic resonance-guided focused ultrasound / magnetic resonance-guided high-intensity focused ultrasound for uterine fibroid ablation (noninvasive thermal ablation under real-time MR guidance).

UAEUterine artery embolization: injection of particles via the uterine arteries to block blood supply to fibroids, causing shrinkage.

LNG-IUDLevonorgestrel-releasing intrauterine device (e.g., Mirena, Skyla, Liletta, Kyleena) delivering local progestin to cause endometrial atrophy and reduce bleeding.

Revision History

2025-11-01material_change_addedLatest

Medical Records Documentation Used for Reviews: added language indicating benefit coverage is determined by federal, state, or contractual requirements; medical records documentation may be required to assess whether the member meets clinical criteria but does not guarantee coverage; patient medical record must fully support medical necessity (including relevant medical history, physical exam, and diagnostic test/procedure results); documentation must be legible, maintained in the medical record, and made available upon request.

2025-11-01supporting_information_revisedLatest

Supporting Information: updated Clinical Evidence and References sections to reflect the most current information; archived previous policy version CS002NM.B.