Currentsierra health and lifePolicy 2026T0442VV

Abnormal Uterine Bleeding and Uterine Fibroids (coverage criteria)

Clinical coverage policy for evaluation and treatment options for abnormal uterine bleeding (AUB) and uterine fibroids, including endometrial ablation, levonorgestrel-releasing intrauterine devices (LNG-IUD), and uterine artery embolization (UAE); applies to UnitedHealthcare Commercial and Individual Exchange benefit plans.

Policy Summary

Payersierra health and life

PolicyAbnormal Uterine Bleeding and Uterine Fibroids

Policy CodePolicy 2026T0442VV

Change TypeNo material clinical or coverage changes

Effective DateJan 1, 2026

Next Review Date

Key ActionRefer to InterQual clinical criteria for medical necessity when requesting authorization for endometrial ablation or uterine artery embolization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3primary treatments described

4procedures/technologies noted

J7296–J7306listed HCPCS/CPT drug & supply codes

35.3% vs 19.1%surgical reintervention rate (LNG-IUS vs RFA)

60%

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amenorrhea rate (LNG-IUS in bleeding disorders)

Coverage Criteria for AUB and Uterine Fibroids

inv-01: Endometrial ablation (medical necessity via InterQual)

Covered when ALL of the following are met or per referenced InterQual criteria:

Endometrial ablation is proven and medically necessary for treating abnormal uterine bleeding in premenopausal individuals; medical necessity determinations should follow the InterQual® CP: Procedures, Hysteroscopy, Operative.

See InterQual criteria for specific patient-level indications and required documentation.

inv-02: Levonorgestrel-releasing IUD (LNG-IUD)

Covered when used for menorrhagia or other medically necessary non-contraceptive indications per plan:

LNG-IUD for menorrhagia: Levonorgestrel-releasing intrauterine devices (e.g., Mirena, Skyla, Liletta, Kyleena) are proven and medically necessary for treating menorrhagia; coverage is subject to plan-specific preventive care or contraception exclusions—when contraception is excluded, LNG-IUDs remain covered for non-contraceptive indications such as treatment of abnormal uterine bleeding.

Document product (e.g., 52-mg LNG-IUS) and prior treatments; evidence from RCTs and Cochrane reviews supports LNG-IUS as a first-line nonsurgical option.

inv-03: Uterine artery embolization (UAE)

Covered when ALL of the following are met or per referenced InterQual criteria:

Uterine artery embolization (UAE): Uterine artery embolization is proven and medically necessary for treating symptomatic uterine fibroids, postpartum or post-hysterectomy bleeding, or uterine arteriovenous malformation; medical necessity determinations should follow the InterQual® CP: Procedures, Uterine Artery Embolization.

Policy notes UAE is unproven for preserving childbearing potential; counsel and document fertility considerations.

inv-04: Unproven / Not medically necessary procedures

Not covered / considered unproven when any of the following apply:

MRgFUS (HIFU): Magnetic resonance-guided focused ultrasound (MRgFUS/HIFU) is considered unproven and not medically necessary for treating uterine fibroids when evidence of durable efficacy is insufficient or when standardized protocols and long-term outcomes are lacking.

See systematic reviews and meta-analyses indicating limited long-term data and heterogeneous results.

UAE to preserve fertility: Use of UAE specifically to preserve childbearing potential is considered unproven and not medically necessary due to insufficient high-quality evidence demonstrating safe and effective fertility outcomes.

Counsel patients and document alternatives; prior authorization recommended for fertility-preserving indications.

inv-05: Coverage considerations (evidence-based)

Evidence-based coverage considerations drawn from systematic reviews and trials in this section:

LNG-IUS as first-line for non-surgical HMB: Multiple RCTs and Cochrane reviews demonstrate that the LNG-IUS (commonly the 52-mg device) provides superior short- to medium-term reduction in menstrual blood loss, improved quality of life, and higher patient satisfaction compared with oral medical therapies; long-term data are limited and reintervention rates vary across studies.short- to medium-term evidence; limited long-term data

Cite randomized trials and systematic reviews (MIRA follow-up, Chen 2022, Bofill Rodriguez 2022).

When to consider invasive or uterine-sparing procedures: Consider myomectomy, hysterectomy, UAE, or HIFU/MRgFUS when medical therapy and LNG-IUS are contraindicated, declined, or ineffective; selection should weigh reintervention rates, complication profiles, and the patient's fertility desires.individualized decision-making

Evidence shows differing reintervention and fertility outcome profiles among options.

inv-06: Guideline-based coverage context

Coverage considerations and comparative effectiveness summaries from professional societies and HTA bodies:

ACR appropriateness context: The ACR considers laparoscopic/open myomectomy, medical management, MRgFUS, or UAE usually appropriate initial therapies for reproductive-age patients with symptomatic fibroids (including heavy bleeding or bulk symptoms) who desire fertility preservation; in most cases medical management should be attempted before more invasive therapies.

Treatments are considered equivalent alternatives; document trial of medical therapy when applicable.

NICE guidance on MRgFUS and UAE: NICE concludes MRgFUS has adequate short-term evidence but uncertain long-term and pregnancy effects and recommends use with appropriate governance, audit, and research arrangements; NICE finds UAE efficacious for short- and medium-term symptom relief and supports its use with clinical governance and audit.

Inform patients about potential need for further treatment and pregnancy uncertainties.

inv-07: Evidence summaries affecting coverage

Evidence summaries that affect coverage considerations:

MRgFUS safety and efficacy summary: Systematic reviews and HTA assessments report that MRgFUS can reduce fibroid volume and symptoms in some patients but overall evidence quality is low and study heterogeneity is high; reported adverse events include pain, skin burns, and rare nerve injury, and many patients are ineligible due to restrictive selection criteria.

Kociuba et al., ECRI, and Hayes assessments highlight limited high-quality RCT data and variable AE rates.

US-HIFU vs MR-HIFU comparative data: Comparative analyses indicate ultrasound-guided HIFU (USgHIFU) often achieves higher NPVR and lower reintervention rates than MR-guided HIFU in pooled studies, with MR-guided procedures generally longer in duration.

Meta-analyses report NPVR differences (e.g., MR 58.9% vs US 81.1%).

UAE vs focused ultrasound RCT findings: A randomized/comprehensive cohort study found focused ultrasound had lower immediate post-procedure pain, less outpatient opioid use, and shorter recovery time compared with UAE, while adverse event rates were similar and mostly minor.

inv-08: Device indications and contraindications affecting coverage

Coverage-relevant device indications and contraindications noted in policy references

LNG-IUD device indications: FDA approvals: Mirena (approved for contraception and an additional indication for treatment of heavy menstrual bleeding), Skyla, Liletta, and Kyleena are FDA-approved intrauterine contraceptives; Mirena includes an HMB treatment indication—coverage should document product and indication.

Refer to FDA labeling for product-specific indications and approved uses.

MRgFUS (ExAblate) PMA indications: The ExAblate 2000/2100 System (Insightec) has PMA indicating use for ablation of uterine fibroid tissue in pre- or perimenopausal women desiring a uterine-sparing procedure when uterine size is less than 24 weeks; labeling was updated to remove a completed-childbearing restriction.uterine size <24 weeks

Coverage decisions may consider device labeling and patient eligibility criteria.

Power morcellation contraindications: FDA safety communication warns that laparoscopic power morcellators may spread unsuspected cancer and recommends against use in the majority of women undergoing myomectomy or hysterectomy for fibroids; morcellators are contraindicated when tissue is known or suspected to contain malignancy and in peri- or postmenopausal patients or candidates for en bloc removal.

Coverage for levonorgestrel-releasing intrauterine devices (LNG-IUD) depends on the member's specific plan. Some plans exclude contraceptive services; in those plans LNG-IUDs are not covered when used solely for contraception, but they remain covered when used for medically necessary non-contraceptive indications such as treatment of heavy menstrual bleeding or other approved therapeutic uses. Document the device brand and indication in the medical record when requesting coverage for a non-contraceptive indication.

Magnetic resonance-guided focused ultrasound (MRgFUS) is considered insufficiently evidenced for routine treatment of uterine fibroids. The policy cites a paucity of long-term durability data, heterogeneous study methods, and lack of standardized treatment protocols; therefore MRgFUS may be classified as investigational or not covered where local coverage rules require higher-quality comparative evidence. Counsel patients on uncertain long-term outcomes and the potential need for subsequent procedures.

The American Association of Gynecologic Laparoscopists (AAGL) position notes that embolic and ablative therapies — including uterine artery embolization (UAE), radiofrequency ablation, cryotherapy, and MRgFUS — are not appropriate for women with submucous myomas who currently have infertility or who wish to conceive, based primarily on consensus/expert opinion. This guidance should be considered when evaluating fertility-preserving treatment options.

The FDA issued a safety communication warning against routine use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for fibroids because uterine tissue may contain unsuspected cancer and morcellation can spread malignancy and worsen survival. The FDA labeling includes a boxed warning and specific contraindications: morcellators are contraindicated when the tissue is known or suspected to contain malignancy and for peri- or postmenopausal women or candidates for en bloc removal. Document discussion of FDA warnings and consider alternative surgical approaches.

MRgFUS is described as unproven and not medically necessary for treatment of uterine fibroids due to limited and low-quality evidence. The policy also highlights that evidence is heterogeneous and that many studies report eligibility restrictions; for UAE, the policy states uncertainty about preserving fertility and advises caution when offering UAE for fertility preservation because of insufficient high-quality evidence on pregnancy outcomes.

Procedures offered to preserve fertility after fibroid treatment have uncertain outcomes. The policy summarizes systematic reviews showing limited, low-quality data on fertility after uterine artery embolization and emphasizes that some studies report higher reintervention rates and inconsistent pregnancy outcomes compared with myomectomy. Prior authorization and documented counseling on alternative options are recommended when fertility preservation is a stated goal.

Patient eligibility for MRgFUS is often limited by strict selection criteria and numerous exclusions, making many women ineligible candidates. In addition to limited candidate eligibility, MRgFUS carries procedure-specific risks including skin burns and other visceral injury concerns reported in case series and assessments. Because of these issues and the inconclusive evidence base, MRgFUS is generally not favored as a first-line uterine-sparing option without careful multidisciplinary selection and informed consent.

The FDA safety communication provides context for the morcellator warning: tissue morcellation can disseminate occult malignancy and reduce long-term survival, so the FDA advises against use of laparoscopic power morcellators in most women undergoing fibroid surgery. The communication lists explicit contraindications and recommends that clinicians inform patients of the risks and consider alternative specimen-extraction methods.

Applicable Procedure, Supply, and Drug Codes

Applicable procedure 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).

Applicable HCPCS/Codes for LNG-IUDHCPCS

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.

No explicit CPT/ICD codes listed in this sectionmixed

No codes listed

Codes mentioned or impliedmixed

N/A	No explicit CPT/ICD/HCPCS codes listed in this document excerpt.

inv-21: Nonperfused volume rate (NPVR) — >= 50% associated with lower reintervention after HIFU

Nonperfused volume rate (NPVR) association>= 50% associated with lower reintervention rates after HIFU (12–60 months)

Evidence sourceSystematic review/meta-analysis reporting lower reintervention when NPVR > =50%

Clinical implicationAim for NPVR >=50% during HIFU to reduce likelihood of later reintervention

inv-22: UF volume inclusion (< 300 cm3)

Fibroid inclusion volumeUterine fibroids with total volume < 300 cm3 were included in many HIFU studies

Study context

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required for Fertility‑Preserving Uterine‑Sparing Procedures: Prior authorization is required for uterine‑sparing procedures performed with the intent to preserve fertility (for example, uterine artery embolization [UAE], myomectomy when billed with fertility‑preservation intent, and other conservative uterine procedures). Requests will be reviewed using InterQual-based medical necessity criteria where applicable and by clinical review when evidence is limited. Authorization does not guarantee payment; coverage is subject to the member's specific benefit plan.

Affected services include UAE, fertility‑preserving myomectomy, and other uterine‑sparing interventions when fertility preservation is claimed.
Review will incorporate InterQual criteria for applicable procedures and device approvals/labeling.

Step Therapy

Prioritize Medical Management / Step Therapy

Stepwise and Medical-First Approach / Step Therapy Preference: In most cases, a trial of appropriate medical management is recommended and should be attempted before more invasive uterine‑sparing procedures. Use of a levonorgestrel‑releasing intrauterine system (LNG‑IUS/LNG‑IUD) is supported by guidelines and high‑quality evidence as a first‑line therapy for heavy menstrual bleeding and is often preferred prior to surgical or procedural interventions when clinically appropriate.

Background and Context

Abnormal uterine bleeding (AUB) encompasses any change in menstrual period frequency or duration, any change in amount of menstrual flow, or bleeding between cycles; in postmenopausal individuals it includes bleeding occurring 12 months or more after cessation of menstruation. AUB is a common presentation associated with causes such as hormonal dysfunction, structural uterine lesions (including fibroids), and coagulopathies, and it guides consideration of medical versus procedural treatment options.

Key Definitions

inv-43: Abnormal uterine bleeding (AUB) definition

DefinitionAny change in menstrual period frequency or duration, change in amount of flow, or bleeding between cycles; in postmenopausal women includes vaginal bleeding 12 months or more after cessation of menstruation

Included patternsTerms include oligomenorrhea, polymenorrhea, menorrhagia, menometrorrhagia, and metrorrhagia

Clinical contextAUB can be idiopathic or associated with uterine lesions, systemic illness, medications, or hormonal imbalance

inv-44: Uterine fibroids (leiomyomata)

DefinitionBenign tumors of the uterus (leiomyomata) that may cause excessive uterine bleeding, uterine enlargement, and bulk-related symptoms such as pelvic pain and pressure

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

Policy Summary

Payersierra health and life

PolicyAbnormal Uterine Bleeding and Uterine Fibroids

Policy CodePolicy 2026T0442VV

Change TypeNo material clinical or coverage changes

Effective DateJan 1, 2026

Next Review Date

Key ActionRefer to InterQual clinical criteria for medical necessity when requesting authorization for endometrial ablation or uterine artery embolization.

SourceLink

On This Page

UAE and fertility preservation evidence: Systematic reviews report insufficient or mixed evidence that UAE preserves fertility; some meta-analyses show higher reintervention and hysterectomy rates compared with myomectomy and limited long-term fertility data—patients desiring pregnancy should be counseled accordingly.insufficient high-quality evidence for assured fertility preservation

Document counseling and alternatives; consider prior authorization for fertility-preserving indications.

HIFU/MRgFUS evidence stance: HIFU (including MRgFUS) may reduce fibroid volume and relieve symptoms in selected patients and is associated with fewer short-term adverse events than surgery in some studies, but evidence is heterogeneous with variable durability and higher reintervention rates; outcomes improve with higher NPVR (e.g., ≥50%) and with device/technique differences.variable depending on device, imaging guidance, and NPVR

Standardized protocols and more RCTs are needed to clarify long-term efficacy.

After adjustment, UAE remained associated with higher opioid use and longer return-to-work times.

Use in contraindicated scenarios may be denied; document alternative approaches and informed consent discussions.

Several MR‑HIFU/US‑HIFU systematic reviews used <300 cm3 as inclusion criterion

Clinical implicationConsider device eligibility and study-derived size limits when selecting patients for HIFU

inv-23: NPVR success threshold (> 80%)

NPVR success threshold> 80% NPVR is considered a successful ablation

Comparative NPVRsReported pooled NPVR: MR‑HIFU ~58.9% vs US‑HIFU ~81.1%

Clinical implicationHigher NPVR (>80%) correlates with clinical success after HIFU

inv-24: Uterine size limit for ExAblate PMA (< 24 weeks)

ExAblate PMA uterine size limitUterine size less than 24 weeks per ExAblate 2000/2100 PMA labeling

Indication detailsPMA indicates use in pre- or perimenopausal women with symptomatic fibroids desiring uterine-sparing procedure

Label update2015 labeling modification removed completed-childbearing restriction

Documented trial and failure or contraindication to medical therapy should be included with authorization requests (medications tried, duration, response, and reasons for failure/intolerance).
If LNG‑IUD is used as first‑line therapy, include device name and indication in records; coverage for LNG‑IUD for contraception depends on member plan benefits — non‑contraceptive use (e.g., treatment of abnormal uterine bleeding) may be covered even when contraceptive use is excluded by the plan.

Prior Authorization

Device/Agent Identification and Verification

Device/Agent Verification and Prior Authorization: Embolic agents, implanted devices, and energy‑based systems used in uterine procedures must be identified in the request and supporting documentation. Some embolic agents and devices are FDA‑cleared or approved for specific indications; others are not. Authorization requires specification of the device/agent (manufacturer, trade name, model/size where applicable) and justification for its selection.

For UAE, list the embolic agent(s) to be used (name, size, manufacturer) and any relevant FDA clearance/labeling information if available.
For MRgFUS, include device model (e.g., ExAblate system) and indication; note that MRgFUS has specific eligibility considerations and manufacturer labeling.
For LNG‑IUD insertions, include specific product (Mirena, Liletta, Skyla, Kyleena) when relevant.

Documentation Required

Clinical Documentation Required

Required Clinical Documentation for Device/Procedure Reviews: Provide complete medical records to support medical necessity determinations. Incomplete documentation may delay review or result in denial. Clinical documentation should demonstrate the diagnosis, prior therapies, objective evaluation, and the member's fertility desires when relevant.

Relevant items to include: history and physical; symptom severity documentation; imaging reports (ultrasound and MRI if obtained) describing size, number, and location of fibroids; laboratory results and pregnancy test when indicated.
Documentation of prior conservative therapy (medications, duration, response) and explicit documentation of the patient’s desire to preserve fertility, if claimed.
Operative reports, pathology when applicable, and prior procedure reports if repeat intervention is requested.

Denial Risk

Documentation May Trigger Denial

Medical Records May Trigger Denial If Incomplete or Inconsistent: Missing, inconsistent, or insufficient clinical documentation that does not meet stated criteria may result in denial of the authorization request. Documentation that contradicts the claimed indication (for example, lack of fertility‑preservation intent when that is the requested justification) may also lead to denial.

Ensure imaging reports include fibroid measurements and location; vague or absent imaging increases denial risk.
If fertility preservation is asserted, include reproductive counseling notes and fertility desire documentation; absence of this may lead to non‑coverage for fertility‑preserving claims.

Note

Evidence Uncertainty for Fertility Preservation

Evidence Uncertainty May Affect Fertility‑Preserving Coverage Decisions: For some uterine‑sparing procedures (for example, UAE and MRgFUS), evidence regarding preservation of fertility and long‑term pregnancy outcomes is limited or mixed. Clinical reviewers may deny coverage for fertility‑preserving intent when evidence is insufficient to support efficacy or safety for that purpose.

UAE: current evidence does not conclusively demonstrate preservation of childbearing potential and has mixed data on pregnancy outcomes—provide detailed counseling notes and informed consent if fertility‑preservation is the intent.
MRgFUS: evidence is limited; include counseling about uncertainty of fertility outcomes and reasons for selecting MRgFUS over other options.

Prior Authorization

MRgFUS Eligibility and Consent

Eligibility, Patient Selection, and Consent for MRgFUS: MRgFUS (e.g., ExAblate systems) has restrictive eligibility criteria and requires careful patient selection. Prior authorization should include documentation that the patient meets device‑specific and guideline‑recommended selection criteria, and that informed consent addressing uncertain fertility effects and other procedure risks was obtained.

Provide device model and inclusion/exclusion assessment (uterine size, number/location of fibroids, prior pelvic surgery, imaging suitability).
Include documentation of multidisciplinary evaluation when applicable (gynecologist and imaging specialist) and written informed consent covering: potential for symptom recurrence, uncertain impact on fertility, risk of skin burns, and potential need for further procedures.
Note that MRgFUS should be performed in specialized centers with clinicians specifically trained in the technique.

Documentation Required

Preoperative Evaluation and Consent

Preoperative Evaluation and Informed Consent Requirements: Preoperative risk assessment and informed consent are required for all surgical and procedural uterine interventions. Preoperative evaluation should include malignancy risk assessment where appropriate and documentation of counseling regarding alternative treatments and risks (including risk of occult malignancy and morcellation concerns).

For procedures where morcellation might be considered, include preoperative risk stratification for uterine malignancy (imaging, endometrial sampling, cervical screening) and documented shared decision making addressing morcellation risks and alternatives.
Document pregnancy testing and relevant preoperative labs, and counseling about likelihood of symptom relief and possibility of reintervention.

Documentation Required

Device Identification and Counseling

Device Identification and Counseling Documentation: For implants and energy‑based devices, document device identifiers and that device‑specific counseling was provided. Counseling should include device risks, benefits, alternatives, and FDA labeling or limitations when relevant.

Record manufacturer, trade name, model/lot when available (LNG‑IUD product name, embolic agent, MRgFUS system model).
Include counseling notes confirming discussion of device‑specific risks, expected outcomes, and follow‑up plan.

Treatment contextUterine fibroid embolization (UFE) is a viable alternative to hysterectomy for clinically symptomatic fibroids

inv-45: 52-mg LNG-IUS

Device/dose description52-mg levonorgestrel intrauterine system releasing ~20 µg/day in year 1

Indication for HMBUsed to treat heavy menstrual bleeding and demonstrated superior short- and medium-term reduction in menstrual blood loss vs oral medical therapies

Regulatory/brandsMirena (additional FDA indication for HMB); other brands include Liletta, Skyla, Kyleena

inv-46: HIFU / MRgFUS

DefinitionHigh‑intensity focused ultrasound (HIFU), including MR‑guided focused ultrasound (MRgFUS), is a noninvasive ablation technique for uterine fibroids

Evidence stanceSystematic reviews report heterogenous evidence with limited long-term durability and variable reintervention rates; additional RCTs needed

Device examplesDevices evaluated include ExAblate 2000/2100, Sonalleve, Chongqing Haifu systems

inv-47: NPVR

DefinitionNonperfused volume ratio (NPVR) is an imaging measure used after HIFU procedures to quantify ablated fibroid volume

Clinical thresholdsNPVR >80% considered successful; NPVR >=50% associated with lower reintervention

Comparative dataReported pooled NPVRs: MR‑HIFU ~58.9% vs US‑HIFU ~81.1%

inv-48: LNG-IUD (examples/brands)

Examples/brandsMirena, Skyla, Liletta, Kyleena are listed examples of levonorgestrel-releasing intrauterine devices

Regulatory notesMirena has an FDA indication for treatment of heavy menstrual bleeding in addition to contraceptive use

Clinical useThese LNG-IUDs may be used for non-contraceptive indications such as treatment of AUB depending on plan coverage

inv-49: UAE definition

DefinitionUterine artery embolization (UAE) is a procedure using embolic agents to devascularize fibroids; the procedure itself is not FDA‑regulated but embolic agents are

IndicationIndicated for individuals with clinically documented fibroids and fibroid-related symptoms as an alternative to hysterectomy

Regulatory noteVerify specific embolic agent approvals; embolic agents are subject to FDA oversight

inv-50: MRgFUS device examples and PMA

PMA device exampleExAblate 2000/2100 System (Insightec) — PMA approved for ablation of uterine fibroid tissue

Device use criteriaIndicated for pre- or perimenopausal women with symptomatic fibroids desiring uterine-sparing procedure and uterine size <24 weeks

Other devices referencedOther MRgFUS/US‑HIFU devices cited in literature include Sonalleve and Chongqing Haifu models