ModifiedUnitedHealthcarePolicy CS002KS.02

Abnormal Uterine Bleeding and Uterine Fibroids (for Kansas Only)

Defines medical necessity and coverage stance for endometrial ablation, levonorgestrel-releasing IUDs, uterine artery embolization, and related procedures for members in Kansas.

Policy Summary

PayerUnitedHealthcare

PolicyAbnormal Uterine Bleeding and Uterine Fibroids (for Kansas Only)

Policy CodePolicy CS002KS.02

Change TypeModified — documentation and clinical evidence updates

Effective Date11/01/2025

Next Review DateN/A

Key ActionProvide complete medical record documentation (history, exam, and diagnostic test results) to support medical necessity and prior authorization when requested.

SourceLink

POLICY UPDATE CHANGES

Added language clarifying that medical records documentation may be required to assess whether the member meets clinical criteria for coverage and that documentation supporting medical necessity must be available upon request.

Updated Clinical Evidence and References sections to reflect the most current information.

CoveredEndometrial ablation

CoveredLevonorgestrel IUDs

CoveredUAE

Not coveredMRgFUS

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Not for fertility preservationUAE limitation

11/01/2025Policy revision date

Coverage Criteria for AUB and Fibroid Treatments

inv-01: Medically Necessary Treatments — Covered when meeting the referenced InterQual clinical criteria and applicable clinical documentation.

Covered when meeting the referenced InterQual clinical criteria and applicable clinical documentation:

Endometrial ablation is proven and medically necessary for treating abnormal uterine bleeding in premenopausal individuals when InterQual CP: Procedures, Hysteroscopy, Operative criteria are met.Refer to InterQual

See InterQual reference in policy (chunk 2)

Levonorgestrel-releasing IUD (LNG-IUS): Levonorgestrel-releasing intrauterine systems (LNG-IUS) are proven and medically necessary for treating heavy menstrual bleeding when clinical selection matches device labeling and InterQual/clinical criteria are met.N/A

See supporting evidence and device information (chunks 20,21)

Uterine artery embolization (UAE): UAE is proven and medically necessary for treating symptomatic uterine fibroids, postpartum or post-hysterectomy bleeding, or uterine arteriovenous malformation when InterQual CP: Procedures, Uterine Artery Embolization criteria are met.Refer to InterQual

See policy statement and InterQual reference (chunks 4,5)

inv-02: Not Medically Necessary / Unproven — Not medically necessary when evidence is insufficient.

Not medically necessary when evidence is insufficient:

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

See policy statement on fertility preservation (chunk 5 and evidence summaries in chunk 26)

MRgFUS / HIFU: Magnetic resonance-guided focused ultrasound ablation (MRgFUS) is considered unproven and not medically necessary for treating uterine fibroids when long-term efficacy, durability, and standardized protocols are not demonstrated.N/A

See insufficiency of evidence and need for larger RCTs (chunk 32)

inv-03: LNG-IUS: Preferred non-surgical therapy — coverage rationale and supporting evidence references.

Coverage rationale and supporting evidence for LNG-IUS:

LNG-IUS indicated as preferred non-surgical therapy: For management of heavy menstrual bleeding (HMB) in non-surgical candidates or when medical therapy is preferred, the levonorgestrel-releasing intrauterine system (LNG-IUS) is supported as the most effective first-line non-surgical option, demonstrating superior short- and medium-term reductions in menstrual blood loss, higher rates of clinical response, improved quality of life, and greater patient satisfaction compared with oral medical therapies.N/A

Randomized trials and systematic reviews support superiority in short- and medium-term outcomes; long-term data beyond ~2 years are limited (chunks 20,21,24)

Documentation of evidence when used: When selecting LNG-IUS for HMB, document relevant randomized trial or systematic review evidence (study identifiers, patient counts, and follow-up duration) as part of the medical record supporting the choice of therapy.N/A

See LNG-IUS evidence documentation requirement (chunk 20,21)

inv-04: UAE: Conditional coverage with counseling — coverage considerations, fertility counseling, and durability concerns.

UAE coverage considerations and counseling points:

UAE may be appropriate with counseling: UAE can be considered for symptomatic uterine fibroids in patients seeking uterine preservation, but counseling must include that UAE has higher mid-term reintervention and hysterectomy rates compared with myomectomy, uncertain effects on fertility, and potential for increased obstetric risks such as postpartum hemorrhage and placenta previa.N/A

Decisions should reflect patient fertility desires and alternatives; reference comparative evidence (chunks 26,27,30)

Prior authorization and documentation considerations: Consider prior authorization and ensure medical record documentation addresses patient counseling on fertility implications, alternative procedures (e.g., myomectomy), and evidence of indication per InterQual criteria.N/A

Policy recommends considering prior authorization for UAE and documenting counseling (chunks 26,4,64)

inv-05: Focused ultrasound: limited/conditional — MRgFUS / HIFU coverage considerations and limitations.

Focused ultrasound (MRgFUS / HIFU) coverage considerations and limitations:

MRgFUS / HIFU evidence limitations: Focused ultrasound therapies (MRgFUS and ultrasound-guided HIFU) show symptom and fibroid volume reduction in some studies but the overall evidence is heterogeneous with variable reintervention rates, device- and technique-dependent outcomes, and limited long-term durability data.N/A

Systematic reviews and evidence assessments note limited quality and need for larger RCTs (chunks 32,35)

Use with governance and selection criteria: When considered, MRgFUS/USgHIFU should be offered only with documented patient selection matching device/labeled indications, multidisciplinary review, informed consent addressing uncertain fertility effects and procedure risks (e.g., skin burns), and local arrangements for clinical governance, audit, or research per NICE/other guidance.N/A

NICE recommends use only with special arrangements; device-specific PMA exists for ExAblate (chunks 47,48,54)

inv-06: Procedure-specific coverage considerations — evidence strength, device indications, and guideline recommendations across procedures.

Procedure-specific coverage considerations reflect evidence strength, device indications, and guideline recommendations.

MRgFUS (ExAblate) device and indications: The ExAblate 2000/2100 System has FDA PMA (P040003) for ablation of uterine fibroid tissue in selected pre- or perimenopausal women with symptomatic fibroids and uterine size less than 24 weeks; coverage should align with device labeling and documented eligibility.uterine size < 24 weeks

See FDA PMA and labeling (chunk 54)

Guideline alignment for procedure selection: Professional society guidance (ACOG, ACR, NICE, SIR) supports trial of medical management before invasive procedures and provides criteria for when UAE, myomectomy, MRgFUS, or medical therapy are appropriate; apply guideline recommendations and document rationale when selecting a given procedure.N/A

Refer to ACOG, ACR, NICE, and SIR summaries (chunks 41,42,45,47,50)

inv-07: Device indications, morcellation contraindications, and documentation — references to device labeling, morcellation warnings, and medical necessity documentation.

Device indications, morcellation contraindications, and required documentation:

MRgFUS (ExAblate) labeled indication: MRgFUS using the ExAblate 2000/2100 System is indicated for ablation of uterine fibroid tissue in pre- or perimenopausal women with symptomatic fibroids who desire uterine preservation and with uterine size less than 24 weeks; the childbearing restriction was removed in 2015. Coverage should confirm device and indication match labeling when applicable.uterine size < 24 weeks

FDA PMA P040003; see device information (chunk 54)

Morcellation contraindications and warnings: Laparoscopic power morcellators carry an FDA black box warning and are contraindicated when the tissue to be morcellated is known or suspected to contain malignancy, and contraindicated for removal of uterine tissue with suspected fibroids in peri- or postmenopausal individuals or when en bloc removal is feasible.clinical suspicion of malignancy or peri/postmenopausal status

FDA safety communication and contraindications (chunks 55,57)

Uterine artery embolization (UAE) is excluded when proposed for the specific purpose of preserving childbearing potential. The policy finds insufficient evidence that UAE reliably preserves fertility, and therefore UAE for fertility preservation is considered unproven and not medically necessary.

Magnetic resonance–guided focused ultrasound (MRgFUS) lacks sufficient high-quality evidence of durable clinical benefit. The document notes a paucity of long-term studies, heterogeneity and lack of standardization of treatment protocols, and limited trial robustness; these uncertainties support the conclusion that MRgFUS effectiveness and long‑term durability are insufficient to establish medical necessity.

Per AAGL guidance, embolic and ablative therapies — including uterine artery embolization and MRgFUS — are not appropriate for women with submucous myomas who have current infertility or who wish to conceive in the future; AAGL recommends further long‑term study of ablation techniques in this subgroup.

Laparoscopic power morcellators are contraindicated when the tissue to be morcellated is known or suspected to contain malignancy. The policy follows FDA labeling that prohibits morcellation in such circumstances and requires alternative tissue‑extraction approaches.

MRgFUS is classified in this policy as unproven and not medically necessary for treatment of uterine fibroids. The policy cites insufficient evidence of efficacy and limited long‑term outcome data as the basis for this coverage stance.

There is insufficient evidence

MRgFUS may yield lower effectiveness for many patients and is limited by restrictive selection criteria and prolonged procedure duration. The evidence base includes small or biased studies and heterogenous protocols, which restrict broad applicability and support for routine coverage outside labeled indications and documented eligibility requirements.

Use of laparoscopic power morcellators is discouraged for the majority of women undergoing myomectomy or hysterectomy for fibroids. The FDA issued a prominent safety communication and black box warning noting the risk of spreading unsuspected cancer; manufacturers have contraindications and labeling that limit morcellator use in many clinical scenarios.

Procedure and Device Coding

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 Intrauterine 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

Device Approvals / Identifiersmixed

P040003

FDA PMA identifier for ExAblate 2000/2100 System

Provider Actions, Prior Authorization & Documentation

Prior Authorization
Endometrial ablation — InterQual-based prior authorization
Endometrial ablation is considered proven and medically necessary for abnormal uterine bleeding when InterQual clinical coverage criteria are met. For UnitedHealthcare determinations, refer to InterQual CP: Procedures, Hysteroscopy, Operative for specific medical necessity requirements.

Prior Authorization
UAE — prior authorization recommended (consider)
Uterine artery embolization (UAE) is considered proven and medically necessary for symptomatic uterine fibroids, postpartum or post-hysterectomy bleeding, or uterine arteriovenous malformation when InterQual criteria are met. Prior authorization is recommended/considered given mixed fertility evidence and higher long-term reintervention and hysterectomy rates versus myomectomy; review InterQual CP: Procedures, Uterine Artery Embolization (UAE) for specific coverage criteria.

Note
MRgFUS device indication match
The ExAblate 2000/2100 MRgFUS system has FDA PMA labeling for ablation of uterine fibroid tissue in pre- or perimenopausal women with symptomatic fibroids and uterine size less than 24 weeks; labeling changes removed the completed-childbearing restriction in 2015. Device-specific coverage may require confirmation that the indication and patient selection align with the device labeling and InterQual criteria.

Background and Clinical Context

Abnormal uterine bleeding (AUB) refers to any change in menstrual frequency, duration, or flow, including bleeding between cycles and postmenopausal bleeding. AUB may present as patterns such as oligomenorrhea, polymenorrhea, menorrhagia, or metrorrhagia and is a common indication for evaluation and interventions described elsewhere in this policy.

Definitions

inv-37: AUB definition — abnormal uterine bleeding description

DefinitionAbnormal uterine bleeding (AUB): any change in menstrual period frequency or duration, a change in amount of flow, or any bleeding between cycles; in postmenopausal women, bleeding 12 months or more after cessation of menstruation or unpredictable bleeding after prolonged hormone therapy.

Included patternsTerms include oligomenorrhea (>35-day intervals), polymenorrhea (<21-day intervals), menorrhagia (heavy flow or >7 days), menometrorrhagia (irregular heavy flow >7 days), and metrorrhagia (irregular intermenstrual bleeding).

Etiology noteMenorrhagia may be idiopathic or associated with fibroids, polyps, anatomical abnormalities, systemic illness, hormonal imbalance, or certain medications.

Conservative managementInitial treatment options include watchful waiting and pharmacologic therapy; dilation and curettage or hysterectomy are options if conservative approaches fail.

inv-38: Uterine fibroids definition — leiomyomata described

Policy Revision History

2025-11-01Revision - documentation and governanceLatest

Added operational language clarifying that benefit coverage is governed by federal, state, or contractual requirements and that medical records documentation may be required to assess whether a member meets clinical criteria for coverage; specified types of documentation that must be available upon request (history, exam, diagnostic test results).

2025-11-01Administrative - references updated

Updated Clinical Evidence and References sections to reflect the most current information (archived prior policy version CS002KS.01).

effective date

Policy Summary

PayerUnitedHealthcare

PolicyAbnormal Uterine Bleeding and Uterine Fibroids (for Kansas Only)

Policy CodePolicy CS002KS.02

Change TypeModified — documentation and clinical evidence updates

Effective Date11/01/2025

Next Review DateN/A

Key ActionProvide complete medical record documentation (history, exam, and diagnostic test results) to support medical necessity and prior authorization when requested.

SourceLink

On This Page

Modality-specific differences: Evidence suggests US-guided HIFU may achieve higher nonperfused volume ratios (NPVR) and lower reintervention rates than MR-guided approaches; NPVR thresholds (eg, >50–80%) correlate with lower reintervention in studies.NPVR > 50%–80% associated with better outcomes

Comparative meta-analyses report MR-HIFU NPVR ~59% vs US-HIFU ~81% and lower reintervention with USgHIFU (chunks 36,32)

Eligibility and selection impact on coverage:

Procedures with restrictive selection criteria, prolonged duration, or limited eligibility (notably MRgFUS) may be subject to coverage review if documentation does not demonstrate that selection criteria and counseling were met.

ECRI and trial reports note eligibility limitations and variable outcomes (chunks 39,37,38)

Trial of medical therapy expectation: Most guidelines recommend a trial of medical management for AUB or symptomatic fibroids prior to invasive procedures when clinically appropriate; document prior therapies, response, or contraindications.N/A

See ACR and guideline guidance on trialing medical management (chunks 45,42)

Medical record documentation requirement: The patient's medical record must fully support medical necessity with relevant history, physical exam, and results of pertinent diagnostic tests or procedures; documentation must be legible, maintained in the record, and made available upon request. Federal, state, or contractual benefit requirements govern coverage determinations.complete medical record

Policy history and instructions clarify documentation expectations (chunks 63,64)

Prior Authorization
Prior authorization and criteria
Prior authorization and clinical criteria: UnitedHealthcare uses InterQual as the primary source for medical/surgical coverage criteria. Coverage determinations remain subject to the member's federal, state, or contractual benefit requirements. When InterQual criteria apply, prior authorization may be required per the benefit plan.

Note
Conservative management expectation
Conservative (nonsurgical) management — including watchful waiting and pharmacologic therapy — is generally expected to be tried before invasive procedures for abnormal uterine bleeding unless clinically contraindicated. Medical management options include NSAIDs, antifibrinolytics, combined hormonal contraceptives, progestogens, and levonorgestrel-releasing intrauterine system (LNG-IUS).

Note
LNG-IUS as preferred first-line non-surgical therapy
Levonorgestrel-releasing intrauterine system (LNG-IUS) is supported by systematic reviews and RCT evidence as the preferred first-line non-surgical therapy to reduce menstrual blood loss in many patients with heavy menstrual bleeding; consider LNG-IUS prior to surgical interventions when appropriate.

Note
Trial of medical therapy before invasive procedures
Trial of medical therapy is expected prior to invasive procedures for abnormal uterine bleeding in most cases, consistent with guideline recommendations, unless the patient is unstable, has contraindications to medical therapy, or declines medical management.

Documentation Required
Required medical record documentation
Medical records documentation used for reviews: benefit coverage is determined by federal, state, or contractual requirements and applicable law. The patient's medical record must contain documentation that fully supports medical necessity for requested services, including relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures. Documentation should be legible, maintained in the medical record, and available upon request. Lack of complete documentation may lead to denial of requested services.

Note
LNG-IUS evidence documentation
Evidence documentation for LNG-IUS: systematic reviews and randomized controlled trials (including Cochrane and other syntheses) demonstrate superiority of LNG-IUS over oral medical therapies for short- and medium-term control of heavy menstrual bleeding, improved quality of life, and patient satisfaction. Include trial history and prior medical therapy documentation when requesting coverage for invasive procedures.

Denial Risk
UAE long-term durability and fertility concerns
UAE fertility and durability concerns: evidence is insufficient to conclude UAE preserves childbearing potential; studies are limited, and meta-analyses show higher reintervention and hysterectomy rates at four years versus myomectomy. Consider these factors during prior authorization and counseling.

Documentation Required
Preoperative evaluation and informed consent for morcellation
Preoperative evaluation and informed consent for morcellation: follow ACOG guidance — evaluate risk of uterine corpus malignancy prior to morcellation with risk stratification, appropriate imaging, cervical cancer screening, and endometrial sampling. Ensure documented shared decision-making and informed consent that discuss risks of dissemination of occult malignancy and alternatives to morcellation.

Documentation Required
Documentation and governance for US-guided HIFU
Ultrasound-guided HIFU governance and documentation: patient selection should be multidisciplinary and include counseling about limited evidence, procedure duration, eligibility restrictions, and outcomes uncertainty. Documentation of multidisciplinary review and informed consent is recommended for coverage evaluation.

Documentation Required
Medical record documentation required
Medical record documentation required: records must fully support medical necessity and align with InterQual or applicable UnitedHealthcare criteria. Documentation insufficiency may result in denial; include trial of medical therapies, imaging, objective measures of bleeding or symptom burden, and fertility desires when relevant.

Denial Risk
Morcellation contraindications
Morcellation contraindications: laparoscopic power morcellators are contraindicated when uterine tissue is known or suspected to contain malignancy, and for removal of uterine tissue in peri- or postmenopausal individuals when en bloc removal is appropriate. Refer to FDA guidance for updates.

DefinitionUterine fibroids (leiomyomata): benign tumors of the uterus with a rich blood supply that may cause excessive uterine bleeding, uterine enlargement, and bulk-related symptoms (pelvic pain/pressure, urinary frequency, abdominal distension).

Alternate nameAlso referred to as leiomyomata.

Clinical relevanceFibroids can be associated with menorrhagia and may be treated with alternatives to hysterectomy, including uterine fibroid embolization in selected patients.

inv-39: LNG-IUS / LNG-IUD definition — device description and typical release profile

Device classLevonorgestrel-releasing intrauterine system (LNG-IUS / LNG-IUD): an intrauterine device that continuously releases levonorgestrel locally to reduce menstrual blood loss.

Typical payload/profileCommon device described: 52 mg levonorgestrel releasing approximately 20 µg/day during the first year.

IndicationUsed to treat heavy menstrual bleeding and reduce menstrual blood loss, often favored as a first-line non-surgical option in non-surgical candidates.

inv-40: MRgFUS / HIFU definition — magnetic resonance- or ultrasound-guided high-intensity focused ultrasound techniques

TechniqueMagnetic resonance-guided or ultrasound-guided high-intensity focused ultrasound (MRgFUS / HIFU): noninvasive ablative techniques that focus acoustic energy to thermally ablate uterine fibroid tissue under image guidance.

Modality differencesUS-guided HIFU (USgHIFU) and MR-guided HIFU (MR-HIFU) show differing NPVR and treatment times; USgHIFU generally reports higher NPVR and shorter procedure times in comparative analyses.

Evidence noteInsufficient long-term data and heterogeneous protocols limit broad conclusions about durability and comparative effectiveness; reintervention rates vary by modality and NPVR achieved.

inv-41: UAE definition — uterine artery embolization description and associated considerations

ProcedureUterine artery embolization (UAE): an image-guided endovascular procedure that occludes uterine arterial blood flow to reduce fibroid size and bleeding.

Clinical considerationsUsed as a uterine-preserving alternative to hysterectomy; counseling should include higher mid-term reintervention and hysterectomy rates versus myomectomy and uncertain effects on fertility and pregnancy outcomes.

Preprocedural recommendationsPreprocedural evaluation may include endometrial biopsy to rule out malignancy and thorough counseling about reproductive implications.

inv-42: NPVR (Nonperfused Volume Ratio) — definition and clinical relevance

DefinitionNonperfused Volume Ratio (NPVR): the percentage of fibroid volume that is nonperfused after treatment, used as a parameter correlated with clinical success.

Success thresholdNPVR ≥ 80% is generally considered successful in studies; reported NPVRs vary by modality (e.g., MR-HIFU ~58.9%, US-HIFU ~81.1% in comparative meta-analyses).

Clinical relevanceHigher NPVR is associated with lower reintervention rates and better clinical outcomes after focused ultrasound ablation.

inv-43: MRgFUS ExAblate System — device PMA-approved indication summary

DeviceExAblate 2000/2100 System (Insightec): an MR-guided focused ultrasound system with FDA premarket approval (PMA P040003).

Indication summaryIndicated for ablation of uterine fibroid tissue in pre- or perimenopausal women with symptomatic fibroids who desire a uterine-sparing procedure and whose uterine size is less than 24 weeks; childbearing completion restriction was removed in 2015.

Regulatory detailPMA approval initially granted October 22, 2004; labeling updates approved August 9, 2011; FDA PMA reference P040003.

inv-44: Magnetic Resonance-Guided Focused Ultrasound — shorthand device naming (ExAblate)

ShorthandMagnetic Resonance-Guided Focused Ultrasound (MRgFUS) commonly referenced by device name ExAblate (ExAblate 2000/2100 System).

ContextExAblate denotes the MRgFUS system that received FDA PMA for selected patients with symptomatic uterine fibroids (see PMA P040003).

inv-45: Power morcellator — definition and context

DefinitionPower morcellator: a laparoscopic device used to fragment larger tissue specimens into smaller pieces for removal through small incisions during minimally invasive gynecologic surgery.

Safety warningFDA safety communication (Nov 24, 2014) recommends manufacturers include a black box warning that morcellation may spread unsuspected cancer and decrease long-term survival; use is discouraged for the majority of women undergoing myomectomy or hysterectomy for fibroids.

ContraindicationsContraindicated when tissue to be morcellated is known or suspected to contain malignancy, and contraindicated for removal of uterine tissue with suspected fibroids in peri- or postmenopausal individuals or when en bloc removal is feasible.

Policy effective date

Policy effective date listed in policy metadata (effective date of revised policy).