ModifiedUnitedHealthcarePolicy CS002LA.AB

Abnormal Uterine Bleeding and Uterine Fibroids (for Louisiana Only)

Defines medical necessity and coverage stance for treatments of abnormal uterine bleeding (AUB) and uterine fibroids for members in Louisiana, including endometrial ablation, levonorgestrel-releasing IUDs, uterine artery embolization, and MRgFUS.

Policy Summary

PayerUnitedHealthcare

PolicyAbnormal Uterine Bleeding and Uterine Fibroids (for Louisiana Only)

Policy CodePolicy CS002LA.AB

Change TypeDocumentation and evidence updates

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionProvide complete, legible medical record documentation of history, exam, diagnostics, prior treatments, and counseling to support medical necessity and make records available upon request for utilization review.

SourceLink

POLICY UPDATE CHANGES

Added language clarifying medical records documentation required for reviews and that documentation supporting medical necessity must be maintained and made available upon request.

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

LouisianaApplies to

InterQual referencedAuthorization source

MultipleLNG-IUD products

13%–29%HIFU reintervention range

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≥50%NPVR threshold

Coverage Criteria for AUB and Uterine Fibroids

Endometrial Ablation

Endometrial ablation coverage statement

Endometrial ablation is proven and medically necessary for treating abnormal uterine bleeding in premenopausal individuals.

For clinical coverage criteria reference InterQual CP: Procedures, Hysteroscopy, Operative.

Levonorgestrel-Releasing Intrauterine Device (LNG-IUD)

Levonorgestrel-releasing IUD coverage and evidence summary

LNG-IUD: Levonorgestrel-releasing intrauterine devices are proven and medically necessary for treating menorrhagia (heavy menstrual bleeding).

Refer to FDA section and cited systematic reviews and RCTs for evidence on effectiveness and long-term outcomes; Cochrane and RCT evidence summarized in policy.

Comparative effectiveness: Systematic reviews and randomized trials show LNG-IUS provides superior short- and medium-term reduction in menstrual blood loss, improved quality of life, and higher patient satisfaction compared with oral medical therapies.

See Cochrane review and RCT long-term follow-up (chunks 21, 20, 16, 17) for outcome and reintervention data.

Uterine Fibroids — UAE and MRgFUS

Uterine fibroid interventions

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 (AVM).

For clinical coverage criteria reference InterQual CP: Procedures, Uterine Artery Embolization (UAE).

UAE not for fertility preservation: 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 and uncertain reproductive outcomes.

Documentation of counseling about fertility risks is required; see evidence summaries showing limited fertility data (chunks 26, 27).

MRgFUS (MR-guided focused ultrasound): Magnetic resonance-guided focused ultrasound ablation (MRgFUS) is considered unproven and not medically necessary for treating uterine fibroids when evidence of long-term efficacy and durability is insufficient.

Codes 0071T/0072T referenced for focused ultrasound procedures; see systematic reviews and ECRI/Hayes assessments (chunks 32, 35, 36).

LNG-IUS — First-line nonsurgical therapy for HMB

Covered when ALL of the following are met

LNG-IUS coverage criteria: Patient has heavy menstrual bleeding (HMB) and is a non-surgical candidate or prefers a uterine-sparing approach; prior counseling on alternatives is documented; provider documents indication for LNG-IUS placement; short- to medium-term efficacy expected.N/A

Cochrane and RCT evidence supports LNG-IUS as the most effective first-line medical therapy for HMB in non-surgical candidates.

Uterine artery embolization — coverage considerations

Covered when ALL of the following are met

UAE coverage criteria: Patient has symptomatic uterine fibroids and desires uterine-sparing therapy; documentation addresses fertility desires and counseling on potential reduced postoperative pregnancy rates and increased risk of postpartum hemorrhage; alternative treatments (myomectomy, hysterectomy) discussed when fertility preservation is a priority.N/A

Evidence shows UAE reduces fibroid size and improves bleeding and quality of life but has uncertain reproductive outcomes and higher reintervention rates versus myomectomy in some analyses; document counseling and informed consent.

Image-guided ablation (HIFU/MRgFUS/RFA/TFA) — coverage considerations

Considered when ALL of the following are met

HIFU/MRgFUS/RFA/TFA coverage criteria: Patient has symptomatic fibroids amenable to imaging-guided ablation and meets device-specific eligibility (e.g., size, location, imaging characteristics, expected NPVR); informed consent documents discussion of variable reintervention rates, limited long-term durability data, device-specific adverse event profiles, and uncertainty regarding fertility outcomes; provider documents imaging criteria, expected NPVR, and that conservative medical therapy was considered or contraindicated.N/A

Evidence is heterogeneous; NPVR thresholds and fibroid size criteria (e.g., NPVR ≥50% or >80% associated with better outcomes; many HIFU studies limited to fibroid volume <300 cm3) should be documented when applicable.

Evidence and guideline-based criteria for image-guided and uterine-preserving therapies

Clinical evidence and guideline summaries relevant to coverage decisions:

MRgFUS effectiveness and limitations: Systematic reviews and RCT data indicate MRgFUS and other focused ultrasound approaches can reduce fibroid volume and symptoms in the short term but have limitations including lower NPVR versus US-guided HIFU, longer procedure times, restrictive eligibility criteria, and lack of robust long-term comparative outcome data.

Supported by multiple systematic reviews, ECRI and Hayes assessments (chunks 36, 35, 34, 39, 43).

Comparative volumetric outcomes: Pooled fibroid volume reduction at six months was reported as greatest with RFA (~70%), followed by UAE (~54%), and FUS (~32%).

From comparative reviews and meta-analyses (chunk 36).

UAE role per guidelines: Professional guidelines (ACOG, ACR, AAGL, NICE) generally recognize UAE as an appropriate uterine-preserving option for symptomatic fibroids in patients desiring uterine preservation, while recommending counseling on limited reproductive outcome data and preprocedure imaging assessment.

See guideline summaries and appropriateness criteria (chunks 43, 45 and related guideline citations).

Uterine artery embolization (UAE) is explicitly stated as unproven and not medically necessary when performed with the intent of preserving childbearing potential. The policy reflects the limited quality and quantity of fertility data after UAE, noting that most fertility studies are small, observational, and lack long‑term follow‑up; therefore UAE should not be used as a fertility‑preserving procedure absent stronger evidence supporting reproductive outcomes.

Magnetic resonance‑guided focused ultrasound ablation (MRgFUS) for uterine fibroids is designated unproven and not medically necessary due to insufficient evidence of durable efficacy. The policy cites a paucity of long‑term studies, variability in treatment protocols, and limitations across published series (small sample sizes, risk of bias, and inconsistent outcomes) as the basis for this determination.

When procedures are proposed with the goal of preserving fertility (for example UAE or MRgFUS/HIFU), the policy requires documented counseling and informed consent that addresses the uncertainty of post‑procedure reproductive outcomes. Specifically, providers must document that the patient was counseled about potential decreases in pregnancy rates, possible increased obstetric risks (e.g., postpartum hemorrhage, placenta abnormalities), and alternative fertility‑preserving surgical options prior to authorization.

Embolic and ablative therapies — including UAE, uterine artery occlusion, radiofrequency ablation, cryotherapy, and MRgFUS — are not considered appropriate for women with submucous myomas who currently have infertility or who wish to conceive. This position follows AAGL guidance that such techniques are not recommended for patients with submucous leiomyomas when future fertility is desired.

Laparoscopic power morcellators carry important safety warnings and contraindications. The FDA warns that morcellation can spread unsuspected uterine cancer and decrease long‑term survival, and the devices are contraindicated when tissue is known or suspected to contain malignancy or when en bloc removal is feasible. Preoperative evaluation and informed consent should document risk stratification, appropriate imaging, and endometrial sampling when morcellation is contemplated; alternatives to power morcellation should be considered and discussed.

As an alternative wording of the MRgFUS coverage position, the policy reiterates that MRgFUS is unproven and not medically necessary for treatment of uterine fibroids. This alternative statement emphasizes the insufficiency of high‑quality, long‑term evidence demonstrating sustained symptom relief or favorable reproductive outcomes.

The policy classifies MRgFUS as limited by the quality and consistency of available evidence: pooled analyses show lower non‑perfused volume ratios and longer procedure times for MR‑HIFU compared with ultrasound‑guided HIFU, and many studies are at high risk of bias. Because NPVR and other technical parameters are linked to clinical success, the limited and heterogeneous data constrain endorsement of MRgFUS as an effective, durable therapy.

Evidence for MRgFUS is inconclusive and patient eligibility is restrictive: many series exclude larger or unfavorably located fibroids, and registry and systematic‑review data report variable reintervention rates over time. The policy therefore notes that MRgFUS may only be considered in narrowly selected patients who meet device‑specific eligibility criteria and after documentation of counseling about uncertain long‑term outcomes and potential need for additional procedures.

Procedure, Device, and Related Codes

Procedures referencedCPT

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 IUDs and related 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.

LNG-IUS descriptionmixed

device description

LNG-IUS 52 mg levonorgestrel releasing ~20 µg/day

FDA-approved LNG-IUDs (device names)mixed

Mirena	LNG-IUD (Mirena) — FDA approved for contraception and HMB indication
Skyla	LNG-IUD (Skyla) — FDA approved for contraception
Liletta	LNG-IUD (Liletta) — FDA approved for contraception
Kyleena	LNG-IUD (Kyleena) — FDA approved for contraception

UAE embolic agentsmixed

embolic agents

Embolic agents used for UAE (various FDA-approved agents for embolization procedures)

MRgFUS device PMAmixed

P040003

Premarket approval (PMA) identifier for ExAblate 2000/2100 System

Device PMA referencemixed

P040003

FDA PMA identifier for ExAblate 2000/2100 System

Non-perfused volume ratio (NPVR)

NPVR threshold linked to reinterventionNon-perfused volume ratio (NPVR) ≥ 50% is associated with lower reintervention rates after HIFU

NPVR as outcome measureNPVR is percentage of fibroid volume that is non-perfused after HIFU treatment

Clinical implicationHigher NPVR correlates with improved clinical success and reduced need for subsequent procedures

Fibroid volume inclusion for HIFU studies

HIFU study inclusion volumeMany HIFU/MR-HIFU studies included fibroids with total volume < 300 cm3

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required — UAE

Prior authorization is required for uterine artery embolization (UAE). Document the patient’s symptoms (e.g., heavy menstrual bleeding, bulk/pain symptoms), failure or contraindication to medical management, counseling about fertility implications and alternative treatments, and informed consent discussion. Include specific clinical rationale for selecting UAE over less invasive options.

Document symptoms and severity (bleeding, pain, bulk effects)
Record trial and response to medical therapy and reasons for failure or ineligibility
Document counseling on risks/benefits, fertility implications, and alternatives (including LNG-IUS, myomectomy, hysterectomy)
Include signed informed consent

Prior Authorization

MRgFUS (ExAblate) — Indication Alignment

MRgFUS (ExAblate) is device-specific and must align with FDA PMA indications: symptomatic uterine fibroids in pre- or perimenopausal individuals desiring uterine-sparing treatment with uterine size typically <24 weeks (updated labeling removed completed-childbearing restriction). Ensure documentation demonstrates the member meets these device indications and that patient selection follows published guidance.

Background and Scope

Abnormal uterine bleeding (AUB) encompasses changes in menstrual frequency, duration, or flow, and postmenopausal bleeding occurring at least 12 months after cessation of menses. Uterine fibroids (leiomyomata) are benign uterine tumors that can cause heavy menstrual bleeding, pelvic pressure, and bulk symptoms. Minimally invasive, uterine‑sparing alternatives (for example endometrial ablation, levonorgestrel‑releasing IUDs, and uterine artery embolization) are described in the policy; selection among options should consider symptom profile, reproductive desires, prior treatment trials, and guideline recommendations for conservative management before invasive therapies.

Definitions

Abnormal uterine bleeding (AUB)

AUB definition (reproductive-age)Any change in menstrual period frequency or duration, change in amount of flow, or any bleeding between cycles

AUB in postmenopausePostmenopausal AUB includes vaginal bleeding 12 months or more after cessation of menstruation

Included termsIncludes oligomenorrhea, polymenorrhea, menorrhagia, menometrorrhagia, and metrorrhagia as described in policy

Uterine fibroids (leiomyomata)

Definition of uterine fibroidsBenign tumors of the uterus (leiomyomata) that may cause excessive uterine bleeding, uterine enlargement, and bulk-related symptoms

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

Policy Summary

PayerUnitedHealthcare

PolicyAbnormal Uterine Bleeding and Uterine Fibroids (for Louisiana Only)

Policy CodePolicy CS002LA.AB

Change TypeDocumentation and evidence updates

Effective DateJan 1, 2026

Next Review DateN/A

SourceLink

On This Page

Trial of medical management: Guidelines advise a trial of medical management before pursuing invasive procedures in most reproductive-age patients with symptomatic fibroids unless clinical circumstances warrant earlier intervention.

Guideline-based recommendation reflected in ACR appropriateness criteria (chunk 45).

Study contextVolume threshold used in comparative meta-analyses of MR- and US-guided HIFU

RelevancePatient selection for focused ultrasound trials often limits fibroid burden to < 300 cm3

Fibroid volume inclusion

Fibroid volume inclusion thresholdFibroid volume < 300 cm3 used as inclusion criterion in HIFU studies

Evidence sourceReported in comparative meta-analyses of MR-HIFU and US-HIFU (Yu et al., 2021)

Implication for eligibilityExclusion of larger-volume fibroid burdens from many HIFU trial populations

NPVR success threshold

NPVR success benchmark> 80% NPVR is considered a successful treatment outcome in some HIFU series

Comparative valuesMR-HIFU reported mean NPVR ~58.9% vs US-HIFU ~81.1% in pooled analyses

Clinical meaningNPVR >80% associated with higher likelihood of clinical success in focused ultrasound reports

Fibroid diameter for LNG-IUS recommendation (NICE)

NICE recommendation for LNG-IUS and fibroid diameterRecommend LNG-IUS as first treatment for women with fibroids less than 3 cm in diameter

Consent considerationsInform patients that symptoms may not be fully relieved and effects on fertility are uncertain

Patient selectionLNG-IUS favored in women with no identified pathology or small fibroids (<3 cm) per NICE guidance

Fibroid size threshold for UAE (NICE)

NICE size threshold for UAENICE lists uterine artery embolization (UAE) as an option for women with fibroids 3 cm or more in diameter

Preprocedure imagingRecommend ultrasound assessment and consider MRI for further characterization of fibroid size, position, number, and vascularity

Patient counselingInform patients that symptoms may recur and further procedures may be needed; discuss fertility uncertainty

Confirm uterine size and symptomatology
Document desire for uterine preservation and discussion of fertility/uncertainty
Record that candidate selection meets published exclusion/inclusion criteria for ExAblate

Denial Risk

Denial Risk — MRgFUS Eligibility and Evidence Limitations

Requests for MRgFUS may be denied based on restrictive eligibility criteria, insufficient evidence of benefit, or patient ineligibility (e.g., fibroid size/number/location, body habitus, contraindications, or inability to tolerate procedure). Counsel patients about the investigational/limited evidence base and higher selection-stringency compared to other uterine-preserving options.

Assess and document all ExAblate selection criteria and exclusions
Document discussion about uncertain efficacy, potential need for subsequent procedures, and alternative therapies

Documentation Required

Medical Records Documentation Required for Review

The patient’s medical record must fully support medical necessity for requested services. Include relevant history, focused physical exam, diagnostic testing (imaging reports, labs, pathology), treatment timelines, and legible documentation that is available on request. Lack of adequate records may result in delay or denial.

History and physical exam notes relevant to AUB or fibroid symptoms
Imaging: pelvic ultrasound and MRI reports (size, number, location, vascularity) when indicated
Endometrial sampling or cervical screening when indicated
Operative reports, prior procedure notes, and pathology if applicable
Signed informed consent and counseling notes

Documentation Required

Document Prior Treatments and Candidacy for Less Invasive Options

Document prior nonsurgical treatments and candidacy for less invasive options before authorization of invasive therapies. Include prior use and response to pharmacologic therapy, LNG-IUS, tranexamic acid, NSAIDs, hormonal therapy, and any procedural interventions. If less invasive options were not appropriate, clearly explain the contraindication or failure.

List prior medical therapies tried, doses, duration, and clinical response
Document candidacy or contraindications for LNG-IUS and reasons for preferring procedural therapy
Include dates and outcomes of any prior procedures (e.g., dilation and curettage, hysteroscopy)

Documentation Required

Preoperative Evaluation and Consent — Morcellation

Before performing morcellation, complete a preoperative evaluation to stratify malignancy risk and obtain informed consent that addresses the risk of disseminating occult malignancy and benign tissue. Evaluation should include imaging, cervical cancer screening, and endometrial tissue sampling when indicated. Document shared decision-making and discussion of alternatives to morcellation.

Risk stratification for uterine corpus malignancy
Preoperative imaging and interpretation
Cervical screening and endometrial sampling results when indicated
Documentation of informed consent addressing dissemination risk and alternatives

Step Therapy

Step Therapy Preference — LNG-IUS for HMB

Step therapy preference: for heavy menstrual bleeding (HMB), consider LNG-IUS (levonorgestrel-releasing intrauterine system) as first-line nonsurgical therapy when appropriate. Document rationale if proceeding to ablation, UAE, or hysterectomy without prior LNG-IUS trial (e.g., contraindication, patient preference, size/location of fibroids).

Prefer LNG-IUS as first-line for HMB without identified pathology or with fibroids <3 cm when appropriate
If skipping LNG-IUS, document contraindication or informed patient preference

Prior Authorization

Trial of Medical Therapy Expected Before Invasive Procedures

Clinical guidance and major society recommendations expect a trial of medical management before invasive procedures for AUB and uterine fibroids unless emergent clinical circumstances or clear contraindications exist. Document duration, agents used, response, and reason for proceeding to invasive therapy.

Record trial duration and response to medical therapies (hormonal, tranexamic acid, NSAIDs, LNG-IUS)
If immediate surgery is needed, document clinical instability or failed/noncandidacy for medical therapy

Clinical manifestationsCan cause pelvic pain, pressure, urinary frequency, and abdominal distension

Levonorgestrel-releasing intrauterine device (LNG-IUD)

LNG-IUD mechanismAn intrauterine device that locally delivers levonorgestrel causing endometrial gland atrophy and suppression of endometrial activity to reduce bleeding

Local delivery advantageLocal hormone delivery reduces systemic exposure compared with oral therapy

Therapeutic goalUsed to treat heavy menstrual bleeding by producing endometrial atrophy and decreasing menstrual blood loss

LNG-IUS (LNG-IUD) — device description

Device description (LNG-IUS)A continuous-release intrauterine system containing 52 mg levonorgestrel, releasing ~20 µg/day in year 1

Indication contextUsed in RCTs comparing LNG-IUS to medical treatments for heavy menstrual bleeding

Clinical outcomesRCT evidence shows greater number of clinical responders and improved blood loss control versus medical therapy in short- and medium-term

NPVR (Non-Perfused Volume Ratio)

NPVR definitionNon-perfused volume ratio (NPVR) is the percentage of fibroid volume that is non-perfused after HIFU/MRgFUS treatment

Clinical relevanceHigher NPVR is positively associated with clinical success and lower reintervention rates after focused ultrasound treatments

Reported benchmarksStudies report NPVR thresholds (≥50% associated with lower reintervention; >80% considered successful in some series)

NPVR — success threshold (>80%)

NPVR success definition> 80% NPVR is considered a successful outcome in some HIFU/MRgFUS reports

Evidence basisComparative analyses report NPVR >80% as an efficacy benchmark correlated with improved outcomes

Usage noteNPVR thresholds vary across studies and influence reported reintervention rates and clinical success

MRgFUS (ExAblate) — device definition and FDA context

Device identificationExAblate 2000/2100 System (Insightec) — magnetic resonance-guided focused ultrasound system (MRgFUS)

FDA PMA statusReceived premarket approval (PMA P040003) on October 22, 2004 with updated labeling in 2011 and indication modification in 2015

IndicationsIndicated for ablation of uterine fibroid tissue in pre- or perimenopausal women desiring uterine preservation and uterine size <24 weeks

Magnetic Resonance-Guided Focused Ultrasound (MRgFUS) — short form

Short formMagnetic resonance-guided focused ultrasound (MRgFUS), also referred to as MR-HIFU or ExAblate

Technique summaryNoninvasive focused ultrasound energy delivered under MRI guidance to thermally ablate uterine fibroid tissue

Regulatory noteExAblate systems have FDA PMA (P040003) with labeling describing patient selection criteria

Laparoscopic power morcellation — definition and FDA warning

DefinitionLaparoscopic power morcellators are devices used during minimally invasive surgery to fragment tissue for removal through small incisions

FDA safety warningFDA Safety Communication (Nov 24, 2014) includes a black box warning advising against use in majority of women undergoing myomectomy or hysterectomy due to risk of spreading unsuspected cancer

ContraindicationsContraindicated when tissue is known or suspected to contain malignancy and in peri-/post-menopausal women or when en bloc removal is feasible