CurrentUnitedHealthcarePolicy CSOOZOH.C

Abnormal Uterine Bleeding and Uterine Fibroids (for Ohio Only)

State-specific UnitedHealthcare medical policy for Ohio covering endometrial ablation, levonorgestrel-releasing IUDs (LNG-IUD), uterine artery embolization (UAE), and magnetic resonance-guided focused ultrasound ablation (MRgFUS) for abnormal uterine bleeding (AUB) and uterine fibroids. The document references InterQual criteria for detailed medical necessity determinations and lists applicable procedure and drug codes.

Policy Summary

PayerUnitedHealthcare

PolicyAbnormal Uterine Bleeding and Uterine Fibroids (for Ohio Only)

Policy CodePolicy CSOOZOH.C

Change TypeRevised sections (Coverage Rationale, Evidence, FDA, References)

Effective DateJan 1, 2025

Next Review Date

Key ActionProviders must follow InterQual clinical policy criteria for operative hysteroscopy (endometrial ablation) and uterine artery embolization to determine medical necessity as referenced in the policy.

POLICY UPDATE CHANGES

Coverage Rationale, Supporting Information, Description of Services, Clinical Evidence, FDA, and References sections updated to reflect current information.

3Principal procedural/therapeutic topics covered (Ablation, LNG-IUD, UAE/MRgFUS)

1State-specific policy (Ohio only)

MultipleGuidelines referenced

HighReintervention rate reported for MRgFUS

Low-qualityOverall strength of evidence for MRgFUS/HIFU

Coverage Summary

This Ohio-specific UnitedHealthcare coverage policy (Policy Number: CSOOZOH.C) addresses management of Abnormal Uterine Bleeding (AUB) and uterine fibroids, covering endometrial ablation, levonorgestrel-releasing intrauterine devices (LNG-IUD), uterine artery embolization (UAE), and magnetic resonance-guided focused ultrasound ablation (MRgFUS). Coverage stance is mixed: endometrial ablation, LNG-IUD, and UAE are identified as proven/medically necessary for specified indications, while MRgFUS is characterized as unproven/not medically necessary. The policy relies on InterQual criteria for detailed medical necessity determinations and references federal/state requirements (Ohio Administrative Code) in application. This version is effective January 1, 2025, reflects a material update from the prior archived version, and notes InterQual as the primary medisurgical criteria source.

Key Facts

Effective dateJanuary 1, 2025

Policy numberCSOOZOH.C

ScopeState-specific UnitedHealthcare medical policy for Ohio covering endometrial ablation, LNG-IUD, UAE, and MRgFUS for AUB and uterine fibroids; references InterQual for medical necessity determinations.

Coverage stanceMixed: endometrial ablation and LNG-IUD proven/medically necessary; UAE proven for symptomatic fibroids but not for fertility preservation; MRgFUS unproven and not medically necessary.

StateOhio

Medical‑Necessity Criteria

Endometrial Ablation

Endometrial ablation coverage position:

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)

LNG-IUD coverage position and references:

Levonorgestrel-releasing intrauterine devices (eg, Mirena, Skyla, Liletta, Kyleena) are proven for treatment of abnormal uterine bleeding and supported by evidence summaries and guideline references.

Clinical use and medical necessity criteria are informed by referenced evidence and guidance; InterQual referenced elsewhere for operative procedures.

Uterine Artery Embolization (UAE)

UAE coverage position:

Clinical Evidence & Guideline‑Informed Considerations

Clinical evidence and guideline-informed coverage considerations

Coverage considerations informed by evidence and guidelines; not a discrete set of authorization rules in this excerpt. Statements summarize when procedures may be appropriate or limited:

Uterine Artery Embolization (UAE) appropriate when: Patient desires uterine preservation; uterine fibroids causing significant symptoms (heavy/prolonged menstrual bleeding, severe cramping, pelvic pain, pelvic pressure/fullness, urinary symptoms, hydronephrosis).

SIR guidelines list common indications; NICE and ACOG provide recommendations on assessment and counseling.

Magnetic Resonance-Guided Focused Ultrasound (MRgFUS / MR-HIFU) considerations: Limited, low-quality evidence suggests short-term reduction in fibroid/uterine size and symptom improvement but with higher reintervention rates versus some alternatives; eligibility restricted by anatomy and risk of visceral injury; procedure duration often prolonged.

NICE and ACOG recommend use with clinical governance, informed consent, audit/research, and specialized centers with trained clinicians.

Relevant Codes

Uterine Fibroids / Procedural Codes (reference list)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 (LNG-IUD) 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.

Procedures and devices discussed (informational, not explicit billing list in excerpt)mixed

No codes listed

Provider Actions & Administrative Requirements

Documentation Required

InterQual criteria references for medical necessity

Providers must follow InterQual clinical policy criteria for operative hysteroscopy (endometrial ablation) and uterine artery embolization to determine medical necessity as referenced in the policy.

InterQual CP: Procedures, Hysteroscopy, Operative (endometrial ablation)
InterQual CP: Procedures, Uterine Artery Embolization (UAE)

Denial Risk

UAE for fertility preservation is not covered

Claims for UAE performed specifically to preserve childbearing potential for individuals with symptomatic uterine fibroids are considered unproven and not medically necessary and may be denied.

Background

Abnormal uterine bleeding (AUB) is defined as changes in menstrual frequency, duration, amount of flow, or bleeding between cycles; postmenopausal bleeding is included when occurring ≥12 months after cessation of menses. Management ranges from conservative approaches (watchful waiting, pharmacologic therapies including hormonal treatment and tranexamic acid, and dilation and curettage) to procedural interventions (endometrial ablation, LNG-IUD insertion, UAE, MRgFUS, and hysterectomy). Uterine-sparing procedures offer shorter recovery and avoidance of hysterectomy but have limitations — variable eligibility, uncertain effects on fertility, and higher reintervention rates for some techniques (notably MRgFUS). Guideline and evidence reviews (ACOG, ACR, NICE, AHRQ, ECRI) inform appropriateness, recommend endometrial sampling before certain procedures, and support use of LNG-IUD and UAE in selected patients while urging clinical governance and further research for MRgFUS.

Definitions

Abnormal Uterine Bleeding (AUB)Any change in menstrual frequency or duration, change in amount of flow, or bleeding between cycles; in postmenopausal women, vaginal bleeding ≥12 months after cessation or unpredictable bleeding while on hormone therapy ≥12 months.

MRgFUS / MR-HIFUMagnetic resonance-guided focused ultrasound / high-intensity focused ultrasound — noninvasive thermal ablation of uterine fibroid tissue guided by MRI.

UAEUterine artery embolization — transcatheter embolization of uterine arteries to induce fibroid ischemia and shrinkage by injecting particles to block fibroid blood supply.

Evidence Summary

Source	Takeaway
InterQual references	Policy relies on InterQual clinical policy (Procedures, Hysteroscopy, Operative and Procedures, Uterine Artery Embolization) for detailed medical necessity criteria.
Systematic reviews / RCTs cited	Multiple recent systematic reviews, meta-analyses, cohort studies and RCT follow-ups (2022–2024) support LNG-IUD effectiveness and highlight low-quality / limited evidence for MRgFUS; UAE evidence mixed for fertility outcomes.
Barnard RCT (Barnard et al., 2017)	Focused ultrasound had longer procedure time but less immediate post-procedure pain, lower outpatient opioid use, and shorter median recovery time versus UAE; no difference in major adverse events.
Froeling long-term cohort (Froeling et al., 2013)	Long-term reintervention was lower after UAE (12.2%) versus MR‑gHIFU (66.2%) with better symptom and QOL improvements after UAE.
PROMISe pilot RCT (Jacoby et al., 2016)	Small pilot RCT showed symptom improvement in both MRgFUS and sham groups with modest fibroid volume reduction in MRgFUS; possible placebo effect and small sample limit inference.
ECRI / NICE / AHRQ conclusions (ECRI 2020/2022; Hayes; AHRQ 2017; NICE guidance)	Assessments conclude MRgFUS/HIFU evidence is limited by small, biased studies and short follow-up; MRgFUS may reduce size/symptoms short‑term but has higher reintervention and uncertain fertility effects; UAE effective for symptom relief but reproductive outcomes remain uncertain.
Meta-analyses of HIFU (Dou et al., 2024; Yu et al., 2021; Hu et al., 2023)	Reintervention rates after HIFU vary; US‑guided HIFU often shows lower reintervention and higher NPVR than MRgFUS; NPVR and fibroid characteristics affect outcomes.
Hayes / ECRI evidence assessments	Clinical evidence assessments find low overall quality for MRgFUS studies, recommending further high‑quality RCTs and standardized protocols; some favorable short‑term outcomes but inconclusive long‑term effectiveness.
Nonrandomized and cohort studies on UAE fertility and outcomes (Pisco, Mailli, Karlsen, Yan)	Studies show variable pregnancy and live birth rates after UAE; some analyses report reduced postoperative pregnancy rates and increased risks (eg, PPH, placenta previa) versus comparators; evidence limited by heterogeneity and study quality.
MRgFUS safety/complications reviews (Kociuba et al., 2023; Havryliuk et al., 2017)	MRgFUS has generally low major complication rates but notable adverse events (pain, skin burns, potential nerve injury); concerns about eligibility, procedure duration, and higher reintervention rates.

Revision History

2025-01-01revisedLatest

Coverage Rationale, Supporting Information, Description of Services, Clinical Evidence, FDA, and References sections updated to reflect the most current information; prior policy version CSOO2OH.B archived.

2025-01-01revisedLatest

Policy effective date set to January 1, 2025 and document designated as applicable to Ohio only (Policy Number CSOOZOH.C).

revised

Policy Summary

PayerUnitedHealthcare

PolicyAbnormal Uterine Bleeding and Uterine Fibroids (for Ohio Only)

Policy CodePolicy CSOOZOH.C

Change TypeRevised sections (Coverage Rationale, Evidence, FDA, References)

Effective DateJan 1, 2025

Next Review Date

On This Page

Uterine artery embolization (UAE) is proven and medically necessary for treating symptomatic uterine fibroids, postpartum or post-hysterectomy bleeding, or uterine arteriovenous malformation (AVM).

For medical necessity clinical coverage criteria, refer to the InterQual CP: Procedures, Uterine Artery Embolization (UAE).

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

Evidence on fertility preservation after UAE is limited and inconsistent; pregnancy outcomes and risks are uncertain.

Magnetic Resonance-Guided Focused Ultrasound Ablation (MRgFUS / HIFU)

MRgFUS coverage position:

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

Evidence limitations include low-quality studies, lack of long-term outcomes, lack of standardized protocols, and variability in eligibility for the procedure.

Evidence limitations: Studies show small sample sizes, short follow-up, heterogeneity, higher reintervention rates versus some alternatives, and exclusion of many patients due to anatomic or safety criteria.

Guidelines (NICE, ACOG, ECRI/Hayes assessments) recommend use with clinical governance, informed consent, and further research.

Levonorgestrel-Releasing IUD (LNG-IUD) for heavy menstrual bleeding (HMB): ACOG: LNG-IUD may be considered for treatment of abnormal uterine bleeding; NICE: LNG-IUS recommended as first treatment for women with no identified pathology, fibroids <3 cm, or suspected/diagnosed adenomyosis.

Systematic reviews and RCT evidence support LNG-IUD effectiveness for reducing menstrual blood loss.

Percutaneous microwave ablation / other ablation: Systematic reviews and small studies suggest safety and fibroid shrinkage but evidence is limited; larger RCTs are needed.

Percutaneous microwave ablation data are preliminary and require further research.

Laparoscopic power morcellation: FDA warning: morcellators may spread occult cancer; contraindicated when tissue is known or suspected to contain malignancy and contraindicated in peri- or postmenopausal women or when en bloc removal is possible.

Patients should be evaluated preoperatively to determine malignancy risk and informed of morcellation risks per ACOG/FDA guidance.

Key evidence considerations include primary reliance on InterQual for clinical necessity criteria, systematic reviews and RCTs supporting LNG-IUD effectiveness for heavy menstrual bleeding, and mixed/limited evidence for MRgFUS. A randomized trial (Barnard RCT) reported longer procedure time but less immediate post-procedure pain, lower outpatient opioid use, and shorter median recovery time with focused ultrasound versus UAE and no difference in major adverse events. Long-term cohort data (Froeling) showed substantially lower reintervention after UAE (12.2%) vs MRgHIFU (66.2%). A small pilot RCT (PROMISe) suggested symptom improvement in both MRgFUS and sham arms, raising concerns about placebo effects and limited inference. Evidence assessments by ECRI/NICE/AHRQ concluded MRgFUS/HIFU evidence is low-quality/limited with uncertain long-term outcomes and higher reintervention relative to some alternatives.

Denial risk for claims where the stated purpose of UAE is fertility preservation

Documentation Required

Pre-procedure recommendations

Recommendation to perform endometrial biopsy prior to UAE to rule out malignancy or hyperplasia is cited as a pre-treatment recommendation.

Endometrial biopsy to rule out malignancy or hyperplasia prior to UAE

Documentation Required

Informed consent and shared decision-making

Providers should inform patients of potential benefits, limited evidence, and risks, and engage in shared decision-making using written information where available.

Skin burns
Visceral injury (eg, bowel, bladder)
Higher reintervention rate (compared with some alternatives)
Uncertain effects on fertility and pregnancy

Documentation Required

Pre-procedure assessment and selection

For MRgFUS and ultrasound-guided HIFU, patient selection should include multidisciplinary review (gynecologist and appropriate imaging specialist) and assessment of fibroid size, number, location, and proximity to bowel/bladder/sacral nerves.

Fibroid size
Number of fibroids
Location of fibroids
Proximity to bowel, bladder, or sacral nerves

Prior Authorization

Use of policy with InterQual/state rules

When deciding coverage, reference federal, state (eg Ohio Administrative Code) and contractual requirements; UnitedHealthcare uses InterQual as the primary medisurgical criteria and may use UHC policies if InterQual is not applicable.

Ohio Administrative Code 5160-1-01 must be considered for services stated as unproven or with coverage limits
UnitedHealthcare uses InterQual as primary medisurgical criteria; UHC policies used if InterQual does not have applicable criteria

Billing Rule

Device and drug oversight

Embolic agents used for UAE are subject to FDA oversight; MRgFUS ExAblate system has PMA indications—providers should follow device labeling and indications.

Embolic agents for UAE are subject to FDA oversight
ExAblate 2000/2100 System (Insightec) has PMA and labeled indications for uterine fibroid ablation

LNG-IUD / LNG-IUSLevonorgestrel-releasing intrauterine device/system used to reduce heavy menstrual bleeding by local progestin delivery causing endometrial atrophy and suppression of endometrial activity.

Magnetic resonance-guided focused ultrasound (MRgFUS) and uterine artery embolization (UAE) positions clarified: UAE is proven and medically necessary for symptomatic fibroids and certain bleeding indications; MRgFUS is unproven and not medically necessary due to insufficient evidence.

revised

Endometrial ablation and levonorgestrel-releasing IUD (LNG-IUD) affirmed as proven treatments for abnormal uterine bleeding with reference to InterQual clinical criteria for medical necessity determinations.