Colorado Rocky Mountain Health Plans AUB Fibroids Coverage Update

Coverage Criteria for AUB and Fibroids

Endometrial Ablation (proven/medically necessary)

Covered when ALL of the following are met:

Endometrial ablation is proven and medically necessary for treating abnormal uterine bleeding in premenopausal individuals; medical necessity clinical coverage criteria are based on InterQual CP: Procedures, Hysteroscopy, Operative.

See InterQual for specific clinical criteria and prior authorization requirements.

LNG-IUD (proven/medically necessary)

Covered when ALL of the following are met:

Levonorgestrel-releasing IUD: Levonorgestrel-releasing intrauterine devices (e.g., Mirena, Skyla, Liletta, Kyleena) are proven and medically necessary for treating menorrhagia.

Refer to FDA labeling and device-specific billing codes; documentation should include diagnosis of heavy menstrual bleeding (HMB) and prior treatments or rationale for IUD selection.

Supporting evidence: Systematic reviews and randomized trials demonstrate LNG-IUS reduces menstrual blood loss and improves quality of life versus oral medical therapies in short- and medium-term follow-up.short- and medium-term

Cochrane and other systematic reviews support LNG-IUS as a first-line nonsurgical option for HMB.

Uterine Artery Embolization and MRgFUS (mixed)

Coverage stance varies by indication — follow the specific logic below:

UAE - covered uses: Uterine artery embolization (UAE) is proven and medically necessary for treating symptomatic uterine fibroids, postpartum or post-hysterectomy bleeding, or uterine arteriovenous malformation (AVM); clinical criteria reference InterQual CP: Procedures, Uterine Artery Embolization (UAE).

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

Explicitly listed as not medically necessary.

MRgFUS: Magnetic resonance-guided focused ultrasound ablation (MRgFUS) is unproven and not medically necessary for treating uterine fibroids due to insufficient evidence of efficacy and limited long-term durable outcome data.

CPT category III codes for focused ultrasound are listed in coding section.

Evidence-based coverage considerations

Clinical findings and comparative evidence that inform coverage decisions:

LNG-IUS for HMB: LNG-IUS is more effective than oral medical therapies for reducing menstrual blood loss, improving quality of life, and increasing patient satisfaction in short- and medium-term follow-up; it is supported as first-line nonsurgical therapy for non-surgical candidates.short- and medium-term

Based on multiple systematic reviews and randomized trials.

Uterine-sparing procedures for fibroids: UAE, HIFU/MRgFUS, and myomectomy are uterine-sparing options that reduce symptoms but differ in reintervention rates and fertility outcomes: UAE reduces volume and improves bleeding yet may have higher reintervention and uncertain fertility outcomes compared with myomectomy; MRgFUS/HIFU show variable efficacy by technique and NPVR.variable

Evidence quality ranges from low to moderate; patient age and fertility desires influence choice.

Comparative efficacy for volume reduction:

Evidence and guideline-based criteria context

Guideline and evidence context to guide patient selection, governance, and informed consent:

MRgFUS evidence summary: Systematic reviews and trials show MRgFUS reduces fibroid size and symptoms in the short term but may have lower NPVR and higher reintervention rate versus some alternatives; procedure duration and strict eligibility limit uptake.

Supported by meta-analyses, RCTs, and ECRI/ACOG/NICE findings.

Guideline recommendations: Major guidelines (ACOG, ACR, NICE) recommend careful patient selection, trial of medical management before invasive therapies in most cases, counseling on reproductive implications, and use of clinical governance/audit for HIFU/MRgFUS.

Guideline-based operational considerations.

Technical and selection limits: MRgFUS/HIFU candidacy is constrained by fibroid size/volume, location, and NPVR expectations; studies often included fibroids < 300 cm3 and consider NPVR > 80% as successful for HIFU.< 300 cm3; NPVR > 80%

Indications and Contraindications

Regulatory indications and safety-related contraindications relevant to coverage and informed consent:

MRgFUS (ExAblate) indication: The ExAblate 2000/2100 System is indicated 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; the labeling was modified in 2015 to remove the completed-childbearing restriction.uterine size < 24 weeks

PMA P040003; verify current device labeling for patient eligibility.

Morcellation contraindications: Laparoscopic power morcellators are contraindicated when the tissue to be morcellated is known or suspected to contain malignancy, and contraindicated for removal of uterine tissue containing suspected fibroids in peri- or post-menopausal patients or candidates for en bloc removal; FDA warns against routine use due to risk of spreading occult cancer.

FDA Safety Communication (11/24/2014) recommends black box warning and contraindications.

UAE fertility caution: UAE performed with the intent to preserve childbearing potential is considered unproven and not medically necessary because of insufficient evidence of efficacy and concerns about fertility outcomes; counsel and document fertility goals when considering UAE.

Uterine artery embolization (UAE) and magnetic resonance-guided focused ultrasound (MRgFUS) are addressed specifically in this policy as mixed‑stance interventions. UAE is considered proven and medically necessary for certain symptomatic indications (see InterQual‑based medical necessity criteria), but it is unproven and not medically necessary when performed for the purpose of preserving childbearing potential because evidence does not support efficacy for fertility preservation. Similarly, MRgFUS is described as unproven and not medically necessary for treating uterine fibroids due to insufficient evidence of durable effectiveness and standardized protocols.

The policy identifies limitations in the evidence for MRgFUS: available studies are few, vary in protocol, and lack long‑term outcome data, so durability of symptom relief and recurrence rates are uncertain. Systematic reviews and meta‑analyses report variable reintervention rates and note that ultrasound‑guided HIFU often has lower reintervention rates than MRgFUS; subgroup factors such as NPVR thresholds and fibroid imaging characteristics influence outcomes. ECRI and other assessments concluded the evidence for devices such as ExAblate is inconclusive because of small studies, high risk of bias, and limited outcomes, supporting the policy position that MRgFUS is not medically necessary.

Professional guidance from AAGL is cited to clarify reproductive considerations: embolic and ablative therapies—this includes UAE, vessel occlusion, radiofrequency ablation, cryotherapy, and MRgFUS—are not appropriate for women with submucous myomas who currently have infertility or who wish to conceive. The policy therefore excludes these therapies for that patient group and recommends caution and long‑term study of reproductive outcomes when considering such options.

The policy emphasizes FDA safety communications regarding laparoscopic power morcellators: because morcellation can disseminate occult uterine malignancy and adversely affect long‑term survival, the FDA has recommended against use of power morcellators in the majority of women undergoing myomectomy or hysterectomy for fibroids. The policy therefore discourages routine use of laparoscopic power morcellation for fibroid surgery and expects providers to disclose this safety concern.

The policy lists specific morcellator contraindications consistent with FDA guidance: do not use laparoscopic power morcellators when the tissue to be morcellated is known or suspected to contain malignancy, and do not use them for removal of uterine tissue containing suspected fibroids in peri‑ or postmenopausal patients or when en bloc removal is appropriate. The FDA Safety Communication (11/24/2014) and updated labeling require warnings and contraindications be included in device product information; failure to follow these contraindications may have regulatory and coverage consequences.

Based on the evidence synthesis and coverage rationale, the policy states that MRgFUS is not medically necessary for treating uterine fibroids. Similarly, UAE performed with the intent to preserve childbearing potential is not medically necessary because current studies do not provide sufficient, high‑quality evidence demonstrating favorable fertility or pregnancy outcomes compared with alternatives.

When fertility or future pregnancy is an important goal, the policy highlights comparative reproductive outcomes: systematic reviews report that pregnancy rates after UAE are often lower and miscarriage rates higher compared with myomectomy in some studies, though evidence quality is low and proportions are uncertain. Because of these findings, UAE is not recommended when preservation of fertility is the primary objective and patient counseling and documentation of alternative options and informed consent are advised.

Independent assessments such as ECRI have found the evidence for the ExAblate MRgFUS system to be inconclusive: studies show short‑term symptom improvement and quality‑of‑life benefits in some patients but are limited by small sample sizes, high risk of bias, retrospective designs, and inadequate comparative data. The policy therefore references these conclusions when determining that MRgFUS lacks sufficient evidence to be considered medically necessary for routine treatment of fibroids.

The policy underscores the FDA’s formal warning about laparoscopic power morcellation and the requirement for a prominent black‑box style warning in device labeling: clinicians should be aware that morcellation may spread unsuspected uterine cancer and that the FDA recommends against morcellator use in the majority of women undergoing procedures for fibroids. This guidance is central to the policy’s cautionary approach to morcellation and to required preoperative counseling and documentation.

Applicable Codes and Device Identifiers

Applicable procedural CPT/CodesCPT | mixed

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).

LNG-IUD HCPCS/J codes and supply codesHCPCS | CPT

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 PMA identifiermixed

P040003

PMA identifier for ExAblate 2000/2100 System

UF volume inclusion — numeric constraint

UF volume inclusionTotal uterine fibroid volume inclusion criterion: < 300 cm3

Evidence sourceInclusion criterion for MR‑HIFU studies included fibroids with volume < 300 cm3

Implication for coding/selectionVolume threshold used in comparative analyses and may inform patient eligibility for focused ultrasound procedures

Uterine size for ExAblate labeling

ExAblate uterine size limitUterine size less than 24 weeks as specified in device labeling

Labeling history

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required and InterQual criteria are used to determine medical necessity for procedures including endometrial ablation and uterine artery embolization (UAE). Submit complete clinical documentation with the prior authorization request to allow review against InterQual CP: Procedures (Hysteroscopy, Operative; Uterine Artery Embolization). Incomplete documentation may result in denial or delay.

Affected procedures: endometrial ablation, UAE, MRgFUS
Include specific InterQual checklist name on request (e.g., Procedures, Hysteroscopy, Operative; Procedures, Uterine Artery Embolization)

Documentation Required

Documentation Requirements for Reviews

The patient's medical record must contain legible documentation that fully supports medical necessity. This includes relevant medical history, documentation of prior medical management and response, physical exam findings, and results of pertinent diagnostic testing (e.g., pelvic ultrasound, MRI when indicated). Documentation may be requested and lack of sufficient records is an operational reason for denial.

Background

Abnormal uterine bleeding (AUB) is an umbrella term for changes in menstrual frequency, duration, or amount and includes subtypes such as oligomenorrhea, polymenorrhea, and menorrhagia. Uterine fibroids (leiomyomata) are benign uterine tumors that commonly cause heavy menstrual bleeding and bulk symptoms (pelvic pressure, pain, urinary frequency). Minimally invasive and uterine‑sparing options—such as levonorgestrel‑releasing IUDs, endometrial ablation, uterine artery embolization, and MRgFUS—are discussed in this policy with respect to their mechanisms, indications, and evidence for symptom control and reproductive impact.

Definitions and Terms

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, vaginal bleeding 12 months or more after cessation of menstruation

Included subtypesOligomenorrhea, polymenorrhea, menorrhagia, menometrorrhagia, and metrorrhagia

Clinical relevanceMenorrhagia may be idiopathic or associated with fibroids, polyps, anatomical abnormalities, systemic illness, hormonal imbalance, or medications

Uterine fibroids (leiomyomata)

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

Typical age

Revision History and Policy Changes

12/01/2025material_changeLatest

Added language clarifying medical records documentation requirements for prior authorization and medical necessity review; specified that providing records does not guarantee coverage and listed examples of required documentation (medical history, physical exam, diagnostic test results).

OpenPayer

Abnormal Uterine Bleeding and Uterine Fibroids (for Ohio Only)