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    v1.0.28
    OpenPayerPolicy UpdatesObstetrics/GynecologyCapital Bluecross RFA Coverage & Prior Auth | Open…
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    CurrentCapital BluecrossPolicy MP 7.027

    Laparoscopic, Percutaneous, and Transcervical Techniques for Uterine Fibroid Myolysis

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    Defines medical necessity and investigational status for laparoscopic and transcervical radiofrequency ablation (RFA) for symptomatic uterine fibroids in adults and states that other myolysis techniques (laser, bipolar needles, cryomyolysis, MRI-guided laser) are investigational. Applies to Capital BlueCross-administered products with benefit variations.

    Policy Summary
    PayerCapital Bluecross
    PolicyLaparoscopic, Percutaneous, and Transcervical Techniques for Uterine Fibroid Myolysis
    Policy CodePolicy MP 7.027
    Change TypeNo material change
    Effective DateJun 1, 2026
    Last ReviewFeb 24, 2026
    Next Review DateN/A
    Key ActionObtain prior authorization when required by the member's benefit plan and document medical necessity per member benefit terms.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    18+min age for covered RFA
    <=10 cmmax fibroid diameter (lap)
    <=7 cmmax fibroid diameter (trans)
    insufficient evidence

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    investigational techniques
    ≤16 weeksuterine size in trials

    Coverage Criteria and Policy Stance

    Laparoscopic or transcervical RFA — Medical necessity

    Covered when ALL of the following are met

    Age: Individual is 18 years or older>=18 years
    Fibroid size limits: Ultrasound evidence of uterine fibroids less than 10 cm for laparoscopic RFA (Acessa) or less than 7 cm for transcervical RFA (Sonata)<10 cm (lap), <7 cm (trans)
    Treatment intent or alternatives: Individual desires a uterine-sparing treatment approach or is ineligible for hysterectomy or other uterine-sparing alternatives to RFA (e.g., laparoscopic myomectomy, uterine artery embolization)

    See Policy Guidelines for evaluation and alternatives

    Symptoms attributable to fibroids: Individual has experienced at least one symptom directly resulting from the fibroid(s): menorrhagia/abnormal uterine bleeding interfering with activities or causing anemia; pelvic pain or pressure; urinary symptoms from bladder compression; gastrointestinal symptoms from bowel compression; or dyspareunia

    Clinical guidance supporting coverage decisions

    Coverage stance and clinical context provided in policy and guideline citations

    Guideline support: ACOG (2021) considers radiofrequency ablation a minimally invasive option for patients desiring uterine preservation, noting limited reproductive outcome data; laparoscopic, transvaginal, or transcervical ultrasound-guided approaches are considered similarly effective.

    Reference: ACOG Practice Bulletin 228

    NICE recommendation for transcervical RFA: NICE (2021) states transcervical ultrasound-guided RFA should only be used with special arrangements for clinical governance, consent, and audit or research due to limited efficacy evidence.

    Reference: NICE IPG689

    Policy coding note: Procedure codes associated with laparoscopic ultrasound-guided radiofrequency ablation are noted as covered when medically necessary (see Coding section).

    Reference: policy coding information

    Other laparoscopic, transcervical, or percutaneous myolysis techniques for uterine fibroids — including use of laser, bipolar needles, cryomyolysis, and magnetic resonance imaging-guided laser ablation — are considered investigational. The policy states there is insufficient evidence to support a general conclusion that these procedures improve net health outcomes, and they are therefore not covered under this policy.

    Specifically, use of cryomyolysis and magnetic resonance imaging-guided laser ablation for treatment of uterine fibroids is labeled investigational and not covered. The policy lists CPT codes 58578 and 58999 as associated with these investigational procedures and notes they may be denied if billed.

    The evidence supporting laser and bipolar-needle myolysis, cryomyolysis, and MR-guided laser ablation is limited to small case series or a single study with historical controls. Many reports are small (for cryomyolysis ≤20 patients) or dated (laser and bipolar needle series from the 1990s), and no robust randomized controlled trial data exist to establish safety and efficacy compared with alternative treatments. Consequently, the data are insufficient to determine an improvement in net health outcome for these techniques.

    As reiterated in the policy, use of cryomyolysis or MR-guided laser ablation for uterine fibroids is considered investigational and not medically necessary. The policy emphasizes that randomized controlled trials comparing these techniques with established alternatives are needed before coverage can be recommended.

    Regulatory Clearances, Code Status, and Size Limits

    Regulatory clearances referencedmixed
    K121858FDA 510(k) clearance for Acessa System (percutaneous laparoscopic coagulation and ablation of soft tissue and treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance) — product code GEI
    K132744FDA 510(k) clearance for ultrasound guidance system for Acessa
    K181124FDA 510(k) clearance for Acessa ProVu System (percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids) — product code HFG
    K173703FDA 510(k) clearance for Sonata Sonography-Guided Transcervical Fibroid Ablation System (formerly Vizablate) — product codes KNF, ITX, IYO
    Covered when Medically Necessary — Laparoscopic ultrasound-guided radiofrequency ablationmixedCovered
    not listedProcedure codes associated with laparoscopic ultrasound-guided radiofrequency ablation are noted as covered when medically necessary; exact codes not listed in source document
    Investigational — not coveredCPTNot Covered
    58578Procedure code listed under investigational therefore not covered when used for Cryomyolysis, Magnetic resonance imaging-guided laser ablation
    58999Procedure code listed under investigational therefore not covered when used for Cryomyolysis, Magnetic resonance imaging-guided laser ablation
    inv-10: Maximum fibroid diameter for laparoscopic RFA (Acessa)
    Maximum fibroid diameter (laparoscopic RFA - Acessa)Less than 10 cm in diameter
    Applicable patient ageAdults 18 years and older (policy applies when all criteria met)
    Imaging requirementEvidence of uterine fibroids via ultrasound documenting size
    inv-11: Maximum fibroid diameter for transcervical RFA (Sonata)
    Maximum fibroid diameter (transcervical RFA - Sonata)Less than 7 cm in diameter
    Device referencedSonata Sonography-Guided Transcervical Fibroid Ablation System (FDA 510(k) K173703)

    What Providers Must Do

    Prior Authorization

    Product- and program-specific prior authorization

    This policy applies only to certain Capital Blue Cross programs and products and is subject to benefit variations; consult program-specific guidance (for example, FEP PPO uses the FEP medical policy manual).

    Prior Authorization

    Obtain prior authorization as required by benefit

    Obtain prior authorization when required by the member's benefit plan; the coding list in the policy may not be all-inclusive and identification of a code does not guarantee coverage—coverage is determined by the member's benefit terms.

    Step Therapy

    Consider and document alternative uterine‑sparing interventions

    Consider and document prior inadequate response to alternative uterine‑sparing interventions (e.g., laparoscopic myomectomy, uterine artery embolization) before proceeding with RFA when these alternatives are appropriate for the patient.

    Clinical Background

    Uterine fibroids (leiomyomas) are benign smooth-muscle tumors of the uterus that are common in reproductive-age individuals. They can be asymptomatic or cause symptoms such as menorrhagia or abnormal uterine bleeding, pelvic pain or pressure, urinary or gastrointestinal symptoms from bulk compression, and dyspareunia. Management ranges from medical therapy to surgical options (hysterectomy, myomectomy) and minimally invasive uterine-sparing procedures such as radiofrequency ablation, which aim to reduce symptoms while preserving the uterus.

    Key Definitions

    inv-21: Uterine fibroids (leiomyomas) — definition and clinical relevance
    DefinitionUterine fibroids (leiomyomas) are benign smooth muscle tumors of the uterus; common in reproductive-age women and can cause menorrhagia, pelvic pressure, or pain.
    PrevalenceEstimated to occur in up to 70% of women by menopause, with ~25% clinically significant
    Common symptomsMenorrhagia/abnormal uterine bleeding, pelvic pressure or pain, urinary or gastrointestinal symptoms, dyspareunia
    inv-22: Radiofrequency ablation (RFA) — definition and delivery approaches (laparoscopic Acessa, transcervical Sonata)
    Definition of RFARadiofrequency ablation (RFA) uses radiofrequency energy to create necrosis within fibroids to reduce fibroid volume and symptoms.
    Laparoscopic approach (Acessa)
    Policy Summary
    PayerCapital Bluecross
    PolicyLaparoscopic, Percutaneous, and Transcervical Techniques for Uterine Fibroid Myolysis
    Policy CodePolicy MP 7.027
    Change TypeNo material change
    Effective DateJun 1, 2026
    Last ReviewFeb 24, 2026
    Next Review DateN/A
    Key ActionObtain prior authorization when required by the member's benefit plan and document medical necessity per member benefit terms.
    SourceLink
    On This Page
    Coverage Criteria and Policy StanceRegulatory Clearances, Code Status, and Size LimitsWhat Providers Must DoClinical BackgroundKey Definitions
    Imaging requirementUltrasound evidence documenting fibroid size
    • Ensure documentation shows the individual desires uterine preservation or is ineligible for hysterectomy or other uterine‑sparing alternatives.
    Documentation Required

    Document medical necessity per policy criteria

    Document clinical indications and medical necessity per the policy criteria (age, fibroid size limits, symptoms attributable to fibroids) prior to RFA.

    • Include ultrasound documentation of fibroid size and symptoms caused by the fibroid(s).
    Documentation Required

    Endometrial biopsy recommended for individuals >45 years

    For individuals older than 45 years with menorrhagia or other abnormal uterine bleeding, obtain an endometrial biopsy prior to treatment to rule out endometrial malignancy and consider additional assessment to exclude risk for uterine leiomyosarcoma.

    Documentation Required

    Documentation and benefit verification required

    Verify member benefits and document that coding and submitted claims align with the member's contract—coding listed in the policy does not guarantee coverage; final claim processing depends on the member's benefit program and eligibility.

    • The policy's code list may not be all‑inclusive; confirm coverage and prior authorization requirements with the member's plan before performing procedures.
    Denial Risk

    Investigational procedures not covered — do not bill

    Do not perform or bill procedures considered investigational (e.g., laser myolysis, bipolar needle myolysis, cryomyolysis, MRI‑guided laser ablation); these techniques are investigational and may be denied if billed.

    • Examples of investigational/not covered procedure codes include 58578 and 58999 when used for cryomyolysis or MR‑guided laser ablation.
    Note
    Percutaneous laparoscopic coagulation and ablation of fibroids under laparoscopic ultrasound guidance (Acessa systems; FDA 510(k) K121858, K181124)
    Transcervical approach (Sonata)Sonography-guided transcervical fibroid ablation delivered transcervically using the Sonata system (FDA 510(k) K173703)
    inv-23: Definitions — note that no additional definitions provided in that section
    Definitions provided in documentNone—section states N/A (no additional definitions provided).
    ImplicationPolicy uses clinical terms defined elsewhere in the document (e.g., uterine fibroids, RFA) rather than providing further definitions in this section.
    Reference noteSee 'Definitions' section of policy for availability—listed as N/A in this document.