DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Laparoscopic, Percutaneous, and Transcervical Techniques for the Myolysis of Uterine Fibroids & Hysterectomies

Defines medical necessity, coverage, coding, and state-mandated hysterectomy coverage amendments for minimally invasive myolysis procedures (including RFA) and hysterectomies for individuals with symptomatic uterine fibroids; applies to Medicare Advantage and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyLaparoscopic, Percutaneous, and Transcervical Techniques for the Myolysis of Uterine Fibroids & Hysterectomies

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and verify member-specific benefits before scheduling RFA procedures.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum age for RFA eligibility

10 cm / 7 cmmax fibroid diameter (lap/trans)

58674, 0404T, 58999CPT codes referenced

58140–58575hysterectomy CPT range

~35

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria — Myolysis and Hysterectomy

Medically necessary criteria for RFA

Laparoscopic or transcervical radiofrequency ablation (RFA) is considered medically necessary when ALL of the following are met:

Age: Individual is 18 years or older.18+

Fibroid size: Evidence of uterine fibroids via ultrasound with diameter ≤10 cm for laparoscopic RFA (Acessa) or ≤7 cm for transcervical RFA (Sonata).≤10 cm or ≤7 cm

Symptoms: Individual has at least one symptom directly resulting from the fibroid(s), including menorrhagia or other abnormal uterine bleeding interfering with daily activities or causing anemia; pelvic pressure or pain; gastrointestinal symptoms from bulk compression (e.g., constipation, bloating); urinary symptoms from bladder compression (e.g., frequency, urgency); or dyspareunia.≥1 symptom

Treatment preference or ineligibility: Individual desires a uterine-sparing treatment approach or is ineligible for hysterectomy or other uterine-sparing alternatives (e.g., laparoscopic myomectomy, uterine artery embolization).

Facility and product requirements: Procedure must be performed at a certified Obstetrical and Gynecological surgery center and, when above criteria are met, is covered using specified cleared RFA systems.

Not covered / not medically necessary techniques

Other myolysis techniques: Other laparoscopic, transcervical, or percutaneous myolysis techniques (including laser or bipolar needles, cryomyolysis, and MRI-guided laser ablation) are considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products due to insufficient evidence.

Other laparoscopic, transcervical, or percutaneous myolysis techniques — including use of laser or bipolar needles, cryomyolysis, and MRI-guided laser ablation — are explicitly addressed in this policy. The document states these approaches are considered to have insufficient evidence to determine effects on health outcomes and therefore are not accepted as covered alternatives to radiofrequency ablation (RFA) within the scope of this policy.

Services that are determined to be not medically necessary or designated as non-covered benefits by the member’s benefit documents are exclusions to coverage under this policy. Providers should confirm member-specific benefits and eligibility via the member’s subscriber agreement, member certificate, or employer agreement, since those documents govern coverage determinations.

Per the policy, non-RFA myolysis techniques (for example, laser ablation, bipolar-needle myolysis, cryomyolysis, and MRI-guided laser ablation) are considered not medically necessary for Commercial Products and are not covered for Medicare Advantage Plans because the available evidence is insufficient to establish effectiveness.

Consistent with the policy’s exclusion language, any service found to be not medically necessary according to the member’s benefit documents is not a covered service. Member financial responsibility may apply only when the member has been informed and has provided written agreement to accept financial liability in advance.

Coding — Procedure Codes and Size Limits

Covered CPT Codes for RFACPTCovered

58674	Laparoscopy, surgical, ablation of uterine fibroid(s) including intraoperative ultrasound guidance and monitoring, radiofrequency
0404T	Transcervical uterine fibroid(s) ablation with ultrasound guidance, radiofrequency

Unlisted procedures (use when CPT not assigned)CPT

58999

Unlisted procedure, female system (nonobstetrical) genital

Covered CPT Codes for HysterectomiesCPTCovered

58140	Hysterectomy
58294	Hysterectomy
58541	Hysterectomy
58554	Hysterectomy
58570	Hysterectomy
58575	Hysterectomy

Fibroid size limits — RFA eligibility

Laparoscopic RFA maximum fibroid diameter≤ 10 cm (evidence requirement for Acessa laparoscopic RFA)

Transcervical RFA maximum fibroid diameter≤ 7 cm (evidence requirement for Sonata transcervical RFA)

Imaging modality for size confirmationUltrasound evidence of uterine fibroids with diameter at or below the specified limits

Provider Actions — Authorization, Documentation, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for Medicare Advantage Plans and Commercial Products for these procedures.

Applies to laparoscopic and transcervical radiofrequency ablation (RFA) procedures.

Note

Confirm Benefits and Authorization

Confirm member-specific benefits and eligibility before scheduling. Prior authorization requirements are determined by the member's subscriber agreement, member certificate, and/or employer agreement.

Contact the provider call center for member-specific information.

Step Therapy

Background and Clinical Rationale

Uterine fibroids (leiomyomas) are common benign smooth-muscle tumors in reproductive‑aged individuals and can produce symptoms such as menorrhagia or abnormal uterine bleeding, pelvic pressure or pain, bulk-related gastrointestinal or urinary symptoms (for example, constipation, bloating, urinary frequency/urgency), and dyspareunia. Surgical approaches such as hysterectomy and myomectomy are standard for definitive symptom resolution but do not preserve the uterus; minimally invasive myolysis techniques, including radiofrequency ablation (RFA), aim to reduce fibroid volume while preserving the uterus, using energy sources to induce necrosis of fibroid tissue under imaging guidance.

Definitions — Terminology and Devices

Myolysis — definition

DefinitionProcedures that induce necrosis within uterine fibroids using an energy source (e.g., radiofrequency, laser, cryo) to reduce fibroid volume and relieve symptoms.

MechanismEnergy delivery creates areas of coagulative necrosis within fibroid tissue leading to volume reduction.

Techniques includedLaparoscopic, transcervical, percutaneous approaches using RFA, laser, bipolar needles, cryomyolysis, or MRI-guided laser ablation.

Acessa and Sonata systems — FDA-cleared RFA platforms

Acessa (laparoscopic)FDA-cleared laparoscopic system for percutaneous/laparoscopic coagulation and radiofrequency ablation of uterine fibroids under laparoscopic ultrasound guidance (cleared via 510(k); multiple generations: K121858, K181124).

Sonata (transcervical)

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyLaparoscopic, Percutaneous, and Transcervical Techniques for the Myolysis of Uterine Fibroids & Hysterectomies

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and verify member-specific benefits before scheduling RFA procedures.

SourceLink

On This Page

Policy requires consideration of uterine-sparing alternatives and documentation of eligibility for RFA; no specific step-therapy sequence is defined in this policy.

Providers should document that the individual desires a uterine-sparing treatment or is ineligible for hysterectomy/other uterine-sparing alternatives (e.g., laparoscopic myomectomy, uterine artery embolization).

Documentation Required

Required Clinical Documentation

Ultrasound evidence of uterine fibroids is required, with size limits: <10 cm diameter for laparoscopic RFA (Acessa) and <7 cm for transcervical RFA (Sonata). Document symptoms attributable to fibroids and that criteria for medical necessity are met.

Include ultrasound measurements, symptom description (e.g., menorrhagia causing anemia, pelvic pressure/pain, GI or urinary symptoms, dyspareunia), and rationale for uterine-sparing approach.

Note

Verify Member Benefits

Verify member benefits and eligibility; benefits are governed by subscriber/member/employer agreements which supersede this policy.

Do not charge members for services determined not medically necessary or non-covered unless you obtained written informed consent acknowledging member financial responsibility.
Refer to participation agreements for applicable provisions.

Prior Authorization

Prior Authorization and Facility Requirement

Prior authorization is required and procedures must be performed at a certified Obstetrical and Gynecological surgery center as specified in the policy.

Applicable to Medicare Advantage Plans and Commercial Products.

Denial Risk

Member Financial Liability and Denial Risk

Services determined to be not medically necessary or non-covered may not be billed to the member unless the member has been informed and has agreed in writing to accept financial responsibility prior to treatment.

Follow the member's subscriber agreement and provider participation agreement for billing rules and denial risk handling.

FDA-cleared transcervical sonography-guided radiofrequency ablation system for treatment of symptomatic uterine fibroids (cleared via 510(k); K173703 and subsequent clearances).

Imaging guidanceBoth systems are used under imaging guidance (laparoscopic ultrasound for Acessa; intrauterine/transcervical sonography for Sonata) as specified in regulatory clearances.

Transcervical ultrasound-guided RFA (e.g., Sonata)

Procedure descriptionA minimally invasive transcervical procedure using ultrasound-guided radiofrequency energy to ablate uterine fibroids via the Sonata system.

Supporting evidenceClinical support includes the SONATA pivotal trial (2-year and 3-year results) and registry data cited in the references (SONATA publications and SAGE registry).

Guidance referenceNICE Interventional Procedures Guidance IPG689 addresses transcervical ultrasound-guided RFA for symptomatic uterine fibroids.