CurrentMass General Brigham Health PlanPolicy 050

Radiofrequency Ablation to Treat Uterine Fibroids

Defines medical necessity and prior authorization requirements for laparoscopic or transcervical ultrasound‑guided radiofrequency ablation (RFA) for symptomatic uterine fibroids for Mass General Brigham Health Plan membership populations (commercial, ACO, Medicare Advantage, OneCare, Senior Care Options).

Policy Summary

PayerMass General Brigham Health Plan

PolicyRadiofrequency Ablation to Treat Uterine Fibroids

Policy CodePolicy 050

Change TypeAd-hoc and annual updates

Effective DateJanuary 2026

Next Review Date

Key ActionThe treating specialist must request prior authorization and document qualifying symptoms and absence of contraindications to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

Updated prior authorization table and added variation for OneCare and SCO members.

Allowed exceptions to the fibroid size exclusion (#1).

CPT coding updated: 0404T replaced with CPT 58580.

Summary of evidence and references were added/updated.

2FDA‑cleared RFA systems referenced (Acessa, Sonata)

9 cm / 7 cmMaximum fibroid size exclusions (Acessa / Sonata)

58580,58674CPT procedure codes listed

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Medical Necessity Criteria for RFA of Uterine Fibroids

Medically Necessary — Initial Treatment

Laparoscopic or transcervical ultrasound‑guided radiofrequency ablation using an FDA‑approved device may be considered medically necessary when ALL of the following are met:

ALL of the following

Procedure is performed using an FDA‑approved device for uterine fibroid RFA (examples: Acessa, Sonata).
Treating specialist has requested prior authorization for the procedure.
Prior authorization is required for the listed plan types per authorization table.
Member has one or more of the following symptoms directly attributable to uterine fibroids
- Excessive menstrual bleeding (menorrhagia)
- Urinary symptoms or gastrointestinal symptoms (e.g., urinary frequency, abdominal bloating, constipation)
- Pelvic pain
- Lower back pain
- Painful sexual relations (dyspareunia)

Exclusions / Contraindications

The following conditions render RFA not appropriate unless exception is granted by a Medical Director:

ANY of the following

Fibroid size greater than device‑specific limits: >9 cm for Acessa or >7 cm for Sonata.
Exceptions to this exclusion will be considered on an individual basis by a Medical Director.
Acute pelvic infection.
Diagnosis of gynecological cancer or a pre‑cancerous lesion (e.g., atypical endometrial hyperplasia, leiomyosarcoma).
Abnormal Pap smear result without appropriate follow‑up.
Current pregnancy.

Medicare / MassHealth / Plan Variations

Policy follows CMS or MassHealth guidance where applicable; otherwise MGB Health Plan policy applies:

ANY of the following

Medicare Advantage: CMS NCDs/LCDs/LCAs and Medicare manual documentation are the basis for medical necessity determinations; when no CMS guidance exists, MGB Health Plan policy is used. As of the most recent review, CMS had no NCDs/LCDs specific to RFA for uterine fibroids.
Mass General Brigham ACO / MassHealth: MassHealth guidance is used for ACO members; when no MassHealth guidance exists, MGB Health Plan policy is used. At last review, MassHealth had no specific guidelines for RFA.
OneCare and SCO: CMS guidance is used for these members; when no CMS or MassHealth guidance exists, MGB Health Plan policy applies.

Procedure Codes and Authorization-specific Coding Notes

Procedure codes mentioned (informational)CPT

58580	Transcervical ablation of uterine fibroid(s), including intraoperative ultrasound guidance and monitoring, radiofrequency.
58674	Laparoscopy, surgical, ablation of uterine fibroid(s) including intraoperative ultrasound guidance and monitoring, radiofrequency.

Authorization-specific coding notesmixed

58580/58674

Listed in authorization/prior authorization table: certain plan variations require authorization (Medicare Advantage, OneCare, SCO references include 58580 and 58674 in table).

Prior Authorization and Documentation Requirements

Prior Authorization

Prior authorization required

The treating specialist must request prior authorization for RFA procedures; authorization requirements vary by plan as shown in the policy's authorization table. Providers should check the member's plan type and follow the specific authorization entries for that plan prior to scheduling the procedure.

CPT 58580
CPT 58674
Applies to: Commercial, ACO, Medicare Advantage, OneCare, Senior Care Options (SCO) — check table for plan-specific code/authorization notes

Documentation Required

Document symptoms attributable to fibroids

Document that the member has one or more qualifying symptoms directly attributable to uterine fibroids to support medical necessity for RFA.

Excessive menstrual bleeding (menorrhagia)

Device-specific Size Thresholds

Maximum fibroid size

Maximum fibroid size — Acessa<= 9 cm

Maximum fibroid size — Sonata<= 7 cm

2 device systems namedFDA-cleared RFA systems referenced (Acessa, Sonata)

Size limits: 9 cm / 7 cmMaximum fibroid size exclusions for Acessa (9 cm) and Sonata (7 cm)

58580, 58674CPT codes listed for procedures

Clinical Background

Laparoscopic and transcervical ultrasound‑guided radiofrequency ablation (RFA) are minimally invasive, uterine‑sparing procedures used to destroy symptomatic uterine fibroids. Laparoscopic volumetric RFA (example device: Acessa) uses a laparoscopic ultrasound probe to localize fibroids and delivers radiofrequency energy via a small electrode array; transcervical incisionless RFA (example device: Sonata) integrates intrauterine ultrasound imaging with transcervical radiofrequency delivery to ablate fibroids. (See device examples: Acessa K121858; Sonata K173703.)

Evidence supporting these procedures comes largely from prospective single‑arm trials and consensus guidance. Multiple single‑arm studies (including the HALT trials for Acessa and the FAST‑EU, INTEGRITY, and SONATA trials for Sonata) demonstrated significant improvements in symptom scores, reductions in fibroid volume or blood loss, maintenance of uterine wall integrity on MRI, and durable quality of life benefits through 1–3 years of follow‑up. Meta‑analyses and systematic reviews of prospective studies and real‑world registry reports broadly align with these findings.

While the available data indicate favorable efficacy, safety, and cost outcomes compared with more invasive surgical options, randomized trial evidence is limited and reproductive outcome data remain sparse. Professional guidance (e.g., ACOG practice bulletin) recognizes RFA as a minimally invasive option for symptomatic fibroids but highlights the limited evidence on reproductive outcomes; expert consensus documents and guidance (including NICE IPG689) further note patient selection considerations such as fibroid size and symptom severity.

Because the evidence base is weighted toward single‑arm prospective studies rather than randomized controlled trials, and because reproductive outcome data are limited, the policy includes device‑specific size thresholds and exclusions and allows case‑by‑case Medical Director review for exceptions where appropriate.

Defined Terms

Definitions

Laparoscopic Ultrasound‑Guided Radiofrequency AblationA minimally invasive procedure that uses a laparoscopic ultrasound probe to determine fibroid location and size and delivers radiofrequency energy via a small electrode array to destroy fibroids.

Transcervical Radiofrequency AblationA minimally invasive, incisionless procedure that integrates intrauterine ultrasound imaging with transcervical radiofrequency delivery to ablate uterine fibroids (e.g., Sonata system).

Policy Changes and Updates

2026-01Ad-hoc update (effective January 2026)Latest

Updated the prior authorization table and added plan variations for OneCare and Senior Care Options (SCO) members; fixed code disclaimer.

2025-03Annual review (March 2025)

Annual review with addition of a summary of evidence and updated references.

2024-04Ad-hoc update (April 2024)

Permitted case-by-case exceptions to the fibroid size exclusion (exclusion #1) to be reviewed by a Medical Director.