priority health uterine fibroid coverage update

Coverage Criteria for Uterine Fibroid Treatments

Uterine artery embolization / Myomectomy / Hysterectomy

Covered when ALL of the following are met

Primary procedural coverage: Uterine artery embolization, myomectomy, or hysterectomy are covered when conservative medical management (e.g., hormonal therapies) has failed to control symptoms attributable to uterine fibroids.conservative management failed

Conservative medical management must have failed to control symptoms prior to coverage of these procedures.

Laparoscopic ultrasound-guided RFA (Acessa)

Covered when ANY one or more of the following are met

Acessa indications: 1) An abdominally palpable fibroid; 2) Bulk-related symptoms (e.g., pelvic pain, pressure or discomfort, urinary symptoms related to compression of the ureter or bladder, and/or dyspareunia) resulting directly from the fibroid; 3) Dyspareunia resulting directly from the fibroid; 4) Gastrointestinal symptoms related to compression of the bowel (e.g., constipation, bloating) resulting directly from the fibroid; 5) Severe menorrhagia causing anemia resulting directly from the fibroid (e.g., not resulting from hyperplasia, atypia, or cancer).one or more

Acessa is a uterine-sparing laparoscopic ultrasound-guided radiofrequency ablation procedure; counsel regarding fertility implications as appropriate.

Transcervical ultrasound-guided RFA (Sonata)

Covered when ANY one or more of the following are met and provider is certified

Sonata indications: 1) An abdominally palpable fibroid less than 7 cm; 2) Bulk-related symptoms (e.g., pelvic pain, pressure or discomfort, urinary symptoms related to compression of the ureter or bladder, and/or dyspareunia) resulting directly from the fibroid; 3) Dyspareunia resulting directly from the fibroid; 4) Gastrointestinal symptoms related to compression of the bowel (e.g., constipation, bloating) resulting directly from the fibroid; 5) Severe menorrhagia causing anemia resulting directly from the fibroid (e.g., not resulting from hyperplasia, atypia, or cancer).one or more

Provider must be a board-certified obstetrician-gynecologist who has received training and certification in the use of the Sonata device from Gynesonics; certification should be made available if requested by Priority Health. Exclusions (e.g., active pelvic infection, intra-tubal sterilization implants, presence of IUD unless removed, pregnancy, unusually short endometrial cavity <4.5 cm, only Type 0 or 7 fibroids, risk factors for leiomyosarcoma) apply as specified in policy.

The use of laparoscopic (Acessa) or transcervical (Sonata) ultrasound-guided radiofrequency ablation is excluded in specific clinical circumstances. These exclusions include members who have only Type 0 (pedunculated intracavitary, submucosal) or Type 7 (subserosal pedunculated) fibroids. Procedures are also excluded for members with risk factors for leiomyosarcoma or with known or suspected gynecologic malignancy or premalignant disorders (e.g., atypical endometrial hyperplasia).

Transcervical (Sonata) and laparoscopic (Acessa) approaches are not appropriate for pre-menopausal members who are seeking future fertility. Additional Sonata-specific exclusions include active pelvic infection, presence of one or more intra-tubal sterilization implants, presence of an intrauterine device unless removed prior to the procedure, current pregnancy, and a member with an unusually short endometrial cavity (4.5 cm fundus-to-external cervix os).

Providers must assess these exclusion criteria before recommending Acessa or Sonata; when any exclusion applies the procedure is not covered under this policy.

All other laparoscopic, transcervical, or percutaneous ablation techniques performed with imaging guidance for treatment of uterine fibroids are considered investigational and not medically necessary. Examples include ablative approaches using modalities such as lasers, bipolar electrodes, interstitial thermotherapy, cryotherapy, and similar techniques when used outside the specific, covered device indications.

Claims for these investigational ablation techniques may be denied; providers should submit alternative, covered treatment plans (e.g., uterine artery embolization, myomectomy, or hysterectomy) when conservative management has failed.

Focused ultrasound ablation of uterine leiomyomata delivered with MR guidance is explicitly listed as Not Covered under codes 0071T (total leiomyomata volume < 200 cc) and 0072T (total leiomyomata volume ≥ 200 cc).

Claims submitted with CPT/Category III codes 0071T or 0072T for focused ultrasound ablation of fibroids may be denied per this policy.

MRI-guided focused ultrasound (MRgFUS) technologies (for example, ExAblate) and other listed ablation modalities such as lasers, bipolar electrodes, interstitial thermotherapy, and cryotherapy are considered experimental and investigational and therefore not medically necessary for the treatment of uterine fibroids.

This policy distinguishes MRgFUS and other non‑RFA ablation modalities from the covered RFA systems (Acessa and Sonata) and does not support routine coverage for these modalities given insufficient evidence of safety and effectiveness for fibroid treatment.

Use of laparoscopic power morcellation for fibroid removal is restricted and considered medically necessary only in specified scenarios: (1) premenopausal women who wish to preserve fertility and have no risk factors for uterine sarcoma, or (2) women with comorbidities where alternative surgical options pose unacceptable risk. In all cases, members must be informed of alternatives and the risks of morcellation spreading unsuspected cancerous tissue.

Myomectomy or hysterectomy using power morcellation for indications other than the specified exceptions is considered experimental and investigational and therefore not covered; providers should document counseling about the FDA safety communication regarding the risk of spreading unsuspected uterine sarcoma.

Coding, Size Limits, and Related Parameters

FDA PMA identifiers referencedmixed

K181124	Acessa ProVu System PMA number
K132744	Acessa Guidance System PMA number
K132184	Acessa Guidance Handpiece PMA number
K250705	Sonata Transcervical Fibroid Ablation System 2.2 PMA number
K233848	Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) PMA
K222304	Sonata Transcervical Fibroid Ablation System 2.2 PMA
K211535	Sonata Transcervical Fibroid Ablation System 2.2 PMA
K193516	Sonata Sonography-Guided Transcervical Fibroid Ablation System 2.1 PMA
K173703	Sonata Sonography-Guided Transcervical Fibroid Ablation System PMA
K231378	Exablate Model 2100V1 PMA (Prostate/MRgFUS)

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ICD-10 Diagnosis CodesICD-10

D25.0	Submucous leiomyoma of uterus
D25.1	Intramural leiomyoma of uterus
D25.2	Subserosal leiomyoma of uterus
D25.9	Leiomyoma of uterus, unspecified

Procedure CPT/HCPCS Codesmixed

37243	Vascular embolization or occlusion ... for tumors, organ ischemia, or infarction
58140	Myomectomy, excision of fibroid tumor(s) of uterus, abdominal approach (1-4 intramural, <=250 g)
58145	Myomectomy; vaginal approach
58146	Myomectomy; 5 or more intramural myomas and/or >250 g, abdominal approach
58150	Total abdominal hysterectomy (corpus and cervix)
58152	Total abdominal hysterectomy with colpo-urethrocystopexy
58180	Supracervical abdominal hysterectomy (subtotal)
58200	Total abdominal hysterectomy with lymph node sampling
58210	Radical abdominal hysterectomy with bilateral total pelvic lymphadenectomy
58240	Pelvic exenteration for gynecologic malignancy, with total abdominal hysterectomy or cervicectomy

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Not Covered - Focused ultrasound Category IIICPTNot Covered

0071T	Focused ultrasound ablation of uterine leiomyomata, MR guidance; total volume <200 cc
0072T	Focused ultrasound ablation of uterine leiomyomata, MR guidance; total volume >=200 cc

inv-13: Endometrial cavity length exclusion — Sonata excluded when fundus-to-external cervix os < 4.5 cm

ThresholdFundus-to-external cervical os length less than 4.5 cm excludes Sonata

ApplicabilityApplies to members considered for transcervical ultrasound-guided radiofrequency ablation (Sonata)

Policy actionMember with endometrial cavity length < 4.5 cm is excluded from Sonata per Priority Health criteria

inv-14: Sonata size limit — abdominally palpable fibroid < 7 cm

Size limitSonata indicated for an abdominally palpable fibroid less than 7 cm

Context

Provider Requirements, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization may be required — providers must submit requests demonstrating medical necessity per Priority Health Provider Manual.

Providers should verify prior authorization requirements for procedures listed in this policy (e.g., uterine artery embolization, myomectomy, hysterectomy, transcervical and laparoscopic ablation).
When prior authorization is required, include documentation that conservative medical management has failed when applicable.

Prior Authorization

Prior Authorization for Specific Procedure Codes

Prior authorization may be required for listed fibroid procedure codes; submit documentation supporting medical necessity and relevant clinical criteria.

Affected CPT/HCPCS include, but are not limited to: 37243, 58140–58180 series, 58200–58292 series, 58353, 58356, 58541–58575 series, 58674, 58580, and HCPCS C1782 (Morcellator).
Confirm PA requirements for device- or procedure-specific codes (e.g., transcervical or laparoscopic ablation codes).

Background and Context

Uterine fibroids (leiomyomas) are benign smooth muscle tumors of the uterus that may be asymptomatic or produce clinically significant symptoms. Common presentations include abnormal uterine bleeding (menorrhagia) leading to anemia, pelvic pain or pressure, bulk-related symptoms such as urinary frequency or bowel compression, and dyspareunia. Treatment selection depends on fibroid size, location, symptom severity, the member’s age, and fertility desires.

Conservative medical management (for example, hormonal therapies) is frequently used as first-line therapy; procedural interventions such as uterine artery embolization, myomectomy, or hysterectomy are covered when conservative management has failed to control symptoms attributable to fibroids.

Power morcellation has been associated with a risk of spreading an unsuspected uterine sarcoma; the FDA has estimated the occurrence of unsuspected uterine sarcoma in women undergoing hysterectomy or myomectomy for fibroids to be approximately 1 in 350, and this safety concern informs the policy’s morcellation restrictions and counseling requirements.

Definitions of Devices and Procedures

inv-25: Transcervical ultrasound-guided radiofrequency ablation (Sonata) — device/procedure definition

DefinitionTranscervical ultrasound-guided radiofrequency ablation (Sonata) is a uterine-sparing transcervical procedure combining intrauterine ultrasound and radiofrequency ablation in a single device for diagnostic imaging and treatment of symptomatic fibroids

ApproachTranscervical approach without abdominal incisions; includes intrauterine ultrasound probe and single-use RFA handpiece

Clinical notePerinatal and postpartum outcomes for future pregnancy are unknown

inv-26: Laparoscopic ultrasound-guided radiofrequency ablation (Acessa) — device/procedure definition

DefinitionLaparoscopic ultrasound-guided radiofrequency ablation (Acessa) is a minimally invasive laparoscopic procedure using ultrasound-guided radiofrequency energy to ablate fibroids via small abdominal incisions

OpenPayer

UTERINE FIBROID TREATMENT

Coverage Criteria for Uterine Fibroid Treatments

Coding, Size Limits, and Related Parameters

Provider Requirements, Authorization, and Documentation

Background and Context

Definitions of Devices and Procedures