National Medical Policy Subject:

Laparoscopic Ultrasound-Guided Radiofrequency Ablation of Uterine Fibroids (e.g. Acessa)

Policy Number:

NMP532

Effective Date*: May 2014 Updated:

September 2015 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document

For Medicaid Plans: Please refer to the appropriate Medicaid Manuals for coverage guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use

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Source National Coverage Determination (NCD) National Coverage Manual Citation Local Coverage Determination (LCD)*

Reference/Website Link

Article (Local)*

Coverage and Non-Coverage of CPT Category III Codes: http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx

Other None

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Instructions  Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions.  Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under “Reference/Website” and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2)

Laparoscopic Ultrasoun Guided Radiofrequency Ablation of Uterine Fibroids Sep 15

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If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance.

Current Policy Statement Health Net, Inc. considers Laparoscopic Ultrasound-Guided Radiofrequency Ablation of uterine fibroids (e.g., Acessa) investigational. Studies to date are limited with small patient size and lack of long term results. Further studies are needed to determine the long-term efficacy of this procedure and to evaluate the efficacy and safety of this procedure relative to other treatments for uterine fibroids.

Definitions RFVTA GnRH LM UAE MRgFUS

Radiofrequency volumetric thermal ablation Gonadotropin-releasing hormone Laparoscopic myomectomy Uterine artery embolization Magnetic resonance-guided high-intensity focused ultrasound

Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures will be replaced by ICD-10 code sets. Health Net National Medical Policies will now include the preliminary ICD-10 codes in preparation for this transition. Please note that these may not be the final versions of the codes and that will not be accepted for billing or payment purposes until the October 1, 2015 implementation date.

ICD-9 Codes 218.0 – 218.9

Uterine leiomyoma

ICD-10 Codes D25.0 - D25.9

Leiomyoma of uterus

CPT Codes 0336T

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

HCPCS Codes N/A

Scientific Rationale – Update September 2015 Hahn et al. (2015) completed a 1:1 parallel, randomized, prospective, single-center, longitudinal, comparative analysis of radiofrequency volumetric thermal ablation (RFVTA) of fibroids to laparoscopic myomectomy (LM) for fibroid treatment in women ≥18 years of age who desired uterine conservation. Fifty women were randomized Laparoscopic Ultrasoun Guided Radiofrequency Ablation of Uterine Fibroids Sep 15

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intraoperatively to RFVTA (n=25) or to LM (n=25) after laparoscopic ultrasound mapping of the uterus. Post surgery, ablation and myomectomy patients took pain medications for 4 days (range: 1-46) and 7 days (range: 1-83) days) respectively (p=0.60). Ablation and myomectomy subjects missed 10.0 workdays (range: 2-86 days) and 17.0 workdays (range: 7-30 days) (p=0.28), resumed normal activities in 20.5 days (range: 5-103 days) versus 28.0 days (range: 10-42 days) (p=0.86) respectively. Mean symptom severity scores decreased (improved) by -7.8 for the ablation subjects and by -17.9 for the myomectomy subjects (p=0.16). Healthrelated quality of life improved (increased) by 7.5 and 13.1, respectively, for the two groups (p=0.46). Two myomectomy subjects had pregnancies that ended in a Cesarean delivery and a vaginal delivery of healthy infants. Two pregnancies in the RFVTA group ended in full-term vaginal deliveries of healthy infants. Conclusions: Early postoperative recovery and twelve-month results attest to similar clinical benefits from RFVTA and LM. Berman et al. (2015) completed a retrospective analysis of fibroid characteristics, treatment parameters, and pregnancy outcomes of 6 subjects in 3 prospective trials f laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation (RFVTA). Despite the requirement that women enrolled in the RFVTA studies did not desire current or future childbearing and were to continue contraception, 6 patients conceived at between 3.5 and 15 months postreatment. The number of fibroids treated per patient ranged from 1 to 7, measured between 1.0 cm and 7.6 cm at the greatest diameter, and included multiple types (submucosal, intramural, transmural, and subserosal). Five patients (5/6, 83%) delivered full-term healthy infants: 1 by vaginal delivery and 4 by cesarean section. One patient (1/6, 17%) had a spontaneous miscarriage in the first trimester. Viable, full-term pregnancies are possible after RFVTA. Further, in-depth study of pregnancy outcomes following laparoscopic ultrasound-guided radiofrequency, volumetric ablation of fibroids is warranted. Brucker et al. (2014) completed a blinded RCT to compare RFVTA and laparoscopic myomectomy in 51 women with symptomatic fibroids. Study authors reported interim study results of hospitalization time and perioperative outcomes. Participants in the treatment group experienced significantly faster discharge from the hospital (8.2±5.3 hours) compared with participants in the myomectomy group (28±13.8 hours) (p