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

Policy Number: MP-208

Latest Review Date: February 2024

Category:  Surgery                                                                

POLICY:

Effective for dates of service 4/15/22 and after:

Laparoscopic or transcervical radiofrequency ablation (RFA) as a treatment of symptomatic uterine fibroids is considered medically necessary in individuals 18 years and older when ALL of the following conditions are met:

  • Evidence of uterine fibroids via ultrasound that are less than 10 cm in diameter for laparoscopic RFA with Acessa or 7 cm for transcervical RFA with Sonata; AND
  • 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 [UAE]); AND
  • Individual has experienced at least 1 of the following symptoms that are a direct result of the fibroid(s):
    • Menorrhagia or other abnormal uterine bleeding that interferes with daily activities or causes anemia*;
    • Pelvic pain or pressure;
    • Urinary symptoms (e.g., urinary frequency, urgency) related to bulk compression of the bladder;
    • Gastrointestinal symptoms related to bulk compression of the bowel (e.g., constipation, bloating);
    • Dyspareunia (painful or difficult sexual relations).

 

*In individuals >45 years of age with menorrhagia or other abnormal bleeding, endometrial biopsy is recommended prior to treatment to rule out endometrial malignancy and/or additional assessment to rule out a risk for uterine leiomyosarcoma.

 

Reintervention with RFA may be considered medically necessary for patients meeting policy criteria above with documentation of new or recurrent fibroid development following a partial response with the initial procedure.

 

Other laparoscopic, transcervical, or percutaneous techniques for myolysis of uterine fibroids, including use of laser or bipolar needles, cryomyolysis, and magnetic resonance imaging-guided laser ablation, are considered investigational.

 

Effective for dates of service prior to 4/15/22:

Laparoscopic, percutaneous, and transcervical techniques of myolysis is considered investigational for the treatment of uterine fibroids.

DESCRIPTION OF PROCEDURE OR SERVICE:

Various minimally invasive treatments for uterine fibroids have been proposed as alternatives to surgery. Among these approaches are laparoscopic, percutaneous, and transcervical techniques to induce myolysis which includes radiofrequency ablation (RFA), laser and bipolar needles, cryomyolysis and magnetic resonance imaging (MRI)-guided laser ablation.

Uterine Fibroids

Uterine fibroids, also known as leiomyomas, are among the most common conditions affecting women in the reproductive years; symptoms include menorrhagia, pelvic pressure, or pain. It is estimated that uterine fibroids occur in up to 70% of women by menopause, with approximately 25% of these being clinically significant and requiring intervention.

Treatment

Surgery, including hysterectomy and various myomectomy procedures, is considered the criterion standard for symptom resolution. However, there is the potential for surgical complications and, in the case of hysterectomy, the uterus is not preserved. In addition, multiple myomectomies may be associated with longer operating time, postoperative febrile morbidity and development of pelvic adhesions. There has been longstanding research interest in developing minimally invasive alternatives for treating uterine fibroids, including procedures that retain the uterus and allow for future childbearing. Treatment options include uterine artery embolization (UAE) (see medical policy #022 – Occlusion of Uterine Arteries using Transcatheter Embolization or Laparoscopic Occlusion to Treat Uterine Fibroids) and magnetic resonance imaging guided focused ultrasound therapy (see medical policy #178 – Magnetic Resonance Guided Focused Ultrasound).

Various techniques to induce myolysis have also been studied including Nd:YAG lasers, bipolar electrodes, cryomyolysis and radiofrequency ablation. With these techniques, an energy source is used to create areas of necrosis within uterine fibroids, reducing their volume and thus relieving symptoms. Early methods involved the insertion of probes multiple times into the fibroid and were performed without imaging guidance. There were concerns about serosal injury and abdominopelvic adhesions with these techniques, possibly due to the multiple passes through the serosa needed to treat a single fibroid. Newer systems using radiofrequency energy do not require multiple repetitive insertions of needle electrodes. Ultrasonography is used laparoscopically or transcervically to determine the size and location of fibroids, to guide the probe, and to ensure the probe is in the correct location so that optimal energy is applied to the fibroid. Percutaneous approaches using MRI guidance have also been reported.

KEY POINTS:

The most recent literature review was updated through December 20. 2023.

Summary of Evidence

For individuals who have symptomatic uterine fibroids who receive RFA, the evidence includes prospective cohorts, randomized controlled trials (RCT) and systematic reviews. The relevant outcomes are symptoms, QOL, and treatment-related morbidity. The meta-analysis found low rates of reintervention with RFA and QOL outcomes that were similar to uterine artery embolization and myomectomy at 12 months. Data on reintervention rates at 36 months were limited to 1 RCT and 1 cohort study with high loss to follow-up. No studies reported reintervention rates at 60 months. Two RCTs found that RFA was noninferior and one RCT found that RFA was superior to laparoscopic myomectomy on the trial’s primary outcome: length of hospitalization. A number of secondary outcomes were reported at 12 or 24 months in 2 RCTs, including symptoms and quality of life. One RCT found that both symptoms and quality of life were significantly better with myomectomy compared with RFA at 12 months. The procedure has a faster recovery than myomectomy, and provides a reduction in symptoms and improvement in QOL in the short term. Additionally, clinical input was sought in 2021. The consensus was supportive of the use of laparoscopic or transcervical RFA for individuals with symptomatic uterine fibroids. These technologies provide a clinically meaningful improvement in the net health outcome and is consistent with generally accepted medical practice. 

For individuals who have symptomatic uterine fibroids who receive laser or bipolar needles, the evidence includes case series. The relevant outcomes are symptoms, QOL, and treatment-related morbidity. The case series were published in the 1990s and the procedures utilized may not reflect current practice. RCTs comparing laser or bipolar needles to alternative treatments for uterine fibroids are needed to evaluate the safety and efficacy of this technology adequately. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have uterine fibroids who receive cryomyolysis, the evidence includes case series. The relevant outcomes are symptoms, QOL, and treatment-related morbidity.

Among the few case series, sample sizes were small (≤20 patients). RCTs comparing cryomyolysis with alternative treatments for uterine fibroids are needed to evaluate the safety and efficacy of this technology adequately. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

For individuals who have symptomatic uterine fibroids who receive MRI-guided laser ablation, the evidence includes a study with historical controls. The relevant outcomes are symptoms, QOL, and treatment-related morbidity. A single study with historical controls is not sufficiently robust to evaluate the technology. RCTs comparing MRI-guided laser ablation to alternative treatments for uterine fibroids are needed to adequately evaluate the safety and efficacy of this technology. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

Practice Guidelines and Position Statements

American College of Obstetricians and Gynecologists

In 2021, the American College of Obstetricians and Gynecologists updated their practice bulletin on the management of symptomatic leiomyomas. Recommendations based on a review of evidence included the following:

  • Radiofrequency ablation can be considered as a minimally invasive treatment option in patients who desire to retain their uterus, provided they are counseled about the limited data on reproductive outcomes. Laparoscopic, transvaginal, or transcervical approaches using ultrasound guidance are considered similarly effective.
  • Focused ultrasound is associated with a reduction in leiomyoma and uterine size, but is associated with less improvement in symptoms and quality of life and a higher risk of reintervention compared with uterine artery embolization.
  • Myomectomy was recommended as an option in patients who desire uterine preservation or future pregnancy and are counseled about the risk of recurrence. The laparoscopic approach is associated with shorter hospitalization, less postoperative pain, faster return to work, and earlier return to normal activities.
  • Hysterectomy is recommended as a definitive surgical manage option in patients who do not desire future childbearing or do not wish to retain their uterus.

National Institute for Health and Care Excellence

In 2021, the National Institute for Health and Care Excellence (NICE) published an interventional procedures guidance on the use of transcervical ultrasound-guided radiofrequency ablation (RFA) for symptomatic uterine fibroids.  The NICE guidance noted that while evidence on the safety of transcervical RFA raises no major safety concerns, evidence on the efficacy of the procedure is limited in quality. Therefore, NICE recommends that the procedure should only be used with special arrangements for clinical governance, consent, and audit or research.

U.S. Preventive Services Task Force

Not applicable

KEY WORDS:

Uterine fibroids, leiomyomata, hysterectomy, myomectomy, myolysis, Nd:YAG laser, bipolar electrodes, cryomyolysis, radiofrequency ablation, MRI guidance, laparoscopic procedure, percutaneous procedure, ExAblate®, Acessa, Halt, cryoablation, interstitial laser photocoagulation of uterine fibroids, laser myolysis, RFA, transcervical, sonata system

APPROVED BY GOVERNING BODIES:

In 2012, the Acessa™ System (Acessa Health, formerly Halt Medical) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for percutaneous laparoscopic coagulation and ablation of soft tissue and treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance (K121858). The technology was previously approved in 2010, at which time it was called the Halt 2000GI™ Electrosurgical Radiofrequency Ablation System. In 2014, the ultrasound guidance system received marketing clearance from the FDA (K132744). FDA product code: GEI. In 2018, the third-generation Acessa™ ProVu System® was cleared for marketing by the FDA through the 510(k) process for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. (K181124). Hologic acquired Accessa Health in 2020. 

In 2018, the Sonata® Sonography-Guided Transcervical Ablation System (Gynesonics, Inc, Redwood City, CA) was cleared for marketing by the FDA through the 510(k) process for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids (K173703). The Sonata System 2.1 received marketing clearance in 2020 (K193516) and the Sonata System 2.2received marketing clearance in 2021 (K211535). The Sonata system was previously known as Vizablate.

Cryoablation is a surgical procedure that uses previously approved and available cryoablation systems; and as a surgical procedure, it is not subject to regulation by the FDA. Other products addressed in this review (e.g., Nd:YAG lasers, bipolar electrodes) have long-standing FDA approval, and there are not products specifically approved for the treatment of uterine fibroids.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

CPT codes:

58674

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

 

The following unlisted codes might be used for other non-RFA laparoscopic, transcervical, or percutaneous techniques for myolysis of uterine fibroids.

58578

Unlisted laparoscopy procedure, uterus

58999

Unlisted procedure, female genital system (non-obstetrical)

 

For percutaneous procedures, the following code would likely be used to describe the MRI imaging component of the procedure.

77022

Magnetic resonance guidance for, and monitoring of, parenchymal tissue ablation

 

For ultrasound guidance, one of the following codes might be used:

76940

Ultrasound guidance for and monitoring of, parenchymal tissue ablation

76998

Ultrasound guidance, intraoperative

 

For transcervical fibroid ablation:

58580 Transcervical ablation of uterine fibroid(s) including intraoperative ultrasound guidance and monitoring, radiofrequency (Effective 1/1/24)

PREVIOUS CODING:

For transcervical fibroid ablation:

0404T

Transcervical uterine fibroid(s) ablation with ultrasound guidance, radiofrequency (Deleted 12/31/23)

 

REFERENCES:

  1. American College of Obstetricians and Gynecologists (ACOG). Alternatives to hysterectomy in the management of leiomyomas. ACOG practice bulletin; no. 96. Available online at: www.guideline.gov. 
  2. Arnreiter C, Oppelt P. A Systematic Review of the Treatment of Uterine Myomas Using Transcervical Ultrasound-GuidedRadiofrequency Ablation with the Sonata System. J Minim Invasive Gynecol. Apr 21 2021.
  3. Berman JM, Bolnick MD, Pemueller RR, et al. Reproductive outcomes in women following radiofrequency volumetric thermal ablation of symptomatic fibroids.  Journal of Reproductive Medicine, May-June 2015; 60(5-6): 194-198.
  4. Berman JM, Bradley L, Hawkins SM, et al. Uterine Fibroids in Black Women: A Race-Stratified Subgroup Analysis of Treatment outcomes after laparoscopic radiofrequency ablation. J Women's Health (Larchmt). Apr 2022; 31(4): 593-599.
  5. Berman JM, Guido RS, Garza Leal JG et al. Three-Year Outcome of the Halt Trial: A prospective analysis of radiofrequency volumetric thermal ablation of myomas. J Minim Invasive Gynecol. 2014 Mar 5. pii: S1553-4650(14)00194-0.
  6. Berman JM, Shashoua A, Olson C, et al. Case Series of Reproductive Outcomes after Laparoscopic Radiofrequency Ablationof Symptomatic Myomas. J Minim Invasive Gynecol. Mar 2020; 27(3): 639-645.
  7. Bongers M, Gupta J, Garza-Leal JG, et al. The integrity trial: Preservation of uterine wall integrity 12 months after transcervical fibroid ablation with the sonata system. J Gynecol Surg. 2019 Oct 1;35(5):299-303.
  8. Bradley LD, Pasic RP, Miller LE. Clinical Performance of Radiofrequency Ablation for Treatment of Uterine Fibroids: Systematic Review and Meta-Analysis of Prospective Studies. J Laparoendosc Adv Surg Tech A. Dec 2019; 29(12): 1507-1517.
  9. Brolmann H, Bongers M, Garza-Leal JG, et al. The FAST-EU trial: 12-month clinical outcomes of women after intrauterine sonography-guided transcervical radiofrequency ablation of uterine fibroids. Gynecol Surg. NA 2016; 13: 27-35.
  10. Brucker SY, Hahn M, Kraemer D et al. Laparoscopic radiofrequency volumetric thermal ablation of fibroids versus laparoscopic myomectomy. Int J Gynaecol Obstet. 2014 Jun; 125(3):261-5.
  11. Christoffel L, Bends R, Toub D, et al. Pregnancy Outcomes After Transcervical Radiofrequency Ablation of Uterine Fibroids with theSonata System. J Gynecol Surg. Jun 01 2022; 38(3): 207-213.
  12. Christoffel L, Romer T, Schiermeier S. Transcervical radiofrequency ablation of uterine fibroids global registry (SAGE):Study protocol and preliminary results. Med Devices (Auckl). 2021; 14: 77-84.
  13. Chudnoff S, Guido R, Roy K, et al. Ultrasound-guided transcervical ablation of uterine leiomyomas. Obstet Gynecol. 2019 Jan;133(1):13-22.
  14. Davis MR, Soliman AM, Castelli-Haley J, et al. Reintervention rates after myomectomy, endometrial ablation, and uterine artery embolization for patients with uterine fbeibroids. J Womens Health (Larchmt). Oct 2018; 27(10): 1204-1214.
  15. Donnez J, et al.  Laparoscopic myolysis. Human Reproduction Update 2000; 6(6): 609-613.
  16. Food and Drug Administration. Sonata System FDA clearance. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/K173703.pdf.
  17. Galen DI, Pemueller RR, Leal JG et al. Laparoscopic radiofrequency fibroid ablation: phase II and phase III results. JSLS 2014, 18:182-192.
  18. Garza-Leal JG. Long term clinical outcomes of transcervical radiofrequency ablation of uterine fibroids: the vitality study. J Gynecol Surg. 2019 Feb1;35(1):19-23.
  19. Goldfarb HA.  Bipolar laparoscopic needles for myoma coagulation, Journal of the American Association of Gynecologic Laparoscopists, February 1995; 2(2): 175-179.
  20. Goldfarb HA.  Myoma coagulation (myolysis), Obstetrics and Gynecology Clinics, June 2000, Vol. 27, No. 2.
  21. Goldfarb HA.  Nd:YAG laser laparoscopic coagulation of symptomatic myomas, Journal of Reproductive Medicine, July 1992; 37(7): 636-638.
  22. Grube, MM, Neis, FF, Brucker, SS. Uterine Fibroids - Current Trends and Strategies. Surg Technol Int, 2019 Mar 20;34:257-263.
  23. Hahn M, Brucker S, Kraemer D et al.  Radiofrequency volumetric thermal ablation of fibroids and laparoscopic myomectomy: Long term follow up from a randomized trial. GebFra Science, 2015, 75:442-449.
  24. Havryliuk Y, Setton R, Carlow JJ, et al. Symptomatic fibroid management: Systematic review of the literature. JSLS July-Sept 2017; 21(3) e2017.00041.
  25. Hindley JT, et al.  Clinical outcomes following percutaneous magnetic resonance image guided laser ablation of symptomatic uterine fibroids, Human Reproduction 2002, Vol., 17, No. 10, pp. 2737-2741.
  26. Hudgens J, Johns DA, Lukes AS, et al. 12 month outcomes of the US patient cohort in the sonata ivotal IDE trial of transcervical ablation of uterine fibroids. Int J Womens Health. 2019 Jul5;11:387-394.
  27. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  28. Jacoby VL, Parvataneni R, Oberman E, et al. Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas: Clinical Outcomes during Early Adoption into Surgical Practice. J Minim Invasive Gynecol. May 2020; 27(4): 915-925.
  29. Jones S, O'Donovan P, Toub D. Radiofrequency ablation for treatment of symptomatic uterine fibroids. Obstet Gynecol Int 2012; 2012:194839.
  30. Keltz J, Levie M, Chudnoff S. Pregnancy outcomes after direct uterine myoma thermal ablation: review of the literature. J Minim Invasive Gynecol. May - Jun 2017; 24(4):538-545.
  31. Kramer B, Hahn M, Taran FA, et al. Interim analysis of a randomized controlled trial comparing laparoscopic radiofrequency volumetric thermal ablation of uterine fibroids with laparoscopic myomectomy. Int J Gynaecol Obstet. May 2016; 133(2):206-211.
  32. Laughlin-Tommaso SK, Jacoby VL, Myers ER. Disparities in fibroid incidence, prognosis, and management. Obstet Gynecol Clin North Am. Mar 2017; 44(1): 81-94.
  33. Lefebvre G, et al.  The management of uterine leiomyomas, Journal of Obstetrics and Gynecology Canada, May 2003; 25(5): 396-418.
  34. Lin L, Ma H, Wang J. Quality of life, adverse events, and reintervention outcomes after laparoscopic radiofrequency ablation for symptomatic uterine fibroids: A Meta-Analysis. J Minim Invasive Gynecol, 2018 Sep 27;26(3).
  35. Lukes A, Green MA. Three year results of the SONATA pivotal trial of transcervical fibroid ablation for symptomatic uterine myomata. Journal of Gynecologic Surgery. DOI: 10.1089/gyn.2020.0021.
  36. Miller CE, Osman KM. Transcervical Radiofrequency Ablation of Symptomatic Uterine Fibroids: 2-Year Results of the SONATA Pivotal Trial. J Gynecol Surg. Dec 01 2019; 35(6): 345-349.
  37. National Institute for Health and Care Excellence (NICE). Interventional procedures guidance: Transcervical ultrasound-guided radiofrequency ablation for symptomatic uterine fibroids [IPG689]. March 31, 2021; https://www.nice.org.uk/guidance/ipg689. 
  38. Nisolle M, et al.  Laparoscopic myolysis with the Nd:YAG laser, Journal of Gynecologic Surgery, July 1993; 9(2): 95-99.
  39. Olive D.  New approaches to the management of fibroids, Obstetrics and Gynecology Clinics, September 2000, Vol. 27, No. 3.
  40. Olive DL, Lindheim SR and Pritts EA.  Conservative surgical management of uterine myomas.  Obstetrics and Gynecology Clinics, March 2006, vol. 33, No. 1.
  41. Phillips DR, Nathanson HG, Milim SJ et al. Laparoscopic Leiomyoma Coagulation. J Am Assoc Gynecol Laparosc 1996; 3(4, Supplement):S39.
  42. Polin M, Hur HC. Radiofrequency Ablation of Uterine Myomas and Pregnancy Outcomes: An Updated Review of the Literature. J MinimInvasive Gynecol. Jun 2022; 29(6): 709-715.
  43. Rattray DD, Weins L, Regush LC, et al. Clinical outcomes and health care utilization pre- and post-laparoscopic radiofrequencyablation of symptomatic fibroids and laparoscopic myomectomy: a randomized trial of uterine-sparing techniques (TRUST) inCanada. Clinicoecon Outcomes Res. 2018; 10: 201-212.
  44. Robles R, Aguirre VA, Argueta AL, Guerrero MR.  Confirmation of results of an earlier study assessing the safety and efficacy of a laparoscopic RF volumetric thermal ablation system.  Intl J of Gynecol and Obstetrics 2013; Vol. 120, No. 1:65-69.
  45. Sandberg EM, Tummers F, Cohen SL, et al. Reintervention risk and quality of life outcomes after uterine-sparing interventions for fibroids: a systematic review and meta-analysis. Fertil Steril. Apr 2018;109(4):698-707 e691.
  46. Shifrin G, Engelhardt M, Gee P, et al. Transcervical fibroid ablation with the Sonata system for treatment of submucous andlarge uterine fibroids. Int J Gynaecol Obstet. Feb 05 2021.
  47. Stewart EA, Nicholson WK, Bradley L, et al. The burden of uterine fibroids for African-American women: results of a national survey. J Womens Health (Larchmt). Oct 2013; 22(10): 807-16.
  48. Stewart MR, Adelman VL, Jacoby MR. Management of Symptomatic Uterine Leiomyomas: ACOG Practice Bulletin, Number228. Obstet Gynecol. Jun 01 2021; 137(6): e100-e115.
  49. Taheri, MM, Galo, LL, Potts, CC. Nonresective treatments for uterine fibroids: a systematic review of uterine and fibroid volume reductions. Int J Hyperthermia, 2019 Jan 25;36(1).
  50. Toub DB. Anew paradigm for uterine fibroid treatment: Transcervical, intrauterine sonography-guided radiofrequency ablation of uterin efibrids with the sonata system. Curr Obstet Gynecol Rep. 2017;6(1):67-73.
  51. Vilos GA, Allaire C, Laberge PY, et al. The management of uterine leiomyomas. J Obstet Gynaecol Can. Feb 2015; 37(2):157-181.
  52. Yin G, Chen M, Yang S, et al. Treatment of uterine myomas by radiofrequency thermal ablation: a 10-year retrospective cohort study. Reprod Sci. May 2015; 22(5):609-614.
  53. Yu S, Bhagavath B, Shobeiri SA, et al. Clinical and Patient Reported Outcomes of Pre- and Postsurgical Treatment of SymptomaticUterine Leiomyomas: A 12-Month Follow-up Review of TRUST, a Surgical Randomized Clinical Trial Comparing LaparoscopicRadiofrequency Ablation and Myomectomy. J Minim Invasive Gynecol. Jun 2022; 29(6): 726-737.
  54. Yu S, Silverberg K, Bhagavath B, et al. Post-Market Safety of Laparoscopic Ultrasound-Guided Radiofrequency Ablation. JSLS. Oct-Dec 2020; 24(4)
  55. Zhang J, Go VA, Blanck JF, et al. A Systematic Review of Minimally Invasive Treatments for Uterine Fibroid-Related Bleeding. ReprodSci. Oct 2022; 29(10): 2786-2809.
  56. Zreik TG, et al.  Cryomyolysis, a new procedure for the conservative treatment of uterine fibroids, Journal of the American Association of Gynecologic Laparoscopists, February 1998; 5(1): 33-38.
  57. Zupi E, Marconi D, Sbracia M et al. Directed laparoscopic cryomyolysis for symptomatic leiomyomata: one-year follow up. J Minim Invasive Gynecol 2005; 12(4):343-6.
  58. Zupi E, Piredda A, Marconi D, et al.  Directed laparoscopic cryomyolysis:  A possible alternative to myomectomy and/or hysterectomy for symptomatic leiomyomas, American Journal of Obstetrics and Gynecology 2004, Vol. 190, pp. 639-643.

POLICY HISTORY:

Medical Policy Group, October 2004 (4)

Medical Policy Administration Committee, October 2004

Available for comment November 24, 2004-January 7, 2005

Medical Policy Group, October 2006 (1)

Medical Policy Group, October 2008 (1)

Medical Policy Group, October 2010 (1): No coverage statement change 

Medical Policy Group, September 2012 (3): Active Policy but no longer scheduled for regular literature reviews and updates.

Medical Policy Panel, July 2013

Medical Policy Group, September 2013 (1): Policy placed back on schedule for regular review; updated Descriptions, Key Points, Governing Bodies, Coding (addition of new code 0336T effective 01/01/2014) and References; no change to policy statement

Medical Policy Group, April 2014 (1): Added on missing Reference (Bruckner et al). No other updates or changes.

Medical Policy Panel, July 2014

Medical Policy Group, July 2014 (1): Update to Key Points, Key Words and References; no change to policy statement

Medical Policy Panel, July 2015

Medical Policy Group, July 2015 (4): Updates to Key Points and References.  No change to policy statement.

Medical Policy Panel, August 2016

Medical Policy Group, August 2016 (4): Updates to Key Points, Key Words and References.  No change to policy statement.

Medical Policy Group, December 2016: 2017 Annual Coding Update.  Created Previous Coding section and moved deleted code 0336T to this section.  Added new cpt code 58674 to Current Coding Section.

Medical Policy Panel, August 2017

Medical Policy Group, August 2017 (4): Updates to Key Points, Approved by Governing Bodies and References.  No change to policy statement.

Medical Policy Panel, August 2018

Medical Policy Group, August 2018 (4): Updates to Key Points, Approved by Governing Bodies, and References.  No change to policy statement.

Medical Policy Panel, August 2019

Medical Policy Group, August 2019 (5): Updates to Description, Key Points, Approved by Governing Bodies, and References. No change to Policy Statement.

Medical Policy Group, March 2020 (4): Updates to Description, Key Points, Approved by Governing Bodies, Coding, Key Words and References.  Added “transcervical” techniques to the investigational statement. Previously on IV listing.  Added Key Words transcervical and sonata system.  Added CPT code 0404T.

Medical Policy Panel, July 2020

Medical Policy Group, August 2020 (4): Updates to Description, Key Points, Approved by Governing Bodies, and References.  No change to policy statement. Removed Previous Coding section.

Medical Policy Panel, February 2022

Medical Policy Group, February 2022 (4): Updates to Key Points, Approved by Governing Bodies, and References.  Policy statements updated to allow coverage for laparoscopic and transcervical RFA with certain criteria.  IV statement updated to remove “not medically necessary,” no change to intent for this statement.  The following references were removed: Chapman R.  New therapeutic technique for treatment of uterine leiomyomas using laser-induced interstitial thermotherapy (LITT) by a minimally invasive method, Lasers in Surgery and Medicine, Cowan B, et al.  Interventional magnetic resonance imaging cryotherapy of uterine fibroid tumors:  Preliminary observation, Horowitz I.  What’s new in gynecology and obstetrics,  Law P, et al.  Interstitial thermo-ablation under MRI guidance for the treatment of fibroids, Law P, et al.  Magnetic resonance-guided percutaneous laser ablation of uterine fibroids, Myers E, et al.  Management of uterine leiomyomata; What do we really know?; Bergamini V, Ghezzi F, Cromi A, Bellini G, et al.  Laparoscopic radiofrequency thermal ablation:  A new approach to symptomatic uterine myomas; Chudnoff SG, Berman JM, Levine DJ et al. Outpatient procedure for the treatment and relief of symptomatic uterine myomas; Guido RS, Macer J, Abbott K, Falls JL, Tilley IB, Chudnoff SG.  Prospective analysis of the 24-month outcome from the IDE trial; Garza Leal JG, Hernandez Leon I, Castillo Saenz L et al. Laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of symptomatic uterine leiomyomas: feasibility study using the Halt 2000 Ablation System; Ghezzi F, Cromi A, Bergamini V, Scarperi S, Bolis P and Franchi M.  Midterm outcome of radiofrequency thermal ablation for symptomatic uterine myomas; Kim HS, Tsai J, Jacobs MA and Kamel IR.  Percutaneous image-guided radiofrequency thermal ablation for large symptomatic uterine leiomyomata after uterine artery embolization:  A feasibility and safety study.  J Vasc Interv Radiol, January 2007; 18(1 Pt 1): 41-8.; Kolankaya A and Arici A.  Myomas and assisted reproductive technologies:  When and how to act?  Obstet Bynecol Clin North Am, March 2006; 33(1): 145-152; Visvanathan D, et al.  Interstitial laser photocoagulation for uterine myomas, American Journal of Obstetrics and Gynecology 2002, Vol. 187, No. 2, pp. 382-384.

Medical Policy Administrative Committee, February 2022

Available for Comment March 1, 2022 – April 15, 2022

Medical Policy Group, April 2022: Clarified Current coding section by adding verbiage above unlisted codes to include “other non RFA laparoscopic, transcervical, or percutaneous techniques for myolysis of uterine fibroids.”

Medical Policy Panel, February 2023

Medical Policy Group, February 2023 (4): Updates to Key Points and References.  No change to policy statements.

Medical Policy Group, November 2023: 2024 Coding Update.  Added new code 58580 to Current coding and created Previous coding section.  Removed deleted code 0404T from Current coding and added to Previous coding.  New code effective 1/1/24 and deleted code effective 12/31/23.

Medical Policy Panel, February 2024

Medical Policy Group, February 2024 (4): Updates to Key Points and References. No change to policy statements.

 

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.