mp-178
print Print Back Back

Magnetic Resonance Guided Focused Ultrasound (MRgFUS)

Policy Number: MP-178

Latest Review Date:  July 2020

Category:  Surgery                                                                 

Policy Grade: B

POLICY:

Effective for dates of service on and after November 18, 2020:

Magnetic resonance-guided high-intensity ultrasound ablation may be considered medically necessary for the treatment of medicine-refractory essential tremors.

Magnetic resonance-guided high intensity ultrasound ablation may be considered medically necessary for pain palliation in adults with metastatic bone cancer who have failed or are not candidates for radiotherapy.

Magnetic resonance imaging (MRI)-guided high-intensity ultrasound ablation is considered not medically necessary and investigational for all other situations, including but not limited to:

  • Treatment of uterine fibroids;
  • Treatment of other tumors e.g., brain cancer, prostate cancer and breast cancer

Transurethral Ultrasound Ablation of the Prostate (TULSA) is considered investigational. This includes, but is not limited to its use in the following situations:

  • Treatment of prostate cancer.
  • Treatment of benign prostatic hypertrophy (BPH)

*For coverage information regarding radiofrequency ablation of bone tumors, refer to medical policy #119- Radiofrequency Ablation of Solid Tumors Excluding Liver Tumors.

*For coverage information regarding cryosurgical ablation of bone tumors, refer to medical policy #429- Cryosurgical Ablation of Miscellaneous Solid Tumors other than Liver, Prostate, or Dermatologic Tumors.

*For coverage information regarding focal treatments of the prostate, refer to medical policy 596- Focal Treatments for Prostate Cancer.

Effective for dates of service on and after July 27, 2020 through November 17, 2020:

Magnetic resonance-guided high-intensity ultrasound ablation may be considered medically necessary for the treatment of medicine-refractory essential tremors.

Magnetic resonance-guided high intensity ultrasound ablation may be considered medically necessary for pain palliation in adults with metastatic bone cancer who have failed or are not candidates for radiotherapy.

Magnetic resonance imaging (MRI)-guided high-intensity ultrasound ablation is considered not medically necessary and investigational for all other situations, including but not limited to:

  • Treatment of uterine fibroids;
  • Treatment of other tumors e.g., brain cancer, prostate cancer and breast cancer

*For coverage information regarding radiofrequency ablation of bone tumors, refer to medical policy #119- Radiofrequency Ablation of Solid Tumors Excluding Liver Tumors.

*For coverage information regarding cryosurgical ablation of bone tumors, refer to medical policy #429- Cryosurgical Ablation of Miscellaneous Solid Tumors other than Liver, Prostate, or Dermatologic Tumors.

*For coverage information regarding focal treatments of the prostate, refer to medical policy 596- Focal Treatments for Prostate Cancer.

Effective for dates of service on and after August 17, 2018 through July 26, 2020:

Magnetic resonance-guided high-intensity ultrasound ablation may be considered medically necessary for the treatment of medicine-refractory essential tremors.

Magnetic resonance imaging (MRI)-guided high-intensity ultrasound ablation is considered not medically necessary and investigational for all other situations, including but not limited to:

  • Treatment of uterine fibroids;
  • Pain palliation for patients with metastatic bone cancer;
  • Treatment of other tumors e.g., brain cancer, prostate cancer and breast cancer

*For coverage information regarding radiofrequency ablation of bone tumors, refer to medical policy #119- Radiofrequency Ablation of Solid Tumors Excluding Liver Tumors.

*For coverage information regarding cryosurgical ablation of bone tumors, refer to medical policy #429- Cryosurgical Ablation of Miscellaneous Solid Tumors other than Liver, Prostate, or Dermatologic Tumors.

*For coverage information regarding focal treatments of the prostate, refer to medical policy 596- Focal Treatments for Prostate Cancer.

Effective for dates of service prior to August 17, 2018:

Magnetic resonance imaging (MRI)-guided high-intensity ultrasound ablation is considered not medically necessary and investigational. This includes, but is not limited to, its use in the following situations:

  • Treatment of uterine fibroids;
  • Pain palliation for patients with metastatic bone cancer;
  • Treatment of other tumors e.g., brain cancer, prostate cancer and breast cancer.

DESCRIPTION OF PROCEDURE OR SERVICE:

An integrated system providing magnetic resonance guided focused ultrasound (MRgFUS) treatment is proposed as a noninvasive therapy for uterine fibroids, pain palliation of bone metastases and medicine refractory essential tremors. MRgFUS is also being investigated for the treatment of other benign and malignant tumors.

Uterine Fibroids

Uterine fibroids are one of the most common conditions affecting women in the reproductive years. Symptoms of uterine fibroids include menorrhagia, pelvic pressure, or pain.

Treatment

Several approaches currently available to treat symptomatic uterine fibroids include: hysterectomy, abdominal myomectomy, laparoscopic and hysteroscopic myomectomy, hormone therapy, uterine artery embolization, and watchful waiting. Hysterectomy and various myomectomy procedures are considered the criterion standard treatment.

Metastatic Bone Disease

Metastatic bone disease is one of the most common causes of cancer pain.

Treatment

Existing treatments include conservative measures (e.g., massage, exercise) and pharmacologic agents (e.g., analgesics, bisphosphonates, corticosteroids). For patients who do not respond to these treatments, the standard care is to use external-beam radiotherapy. However, a substantial proportion of patients have residual pain after radiotherapy.

Essential Tremors

Essential tremor (ET) is the most common movement disorder, with an estimated prevalence of 5% worldwide. ET most often affects the hands and arms, may affect head and voice, and rarely includes the face, legs, and trunk. ET is heterogeneous among patients, varying in frequency, amplitude, causes of exacerbation, and association with other neurologic deficits.

Treatment

The neuropathology of ET is uncertain, with some evidence suggesting that ET is localized in the brainstem and cerebellum. If patients with ET experience intermittent or persistent disability due to the tremors, initial therapy is with drugs (beta-blockers or anticonvulsants). For medicine-refractory patients, surgery (deep brain stimulation or thalamotomy) may be offered, though high rates of adverse events have been observed.

Magnetic Resonance-Guided Focused Ultrasound

MRgFUS is a noninvasive treatment that combines two technologies, focused ultrasound and MRI. The ultrasound beam penetrates through the soft tissues and, using MRI for guidance and monitoring, the beam can be focused on targeted sites. The ultrasound causes a local increase in temperature in the target tissue, resulting in coagulation necrosis while sparing the surrounding normal structures. The ultrasound waves from each sonication are focused at a focal point which has a maximum focal volume of 20 nm in diameter and 15 nm in height/length. This causes a rapid rise in temperature (i.e., to approximately 65°C to 85°C), which is sufficient to achieve tissue ablation at the focal point. In addition to providing guidance, the associated MRI can provide on-line thermometric imaging that provides a temperature “map” that can further confirm the therapeutic effect of the ablation treatment and allow for real-time adjustment of the treatment parameters.

The U.S. Food and Drug Administration (FDA) have approved the ExAblate® MRgFUS system for two indications: treatment of uterine fibroids and for palliation of pain associated with tumors metastatic to bone. The ultrasound equipment is specially designed to be compatible with MR magnets and is integrated into standard clinical MRI units. It includes a patient table, which includes a cradle housing the focused ultrasound transducer in a water or light oil bath. Some models of the device have a detachable cradle; only certain cradle types can be used for palliation of pain associated with metastatic bone cancer. For treating pain associated with bone metastases, the aim of MRgFUS is to destroy nerves in the bone surface surrounding the tumor.

MRgFUS is also being investigated for treatment of other tumors, including breast, prostate, and brain tumors.

KEY POINTS:

The most recent literature search was performed through May 18, 2020.

Summary

For individuals with medicine-refractory essential tremors who receive MRgFUS, the evidence includes 2 systematic reviews that identified an RCT and several observational studies. Relevant outcomes include symptoms, functional outcomes, quality of life, and treatment-related morbidity. The assessment did not pool study results but concluded that, overall, MRgFUS decreased tremor severity and improved quality of life. The sham-controlled randomized trial found significant improvements in the treatment group in tremor severity, functional improvement, and quality of life after 3 months of follow-up. The improvements in hand tremor score, function, and quality of life were maintained at the 2-year follow-up. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals with metastatic bone cancer who have failed or are not candidates for radiotherapy who receive MRgFUS, the evidence includes a randomized trial and several case series. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related morbidity. The RCT found improvements after MRgFUS in a composite outcome comprised of a reduction in pain and morphine use, and in pain reduction as a stand-alone outcome. A substantial proportion of patients in the treatment goroup experienced  adverse events but most events were transient and not severe.  The case series reported reductions in pain following MRgFUS treatment, consistent with the RCT. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have uterine fibroids who receive MRgFUS, the evidence includes 2 small RCTs, nonrandomized comparative studies, and case series. Relevant outcomes are symptoms, quality of life, resource utilization, and treatment-related morbidity. One RCT (N=20) has reported some health outcomes, but its primary purpose was to determine the feasibility of a larger trial. It did not find statistically significant differences in quality of life outcomes between active and sham treatment groups, but it did find lower fibroid volumes after active treatment. This trial did not have an active comparator, the clinical significance of the primary outcome was unclear, and there were no follow-up data beyond 1 year. The second RCT (N=49) is ongoing; preliminary results at 6 weeks posttreatment, comparing MRgFUS with uterine artery embolization have shown that the 2 groups are comparable in medication use and symptom improvement following treatments. Patients in the MRgFUS group reported recovering significantly faster than patients in the uterine artery embolization group, as measured by time to return to work and time to normal activities. In a separate 2013 comparative study, outcomes appeared to be better with uterine artery embolization than with MRgFUS. Long-term data on the treatment effects, recurrence rates, and impact on future fertility and pregnancy are lacking. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with other tumors (e.g., breast cancer, brain cancer, prostate cancer, desmoid, nonspinal osteoid osteoma) who receive MRgFUS, the evidence includes small case series. Relevant outcomes are symptoms, health status measures, and treatment-related morbidity. The evidence is insufficient to determine the effects of the technology on health outcomes.

PRACTICE GUIDELINES AND POSITION STATEMENTS

American Society for Radiation Oncology

The American Society for Radiation Oncology (2017) published guidelines on palliative radiotherapy for bone metastases, which stated that external-beam radiotherapy continues to be the primary therapy for treating painful uncomplicated bone metastases. The guidelines did not mention magnetic resonance-guided focused ultrasound. If patients experience persistent or recurrent pain more than 1 month after initial treatment, the guidelines recommended retreatment with external-beam radiotherapy. As for advanced radiotherapy such as stereotactic body radiotherapy for retreatment of recurrent pain in spine bone lesions, these “may be feasible, effective, and safe, but the panel recommends that this approach should be limited to clinical trial participation or on a registry given limited data supporting routine use.”

National Comprehensive Cancer Network

Guidelines from the National Comprehensive Cancer Network on bone cancer (v.1.2020), breast cancer (v.4.2020), brain cancer (v.2.2020), and prostate cancer (v.1.2020) do not mention MRgFUS as a treatment option.

U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS

Not applicable.

KEY WORDS:

Fibroids, ultrasound ablation, MRI-guidance, ultrasound ablation of uterine fibroids, ExAblate 2000, high intensity ultrasound ablation; uterine, leiomyoma; uterine; high intensity ultrasound ablation (HIFU), ExAblate, ultrasound ablation of breast tumors, ultrasound ablation of brain tumors, ultrasound ablation of prostate cancer, ultrasound ablation of bone metastasis, trans rectal high intensity focused ultrasound for prostate cancer, Ablatherm®, Sonablate 500®; MRgFUS, essential tremors, TULSA, TULSA-PRO, Transurethral Ultrasound Ablation of the Prostate

APPROVED BY GOVERNING BODIES:

In October 2004, the U.S. Food and Drug Administration (FDA) approved via the premarket application (PMA) process, the ExAblate® 2000 System (Insightec, Inc., Haifa, Israel) for “ablation of uterine fibroid tissue in pre- or perimenopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure.” Treatment is indicated for women with a uterine gestational size of less than 24 weeks who have completed childbearing.

In October 2012, the FDA approved the ExAblate® System, Model 2000/2100/2100 VI via the PMA process. The intended use of the device is for pain palliation in adult patients with metastatic bone cancer who failed or are not candidates for radiation therapy. The device was evaluated through an expedited review process. The FDA required a post-approval study with 70 patients to evaluate the effectiveness of the system under actual clinical conditions.

In July 2016, FDA approved the use of the ExAblate® Neuro System for the treatment of essential tremors in patients who have not responded to medication (beta blockers or anticonvulsant drugs) through the premarket approval process.

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: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING: 

CPT codes:

0398T

Magnetic resonance image guided high intensity focused ultrasound (MRgFUS), stereotactic ablation lesion, intracranial for movement disorder including stereotactic navigation and frame placement when performed

0071T

Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total leiomyomata volume of less than 200 cc of tissue

0072T

Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total leiomyomata volume greater or equal to 200 cc of tissue

20999 Unlisted procedure, musculoskeletal system, general
55880 Ablation of malignant prostate tissue (Effective 01/01/2021)

 

There is no specific code for MRgFUS in reference to bone cancer.  This code may come in on unlisted code 20999 along with the appropriate radiology guidance code.

These CPT codes should not be used in conjunction with 51702 (insertion of temporary indwelling bladder catheter, simple) or 77022 (magnetic resonance imaging guidance for, and monitoring of, visceral tissue ablation).  Prior to the introduction of the above codes, the procedure may have been coded for using several codes describing the individual components of the procedure. CPT codes 0071T-0072T describe the comprehensive service.

REFERENCES:

  1. Alongi F, Russo G, Spinelli A et al. Can magnetic resonance image-guided focused ultrasound replace local oncology treatments? A review. Tumori 2011; 97(3):259-64.
  2. Arrigoni F, Barile A, Zugaro L, et al. Intra-articular benign bone lesions treated with magnetic resonance-guided focused ultrasound (MRgFUS): imaging follow-up and clinical results. Med Oncol. Apr 2017; 34(4):55.
  3. Avedian RS, Bitton R, Gold G, et al. Is MR-guided high-intensity focused ultrasound a feasible treatment modality for desmoid tumors? Clin Orthop Relat Res. Mar 2016; 474(3):697-704.
  4. Barnard EP, AbdElmagied AM, Vaughan LE, et al. Periprocedural outcomes comparing fibroid embolization and focused ultrasound: a randomized controlled trial and comprehensive cohort analysis. Am J Obstet Gynecol. May 2017; 216(5):500 e501-500 e511.
  5. Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Magnetic resonance-guided focused ultrasound therapy for symptomatic uterine fibroids. TEC Assessments 2005; Volume 20, Tab 10.
  6. Bucknor MD, Rieke V. MRgFUS for desmoid tumors within the thigh: early clinical experiences. J Ther Ultrasound. 2017; 5:4.
  7. Carranza-Mamane B, Havelock J, Hemmings R, et al. The management of uterine fibroids in women with otherwise unexplained infertility. J Obstet Gynaecol Can. Mar 2015; 37(3):277-288.
  8. Chang JW, Park CK, Lipsman N, et al. A prospective trial of magnetic resonance-guided focused ultrasound thalamotomy for essential tremor: Results at the 2-year follow-up. Ann Neurol. Jan 2018; 83(1):107-114.
  9. Chen R, Keserci B, Bi H, et al. The safety and effectiveness of volumetric magnetic resonance-guided high-intensity focused ultrasound treatment of symptomatic uterine fibroids: early clinical experience in China. J Ther Ultrasound. 2016; 4:27.
  10. Diederich CJ, Nan WH, Ross AB, et al.  Catheter-based ultrasound applications for selective thermal ablation:  Progress towards MRI-guided applications in prostate.  Int J Hyperthermia 2004; 20: 739-756.
  11. Elias WJ, Lipsman N, Ondo WG, et al. A randomized trial of focused ultrasound thalamotomy for essential tremor. N Engl J Med. Aug 25 2016; 375(8):730-739.
  12. Food and Drug Administration (FDA). Summary of safety and effectiveness data: PMA number: P110039. 2012. Available online at: www.accessdata.fda.gov/cdrh_docs/pdf11/p110039b.pdf. Last accessed January, 2014.
  13. Fennessy FM, et al.  Uterine leiomyomas:  MR imaging-guided focused ultrasound surgery-results of different treatment protocols.  Radiology, June 2007; 243(3): 885-893.
  14. Froeling V, Meckelburg K, Schreiter NF et al. Outcome of uterine artery embolization versus MR-guided high-intensity focused ultrasound treatment for uterine fibroids: long-term results. Eur J Radiol 2013; 82(12):2265-9.
  15. Funaki K, Fukunishi H, Sawada K. Clinical outcomes of magnetic resonance-guided focused ultrasound surgery for uterine myomas: 24-month follow-up. Ultrasound Obstet Gynecol 2009; 34(5): 584-9.
  16. Geiger D, Napoli A, Conchiglia A, et al. MR-guided focused ultrasound (MRgFUS) ablation for the treatment of nonspinal osteoid osteoma: a prospective multicenter evaluation. J Bone Joint Surg Am. May 7 2014; 96(9):743-751.
  17. Gelet A, Chapelon JY, Bouvier R, et al.  Local control of prostate cancer by transrectal high intensity focused ultrasound therapy: Preliminary results, J Urol 1999; 161: 156-62.
  18. Ghanouni P, Dobrotwir A, Bazzocchi A, et al. Magnetic resonance-guided focused ultrasound treatment of extra-abdominal desmoid tumors: a retrospective multicenter study. Eur Radiol. Feb 2017; 27(2):732-740.
  19. Gianfelice D, Gupta C, Kucharczyk W et al. Palliative treatment of painful bone metastases with MR imaging-guided focused ultrasound. Radiology 2008; 249(1):355-63.
  20. Gianfelice D, Khiat A, Amara M et al. MR imaging-guided focused US ablation of breast cancer: histopathologic assessment of effectiveness – initial experience. Radiology 2003; 227(3):849-55.
  21. Gianfelice D, Khiat A, Amara M et al. MR imaging-guided focused ultrasound surgery of breast cancer: correlation of dynamic contrast-enhanced MRI with histopathologic findings. Breast Cancer Res Treat 2003; 82(2):93-101.
  22. Gianfelice D, Khiat A, Boulanger Y et al. Feasibility of magnetic resonance imaging-guided focused ultrasound surgery as an adjunct to tamoxifen therapy in high-risk surgical patients with breast carcinoma. J Vasc Interv Radiol 2003; 14(10):1275-82.
  23. Gizzo S, Saccardi C, Patrelli TS et al. Magnetic Resonance-Guided Focused Ultrasound Myomectomy: Safety, Efficacy, Subsequent Fertility and Quality-of-Life Improvements, A Systematic Review. Reprod Sci 2013.
  24. Gorny KR, Woodrum DA, Brown DL et al. Magnetic resonance-guided focused ultrasound of uterine leiomyomas: review of a 12-month outcome of 130 clinical patients. J Vasc Interv Radiol 2011; 22(6):857-64.
  25. Health Quality Ontario (HQO). Magnetic Resonance-Guided Focused Ultrasound Neurosurgery for Essential Tremor: A Health Technology Assessment. Ont Health Technol Assess Ser. May 2018; 18(4):1-141.
  26. Hindley J, Gedroyc WM, Regan L et al. MRI guidance of focused ultrasound therapy of uterine fibroids: early results. AJR Am J Roentgenol 2004; 183(6):1713-9.
  27. Huber PE, Jenne JW, Rastert R et al. A new noninvasive approach in breast cancer therapy using magnetic resonance imaging-guided focused ultrasound surgery. Cancer Res 2001; 61(23):8441-7.
  28. Hurwitz MD, Ghanouni P, Kanaev SV, et al. Magnetic resonance-guided focused ultrasound for patients with painful bone metastases: phase III trial results. J Natl Cancer Inst. May 2014; 106(5).
  29. Hynynen K, Pomeroy O, Smith DN, et al.  MRI imaging-guided focused ultrasound surgery of fibroadenomas in the breast:  A feasibility study, Radiology 2001; 219: 176-85.
  30. Jaaskelainen J. Non-invasive transcranial high intensity focused ultrasound (HIFUS) under MRI thermometry and guidance in the treatment of brain lesions. Acta Neurochir Suppl 2003; 88: 57-60.
  31. Jacoby VL, Kohi MP, Poder L, et al. The PROMISe trial: a pilot, randomized, placebo-controlled trial of magnetic resonance guided focused ultrasound for uterine fibroids. Fertil Steril. Nov 30 2015.
  32. Jolesz FA. MRI-guided focused ultrasound surgery. Annu Rev Med 2009; 60: 417-30.
  33. Kim HS, Baik JH, Pham LD et al. MR-guided high-intensity focused ultrasound treatment for symptomatic uterine leiomyomata: long-term outcomes. Acad Radiol 2011; 18(8):970-6.
  34. Kohrmann KU, Michel MS, Gaa J, et al.  High intensity focused ultrasound as noninvasive therapy for multilocal renal cell carcinoma:  Case study and review of the literature, J Urol 2002; 167: 2397-403.
  35. Liberman B, Gianfelice D, Inbar Y et al. Pain palliation in patients with bone metastases using MR-guided focused ultrasound surgery: a multicenter study. Ann Surg Oncol 2009; 16(1):140-6.
  36. Lutz S, Berk L, Chang E, et al. Palliative radiotherapy for bone metastases: an ASTRO evidence-based guideline. Int J Radiat Oncol Biol Phys. Mar 15 2011; 79(4):965-976.
  37. McDannold N, Clement GT, Black P et al. Transcranial magnetic imaging-guided focused ultrasound surgery of brain tumors: initial findings in 3 patients. Neurosurgery 2010; 66(2):323-32.
  38. Merckel LG, Knuttel FM, Deckers R, et al. First clinical experience with a dedicated MRI-guided high-intensity focused ultrasound system for breast cancer ablation. Eur Radiol. Nov 2016; 26(11):4037-4046.
  39. Mohammed N, Patra D, Nanda A. A meta-analysis of outcomes and complications of magnetic resonance-guided focused ultrasound in the treatment of essential tremor. Neurosurg Focus. Feb 2018; 44(2):E4.
  40. Morita Y, Ito N, Hikida H et al. Non-invasive magnetic resonance imaging-guided focused ultrasound treatment for uterine fibroids - early experience. Eur J Obstet Gynecol Reprod Biol 2008; 139(2):199-203.
  41. Napoli A, Anzidei M, De Nunzio C et al. Real-time magnetic resonance-guided high-intensity focused ultrasound focal therapy for localised prostate cancer: preliminary experience. Eur Urol 2013; 63(2):395-8.
  42. Napoli A, Anzidei M, Marincola BC et al. Primary pain palliation and local tumor control in bone metastases treated with magnetic resonance-guided focused ultrasound. Invest Radiol 2013; 48(6):351-8.
  43. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf.
  44. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Bone Cancer. https://www.nccn.org/professionals/physician_gls/pdf/bone.pdf.
  45. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Central Nervous System Cancers. https://www.nccn.org/professionals/physician_gls/pdf/cns.pdf.
  46. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf.
  47. Rabinovici J, David M, Fukunishi H et al. Pregnancy outcome after magnetic resonance-guided focused ultrasound surgery (MRgFUS) for conservative treatment of uterine fibroids. Fertil Steril 2010; 93(1):199-209.
  48. Schaink A, Li C, Gajic-Veljanoski O, et al. Magnetic resonance guided focused ultrasound treatment of extra-abdominal desmoid tumors: a retrospective multicenter study. Eur Radiol. Feb 2017; 27(2): 732-740.
  49. Smart OC, Hindley JT, Regan L, et al.  Gonadotrophin-releasing hormone and magnetic-resonance-guided ultrasound surgery for uterine leiomyomata.  Obstet Gynecol 2006; 108: 49-54.
  50. Stewart EA, et al.  Sustained relief of leiomyoma symptoms by using focused ultrasound surgery.  Obstetrics and Gynecology, August 2007, Vol. 100, No. 2, Part I, pp. 279-287.
  51. Stewart EA, Gedroyc WMW, Tempany CMC, et al.  Focused ultrasound treatment of uterine fibroid tumors:  Safety and feasibility of a noninvasive thermoablative technique, Am J Obstet Gynecol 2003; 189: 48-54.
  52. Stewart EA, Rabinovici J, Tempany CM, et al.  Clinical outcomes of focused ultrasound surgery for the treatment of uterine fibroids.  Fertil Steril 2006; 85: 22-29.
  53. Taran FA, Tempany CM, Regan L et al. Magnetic resonance-guided focused ultrasound (MRgFUS) compared with abdominal hysterectomy for treatment of uterine leiomyomas. Ultrasound Obstet Gynecol 2009; 34(5):572-8.
  54. Viswanathan M, Hartmann K, McKoy N, et al.  Management of uterine fibroids:  An update of the evidence.  Evidence Report/Technology Assessment No. 154 (Prepared by RTI International-University of North Carolina Evidence-based Practice Center under Contract No. 290-02-0016.  AHRQ Publication No. 07-E011.  Rockville, MD: Agency for Healthcare Research and Quality, July 2007.  www.ahrq.gov/downloads/pub/evidence/pdf/uterupdate/uterup.pdf.
  55. Zippel DB, Papa MZ. The use of MR imaging guided focused ultrasound in breast cancer patients; a preliminary phase one study and review. Breast Cancer 2005; 12(1):32-8.

POLICY HISTORY:

Medical Policy Group, June 2004 (3)

Medical Policy Administration Committee, July 2004

Available for comment September 7-October 21, 2004

Medical Policy Group, June 2005 (2)

Medical Policy Group, June 2006 (1)

Medical Policy Group, August 2006 (2)

Medical Policy Administration Committee, August 2006

Available for comment August 30-October 13, 2006

Medical Policy Group, August 2007 (1)

Medical Policy Group, October 2007 (3)

Medical Policy Group, May 2009 (1)

MPRM Update, February 2010

Medical Policy Group, February 2010 (2)

Medical Policy Administration Committee, February 2010

Available for comment February 23-April 8, 2010

Medical Policy Group, March 2011; Reference added to Policy section

Medical Policy Administration Committee, Marcy 2011

Available for comment April 4 – May 18, 2011

Medical Policy Group March 2012 (2): 2012 Update: Key Points & References

Medical Policy Panel February 2013

Medical Policy Group, May 2013 (4): Update to Title (removed for the treatment of Uterine Fibroids and Other Tumors), Description, changed Policy verbiage, Key Points, Approved governing bodies and references.

Medical Policy Administration Committee May 2013

Available for comment May 22 through July 5, 2013

Medical Policy Panel, February 2014

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

Medical Policy Panel, February 2015

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

Medical Policy Group (4): Added statement under policy section to refer to MP# 596 for Focal Treatments for Prostate Cancer.

Medical Policy Group, November 2015: 2016 Annual Coding Update.  Added CPT code 0398T to current coding.

Medical Policy Panel, February 2016

Medical Policy Group, February 2016 (4): Updates to Description, Key Points, and References. No change to policy statement. Title change to take out “Imaging”.

Medical Policy Panel, July 2017

Medical Policy Group, July 2017 (4): Updates to Description, Key Points, Coding and References. Removed CPT code 0398T from Current Coding. Code was added in error.

Medical Policy Panel, July 2018

Medical Policy Group, August 2018 (4): Updates to Description, Policy, Key Points, Key Words, Coding, and References.  Added 0398T to Current Coding for essential tremors.  Added Key Word essential tremors.  Updated policy section to include coverage for medicine refractory essential tremors. Available for comment August 18 through October 1, 2018

Medical Policy Panel, July 2019

Medical Policy Group, July 2019 (4): Updates to Key Points and Policy statements.  Added coverage for patients with metastatic bone cancer in those who have failed or are not candidates for radiotherapy. Added CPT code 20999

Medical Policy Administrative Committee: August 2020

Available for Comment: July 28, 2020 through September 10, 2020.

Medical Policy Group, November 2020 (5): 2021 Annual Coding Update. Added CPT code 55880 to the Current Coding section. 

Medical Policy Group, November 2020 (5): Updated Key Words, and Policy Statement to include: Transurethral Ultrasound Ablation of the Prostate (TULSA) is considered investigational. This includes, but is not limited to its use in the following situations: Treatment of prostate cancer and Treatment of benign prostatic hypertrophy (BPH). Available for Comment: November 18, 2020 through January 02, 2021.

 

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.