MEDICAL POLICY

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DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
CODING
APPENDIX
HISTORY

Magnetic Resonance Imaging‒Guided Focused Ultrasound

Number 7.01.109

Effective Date April 14, 2015

Revision Date(s) 04/14/15; 04/14/14; 04/08/13; 04/10/12; 05/10/11; 04/13/10; 03/10/09; 04/08/08; 03/13/07; 09/12/06; 08/09/05; 09/14/04

Replaces N/A

Policy

Magnetic resonance imaging (MRI) ‒ guided high-intensity ultrasound ablation may be considered medically necessary for pain palliation in adult patients with metastatic bone cancer who failed or are not candidates for radiotherapy.

MRI-guided high-intensity ultrasound ablation is considered investigational in 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.

Related Policies

7.01.548

Hysterectomy Surgery

Policy Guidelines

Coding

CPT

0071T

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

0072T

As above, but with total leiomyomata volume greater or equal to 200 cc of tissue

The CPT codes above 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).

The procedure may be performed in an MRI suite with an open MRI scanner, which may not be available at many institutions. The procedure is performed in an outpatient setting, with the patient under conscious sedation.

There are no specific CPT codes for the use of MRI-guided high-intensity ultrasound ablation in metastatic bone cancer. An unlisted code would be used based on the anatomic location of the metastasis being treated (e.g., 23929 for the clavicle) or perhaps one of the radiation oncology unlisted codes (e.g., 77299 or 77499).

Description

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

Background

MRgFUS is a noninvasive treatment that combines two technologies, focused ultrasound (US) and magnetic resonance imaging (MRI). The US beam penetrates through the soft tissues and, using MRI for guidance and monitoring, the beam can be focused on targeted sites. The US causes a local increase in temperature in the target tissue, resulting in coagulation necrosis while sparing the surrounding normal structures. The US waves from each sonication are focused at a focal point that 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-85°C), which is sufficient to achieve tissue ablation at the focal point. In addition to providing guidance, the associated MRI can provide online 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) has approved the ExAblate® MRgFUS system (InSightec Inc., Haifa, Israel) for two indications; treatment of uterine fibroids (leiomyomata) and palliation of pain associated with tumors metastatic to bone. The US 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 US 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.

As noted, FDA has approved an MRgFUS for treatment of uterine fibroids, which is one of the most common conditions affecting women in the reproductive years. Symptoms of uterine fibroids include menorrhagia, pelvic pressure, or pain. There are several approaches that are currently available to treat symptomatic uterine fibroids: 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.

Regarding treating pain associated with bone metastases, the other FDA approved indication, the aim of MRgFUS treatment is to destroy nerves in the bone surface surrounding the tumor. Metastatic bone disease is one of the most common causes of cancer pain. Existing treatments include conservative measures (e.g., massage, exercise) and pharmacologic agents (e.g., analgesics, bisphosphonates, corticosteroids). For patients who fail the above treatments, standard care is use of external beam radiotherapy. However, a substantial proportion of patients have residual pain after radiotherapy, and there is a need for alternative treatments for these patients. (One option, radiofrequency ablation, is addressed in a Related Policy).

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

Regulatory Status

In October 2004, the ExAblate® 2000 System (Insightec Inc., Haifa, Israel) was FDA approved via the premarket approval process 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, 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 radiotherapy. The device was evaluated through an expedited review process. FDA required a post-approval study with 70 patients to evaluate the effectiveness of the system under actual clinical conditions.

FDA product code: NRZ.

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

Benefit Application

Magnetic resonance imaging (MRI)-guided high-intensity ultrasound ablation of uterine fibroids is currently performed at a limited number of institutions; therefore, out of network referral may be requested.

Rationale

This policy was originally created in July 2004. A June 2005 TEC Assessment on magnetic resonance imagingguided focused ultrasound (MRgFUS) for symptomatic uterine leiomyomata found insufficient evidence of efficacy compared with conventional therapies. (1) The policy was updated regularly with searches of the MEDLINE database. The most recent review was through January 6, 2015. Following is a summary of the literature to date.

Assessment of efficacy for therapeutic interventions such as MRgFUS involves a determination of whether the intervention improves health outcomes. The optimal study design for a therapeutic intervention is a randomized controlled trial (RCT) that includes clinically relevant measures of health outcomes. The technology should be compared with the best alternative treatment when available, as is the case of MRgFUS for treating uterine fibroids. In the case of subjective outcomes such as pain or quality of life (QOL), a sham comparison is also appropriate. Nonrandomized comparative studies and uncontrolled studies can sometimes provide useful information on health outcomes but are prone to biases such as selection bias (e.g., noncomparability of treatment groups) and observational bias (e.g., the placebo effect).

Uterine Fibroids

To date, no RCTs have been published evaluating MRgFUS for treating uterine fibroids. A systematic review, published by Gizzo et al in 2013, identified 38 uncontrolled studies with a total of 2500 patients who underwent MRgFUS for treatment of uterine fibroids. (2) All of the published studies included women older than age 18 years with symptomatic uterine fibroids, and most excluded patients who desired future pregnancies. The authors of the systematic review did not pool study findings. The review confirms the continued absence of published controlled studies on MRgFUS for uterine fibroids.

A “pivotal” study designed for U.S. Food and Drug Administration (FDA) approval of the ExAblate® 2000 device was nonrandomized and included 109 women treated with MRgFUS and 83 women treated with abdominal hysterectomy.(3,4) The primary outcome was change in the symptom severity score (SSS) that is part of the validated Uterine Fibroid Symptom Quality of Life. Symptom severity is measured by 8 questions relevant to bulk and bleeding symptoms; it is a 0 to 100 scale, with the higher number representing greater severity of symptoms. Outcome data were initially reported for the MRgFUS group only. At 6 -month follow-up, 71% of the MRgFUS group achieved a 10-point or greater reduction in SSS, but this decreased to 51% at 12 months. It is unclear what represents a clinically meaningful change in SSS, the primary outcome measure. A threshold of greater than 10 points was selected for the analysis, but this is somewhat arbitrary and not substantiated by other research. Twenty-one percent of those treated by MRgFUS needed additional surgical treatment, and 4% underwent a repeat MRgFUS by 12 months.

In 2009, Taran et al. reported outcomes for the hysterectomy group. (5) The Taran article did not include the original primary outcome measure, SSS scores, and instead reported findings on a different QOL measure, the 36-Item Short -Form Health Survey (SF-36); also reported were safety data. A significantly higher proportion of women in the hysterectomy group (82/83 [99%]) reported at least one adverse event (AE) compared with women in the MRgFUS group (88/109 [81%]). Pain or discomfort, AEs associated with the gastrointestinal tract, dermatologic system, nervous system, and cardiovascular system, were significantly more common in the hysterectomy group. However, a similar proportion reported a serious AE, 9 of 109 (8%) in the MRgFUS group and 8 of 83 (10%) in the hysterectomy group. At 6 months, there were significantly higher scores in the hysterectomy group on 2 of 8 SF-36 subscales; scores on the remaining subscales did not differ significantly between groups. SF-36 scores were subject to a multiple comparison bias; a large number of statistical comparisons were done for secondary outcomes and p values were not adjusted.

Several other nonrandomized comparative studies have been published. In 2013, Froeling et al. reported on 121 women with symptomatic uterine fibroids who were equally eligible for treatment with MRgFUS and uterine artery embolization (UAE). (6) Forty-four (36%) women were lost to follow-up. Follow-up data at approximately 60 months were available on 77 women, 41 in the UAE group and 36 in the MRgFUS group. The primary study outcome was the rate of reintervention (eg, repeat MRgFUS, myomectomy, hysterectomy, endometrial ablation). During follow-up, 5 (12%) women in the UAE group and 24 (67%) women in the MRgFUS group experienced a reintervention (statistical comparison not reported).Healthcare QOL scores, secondary outcomes, were significantly better in the UAE group compared with the MRgFUS group at follow-up. Fennessy et al compared 2 variations on the MRgFUS procedure. (7) Patients were either treated with the original protocol (33% of fibroid volume with a maximum treatment time of 120 min, n=96) or modified protocol (50% treatment volume, 180 min maximum treatment time, and a second treatment if within a 14-day period, n=64). In the original group, the nonperfused (effectively treated) area was calculated at 17% of fibroid volume compared with 26% of fibroid volume with the modified protocol. Overall, symptom severity was reported to have decreased from a score of 62 at baseline to 33 at 12 months, with fewer patients in the modified group choosing alternative treatment (28% vs 37%, respectively). Interpretation of these results was limited by 49% loss to follow-up; 55 patients (57%) from the original treatment protocol completed follow-up. Only 21 patients (33%) from the modified protocol group were evaluable at 12-month follow-up.

A 2007 publication reported 24-month follow-up from 3 phase 3 trials and 1 postmarketing study (total of 416 patients). (8) The study found a relationship between the nonperfused volume ratio and the probability of undergoing additional leiomyoma treatment. For nonperfused volume ratios of 20% to 50%, there was a 25% probability of additional treatment. Patients with a nonperfused volume ratio of less than 20% of fibroid volume had a 40% probability of additional treatment. No shrinkage (and a trend toward growth) was seen with nonperfused volume ratios of 10% or less. Most women were found to have had limited treatments, with 57% of the patients having a nonperfused volume of 20% or less and 34% of the patients having a nonperfused volume between 30% and 70%. Fewer than 3% of women had a nonperfused volume ratio of 70% or greater. These results raise questions about the amount of nonperfusion achieved with current treatment protocols.

In addition to nonrandomized comparative studies, a number of case series have been published on MRgFUS for treating uterine fibroids. A representative case series, published in 2011, included 40 women who were treated with MRgFUS for symptomatic uterine fibroids at one center in the United States. (9) The primary study end points were change from baseline in QOL and symptom severity. (Higher scores on the QOL measure and lower scores on the symptom severity measure indicated improvement.) The mean symptom severity score in the 29 (73%) of patients who completed the three-year follow-up was 64.8 at baseline and 17.0 at 3 years; this represents a mean reduction of 47.8 points. The mean baseline QOL score was 44.1 and the mean QOL at the 3-year follow-up was 83.9, a mean increase of 39.8 points. The improvement from baseline to 3 years was statistically significant for both outcome variables. Another representative case series reported 12-month outcome data on 130 women treated with MRgFUS. (10) Eight women had additional procedures to relieve symptoms within one-year of MRgFUS treatment; 7 underwent hysterectomy and 1 underwent endometrial ablation. Data on symptom relief at 12 months were available for 70 of 130 (54%) of patients. Fifty-one of the 70 (73%) reported excellent symptom relief.

Fertility Following MRgFUS for Treatment of Uterine Fibroids

A prospective registry of pregnancies after MRgFUS had been maintained by the manufacturer of the ExAblate® device. A 2010 article reported that there were 54 known pregnancies a mean of 8 months after treatment. (11) They included 8 pregnancies from clinical trials designed for women who did not desire pregnancy, 26 pregnancies after commercial treatment, and 20 pregnancies in 17 patients from an ongoing study of MRgFUS in women trying to conceive. Twenty-two of the 54 pregnancies (42%) resulted in deliveries, 11 were ongoing beyond 20 weeks at the time the article was written. There were 14 miscarriages (26%) and 7 elective terminations (13%). Among the 22 live births, the mean birth weight of live births was 3.3 kg, and the vaginal delivery rate was 64%. The article provided initial information on the impact of MRgFUS for uterine fibroids on pregnancy; findings suggest that fertility may be maintained but that the number of cases is too small to draw definitive conclusions. Moreover, the study did not address the possible impact of MRgFUS treatment on the ability to become pregnant.

Section Summary

For the treatment of uterine fibroids, there are no RCTs and only two nonrandomized studies comparing MRgFUS with a different treatment. Limitations of the pivotal FDA study include lack of randomization, data on the comparison group were not published until 5 years after data on the treatment group, the clinical significance of the primary outcome was unclear, and there were no follow-up data beyond 1 year. In the 2013 comparative study, outcomes appeared to be better with UAE than with MRgFUS. There is insufficient evidence on the long-term treatment effects, recurrence rates, and impact on future fertility and pregnancy.

Palliative Treatment of Bone Metastases

An RCT evaluating the ExAblate MRgFUS system was published by Hurwitz et al. in 2014. (12) Previously, findings of this study, the pivotal trial leading to FDA approval of the device for treatment of painful bone metastases, were available on the FDA website. Data from the published version of the study are described here. The study included patients with at least 3 months of life expectancy who had bone metastases that were painful, despite radiotherapy treatment or who were unsuitable for or declined radiotherapy. Patients needed to rate tumor pain on a numeric rating scale (NRS) of at least 4 of a maximum score of 10. They could have up to 5 painful lesions; however, only 1 lesion was treated and it had to cause at least 2 points greater pain on the NRS than any other lesion. In addition, targeted tumors needed to be device accessible.

Study participants were randomized in a 3:1 ratio to active (n=122) or sham (n=39) MRgFUS treatment. Ten patients in the treatment group and 4 in the sham group did not receive the allocated treatment. An additional 26 patients in the treatment group and 23 in the sham group did not complete the 3-month follow-up. A much larger proportion of the placebo group dropped out; 17 of 35 who were treated (49%) decided to have rescue MRgFUS treatment after lack of response to placebo. A modified intention-to-treat analysis was used that included patients who had at least 1 MRgFUS or placebo sonication. Missing values were imputed using the last observation carried forward method.

The primary efficacy outpoint, assessed at 3 months, was a composite outcome comprised of change in baseline in worst NRS score and morphine equivalent daily dose (MEDD) intake. Patients were considered responders if their worst NRS score decreased by at least 2 points and if their MEDD intake did not increase more than 25% from baseline to 3 months. NRS score and MEDD intake separately were reported as secondary outcomes.

Seventy-two of 112 (64.3%) patients in the MRgFUS group and 7 of 35 patients (20%) in the control group were considered responders, as previously defined. The difference between groups was statistically significant (p=0.01), favoring active treatment. When the 2 measures that made up the primary end point were analyzed separately, there was a statistically significant difference between groups in change in worst NRS score and a nonsignificant difference in change from baseline in pain medication. The NRS score decreased by a mean (SD) of 3.6 (3.1) points in the MRgFUS group and a mean of 0.7 (2.4) in the placebo group (p<0.01). Change in MEDD was only reported in a figure. Fifty-one patients (45.5%) in the MRgFUS group and 1 (2.9%) in the placebo group experienced at least 1 AE. Most AEs were transient, and the most common was sonication pain, experienced by 36 patients (32.1%) in the MRgFUS group. In 17 patients (15.2%), sonication pain was severe; 3 patients did not complete treatment due to pain. The most clinically significant AEs that lasted more than a week were third-degree skin burns in 1 patient (associated with noncompliance with the treatment protocol) and fracture in 2 patients (one of which was outside the treatment location). Potential limitations of the trial include a nonconventional primary outcome measure and, the small initial size of the sham group. Moreover, a large number of sham patients (66%) did not complete the 3-month follow-up; however, the authors stated that this low completion rate was due to lack of response to placebo treatment.

In addition to the single RCT, Several manufacturer-sponsored case series on MRgFUS for pain palliation in bone metastases have been published. (13,14) For example, In 2009, Liberman et al. published findings of a multicenter prospective study conducted in Canada, Israel, and Germany. (13) The study included 31 patients with painful bone metastases who had failed or refused other treatment options; 25 patients (81%) were available for 3-month follow-up. The mean visual analog scale score decreased from 5.9 before treatment to 1.8 three months after treatment. Thirteen of 25 patients who used non-opioid analgesics and 6 of 10 who used opioids decreased medication use after treatment. Neither group reported any treatment-related AEs.

Section Summary

The evidence base consists of a single industry-sponsored RCT which found significant improvement after MRgFUS in a composite outcome comprised of reduction in pain and morphine use, and in pain reduction as a stand-alone outcome. This study was appropriately sham-controlled. A substantial proportion of patients in the treatment group experienced AEs, but most of these were nonsevere and transient.

Treatment of other Tumors

Only small case series have been published investigating the safety and/or efficacy of MRgFUS for treating other tumors, including breast cancer, (15-18) brain cancer, (19) prostate cancer, (20) and nonspinal osteoid osteoma. (21)

Ongoing and Unpublished Clinical Trials

A search of the ClinicalTrials.gov database, identified the following ongoing RCTs:

  • NCT00995878 The FIRSST Comparing MRgFUS (MR guided Focused Ultrasound) versus UAE (Uterine Artery Embolization): This is an RCT comparing MRgFUS with UAE in pre-menopausal women at least 25 years of age who have symptomatic uterine fibroids. The study is sponsored by the Mayo Clinic. Estimated enrollment is 180 patients with an estimated completion date of December 2015.
  • NCT01827904 ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors: This is a double-blind, sham-controlled RCT evaluating transcranial MRgFUS treatment in patients with a diagnosis of essential tremor who experience significant disability from the condition, despite medical treatment. The study is sponsored by Insightec. Estimated enrollment is 72 patients and the expected date of study completion is September 2015.
  • NCT01772693 ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson’s Disease: This is a feasibility trial comparing MRgFUS to sham treatment in patients with idiopathic Parkinson disease who experience significant disability from tremor associated with the condition. The study is sponsored by InSightec. Estimated enrollment is 30 patients. The stated expected date of study completion is September 2014; however, as of December 2014, patients continue to be recruited.

Summary of Evidence

There is evidence from a sham-controlled, randomized trial that magnetic resonance imaging‒guided focused ultrasound (MRgFUS) improves the net health outcome for adults with painful bone metastases who failed or are unsuitable for radiotherapy treatment. There is insufficient evidence from randomized controlled trials or other controlled studies that MRgFUS improves the net health outcome for patients with other clinical conditions. Thus, MRgFUS may be considered medically necessary for pain palliation in selected patients with metastatic bone cancer and investigational in all other situations.

Practice Guidelines and Position Statements

A search of the National Guideline Clearinghouse database in December 2014 did not identify any practice guidelines that included recommendations on MRgFUS for treating uterine fibroids.

American Society for Radiation Oncology (ASTRO)

In 2011, the ASTRO published a guideline on palliative radiotherapy for bone metastases, which stated that external beam radiotherapy continues to be the primary therapy for treating painful uncomplicated bone metastases. (22) The guideline does not mention MRgFUS and does not have specific recommendations for patients who fail or are not candidates for radiotherapy.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Medicare National Coverage

There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.

References

  1. 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.
  2. 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. Jul 18 2013. PMID 23868442
  3. 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):1713-1719.
  4. Stewart EA, Rabinovici J, Tempany CM, et al. Clinical outcomes of focused ultrasound surgery for the treatment of uterine fibroids. Fertil Steril. 2006;85(1):22-29.
  5. 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):572-578.
  6. 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. Dec 2013; 82(12):2265-2269. PMID 24075785
  7. Fennessy FM, Tempany CM, McDannold NJ, et al. Uterine leiomyomas: MR imaging-guided focused ultrasound surgery--results of different treatment protocols. Radiology. 2007; 243(3):885-893.
  8. Stewart EA, Gostout B, Rabinovici J, et al. Sustained relief of leiomyoma symptoms by using focused ultrasound surgery. Obstet Gynecol. 2007; 110(2 pt 1):279-287.
  9. 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):970-976.
  10. 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):857-864.
  11. 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. Jan 2010; 93(1):199-209. PMID 19013566
  12. 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). PMID 24760791
  13. 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):140-146.
  14. 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. Jun 2013; 48(6):351-358. PMID 23571832
  15. 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):32-38.
  16. Hynynen K, Pomeroy O, Smith DN, et al. MR imaging-guided focused ultrasound surgery of fibroadenomas in the breast: a feasibility study. Radiology. 2001; 219(1):176-184.
  17. 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):849-855.
  18. 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.
  19. 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):323-332.
  20. 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. Feb 2013; 63(2):395-398. PMID 23159454
  21. 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. PMID 24806011
  22. 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. PMID 21277118
  23. Blue Cross and Blue Shield Association (BCBSA). Magnetic Resonance Imaging‒Guided Focused Ultrasound. Medical Policy Reference Manual, Policy No. 7.01.109, 2015.

Coding

Codes

Number

Description

CPT

0071T

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

 

0072T

total leiomyomata volume greater or equal to 200 cc of tissue

 

19499

Unlisted procedure, breast

 

55899

Unlisted procedure, male genital system

 

58999

Unlisted procedure, female genital system (nonobstetrical)

ICD-9 Procedure

   

ICD-9 Diagnosis

218.0

Uterine leiomyoma, submucous leiomyoma of uterus

 

218.1

Intramural leiomyoma of uterus

 

218.2

Subserous leiomyoma of uterus

 

218.9

Leiomyoma of uterus, unspecified

ICD-10-CM
(effective 10/01/15)

D25.0-D25.9

Leiomyoma of uterus code range

ICD-10-PCS
(effective 10/01/15)

BU36ZZZ

Imaging, female reproductive system, magnetic resonance imaging (MRI), uterus, no contrast

Appendix

N/A

History

Date

Reason

09/14/04

Add to OB/GYN Section - New Policy

08/09/05

Replace Policy - Policy updated with June 2005 TEC Assessment; references added; policy statement unchanged.

06/23/06

Update Scope and Disclaimer - No other changes.

09/12/06

Replace Policy - Policy updated with literature review; title expanded to include, “and Other Tumors” reflecting indications other than uterine fibroids; “MRI-guided high intensity ultrasound ablation of other tumors…is considered investigational” added to policy statement; references added.

03/13/07

Replace Policy - Policy moved from OB/GYN to Surgery section and assigned a new number (previously BC.4.01.20).

04/08/08

Replace Policy - Policy updated with literature search; no change to the policy statement. References added.

03/10/09

Replace Policy - Policy updated with literature search; no change to the policy statement. Title updated to remove “High-intensity” and “ablation of”. References added.

04/13/10

Replace Policy - Policy updated with literature search. Policy statement updated to include palliative treatment of bone metastases added to the investigational statement regarding treatment of conditions other than uterine fibroids. References added.

05/10/11

Replace Policy - Policy updated with literature review through December 2010. Reference numbers 10, 21, 22 and 25 added; other references reordered or removed. No change to policy statements. ICD-10 codes added to policy.

04/25/12

Replace policy. Policy updated with literature review through December 2011. Reference numbers 7, 8 and 10 added; other references reordered or removed. No change to policy statements.

09/25/12

Update Coding Section – ICD-10 codes are now effective 10/01/2014.

11/20/12

Code update: CPT codes 19499, 55899 and 58999 added to the policy to support policy information and tumors.

02/15/13

Update Related Policies, add 7.01.548.

04/08/13

Replace policy. Policy updated with literature review. Policy changed to single investigational statement; no change to intent of policy. Policy title changed to MRI-Guided Focused Ultrasound (MRgFUS). References 10 and 17 added; other references renumbered or removed. CPT code 58999 corrected; it previously appeared as 55899, which is not the correct code.

05/05/14

Annual Review. Policy updated with literature review through January 6, 2014; references 2, 6, and 14 added; other references renumbered or removed. Coding update: add CPT code 55899 and remove 55999 (wrong code); update descriptor for 58999.

04/14/15

Annual Review. Policy updated with literature review through January 6, 2015. Statement added that MRgFUS may be considered medically necessary for pain palliation in adult patients with metastatic bone cancer. (Previously considered Investigational). References 12, 21-22 added; others renumbered or removed. Policy statement changed as noted.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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