Magnetic Resonance Imaging-Guided Focused Ultrasound
|Original Policy Date
|Last Review Status/Date
Reviewed with literature search/2:2015
|Return to Medical Policy Index|
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MRgFUS is a noninvasive treatment that combines 2 technologies, focused ultrasound (US) and 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 (ie, 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.
FDA has approved the ExAblate® MRgFUS system (InSightec Inc., Haifa, Israel) for 2 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 (eg, massage, exercise) and pharmacologic agents (eg, 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 related Policy No. 7.01.95).
MRgFUS is also being investigated for treatment of other tumors, including breast, prostate, and brain tumors.
In October 2004, FDA approved via the premarket application 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, 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. FDA required a postapproval study with 70 patients to evaluate the effectiveness of the system under actual clinical conditions. FDA product code: NRZ
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, eg, brain cancer, prostate cancer and breast cancer.
MRI-guided high-intensity ultrasound ablation of uterine fibroids is specifically identified by the following category III CPT codes:
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
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 specific category III CPT codes, the procedure may have been coded by using several codes describing the individual components of the procedure. CPT codes 0071T-0072T describe the comprehensive service.
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 (eg, 23929 for the clavicle) or perhaps one of the radiation oncology unlisted codes (eg, 77299 or 77499).
BlueCard/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational. However, this policy considers specific applications of an FDA-approved device as investigational. Alternatively, FDA-approved devices may be assessed on the basis of their medical necessity.
This policy was originally created in July 2004. A June 2005 TEC Assessment on magnetic resonance imaging‒guided 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. Most recently, the literature was reviewed 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 (eg, noncomparability of treatment groups) and observational bias (eg, the placebo effect).
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 1 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 1 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 3-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 1 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.
For the treatment of uterine fibroids, there are no RCTs and only 2 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 nonopioid analgesics and 6 of 10 who used opioids decreased medication use after treatment. Neither group reported any treatment-related AEs.
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 on December 10, 2014, identified the following ongoing RCTs evaluating the FDA-approved MRgFUS device.
- The FIRSST: Comparing MRgFUS (MR guided Focused Ultrasound) versus UAE (Uterine Artery Embolization) (NCT00995878): This is an RCT comparing MRgFUS with UAE in premenopausal 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.
- ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors (NCT01827904): 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.
- ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson’s Disease (NCT01772693): 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
In 2011, the American Society for Radiation Oncology 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
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.
- 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.
- 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
- 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.
- 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.
- 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.
- Froeling V, Meckelburg K, Schreiter NF, et al. Outcome of uterine artery embolization versus MR-guided highintensity focused ultrasound treatment for uterine fibroids: long-term results. Eur J Radiol. Dec 2013;82(12):2265-2269. PMID 24075785
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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
|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|
|C9734||Focused ultrasound ablation/therapeutic intervention, other than uterine leiomyomata, with magnetic resonance (MR) guidance|
|ICD-9 Diagnosis||198.5||Secondary malignant neoplasm of other specified sites-bone and bone marrow|
|ICD-10-CM (effective 10/1/15)||C79.51||Secondary malignant neoplasms of bone|
|D25.0-D25.9||Leiomyoma of uterus code range|
|ICD-10-PCS (effective 10/1/15)||ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for this procedure.|
|BU36ZZZ||Imaging, female reproductive system, magnetic resonance imaging (MRI), uterus, no contrast|
ExAblate 2000/2100/2100 VI
Fibroids, Ultrasound Ablation
High Intensity Ultrasound Ablation, Uterine
Leiomyoma, Uterine, High Intensity Ultrasound Ablation
MRI-Guidance, Ultrasound Ablation of Uterine Fibroids
Ultrasound Ablation of Uterine Fibroids
Uterine Leiomyoma, High Intensity Ultrasound Ablation
|07/15/04||Add policy to OB/GYN/ Reproduction section||New policy|
|06/27/05||Replace policy||Policy updated with a June 2005 TEC Assessment; policy statement unchanged. FDA statement added to benefit application section. Reference numbers 1-3 and 7-13 added|
|10/10/06||Replace policy/Moved to surgery section – assigned new number||Policy updated with a literature review; “and Other Tumors” added to the title to reflect indications other than uterine fibroids. Added to the policy statement “MRI-guided high-intensity ultrasound ablation of other tumors … is considered investigational.” Reference numbers 14 to 16 added. Policy moved from OB/GYN/Reproduction section to Surgery section and assigned new number (previous No. 4.01.20)|
|12/13/07||Replace policy||Policy updated with literature review; references 17-19 added; policy statement unchanged.|
|1/08/09||Replace policy||Policy updated with literature review; references 1, 21, 22 added; references re-ordered; Policy statement unchanged. Title changed “High-intensity”, “ablation of” removed from title.|
|02/11/10||Replace policy||Policy updated with literature review through November 2009; Rationale substantially rewritten, reference numbers 5, 9-13, 21-22 added; other references renumbered/removed; palliative treatment of bone metastases added to the policy statement on treatment of conditions other than uterine fibroids.|
|2/10/11||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.|
|02/09/12||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.|
|2/14/13||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.|
|7/1/13||coding update only||added C9734 new code for 7/1/2013|
|2/13/14||Replace policy||Policy updated with literature review through January 6, 2014; references 2, 6, and 14 added; other references renumbered or removed|
|2/12/15||Replace policy||Policy updated with literature review through January 6, 2015. Statement added the MRgFUS may be considered medically necessary for pain palliation in adult patients with metastatic bone cancer who failed or are not candidates for radiotherapy. Bullet point on bone metastases removed from Investigational statement. References 12 and 21-22 added.|