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MEDICAL POLICY 7.01.109
Magnetic ResonanceGuided Focused Ultrasound
BCBSA Ref. Policy: 7.01.109
Effective Date: Sept. 1, 2017
Last Revised: Aug. 22, 2017
Replaces: N/A
RELATED MEDICAL POLICIES:
8.01.61 Focal Treatments for Prostate Cancer
Select a hyperlink below to be directed to that section.
POLICY CRITERIA | CODING | RELATED INFORMATION
EVIDENCE REVIEW | REFERENCES | HISTORY
Clicking this icon returns you to the hyperlinks menu above.
Introduction
Magnetic resonance-guided high-intensity ultrasound uses two technologies: magnetic
resonance imaging (MRI) and ultrasound to treat part of your body. It is a noninvasive
procedure, which means the skin is not cut. MRI uses a magnetic field, radio frequency, and a
computer to create detailed images of organs, tissues, and bones. Ultrasound uses sound waves
at a higher frequency than a person can hear. Ultrasound is usually used to create images of
body structures to help diagnose illnesses. But in this treatment, the ultrasound beams are at a
different frequency and are focused on one area. Heat is created at the point where the high
frequency beams meet, and the heat ablates (destroys) unhealthy tissue. The MRI is used to
both guide the location of the ultrasound beams and to monitor treatment. This policy discusses
when magnetic resonance-guided high-intensity ultrasound ablation may be considered
medically necessary and covered by the health plan
Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The
rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for
providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can
be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a
service may be covered.
https://www.lifewisewa.com/medicalpolicies/8.01.61.pdf
Page | 2 of 12
Policy Coverage Criteria
Service Medical Necessity Magnetic resonance-
guided high-intensity
ultrasound ablation
Magnetic resonance-guided high-intensity ultrasound ablation
may be considered medically necessary to help control pain in
adult patients with metastatic bone cancer who have failed or
are not candidates for radiotherapy.
Service Investigational Magnetic resonance-
guided high-intensity
ultrasound ablation
Magnetic resonance-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,
desmoid, and breast cancer) (see Related Policy 8.01.61 Focal
Treatments for Prostate Cancer)
Coding
Code Description
CPT 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
Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS
codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).
Related Information
Page | 3 of 12
Consideration of Age
Magnetic resonanceguided focused ultrasound (MRgFUS)is considered medically necessary for
bone metastases in adult patients, age 18 and older. This is based on the randomized controlled
trial that studied the use of MRgFUS in patients with bone metatsases.
Evidence Review
Description
An integrated system providing magnetic resonanceguided focused ultrasound (MRgFUS)
treatment is proposed as a noninvasive therapy for uterine fibroids and pain palliation of bone
metastases. MRgFUS is also being investigated as a treatment of other benign and malignant
tumors.
Background
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. 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. Existing treatments
include conservative measures (eg, massage, exercise) and pharmacologic agents (eg,
analgesics, bisphosphonates, corticosteroids). For patients who fail the above treatments, the
standard care is to use 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.
Page | 4 of 12
Magnetic ResonanceGuided Focused Ultrasound
MRgFUS is a noninvasive treatment that combines two technologies: focused ultrasound and
magnetic resonance imaging (MRI). The ultrasound beam penetrates through the soft tissues
and, using MRI for guidance and monitoring, the beam can be focused on targeted sites.
Ultrasound causes a local increase in temperature in the target tissue, resulting in coagulation
necrosis while sparing the surrounding normal structures. Ultrasound waves from each
sonication are directed 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 65C-
85C), which is sufficient to ablate tissue 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 ultrasound equipment is
specially designed to be compatible with MR magnets and is integrated into standard clinical
MRI units; it also includes a patient table, which has a cradle that houses the focused ultrasound
transducer in a water or a light oil bath. Some models have a detachable cradle; only certain
cradle types can be used for palliation of pain associated with bone metastases. 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,
brain, and desmoid tumors as well as nonspinal osteoid osteoma. (For prostate cancer see
Related Policy 8.01.61 Focal Treatments for Prostate Cancer.)
Summary of Evidence
For individuals who have uterine fibroids who receive magnetic resonance-guided focused
ultrasound (MRgFUS), the evidence includes two small randomized controlled trials (RCT),
nonrandomized comparative studies, and case series. Relevant outcomes are symptoms, quality
of life, resource utilization, and treatment-related morbidity. One RCT (N=20 patients) 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
Page | 5 of 12
active and sham treatment groups, but it did find lower fibroid volumes after active treatment.
The pivotal Food and Drug Administration trial was not randomized, 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; it has provided preliminary results at 6 weeks posttreatment, comparing
MRgFUS with uterine artery embolization (UAE). The 2 groups were comparable in medication
use and symptom improvement following treatments. Patients in the MRgFUS group reported
recovering significantly faster than patients in the UAE 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 (UAE) than with MRgFUS. There are insufficient data
on the long-term treatment effects, recurrence rates, and impact on future fertility and
pregnancy. The evidence is insufficient to determine the effects of the technology on health
outcomes.
For individuals with painful metastatic bone cancer who failed or are not candidates for
radiotherapy who receive MRgFUS, the evidenceincludes a sham-controlled 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 statistically 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. A substantial proportion of
patients in the treatment group experienced adverse events, but most of these were not severe
and were transient. The evidence is sufficient to determine qualitatively that the technology
results in a meaningful improvement in the net health outcome.
For individuals with other tumors (eg, brain cancer, prostate cancer, breast cancer, desmoid), 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.
Ongoing and Unpublished Clinical Trials
Some currently ongoing and unpublished trials that might influence this review are listed in
Table 1.
Page | 6 of 12
Table 1. Summary of Key Trials
NCT No. Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01965002 A Feasibility Study to Evaluate the Safety and Effectiveness of
ExAblate Magnetic Resonance Imaging Guided High-Intensity
Focused Ultrasound Treatment of Soft Tissue Tumors of the
Extremities
30 Feb 2017
(ongoing)
NCT00981578a
A Feasibility Study to Evaluate the Safety and Initial
Effectiveness of ExAblate MR Guided Focused Ultrasound
Surgery in the Treatment of Pain Resulting from Metastatic
Bone Tumors with the ExAblate 2100 Conformal Bone System
50 Jun 2017
NCT01833806a
A Phase IV Post Approval Clinical Study of ExAblate Treatment
of Metastatic Bone Tumors for the Palliation of Pain
70 Oct 2017
NCT01473485a
A Study to Evaluate the Safety and Feasibility of Transcranial
MRI-Guided Focused Ultrasound Surgery in the Treatment of
Brain Tumors
10 Oct 2017
NCT00147056a
A Study to Evaluate the Safety and Feasibility of Transcranial
MRI-Guided Focused Ultrasound Surgery in the Treatment of
Brain Tumors
10 Dec 2017
NCT01226576a
Focal MR Guided Focused Ultrasound Treatment of Localized
Low-Intermediate Risk Prostate Cancer: Feasibility Study
8 Dec 2017
NCT00995878 The FIRSTT Study: Comparing Focused Ultrasound and Uterine
Artery Embolization for Uterine Fibroids
180 Dec 2017
NCT01091883a
Phase IIIA Study Comparing the Safety and Effectiveness of MR
Guided Focused Ultrasound and External Beam Radiation for
Treatment of Metastatic Bone Tumors and Multiple Myeloma
60 Mar 2018
NCT02968784a
Focal ExAblate MR Guided Focused Ultrasound Treatment for
Management of Organ-Confined Intermediate Risk Prostate
Cancer: Evaluation of Safety and Effectiveness
69 Jun 2019
NCT02260752 Comparing Options for Management: Patient Centered Results
for Uterine Fibroids
10,000 Sep 2019
NCT01657942a
Focal MR Guided Focused Ultrasound Treatment of Localized
Low and Intermediate Risk Prostate Lesions
100 Oct 2019
NCT02794558a
A Clinical Study to Evaluate the Safety and Effectiveness of MR
Guided Focused Ultrasound Surgery in the Treatment of Early
Breast Carcinomas
100 Apr 2021
Unpublished
https://www.clinicaltrials.gov/ct2/show/NCT01965002?term=NCT01965002&rank=1https://www.clinicaltrials.gov/ct2/show/NCT00981578?term=NCT00981578&rank=1https://www.clinicaltrials.gov/ct2/show/NCT01833806?term=NCT01833806&rank=1https://www.clinicaltrials.gov/ct2/show/NCT01473485?term=NCT01473485&rank=1https://www.clinicaltrials.gov/ct2/show/NCT00147056?term=NCT00147056&rank=1https://www.clinicaltrials.gov/ct2/show/NCT01226576?term=NCT01226576&rank=1https://www.clinicaltrials.gov/ct2/show/NCT00995878?term=NCT00995878&rank=1https://www.clinicaltrials.gov/ct2/show/NCT01091883?term=NCT01091883&rank=1https://www.clinicaltrials.gov/ct2/show/NCT02968784?term=NCT02968784&rank=1https://www.clinicaltrials.gov/ct2/show/NCT02260752?term=NCT02260752&rank=1https://www.clinicaltrials.gov/ct2/show/NCT01657942?term=NCT01657942&rank=1https://www.clinicaltrials.gov/ct2/show/NCT02794558?term=NCT02794558&rank=1
Page | 7 of 12
NCT No. Trial Name Planned
Enrollment
Completion
Date
NCT01285960a
A Clinical Study to Evaluate Safety of the ExAblate Model 2100
Type 1.1 System in the Treatment of Symptomatic Uterine
Fibroids
106 Apr 2016
(completed)
NCT01620359a
Study of ExAblate Focused Ultrasound Ablation of Breast
Cancer under MR Guidance and MRI Evaluation of Ablation
14 Jul 2016
(completed)
NCT01834937a A Post Approval Registry: ExAblate Treatment of Metastatic
Bone Tumors for the Palliation of Pain
17 Apr 2017
(completed)
NCT: national clinical trial. a Denotes industry-sponsored or cosponsored trial.
Practice Guidelines and Position Statements
Society of Obstetricians and Gynaecologists of Canada
In 2015, the Society of Obstetricians and Gynaecologists of Canada published clinical practice
guidelines on the management of uterine fibroids in women with otherwise unexplained
infertility.30 The guideline found no studies comparing MRgFUS with myomectomy or in women
with fibroids who have infertility as their primary complaint, and thus additional data are needed
before the treatment is offered to this patient population.
American Society for Radiation Oncology (ASTRO)
In 2011, the ASTRO 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.31 The guidelines do not mention MRgFUS and did not offer
specific recommendations for patients who fail or are not candidates for radiotherapy.
National Comprehensive Cancer Network
Guidelines from the National Comprehensive Cancer Network on breast cancer (v.2.2017),32
brain cancer (v.1.2016),33 and prostate cancer (v.2.2017)34 do not mention MRgFUS as a
treatment option.
https://www.clinicaltrials.gov/ct2/show/NCT01285960?term=NCT01285960&rank=1https://www.clinicaltrials.gov/ct2/show/NCT01620359?term=NCT01620359&rank=1https://www.clinicaltrials.gov/ct2/show/NCT01834937?term=NCT01834937&rank=1
Page | 8 of 12
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.
Regulatory Status
In October 2004, the ExAblate 2000 System (InSightec, Haifa, Israel) was FDA approved
through 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, the ExAblate System, Model 2000/2100/2100 VI, was approved by FDA
through the premarket approval process 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.
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. 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. PMID 28063909
3. Jacoby VL, Kohi MP, Poder L, et al. PROMISe trial: a pilot, randomized, placebo-controlled trial of magnetic resonance guided
focused ultrasound for uterine fibroids. Fertil Steril. Mar 2016;105(3):773-780. PMID 26658133
4. 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. Apr 2014;21(4):465-476. PMID 23868442
5. Hindley J, Gedroyc WM, Regan L, et al. MRI guidance of focused ultrasound therapy of uterine fibroids: early results. AJR Am J
Roentgenol. Dec 2004;183(6):1713-1719. PMID 15547216
6. Stewart EA, Rabinovici J, Tempany CM, et al. Clinical outcomes of focused ultrasound surgery for the treatment of uterine
fibroids. Fertil Steril. Jan 2006;85(1):22-29. PMID 16412721
Page | 9 of 12
7. Fennessy FM, Tempany CM, McDannold NJ, et al. Uterine leiomyomas: MR imaging-guided focused ultrasound surgery--results
of different treatment protocols. Radiology. Jun 2007;243(3):885-893. PMID 17446521
8. 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. Nov 2009;34(5):572-578. PMID 19852046
9. Stewart EA, Gostout B, Rabinovici J, et al. Sustained relief of leiomyoma symptoms by using focused ultrasound surgery. Obstet
Gynecol. Aug 2007;110(2 Pt 1):279-287. PMID 17666601
10. Kim HS, Baik JH, Pham LD, et al. MR-guided high-intensity focused ultrasound treatment for symptomatic uterine leiomyomata:
long-term outcomes. Acad Radiol. Aug 2011;18(8):970-976. PMID 21718955
11. 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. Jun 2011;22(6):857-864. PMID 21482137
12. 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. PMID
27822376
13. 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
14. 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
15. 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
16. 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. Jan 2009;16(1):140-146. PMID 19002530
17. 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
18. 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. PMID 28244018
19. 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. PMID 15657521
20. Hynynen K, Pomeroy O, Smith DN, et al. MR imaging-guided focused ultrasound surgery of fibroadenomas in the breast: a
feasibility study. Radiology. Apr 2001;219(1):176-185. PMID 11274554
21. Gianfelice D, Khiat A, Amara M, et al. MR imaging-guided focused US ablation of breast cancer: histopathologic assessment of
effectiveness-- initial experience. Radiology. Jun 2003;227(3):849-855. PMID 12714680
22. 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. Nov 2003;82(2):93-101. PMID 14692653
23. 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. PMID 26852219
24. McDannold N, Clement GT, Black P, et al. Transcranial magnetic resonance imaging- guided focused ultrasound surgery of
brain tumors: initial findings in 3 patients. Neurosurgery. Feb 2010;66(2):323-332; discussion 332. PMID 20087132
25. 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
26. 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
27. 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. PMID 26040967
Page | 10 of 12
28. Bucknor MD, Rieke V. MRgFUS for desmoid tumors within the thigh: early clinical experiences. J Ther Ultrasound. 2017;5:4.
PMID 28174660
29. 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. PMID 27147222
30. 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. PMID 26001875
31. 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
32. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version
2.2017. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf Accessed August 2017.
33. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Central Nervous System
Cancers. Version 1.2016. https://www.nccn.org/professionals/physician_gls/pdf/cns.pdf Accessed August 2017.
34. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer. Version
2.2017. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf Accessed August 2017.
History
Date Comments 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 tumorsis 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.
https://www.nccn.org/professionals/physician_gls/pdf/breast.pdfhttps://www.nccn.org/professionals/physician_gls/pdf/cns.pdfhttps://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf
Page | 11 of 12
Date Comments 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.
08/25/15 Update Related Policies. Remove 7.01.548 as it was archived and add 8.01.61.
05/01/16 Annual Review, approved April 12, 2016. Policy updated with literature review through
December 15, 2015; references 2 and 23 added. Policy coverage unchanged. Global
change to policy to remove imaging (e.g., title, policy statement) to standardize
terminology to magnetic resonanceguided focused ultrasound (MRgFUS). Coding
update; CPT codes 47999 and 55899 removed from policy; these are moving to review
by AIM.
06/24/16 Minor update. Removed codes 77299 and 77499 from information in the coding
section that discusses radiation oncology unlisted codes. Correction to 4/12/16 History
note: AIM is not reviewing 47999 and 55899.
09/30/16 Coding update. Added CPT code 55899.
11/08/16 Minor update. Language added to Rationale section to indicate that MRgFUS is
considered medically necessary only in those age 18 and older based on randomized
controlled trials.
07/01/17 Annual Review, approved June 22, 2017. Policy moved into new format. Reference to
Page | 12 of 12
Date Comments policy 8.01.61 added for prostate cancer diagnosis. No changes to policy statement.
09/01/17 Interim review, approved August 22, 2017. Policy updated with literature review
through June 2, 2017; references 2, 12, 18, 23, and 27-29 added. Removed CPT code
19499. Policy statements unchanged.
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). 2017 Premera
All Rights Reserved.
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.
037336 (07-2016)
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If you need these services, contact the Civil Rights Coordinator. If you believe that LifeWise has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator - Complaints and Appeals PO Box 91102, Seattle, WA 98111 Toll free 855-332-6396, Fax 425-918-5592, TTY 800-842-5357 Email [email protected] You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue SW, Room 509F, HHH Building Washington, D.C. 20201, 1-800-368-1019, 800-537-7697 (TDD) Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. Getting Help in Other Languages This Notice has Important Information. This notice may have important information about your application or coverage through LifeWise Health Plan of Washington. There may be key dates in this notice. You may need to take action by certain deadlines to keep your health coverage or help with costs. You have the right to get this information and help in your language at no cost. Call 800-592-6804 (TTY: 800-842-5357). (Amharic): LifeWise Health Plan of Washington 800-592-6804 (TTY: 800-842-5357)
:(Arabic) .
LifeWise Health Plan of Washington. .
. (TTY: 800-842-5357) 6804-592-800 .
(Chinese): LifeWise Health Plan of Washington
800-592-6804 (TTY: 800-842-5357)
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(Japanese): LifeWise Health Plan of Washington
800-592-6804 (TTY: 800-842-5357) (Korean): . LifeWise Health Plan of Washington . . . . 800-592-6804 (TTY: 800-842-5357) . (Lao): . LifeWise Health Plan of Washington. . . . 800-592-6804 (TTY: 800-842-5357). (Khmer):
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800-592-6804 (TTY: 800-842-5357) (Punjabi): . LifeWise Health Plan of Washington . . , , 800-592-6804 (TTY: 800-842-5357).
:(Farsi) .
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