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

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POLICY CRITERIA | CODING | RELATED INFORMATION

EVIDENCE REVIEW | REFERENCES | HISTORY

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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.premera.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.

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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

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CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). 2017 Premera

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applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

037338 (07-2016)

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If you need these services, contact the Civil Rights Coordinator. If you believe that Premera 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 855-332-4535, Fax 425-918-5592, TTY 800-842-5357 Email AppealsDepartmentInquiries@Premera.com 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 Premera Blue Cross. 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 800-722-1471 (TTY: 800-842-5357). (Amharic): Premera Blue Cross 800-722-1471 (TTY: 800-842-5357)

:(Arabic) .

Premera Blue Cross. . . . (TTY: 800-842-5357) 1471-722-800

(Chinese): Premera Blue Cross

800-722-1471 (TTY: 800-842-5357)

Oromoo (Cushite): Beeksisni kun odeeffannoo barbaachisaa qaba. Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandaa. Guyyaawwan murteessaa taan beeksisa kana keessatti ilaalaa. Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandaa. Kaffaltii irraa bilisa haala taeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu. Lakkoofsa bilbilaa 800-722-1471 (TTY: 800-842-5357) tii bilbilaa. Franais (French): Cet avis a d'importantes informations. Cet avis peut avoir d'importantes informations sur votre demande ou la couverture par l'intermdiaire de Premera Blue Cross. Le prsent avis peut contenir des dates cls. Vous devrez peut-tre prendre des mesures par certains dlais pour maintenir votre couverture de sant ou d'aide avec les cots. Vous avez le droit d'obtenir cette information et de laide dans votre langue aucun cot. Appelez le 800-722-1471 (TTY: 800-842-5357). Kreyl ayisyen (Creole): Avi sila a gen Enfmasyon Enptan ladann. Avi sila a kapab genyen enfmasyon enptan konsnan aplikasyon w lan oswa konsnan kouvti asirans lan atrav Premera Blue Cross. Kapab genyen dat ki enptan nan avi sila a. Ou ka gen pou pran kk aksyon avan sten dat limit pou ka kenbe kouvti asirans sante w la oswa pou yo ka ede w avk depans yo. Se dwa w pou resevwa enfmasyon sa a ak asistans nan lang ou pale a, san ou pa gen pou peye pou sa. Rele nan 800-722-1471 (TTY: 800-842-5357). Deutsche (German): Diese Benachrichtigung enthlt wichtige Informationen. Diese Benachrichtigung enthlt unter Umstnden wichtige Informationen bezglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross. Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung. Sie knnten bis zu bestimmten Stichtagen handeln mssen, um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten. Sie haben das Recht, kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten. Rufen Sie an unter 800-722-1471 (TTY: 800-842-5357). Hmoob (Hmong): Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb. Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross. Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no. Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd. Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj. Hu rau 800-722-1471 (TTY: 800-842-5357). Iloko (Ilocano): Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion. Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross. Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar. Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos. Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo. Tumawag iti numero nga 800-722-1471 (TTY: 800-842-5357). Italiano (Italian): Questo avviso contiene informazioni importanti. Questo avviso pu contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross. Potrebbero esserci date chiave in questo avviso. Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione. Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente. Chiama 800-722-1471 (TTY: 800-842-5357).

(Japanese): Premera Blue Cross

800-722-1471 (TTY: 800-842-5357) (Korean): . Premera Blue Cross . . . . 800-722-1471 (TTY: 800-842-5357) . (Lao): . Premera Blue Cross. . . . 800-722-1471 (TTY: 800-842-5357). (Khmer):

Premera Blue Cross

800-722-1471 (TTY: 800-842-5357) (Punjabi): . Premera Blue Cross . . , , 800-722-1471 (TTY: 800-842-5357).

:(Farsi) .

. Premera Blue Cross .

. .

)800-842-5357 TTY( 800-722-1471 .

Polskie (Polish): To ogoszenie moe zawiera wane informacje. To ogoszenie moe zawiera wane informacje odnonie Pastwa wniosku lub zakresu wiadcze poprzez Premera Blue Cross. Prosimy zwrcic uwag na kluczowe daty, ktre mog by zawarte w tym ogoszeniu aby nie przekroczy terminw w przypadku utrzymania polisy ubezpieczeniowej lub pomocy zwizanej z kosztami. Macie Pastwo prawo do bezpatnej informacji we wasnym jzyku. Zadzwocie pod 800-722-1471 (TTY: 800-842-5357). Portugus (Portuguese): Este aviso contm informaes importantes. Este aviso poder conter informaes importantes a respeito de sua aplicao ou cobertura por meio do Premera Blue Cross. Podero existir datas importantes neste aviso. Talvez seja necessrio que voc tome providncias dentro de determinados prazos para manter sua cobertura de sade ou ajuda de custos. Voc tem o direito de obter esta informao e ajuda em seu idioma e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357).

Romn (Romanian): Prezenta notificare conine informaii importante. Aceast notificare poate conine informaii importante privind cererea sau acoperirea asigurrii dumneavoastre de sntate prin Premera Blue Cross. Pot exista date cheie n aceast notificare. Este posibil s fie nevoie s acionai pn la anumite termene limit pentru a v menine acoperirea asigurrii de sntate sau asistena privitoare la costuri. Avei dreptul de a obine gratuit aceste informaii i ajutor n limba dumneavoastr. Sunai la 800-722-1471 (TTY: 800-842-5357). P (Russian): . Premera Blue Cross. . , , . . 800-722-1471 (TTY: 800-842-5357). Faasamoa (Samoan): Atonu ua iai i lenei faasilasilaga ni faamatalaga e sili ona taua e tatau ona e malamalama i ai. O lenei faasilasilaga o se fesoasoani e faamatala atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua atu i ai. Faamolemole, ia e iloilo faalelei i aso faapitoa oloo iai i lenei faasilasilaga taua. Masalo o lea iai ni feau e tatau ona e faia ao lei aulia le aso ua taua i lenei faasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo oloo e iai i ai. Oloo iai iate oe le aia tatau e maua atu i lenei faasilasilaga ma lenei famatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY: 800-842-5357). Espaol (Spanish): Este Aviso contiene informacin importante. Es posible que este aviso contenga informacin importante acerca de su solicitud o cobertura a travs de Premera Blue Cross. Es posible que haya fechas clave en este aviso. Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura mdica o ayuda con los costos. Usted tiene derecho a recibir esta informacin y ayuda en su idioma sin costo alguno. Llame al 800-722-1471 (TTY: 800-842-5357). Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471 (TTY: 800-842-5357). (Thai): Premera Blue Cross 800-722-1471 (TTY: 800-842-5357) (Ukrainian): . Premera Blue Cross. , . , , . . 800-722-1471 (TTY: 800-842-5357). Ting Vit (Vietnamese): Thng bo ny cung cp thng tin quan trng. Thng bo ny c thng tin quan trng v n xin tham gia hoc hp ng bo him ca qu v qua chng trnh Premera Blue Cross. Xin xem ngy quan trng trong thng bo ny. Qu v c th phi thc hin theo thng bo ng trong thi hn duy tr bo him sc khe hoc c tr gip thm v chi ph. Qu v c quyn c bit thng tin ny v c tr gip bng ngn ng ca mnh min ph. Xin gi s 800-722-1471 (TTY: 800-842-5357).