Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Magnetic Resonance Imaging (MRI)--Guided Focused Ultrasound Ablation
Policy #:MA09.021c

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

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

MRI‒guided focused ultrasound ablation may be considered medically necessary for medicine-refractory essential tremors in adult individuals aged 22 years of age or older, when all of the following criteria are met:
  • Documented diagnosis of essential tremor confirmed by a neurologist specializing in movement disorders
  • Score two or greater on the Clinical Rating Scale for Tremor
  • Substantial disability in the performance of at least two daily activities from the disability subsection of the Clinical Rating Scale for Tremor

MRI-guided focused ultrasound ablation in all other situations, including but not limited to, 1) treatment of uterine leiomyomata (fibroids) and 2) treatment of other tumors, e.g., brain cancer, prostate cancer, and breast cancer, is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.
Policy Guidelines

There is no Medicare coverage determination addressing magnetic resonance imaging (MRI)--guided focused ultrasound ablation; therefore, the Company policy is applicable.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, MRI‒guided focused ultrasound ablation is covered under the medical benefits of the Company's Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as experimental/investigational are not eligible for coverage or reimbursement by the Company.

CLINICAL RATING SCALE FOR TREMOR

Fahn - Tolosa - Marin* developed a rating scale used for quantifying rest, postural, and action/intention tremors. The scale evaluates voice tremor, handwriting/drawing, and other specific functional daily living tasks. The scale is measured for severity on a five point assessment, with a maximum total score of 144. Higher scores indicate higher tremor severity.

The rating scale is divided into three parts (A, B, and C):

Part A (scores 1 to 9; maximum score of 80) quantifies the tremor at rest, with maintaining a posture, and with performing an action or intentional maneuvers, for nine parts of the body (e.g., limbs, tongue, head and trunk). All body part would not naturally present with tremor and as such, not all body parts would not be measured in all situations.

Part B (scores 10 to 14; maximum score of 36) relates to action tremors of the upper extremities, five tasks are measured involving handwriting, drawing, and pouring. To assess handwriting, the dominant hand will write a standard sentence. Drawing is evaluated by having the individual perform the activity on the scale. Pouring is analyzes using specified water levels to measure the amount of spillage after pours between two cups.

Part C (scores 15 to 21; maximum score of 28) assesses functional disability. Tremor severity scores are evaluated for speaking, feeding, ability to bring liquids to mouth, hygiene, dressing, and working. All scores, expect speaking are self reported based on the definitions provided in the scale.

Refer to for the direct link to the Clinical Rating Scale for Tremor to represent the medically necessary criteria in the policy.

*Fahn S, Tolosa E, Marin C. Clinical rating scale for tremor. In: Jankovik J and Tolosa E. Parkinson's disease and movement disorders.Baltimore-Munich: Urban & Schwarzenberg; 1988:225-34.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

In October 2004, the ExAblate® 2000 System (InSightec Inc., Haifa, Israel) received FDA approval through the premarket approval (PMA) process. This device is indicated for "ablation of uterine fibroid tissue in
pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and have completed child bearing."

In October 2012, the ExAblate® System, Model 2000/2100/2100 VI FDA approval through the PMA process. This device is indicated for "pain palliation of metastatic bone cancer in patients 18 years of age or older who are suffering from bone pain due to metastatic disease and who are failures of standard radiation therapy, or not candidates for, or refused radiation therapy."

In July 2016, the ExAblate® Neuro System received FDA approval through the PMA process. The device is indicated for "essential tremors in patients who have not responded to medication (beta-blockers or anticonvulsant drugs)."

Description

BONE METASTASES

Bone metastases, or metastatic bone disease, is a class of cancer metastases that results from primary tumor invasion to bone. Bone-originating primary tumors such as osteosarcoma, chondrosarcoma, and Ewing's sarcoma are rare. Unlike hematological malignancies that originate in the blood and form non-solid tumors, bone metastases generally arise from epithelial tumors and form a solid mass inside the bone.

Bone is the third most common location for metastasis, after the lung and liver. Bone metastases can develop in any bone; however, some cancers, particularly solid tumors (e.g., breast, prostate, lung, thyroid, and kidney cancers), are more likely to spread to the bone than others. Common sites of bone metastases are the spine, pelvis, ribs, skull, and proximal femur.

Bone metastases cause severe pain, characterized by a dull, constant ache with periodic spikes of incident pain. Between 50% and 70% of patients with bone metastases experience severe pain that can significantly interfere with daily functioning and quality of life.

Current treatments for pain from bone metastases include conservative measures (e.g., massage, exercise) and pharmacologic agents (e.g., analgesics, bisphosphonates, corticosteroids). Standard second-line treatment for patients who fail conservative measures and pharmacological agents is external beam radiation therapy (EBRT); however treatment is only effective in 60-65% of patients, and there is additional concern regarding the radiation effects to healthy surrounding tissue.

UTERINE LEIOMYOMATA (FIBROIDS)

Uterine leiomyomata, commonly known as fibroids or myomas, are the most common uterine neoplasm of the female genital tract. They are diagnosed in up to 25 percent of women and are a significant source of morbidity for reproductive-aged women.

Most fibroids are asymptomatic and require no treatment, but women with problematic fibroids often experience heavy menstrual bleeding, constant cramping, feelings of fullness in the lower abdomen, frequent urination, incontinence, pain during sexual intercourse, lower back pain, and infertility. The number and severity of symptoms is typically related to the size, location, and number of fibroids in the uterus. Until recently, hysterectomy (removal of the uterus) was considered the most effective method of treating symptomatic uterine fibroids.

Less invasive alternatives to hysterectomy include myomectomy (laparoscopic, hysteroscopic, and vaginal), uterine artery embolization, laser myolysis, and hormonal therapy. However, they allow for the possibility of new leiomyomas to form. In addition, pre-existing leiomyomas that were previously too small to be detected, or were intentionally not removed may exhibit significant growth, which can lead to other problems.

ESSENTIAL TREMOR

Essential tremor (ET) is the most prevalent movement disorder, with an estimated prevalence of five percent of the population. ET commonly affects the hands and arms, may affect head and voice, and rarely presents in the face, legs, and trunk. ET is heterogeneous among individuals, with variations in frequency, amplitude, causes of exacerbation, and association with other neurologic deficits.

ET may be idiopathic with no known etiology. For individuals with intermittent or persistent disability due to the tremor, medical management with pharmaceuticals are considered first-line therapy. In individuals who are found to be medicine refractory, surgery (e.g., deep-brain stimulation or thalamotomy) may be offered, however, for individuals who are found to not be good surgical candidate and because there are high rates of adverse evenst has been reported in surgical procedures, MRgFUS could be a treatment.

MAGNETIC RESONANCE IMAGING (MRI)--GUIDED FOCUSED ULTRASOUND (MRgFUS)

Magnetic resonance imaging (MRI)--guided focused ultrasound (MRgFUS) is a noninvasive thermal ablation technique that combines high-intensity focused ultrasound (HIFU) with real time MRI. Focused ultrasound penetrates through soft tissues and delivers acoustic energy to heat targeted lesions to ablative temperatures (i.e., to approximately 65°C-85°C), which is sufficient to achieve tissue ablation at the focal point, while minimizing damage to surrounding tissues. With the addition of magnetic resonance imaging, providers are able to perform precise localized tumor tissue ablation with real-time thermal monitoring.

The US Food and Drug Administration (FDA) has approved the ExAblate® MRgFUS system (InSightec Inc., Haifa, Israel) for three indications: the treatment of uterine fibroids (leiomyomata), palliation of pain associated with tumors metastatic to bone, and idiopathic essential tremor. MRgFUS is also being investigated for treatment of other tumors, including breast, prostate, and brain tumors.
References

Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Magnetic resonance- focused ultrasound therapy for symptomatic uterine fibroids. TEC Assessments. 2005;Volume 20, Tab 10.

Carranza-Mamane B, Havelock J, Hemmings R, et al. The management of uterine fibroids in women with otherwise unexplained infertility. J Obstet Gynaecol Can. 2015;37(3):277-288.

Chang JW, Park CK, Lipsman N, et al. A prospective trial of magnetic resonance-guided focused ultrasound thalamotomy for essential tremor: Results at the 2-year follow-up. Ann Neurol. 2018;83(1):107-114.

ECRI Institute. Magnetic Resonance-guided Focused Ultrasound for Palliating Pain from Bone Metastases. Plymouth Meeting (PA): ECRI Institute; 2014 August. (ECRI Emerging Technology Evidence Report). Also available at: https://www.ecri.org. Accessed August 15, 2018.

Elias WJ, Lipsman N, Ondo WG, et al. A randomized trial of focused ultrasound thalamotomy for essential tremor. N Engl J Med. 2016;375(8):730-739.

Fahn S, Tolosa E, Marin C. Clinical rating scale for tremor. In: Jankovik J and Tolosa E. Parkinson's disease and movement disorders.Baltimore-Munich: Urban & Schwarzenberg; 1988:225-34.

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.

Froeling V, Meckelburg K, Schreiter NF, et al. Outcome of uterine artery embolization versus MR-guided high-intensity focused ultrasound treatment for uterine fibroids: long-term results. Eur J Radiol. 2013;82(12):2265-2269.

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. 2014;96(9):743-751.

Gelet A, Chapelon JY, Bouvier R, et al. Local control of prostate cancer by transrectal high intensity focused ultrasound therapy: Preliminary results. J Urol. 1999;161(1):156-162.

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.

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, Boulanger Y, et al. Feasibility of magnetic resonance imaging-guided focused ultrasound surgery as an adjunct to tamoxifen therapy in high-risk surgical patients with breast carcinoma. J Vasc Interv Radiol. 2003;14(10):1275-1282.

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. 2014;21(4):465-476.

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.

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.

Huber PE, Jenne JW, Rastert R, et al. A new noninvasive approach in breast cancer therapy using magnetic resonance imaging-guided focused ultrasound surgery. Cancer Res. 2001;61(23):8441-8447.

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. 2014;106(5).

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):176-185.

Jaaskelainen J. Non-invasive transcranial high intensity focused ultrasound (HIFUS) under MRI thermometry and guidance in the treatment of brain lesions. Acta Neurochir Suppl. 2003;88:57-60.

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. 2016;105(3):773-80.

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.

Kohrmann KU, Michel MS, Gaa J, Marlinghaus E, Alken P. High intensity focused ultrasound as noninvasive therapy for multilocal renal cell carcinoma: Case study and review of the literature. J Urol. 2002;167(6):2397-2403.

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.

Lutz S, Berk L, Chang E, et al. Palliative radiotherapy for bone metastases: an ASTRO evidence-based guideline. Int J Radiat Oncol Biol Phys. 2011;79(4):965-976.

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.

Mohammed N, Patra D, Nanda A. A meta-analysis of outcomes and complications of magnetic resonance-guided focused ultrasound in the treatment of essential tremor. Neurosurg Focus. 2018;44(2):E4.

Napoli A, Anzidei M, De Nunzio C, et al. Real-time magnetic resonance-guided high-intensity focused ultrasound focal therapy for localised prostate cancer: preliminary experience. Eur Urol. 2013;63(2):395-398.

Napoli A, Anzidei M, Marincola BC, et al. Primary pain palliation and local tumor control in bone metastases treated with magnetic resonance-guided focused ultrasound. Invest Radiol. 2013;48(6):351-358.

National Institute for Health and Clinical Excellence. NICE Interventional procedures guidance [IPG413]. Magnetic resonance image-guided transcutaneous focused ultrasound for uterine fibroids. Available online at: https://www.nice.org.uk/guidance/ipg413/resources/magnetic-resonance-imageguided-transcutaneous-focused-ultrasound-for-uterine-fibroids-pdf-1899869566932421. Accessed September 17, 2018.

Rabinovici J, David M, Fukunishi H, et al. Pregnancy outcome after magnetic resonance-guided focused ultrasound surgery (MRgFUS) for conservative treatment of uterine fibroids. Fertil Steril. 2010;93(1):199-209.

Smart OC, Hindley JT, Regan L, Gedroyc WM. Magnetic resonance guided focused ultrasound surgery of uterine fibroids--the tissue effects of GnRH agonist pre-treatment. Eur J Radiol. 2006;59(2):163-167.

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.

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.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. ExAblate® 2000 System. Premarket approval letter. [FDA Web site]. 10/22/2004. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040003A.pdf. Accessed September 17, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. InSightec ExAblate® System, Model 2000/2100/2100 V1. Premarket approval letter. [FDA Web site]. 10/18/2012. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/p110039a.pdf. Accessed September 17, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health.
ExAblate Model 4000 Type 1.0 System (ExAblate Neuro). Premarket approval letter. [FDA Web site]. 07/11/2016. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150038A.pdf. Accessed September 05, 2018.

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.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY


0398T

THE FOLLOWING CODE CAN BE USED TO REPRESENT MRI GUIDED FOCUSED ULTRASOUND ABLATION FOR THE PALLIATION OF METASTATIC BONE CANCER:

76498


EXPERIMENTAL/INVESTIGATIONAL

0071T, 0072T



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

C79.51 Secondary malignant neoplasm of bone

C79.52 Secondary malignant neoplasm of bone marrow

G25.0 Essential tremor



HCPCS Level II Code Number(s)



MEDICALLY NECESSARY

C9734 Focused ultrasound ablation/therapeutic intervention, other than uterine leiomyomata, with magnetic resonance (MR) guidance

EXPERIMENTAL/INVESTIGATIONAL

C9747 Ablation of prostate, transrectal, high intensity focused ultrasound (HIFU), including imaging guidanc



Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

Revisions from MA09.021c
10/29/2018This version of the policy will become effective on 10/22/2018.

This policy was updated to communicate the Company's coverage position for essential tremor: essential tremor was added as a Medically Necessary indication.

The following diagnosis code were added to the policy: G25.0.

Revisions from MA09.021b
11/22/2017This policy has undergone a routine review, and no revisions have been made.
07/01/2017This policy has been identified for the HCPCS code update, effective 07/01/2017.

The following HCPCS code has been added to this policy:
    C9747 Ablation of prostate, transrectal, high intensity focused ultrasound (HIFU), including imaging guidance

Revisions from MA09.021a:
11/23/2016This policy has been reviewed and reissued to communicate the Company’s continuing position on Magnetic Resonance Imaging (MRI)--Guided Focused Ultrasound Ablation.
01/01/2016This policy has been identified for the CPT code update, effective 01/01/2016.

The following CPT code has been added to this policy: 0398T

Revisions from MA09.021:
11/06/2015This policy will become effective 11/06/2015.

The following new policy has been developed to communicate the Company’s coverage criteria for Magnetic Resonance Imaging (MRI)--Guided Focused Ultrasound Ablation.





Version Effective Date: 10/29/2018
Version Issued Date: 10/29/2018
Version Reissued Date: N/A