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High Intensity Focused Ultrasound (HIFU)

» Summary» Procedure Codes
» Description» Selected References
» Prior Approval» Policy History
» Policy
 

Medical Policy: 02.01.53 
Original Effective Date: March 2014 
Reviewed: February 2015 
Revised: February 2015 


Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.


Description: 

This medical policy is addressing high intensity focused ultrasound (HIFU). For magnetic resonance (MR) guided focused ultrasound (MRgFUS), see medical policy 04.01.09 MRI Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids and Other Tumors.   

 

High intensity focused ultrasound (HIFU) is one of several less invasive alternatives to surgery that are currently under clinical study for treatment of cancers and other tumor types, including but not limited to prostate, kidney, pancreas, breast, brain and thyroid nodules as well as for treatment of primary and secondary liver cancer. Currently, the primary area of study is for the use in the treatment of prostate cancer. 

 

HIFU devices use imaging ultrasound for treatment planning and monitoring, and they deliver targeted high intensity ultrasound that rapidly elevates the temperature at the precise area and kills cancer cells, while the tissue outside the focal point remains unharmed.

 

Treatment of Prostate Cancer and Benign Prostatic Hypertrophy (BPH)

Benign prostatic hypertrophy (BPH) is a non-cancerous enlargement of the prostate gland. Symptoms of BPH include frequent urination, urgency and excessive urination at night. Drug therapy may benefit patients with mild symptoms. Transurethral resection of the prostate has been established as the standard treatment for moderate to severe BPH. HIFU is one of several less invasive alternatives to surgical resection of the prostate that are currently under clinical study. HIFU delivers targeted high intensity ultrasound that rapidly elevates the temperature in a precise focal zone, thereby ablating excess prostate tissue.

 

Evidence in the peer reviewed medical literature evaluating HIFU for BPH consists primarily of few case series studies and there is insufficient evidence regarding the safety and efficacy of HIFU for BPH.   

 

High intensity focused ultrasound (HIFU) has been proposed as a method for treating prostate cancer. HIFU involves the use of a specialized rectal ultrasound probe that emits a focused high intensity convergent ultrasound beam to destroy targeted tissue. A proposed benefit to this method is that it requires no invasive surgery and allows treatment of prostate cancer without damaging surrounding tissue, eliminating the need for incisions and shortening of healing time.  

 

Based on the peer reviewed published medical literature high intensity (HIFU) has not been compared with standard treatment approaches for prostate cancer in randomized trials, nor is it included in guidelines for the initial management of men with prostate cancer. Therefore, there is insufficient evidence in the peer reviewed medical literature regarding the safety and efficacy of HIFU for the treatment of prostate cancer. Also, no HIFU device has received pre-market approval or 510k clearance by the U.S. Food and Drug Administration for the treatment of prostate cancer. 

 

Liver Cancer
Hepatocellular carcinoma (HCC) is the most common primary malignancy of the liver. The only potentially curative treatments are surgical resection and liver transplantation. The majority of patients with primary or metastatic liver cancers are not suitable candidates for surgical resection at the time of diagnosis. In addition, chemotherapy and radiotherapy rarely produce a complete or sustained response in patients with advanced disease. High intensity focused ultrasound (HIFU) is under investigation for the ablation of unresectable HCC.

 

Based on the peer reviewed medical literature HIFU for the treatment of liver cancer has been evaluated primarily in case series studies and there were limitations which include lack of randomization and short-term follow up. Additional studies with larger patient populations are needed to support the safety and effectiveness of HIFU for the treatment of unresectable liver cancer.

 

Renal Cancer   
Renal cell carcinoma (RCC), also referred to as kidney cancer is a disease in which cancer cells are found in the lining of the tubules in the kidney. Symptoms of renal cell carcinoma may include: blood in the urine, loss of appetite, pain in the side that doesn’t subside, weight loss and anemia. Standard treatment available for patients with RCC includes surgery, chemotherapy, external or internal radiation therapy, and immunotherapy. Surgical excision in the form of a simple or radical nephrectomy is the accepted, often curative, treatment for stages I, II and III of RCC. HIFU has been proposed as an intervention for small renal masses as well as advanced stage renal malignancy. 

 

Based on the peer reviewed medical literature there are a small amount of studies, primarily case series with small patient populations and insufficient data to draw conclusions. The safety and effectiveness of the use of HIFU for the treatment of renal cancer has not been established. 


Thyroid Nodules
Nodular thyroid tissue is common, however most thyroid nodules are benign. Causes of benign thyroid nodules include goiter and Hashimoto’s thyroiditis. The incidence of malignancy, or thyroid cancer, depends on factors such as age, gender, radiation exposure and family history. Treatment of thyroid cancer depends on the type of cancer, but may include one or more of the following treatments: radioiodine, thyroid hormone suppression and surgical removal of the thyroid gland. Minimally invasive treatments, such as percutaneous ethanol injection sclerotherapy, laser photocoagulation, and HIFU ablation have been proposed as an alternative to surgery.    

 

Based on the peer reviewed medical literature there are limited studies, primarily case series with small patient populations and insufficient data to draw conclusions. The safety and effectiveness of the use of HIFU for the treatment of thyroid nodules has not been established. 

 

Brain, Breast and Pancreatic Cancer
Based on the peer reviewed medical literature there have been isolated case series studies published utilizing HIFU to treat indications such as brain, breast and pancreatic cancers. The evidence is insufficient to make any determinations regarding safety and effectiveness for the use of HIFU for these indications. 

 

Summary
Based on the peer reviewed medical literature the long term efficacy and safety of high intensity focused ultrasound (HIFU) compared to established interventions for various conditions including but not limited to the following: prostate cancer, liver cancer, renal cancer, pancreatic cancer, breast cancer, brain cancer, thyroid nodules and benign prostatic hypertrophy (BPH) have not been proven in controlled clinical trials. Additional clinical trials with larger patient populations comparing established interventions are needed to determine the role of HIFU. Presently, there are no U.S. Food and Drug Administration (FDA) approved HIFU devices in the United States.  Therefore, high intensity focused ultrasound (HIFU) is considered investigational for all indications.      

 

Practice Guidelines and Position Statements 

 

National Comprehensive Cancer Network (NCCN)
Prostate Cancer Version 1.2015
Other Local Therapies:
Other emerging local therapies, such as high intensity focused ultrasound (HIFU) and vascular targeted photodynamic therapy (VPT), also warrant further study.

 

Other NCCN guidelines do not specifically refer to HIFU.

 

American Urological Association (AUA)
The AUA guideline for the Management of Clinically Localized Prostate Cancer reports that standard options for the management of clinically localized prostate cancer include watchful waiting and active surveillance, interstitial prostate brachytherapy, external beam radiotherapy, radical prostatectomy, as well as primary hormonal therapy. HIFU is listed under other treatment options in this guideline. The panel did not include other treatment options on the analysis and recommendations due to combination of factors, including limited published experience and short term follow up as well as the similar issues that affected evaluation of other treatment options. (This guideline was reviewed and validity confirmed in 2011).


American College of Radiology (ACR) Appropriateness Criteria: The 2011 American College of Radiology Expert Panel on Radiation Oncology-Prostate Work Group’s guideline on locally advanced (high risk) prostate cancer does not mention the use of HIFU in the list of treatment options. The summary states that HIFU is currently an experimental therapy. 

 

American Cancer Society (ACS)
Newer Treatments for early stage cancers:
Researchers are looking at new forms of treatment for early stage prostate cancer. These new treatments could be used either as the first type of treatment or after radiation therapy in cases where it was not successful.

 

One treatment known as high intensity focused ultrasound (HIFU), destroys cancer cells by heating them with highly focused ultrasonic beams. This treatment has been used more in Europe, but it is not available outside of clinical trials in the United States at this time. Studies are now under way to determine its safety and effectiveness.  (ACS last updated content of this information January 2015)  
             
National Cancer Institute:
High intensity focused ultrasound (HIFU) is not discussed in the 2014 Prostate Cancer Treatment Health Professional Version PDQ. In the 2014 Prostate Cancer Treatment patient version PDQ HIFU is listed as a new type of treatment being tested in clinical trials.

  

National Institute for Health and Clinical Excellence (NICE)
Prostate Cancer: Diagnosis and Treatment (January 2014)

Do not offer high intensity focused ultrasound (HIFU) and cryotherapy to men with localized prostate cancer other than in the context of controlled clinical trials comparing them with established interventions.

 

Regulatory Status
Two HIFU devices are currently being evaluated in the United States under a premarket approval Investigational Device Exemption granted by the U.S. Food and Drug Administration (FDA). They are the Sonablate 500 system (developed by Focus Surgery, Inc,, Indianapolis, IN, USA, distributed by US HIFU, LLC, Charlotte, NC, USA) and Ablatherm HIFU (EDAP TMS S.A., Vaulx-en-Velin, France). According to the manufacturer and distributor websites, the Sonablate 500 System has not been cleared for marketing in the United States and is in the clinical trials for treatment of prostate cancer. Ablatherm HIFU is currently under phase II/III FDA clinical trial for prostate cancer treatment.

 

October 2014 The U.S. Food and Drug Administration (FDA) Gastroenterology and Urology Devices advisory panel has recommended that the FDA not grant SonaCare Medical, LLC (Charlotte, NC) premarket approval for its Sonablate® 450 high intensity focused ultrasound (HIFU) technology to treat recurrent prostate cancer.


No HIFU system is FDA approved in the United States for treating prostate cancer; Sonablate 450 is not approved for any indications in the United States. A version of the system (Sonablate 500) has received the CE (Conformite Europeenne) mark and has been approved to treat prostate cancer in 30 countries outside the United States, according to the manufacturer.


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Prior Approval: 

Not required.


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Policy: 

High Intensity Focused Ultrasound (HIFU) is considered investigational for all indications including but not limited to the following:

  • Benign prostatic hypertrophy (BPH)
  • Thyroid nodules
  • Prostate cancer
  • Primary and secondary liver cancer
  • Renal cell carcinoma (RCC) (kidney cancer)
  • Pancreatic cancer
  • Breast cancer
  • Brain cancer

Based on the peer reviewed medical literature the long term efficacy and safety of high intensity focused ultrasound (HIFU) compared to established interventions for various conditions including but not limited to the following: prostate cancer, liver cancer, renal cancer, pancreatic cancer, breast cancer, brain cancer, thyroid nodules and benign prostatic hypertrophy (BPH) have not been proven in controlled clinical trials. Additional clinical trials with larger patient populations comparing established interventions are needed to determine the role of HIFU. Presently, there are no U.S. Food and Drug Administration (FDA) approved HIFU devices in the United States. Therefore, high intensity focused ultrasound (HIFU) is considered investigational for all indications.





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Procedure Codes and Billing Guidelines: 

  • To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
  • 55899 unlisted procedure, male genital system
  • 76999 unlisted ultrasound procedure (eg diagnostic, interventional)

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Selected References: 

Wellmark's policy is based on:

  • UptoDate. Cyrotherapy and Other Ablative Techniques for the Initial Treatment of Prostate Cancer. Louis L. Pisters, M.D., Philippe E. Spiess, M.D., M.S., FRCSC. Topic last updated December 16, 2013.
  • ECRI. U.S. Trial Planned for HIFU System. Published July 2007.
  • ECRI. Hotline Response. High Intensity Focused Ultrasound for Treating Prostate Cancer. published 2011.
  • ECRI. Hotline Response. High Intensity Focused Ultrasound for Treating Benign Prostatic Hyperplasia. published 2011.
  • ECRI. Hotline Response. High Intensity Focused Ultrasound for Treatment for Hepatocellular Carcinoma. Published 2012.
  •  ECRI.Research & Development: Cancer (Genitourinary). Published August 2013.
  • National Institute for Health and Clinical Excellence (NICE), Focal Therapy Using High Intensity Focused Ultrasound for Localized Prostate Cancer.
  • National Guideline Clearinghouse. Prostate Cancer. Alberta Provincial Genitourinary Tumor Team. Prostate Cancer. Clinical Practice Guideline; no. GU-004. January 2011.
  • American Cancer Society (ACS). What’s New in Prostate Cancer Research and Treatment? Last Revised 2/24/2014.
  • American Cancer Society (ACS) What’s New in Kidney Cancer Research and Treatment? Last Revised 1/18/2013.
  • American Cancer Society (ACS). Hyperthermia to Treat Cancer. 

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Policy History: 

Date                                     Reason                                   Action

March 2014                                                                        New policy created

February 2015                      Annual review                          Policy revised


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Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.

 
Contact Information
New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
  Wellmark Blue Cross and Blue Shield
  Medical Policy Analyst
  P.O. Box 9232
  Des Moines, IA 50306-9232
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