BlueCross and BlueShield of Montana Medical Policy/Codes
High-Intensity Focused Ultrasound (HIFU) for Treatment of Cancer
Chapter: Surgery: Procedures
Current Effective Date: October 25, 2013
Original Effective Date: October 25, 2013
Publish Date: July 25, 2013
Description

High intensity focused ultrasound or HIFU is a new type of cancer treatment using high frequency sound waves. A potential advantage of HIFU is that it may have fewer side effects than other types of cancer treatments.

HIFU, which was originally developed to treat benign prostatic hypertrophy, has been proposed as a non-invasive procedure for destruction of prostatic cancer. HIFU is performed transrectally under general or spinal anesthesia. A HIFU probe is placed in the rectum. The targeted prostatic tissue is localized with the ultrasound (US), and a burst of high-intensity US waves are focused through the rectal wall to a focal point in the prostate, where the US beam creates a sudden temperature increase (85-100o C) that destroys the cells in the targeted zone. Each burst destroys a small area; larger amounts of tissue can be destroyed by moving the focal point and repeating the process. HIFU allows the surgeon to accurately target tissue to be destroyed without injuring adjacent tissue. The treatment lasts from one to three hours, depending on the volume of tissue to be destroyed. This procedure can be done on an outpatient basis.

HIFU is also being studied for treatment of other cancers, including kidney, bladder, pancreas, and liver cancers.

Currently there are two companies that manufacture HIFU devices for patient use. Focus Surgery, Inc., (Indianapolis, IN) makes the Sonablate®500, and EDAP Technomed (Lyon, France) makes the Ablatherm®HIFU; neither device has received approval of the United States Food and Drug Administration (FDA).

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Investigational

Blue Cross and Blue Shield of Montana (BCBSMT) considers high-intensity focused ultrasound (HIFU) is considered experimental, investigational and unproven for treatment of cancer, including but not limited to:

  • Prostate,
  • Kidney,
  • Liver,
  • Pancreas, or
  • Bladder.

Policy Guidelines

There are no specific codes for this services; unlisted codes should be used to bill for this service.

76872 is transrectal US, but is not specifically for HIFU.

Rationale

In February 2008, Barqawi et al. (2) reviewed and summarized current knowledge about the basic principles of HIFU and its reported efficacy and morbidity in clinical series published since 2000. They concluded that long-term results from controlled studies are needed before we embrace this technology, and that a better understanding of HIFU’s clinical limitations is vital before this treatment can be recommended to patients who are not involved in well-designed studies.

In an article published in May 2008, Rebillard et al. (3) discuss the efficacy and safety of HIFU in patients with prostate cancer, and attempt to define the best indications for HIFU in daily clinical practice as primary therapy. They searched MedLine and Embase for clinical studies, and selected 37 articles, consisting of case series only. They concluded that HIFU achieved some short-term cancer control, and the median survival rate also seemed promising, but long-term follow-up studies are needed to further evaluate cancer-specific and overall survival rates.

In Europe, HIFU has been used to treat some men with prostate cancer, and is still in research trials for treatment of kidney, bladder, pancreas, and liver cancers. In the United States, clinical trials are currently underway.

2010 Update

The clinical trials in the United States are not yet completed (7-9); these trials have the following current status:

  • NCT00485381—a prospective, non-randomized concurrently controlled clinical trial underway to determine the effectiveness of the Sonoblate 500 using HIFU to treat localized prostate cancer. This study is currently recruiting participants.
  • NCT00005075—an open-label multicenter, Phase III trial underway to determine the effectiveness of US therapy (using the Ablatherm) in treating patients who have stage I or II prostate cancer that has recurred following radiation therapy. This study has been terminated because Ablatherm devices were not available any longer at trial centers.
  • NCT00295802—(currently recruiting participants) to determine the substantial equivalence of the Ablatherm HIFU as compared to cryotherapy for the treatment of low risk, localized prostate cancer. This study is ongoing, but not recruiting participants.

In 2009, Park et al. (11) conducted a study to determine the efficacy and safety of using HIFU to treat liver metastasis from colon and stomach cancer. Ten patients with liver metastasis from colon cancer and three from stomach cancer underwent HIFU under general anesthesia. HIFU was performed using an extracorporeal, ultrasound-guided focused system. Complications during the study, extent of coagulative necrosis at two-week follow up, and evidence of tumor on further follow up were analyzed. Patients were divided into four categories: (I) complete ablation with no evidence of recurrence on follow up; (II) apparent complete ablation of target mass with new foci of disease in the target organ or distant malignancy and no local tumor progression; (III) local tumor progression after apparent complete ablation; (IV) partial ablation. Mean follow-up period was 22 weeks in the colon cancer group and 58 weeks in the stomach cancer group. The sum of total lesion size was between 1.8 cm and 21.4 cm (mean: 8.4 cm +/- 6.7 cm) for the colon cancer group and between 1.7 and 16.3 cm (mean: 8.8 cm +/- 7.3 cm) for the stomach cancer group. In the colon cancer group, one patient was categorized as category I, one as category II, three as category III, and the remaining five as category IV. The stomach cancer group showed two patients as category I, and one as category II. The authors concluded that for treating liver metastasis from colon and stomach cancer HIFU seems safe, but its efficacy is questionable, and further research is warranted.

A search of peer reviewed literature through May 2010 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

2012 Update

At the time of this update, the peer-reviewed published literature addressing HIFU consists of case series and other types of non-randomized studies. Two controlled trials were available, Beerlage et al. and Chaussy et al.

Beerlage et al. (12) conducted a controlled trial at a University Hospital in the Netherlands in 1999. In 14 patients treated with HIFU before radical prostatectomy, complete necrosis was seen in the treated region in all cases. On the dorsal border, however, incomplete destruction of tissue was noted, and in 4 cases a small vital tumor focus was seen. In the second group, of those patients in whom the entire prostate was treated, a negative biopsy result and a prostate-specific antigen (PSA) level less than 4 ng/mL was obtained in 60% and a PSA nadir less than 0.5 ng/mL in 55% of patients. The study concluded that HIFU treatment results in the two groups clearly demonstrated the potential of this modality in the treatment of localized prostate carcinoma. This study showed that extensive coagulative necrosis can be obtained in the treated areas; however, exact targeting is crucial and a prerequisite for extended clinical application of HIFU. There were no short- or long-term follow-up data available.

A German study, Chaussy et al. (13), was conducted to evaluate the impact of a combined transurethral resection of the prostate (TURP) and HIFU. In all, 271 patients were selected for 2 groups (non-randomized): 96 in the HIFU group and 175 in the TURP plus HIFU group. A statistically significant impact was observed on catheter time (40.0 days versus 7.0 in median), incontinence (15.4% versus 6.9%), urinary infection (47.9% versus 11.4%), and the evolution of the post-treatment International Prostate Symptom Score (IPSS) (8.91 versus 3.37 in average) in favor of the TURP plus HIFU group. No significant changes were observed regarding efficacy during short-term follow-up when considering a 25% retreatment rate in the HIFU group versus a 4% retreatment rate in the TURP plus HIFU group. The combination of a TURP and HIFU treatment reduces the treatment-related morbidity significantly. The patient management after a combined TURP and HIFU treatment is comparable with the management after a single TURP. This study also did not report short- or long-term follow-up data to evaluate morbidity and mortality.

Warmuth et al. (14) performed a systematic review to assess the efficacy and safety of HIFU in both primary treatment of men with localized and locally advanced prostate cancer as well as salvage treatment of men with recurrent prostate cancer following treatment failure of radical prostatectomy or external-beam radiation therapy. They searched for studies conducted on humans and published in either English or German in several databases from 2000 to 2010. In addition, they screened several Web sites for assessments on HIFU in prostate cancer and contacted the manufacturers of the two currently available HIFU devices for supplemental information on HIFU; they included all prospective studies with >50 study participants and assessed their quality using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. In all, they identified 20 uncontrolled prospective case series, each of which treated between 58 and 517 patients. These studies were all conducted within the stated decade. In total, 3018 patients were treated with HIFU, 93% for primary therapy and 7% for salvage HIFU. For all HIFU procedures, the biochemical disease-free survival rate at 1, 5, and 7 years, respectively, was 78-84%, 45-84%, and 69%. The negative biopsy rate was 86% at 3 months and 80% at 15 months. Overall survival rates and prostate cancer-specific survival rates were 90% and 100% at 5 years and 83% and 98% at 8 years, respectively. Adverse events concerned the urinary tract (1-58%), potency (1-77%), the rectum (0-15%), and pain (1-6%). Quality-of-life assessment yielded controversial results. They concluded that, applying the GRADE approach, the available evidence on efficacy and safety of HIFU in prostate cancer is of very low quality, mainly due to study designs that lack control groups. More research is needed to explore the use of HIFU in prostate cancer.

The clinical trials mentioned in the 2010 update above are still in progress. There are many more trials listed in the ClinicalTrials.gov database, for prostate cancer as well as other cancers and indications; however, none are completed or reporting results.

The American Cancer Society’s 2012 Prostate Cancer Guide identifies new treatments for early stage cancers, stating “[HIFU] 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 underway to determine its safety and effectiveness.” (15)

The American College of Radiology (ACR) Appropriateness Criteria for Locally Advanced (High-Risk) Prostate Cancer (last reviewed 2011) lists HIFU under “Other Therapies;” they indicate that further analysis of HIFU would clarify the efficacy. (16)

The National Comprehensive Cancer Network (NCCN) 2012 Prostate Cancer Guidelines do not mention HIFU. (17)

The National Institute for Health and clinical Excellence (NICE) issued an April 2012 Interventional Guidance on HIFU. The Guidance states that current evidence on safety of HIFU does not raise any major safety concerns. However, “evidence on efficacy is limited in quantity and there is a concern that prostate cancer is commonly multifocal. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research;” NICE encourages further research. (18)

A search of peer reviewed literature through June 2012 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

Coding

Disclaimer for coding information on Medical Policies          

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.           

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.           

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

ICD-9 Codes

Experimental, investigational and unproven for all diagnoses.

ICD-10 Codes

Experimental, investigational and unproven for all diagnoses.

Procedural Codes: 55899, 76872, 76999
References
  1. Chinn, D.O. Transrectal HIFU: the next generation?  Prostate Cancer research Institute (PCRI) (2005 February) 8(1) (Also, 2006 June update) Available at: www.prostate-cancer.org (Accessed on 6/19/2008).
  2. Barqawi AB, and ED Crawford. Emerging role of HIFU as a noninvasive ablative method to treat localized prostate cancer. Oncology (Williston Park) (2008 Feb) 22(2):123-9; discussion 129, 133, 137 passim.
  3. Rebillard X, Soulie M, et al. High-intensity focused ultrasound in prostate cancer; a systematic literature review of the French Association of Urology. British Journal of Urology International (2008 May) 101(10):1205-13.
  4. About Ablatherm. HIFU Maple Leaf HIFU Co. Available at www.hifu.ca (Accessed on 6/20/2008).
  5. HIFU Treatment with Ablatherm. The HIFU Clinic Patient information. Available at <www.hifu.org.uk> (Accessed on 6/20/2008).
  6. Sonablate®500. Focus Surgery Inc. Available at www.focus-surgery.com (Accessed on 6/20/2008).
  7. Ablatherm integrated imaging high intensity focused ultrasound for the indication of low risk prostate cancer. Clinical trial NCT00295802. Sponsored by EDAP TMS S.A. Available at www.clinicaltrials.gov (Accessed on 6/23/2010).
  8. Ultrasound in treating patients with recurrent stage I or stage II prostate cancer. Clinical trial NCT00005075. Sponsored by EDAP Technomed. Available at www.clinicaltrials.gov (Accessed on 6/23/2010).
  9. Pivotal study of the Sonablate®500 HIFU treatment of localized prostate cancer (set pace). Clinical trial NCT00485381. Sponsored by Focus Surgery. Available at www.clinicaltrials.gov (Accessed on 6/23/2010).
  10. High Intensity Focused Ultrasound. Cancer Research UK. (2008 July 21) Available at www.cancerhelp.org.uk (Accessed on 7/21/2008).
  11. Park MY, Jung SE, et al. Preliminary experience using high intensity focused ultrasound for treating liver metastasis from colon and stomach cancer. Int J Hyperthermia. 2009 May; 25(3):180-8.
  12. Beerlage HP, Thüroff S, et al. Transrectal high-intensity focused ultrasound using the Ablatherm device in the treatment of localized prostate carcinoma. Urology 1999 August; 54(2):273-7.
  13. Chaussy C and S Thüroff. The status of high-intensity focused ultrasound in the treatment of localized prostate cancer and the impact of a combined resection. Curr Urol Rep 2003 June; 4(3):248-52.
  14. Warmuth M, Johansson T, et al. Systematic review of the efficacy and safety of high-intensity focussed ultrasound for the primary and salvage treatment of prostate cancer. Eur Urol. 2010 December; 58(6):803-15. Epub 2010 Sep 17.
  15. Prostate Cancer: What’s New in Prostate Cancer Research? American Cancer Society February 27, 2012. Available at www.cancer.org (accessed 7/26/2012).
  16. Ciezki JP, Merick G, et al. ACR Appropriateness criteria: Locally advanced (high-risk) prostate cancer. American College of Radiology. 1996 (last review date 2011). Available at www.acr.org (accessed 7/26/2012).
  17. Mohler JL, Armstrong AJ, et al. Prostate Cancer. NCCN Clinical Practice in Oncology (NCCN Guideline) version 3.2012.
  18. Focal therapy using high-intensity focused ultrasound for localized prostate cancer. NICE Interventional Procedure Guideline 424. National Institute for Health and Clinical Excellence. April 2012. Available at www.guidance.nice.org.uk  (accessed 7/26/2012).
History
July 2013  New 2013 BCBSMT medical policy.  High-intensity focused ultrasound (HIFU) is considered experimental, investigational and unproven for treatment of cancer.
BCBSMT Home
®Registered marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. ®LIVE SMART. LIVE HEALTHY. is a registered mark of BCBSMT, an independent licensee of the Blue Cross and Blue Shield Association, serving the residents and businesses of Montana.
CPT codes, descriptions and material only are copyrighted by the American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS Restrictions Apply to Government Use. CPT only © American Medical Association.
High-Intensity Focused Ultrasound (HIFU) for Treatment of Cancer