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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:
- Pancreas, or
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.
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.
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.
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.
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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.