Pending Policies - Surgery


High-Intensity Focused Ultrasound (HIFU) for Treatment of Cancer

Number:SUR717.014

Effective Date:05-15-2018

Coverage:

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High-intensity focused ultrasound (HIFU) is considered experimental, investigational and/or unproven for the treatment of cancer, including but not limited to:

Prostate,

Kidney,

Liver, or

Pancreas.

Description:

High intensity focused ultrasound (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 but not limited to kidney, liver, and pancreas cancer.

Regulatory Status

Sonablate® 450 (SonaCare Medical; Focus Surgery, Inc.) has obtained 510(K) Food and Drug Administration (FDA) clearance in the U.S. under a De Novo regulatory classification which is an evaluation of automatic class III designation.

Sonablate® 500, (SonaCare Medical; Focus Surgery, Inc.) is manufactured by SonaCare Medical, Inc. (Charlotte, NC) and Misonix, Inc. (Farmingdale, NY) and is approved by the FDA as an investigational device for clinical trials in the U.S.

Sonatherm® laparoscopic HIFU surgical ablation system (SonaCare Medical; Focus Surgery, Inc.) has obtained 510(K) clearance in the U.S. and has a CE (Conformité Européene or European Conformity) mark and regulatory authorization in more than 30 countries outside the U.S.

Ablatherm Integrated Imaging HIFU device (EDAP Technomed, Inc., Austin, TX) was granted 510(k) marketing clearance by the FDA since it was determined to be substantially equivalent to the Sonablate device and is indicated for the ablation of prostate tissue.

Rationale:

This medical policy was originally created in November 2008 and has been updated periodically with searches of the MEDLINE database. The most recent literature update was performed through March 20, 2018. Following is a summary of the key literature to date.

Prostate Cancer

In February 2008, Barqawi et al. reviewed and summarized current knowledge about the basic principles of high-intensity focused ultrasound (HIFU) and its application as a radical and noninvasive, intent-to-treat ablative method for treating organ-confined prostate cancer. (1) 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. discussed 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. (2) They searched MedLine and Embase for clinical studies, and selected 37 articles, consisting of case series only. They concluded that HIFU achieved short-term cancer control, as shown by a high percentage of negative biopsies and significantly reduced prostate-specific antigen (PSA) levels. The median survival rate also seemed promising, but long-term follow-up studies are needed to further evaluate cancer-specific and overall survival rates before the indications for primary therapy can be expanded.

Warmuth et al. 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. (3) 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 (OS) 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.

In 2012, Cordeiro et al. provided a review of the available literature regarding HIFU for the treatment of prostate cancer. (4) Data was collected using MEDLINE and EMBASE from January 2000 to December 2011. English-language, human-based manuscripts that reported on case series studies with >50 participants, patient characteristics, efficacy and safety data were included. No randomized controlled trials (RCT) were identified. Thirty-one uncontrolled studies that examined the efficacy of HIFU as primary treatment and 2 studies that examined the efficacy of HIFU as salvage treatment were evaluated. Most treated patients had localized prostate cancer (stage T1-T2); Gleason scores of 2-10 and mean PSA values of 4.6-12.7 ng/mL. The mean age range of the patients was 64.1-72 years. The mean follow-up ranged from 6.4 to 76.8 months. Negative biopsy rates ranged from 35 to 95%. PSA nadirs ranged from 0.04 to 18 ng/mL. The 5-year disease free survival rates ranged from 61.2 to 95%; 7- and 8-year disease free survival rates ranged from 69 to 84%. The most common complications associated with the HIFU procedure as the primary treatment included: urinary retention (<1-20%); urinary tract infections (1.8-47.9%); stress or urinary incontinence (<1-34.3%); and erectile dysfunction (20-81.6%). Recto-urethral fistula was reported in <2% of patients. Treatment-related morbidity appeared to be reduced by the combination of transurethral resection (TURP) of the prostate and HIFU. The authors concluded that HIFU seems to result in short to medium term cancer control, with a low rate of complications comparable with those of established therapies. However, longer term follow-up studies are needed to evaluate cancer specific and OS. If available promising results on HIFU for definitive treatment of prostate cancer are confirmed in future prospective trials, focal therapy could start to challenge the current standard of care.

Uddin et al. (2012) assessed whole-gland salvage HIFU therapy for localized prostate cancer recurrence after external beam radiation therapy. (5) An evaluation was performed on a consecutive group of men with biochemical failure after external beam radiation therapy with histologically proven local recurrence and bone-scan and pelvic MRI to exclude macroscopic metastases, and who chose to have whole-gland salvage HIFU (Sonablate 500) at 2 centers (3 expert HIFU surgeons at each center). The modified Clavien system was used to categorize adverse events and validated questionnaires for functional outcomes. Progression following HIFU treatment was defined as ASTRO-Phoenix criteria (prostate serum antigen [PSA] >nadir+2 ng/mL) and/or a positive biopsy and/or start of hormone therapy. Eighty-four men underwent whole-gland salvage HIFU (2004-2009). Median age, pretreatment serum PSA, and biopsy Gleason score was 68 years (range, 64-72 years), 4.3 ng/mL (range, 1.9-7.9 ng/mL), and 7 (range, 6-7), respectively. Mean follow-up was 19.8 months (range, 3.0-35.1 months). After salvage HIFU, 62% of the men were pad-free and leak-free. Mean International Index of Erectile Function-5 point score fell from 8.8 to 4.7 (P < .001). International Prostate Symptoms Score and RAND-SF36 scores were not affected. Two men developed rectourethral fistulae after 1 salvage procedure. A further 2 fistulae occurred in the 6 men undergoing a second salvage HIFU. Intervention for bladder outlet obstruction was needed in 20% (17 of 84 patients). If PSA nonresponders were included, 1- and 2-year progression free survival rates were 59% (50 of 84 patients) and 43% (36 of 84 patients), respectively. If PSA nonresponders were excluded, 1- and 2-year progression free survival rates were 62% (48 of 77 patients) and 48% (37 of 77 patients), respectively. The research determined that salvage whole-gland HIFU is a high-risk procedure. Although its use in early cancer control is promising, strategies to better identify metastatic disease prior to salvage therapy and reduce local toxicity are needed to improve on this.

In 2015, Ramsay et al. aimed to determine the relative clinical effectiveness and cost-effectiveness of ablative therapies compared with radical prostatectomy (RP), external beam radiotherapy (EBRT) and active surveillance (AS) for primary treatment of localized prostate cancer, and compared with RP for salvage treatment of localized prostate cancer which has recurred after initial treatment with EBRT. (6) Evidence was drawn from RCTs and non-RCTs, and from case series. Reviewers identified 121 studies for inclusion in the review of patients undergoing primary treatment and nine studies for the review of salvage treatment.All studies were considered at high risk of bias. There was no robust evidence that mortality or other cancer-specific outcomes differed between treatments. For functional and quality-of-life outcomes, the paucity of data prevented any definitive conclusions from being made, although data on incontinence rates and erectile dysfunction for all ablative procedures were generally numerically lower than for non-ablative procedures. The safety profiles were comparable with existing treatments. The cost-effectiveness analysis confirmed the uncertainty from the clinical review and that there is no technology which appears superior, on the basis of current evidence, in terms of average cost-effectiveness. Reviewers concluded that the findings indicate that there is insufficient evidence to form any clear recommendations on the use of ablative therapies in order to influence current clinical practice. Research efforts in the use of ablative therapies in the management of prostate cancer should now be concentrated on the performance of RCTs and the generation of standardized outcomes.

Veereman et al. (2015) systematically evaluated the evidence on the efficacy and side effects of HIFU in the primary treatment of localized prostate cancer. (7) The review included one systematic review and 18 primary studies (all case reviews). Outcomes were summarized and evidence was evaluated using GRADE methodology. Low-quality evidence suggests an overall survival rate after Ablatherm HIFU ranging from 80% to 89% for >5 yr. The survival rate ranges from 97% to 99% for >5 yr. Effect of HIFU on quality of life remains undetermined. Erectile dysfunction was the most frequent adverse event reported from zero but up to 74% of patients. Adverse events affecting the urinary tract occurred in 0.7-31% of patients, bladder outlet obstruction in 4-51.5%, and they were more frequent in patients who had transurethral resection of the prostate the same day or within 2 days of HIFU. Outcomes varied for low- and high-risk categories. Reviewers concluded that good quality evidence on the efficacy of HIFU treatment for localized prostate cancer is lacking.

In 2017, Golan et al. performed a systematic review for partial gland treatment of prostate cancer using HIFU in the primary and salvage settings. (8) A total of 13 studies that enrolled 543 patients were included. Of the studies, 11 were performed in the primary setting and 2 in the salvage setting. Median follow-up ranged from 6 months to 10.6 years. Rates of posttreatment erectile dysfunction and urinary incontinence ranged from 0% to 48% and 0% to 50%, respectively, with definitions varying by study. Overall there were 254 reported complications. Marked heterogeneity between studies limited the ability to pool results regarding functional and oncologic outcomes. A total of 76 patients (14%) subsequently received further oncologic treatment. Reviewers concluded that early evidence suggests that partial gland ablation is a safe treatment option for men with localized disease. Longer term data are needed to evaluate oncologic efficacy and functional outcomes, and will aid in identifying the optimal candidates for therapy. Standardization of outcomes definitions will allow for better comparison between studies and among treatment modalities.

Practice Guidelines and Position Statements - Prostate Cancer

National Comprehensive Cancer Network

The National Comprehensive Cancer Network guidelines for prostate cancer (v.2.2018) recommend high-intensity focused ultrasound (HIFU) as an option for radiotherapy recurrence for nonmetastatic disease. (9)

The American Urological Association

The American Urological Association, along with the American Society for Radiation Oncology and the Society for Urologic Oncology, updated their joint guidelines on the management of clinically localized prostate cancer in 2017. (10) The guidelines included the following recommendation on focal treatments:

“Clinicians should inform low-risk prostate cancer patients who are considering focal therapy or high intensity focused ultrasound (HIFU) that these interventions are not standard care options because comparative outcome evidence is lacking. (Expert Opinion)”

“Clinicians should inform intermediate-risk prostate cancer patients who are considering focal therapy or HIFU that these interventions are not standard care options because comparative outcome evidence is lacking. (Expert Opinion)”

“Cryosurgery, focal therapy and HIFU treatments are not recommended for men with high-risk localized prostate cancer outside of a clinical trial. (Expert Opinion)”

The National Institute for Health and Clinical Excellence

The National Institute for Health and Care Excellence (NICE) issued guidance on the use cryoablation for localized prostate cancer in 2012. (11) NICE concluded that current evidence on focal therapy using cryoablation for localized prostate cancer raised no major safety concerns. However, evidence on efficacy is limited in quantity, with concern that prostate cancer is commonly multifocal.

NICE also issued guidance on the use of focal therapy using HIFU for localized prostate cancer in 2012. (12) It concluded that current evidence on HIFU for localized prostate cancer raises no major safety concerns. However, evidence on efficacy was limited in quantity, with concern that prostate cancer is commonly multifocal.

In 2014, NICE issued guidance on diagnosis and management of prostate cancer. The recommendations stated that neither cryotherapy or HIFU should be offered to men with localized prostate cancer or locally advanced prostate cancer outside of controlled trials comparing their use with established interventions. (13)

National Cancer Institute

In a 2018 Prostate Cancer Treatment health professional version Physician Data Query (PDQ), HIFU is listed as a new type of treatment being tested in clinical trials. (14) Although HIFU has been reported in case series to produce good local disease control, it has not been directly compared with more standard therapies, and experience with it is limited.

American Cancer Society

HIFU is mentioned as a newer treatment for early stage prostate cancer. The American Cancer Society states that new treatments could be used either as the first type of treatment or after radiation therapy in cases where it was not successful. HIFU treatment has been used in some European countries for a while, but it has just recently become available in the United States. Studies are now under way to determine its safety and effectiveness (15)

American College of Radiology

The American College of Radiology Appropriateness Criteria for Locally Advanced (High-Risk) Prostate Cancer indicates that while HIFU is a treatment option available for men with high-risk prostate cancer, data for this modality is limited. (16)

Kidney Cancer

No randomized controlled trials (RCT’s) were identified that support the safety and efficacy of HIFU for the treatment of renal cancer. In 2012, Olweny et al. provided an overview of the current research on renal tissue ablation. (17) Olweny stated, “Novel ablation technologies including microwave ablation, irreversible electroporation and high-intensity focused ultrasound among others have undergone preliminary preclinical and clinical evaluation in select series but require further development and assessment of outcomes prior to routine clinical use for renal tumor ablation.”

Practice Guidelines and Position Statements - Kidney Cancer

National Comprehensive Cancer Network (NCCN)

The 2018 National Comprehensive Cancer Network (NCCN) Guideline on Kidney Cancer (v3.2018) does not mention HIFU as a treatment option. (18)

Liver Cancer

In 2009, Park et al. (19) 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.

In 2013 Chan and associates (20) evaluated the survival rates of HIFU therapy versus radiofrequency ablation (RFA) in the treatment of recurrent hepatocellular carcinoma (HCC). The goal was to determine whether HIFU incurred a survival benefit similar to that of RFA. Data of 27 patients post HIFU ablation and 76 patients post RFA for recurrent HCC were reviewed from October 2006 to October 2009. Survival outcomes between the 2 groups were compared using the log-rank test. A value of P < 0.05 was considered significant. The median follow-up was 27.9 months. There was no difference in tumor size (HIFU, 1.7 cm; RFA, 1.8 cm; P = 0.28) between the 2 groups. Procedure-related morbidity rate was 7.4% in the HIFU group and 6.5% in the RFA group (P = 1.00). Skin burn and pleural effusion were the 2 morbidities associated with HIFU. There was no hospital mortality in the HIFU group, whereas 2 deaths occurred in the RFA group. The 1-, 2-, and 3-year disease free survival rates were 37.0%, 25.9%, and 18.5%, respectively, for the HIFU group, and 48.6%, 32.1%, and 26.5%, respectively for the RFA group (P = 0.61). The 1-, 2-, and 3-year overall survival rates were 96.3%, 81.5%, and 69.8%, respectively, for the HIFU group, and 92.1%, 76.1%, and 64.2%, respectively, for the RFA group (P = 0.19). The author concluded the preliminary experience using HIFU for recurrent HCC is promising. Further studies are needed to explore its treatment value for primary HCC.

Luo et al. (2017) published a meta-analysis evaluating the evidence (n=30 studies) for the therapeutic effects of RFA compared to other ablative techniques including HIFU microwave ablation, percutaneous ethanol injection, and cryoablation on hepatocellular carcinomas (HCC). (21) The review consisted of cohort studies (n=14), and RCTs (n=16), with a single cohort study (n=103 patients) only referring to HIFU versus RFA. Outcomes measured were complete tumor ablation, overall survival, local tumor recurrence, and rate of complications. No obvious difference in therapeutic effects was found between HIFU and RFA. Overall survival rates were > 60% and complete tumor ablation were > 80% in both groups (p>0.05). Procedure-related complications were also comparable in both groups (p=0.06). The small amount of evidence on HIFU for HCC did not allow for meta-analysis. The authors noted that in general, additional well-designed RCTs are needed to support study results.

Practice Guidelines and Position Statements - Liver Cancer

National Comprehensive Cancer Network (NCCN)

The 2018 NCCN Guideline on Hepatobiliary Cancer (v1.2018) does not mention HIFU as a treatment option. (22)

Pancreas Cancer

In 2010, Zhao et al. (23) conducted a phase II trial to evaluate the safety and efficacy of concurrent gemcitabine and HIFU therapy in patients with locally advanced pancreatic cancer. Patients with localized unresectable pancreatic adenocarcinoma in the head or body of the pancreas received gemcitabine (1000 mg/m) intravenously over 30 min on days 1, 8, and 15, and concurrent HIFU therapy on days 1, 3, and 5. The treatment was given every 28 days. Thirty-seven (94.9%) of the 39 patients were assessable for response, and two cases of complete response and 15 cases of partial response were confirmed, giving an overall response rate of 43.6% [95% confidence interval (CI), 28.0-59.2%]. The median follow-up period was 16.5 months (range: 8.0-28.5 months). The median time to progression (TTP) and overall survival (OS) for all patients were 8.4 months (95% CI, 5.4-11.2 months) and 12.6 months (95% CI, 10.2-15.0 months), respectively. OS at 12 and 24 months were 50.6% (95% CI, 36.7-64.5%) and 17.1% (95%CI, 5.9-28.3%). A total of 16.2% of patients experienced grade 3/4 neutropenia. Grade 3 thrombocytopaenia was documented in 2 (5.4%) patients. Grade 3 nausea, vomiting and diarrhea were observed in 3 (8.1%), and 2 (5.4%) patients, respectively. Grade 1 or 2 fever was detected in 70.3% of patients. Twenty-eight patients (71.8%) complained of abdominal pain consistent with tumor-related pain before HIFU therapy. Pain was relieved in 22 patients (78.6%). In conclusion, concurrent gemcitabine and HIFU is a tolerated treatment modality with promising activity in patients with previously untreated locally advanced pancreatic cancer.

In 2011, Sung et al. (24) evaluated the safety and efficacy of HIFU for advanced pancreatic cancer (PC). Patients with PC TNM stage III or IV were included. The TNM Staging System is based on the extent of the tumor (T), the extent of spread to the lymph nodes (N), and the presence of metastasis (M). Magnetic resonance imaging (MRI) was performed 2 weeks before and after the HIFU. The ablating tumor volume was calculated by ratio of the nonperfused necrotic area of the planned area on contrast enhanced T1 weighted image on post HIFU MRI. The ablation results were stratified into 4 ranges: 100% to 90% unenhanced area of targeting area, 90% to 50%, within 50% and no change. High-intensity focused ultrasound treatment was performed without severe adverse event in 46 patients, 49 times (male-female = 25:21; mean age, 60.7 ± 10.0; TNM stage 3-stage 4 = 18:28). Average size of the PC lesion was 4.2 ± 1.4 cm (1.6-9.3 cm). After HIFU treatment, ablating tumor volume was as follows: 90% to 100% in 38 lesions, 90% to 50% in 8, and within 50% in 3. Overall median survival (S1) from initial PC diagnosis was 12.4 months. Overall survival rates at 6, 12, and 18 months from HIFU were 52.2%, 30.4%, and 21.79%, respectively, with a median survival of 7.0 months. The study concluded that HIFU is safe and effective, which induced excellent local tumor control in most patients with advanced PC.

In 2017, Li et al. explored the efficacy and safety of HIFU combined with other physical therapies for the treatment of pancreatic cancer. (25) A total of 23 studies including 19 RCTs and four clinical controlled trials were included, of which 14 studies reported the safety. The results of meta-analyses showed that: the survival rate at 6 months and 12 months, overall efficacy, and clinical benefit rate in HIFU plus radiation and chemotherapy group were significantly higher than those in groups treated with three-dimensional conformal radiation therapy (P < 0.05), gemcitabine (P < 0.05), gemcitabine plus cisplatin (P < 0.05), and gemcitabine plus 5-fluorouracil (P < 0.05). The adverse effect caused by HIFU plus other therapy was equal to those in the control group. The major HIFU-related adverse effect was skin damage and fever. Reviewers concluded that the current evidence suggests that the efficacy of HIFU for pancreatic cancer was superior to other therapies. However, the poor quality of trials may reduce the reliability of outcome to some extent. Additionally, the efficacy of HIFU for pancreatic cancer was superior to other therapies, but with poor quality. Therefore, a standard and unified criterion for the diagnosis and outcome measures of pancreatic cancer is needed, and the quality of study design and implementation should be bettered, so as to improve the high quality of evidence for its clinical application.

Practice Guidelines and Position Statements - Pancreatic Cancer

National Comprehensive Cancer Network (NCCN)

The 2017 NCCN Guideline on Pancreatic Adenocarcinoma (v3.2017) does not mention HIFU as a treatment option. (26)

Summary of Evidence

The evidence for high-intensity focused ultrasound (HIFU) for treatment of cancer consists primarily of case series and small non-randomized comparative trials. Currently there is insufficient data to evaluate the effects of this technology on health outcomes. The long-term safety and efficacy of HIFU compared to established interventions for various cancer diagnoses such as kidney, liver and pancreatic cancer, has not been proven in published literature. Therefore, HIFU is considered experimental, investigational and/or unproven for treatment of cancer.

Contract:

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.

Coding:

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.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

55899, 76872, 76999

HCPCS Codes

C9747

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Barqawi AB, Crawford ED. Emerging role of HIFU as a noninvasive ablative method to treat localized prostate cancer. Oncology (Williston Park). 2008 Feb; 22(2);123-9. PMID 18409659

2. Rebillard X, Soulie M, Chartier-Kastler E, et al. High-intensity focused ultrasound in prostate cancer; a systematic literature review of the French Association of Urology. BJU Int. 2008 May; 101(10):1205-13. PMID 18325057

3. Warmuth M, Johansson T, Mad P. Systematic review of the efficacy and safety of high-intensity focussed ultrasound for the primary and salvage treatment of prostate cancer. Eur Urol. 2010 Dec; 58(6):803-15. PMID 20864250

4. Cordeiro ER, Cathelineau X, Thüroff S, et al. High-intensity focused ultrasound (HIFU) for definitive treatment of prostate cancer. BJU Int. 2012 Nov; 110(9):1228-42. PMID 2672199.

5. Uddin Ahmed H, Cathcart P, Chalasani V, et al. Whole-gland salvage high-intensity focused ultrasound therapy for localized prostate cancer recurrence after external beam radiation therapy. Cancer. 2012 Jun 15; 118(12):3071-3078. PMID 22071795

6. Ramsay CR, Adewuyi TE, Gray J. Ablative therapy for people with localised prostate cancer: a systematic review and economic evaluation. Health Technol Assess. 2015 Jul: 19(49):1-490. PMID 26140518

7. Veereman G, Jonckheer P, Desomer A, et al. Systematic Review of the Efficacy and Safety of High-intensity Focussed Ultrasound for Localised Prostate Cancer. Eur Urol Focus. 2015 Sep; 1(2):158-170. PMID 28723429

8. Golan R, Bernstein AN, McClure TD, et al. Partial Gland Treatment of Prostate Cancer Using High-Intensity Focused Ultrasound in the Primary and Salvage Settings: A Systematic Review. J Urol. 2017 Nov; 198(5):1000-1009. PMID 28433640

9. National Comprehensive Cancer Network (NCCN) Clinical Practice Guideline for Prostate Cancer. V2.2018. Available at: <http://<www.nccn.org> (accessed March 20, 2018).

10. Sanda MG, Chen RC, Crispino T, et al. Clinically Localized Prostate Cancer: AUA/ASTRO/SUO Guideline. 2017. Available at: <http://www.auanet.org> (accessed March 20, 2018).

11. National Institute for Health and Care Excellence (NICE). Focal Therapy Using Cryoablation for Localised Prostate Cancer [IPG423]. 2012. Available at: <https://www.nice.org.uk> (accessed March 20, 2018).

12. National Institute for Health and Care Excellence (NICE). Focal Therapy Using High-Intensity Focused Ultrasound for Localized Prostate Cancer [IPG424]. 2012. Available at: < http://www.nice.org.uk> (accessed March 20, 2018).

13. National Institute for Health and Care Excellence (NICE). Prostate cancer: diagnosis and management [CG175]. 2014. Available at: <https://www.nice.org.uk> (accessed March 20, 2018).

14. National Cancer Institute (NCI). Prostate Cancer (PDQ®): Treatment. Health Professional Version. Modified February 6, 2018. Available at: <http://www.cancer.gov> (accessed March 20, 2018).

15. American Cancer Society (ACS). What’s new in prostate cancer research and treatment? Last reviewed Feb 16, 2016 and revised Mar 11, 2016. Available at: <http://www.cancer.org> (accessed March 20, 2018).

16. Merick G, et al. ACR Appropriateness criteria: Locally advanced (high-risk) prostate cancer. American College of Radiology. 1996 (last review date 2016). Available at: <http://www.acr.org> (accessed March 20, 2018).

17. Olweny EO, Cadeddu JA. Novel methods for renal tissue ablation. Curr Opin Urol. 2012 Sep; 22(5):379-84. PMID 22706069

18. National Comprehensive Cancer Network. (NCCN) Clinical Practice Guideline for Kidney Cancer. V3.2018. Available at: <http://<www.nccn.org> (accessed March 20, 2018).

19. Park MY, Jung SE, Cho SH, 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. PMID 19212862

20. Chan AC, Cheung TT, Fan ST, et al. Survival analysis of high-intensity focused ultrasound therapy versus radiofrequency ablation in the treatment of recurrent hepatocellular carcinoma. Ann Surg. 2013 Apr; 257(4):686-92. PMID 23426335

21. Luo W, Zhang Y, He G, et al. Effects of radiofrequency ablation versus other ablating techniques on hepatocellular carcinomas: a systematic review and meta-analysis. World J Surg Oncol. 2017 Jul 10; 15(1):126. PMID 28693505

22. National Comprehensive Cancer Network. (NCCN) Clinical Practice Guideline for Hepatobiliary Cancer. V1.2018. Available at: <http://<www.nccn.org> (accessed March 20, 2018).

23. Zhao H, Yang G, Wang D, et al. Concurrent gemcitabine and high-intensity focused ultrasound therapy in patients with locally advanced pancreatic cancer. Anticancer Drugs. 2010 Apr; 21(4):447-52. PMID 20075714

24. Sung HY, Jung SE, Cho SH, et al. Long-term outcome of high-intensity focused ultrasound in advanced pancreatic cancer. Pancreas. 2011 Oct; 40(7):1080-6. PMID 21926543

25. Li CC, Wang YQ, Li YP, et al. High-intensity focused ultrasound for treatment of pancreatic cancer: a systematic review. J Evid Based Med. 2014 Dec; 7(4):270-81. PMID 25586458

26. National Comprehensive Cancer Network (NCCN) Clinical Practice Guideline for Pancreatic Adenocarcinoma. V3.2017. Available at: <http://<www.nccn.org> (accessed March 20, 2018).

27. Focal Treatments for Prostate Cancer. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2017 September) Therapy 8.01.61.

Policy History:

Date Reason
5/15/2018 Document updated with literature review. Coverage unchanged. References 6-8, 11, 13-14, 21, 25 added.
3/1/2017 Reviewed. No changes.
4/1/2016 Document updated with literature review. Coverage unchanged.
2/1/2015 Document updated with literature review. Rationale significantly revised. Coverage unchanged.
9/1/2012 Document updated with literature review. Coverage unchanged.
8/1/2010 Document updated with literature review. Coverage unchanged.
11/15/2008 New medical document

Archived Document(s):

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