National Medical Policy

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1 National Medical Policy Subject: Policy Number: Laser Ablation (Interstitial Laser Coagulation) for Treatment of Localized Breast Cancer NMP416 Effective Date*: March 2008 Updated: December 2015 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State s Medicaid manual(s), publication(s), citation(s), and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link National Coverage Determination (NCD) National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* Other X None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Laser Ablation for Treatment of Breast Cancer Dec 15 1

2 Current Policy Statement Health Net, Inc. considers laser ablation (i.e., interstitial laser coagulation, interstitial laser therapy, interstitial laser photocoagulation, laser-induced interstitial thermal therapy) for the treatment of small breast tumors, (benign or malignant), investigational due to a lack of evidence in the peer review published literature to demonstrate the safety and efficacy of laser therapy for this indication. Both large randomized controlled trials and studies comparing interstitial laser coagulation to conventional excisional biopsy or lumpectomy are lacking. Definitions ILT ILC ILP LITT ABLATE Interstitial laser therapy Interstitial laser coagulation Interstitial laser photocoagulation Laser-induced interstitial thermal therapy American Breast Laser Ablation Therapy Evaluation Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets. ICD-9 Codes Malignant neoplasm of female breast Malignant neoplasm of male breast Secondary malignant neoplasm of breast 217 Benign neoplasm of breast Carcinoma in situ of breast Neoplasm of uncertain behavior of breast Neoplasm of unspecified nature, breast ICD-10 Codes C Malignant neoplasm of breast C C79.81 Secondary malignant neoplasm of breast D Carcinoma in situ of breast D05.92 D24.1- Benign neoplasm of breast D24.9 D Neoplasm of uncertain behavior of breast D48.62 CPT Codes Unlisted procedure, breast HCPCS Codes N/A Scientific Rationale Update December 2015 Laser Ablation for Treatment of Breast Cancer Dec 15 2

3 National Cancer Comprehensive Network (NCCN) clinical practice guidelines on breast cancer (V ) do not mention laser ablation for the treatment of localized breast cancer. There is a Clinical Trial on Local Treatment by Thermic Destruction of Primitive Breast Cancer (LASERBREAST1) which is currently recruiting participants. The ClinicalTrials.gov Identifier is NCT and it was last updated on October 20, The purpose of the study is to demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating with histological analysis of the specimen the percentage of tumor cells remaining in the area treated by the laser. The estimated primary completion date is December There are a number of ongoing Clinical Trials on laser ablation of breast tumors that have not been completed yet. Yang et al. (2015) completed a study with the purpose to describe the follow-up ultrasound (US) findings of percutaneous US-guided laser ablation for small benign breast lesions, and to define the procedural success. There are limited reports on follow-up imaging after laser ablation, because the ablated tumors were generally resected by surgery. US-guided laser ablation was performed on 19 benign breast lesions in 10 patients. The median size of the lesions was 7.8mm (range, 3-11mm). The lesions were diagnosed as image-pathology concordant benign by US-guided core biopsy. After ablation, follow-up US was performed with an interval of 3-12 months; the median follow-up period was 32 months (range, months). The morphologic and size changes were evaluated by using serial follow-up US. US findings of the 13 cases followed within the first 6 months after ablation showed hypoechoic lesions having inner hyperechogenicity with or without a hypoechoic center. The size of these lesions during this period increased in comparison with the initial lesion size, and then decreased or became stable on serial follow-up US. On the last follow-up US examination, in 14 cases (73.6%), the lesions were invisible, 4 cases (21.1%) showed scar changes, and 1 case (5.3%) showed a hypoechoic remnant lesion. US findings within 6 months after laser ablation showed mixed echoic lesions with increased size, followed by gradual decrease in size. This study notes that the success of laser ablation may be evaluated by checking the changes in the lesions by comparing the size of the lesions with the first follow-up US within 6 months and not the original tumor. However, this is a very small study of only 10 patients. Additional, larger, peer-reviewed comparative studies are necessary to determine the efficacy of laser ablation for the treatment of breast lesions. Scientific Rationale Update December 2014 National Cancer Comprehensive Network (NCCN) clinical practice guidelines on breast cancer (V ) do not mention laser ablation for the treatment of localized breast cancer. The position statement from the American Society of Breast Surgeons on Ablative and Percutaneous Treatment of Breast Cancer has not been updated since its approval in Per the position statement, Until such a time that safety and efficacy of these techniques are ascertained, ablative and percutaneous excisional treatments for breast cancer are investigational and should not be performed outside the realm of clinical research trials. A observational study, the American Breast Laser Ablation Therapy Evaluation (ABLATE), is currently recruiting participants (ClinicalTrials.gov Identifier: NCT ). The purpose of this patient tracking program is to monitor long term safety and effectiveness of the Novilase device and method in real world application. Laser Ablation for Treatment of Breast Cancer Dec 15 3

4 Another study recruiting participants is the multicenter "Ablate and Resect" Study of Novilase Interstitial Laser Therapy for the Ablation of Small Breast Cancers (ClinicalTrials.gov Identifier:NCT ). This study will determine the rate of complete tumor ablation of small breast cancers ( 20mm) by Novilase Interstitial Laser Therapy (ILT), and determine the sensitivity and specificity of imaging (MRI, mammography and ultrasound) in detecting residual tumor post ILT ablation as correlated to histopathology from the post-ablation excision. Scientific Rationale Update December 2013 There continues to be no mention of Laser Ablation (Interstitial Laser Coagulation) for Treatment of Localized Breast Cancer in the NCCN Guidelines on Breast Cancer (Version 3, 2013). Scientific Rationale Update December 2012 The 2012 clinical practice guidelines on breast cancer from the National Cancer Comprehensive Network (NCCN) do not mention laser ablation for the treatment of localized breast cancer. Zhao et al. (2010) completed a broad search that was conducted in Pubmed, Embase and the Cochrane databases between January 1990 and December Clinical results of the relevant articles were collected and analyzed. The analyzed studies were almost all feasibility or pilot studies using different energy sources, patients, tumor characteristics and ablation settings. They were conducted in research settings for the assessment of technical safety and feasibility, and none of those was used alone in clinical practice. Despite many methodological differences, complete tumor ablation could be achieved in % of breast cancer patients treated with radiofrequency ablation, 13-76% in laser ablation, 0-8% in microwave ablation, 36-83% in cryoablation, and % in high-intensity focused ultrasound ablation. Minimally-invasive thermal ablation is a promising new tool for local destruction of small carcinomas of the breast. Large randomized control studies are required to assess the long-term advantages of minimally-invasive thermal ablation techniques compared to the current breast conserving therapies. There are currently no ongoing Clinical Trials on laser ablation for the treatment of localized breast cancer. There continues to be a paucity of peer-reviewed medical literature to support laser ablation for localized breast cancer. Scientific Rationale Update December 2011 The 2011 clinical practice guidelines on breast cancer from the National Cancer Comprehensive Network (NCCN) do not mention laser ablation for the treatment of localized breast cancer. There are no ongoing Clinical Trials on Laser Ablation for the Treatment of Localized Breast Cancer at this time. There continues to be a paucity of peer-reviewed scientific evidence to support laser ablation for the treatment of localized breast cancer. Scientific Rationale Update March 2011 At this time, there is a paucity of data in the peer review literature regarding interstitial laser therapy for the treatment of small breast cancers or breast fibroadenomas. Laser Ablation for Treatment of Breast Cancer Dec 15 4

5 An ongoing trial, the American Breast Laser Ablation Therapy Evaluation (ABLATE): Monitoring the Long Term Safety and Efficacy of Novilase Breast Interstitial Laser Therapy in Real World Application, sponsored by Novian Health Inc continues to evaluate clinical outcomes from patients undergoing Novilase for benign breast conditions (i.e. fibroadenomas, papillomas, etc). Data captured will assess the potential advantages and disadvantages of the procedure as compared with lumpectomy. Tumor characteristics, equipment used, complications, patient satisfaction and cosmesis ratings will also be tracked. Estimated Study Completion Date is December 2012 Scientific Rationale Update March 2010 Peer review published literature continues to be limited. In a very small feasablility study reported by van Esser et al (2009), fourteen patients with large-core needle biopsy-proven invasive, palpable breast carcinoma (clinically < 2 cm) underwent ultrasound-guided laser-induced thermal therapy (LITT), followed by surgical excision. Completeness of ablation was determined by both hematoxylin and eosin staining and nicotinamide adenosine diaphorase staining. The mean histological tumor size was 17 mm (range, 8-37 mm); 6 of 14 tumors were histologically larger than the clinical entry threshold of 2 cm. The power applied in all patients was 7 W, and the mean treatment time was 21.4 min. In one patient, a skin burn occurred, and one patient had a localized pneumothorax that was treated conservatively. In 7 (50%) of 14 patients, the tumor was completely ablated, as confirmed by nicotinamide adenosine diaphorase staining. In 11 cases, extensive in-situ carcinoma was present. In one case, the in-situ carcinoma was also completely ablated. A total of seven (88%) of eight tumors <2 cm in size were completely ablated versus one (17%) of six tumors that were > 2 cm in size (P =.026). The investigator concluded that successful LITT of invasive breast cancer seems to be feasible when confined to small (<2 cm) nonlobular carcinomas without surrounding extensive in-situ component and angioinvasion. The authors further noted that to implement LITT in a curative setting, improvements in imaging to more reliably preoperatively assess tumor size and monitoring of fiber tip placement and treatment affect are essential. The prospective, observational multi-center study evaluating the clinical outcomes of Novilase for benign breast fibroadenomas versus lumpectomy, [American Breast Laser Ablation Therapy Evaluation (ABLATE)], is ongoing and continues to recruit individuals. The estimated study completion date is December Scientific Rationale Update July 2009 A variety of minimally invasive therapies have been applied to the treatment of breast lesions. These therapies include thermal treatments (interstitial laser coagulation, focused ultrasound, radiofrequency and cryotherapy), percutaneous excision, and interstitial radiotherapy. Interstitial laser coagulation (ILC) is also known as interstitial laser therapy (ILT), interstitial laser photocoagulation (ILP), and laser-induced interstitial thermal therapy (LITT). This technique utilizes needle probes to deliver laser energy into the tumor to slowly heat and destroy the localized tumor cells and fibroids. It has been proposed as a microinvasive alternative to lumpectomy for small breast tumors, including benign growths such as fibroadenomas that are 2 cm or less in size, as well as localized breast cancers. The interstitial laser coagulation or therapy system includes the following steps: 1. The breast is compressed similar to a mammogram; Laser Ablation for Treatment of Breast Cancer Dec 15 5

6 2. A small nick is made on the breast above the lesion; 3. A laser probe is inserted into the breast through the nick; 4. A laser fiber is inserted into the probe through the center of the lesion. 5. A thermal probe is inserted into the side of the lesion, which is then destroyed by the laser. Potential advantages of laser ablation compared to surgical excision include: Shorter procedure time; Outpatient / ambulatory surgery setting; Precise tissue ablation, smaller incision and minimal scarring, less bleeding and tissue damage; Lowered risk of infection due to heat sterilization of surrounding tissue; and Decreased healing time. Potential disadvantages of interstitial laser coagulation versus conventional excision include: A second treatment may be required to completely eliminate the fibroma or adenoma; Local burns at the needle site; Local infection; and Bleeding if the needle strikes a blood vessel. U.S. Food and Drug Administration (FDA) In June 2007, Novian Health, Inc. developed an Interstitial Laser Therapy (ILT) device known as Novilase, used to treat fibroadenomas of the breast with tumors <2cm in size. This device was previously known as Kelsey Interstitial Laser Therapy System. It received 510 marketing clearance from the U.S. Food and Drug Administration on May 2, 2007 with the 510K number, K Several other laser systems have been cleared by the FDA for the ablation of soft tissue tumors, however not specifically approved for the treatment of breast tumors. The FDA opened a comment period until November 2008 regarding the formation of a registry for patients treated by thermal-ablation breast cancer therapies. The object is to facilitate comparison of trials that investigate local treatment of small breast cancers with different thermal-ablation devices. The FDA is interested in standardized protocols for evaluating thermal-ablation methods with regard to patient parameters, tumor characteristics, device mode and attributes, treatment procedures, follow-up, and other variables. Patients receiving ILT for treatment of benign tumors are not included in the scope of the proposed registry at this time. Breast Fibroadenomas Breast fibroadenomas are benign solid tumors that develop in the fibrous subcutaneous connective tissue of the breast, and are thought to result from an increased sensitivity to estrogen. Fibroadenomas of the breast are relatively common Laser Ablation for Treatment of Breast Cancer Dec 15 6

7 and generally occur most frequently in women under the age of 35, with incidence peaking in the late 20 s. In addition, these benign growths tend to occur more frequently and at an earlier age in black women than in white women. Fibroadenomas normally grow to 1 to 5 cm in diameter, and multiple tumors in one or both breasts may be found in 10-15% of patients. For patients with a fibroadenoma smaller than 2 cm, complete resolution can be expected in 2/3 of the patients at 6 months and 3/4 by 12 months. The diagnosis of fibroadenoma is best confirmed with a core biopsy or excisional biopsy, for lesions larger than 2cm. Ultrasound alone or fine needle aspiration cannot differentiate between a fibroadenoma and a phyllodes tumor, which is a very rare type of breast tumor that can be benign or malignant. In some instances, particularly when excision may produce an undesirable cosmetic appearance, watchful waiting may be appropriate. Fibroadenomas are usually managed conservatively, with periodic ultrasound evaluation, after the initial diagnosis is established. Professional Society Recommendations No professional medical society recommends the use of interstitial laser coagulation or therapy, for breast tumors. Excisional biopsy is considered the gold standard for evaluating breast masses and it is both diagnostic and therapeutic. A completely removed mass with good margins of normal tissue may mean that further surgery is not required. (1998) Recommendations by the Canadian Association of Radiation Oncologists on the palpable breast lump stated: Whenever reasonable doubt remains as to whether a lump is benign or malignant, a biopsy to remove the entire lump in one piece along with a surrounding cuff of normal tissue for cytological examination should be carried out. (2005) Recommendations from the National Institute for Clinical Excellence (NICE) concluded the following: "Current evidence on the safety and efficacy of interstitial laser therapy for fibroadeomas of the breast does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research." The NICE assessment noted that adverse events include local burns at the needle site and theoretical complications include local infection, and bleeding if the needle strikes a blood vessel. Furthermore, the specialist advisors noted that the lack of material for biopsy means that the benign diagnosis cannot be confirmed. (2008) The American Society of Breast Surgeons note: The traditional management options available to women diagnosed with a fibroadenoma include observation or surgical excision. Two newer approaches, percutaneous excision and in situ cryoablation, have been developed and are less invasive than surgical excision. The American Society of Breast Surgeons does not note interstitial laser coagulation as an acceptable procedure for breast lesions. In most patients with fibroadenomas, the ideal approach is confirmation with percutaneous core biopsy and conservative follow-up. (2009) The National Comprehensive Cancer Network [NCCN} states: Laser Ablation for Treatment of Breast Cancer Dec 15 7

8 Lumpectomy with node dissection and radiation therapy is as effective as mastectomy and dissection for most stage I localized breast cancers. Studies Although a few groups have reported early results with laser treatment of breast tumors, no controlled or comparative trials to evaluate the interstitial laser coagulation verses conventional excision or lumpectomy have been completed. In addition, the studies that were done were small with no short or long-term follow up or outcomes to determine the efficacy and safety of the procedure. There was a small controlled non-randomized trial by Dowlatshahi et al. (2002) and a review done by the same author in 2004, as well as the studies noted below. Basu et al. (1999) completed an uncontrolled prospective study on 27 patients younger than 35 years, who received laser phototherapy for breast fibroadenomas. YAG laser was used in a continuous wave mode to produce interstitial hyperthermia. Follow-ups were done at 2, 4, and 8 weeks. There was a significant decrease in clinical and sonographic sizes (p < 0.001). There were minimal scars (2-3 mm) and no keloid or abscess formation. Excisional biopsy of residual lumps was performed following the interstitial hyperthermia. Although the results of the laser interstitial hyperthermia on breast fibroadenomas were promising, this study was uncontrolled and very small with no long-term outcomes to determine the efficacy of this procedure. Dowlatshahi et al. (2002) The FDA approval of the Novilase ILT System for the treatment of benign breast tumors, was based on a clinical trial of 70 breast tumors in 63 patients. Tumors were a mix of malignant (n=65) and benign (n=5) types. Out of the 65 malignant tumor mix, 56 were surgically excised; overall tumor ablation was 95% based on volume and 89% based on linear dimension. The remaining 9 malignant tumor mixes were not surgically excised, but were followed with x-ray and ultrasound; 77% of these showed no evidence of residual tumor. There was a cm zone of necrosis that surrounded the ablated tumor. The study demonstrated that treatment with the Novilase system resulted in tumor necrosis in greater than 90% of cases. However, this study was not a randomized controlled trial, was very small, there was no comparison to current surgical procedures, and there was no short or long-term follow up. Haraldsdóttir, et al. (2008) completed a case series of 24 patients with invasive breast cancer, who underwent mammography, ultrasound and core biopsy before treatment. The tumors were classifed as invasive ductal carcinoma (n = 15), lobular carcinoma (n = 8) and lobular-ductal cancer (n = 1). Average tumor diameter was 14 mm on ultrasound. Probes were placed in 19 patients, and ILT was performed. Standard surgical excision was performed 12 (range of 4 to 23) days after ILT and was preceded by Doppler ultrasound. Treatment-induced necrosis of invasive cancer was 33% (range 0 to 100) and was complete in 3 patients. At follow-up before surgery, the extent of laser damage could not be judged with ultrasound, although abolished tumor blood flow was demonstrated after treatment resulting in large necroses. Efficacy of treatment varied negatively with tumor size. The inefficacy of ILT was mainly due to the under-estimation of tumor size by mammography and ultrasound and the shortcomings of these methods to demonstrate tumor borders, tumor irregularity and carcinoma in situ (CIS). Five patients had breast tenderness and 3 patients had pain during the first day after treatment. Small skin necroses were observed in 2 patients. The authors concluded that small breast cancers can be treated radically with ILT and that the method may become useful in the treatment of breast cancer in the future, but needs further refinement, even for small welldefined breast cancers, if it is going to be employed for radical treatment. Laser Ablation for Treatment of Breast Cancer Dec 15 8

9 (2009) Novian Health, Inc. is currently conducting a prospective, observational multi-center study, which will evaluate the clinical outcomes of Novilase for benign breast fibroadenomas versus lumpectomy. This Clinical Trial named the American Breast Laser Ablation Therapy Evaluation (ABLATE), is still recruiting individuals and hopes to include 500 patients. Data captured will assess the potential advantages and disadvantages of the procedure as compared with lumpectomy. Tumor characteristics, equipment used, complications, patient satisfaction and cosmesis ratings will also be tracked. Novian Health, Inc. is also planning a trial on the use of Novilase for malignant breast tumors. Summary Peer-reviewed published data on interstitial laser coagulation (ILC), also known as interstitial laser therapy (ILT), is limited and additional, larger, randomized controlled studies are necessary to determine the long and short-term outcomes, as well as the efficacy and safety of this technique, compared to the current more conventional excisional biopsy of breast masses. Therefore, it is not known whether ILC or ILT is as effective as lumpectomy or excisional biopsy with a completely removed mass and with good margins of normal tissue. The need for large-scale studies examining the role of minimally invasive therapy in relationship to the overall management of breast cancer (including chemotherapy, radiotherapy, and the management of the axilla) is necessary. To date, experience in the treatment of breast cancer has been restricted to small studies. Large controlled studies are required to validate the efficacy and safety of these newer, minimally invasive therapies in malignant disease. At this time, since surgical excision with negative margins now offers excellent results, surgeons should be cautious in adopting these new technologies, such as interstitial laser coagulation or interstitial laser therapy, outside the arena of clinical trials. Scientific Rationale - Initial According to National Comprehensive Cancer Network (NCCN), breast cancer is the most common malignancy in women in the United States and is second only to lung cancer as a cause of cancer death. The treatment of breast cancer includes the treatment of local disease with surgery, radiation therapy or both. Systemic disease is treated with cytotoxic chemotherapy, endocrine therapy, biologic therapy or a combination of these. Various ablative and minimally invasive percutaneous excisional treatments for early stage breast cancer are being investigated. Ongoing trials seek to show safety and efficacy for laser, radiofrequency, microwave, cryoablation, and focused ultrasound surgery. To be successful, these therapies must achieve equivalent or even greater efficacy as surgical outcomes and must demonstrate total ablation of the dominant lesion with negative margins, while sparing normal tissue beyond the target tissue. Three types of lasers are generally used in cancer treatment today: carbon dioxide (CO2) lasers, argon lasers, and neodymium:yttrium-aluminum-garnet (Nd:YAG) lasers. According to the FDA, carbon dioxide and argon lasers were among the earliest laser technologies used in medicine. The CO2 laser is mainly a surgical tool that cuts or vaporizes tissue with relatively little bleeding as the light energy changes to heat. This type of laser is used to remove thin layers from the skin's surface without penetrating the deeper layers. CO2 laser has been used to treat precancerous tissue and very early cancers of the cervix, vagina, and vulva. The argon laser penetrates only a short distance into tissue and is useful in dermatology and in eye surgery. It is also used during colonoscopies to remove polyps and to treat tumors along with light-sensitive dyes in photodynamic therapy (PDT). Nd:Yag Laser Ablation for Treatment of Breast Cancer Dec 15 9

10 lasers penetrate deeper into tissue than other types of lasers and can be delivered to hard-to-reach parts of the body, such as the esophagus or colon through an endoscope. The Nd:YAG is sometimes used with KTP (potassium titanyl phosphate) crystals. Laser therapy can be used alone, however, most often it is used in combination with other treatments (i.e., surgery, chemotherapy, and or radiation.) Interstitial laser therapy is also being investigated as a minimally invasive technique for treating small breast cancers. After locating the tumor using stereotactic techniques or ultrasound, laser energy is delivered into the tumor via a needle probe. The aim is to ablate the tumor entirely. A guidance from the National Institute for Clinical Excellence on interstitial laser therapy for breast cancer concluded that the current evidence on the safety and efficacy does not appear adequate to support the routine use of this procedure. They reported that it is uncertain whether this procedure could achieve thermal ablation of all malignant tissue. They noted that there were no data comparing outcomes of the procedure with those of wide excision and radiotherapy. They recommended that this procedure should not be used outside of a clinical trial. According to the National Cancer Institute (NCI) and the American Cancer Society (ACS), lasers are most commonly used to treat superficial cancers such as basal cell skin cancer and the very early stages of some cancers, such as cervical, penile, vaginal, vulvar, and non-small cell lung cancer. They may also be used to relieve certain symptoms of cancer, such as bleeding or obstruction. Neither the NCI nor ACS addresses the role laser therapy for the treatment of breast cancer. In addition, the National Comprehensive Care Network (NCCN) guidelines on the treatment of breast cancer do not address the role of laser in the treatment of breast cancer. Per the American Society of Breast Surgeons position statement, "Ablative and Percutaneous Treatment of Breast Cancer": "Ablative and minimally invasive percutaneous excisional treatments for early stage breast cancer are being investigated by various groups involved with breast cancer research. At this time, these include ablation by laser, cryotherapy, microwave, and radiofrequency. These techniques raise a number of questions about efficacy and patient safety, staging, margin analysis, and follow-up. Until such a time that safety and efficacy of these techniques are ascertained, ablative and percutaneous excisional treatments for breast cancer are investigational and should not be performed outside the realm of clinical research trials." The peer review published literature addressing the use of laser in the treatment of breast cancer is limited. Akimov et al. (1998) examined the use of interstitial laser thermotherapy in thirty-five patients with primary breast cancer using the Nd:YAG (1,064 nm) pulse-wave laser. In 28 patients, laser thermotherapy was performed before radical resection, and in seven patients it was the only invasive treatment. The author reported seven patients treated without surgery, the local tumor control was achieved in five, and in three stage I-III patients disease-free survival followed for months. After laser thermotherapy plus surgery, 3-year disease-free survival was 27% in premenopausal and 92% in menopausal patients. The authors concluded that laser destruction of relatively small primary breast cancer is possible, however, it should not be used in premenopausal patients. Kuo (1994) investigated the healing process, operative course and follow-up of 422 patients, including 2 males, who underwent breast surgery treated with excisional biopsy, segmentectomy and modified radical mastectomy. One group was operated on by the scalpel while the other group, CO2 Laser (Sharplan Model 733) was used. Laser Ablation for Treatment of Breast Cancer Dec 15 10

11 Eighteen patients with locally advanced mammary carcinoma cases were managed with induction chemotherapy using cyclophosphamide, adriamycin, 5-fluorouracil, followed by definitive extirpative laser surgery. The author reported that after followup up from 12 to 60 months, good cosmetic results without local recurrence of tumor were observed following the laser treatment. An effective massive tumor necrosis of 80% occurred after induction chemotherapy. Swelling and distortion of cancer cells with vesicles filling in the cytoplasm and nucleus were demonstrated. Kott et al. (1994) compared the healing process, postoperative course, and follow-up of patients who underwent modified radical mastectomy in the conventional way with those who underwent a laser procedure. Sixty women, with carcinoma of the breast were randomly divided into two groups: Group 1: surgery was performed using scalpel and electrosurgery; Group 2: surgery was performed with a CO 2 Sharplan laser, skin-to-skin including the axilla dissection; maximal power, W. The postoperative course was uneventful in both groups. Wound healing was normal. Sutures were removed on the tenth day. Patients were followed for 10 years. The circumference of the arm and forearm was measured at fixed points before surgery and at follow-up. Mammography and liver and bone scans were performed every year. Four Group 1 patients developed swelling and edema of 2 to 3 cm at 6 to 8 months after surgery. Also two patients from subgroup A developed local recurrence. No edema or swelling or local recurrence could be detected in patients operated by laser. The author concluded surgery with laser is preferable to the conventional approach. Wyman and Rogers (1994) evaluated the efficacy of Nd:YAG in forty women undergoing modified radical mastectomy who were randomized to operation performed with a conventional or laser scalpel. The laser scalpel was associated with a significant reduction in mean operative blood loss but the mean operating time was longer. The author reported no significant differences in the volume of postoperative wound drainage, incidence of axillary seroma, postoperative pain score or time to return of shoulder mobility. The authors concluded the use of a laser scalpel in breast surgery cannot be recommended. Wang (1987) reported on 48 cases of laser breast operations. Twelve cases of breast cancer were treated by modified radical mastectomy using a CO2 laser. Another twelve cases of breast cancer were treated conventionally using a scalped and electrocautery for the purpose of comparison. The author noted that laser surgery offers some advantages such as less blood loss and shorter operative time. No wound disruption was observed in either group. The author reported that laser surgery can provide a very safe and effective method in the treatment of breast cancer. There is no mention in this abstract what result the laser treatment offered in terms of disease free survival or recurrence. According to Medicare's NCD policy on laser procedures: Procedures performed with lasers are sometimes used in place of more conventional techniques. In the absence of a specific noncoverage instruction, and where a laser has been approved for marketing by the Food and Drug Administration, contractor discretion may be used to determine whether a procedure performed with a laser is reasonable and necessary and, therefore, covered. The determination of coverage for a procedure performed using a laser is made on the basis that the use of lasers to alter, revise, or destroy tissue is a surgical procedure. Therefore, coverage of laser procedures is restricted to practitioners with training in the surgical management of the disease or condition being treated. Laser Ablation for Treatment of Breast Cancer Dec 15 11

12 There are several laser surgical instruments currently approved by the FDA, including but not limited to, use in general and plastic surgery, ophthalmology, otology, rhinology, and laryngology, dermatology and gynecology. In summary, peer review published literature is limited and fails to demonstrate the safety and efficacy of laser therapy for the treatment of breast cancer. The NCCN, NCI and ACS do not address the use of laser for this indication. The American Society of Breast Surgeons considers ablative and percutaneous excisional treatments, such as laser treatment, for breast cancer investigational and recommend that they should not be performed outside the realm of clinical research trials. Additional research is needed to determine the efficacy of these techniques when they are used as the sole therapy and to determine the long-term local recurrence rates and survival associated with these treatment strategies as compared to the current management of breast cancer. Review History March 2008 July 2009 March 2010 March 2011 December 2011 December 2012 December 2013 December 2014 December 2015 Medical Advisory Council, initial approval Policy approved under title of Interstitial Laser Coagulation for Localized Breast Tumors Combined Laser Ablation for Treatment of Breast Cancer and Interstitial Laser Coagulation for Localized Breast Tumors policy. Renamed policy, Laser Ablation (Interstitial Laser Coagulation) for Treatment of Localized Breast Cancer Update no revisions Update. Added revised Medicare Table with link to NCD. No revisions. Update - no revisions Update no revisions. Codes updated. Update no revisions. Update no revisions. Codes updated. This policy is based on the following evidence-based guidelines: 1. The American Society of Breast Surgeons. Position Statement on Ablative and Percutaneous Treatment of Breast Cancer Apr. Available at: ous.pdf 2. National Institute of Clinical Excellence. Interstitial Laser Therapy for Breast Cancer Sept. Available at: 3. National Comprehensive Care Network. NCCN Clinical Practice Guidelines in Oncology. Breast Cancer. V Update Update Version Update Version 3, Update V Update V Update V American Cancer Society. Lasers in Cancer Treatment. Revised 4/5/07. Available at: tment.asp 5. National Cancer Institute. Lasers in Cancer Treatment: Questions and Answers. Available at: 6. National Institute for Clinical Excellence (NICE). Interstitial laser therapy for fibroadenomas of the breast. Interventional Procedure Guidance No London, UK: NICE; June Available at: 8. Canadian Association of Radiation Oncologists. The palpable breast lump: Information and recommendations to assist decision-making when a breast lump is detected. The steering committee on clinical practice guidelines for the care Laser Ablation for Treatment of Breast Cancer Dec 15 12

13 and treatment of breast cancer. CMAJ. 1998;158 Suppl 3:S3-8. Available at: References Update December Clinicaltrials.gov. Local Treatment by Thermic Destruction of Primitive Breast Cancer (LASERBREAST1). ClinicalTrials.gov Identifier: NCT October 20, Yang BR, Kim HJ, Shin KM, et al. Serial Ultrasound Findings After Laser Ablation for Benign Breast Lesions on Long-Term Follow-Up: Implications for Evaluation of Procedural Success. Photomed Laser Surg Aug;33(8): doi: /pho References Update December Fornage BD, Hwang RF. Current status of imaging-guided percutaneous ablation of breast cancer. AJR Am J Roentgenol Aug;203(2): Roubidoux MA, Yang W, Stafford RJ. Image-guided ablation in breast cancer treatment. Tech Vasc Interv Radiol Mar;17(1): References Update December Zaho Z. Minimally-invasive thermal ablation of early-stage breast cancer: a systemic review. Eur J Surg Oncol. 01-DEC-2010; 36(12): References Update December Dowlatshahi K, Wadhwani S, Alvarado R, et al. Interstitial laser therapy of breast fibroadenomas with 6 and 8 year follow-up. Breast J. 2010;16(1): Hayes D. An Overview of Breast Cancer. UpToDate. October 21, References Update March van Esser S, Stapper G, van Diest PJ, et al. Ultrasound-guided laser-induced thermal therapy for small palpable invasive breast carcinomas: a feasibility study. Ann Surg Oncol Aug;16(8): References Update July Novian Health, Inc. Novilase. Chicago, IL: Novian Health; Clinical Trials. org. American Breast Laser Ablation Therapy Evaluation (ABLATE). June 29, Available at: agulation&rank=3 3. American Society of Breast Surgeons. Management of Fibroadenomas of the Breast. April 29, Haraldsdóttir KH, Ivarsson K, Götberg S, et al. Interstitial laser thermotherapy (ILT) of breast cancer. Eur J Surg Oncol. 2008;34(7): U.S. Food and Drug Administration (FDA). Kelsey interstitial laser therapy system. 510(k) Summary K Kelsey, Inc. Chicago, IL. Rockville, MD: FDA; May 2, Vlastos G, Verkooijen HM. Minimally invasive approaches for diagnosis and treatment of early-stage breast cancer. The Oncologist. 2007;12 (1):1-10. Available at: doi: /theoncologist Dowlatshahi K, Dieschbourg JJ, Bloom KJ. Laser therapy of breast cancer with 3- year follow-up. Breast J. 2004;10 (3): Sabel MS, Kaufman CS, Whitworth P, et al. Cryoablation of Early-Stage Breast Cancer: Work-in-Progress. Report of a Multi-Institutional Trial. Annals of Surgical Oncology, 11(5): DOI: /ASO Singletary E. Minimally invasive ablation techniques in breast cancer treatment. Ann Surg Oncol. 2004;9(4): Laser Ablation for Treatment of Breast Cancer Dec 15 13

14 10. Kepple J, Van Zee K, Dowlatshahi K et al. Minimally Invasive Breast Surgery. J Am Coll Surg. 2004;199(6). 11. El-Wakeel H, Umpleby HC. Systematic review of fibroadenoma as a risk factor for breast cancer. Breast. 2003;12(5): Dowlatshahi, K. Interstitial laser treatment of small breast cancers. In: Simunovic, Z ed, Lasers in Medicine, Surgery, Dentistry and Veterinary, Vol. III, European Medical Laser Association Dowlatshahi K, Fan M, Gould VE, et al. Stereotactically guided laser therapy of occult breast tumors: Work-in-progress report. Arch Surg. 2000;135(11): Basu S, Ravi B, Kant R. Interstitial laser hyperthermia, a new method in the management of fibroadenoma of the breast: A pilot study. 1: Lasers Surg Med. 1999;25(2): References - Initial 1. Kuo SJ. Evaluation of the CO2 laser in performance of breast surgery. Zhonghua Yi Xue Za Zhi (Taipei) May;53(5): Wang YH. Laser operation for breast cancer. Int Surg Oct- Dec;72(4): National Cancer Institute. Lasers in Cancer Treatment: Questions and Answers Aug; Available at: 4. Huston TL, Simmons RM. Ablative therapies for the treatment of malignant diseases of the breast. Am J Surg Jun;189(6): Agnese DM, Burak WE Jr. Ablative approaches to the minimally invasive treatment of breast cancer. Cancer J Jan-Feb;11(1): Vlastos G, Verkooijen HM. Minimally invasive approaches for diagnosis and treatment of early-stage breast cancer. Oncologist Jan;12(1): Sabel MS, Edge SB. In-situ ablation of breast cancer. Breast Dis. 2001;12: Dowlatshahi K, Francescatti DS, Bloom KJ. Laser therapy for small breast cancers. Am J Surg Oct;184(4): Kacher DF, Jolesz FA. MR imaging--guided breast ablative therapy. Radiol Clin North Am Sep;42(5):947-62, vii. 9. Noguchi M. Minimally invasive surgery for small breast cancer. J Surg Oncol Oct;84(2):94-101; discussion Minhaj AM, Mann F, Milne PJ, et al. Laser interstitial thermotherapy (LITT) monitoring using high-resolution digital mammography: theory and experimental studies. Phys Med Biol Aug 21;47(16): Hall-Craggs MA, Vaidya JS. Minimally invasive therapy for the treatment of breast tumors. Eur J Radiol Apr;42(1): Singletary SE. Minimally invasive techniques in breast cancer treatment. Semin Surg Oncol Apr-May;20(3): Akimov AB, Seregin VE, Rusanov KV, et al. Nd: YAG interstitial laser thermotherapy in the treatment of breast cancer. Lasers Surg Med. 1998;22(5): Robinson DS, Parel JM, Denham DB, et al. Interstitial laser hyperthermia model development for minimally invasive therapy of breast carcinoma. J Am Coll Surg Mar;186(3): Harries SA, Amin Z, Smith ME, et al. Interstitial laser photocoagulation as a treatment for breast cancer. Br J Surg Nov;81(11): Kott I, Kaplan I, Giler S. The CO 2 laser in mastectomy: a ten-year follow-up. J Clin Laser Med Surg Jun;12(3): Demidov VP, Chissov VI, Rykov VI, et al. Laser scalpel in organ-preserving surgeries for early stages of breast cancer. Khirurgiia (Mosk) May;(5): Russian. Laser Ablation for Treatment of Breast Cancer Dec 15 14

15 18. Wyman A, Rogers K. Randomized trial of laser scalpel for modified radical mastectomy. Br J Surg Jul;80(7): Wyman A, Rogers K. Radical breast surgery with a contact Nd:YAG laser scalpel. Eur J Surg Oncol Aug;18(4): Ansanelli VW. CO2 laser in cancer surgery of the breast: a comparative clinical study. Lasers Surg Med. 1986;6(5): Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. 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Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements Laser Ablation for Treatment of Breast Cancer Dec 15 15