Subject:
Microwave Thermotherapy for Primary Breast Cancer
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Focused microwave phase array thermotherapy has been investigated as a type of heat therapy for treating either primary breast cancer in conjunction with lumpectomy in patients with early-stage breast cancer or as a cytoreductive technique in conjunction with preoperative chemotherapy in patients with advanced breast cancer. Microwave applicators are placed on either side of the compressed breast that, when activated, illuminate a large volume of breast tissue. A probe is placed within the breast to monitor the interstitial temperature. The technique is based on the preferential microwave heating that occurs in high-water content breast carcinoma compared to the surrounding lower water content healthy breast tissues. If successful, the microwave therapy could function similarly to the role of whole breast irradiation therapy after breast-conserving surgery, i.e., by destroying microscopic residual cancer cells. In patients with locally advanced primary breast cancer, microwave thermotherapy may reduce the size of the tumor sufficiently to allow a less invasive surgical procedure to be performed.
Currently, no microwave thermotherapy device that is indicated for the treatment of breast cancer has received approval for marketing from the U.S. Food and Drug Administration (FDA). The Microfocus™ APA 1000 System (Celsion, Columbia, MD) is a device that is currently undergoing clinical trials through the FDA investigational device exemption process (IDE).
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
Focused microwave phase array thermotherapy is considered investigational as a treatment of breast cancer.
Medicare Coverage:
There is no National Coverage Determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
[RATIONALE: As stated above in the Description Section of this policy, no microwave thermotherapy device that is indicated for the treatment of breast cancer has received approval for marketing from the U.S. Food and Drug Administration (FDA). The Microfocus™ APA 1000 System (Celsion, Columbia, MD) is a device that is currently undergoing clinical trials through the FDA investigational device exemption process (IDE).
A literature search revealed limited published data regarding microwave thermotherapy. Gardner and colleagues reported on the results of a phase I and II clinical trial including 10 patients that reported that the technique is technically feasible. Vargas and colleagues reported on a dose-finding study in 25 patients, performed as part of an Investigational Device Exemption (IDE) trial. Patients underwent thermotherapy at various doses before undergoing surgical resection of breast cancer to determine whether or not the use of thermotherapy before breast-conserving surgery could potentially reduce the incidence of positive surgical margins, and thus the need for re-excision.
Additionally, reports of 2 small studies with early, intermediate outcomes were identified. Vargas and colleagues reported on a study of 15 patients who received preoperative focused-microwave thermotherapy in combination with neoadjuvant anthracycline-based chemotherapy for invasive (T2, T3) breast cancer. Compared with 13 patients who received only the anthracycline-based regimen, there was greater (88% vs. 59%) tumor volume reduction in the experimental group. Dooley and colleagues reported on a randomized study of preoperative focused-microwave thermotherapy for early-stage breast cancer. In this study, 34 patients received thermotherapy before surgery and 41 received only surgery. Positive margins were found in 10% (4 of 41 controls) compared with 0% (0 of 34) in the experimental group (p=0.13). These studies provide insufficient data to determine the impact of this technology on health outcomes. Studies involving larger numbers of patients with longer follow-up of clinical outcomes are needed.]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Microwave Thermotherapy for Primary Breast Cancer
Breast Cancer, Microwave Thermotherapy
Thermotherapy, Microwave for Breast Cancer
References:
1. Gardner RA, Vargas HI, Block JB et al. Focused microwave phased array thermotherapy for primary breast cancer. Ann Surg Oncol 2002;9(4):326-32.
2. Vargas HI, Dooley WC, Gardner RA et al. Focused microwave phased array thermotherapy for ablation of early-stage breast cancer: results of thermal dose escalation. Ann Surg Oncol 2004;11(2):139-46.
3. www.celsion.com/breastcancertrials202.htm
4. www.celsion.com/products/trials.cfm (accessed 12/19/2007)
5. Vargas HI, Dooley WC, Fenn AJ et al. Study of preoperative focused microwave phased array thermotherapy in combination with neoadjuvant anthracycline-based chemotherapy for large breast carcinomas. Cancer Therapy 2007; 5(2):401-8. Available at http://www.cancer-therapy.org/vol5b.pdf
6. Dooley WC, Vargas HI, Fenn AJ et al. Randomized study of preoperative focused microwave phased array thermotherapy for early-stage invasive breast cancer. Cancer Therapy 2008; 6(2):395-408. Available at http://www.cancer-therapy.org/vol6b.pdf
7. Dooley WC, Vargas HI, Fenn AJ, et al. Focused microwave thermotherapy for preoperative treatment of invasive breast cancer: A review of clinical studies. AnnSurg Oncol 2010;17(4):1076-1093.
8. Zhao Z, Wu F. Minimally-invasive thermal ablation of early-stage breast cancer: A systemic review. Eur J Surg Oncol 2010;36(12):1149-1155.
9. Stang J, Haynes M, Carson P, et al. A preclinical system prototype for focused microwave thermal therapy of the breast. IEEE Trans Biomed Eng 2012;59(9):2431-2438.
10. Vogl TJ, Frashid P, Naguib NN, et al. Thermal ablation therapies in patients with breast cancer liver metastases: a review. Eur Radiol 2013 Mar;23(3):797-804.
11. Fornage BD, Hwang RF. Current status of imaging-guided percutaneous ablation of breast cancer. AJR Am J Roentgenol 2014 Aug;203(2):442-8.
12. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. Breast Cancer. Version 2.2016. 05/06/2016.
13. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology (NCCN Guidelines). Breast Cancer. Version 1.2019 - March 14, 2019. (Accessed June 6, 2019)
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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