Federal mandate prohibits denial of any drug, device or biological product fully approved by the FDA as investigational for the Federal Employee Program (FEP). In these instances coverage of these FDA-approved technologies are reviewed on the basis of medical necessity alone.
This medical policy was developed through consideration of peer reviewed medical literature, FDA approval status, accepted standards of medical practice in Montana, Technology Evaluation Center evaluations, and the concept of medical necessity. BCBSMT reserves the right to make exceptions to policy that benefit the member when advances in technology or new medical information become available.
The purpose of medical policy is to guide coverage decisions and is not intended to influence treatment decisions. Providers are expected to make treatment decisions based on their medical judgment. Blue Cross and Blue Shield of Montana recognizes the rapidly changing nature of technological development and welcomes provider feedback on all medical policies.
When using this policy to determine whether a service, supply or device will be covered, please note that member contract language will take precedence over medical policy when there is a conflict.
A literature search based on the MEDLINE database 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. (1) 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. (2) The following randomized clinical trials occured in 2005 (3):
Study 102-00-202: A total of 222 female patients with early-stage primary breast cancer will be randomized (ratio 1:1) either to thermotherapy (at one of two different doses) plus surgery or surgery alone. The primary endpoints include reduction of tumor cells at surgical margins and reduction of second incision rates due to unclean surgical margins.
Study 102-00-201: A total of 228 female patients with locally advanced primary breast cancer will be randomized (ratio 1:1) either to chemotherapy plus thermotherapy or chemotherapy alone. The primary endpoints include downsizing from mastectomy to partial mastectomy, and determining the percentage of patients with ≥85% pathological cell death.
A search of the literature was performed through August 2007. No additional studies were identified that would prompt a reconsideration of the coverage position, which remains unchanged.
A search of the literature was conducted through August 2007. No publications of results of additional clinical studies were identified. Trials are ongoing, but are no longer recruiting new patients. (4) In addition, this device still does not have clearance or approval from the FDA. Thus, the policy statement is unchanged.
The policy was updated with a search of peer reviewed literature through June 2009. Reports of two 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. (5) 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 (6) 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 change the coverage statement. Studies involving larger numbers of patients with longer follow-up of clinical outcomes are needed.
Dooley et al. (7) reviewed the results of four multi-institutional clinical studies of preoperative FMT (focused microwave thermotherapy) for treating invasive carcinomas in the intact breast. In phase I, 8 of 10 (80%) patients receiving a single low dose of FMT prior to receiving mastectomy had a partial tumor response quantified by either ultrasound measurements of tumor volume reduction or by pathologic cell kill. In phase II, the FMT thermal dose was increased to establish a threshold dose to induce 100% pathologic tumor cell kill for invasive carcinomas prior to breast-conserving surgery (BCS). In a randomized study for patients with early-stage invasive breast cancer, of those patients receiving preoperative FMT at ablative temperatures, 0 of 34 (0%) patients had positive tumor margins, whereas positive margins occurred in 4 of 41 (9.8%) of patients receiving BCS alone (P = 0.13). In a randomized study for patients with large tumors, based on ultrasound measurements the median tumor volume reduction was 88.4% (n = 14) for patients receiving FMT and neoadjuvant chemotherapy, compared with 58.8% (n = 10) reduction in the neoadjuvant chemotherapy-alone arm (P = 0.048). They concluded that wide-field adaptive phased-array FMT can be safely administered in a preoperative setting, and data from randomized studies suggest both a reduction in positive tumor margins as a heat-alone treatment for early-stage breast cancer and a reduction in tumor volume when used in combination with anthracycline-based chemotherapy for patients with large breast cancer tumors; larger randomized studies are required to verify these conclusions.
In 2010, Zao and Wu (8) published a systematic review of minimally invasive thermal ablation of early-stage breast cancer, searching in Pubmed, Embase and the Cochrane databases between January 1990 and December 2009. 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 76-100% of breast cancer patients treated with radiofrequency ablation, 13-76% in laser ablation, 0-8% in microwave ablation, 36-83% in cryoablation, and 20-100% in high-intensity focused ultrasound ablation. They concluded that 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.
A search of peer reviewed literature through July 2011 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.
A search of peer reviewed literature through March 2013 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.
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.