Tomosynthesis Update

Jul. 07, 2015

Blue Cross and Blue Shield of Montana (BCBSMT) has made a decision to price all screening mammogram services at a single reimbursement rate, independent of technique used. Additional views, digital reconstruction or digital tomosynthesis (including CPT and HCPCS codes 77063, G0279) services are not accorded additional reimbursement as they are considered discretionary by the facility and professional providing the services and have not been proven to improve the outcomes beyond conventional mammograms.

The current BCBSMT Medical Policy, based on comprehensive scientific literature review, concludes that digital breast tomosynthesis mammograms have not been proven to be superior to conventional technology for overall outcomes and long-term results. The current Medical Policy (RAD601.055) is available for review at the bcbsmt.com website. BCBSMT Medical Policies undergo regular review and revisions at least annually and when significant medical literature publications become available. All new medical specialty society recommendations and published literature are considered in determining the coverage rationale.

A significant number of service reimbursement appeals have been submitted to BCBSMT and forwarded for peer review, to multiple different Independent Peer Review Organizations. All of those appeal reviews have validated the initial service denial. The IRO reviews were performed by multiple specialists, including radiologists, gynecologists, surgeons and primary care physicians. Summary information from those reviews is presented below.

Tomosynthesis is a modification of digital mammography and uses a moving x-ray source and digital detector. A three-dimensional volume of data is acquired and reconstructed using computer algorithms to generate thin sections of images. As a modification of digital mammography, tomosynthesis has all the advantages of a standard digital mammogram. In addition, thin slice reconstruction improves the delineation of a lesion in the slice by eliminating overlap from surrounding structures. With the commonly used current technology, this process more than doubles the breast radiation dose of digital mammography. Some studies are finding reduced overall recall rates, but with similar or higher biopsy rates. One factor that may reduce immediate recall rates with tomosynthesis is that the technology obtains additional breast images at the time of initial screening.

  • In the screening setting, some small, unblinded, short-term, retrospective studies have shown that tomosynthesis can help decrease recall rates.
  • In the diagnostic setting, some small, unblinded, short-term, retrospective studies have shown that tomosynthesis improved lesion characterization, thereby decreasing the number of biopsies, leading to fewer false positive biopsies and higher rates of cancer detection.

Multiple sources indicate that the impact of DBT on outcomes (including accuracy and recall rate) needs to be fully investigated prior to routine use in clinical practice. Some of the shortcomings of the published literature include that available studies are all single institutional studies. The studies varied in the number of tomosynthesis views that were used. Additional cases of patients with cancer were added retrospectively to the study population in some studies. In other words, radiologists in the study had prior knowledge of cancer cases before reading DBT. Therefore, these studies were not prospective evaluations of this technology in a clinical setting.

At the present time, routine use of tomosynthesis is not recommended by any national guidelines as part of annual breast cancer screening exam.

The most current position statement from the American College of Radiology states: "A new digital technology, breast tomosynthesis, has shown to be an advance over digital mammography, with higher cancer detection rates and fewer patient recalls for additional testing." The same statement also says it is "important to further elucidate which subgroups of women will benefit most from these exams." This highlights the fact that there is a lack of any randomized trial that helps specify which clinical scenarios such testing will lead to improved outcome over current standard of care. It may be that this test would be best used in conjunction with a diagnostic mammogram and not with a screening mammogram. At the present time, more data is needed to determine what is the best clinical scenario for testing and so it would appear that the current data is still lacking, though the retrospective data is promising.

The American College of Obstetricians and Gynecologists (ACOG) does not recommend routine use of alternative or adjunctive tests to screening mammography. Current published evidence does not demonstrate meaningful outcome benefits (e.g., reduction in breast cancer mortality) with supplemental tests (e.g., ultrasonography and magnetic resonance imaging) to screening mammography or with alternative screening modalities (e.g., breast tomosynthesis or thermography) in women with dense breasts who do not have additional risk factors. Based on ACOG, "Further study will be necessary to confirm whether digital mammography with tomosynthesis is a cost-effective approach, capable of replacing digital mammography alone as the first-line screening modality of choice for breast cancer screening."

The National Comprehensive Cancer Network ("NCCN") practice guideline for breast cancer does not include digital breast tomosynthesis in either screening or diagnostic breast cancer recommendations.

Current USPSTF category A or B recommendations do not include tomosynthesis as a breast cancer screening technique. The draft recommendations for 2015 indicate that current studies do not provide information on diagnostic test characteristics of tomosynthesis for breast cancer screening, as no studies report on a comprehensive reference standard. Ongoing studies registered with clinical trials.gov suggest that results of the application of a comprehensive reference standard to a screening population may become available within a few years. Studies are needed that employ the standard approach to breast imaging interpretation in the United States (single reading), and that report on both interval cancers identified by a comprehensive reference standard and longer term outcomes, including effects of the addition of tomosynthesis to digital mammography on the stage distribution of detected cancers, breast cancer recurrence or 2nd (contralateral) breast cancers and mortality rates. USPSTF summarizes that the evidence is insufficient to assess the harms or benefits of these digital tomosynthesis methods for screening.

In summary, BCBSMT has made a decision to price all screening mammogram services at a single reimbursement rate, independent of technique used. Additional views, digital reconstruction or digital tomosynthesis (including CPT and HCPCS codes 77063, G0279) services are not accorded additional reimbursement, as they are considered discretionary by the facility and professional providing the service. The current Medical Policy (RAD601.055) is available for review at the bcbsmt.com website. BCBSMT Medical Policies undergo regular review and revisions at least annually and when significant medical literature publications become available. All new medical specialty society recommendations and published literature are considered in determining the coverage rationale.

References used for this summary may include information from the following sources:

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