Statement of the New York State Radiological Society, Inc

to: New York State Medicaid Evidence Based Benefit Review Advisory Committee Meeting December 15, 2016

The New York State Radiological Society (NYSRS) is the New York State chapter of the American College of Radiology (ACR) and represents 1523 diagnostic radiologist and radiation oncologists practicing in NY state. The NYSRS is committed to reducing breast cancer mortality by optimizing women’s access to effective breast cancer screening. Regular mammography is the mainstay of breast cancer screening, with ample data to support its efficacy in reducing breast cancer deaths [1]. Full‐field digital mammography (FFDM) became widely utilized over the last decade as studies showed its improved accuracy over traditional film‐screen mammography [2].

The NYSRS strongly recommends that the Medical Evidence Based Benefit Review Advisory Committee (EBBRAC) support and recommend Medicaid coverage of Digital Breast Tomosynthesis (DBT).
Digital Breast Tomosynthesis is an application of digital mammography that allows for 3‐dimensional (3D) imaging of the breast. Multiple studies performed over the last three years show that DBT has significant advantages over conventional mammography (FFDM or film‐screen) including improved accuracy, increased cancer detection rates, and a decrease in false positive results. The decrease in false positive rates results in fewer patient recalls for additional testing in women who do not have breast cancer [3‐11]. Thus, DBT has the potential to decrease both breast cancer mortality and the anxiety and costs associated with known limitations of traditional 2‐dimensional (2‐D) mammography,

Conventional mammography produces planar images in which overlapping tissue can result in both patient recalls from false positive studies and in missed cancers from false negative studies. Approximately 10% to 20% of the cases in which a woman must be recalled from screening mammography are due to superimposed normal tissue simulating a lesion [12]. In addition, overlying tissue can obscure cancers, with as many as 20% to 30% of cancers missed by conventional mammography [13, 14). DBT helps address the problem of overlapping tissues in planar FFDM and reduces interpretation inaccuracy.

The largest study to date published in the Journal of the American Medical Association in 2014 [7] which compared 281,187 conventional mammograms to 173,663 DBT exams reported the following statistically significant findings for DBT exams:

• A 41% increase in the detection of invasive breast cancers.
• A 29% increase in the detection of all breast cancers.
• A 15% decrease in women recalled for additional imaging.
• A 49% increase in positive predictive value for recall.
• A 21% increase in positive predictive value for biopsy.

A study published online on February 18, 2016 by JAMA Oncology reaffirmed that 3‐D mammography is a better test for breast cancer screening. It found lower recall rates and the detection of more cancers than 2‐D mammograms. The authors of the study said that it is the first longitudinal evidence that the benefits of initial 3‐D mammograms can be sustained and improved over time with consecutive 3‐D mammogram screening [15].

A 2015 study showed that wider adoption of DBT presents an opportunity to deliver value‐based care. The study reported a $28.53 savings per woman screened due to the reduction in the number of women recalled for additional follow‐up imaging and the ability of DBT to facilitate earlier diagnosis at less invasive stages where treatment costs are lower [16].

The US Food & Drug Administration (FDA) approved DBT in 2011 for the same indications as traditional 2‐D mammography including breast cancer screening, diagnosis, and intervention. On August 26, 2014, a second vendor received FDA approval for DBT. Other vendors are expected to apply for approval. In the State of New York there are 111 sites that have implemented DBT.

It is important to note that DBT is not investigational. The term investigational implies that studies have not been performed demonstrating improved performance compared with FFDM. Numerous large‐scale studies of DBT have already demonstrated this benefit.

For all of the above reasons, the NYSRS strongly recommends that this Committee recommend Medicaid coverage of digital breast tomosynthesis.

Thank you for the opportunity to present this information.

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