The American College of Radiology (ACR) is committed to ensuring women’s ready access to breast cancer screening. Ample data shows that regular mammography significantly reduces breast cancer deaths. Currently, more than 95 percent of mammography units in the United States are full-field digital. Conversion to digital technology quickly followed the release of the landmark Digital Mammographic Imaging Screening Trial (DMIST) results, which showed better overall accuracy of digital mammography compared to film screen mammography. Digital mammography offers many other advantages, including rapid and reliable electronic storage and retrieval of images, easy image transfer to other facilities, and simplification of quality control.
A further application of digital mammography, breast tomosynthesis has shown great promise as an advance over digital mammography, with higher cancer detection rates and fewer patient recalls for additional testing. This is extremely important. The medical community has long sought ways to improve breast cancer screening accuracy. Better sensitivity will likely translate into more lives saved. Lower recall rates result in fewer patients who may experience short-term anxiety awaiting test results.
While there is strong evidence that tomosynthesis will have an important role in breast imaging, further studies are needed to assess tomosynthesis’ relationship to long-term clinical outcomes, including reduced mortality. It will also be important to learn which subgroups of women might benefit most from these exams (by age, breast density, frequency of examination, etc.). To facilitate such large scale research, the technology must be widely available. Availability is greatly impacted by reimbursement for the service provided. The College urges the Centers for Medicare and Medicaid Services (CMS) and private insurers to facilitate access to these exams by covering beneficiaries for tomosynthesis — now that it has been shown to improve key screening parameters compared to digital mammography.
When new technologies emerge, the College works within the payment policy process to ensure fair reimbursement that will promote access and appropriate use. The ACR worked to develop Current Procedural Terminology (CPT) codes for tomosynthesis once the scientific literature demonstrated that these exams met criteria set by the American Medical Association (AMA) CPT Editorial Panel — the body tasked with developing new codes. Development of a CPT Category 1 code requires evidence that a procedure is approved by the Food and Drug Administration and is in general use. Category 1 CPT codes for tomosynthesis were approved by the CPT Editorial Panel in February 2014.
The ACR subsequently worked with the AMA Relative Value Scale Update Committee to develop recommendations for Relative Value Unit (RVU) values for tomosynthesis. These values, which must be kept confidential until finalized, were sent to the CMS, which will determine what RVU values are assigned to the codes. CMS will also decide whether or not to cover the service. Having a CPT code and RVU value does not guarantee coverage (as evidenced by CMS' failure to cover seniors for screening CT colonography).
In November 2013, CMS declared that tomosynthesis was considered an integral part of digital mammography that could not be billed separately. Based on emerging evidence, and to ensure continued access to this promising technology, ACR opposed this position. CMS will issue its decision in late October regarding what RVU values will be assigned to tomosynthesis and whether they will pay for it separately from digital mammography.
While the College encourages more studies to clarify the clinical role(s) of tomosynthesis and its long-term outcomes, it is fairly clear that tomosynthesis represents an important advance in breast imaging. The ACR will continue to update members and external stakeholders on this important matter.