Feature | Breast Density | October 04, 2016 | Jeff Zagoudis

Legislative efforts to provide direction for breast cancer screening across multiple modalities are driving discussion about best practices

Mammography has long been considered the gold standard for breast cancer detection, acting as the first line of defense for millions of women every year in hopes of catching cancer early. The true efficacy of the modality has come into question in recent years, however, due to increased understanding about the impact of dense fibroglandular breast tissue on screening. This has led to the emergence and/or increased use of other modalities in an effort to improve cancer detection rates above what is currently capable with mammography.

“We have to remind ourselves — mammography saves lives,” said Bonnie Rush, RT(R)(M)(QM), president of Breast Imaging Specialists, during a session at the 2016 annual meeting of the Association for Medical Imaging Management (AHRA) in Nashville. “We also know that there is a subset of women that it does not work as well for.” 

Rush noted that this has led to a great deal of confusion among patients (and providers) about the best course of action for their own care. Over the last 12 months, various entities at the association, state and national levels have been trying to bring clarity through legislative efforts — which have generated their own set of debates. 

 

USPSTF Recommendations 

While not actually legislation itself, the updated breast cancer screening recommendations released by the United States Preventive Services Task Force (USPSTF) in January have arguably the greatest implications for screening practices going forward. 

As a provision of the Affordable Care Act, task force recommendations are used to guide insurance coverage for various preventive care services, including breast imaging. In the 2016 breast cancer screening recommendations, in a departure from conventional wisdom, the task force said that mammography screening every two years was sufficient for women in their 40s, with a “C” grade recommendation. Full coverage with no copay is only required for services graded “B” or higher, and many in the radiology community are concerned that the recommendation will lead to a decrease in screening rates for women in their 40s where the majority of life-years are lost to breast cancer. And according to Rush, recent evidence suggests the incidence of breast cancer is increasing in women under 50. 

Recognizing these concerns, Congress has been working to give all sides more time, starting with the Protecting Access to Lifesaving Screenings (PALS) Act passed in December 2015. The bill placed a two-year moratorium on the implementation of the USPSTF guidelines, during which the Centers for Medicare and Medicaid Services (CMS) may not decrease reimbursement for screening mammography. “This congressionally mandated delay will help providers continue to save tens of thousands of lives each year while the USPSTF recommendations and their creation process are vetted by breast cancer screening experts and lawmakers,” said William T. Thorwarth Jr., M.D., FACR, CEO of the American College of Radiology in a statement. “Women and Congress need to remain vigilant so that coverage decisions based on these recommendations are not simply put into place by insurers when that is not the intent of the task force recommendation.” 

A second bill (S.3040) that would extend the moratorium through 2019 was introduced in the Senate in June. 

 

Insurance Coverage Still Expanding

While the USPSTF recommendations remain on hold, progress is still being made on expanding insurance coverage for alternative screening methods. In August, Cigna became the first national insurer to announce it would be covering 3-D mammography (tomosynthesis) for screening, in addition to existing coverage for diagnostic purposes, beginning immediately. 

The company said that it changed its policy based on recently updated guidelines from the National Comprehensive Cancer Network (NCCN), which for the first time recommended tomosynthesis as a viable option for patient screening. The association acknowledged the significant body of evidence supporting 3-D mammography’s ability to obtain a clearer image at a significantly lower radiation dose than traditional 2-D mammography. 

Several states have been expanding their own insurance mandates. New York took the most pragmatic action, enacting legislation in June requiring insurers to cover all screening and diagnostic exams for the detection of breast cancer — including supplemental imaging for women with dense breast tissue. The bill does not encompass employer plans set up as self-funded, which are generally exempt from state insurance laws. Patients with these types of plans would still have to pay a co-pay and deductible for screening. 

“Eliminating these insurance barriers will prevent women from paying out-of-pocket for breast cancer screening, including imaging for the detection of breast cancer, diagnostic mammograms, breast ultrasounds or magnetic resonance imaging (MRI),” said the office of New York Gov. Andrew Cuomo in a statement. 

 

Breast Density Inform Laws

Breast density has become a hot-button issue in the world of breast cancer screening in recent years, and there has been much debate on how to best optimize patient care in light of greater understanding. 

Breast density patterns were first identified in the 1970s, and the radiology community has known for some time about how dense breast tissue can mask cancers in a mammogram (both entities appear as white on the image). Radiologists were not required, however, to share information about density or its risk with the patient, and so most did not. 

The status quo changed in 2009 when Connecticut became the first state to enact legislation requiring density information to be included in the mammography report given to each patient following an exam. The effort was led by Nancy M. Cappello, Ph.D., who presented alongside Rush at AHRA. Cappello was diagnosed with breast cancer in 2004, just four months after her previous mammogram was deemed normal. The Connecticut law requires density notification to be sent to all women who are determined to have heterogeneous or extremely dense fibroglandular breast tissue. The legislation also prescribes specific language for the notification, covering the risks involved with dense breast tissue and the options for supplemental screening. 

In the seven years since Connecticut blazed the trail, 27 other states have enacted their own form of breast density laws; this year alone has seen four states (Vermont, South Carolina, Oklahoma and Louisiana) join the ranks, and another five state legislatures (Washington, Iowa, Kentucky, West Virginia and Georgia) are discussing an active bill. 

The results of a survey of 121 radiologists from 110 facilities nationwide, published in the June 2016 issue of The Breast Journal, suggest that density inform laws are having a significant impact. The research team sent a 20-question online survey to radiologist members of the Society for Breast Imaging between August 2013 and March 2014. Responses came from facilities in 34 states (and one Canadian facility), half of which had breast density inform laws in place. At the time of response, 36 percent of all facilities were performing formal breast cancer risk assessment, with no significant difference between legislation and non-legislation states. Perhaps most interesting, 40 percent of facilities in density legislation states said that they added risk assessment in response to the legislation.1 

The survey also included questions about the breast screening modalities that respondents employed. Thirty-three percent of facilities in density legislation states added handheld whole breast ultrasound (WBUS) to accommodate the legislation, 6 percent added automated WBUS and 6 percent added tomosynthesis.1 

 

Federal Breast Density Efforts

While the evidence suggests that state density laws have helped improve breast cancer care, a notable lack of standardization remains between one state and the next. A study published in the April 26 Journal of the American Medical Association examined the content, readability and understandability of dense breast notifications, noting significant variability in all three areas.2 A second study in the March 2015 Journal of the American College of Radiology found that out of 174 California primary care physicians surveyed, only 49 percent were aware of the state’s breast density inform law (passed in 2013), and the majority of physicians were only somewhat comfortable (55 percent) or not comfortable (12 percent) discussing density with their patients.3

A proposed national breast density inform standard was introduced in both the U.S. House (H.R. 716) and Senate (S.370) in February 2015. The bills feature identical language, requiring mammography facilities to include up-to-date information about breast density in the mammography reports sent to both the patient and their physician. The summary must include 1) the effect of breast density in masking cancer on a mammogram; and 2) the need for patients to talk to their physician about whether they would benefit from additional testing. 

 

References

1. Nayak, L. (UCSF), Miyake, K.K., Leung, J.W.T., et al. “Impact of Breast Density Legislation on Breast Cancer Risk Assessment and Supplemental Screening: A Survey of 110 Radiology Facilities,” The Breast Journal, June 14, 2016. DOI: 10.1111/tbj.12624

2. Kressin, N.R., Gunn, C.M., Battaglia, T.A. ”Content, Readability, and Understandability of Dense Breast Notifications by State,” JAMA, April 26, 2016. DOI: 10.1001/jama.2016.1712

3. Khong, K.A., Hargreaves, J., Aminololama-Shakeri, S., Lindfors, K.K., “Impact of the California Breast Density Law on Primary Care Physicians,” Journal of the American College of Radiology, March 2015. DOI: http://dx.doi.org/10.1016/j.jacr.2014.09.042

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