The Rise of Digital Breast Tomosynthesis

Earlier this year, a bill known as HB 1036 passed in the Texas House of Representatives and the Texas Senate and was subsequently signed into law by Texas Governor Greg Abbott. Sponsored by Texas Rep. Senfronia Thompson (D-Houston), the law requires all commercial insurance providers in Texas to cover the cost of digital breast tomosynthesis (DBT, also known as 3D mammography) for all patients.

Meanwhile, the American College of Radiology (ACR) estimates that as of May 2017, about 30 percent of mammography units installed in U.S. hospitals and imaging facilities were of the 3D variety, up significantly from a few short years ago. Moreover, research that focuses on the benefits of DBT continues to surface, with such advantages as cost savings, increased cancer detection rates and lower recall rates making a strong case for the radiology community and payors alike.

“The pluses far outweigh the minuses,” says Debra Monticciolo, MD, professor of radiology at Texas A&M Health Science Center College of Medicine in Bryan, Texas, vice-chair for research and section chief of breast imaging in the department of radiology at Baylor Scott & White Healthcare in Temple, Texas, and chairman of the ACR Breast Imaging Commission.

Legislation Is Heating Up

The Centers for Medicare and Medicaid Services (CMS) approved Medicare reimbursement for women undergoing DBT exams in conjunction with 2D digital mammography back in 2014. And on the state level, Texas legislators were not the first to board the DBT train in signing HB 1036 into law. Several other states already have similar legislation in place or are currently considering a bill that would require DBT coverage.

The scope of these laws does vary. For example, New Jersey has in place a breast cancer screening mandate that requires coverage of “certain breast evaluations, including ultrasound evaluation, MRI scan, DBT, and other additional testing of an entire breast or breasts.” In that state, members or covered persons in benefit plans who are subject to the mandate, as well as of administrative services only (ASO), ASC employee health, and self-funded groups that have opted to adopt the mandate, are considered eligible for DBT coverage after a baseline mammogram if the latter reveals extremely dense breast tissue or is abnormal within any degree of breast density (including not dense, moderately dense, heterogeneously dense, or extremely dense).

Also considered eligible for DBT coverage in New Jersey are individuals with additional risk factors for breast cancer. This includes a family history of breast cancer, positive genetic testing, extremely dense breast tissue based on the ACR’s Breast Imaging Reporting and Data System, or “other indications as determined by the member’s health care provider.” When DBT is deemed eligible for coverage, it is limited to “one procedure per mammographic episode of care, in either a screening or diagnostic role.” For benefit plans that are not subject to the mandate and for ASO, ASC employee health, and self-funded plans that have not adopted the mandate, DBT is considered investigational in the screening or diagnosis of breast cancer.

In a somewhat different vein, under New York’s law, health insurers must provide “medically necessary” coverage for DBT screenings without co-pays, coinsurance, or deductibles. And the law in Illinois, which went into effect in 2015, makes a provision for DBT coverage, but only “if the technology is not considered as a mandate under the Affordable Care Act,” according to a statement issued by State Representative Michael McAuliffe (R-Chicago), who sponsored the bill. The law extends DBT coverage to Medicaid recipients.

Despite the differences, this is just the beginning, says Eugenia Brandt, director of state affairs at the ACR. “Although many states have wrapped up their legislative sessions for 2017, private payor coverage of DBT remains a priority for the ACR Managed Care Committee and Network, and we expect more states to work on securing coverage mandates for this important benefit in next year’s legislative session,” she says.

Private insurers are becoming more open to the idea of reimbursement for DBT, in certain cases reversing their initial stance on it. Cigna, for example, revised its medical coverage policy in 2016 to include DBT used for routine breast cancer screening. The provider had previously covered DBT for diagnostic purposes only, based on guidance from the U.S. Preventive Services Task Force (USPSTF), which considers there to be insufficient evidence to determine that DBT is “clinically superior to traditional mammography for breast cancer screening.” Cigna altered the DBT coverage policy in keeping with more recent guidance from the National Comprehensive Care Network, a non-profit alliance of leading cancer centers that sets standards for high-quality cancer care.

Julie Kessel, MD, Cigna’s senior medical director and overseer of the company’s medical policy, says the company remains open to change based on new scientific evidence or guidance from “respected” non-commercial organizations. She adds that in paving the way for earlier detection as well as fewer callbacks and false positives, DBT supports “better-quality care, at a lower cost.”

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The Cost Equation

Recent research bears out the cost-effectiveness of DBT. In a study recently published in the American Journal of Roentgenology, Vivek Kalra, MD, of Medical Center Radiology Group in Orlando, Fla., concluded that adding screening DBT to annual mammography is cost-effective across all ages and breast densities, but especially so in women ages 40 to 49 (AJR Am J Roentgenol. 2016 Nov;207(5):1152-1155).

For the study, Kalra and his colleagues created an annual screening model with DBT and 2D mammography for women in the 40- to 74-year-old age bracket across all breast tissue densities. Model parameters were taken from a multi-institutional study of more than 450,000 patients, institutional data from 13,000 patients, a literature review and Medicare reimbursement rates. The base case for the model was a 56-year-old woman undergoing an annual screening exam.

In addition to other findings, the study revealed that the net monetary benefit per decade was $1,598 per patient in the 40- to 49-year-old subgroup, $546 per patient in the 50- to 59-year-old subgroup, $535 per patient in the 60- to 69-year-old subgroup, and $501 per patient for ages 70 and above.

“Our analysis proves that adding [DBT] to 2D mammography starting at the age of 40 is cost-effective versus 2D mammography by itself,” says Kalra, who was a member of the department of radiology and biomedical imaging at Yale University in New Haven, Conn., when the research was conducted. “However, it is even more significant that three times greater net monetary benefits were found in women ages 40 to 49 compared with those ages 50 to 59.”

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Kalra adds that DBT has been rendered “even more cost-effective” since the study was published, because the number of false positives—which he deems the key to reducing mammography costs—have continued to drop. He believes a heightened tendency among community-practice general radiologists to leave the administration of DBT imaging examinations to their sub-specialist mammographer colleagues rather than “re-training themselves” or undergoing re-training to perform the procedure has a hand in this trend.

“Dedicated mammographers have greater confidence in reading screening exams, and thus have lower recall rates,” Kalra says. With time, he adds, patients have more than one year of 3D images, allowing for side-by-side comparisons and further reducing the need for recalls following mammograms.

In another American Journal of Roentgenology study, researchers concluded that DBT offers cost benefits when used as a screening mammography tool in a community-based setting with privately insured patients (AJR Am J Roentgenol. 2017 May;208(5):1171-1175).

“We found that DBT is a cost-effective alternative to full-field digital mammography (FFDM) in a short-term cost analysis, particularly when comparing cost per cancer detected,” says lead author Sara Hunter, MD, of Northeast Ohio Medical University in Rootstown, Ohio. “While there had been multiple studies showing long-term cost-effectiveness of this modality using model populations, we were interested in a short-term analysis using real patients.”

Hunter and her team performed a year-long retrospective analysis on data from women presenting for screening mammography that included “any additional radiologic workup.” More than 6,300 patients underwent DBT or FFDM based on personal preference, physician suggestion and cost difference. Of these patients, more than 3,600 opted for DBT during the screening period, while more than 2,600 chose FFDM. The summation of findings over the study period were used to calculate recall rates, cancer detection rates and billing costs for a regional private insurer and Medicare. For screening, follow-up imaging and radiologic procedures, private insurance billing was $2.9 million. Medicare costs were $1.2 million for screening.

The team found that per-person costs uncovered in the study were approximately $40 higher for the DBT group using both forms of insurance, and that DBT was not found to be a cost-efficient alternative with respect to Medicare costs after a standardization of the difference in cancer detection rates between the two patient groups. However, Hunter says, the cost per cancer detected was lower in the DBT group for both private and governmental insurance, leading to potential savings of $3.7 million and $899,000 per 100 cancers found.

Beyond Cost Considerations

But cost-effectiveness is not the only factor driving DBT forward; other catalysts are at work as well. The University Breast Center at the University of Tennessee Medical Center in Knoxville, Tenn., has been employing DBT to screen all patients with any degree of breast density since 2014, says Garnetta Morin-Ducote, MD, the breast center’s medical director and an associate professor of radiology. Morin-Ducotte says she doesn’t have the exact data, but she has noticed an increase in cancer detection rates, even in patients with “scattered” breasts, along with decreased recall rates. The results have been so positive, she adds, that the University Breast Center has borne the cost of its two DBT units (one narrow-angle and one wide-angle) rather than build them into what they charge for DBT examinations. The imaging provider is also in the process of establishing a mobile DBT unit to accommodate women who want to take advantage of the modality, but cannot do so at the breast center because of time, distance or other logistical issues.

“It is our belief that monetary considerations should not be a barrier to prevention; fortunately, up to 70 percent of the insurance companies we work with do offer some reimbursement” for the procedure, Morin-Ducote says.

Studies continue to support the assertion that DBT has a significant impact on cancer detection and recall rates. For instance, a recent Breast Cancer Research and Treatment study compared data from more than 278,000 patients screened with FFDM alone with that of more than 173,000 patients screened with both mammography and DBT (Breast Cancer Res Treat. 2017 May 18). Lead author Elizabeth Rafferty, MD, of L&M Radiology in West Acton, Mass., and colleagues found that adding DBT to FFDM yielded significant reduction in recall rates for women in all four age groups studied: 40 to 49 years old, 50 to 59 years old, 60 to 69 years old and 70 years old or older. The largest identified reduction in recall rates was for women ages 40 to 49; the rate changed from 137 per 1,000 scans (FFDM only) to 115 per 1,000 scans (DBT and FFDM). DBT also sparked an improvement in the cancer detection rate for women in the youngest age group studied, from 2.9 per 1,000 scans (FFDM only) to 3.8 per 1,000 scans (DBT and FFDM). Meanwhile, the invasive cancer detection rate trended upward, from 1.6 per 1,000 scans using (FFDM only) to 2.7 per 1,000 scans (DBT and FFDM). Breast density had no impact on these results, the researchers wrote.

Wendy B. DeMartini, MD, division chief of breast imaging and professor in the department of radiology at Stanford University School of Medicine in Stanford, Calif., and president of the Society of Breast Imaging, thinks the statistics related to DBT show just how impactful it can be in improving patient care.

“Major benefits have been demonstrated when DBT is used for screening, including better detection of cancers and, very importantly, a reduction in false positive recalls,” she says. “These benefits directly address the current limitations of standard mammography, including the number of, and impact of, false positives. DBT's false positive reduction is particularly meaningful in light of the USPSTF emphasis on this outcome by standard mammography when establishing their current USPSTF screening guidelines,” which recommend biennial screening mammography for women 50 to 74 years old.

Monticciolo agrees with DeMartini about the effectiveness of DBT. “There is no arguing with statistics, and as more data come to light, the benefits [of DBT] for all age groups will become ever clearer to all payors, as well as to clinicians and imaging facilities,” she says.

DeMartini, Monticciolo, and others foresee DBT gaining even more ground as manufacturers enhance the capabilities of 3D imaging equipment and as these improvements are recognized by such bodies as the FDA. The latter recently deemed one manufacturer’s DBT offering superior to traditional mammography equipment for the imaging of dense breasts.

Patient pressure and influence will have an impact as well. Kalra points out that in response to such pressure, Pennsylvania law now mandates that payors cover DBT with no out-of-pocket costs, a savings that averages $50 to $60.

“Many patients are beginning to understand that they have a choice, and given a choice between what is presented as the more thorough option and the less thorough option, they will take” the former, Morin-Ducote says. “As for us, once we have it, it’s a valuable, valuable tool. There’s no going back.”