Seeking Widespread Coverage

Get the latest on legislative and regulatory efforts to reimburse digital breast tomosynthesis.breast tomosynthesis

Breast cancer mortality rates have declined more than one-third since 1990, according to the American Cancer Society1 — in part, as digital screening has helped enable earlier detection.

Advances in technology, specifically in digital breast tomosynthesis (DBT), improve detection and reduce recalls compared to full-field digital mammography (FFDM). The challenge is getting regulators and legislators to keep pace with technology by making tomosynthesis widely accessible to patients.

The Case for DBT

Conventional FFDM can miss or misidentify up to 20 percent of cancers, according to Dana H. Smetherman, MD, MPH, FACR, section head of breast imaging and vice chair of the radiology department at Ochsner Health System in Louisiana.2,3 Abnormalities hide underneath normal tissue, causing false negatives. Meanwhile, superimposed normal tissue can cause false positives requiring further testing (which increases costs and patient anxiety).

By producing hundreds of additional images with more specificity and sensitivity, tomosynthesis overcomes FFDM's limitations.

"The DBT data is processed and displayed as a series of thin slices at one-millimeter intervals," says Smetherman, chair of ACR Breast Imaging Commission's Economics Committee. "It eliminates the problem of overlapping tissue that looks like an abnormality or could hide cancer."

"If we look at the studies, the research has shown a decrease in recall rates from screening mammography as high as 37 percent and a relative increase in cancer detection as high as 51 percent," says Smetherman.4,5

Against arguments that increased detection means overdiagnosis, Smetherman emphasizes, "With DBT, the vast majority of additional cancers we find are invasive. We find more cancers at earlier, more treatable stages, which are less likely to then spread."

The Push for Coverage

ACR's official position states that, given this evidence, tomosynthesis is no longer investigational and should be covered as mammography. Reimbursement removes financial barriers around tomosynthesis, Smetherman says, both for patients (as co-pays range from $40–60 for this service) and for health systems that want the assurance of consistent coverage to justify $200,000 equipment investments.

The CPT Editorial Panel created CPT codes for tomosynthesis reimbursement in 2015. CMS adopted one and added its own to establish nationwide Medicare coverage. But getting other payers to cover tomosynthesis is an uphill battle.

Outside of Medicare, patients have approximately a 50/50 chance of coverage, depending on where they live. Medicaid covers DBT in 23 states and Washington, D.C. Likewise, many private payers determine coverage state-by-state. Even if an overarching organization — like Blue Cross Blue Shield Association's Center for Clinical Effectiveness — rules that there's insufficient evidence to support tomosynthesis, payers in each state make individual decisions.

"Blue Cross Blue Shield covers tomosynthesis in 22 states (and four other states have private payer coverage), but then 24 states have no private payer coverage at all," says Kathryn J. Keysor, director of the economics and health policy department at ACR.

While private payers can recognize CPT codes for tomosynthesis reimbursement, she says, they don't have to until the United States Preventative Service Task Force issues an A or B rating to mandate coverage. Meanwhile, the ACR is approaching private payers, attempting to disprove the current task force rating of "Insufficient Evidence."

Supporting Local Efforts

Rather than waiting for private payers, states and patients are pursuing legislative and regulatory change locally. Pennsylvania, Illinois, and Connecticut already mandated coverage by changing their definitions of mammography to encompass DBT.

"There's more and more awareness of tomosynthesis. Patients are more educated to ask, 'Do I need it?'" says Eugenia Brandt, director of state affairs at ACR. "Stakeholders are going directly to the plans and saying, 'Consider covering this.'"

In Pennsylvania, stakeholders spurred regulatory change by complaining to the state insurance department. California's state insurance commissioner and legislators are reviewing the issue, after similar patient pushback there.

"In California, a lot of insurance companies have denied tomosynthesis coverage; the patients then have to request an independent medical review," Brandt says. "It's an administrative hassle, but the overturn of denials is really high."

Obtaining coverage takes a perfect storm of support, whether change is legislative or regulatory. As ACR advocates for DBT coverage "one payer, one state at a time," Keysor says, it collects resources for its members, equipping them to make the case with literature confirming DBT's clinical relevance.

"The evidence shows that tomosynthesis saves lives, and the ACR's position is that is should be covered," Keysor says. "We're heading in the right direction; we have Medicare coverage across the country and private payer coverage in half the states. It's just a matter of getting private payers to see that the literature is there. The more published literature there is to address their concerns, the better chance we have."


By Brooke N. Bates, freelance writer for the ACR Bulletin


To view the endnotes for this article, please visit the online version at bit.ly/Tomo-Update.

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