March 2014

Ultrasound Screening — Establishing Its Role in Women With Dense Breast Tissue
By Kathy Hardy
Radiology Today
Vol. 15 No. 3 P. 10

Radiologists, product developers, and health care administrators alike are navigating their way through some unfamiliar territory as ultrasound finds it place in the screening process for women notified that they have dense breast tissue. Ultrasound usage appears to be increasing as states pass notification laws and a national bill has been introduced in the House of Representatives. However, questions regarding insurance coverage, coding, and reimbursement for ultrasound used as a breast cancer screening tool could throw up roadblocks to its widespread adoption.

Some limitations of handheld ultrasound are being eased with automated breast ultrasound (ABUS) systems, one of which is FDA approved for use in screening asymptomatic women with dense breasts. In 2012, the FDA approved the somo-v ABUS system developed by U-Systems, now a GE Healthcare company, for breast cancer screening as an adjunct modality to mammography for asymptomatic women with dense breast tissue. ABUS may work better in a high-volume breast cancer screening environment, with the average ABUS study usually taking one to three minutes.

“Handheld technology is not good in a large-volume practice,” says Jessie Jacob, MD, director of ultrasound at Northern California Women’s Imaging Center in Palo Alto. “Automated breast ultrasound streamlines screening and helps with workflow. Radiologists know that ultrasound is effective in dense breast tissue screening but need to know that things like workflow are being addressed.”

Jacob, who also serves as vice president of medical affairs for U-Systems, notes that mammography remains the gold standard for breast cancer screening, and women should follow their physicians’ recommendations when it comes to scheduling regular screening mammograms. Women informed that they have dense breast tissue should talk to their physicians about the specific risks and additional screening that may be appropriate.

Women should know that dense breast tissue can mask cancer by making it difficult to see on a mammogram. Jacob feels limited when looking at dense breast tissue with mammography and is concerned about artifacts that could be missed. “The cancers identified with ultrasound are the ones we want to identify,” she says. “They are the cancers that kill. They are the cancers that will metastasize. Mammography is still good, but cancers found with ultrasound are the types that will progress.”

Jacob’s patients with known dense breast tissue undergo their annual screening mammogram and ABUS in the same visit. If dense breast tissue is discovered for the first time during a patient’s mammogram, she is offered ABUS the same day. “You don’t want to have to call back a patient to have supplemental imaging done after she’s already been to the office for her mammogram,” Jacob says.

Time Considerations
Vincent Giuliano, MD, DABR, medical director at VinCon Diagnostic Center in Winter Springs, Florida, uses the somo-v ABUS system as a breast screening modality in his practice. When he incorporated ABUS into his practice in 2009, it was as a diagnostic tool. However, with more emphasis on dense breast tissue today and the device’s approval for screening purposes in women with dense breasts, he now uses ABUS as part of a breast screening routine for some patients, even though Florida has yet to pass breast density notification legislation.

“I use ABUS judiciously,” he says. “It’s good for detecting cancers, but it’s not always cost-effective for use with all women. It’s a time-consuming process, taking about 30 minutes per study to read more than 300 scans taken during the imaging process.”

Giuliano conducted a study published last year in Clinical Imaging that reviewed the use of volumetric breast ultrasound (VBUS) in detecting nonpalpable breast cancers in dense breasts when used as an adjunct diagnostic modality to mammography in asymptomatic women. The study looked not only at the ability to detect cancers with a screening ABUS in women with dense breasts but whether this is a cost-effective alternative. The study compared the incremental costs of screening vs. the costs of added treatment related to a change in the staging of missed cancers from stage I to stage II.

“Using volumetric breast ultrasound resulted in the subsequent detection of cancers missed by mammography of smaller size and stage, justifying the basis for the judicious use of implementing VBUS in conjunction with mammography in the dense breast screening population,” Giuliano says. “In the final analysis, there is the issue of the theoretical cost benefit of adding VBUS screening to mammography in an otherwise healthy population. The importance of screening mammographically dense breasts with VBUS has particular relevance based on the small size and early stage of breast cancers. The costs of additional treatment outweighed the costs of screening.”

With increased detection, there’s the potential for increased false-positives. Jacob says that with an automated system and the elimination of the operator-dependent factor, the screening is more consistent, which assists in reducing the false-positive results. “There is a learning curve,” she says, “but as more radiologists use ABUS, they become more comfortable with it. The number of false-positives is reduced with more usage.”

Learning how to read ABUS scans is not difficult, she says, but rather a matter of becoming accustomed to seeing a new view. She compares the learning curve with ABUS to that of interns who are new to mammography. “In the beginning [when learning to read mammograms] everything looks the same,” she says. “But with more knowledge gained over time, the learning curve decreases. It’s the same thing with ultrasound. You question more of what you see in the beginning, but then you learn what’s normal and what you will see in the screening phase. You develop a new threshold and with that you have fewer false-positives.”

Jacob practices in California, where dense breast notification legislation was passed in 2012. She was a proponent of telling patients about their breast density prior to the law, but finds now that, with the publicity surrounding breast density, more patients are asking her whether they have dense breasts. She encourages women to have this conversation with their physicians.

“Women are relieved now that they’re being informed that they have dense breast tissue,” Jacob says. “They understand that it’s not an abnormal condition, but they want to look at their breast tissue in a different way. They want a different solution and not just mammography. They understand that there are limitations with mammography and like to know what other supplemental imaging can be effective with their breast tissue.”

While there currently is no mandatory dense breast notification in Florida, Giuliano works to educate his patients about it. He doesn’t believe that such legislation is necessary on the state level other than to increase public awareness of the issues surrounding dense breast tissue. “Our patients aren’t coming to us on their own with much information about dense breasts,” he says. “There is still some confusion regarding what it means to have dense breasts and what types of screening imaging they should have.”

Reimbursement Issues
The time involved in reviewing the 300 or more scans captured from skin to chest wall during ABUS adds to Giuliano’s belief that, while he has seen some reimbursement for routine ultrasound, the amount is limited at best. The process is time intensive, and with that, should see reimbursements at a higher level than other modalities, he says. “Insurers still see ABUS largely as experimental,” he says. “They’re not handing out any reimbursements for 3D technology. Using a 3D modality takes time, so there should be a greater reimbursement for this technology.”

As the technology evolves, codes for screening ultrasound remain stagnant. GE Healthcare’s website provides examples of possible ICD-9-CM diagnostic codes for reimbursement for ABUS in a screening capacity, stating that “it is the physician’s ultimate responsibility to select” the appropriate codes. Examples include wording such as “inconclusive mammogram,” “breast screening, unspecified,” and “other screening breast examination.” In its disclaimer, GE Healthcare notes that “this notice is general reimbursement information only; it is not legal advice, nor is it advice about how to code, complete, or submit any particular claim for payment.”

Richard Frank, MD, PhD, chief medical officer for Siemens Healthcare in Malvern, Pennsylvania, says that engaging with the Centers for Medicare & Medicaid Services could be the best avenue for effecting change in the existing codes to accommodate screening ultrasound. Looking at several approaches, such as piggybacking onto existing codes, he says the greater consideration should be the value of a procedure, not so much the cost. “When you look at the health economics of supplemental screening with ultrasound, the initial cost is more than balanced by the reduced cost of treatment later if cancers are detected at lower stages,” he says. “It’s not that cost isn’t a factor; everyone has a fiduciary duty. But there are savings in early detection and accurate diagnosis. We find one-third more cancers with ultrasound, and we find them sooner.”

Siemens’ automated breast volume scanner, ACUSON S2000, is approved for use in a diagnostic capacity, according to Jeffrey Stoll, director of global marketing for the company’s ultrasound division. This 3D imaging device provides coronal views that assist in visualizing lesion location and size as well as analysis of volume data and semiautomatic reporting. He says demand for breast ultrasound is increasing in the United States, which he attributes to greater awareness of breast density.

National Standard
In his role as chair of the Coverage Committee of the Medical Imaging and Technology Alliance (MITA), Frank sees a trend in more states passing dense breast notification legislation and, while he agrees with the concept, he believes that it would be better handled with a national standard. It’s difficult to inform the medical community and patients as to what’s best when the law addresses dense breast notification in different ways. Some states are vague about next steps for the patient. In addition, only four states mandate insurance coverage for supplemental screening imaging, creating an unfunded mandate in some states, he says.

“When something like this is done on a state-by-state basis, you end up with too much variability,” he says. “Each state is using different language in their legislation, and in the end there is no one ideal example. This leads to confusion when it comes to mammography.”

Frank says one of the MITA committee’s top projects for 2014 is support of a breast density reporting amendment to the Mammography Quality Standards Act, to be issued as a Notice of Proposed Rulemaking. He sees adoption of this amendment as a “signpost for product development and physicians” involved in breast imaging.
In addition to changes in federal regulations as they pertain to breast imaging, there is another nationwide initiative—the federal Breast Density and Mammography Reporting Act of 2013—which is in committee.

Consistent Screening
For some breast imagers, it didn’t take a law to get them to utilize ultrasound for breast screening. Radiologists such as Kevin Kelly, MD, director of Breast Ultrasound Center in Pasadena, California, and chief medical officer for SonoCiné, has been conducting clinical research on the use of ultrasound to discover and characterize breast cancer since 1993. He also invented the first automated whole-breast ultrasound device for breast cancer screening, the SonoCiné AWBU, which is a system to find cancers by an in-motion process that allows the reader’s eyes to see a disturbance of the breast tissue architecture. He says this instrument has received FDA 510(k) clearance for use as an adjunct to mammography for “any breast program, screening, or diagnostic.”

Kelly, along with fellow breast imager Judy Dean, MD, a diagnostic radiologist with Santa Barbara Women’s Imaging Center in California, made the conscious decision to use ultrasound as a screening tool long before legislation was enacted. In the case of both practitioners, their goal is finding small cancers in women, and each envisions ultrasound as the logical next step after mammography. By adding an automated aspect to ultrasound, the process becomes more uniform patient-to-patient, they say.

“With handheld scanning, we don’t all do the same thing,” Kelly says. “The hallmark of a screening test is it should be methodically and reproducibly done, so that the test is the same for all patients.”

Dean also finds consistency in the ability to store data in a PACS, a feature of the SonoCiné device. When patients make their annual mammogram appointments, it’s easy to pull up their records and see that, if they also have dense breasts, they need to schedule ABUS. This also allows for comparison of images from year to year. “This enables women to undergo their screening all in the same day,” she says.

Creating a multimodality approach to breast imaging is what Jacob sees in the future for breast cancer screening in the United States. Women with dense breasts will undergo mammography and ABUS or other imaging components, such as tomosynthesis or MRI.

“I see the inclusion of a multimodality approach leading to more personalized care based on a patient’s condition and what they want to do regarding their treatment and care,” she says. “This includes more use of ultrasound in a screening environment.”

That all-inclusive future also should include increased communication among all medical parties involved in a woman’s care, Frank says. He advocates a “more sophisticated delivery network” to educate patients on the topic of breast density. That information stream should include all entities of an integrated delivery system—community hospitals, tertiary care centers, physician offices, and clinics—so that all parties involved maintain a consistent solution to women’s imaging needs.

— Kathy Hardy is a freelance writer based in Phoenixville, Pennsylvania. She writes primarily about women’s imaging for Radiology Today.