Experts weigh earthshaking implications of new breast MRI guidelines

Patchy insurance reimbursement for breast MRI screening in high-risk women could become a thing of the past now that the American Cancer Society is backing MRI for routine use in select patient groups. In addition, results of an American College of Radiology Imaging Network trial just released support the use of MRI in breast cancer treatment planning.

ACS guidelines, released on March 28, advise annual MRI screening for women with a high lifetime risk of breast cancer - defined as 20% or more - including women with the BRCA1 or BRCA2 gene or a strong family history .

"An unbiased, internationally recognized group has made a strong statement for obtaining breast MRI on a routine basis. This is the biggest single event that has happened as far as promoting breast MRI," said Dr. Steven Harms, a radiologist at the Breast Center of Northwest Arkansas. "Having a group like the ACS endorse this is a major stop toward getting reimbursement."

Of the 70 million women in the U.S. between 30 and 70 years of age, one million to 1.5 million fall into one of the groups recommended for routine screening with breast MRI, along with mammography.

Only an estimated 495,000 breast MR studies, including screening and diagnostic exams, were performed in 2006, for 1% of the total number of MR studies, according to the IMV Medical Information Division in Des Plaines, IL. That still represents more than a 300% increase from the 161,000 procedures done in 2001.

IMV also estimates that in 2006, 1875 sites offered breast MRI. This is equivalent to one-quarter of total MRI sites, including fixed and mobile units.

Women can calculate their risk using a tool available on the website of the National Cancer Institute. Those with dense breasts, thought to account for one-third of the population, are not included in the groups recommended for annual breast MRI at this time, though they are thought to be at higher risk for breast cancer.

In addition to encouraging more consistent insurance reimbursement for breast MRI screening in high-risk women, the ACS guidelines will increase awareness of the modality's role among primary-care doctors, according to Harms.

Given the large number of trials supporting use of MRI in high-risk women, the ACS findings are not surprising, he said.

"If you combine all of the trials, there are huge numbers of patients. All of them consistently show that MR is significantly better than mammography," Harms said.

Trials have also indicated that the benefits of breast MRI outweigh the disadvantages, such as false-positive results and biopsies of benign lesions, according to Harms. With breast MRI, as with mammography, callbacks and false-positive rates drop on subsequent screening exams, compared with the initial study.

"Breast MRI's false-positive rate is better than that of mammography and is acceptable," he said.

Some insurers and clinicians question the dearth of data showing that breast MRI reduces mortality rates over the long haul.

"The lack of long-term outcomes data has been the battle cry of third-party payers," Harms said.

These data would be difficult to obtain, however, because women could survive for 20 or 30 years with the disease following a breast MRI screening exam. Researchers know that detection of breast cancer at earlier stages, when it is more amenable to treatment, improves mortality rates down the line. Breast MRI has been shown to detect cancers when they are smaller and have not spread, translating into lower morbidity, Harms said.

Breast MRI has also been shown to be of great value in staging and treatment planning. In women who have been recently diagnosed with cancer in one breast, for example, MRI is extremely useful in detecting or reliably ruling out mammographically occult cancer in the contralateral breast, according to a large new multicenter study conducted by the ACRIN and released on 29 March (NEJM 356;13:1295-1313).

The study showed that breast MRI detected additional disease in 3% of women diagnosed with cancer of a single breast. The ability to exclude disease, thereby improving breast conservation therapy, is at least as important as improving the detection rate, Harms said.

Cancers often recur because the extent of disease has been inadequately estimated. Some women with cancer of a single breast opt for mastectomy of the other breast as a preventive measure. Breast MRI helps ensure that the right type of surgery is done at the time of initial diagnosis.

"If you can exclude disease in a large number of people, you can tailor lumpectomy for those who have limited cancer. Knowing the extent of disease is most important. That is what is really going to help people in the future," Harms said.

Even prior to the release of the ACS guidelines, getting reimbursement has been easier for breast MRI screening than for staging and treatment planning. The new ACRIN trial results could remedy that problem, Harms said.

Not surprisingly, the recent breast MRI developments have sent the spirits of industry soaring along with those of clinical proponents. Aurora Imaging, maker of dedicated breast MRI systems, is preparing to double its modest U.S. base of 19 units by the end of this year.

"We are elated to have the endorsement of the ACS - the whole company is floating. We dedicated more than a decade to develop this technology. Breast MRI can have a tremendous impact on patient care," said company president and CEO Olivia Ho Cheng.

The Aurora system costs about $1.5 million, out of reach for some breast centers and hospitals. The company engages in joint-venture revenue-sharing agreements, however, that require next to no money down for system acquisition.

Virtually every high-field MR system in the country can be upgraded to accommodate breast MRI at a quality level that satisfies ACR guidelines, said David Ferguson, general manager of MR premium products for GE Healthcare. For very new systems, this costs as little as $75,000, and for older systems, the upgrade might cost roughly $400,000.

"The barrier to adding breast MRI is not as high as people might think," Ferguson said.

Since ACS guidelines advise that centers offering breast MRI also offer biopsies, centers will need to invest in biopsy equipment as well.

Technological developments have enhanced breast MRI in recent years, according to the ACRIN trial results. GE said its launch of a technology that allows imaging of both breasts at high resolution in 2003 was an important development. The company also launched a CAD product

For more information from the Diagnostic Imaging archives:

Breast MRI pays its way in preoperative planning

Breast MRI's future depends on finding suitable indications

MRI tops CT in detecting intraductal cancer