Will Breast Care Guidelines Make OEMs Nervous?

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The U.S. Preventive Services Task Force (USPSTF) also recommended that women get mammograms every other year instead of annually up to age 74. No guidelines were presented for women over 75.

The panel said that the benefits of early screenings were more frequently outweighed by the anxiety, unnecessary tests, and treatments that accompany false alarms. Many patient advocates and breast cancer experts lauded the guidelines, but scores of patients, politicians, and associations spoke out against them.

“We believe that these recommendations effectively turn back the clock to premammography days by making the diagnosis of breast cancer occur only when the tumor is large enough to be felt on a physical exam,” the American Society of Breast Surgeons said. The American Cancer Society, American College of Radiology, and the Society of Breast Imaging also stand by the current recommended age of 40.

Manufacturers have been mostly mum on the potential business effects of the guidelines. But like many other medical device companies, makers of mammography systems rely on hospitals and other care facilities to purchase their equipment. Although the effects won’t be seen immediately, the guidelines could lead to fewer breast cancer screenings and thus longer periods in between orders (from purchasers) for new mammography equipment.

Such concerns are especially relevant in light of the ongoing healthcare reform debate and hospitals’ efforts to curtail spending. Companies such as General Electric and Hologic manufacture digital mammography systems, which can cost more than $250,000 apiece (systems that use film cost around $40,000). Makers of diagnostic imaging equipment, breast MRI systems, and imaging software could also be affected.

“We have expected this announcement for some time, and have been analyzing the effect it might have on our business,” says Hologic marketing director Jim Culley. “We do not feel there is sound medical evidence supporting changes to the screening age or interval.” Culley also adds that the company doesn’t think the guidelines will have much of an immediate impact on its business.

The Senate recently ignored the panel’s findings, voting to require health insurance companies to provide free mammograms to women. Senator Barbara A. Mikulski (D–MD) said about the amendment she cosponsored: “It does not tell women, ‘You will have a mammogram at 40.’ It says, ‘You will have access to that mammogram if you and your doctor decide it’s medically necessary or medically appropriate.’”

HHS secretary Kathleen Sebelius acknowledged that the new guidelines “caused a great deal of confusion and worry” but stressed that the panel does not set federal policy nor does it determine what services are covered by the government. The group is an independent panel of experts put together by HHS’s Agency for Healthcare Research and Quality. “The task force has presented some new evidence for consideration, but our policies remain unchanged,” she insisted.

Other stakeholders aren’t so sure. Senator Kay Bailey Hutchison (R–TX) called this new outlook on screenings “the beginning of rationing,” saying that it gives the government an excuse not to provide payments for more frequent screenings, and that insurance companies would likely follow suit.

For their part, insurers insist that the guidelines won’t affect their coverage decisions. WellPoint, Aetna, Cigna, and UnitedHealth Group say that coverage depends on a variety of research and guidelines from an array of groups. These companies also say that coverage is likely for screening recommended by a doctor, especially if the patient has a genetic predisposition to or family history of the disease.