In the shadow of unfunded mandates

May 31, 2005
Greg Freiherr

It’s been a long time coming, but the country’s watchdogs are finally starting to bark. For as long as I can remember, legislators concerned over the well-being of U.S. citizens have focused on the makers of equipment as their primary, if not their only, concern. They worried whether equipment was safe and did what it was supposed to do, and for good reason. But, oddly, the hand-wringing in Congress and, consequently, at the FDA typically ended once those products left the loading docks.

It's been a long time coming, but the country's watchdogs are finally starting to bark. For as long as I can remember, legislators concerned over the well-being of U.S. citizens have focused on the makers of equipment as their primary, if not their only, concern. They worried whether equipment was safe and did what it was supposed to do, and for good reason. But, oddly, the hand-wringing in Congress and, consequently, at the FDA typically ended once those products left the loading docks.

One major exception was the Mammography Quality Standards Act of 1992, which to this day requires users of mammography equipment to meet certain performance standards. In a few years, Congress will almost certainly reauthorize this act, as it has several times previously. The scope of these regulations may change, as well it should.

A report requested by Congress from the Institute of Medicine recommends that other modalities, namely MR and ultrasound, be covered where they relate to breast imaging. The IOM also recommends an expansion of record keeping to track how well this equipment detects cancer, how often biopsies are performed, and what effects these and other data have on patient outcomes.

The timing couldn't be better. Digital mammography is booming, and with it has come a plethora of workstations, miniPACS, and software packages that can easily handle exactly what the Institute says should be done.

The fly in this political ointment for women's health could be that Congress will require extended record keeping but not reward practitioners for their work in meeting these requirements. When such Capitol shenanigans affect state or local governments, they are called unfunded mandates. They wreak havoc on budgets. If this happens in imaging, the fallout could be devastating.

Breast imaging centers are now investing heavily in full-field digital mammography, and this trend is expected to continue for the next few years. Large capital costs amid continuing difficulties in making ends meet in breast imaging could cripple many operations if they are exacerbated by government regulations. At the very least, centers hard-pressed by new regulations will pull back from the marketplace, putting off equipment purchases indefinitely.

Congress can avoid such a calamity by upping the reimbursement provided for breast imaging services. Whether it will do so may depend on radiology's Washington lobbyists.

We have two years to make sure the breast imaging community and its patients do not pay a heavy price for politicians' good ideas. The time to start working on this is right now.