Before January 2016, an estimated third of the outpatient installed CT base will need to be replaced, if providers wish to avoid the 5% penalty that Medicare will levy on exams acquired with outdated CT technology. The penalties are associated with an underreported quality measure in the Protecting Access to Medicare Act of 2014, the same legislation that prevented the 24% physician pay cut and that requires physicians to consult appropriateness criteria prior to ordering advanced medical imaging.
Penalties for exams acquired using noncompliant technology will soar to 15% in 2017. They apply to providers billing under the Medicare Physician Fee Schedule and the Hospital Outpatient Prospective Payment System.
The good news is that an estimated two-thirds of installed CT systems already meet (or can readily meet) the NEMA XR 29 (2013) radiation-dose standard with a software upgrade, according to Gail Rodriguez, executive director of the Medical Imaging & Technology Alliance (MITA), a division of NEMA. The association estimates that 40% of the two-thirds already meet the standard and 60% will require a software upgrade.
Rodriguez can’t address the cost of upgrading, but she suggests that vendors are not likely to charge providers unreasonable sums. “I know that the companies made commitments to the FDA, and it is very much in their interest to make these things available as straightforwardly as possible,”
Nonetheless, the cost of upgrades could add up, especially for hospital outpatient departments and freestanding providers with multiple systems to upgrade. In addition, providers (and others) generally begrudge the expense of software upgrades—at any cost. John Boone, PhD, vice chair of radiology at the University of California–Davis Medical Center and president-elect of the American Association of Physicists in Medicine (AAPM), reports that his institution paid a deeply discounted $70,000 per system to purchase iterative-reconstruction software, a more advanced dose-control feature than XR 29 (2013) requires. He reports that this was more expensive than it should be, but probably the best way to control dose.
Rodriguez describes the evolutionary development of the standard, the tremendous effort on the part of all industry stakeholders to address rising concerns about radiation dose, and MITA’s role in the provision to apply penalties to exams acquired on outdated equipment. “We’ve been working with the FDA, physicists, and physicians—the entire industry—for a long time to try to get at how to reduce dose as much as possible,” she reports. “For many imaging folks, this is one logical step in a series of steps we’ve tried to take over the past four years.”
In 2010, the FDA launched the Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging (following a series of widely reported overexposure incidents), in a big-tent effort that included the ACR®, the AAPM, and MITA. “They are driving us hard, trying to make sure that the equipment is easy to use and understand—and that it has as many dose-reduction, dose-reporting, and dose-recording features as possible,” Rodriguez says.
The XR 29 (2013) Standard
Rodriguez refers to XR 29 (2013) as a base standard in that it represents an incremental change over the previous three standards (introduced during the past four years). “These are not burdensome requirements: NEMA XR 25 CT Dose Check, alarm systems, and that sort of thing,” she notes. “Only very old equipment will have difficulty being (or be unable to be) upgraded. It’s really just the old, antiquated equipment that has to go.”
Many 64-slice CT systems either came with the dose-saving features or are upgradable to automatic exposure control with tube-current modulation. They have iterative-reconstruction software as well, Boone says.
“Earlier scanners (such as the 16-slice or four-slice systems), in general, do not have an upgrade path, as far as I know,” he adds. “The fact of the matter is that big companies do not develop new software for legacy systems.”
The XR 29 (2013) standard includes four components: two product features and two standards features. The product features are automatic exposure control and reference protocols. Rodriguez describes automatic exposure control as less a dose-reduction feature than a dose-optimization feature. It automates radiation-dose adjustments based on body mass and greatly reduces the number of images that must be acquired, she says.