The penalties will be applied for failure to meet the quality measure included in H.R. 4302 Protecting Access to Medicare Act of 2014, which prevented the 24% physician pay cut and requires physicians to consult appropriateness criteria prior to ordering advanced medical imaging.
“We’ve been working with the FDA, physicists, physicians—the entire industry—for a long time to try to get at how to reduce dose as much as possible,” she reports. “For most imaging folks, this is one logical step in a series of steps we’ve tried to take over the last four years.”
Shortly after a series of widely reported instances of radiation dose over-exposure, the FDA launched the Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging in 2010, engaging all imaging stakeholders, including the ACR, the American Association of Physicists in Medicine, 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.
Rodriguez refers to standard XR-29-2013 as a base standard, as opposed to a stretch standard, in that it represents an incremental change over the previous three standards introduced during the past four years.
“These are not burdensome requirements: Dose Check, alarm systems, that sort of thing,” she notes. “Only the very old equipment will have difficulty or be unable to be upgraded. It’s really just the old, antiquated equipment that has to go.”
Apparently, there is quite a bit of very old equipment in the field, by MITA’s estimate one-third of all CT scanners in all settings. Of the two-thirds of the installed base that will not need to be replaced, MITA estimates that 40% already meet standard XR-29-2013.
Standard XR-29-2013 includes four components; two product features and two standards features. The product features are automatic dose control and reference protocols. Rodriguez describes automatic exposure controls as less of a dose-reduction feature than a dose optimization feature. It automates the radiation dose adjustments based on body mass and greatly reduces the number of scans that need to be shot, she says.
Reference protocols are those protocols that are loaded into the machine by the vendor and developed by physicists and clinicians. Rodriguez was uncertain whether those protocols would be standard across vendors.
The standards-based features are DICOM Radiation Dose Structured Report, enabling the recording of dose information in a standardized electronic format, and NEMA XR 25 CT Dose Check, which automates dose notifications and dose alerts to warn operators and physicians when dose exceeds established thresholds.
According to Rodriguez, the pushback from the provider community on the new requirement has been negligible. “Providers understand if they have the latest, greatest and safest machine, they should be paid more for it,” she says. “I think that fits very nicely with Medicare and its priorities to reimburse differentially for higher quality care.”
Rodriguez could not speak to the cost of a software upgrade, but she did suggest that vendors are not likely to charge providers unreasonable sums. “I know that the companies made commitments to FDA, and it is very much in their interest to make these things available as straightforwardly as possible,” she says.
Likewise, the FDA has asked vendors to drive adoption of dose reduction features, Rodriguez reports. “Medicare wants to pay for quality, so it made sense,” she reports. “All of those trends coincided,and we thought this is one of the places where we needed to step up, so we did.”
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