A separate but related concern is that OEMs could intentionally exclude certain scanners, (such as the ones they no longer service) from achieving XR-29 compliance by writing software upgrades that abort installation on them.

One ISO told HCB News there are specific lines of code in one OEM's software upgrade patch that prevent it from installing on lower (4 and 8) slice systems.


The OEM denied these allegations. Initially, HCB News was told that the scanner's computer operating system was the "basic line of demarcation" regarding compliance — meaning if it runs on an antiquated software language you're out of luck.

When our research showed that there are many 4 and 8 slice systems that are indeed running on the same operating system as the new, higher slice systems, the OEM acknowledged there were "a few" out there, adding they "did not develop software for these systems."

By the OEM's estimate, there are approximately 850 installed systems that fit this profile and will not be eligible for XR-29 compliance — on average, they are 13 years old.

How did we get here?
Medical radiation concerns captured the public interest ten years ago, due in part to a couple of high profile cases of negligent CT dose overexposure. A few years later, the Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA), unveiled a CT dose standard called XR-29.

The standard would be implemented into the Patient Access to Medicare Act of 2014 to improve dose accountability. XR-29 calls for CT scanners to have four features, without which their reimbursement could be reduced 5 percent in 2016 and 15 percent from 2017 onward (but only if the exams are billed to Medicare from imaging centers, physician offices and hospital outpatient settings):

• Automatic exposure control (AEC) to access radiation dose in real time.
• Built-in adult and pediatric protocols for the operator to choose from.
• MITA Dose Check for automatic notification of when scan settings are likely to exceed dose thresholds.
• DICOM SR (Structured Reporting) to incorporate dose history into the patient record.

According to MITA, roughly one-third of installed systems will be non-compliant with XR-29. These would be older systems, and therefore, equipment predominately serviced independently.

Last year, MITA pointed out ambiguities in the XR-29 certification process to CMS. In a letter, Peter Weems, MITA’s director of policy and strategy, described a meeting of concerned stakeholders at the 2015 RSNA conference, including radiologists, hospital administrators, medical physicists, and individual institutions.

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