After years of planning and preparation, XR-29 is in full swing and impacting hospital revenue through CT reimbursement.

For many imaging providers and their service partners, the standard just means ‘business as usual’ because they were already utilizing compliant scanners or have become compliant through free software upgrades. For others, challenging questions regarding capital equipment investments, third-party software purchases and carefully calculated risk assessment are being asked, and the answers vary from one facility to the next.

XR-29 is intended to ensure providers are adequately monitoring patient exposure to radiation and takes aim at hospitals using outdated systems, incentivizing them to upgrade.

The standard’s origins can be traced back about 10 years, to a time when a few tragic cases of dose overexposure stemming from CT negligence drew major headlines and heightening public concern. A few years later, the Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA), unveiled its CT dose standard, NEMA XR-29, as a way to ensure imaging providers met minimum requirements for safe scanning.

XR-29 calls for CT scanners to have four features, without which Medicare reimbursement would be reduced 5 percent in 2016 and 15 percent from 2017 onward (but only on specific scans performed in 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.

It warrants mentioning that no part of XR-29 mandates facilities show evidence of utilizing these features. The standard currently only requires that they be present on the system.

According to MITA, roughly one-third of installed systems were likely to be noncompliant with XR-29. These would be older systems, and therefore, equipment primarily serviced independently instead of by the OEM.

Who is in charge of determining compliance?
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 stakeholders at the 2015 RSNA conference, who were “deeply concerned with regard to acceptable documentation of compliance” and asked CMS to clarify how certificates would be issued.

In April 2016, CMS responded to these concerns, stating it would “accept manufacturer certification of XR-29 conformance of CT equipment.” Later, it added, "third-party vendors that installed an FDA-approved upgrade" as an alternative option for securing compliance documentation.

Currently, there are two third-party solutions on the market that can help an otherwise noncompliant scanner avoid hits to reimbursement: SafeCT-29 from Medic Vision; and Z-DOSE29 from Zetta Medical Technologies.

A 16-slice sales boom
According to Hitachi, a CT scanner manufacturer, XR-29 has spurred sales for its newer lower slice count system, Supria. Getting new systems on the market also means securing OEM service agreements.

“The 16-slice CT as a market in the U.S. had been declining for years and there were a lot of older 16-slice units out there, predominantly at imaging centers and very small hospitals, that were not getting replaced, but then the XR-29 reimbursement legislation came along and a lot of those old machines couldn’t get upgraded,” Mark Silverman, Hitachi’s director of CT marketing, told HealthCare Business News at last year’s RSNA meeting. “So, suddenly people with old 16-slices were forced into needing to replace.”

While Hitachi’s corporate policy doesn’t allow Silverman to release specific sales data, he says that 2016 Supria deliveries exceeded about 200 percent of the original sales plan.

Manufacturer upgrades and the impact on ISOs
GE Healthcare, a leading CT scanner OEM, says the main differentiator between systems that could be made compliant and those that could not was the operating system the scanner ran on. Like other OEMs, the company provided free upgrades to systems where it was feasible to do so.

“We were unable to reconstitute the software development environment for older technologies,” says Ken Denison, an executive with MICT Digital Marketing, GE Healthcare. “Those devices, all of our 8-slice and lower systems, did not receive a software update and are not compliant with XR 29."

Most OEMs offered an upgrade pathway at no charge for certain scanners. Philips has a page on its website offering free tutorials to help its CT customers understand XR-29 compliance and how to utilize the upgrades.

For some independent service organizations, XR-29 and the push toward newer model systems has been bad for business. The owner of one ISO who asked to remain anonymous said his customers contacted CT manufacturers with questions about XR-29 and were offered new service contracts along with system upgrades. He is concerned that some OEMs may use the standard as an opportunity to create new sales and push the systems he services out of the install base.

Still, other ISOs have barely felt the impact of XR-29 at all. Richard Geertson, director of service for Oxford Instruments, says his customers contacted the company with questions about certification and his team helped them figure out where they stood.

“By digging into the nuts and bolts of what they need to do, we helped them through that process,” says Geertson. “Actually, it was just another opportunity to demonstrate to our customers that we are here to help them.”

Derek Stovesand, vice president of business development and marketing at Richardson Healthcare, a third-party parts and training provider, says his company has been indirectly impacted by XR-29 in instances when it led facilities to upgrade systems or move to a different brand of equipment.

In order to ensure its customers had the option to remain compliant without relying exclusively on equipment manufacturers, Richardson formed a partnership with Medic Vision, which provides a vendor-neutral and FDA-approved solution to meet the standard.

Non-OEM certification
Although some OEMs are witnessing a spike in CT sales, there are still many imaging facilities that are sticking with their old scanners and investing in third-party solutions like the one Richardson is referring its customers to.

"By the second half of 2016, the OEMs declared certain models as non-upgradeable for XR-29 and started referring their customers [with these models] to us," says Eyal Aharon, CEO of Medic Vision. "We do not publish exact numbers, but I can say that by now we have hundreds of systems installed, and most of these customers were referred to us by the OEMs."

The lost income due to XR-29 noncompliance for a CT operator with an average workload of about 12 patients per day is roughly $32,000, according to Aharon, who estimates the price of his solution can usually provide a return on investment for those facilities within a year.

Of course, since those numbers only refer to specific scans being billed to Medicare from imaging centers, physician offices and hospital outpatient settings, there are some facilities that have done the math and discovered it is in their best interest to stay the course without seeking XR-29 compliance in the first place, or only getting certain scanners certified.