by
Gus Iversen, Editor in Chief | August 04, 2017
From the August 2017 issue of HealthCare Business News magazine
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.
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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.
