He said providers 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, “CMS will accept manufacturer certification of XR-29 conformance of CT equipment.” This year they added "third-party vendors that installed an FDA-approved upgrade" as an alternative option.


It warrants mentioning that no part of XR-29 mandates facilities show evidence of utilizing these features. The standard only requires that they be present on the system — which will not prevent the tragic (however rare) instances of extreme overexposure.

A way around the OEM
At a time when competitive options are crucial for helping health care providers balance their budgets, everyone seems to agree that third-party servicers are a vital part of the health care ecosystem. So, shouldn't XR-29 compliance be certified in a way that doesn’t threaten their success?

For providers and ISOs stuck between replacing a system that the OEM cannot (or will not) upgrade and risking significant cuts on reimbursement, there is another option: FDA approved third-party add-ons can bring compliance to a CT scanner when an OEM cannot.

Currently, SafeCT-29 is the only solution on the market that fits this bill — and for Medic Vision, the company that offers it, business has been good.

"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," Eyal Aharon, CEO of Medic Vision, told HCB News via e-mail. "We do not publish exact numbers, but I can say that by now we have hundreds of systems installed and most of these customers were referred to us by the OEMs."

Aharon said that FDA clearance of SafeCT-29 and public endorsements from certain OEMs (it has not been cleared for use with Hitachi or Neusoft scanners) have made all the difference.

"The lost income due to XR-29 noncompliance for a CT operator with an average workload (about 12 patients per day) is about $32,000" said Aharon. "The price of SafeCT-29 presents ROI in about one year."

Should anyone else be allowed to certify compliance?
ISO's servicing newer (and perhaps higher slice count) scanners might be reluctant to contact the OEM to receive certification if it means connecting their customer base with their competitor. At the same time, paying for compliance through a third-party solution would be unjustifiable in cases where the manufacturer can do it for free.

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