DOTmed Healthcare News: Is XR-29 hurting independent service providers?

XR-29 Imagine you are the owner of an independent service organization (ISO) providing maintenance to older model CT scanners at outpatient imaging facilities.

Although they aren’t the most advanced systems on the market, they safely and accurately diagnose patients without putting too much extra strain on the overstretched budgets of your customers, the providers.

Now, imagine new legislation mandates that all CT scanners have certain software features in order to remain fully reimbursable on certain Medicare scans. As you begin researching compliance, you discover that CMS has entrusted the original equipment manufacturer (OEM) with the job of certifying these features are present.

On one hand, this makes perfect sense. If a scanner is compliant, who could verify it with the same degree of certainty as the company that built it? If the scanner requires an upgrade, who better to go in there and install is than the OEM?

But what about the OEM’s business incentives to make older scanners (like the ones your customers utilize) non-compliant in the interest of selling an upgrade? Is it inconceivable that manufacturers might use their newfound knowledge of your customer-base to their advantage?

This is the conundrum facing the third-party medical equipment industry under the NEMA standard, XR-29.

Two ways XR-29 puts OEMs in the driver’s seat
Rob Kerwin, legal counsel for the International Association of Medical Equipment Remarketers and Servicers (IAMERS), told HCB News he has received information indicating some manufacturers are actively seeking the business of providers who initially contacted them for XR-29 certification.

“It is our view that the standards compliance process, advanced by a manufacturer’s organization, should not be used to gain strategic benefits against the independents,” said Kerwin. “This seems to us inconsistent with the American National Standards Institute (ANSI) goals.”

An ISO owner (who asked to be anonymous) said he had firsthand experience with this. A few of his customers reached out to the OEM regarding XR-29 compliance and shortly thereafter told him they received service contract offers.

But does that mean they didn’t know the system was there to begin with? Not necessarily, according to Ken Denison, executive, MICT digital marketing for GE Healthcare, who pointed out that the FDA mandates OEMs know where their systems are installed in order to notify those facilities in the event of a recall.

Still, once a system has been sold by the original buyer, Denison said it’s possible that the OEM would lose track of where it is.

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.

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.

HCB News sought input on this issue from a wide range of organizations. Among third-party stakeholders we were repeatedly told that independent auditors and medical physicists should be charged with XR-29 certification.

“They visit the hospitals once a year to make sure the machine is safe to use on patients,” said one ISO. “There is no reason these people cannot say ‘yes, this machine meets all the guidelines.'”

But according to MITA it’s not that simple.

“There are portions of the standard where it would be difficult for an on-site medical physicist to make a determination,” Megan Hayes, director of Regulatory and Standards Strategy at MITA, told HCB News. “The scope of the standard is directly related to the design of the CT equipment and ultimately, a physicist is a user of the equipment.”

HCB News sought comment on this issue from ACR, but it deferred to CMS.

Over two weeks ago, CMS acknowledged receiving our inquiries into XR-29 certification, but has not yet responded to multiple requests for feedback. We have directed our inquiries to three different sources.

“I think that the main problem is the fact that CMS refrains from defining the specific requirements from a system that can be accepted,” said Aharon. “CMS and ACR claim rightfully that they can’t verify if a certain solution meets all XR-29 requirements or not — this would be the case for any independent auditor.”

The third-party medical equipment industry has matured over the last several years, and keeping the playing field level in the interest of competition is more important than ever. As with the FDA’s examination of equipment refurbishing and servicing, XR-29 may have significant implications for independent service organizations and the providers they do business with.