Jacoby Roth was just two-and-a-half years old when he was sent for a CT scan at the Mad River Community Hospital in Arcata, California. The toddler had fallen off his bed, and was complaining about neck pains, according to the New York Times. His father, Padre, sat with the child in the imaging suite, holding Jacoby’s head still while he was scanned for more than an hour. According to the Times, it was only when Padre became concerned about the length of time the SCAN was taking that it was interrupted.
Investigators found that the technologist had scanned the child 151 times in the same area, producing radiation burns that later surfaced on his face, and dramatically increasing his likelihood of developing cancer. That was in 2009.
The same Times report also recapped the disclosure by Cedars-Sinai Medical Center in Los Angeles that year, “that it had mistakenly administered up to eight times the normal radiation dose to 206 possible stroke victims over an 18-month period during a procedure intended to get clearer images of the brain.”
Those high-profile cases and others like them were catalytic elements in the push for greater adoption of patient safety standards in the use of ionizing radiation, one of which is the NEMA XR-29 (MITA Smart Dose) Standard. Developed to mitigate the number and severity of accidents in the course of receiving a CT scan, XR-29 took effect in 2016.
Medical physicist Mahadevappa Mahesh characterizes XR-29 as a positive development for the imaging industry, and credited medical physicists and imaging device manufacturers with contriving a solution to the problem of imaging dose management.
A professor in the Russell H. Morgan Department of Radiology and Radiological Science at Johns Hopkins University in Baltimore, Maryland, as well as the chief physicist at Johns Hopkins Hospital and an ACR fellow, Mahesh said the standard resolves a number of important controls for the appropriate management of CT.
Under it, scanners must provide:
- DICOM radiation dose structured reports at the conclusion of a scan;
- a pre-scan dose check, which estimates radiation dose prior to the initiation of a study, and provides dose notifications and dose alerts when a scan exceeds those boundaries;
- automatic exposure controls (AECs) that automatically adjust the amount of radiation necessary to get a high-quality image (and which can reduce dose);
- different pre-loaded reference protocols for pediatric and adult studies.
CT studies conducted on devices that do not comply with this standard are subject to a 15 percent reduction in the technical reimbursement portion of their bill to the Centers for Medicare and Medicaid Services (CMS).
In 2016, when that 15 percent penalty was enacted, one-third of the existing U.S. CT install base was already compliant with NEMA XR-29, one-third could be brought into compliance with an OEM software update or third-party vendor upgrade, and one-third wouldn’t be able to be upgraded to compliance, according to the Medical Imaging & Technology Alliance (MITA).
The third of these has created some issues for equipment operators, Mahesh said, especially as the standard has different financial implications for unaffiliated outpatient imaging centers and physician offices serving Medicare patients.
“There is a financial aspect to the whole thing,” he said. “Clinics have to invest in some new equipment. That has been an ongoing issue, especially when revenues in hospitals are going down, and they have to scramble in the yearly budget to accommodate this regulation, since each scanner has to be upgraded.”
Ambulatory clinics were likeliest to feel the sting, not only from the perspective of limited capital purchasing resources, but from that of the two-year compliance onramp, during which reimbursement penalties jumped from 5 to 15 percent. Most of the XR-29 tenets – CT dose check, automatic exposure controls and DICOM structured reporting – require more than a software upgrade to correct. That means that fixes come down to disposing of one of the most expensive pieces of equipment in the imaging suite or investing in a third-party apparatus to perform some of those auxiliary functions.
“That’s a lot of software upgrades in order to provide a structured dose report for each patient,” Mahesh said. “If a clinic goes in the direction of getting a new scanner, that’s where the heartache comes into the picture.”
Although imaging equipment lifecycles can run from eight to 10 years, scanners with pre-XR-29 functionality may have their useful life cut short, even if they essentially have no other impediments to their operation. They could otherwise have functioned normally for an extra decade, and in the context of rural and community hospitals, many of them may still have been repurposed to other uses. Even reselling the scanners within the U.S. market doesn’t offer as much opportunity to recoup sunk costs because of the devices being out of compliance.
“From the point of view of the user, here’s a product that’s very good for our patients, but I’m at a loss because some clinics have to incur so much expense to do this thing,” Mahesh said. “The issue is to find the revenue in a very short amount of time.
“If I’m a small clinic owner, I’m really at a disadvantage on how to go about this issue,” he added.
Purchased directly from the OEM, a new CT scanner could cost around $1 million, with a refurbished 64-slice scanner coming in at about half that amount, Mahesh said. Ballpark figures for upgrades are around $30,000 to $100,000 – not immaterial, but not as much as buying a new unit. These fixes are temporary solutions for smaller operators until their CT scanner reaches the end of its useful life and they can buy a new one.
But Mahesh also points out that scrambling to upgrade the scanners so they’re in compliance may affect budget timelines for the upgrading of other equipment. And, these aftermarket solutions may require separate service contracts that may become future stumbling blocks.
“Depending on what the third party accomplished, sometimes the manufacturers do not like to have that interaction with the scanner,” he said.
It’s also difficult to track where CT scanners in need of upgrade might be, or their current functionality. According to national data, Mahesh said about 8 percent of the U.S. install base of CT scanners offered fewer than 16 slices in 2015; among them, he doesn’t know how many are in outpatient settings.
“Eventually, it’s not going to be a problem because in the next couple of years, hospitals are going to buy new equipment,” Mahesh said. “Most of the hospitals have in-house service and in-house physicists, so they already have some type of a plan to review their protocols to watch out for this situation.”
Furthermore, as valuable as XR-29 compliance is to an institution in terms of patient safety, health outcomes, and full reimbursement, there is little in the way of enforcement to the standard, and little paper trail to evaluate the efficacy of the changes the statute has driven. Until there’s a Joint Commission survey or other investigation into institutional compliance, imaging departments are dependent upon the technology working the way it’s intended to keep patients safe.
“As a medical physicist, I worry about that,” Mahesh said. “An administrator wants his system to be compliant, but more important than that, we have to make sure these work properly.
“Dose check features are very helpful, because that’s what led to unnecessary radiation injuries to patients,” he said. “The role of the medical physicist is increasing in any setting to make sure the scanner is operating correctly [and] to have a critical role in making sure the patients are scanned properly.”
A CMS spokesperson said there have been no delays in the rollout of XR-29 compliance monitoring, but also notes that, short of self-reporting, the agency “has tasked the Advanced Diagnostic Imaging Accrediting Organizations with providing CMS with periodic verification of non-compliant CT systems owned or operated by their accredited ADI suppliers.”
CMS also acknowledged that a “small percentage of Advanced Diagnostic Imaging (ADI) suppliers” with non-XR-29-compliant equipment have elected to purchase new scanners, “even though their older equipment could be upgraded with a manufacturer’s software upgrade or third-party vendor upgrade solution.”
The agency breaks those down into operators of systems less than 15 years old, which “have elected to upgrade their CT systems with a manufacturer’s OEM software upgrade for little or no cost,” and the approximately one-third of the install base that is too old or unable to be OEM-upgraded. CMS noted that only two suppliers of aftermarket compliance solutions, MedicVision, and Zetta Medical, exist, and that the cost of those products might be significant for some operators. Despite these potential hardships, the statute and its mandate offer zero wiggle room.
“The NEMA XR-29 requirements are a statutory requirement created by the legislature,” the spokesperson wrote. “Therefore, we are mandated to implement these requirements as written by Congress. We cannot ‘rethink’ the plan or change the requirements of the statute based on people’s reactions.”
From the OEM perspective, the XR-29 rollout has been largely seamless, especially as the equipment manufacturers that directed its implementation drafted the technical fixes driven by the statute.
Ken Denison, Executive MICT Digital Marketing for GE Healthcare, said that on the back end, a lot of that smoothness came from an early opportunity to update the company’s device installed base “as soon as we could, all the way back to our earliest, 16-slice scanner.”
Denison said more than 80 percent of its installed devices have been updated. Some, like its single-slice, four-slice, and eight-slice systems could not be brought up to code, but that didn’t mean they weren’t operational. Many were being used for biopsies or other interventional procedures that were exempted from the legislation.
Instead, Denison said the biggest compliance hurdle was defining what documentation users might keep on-hand should they be required to demonstrate proof of their compliance with XR-29. GE Healthcare created a compliance letter for every device in its inventory, made them accessible to its internal teams, and created a self-serve website for customers to check their device’s compliance against the GE device ID database, and download verification letters.
“The only straggling challenges we have are systems that change hands,” Denison said. “If it gets resold to a new owner, and the new owner wants another letter saying that it’s compliant, we get the odd call. But we’ve never had someone call in a panic saying, ‘CMS audited us.’ A lot of this is because we were pretty proactive in communicating.”
GE Healthcare can also tell from software release versions whether a system it services or inspects is XR-29 compliant, and the company keeps an internal checklist of “anything that hasn’t changed hands yet,” Denison said. He said GE Healthcare “updated almost 100 percent” of those CT scanners in its install base, and has kept records of each update. Those systems that have changed hands most commonly have their compliance evaluated when a new owner contacts the company for a letter of compliance.
Furthermore, Denison said the XR-29 statute hasn’t affected the GE resale business, as just about everything it’s reselling has either been upgraded to compliance with the standard, or retired. Older, fewer-slice scanners simply don’t have a great deal of value to the business these days.
“There just isn’t a market for those systems that aren’t compliant,” Denison said. “There was maybe an increase in older systems for a year, or a year-and-a-half, but nothing that dramatic. There just weren’t that many devices in the market. At the time we did these updates, anything we weren’t able to update to be compliant was at least 12 to 15 years old. The average lifespan [of a CT scanner] was seven or eight years.”
From the perspective of GE Healthcare, the look into its own inventory was the jumping-off point for the entire exercise of XR-29 rollout, Denison said. What the company found was that even if older scanners weren’t used for diagnostic work, they were being repurposed for other opportunities.
“I think we were mostly surprised to find out that many of them were still in hospitals,” he said. “When we picked a random sample, that’s where we found out that a lot of hospitals still have a [legacy CT] system where they’re doing interventional work, which aren’t covered under the [XR-29] legislation.”
“It’s a suitable purpose for those older devices, and a lot of people had taken an older system and had put it in use anyway,” Denison said.
If there’s any concerns, Denison said they focus on driving greater adoption of the variety of functions the upgraded scanners offer, including preset dose-check values and dose warning notifications. Licensed protocols ship with most new systems at the time of purchase for no extra charge; for systems in the GE Healthcare installed base, there is a nominal cost for systems to upgrade.
“I know there’s frustration on the part of physicists that many sites aren’t taking advantage of the things that XR-29 affords them,” Denison said. “We license protocols that are optimized for our new CT scanners, and those include preset dose check values that our customers can use, that are not only optimized for the system but give them the appropriate warnings and notifications should the techs make any mistakes at the time of scan.”
At least anecdotally, since the statute has been implemented, Denison said there’s been no reporting of patients receiving excessive dose radiation since the initial incidents that led to the crafting of XR-29, which leads him to conclude, “It’s working as advertised.”
“What we see is it’s been working as planned,” he said.