After reviewing a new standard for radiation imaging dose requirements, Mike Hopkins’ first thought was complete replacement of all of his CT scanners.
“I’m looking at my four scanners and realizing none have the abilities to do that,” said Hopkins, director of the imaging center at Nebraska’s Saint Elizabeth Regional Medical Center.
On closer inspection, Hopkins’ projected capital outlay looked more manageable as software upgrades and other options surfaced.
“Yes it’s going to cost money, it’s going to hit hospitals, and it’s not an insignificant financial impact,” Hopkins said. “But when you start to investigate, you find there are options.”
Hopkins’ analysis concerned a radiation standard for CT set by the National Electrical Manufacturers Association (NEMA) and its Medical Imaging & Technology Alliance (MITA) division. The standard, XR-29 Standard Attributes on Computed Tomography Equipment Related to Dose Optimization and Management, is also known as XR-29 and MITA SmartDose. It was created largely in response to a 2009 FDA report that approximately 200 patients in an 18-month period received radiation doses far in excess of protocol, explained Priscilla Butler, senior director in quality and safety with the American College of Radiology and a medical physicist. This was around the same time that a child in California underwent an hour of CT scans.
XR-29 gained traction this year when the U.S. Congress amended Medicare laws. Beginning in 2016, CT scans performed on machines that are not compliant with XR-29 will receive a 5 percent reduction in reimbursement. That reduction increases to 15 percent if machines still aren’t compliant in 2017.
The law has limited reach, however, covering primarily hospital outpatient departments and free-standing imaging centers.
Hospital inpatient settings — which is where the patients in the FDA’s 2009 report received the excessive doses — will not be impacted by the Medicare law, said Sandra L. Katanick, CEO of the Intersocietal Accreditation Commission. Hospitals can voluntarily meet compliance or seek imaging accreditation through organizations such as hers, she said, but are under no legal obligation to comply with XR-29.
The Joint Commission, which accredits hospitals, said in a prepared statement that it “commends” MITA for working to improve the safety of CT equipment but that it has no plans to require compliance with XR-29.
“Our hope is that hospitals will look at this and agree to upgrade,” said Gail Rodriguez, executive director of MITA. Vendors, she said, “have made a commitment to do as much as they possibly can” to help facilities reach compliance, either through replacing or upgrading their systems.
She estimated approximately one-third of outpatient CT scanners will need to be replaced to avoid penalties.
Understanding the Standard
Providers are already contacting GE to find out what they need to do to be in compliance, Ken Denison, micro imaging and CT dose leader for GE Healthcare, said, and GE is helping them review their inventories.
“It isn’t necessarily as simple as saying, ‘that device isn’t compliant,’” Denison said. “Just like any modification or change to policy, there are a lot of nuances to think through – and that is where many of the providers are at the moment.”
At GE, discussions with hospitals, outpatient clinics and free-standing imaging centers start with a conversation about how the scanners are used to determine the potential implications.
Moving a compliant scanner to an outpatient setting could be an option, he said. “You really do have to take the time to collect the information.”
“Significantly more than half” of Siemens scanners in use at facilities across the United States either are in compliance or can be upgraded to compliance, estimated David Fisher, vice president of healthcare policy and strategy at Siemens Healthcare.
“We do our best to manufacture equipment to make dose information transparent,” Fisher said. “Wherever possible, we’re retrofitting products to get them compliant. We’re doing that now to be prepared for 2016.”
Generally speaking, systems older than 10 years probably should be replaced, Fisher said — although there are gray areas depending on the type of system.
Noting the spirit of the law, both Fisher and Denison said facilities should consider the clinical applications as well as the financial in deciding whether to retire or reallocate older systems. “MITA embarked on this effort to enhance patient safety,” Fisher said. “The value of the dose optimization features is important enough that providers and vendors should be incented to include them.”