New rules for CT scanner equipment are designed to help protect patients and medical staff from overexposure to radiation. Upgrades can cost hundreds of thousands of dollars.
Healthcare providers are bracing for new Medicare computed tomography (CT) scan standards that are set to go into effect next year.
The new rules, which embrace medical-imaging industry standards and which were adopted under the Protecting Access to Medicare Act of 2014, include Medicare payment penalties for noncompliance. Starting Jan. 1, 2016, CT scans conducted with noncompliant machinery will take a 5% Medicare payment hit.
In 2017 and subsequent years, the Medicare payment penalty for noncompliance is slated to increase to 15%.
Rebecca Spangler, director of congressional affairs at the American College of Radiology (ACR), says the penalties are set to be applied on a per-scan basis for Medicare payments. "We are envisioning it as something that will be added on to the current accreditation process," she says. ACR is among the organizations that conduct accreditation reviews for CT scanner equipment.
The standards were developed by the Medical Imaging & Technology Association (MITA), which is a division of the Arlington, VA-based National Electrical Manufacturers Association.
The CT scan standards, which are designated as XR-29 by MITA and Congress, have "four key features," according to Dominic Siewko, clinical marketing director for Andover, MA-based Philips Healthcare, an MITA member.
- Digital Imaging and Communications in Medicine-structured reporting (DICOM SR)
- Pediatric and adult reference protocols that are "pre-loaded" in CT scan equipment to serve as a baseline for clinical testing
- CT scan "dose check" technology that alerts radiologists and radiology technicians when a radiation dose exceeds established thresholds
- Automatic exposure control
"They are a blend of equipment technology upgrades and user education that allow healthcare providers to see dose notifications and alerts for pre-determined thresholds," Siewko says of the XR-29 CT scan standards. "These important alerts can prevent unnecessary exposure."
Christoph Wald, MD, PhD, executive vice chairman of Lahey Hospital & Medical Center's Department of Radiology, says the Burlington, MA-based organization is eager to introduce the state-of-the-art technology required under the XR-29 CT scan standards.
"The new MITA standards speak to important technologies that we would like to have available and implement at our institution. However, the specific technologies mentioned in the… standard are not yet broadly commercially available," he said.
Siewko says as much as 35% of the "installed base" of CT scanners in the United States cannot be upgraded with DICOM SR software. "[Those providers] will either have to underutilize their scanners or replace them… DICOM SR makes it much easier to use exposure data in a more meaningful way for analytics purposes as well as patient records."
He says the cost of upgrading Philips scanners is about $300,000 for a new detector, software, and training. Spangler says General Electric is offering to upgrade the company's scanners at no cost. GE is the first CT scanner manufacturer to establish an online feature that healthcare providers can use to see whether their scanners are in compliance with the new standard, according to ACR.
The risk of overexposure to CT scan radiation has been a hot-button issue in the medical community for several years. In October 2009, Cedars-Sinai Medical Center announced four recommendations to improve CT scan safety after more than 200 patients at the Los Angeles-based organization were exposed to high doses of radiation.
Last year, Time magazine reported that the ease and accuracy of CT scans has "fueled an alarming level of overuse."
In January, a study published in the Journal of General Internal Medicine found that CT scans have been part of an overutilization of costly imaging tests in the diagnosis of headache pain.
The XR-29 CT scanner standards are significant step forward in helping to ensure CT scan safety, Wald says. "The new MITA standards address some important technical obstacles to efficient dose monitoring and radiation safety management in the imaging practice. [The standards provide] important guidance to manufacturers of imaging equipment to create this technology, which will ultimately find its way into the installed base so that it can help protect patients and staff."
Impact of Cost Penalties Difficult to Forecast
The Medicare payment penalties for noncompliance to the XR-29 CT scanner standard are expected to be an all-or-nothing proposition, Spangler says, adding that scans on noncompliant equipment in 2016 will be subject to the full penalty rate, "a flat 5%."
Medicare payments for CT scans have two components: a professional fee and a technical fee. The XR-29 CT scanner payment penalty will only apply to the technical component.
Donna Richmond, a senior healthcare consultant at Shrewsbury, NJ-based Panacea Healthcare Solutions, says the XR-29 CT scanner standard will be incorporated in the Medicare Physicians Fee Schedule later this year. She says there is no "simple specific percentage" breakdown of the professional and technical components of Medicare payments for CT scans, because "the calculation is too complex."
"I pulled five random CT codes and the technical component ranged from 55% to 76%," Richmond said of Medicare payments for CT scans. "The final [Medicare] rules usually give a synopsis of how the rates are calculated."
The Centers for Medicare & Medicaid Services, the federal agency responsible for establishing regulations for the XR-29 CT scanner standard, declined to comment on the ruling-making process.