Rebecca Smith-Bindman, professor at the Faculty of Medicine at the University of California-San Francisco, has spent more than a decade investigating the disturbing risk that one of the most valuable tools of modern medicine, computerized tomographies, can sometimes cause cancer.
Smith-Bindman and their related ideas colleagues have pressed for a long time for federal policies aimed at improving safety for patients undergoing computerized tomographs. According to the new effective Medicare regulations this year, hospitals and image centers must begin to collect and share more information about the radiation issued by their scanners.
Around 93 million computerized tomographies are carried out every year in the United States, according to IMV, a medical market research company that tracks the images. More than half of those scanning are for people over 60. However, there is a little regulation of radiation levels as machines scan organs and structures within the bodies. The doses are erratic, varying widely from one clinic to another, and too often they are unnecessarily high, say Smith-Bindman and other critics.
“It’s unfathomable,” said Smith-Bindman. “We continue to do more and more CTS, and the doses continue to rise.”
A computerized tomography can expose a patient 10 or 15 times more radiation than another, said Smith-Bindman. “There is a very large variation,” he said, “and the doses vary according to an order of magnitude, ten times, not 10% different, for patients with the same clinical problem.” In atypical institutions, the variation is even greater, according to the investigation that she and a team of international collaborators have published.
She and other researchers estimated in 2009 that high doses could be responsible for 2% of cancers. Ongoing research shows that it is probably higher, since today many more scanning are carried out.
The risk of cancer of the computerized tomographs for any individual patient is very low, although it increases for patients who have numerous scanns throughout their lives. Radiologists do not want to scare patients who can benefit from images, which plays a crucial role in identifying conditions that threaten life such as cancers and aneurysms and guide doctors through complicated procedures.
But the new data collection rules of the Centers for Medicare and Medicaid services issued in the final months of the Biden Administration aim to make the images safer. They also require a more careful evaluation of dosing, quality and need for computerized tomographs.
The requirements, implemented in January, are being eliminated in more than three years for hospitals, outpatient environments and doctors. According to the complicated report system, not all radiologist or medical care environment must meet immediately. Suppliers could face financial sanctions under Medicare if they do not comply, although they will also be graduated in 2027.
When the Biden administration issued the new guidelines, a CMS spokesman said in an email that excessive and unnecessary exposure to radiation was a health risk that could be addressed through measures and comments to hospitals and doctors. The agency at that time declined to make an official available for an interview. The Trump administration did not respond to a request for comments for this article.
The Leapfrog Group, an organization that tracks hospital security, welcomed the new rules. “Radiation exposure is a very serious patient safety problem, so we recommend CMS for focusing on computerized tomographs,” said Leah Binder, president and CEO of the group. Leapfrog has established standards for pediatric exposure to images radiation, “and we find a significant variation among hospitals,” Binder added.
CMS hired UCSF in 2019 to investigate solutions aimed at promoting a better measurement and evaluation of CTS, which leads to the development of the new agency’s approach.
However, the American School of Radiology and three other associations involved in medical images opposed the draft of the CMS rules when they were under review, arguing in comments written in 2023 that they were excessively cumbersome, they would load suppliers and could increase the cost of scanning. The group was also worried, at that time, that health providers would have to use a single patented technological tool to collect the related dosing and scan data.
The unique company in question, Alara Imaging, supplies free software that radiology and radiology programs must comply with the new regulations. The promise to keep it for free is included in the copyright of the company. Smith-Bindman is Alara Imaging co-founder, and UCSF also has a participation in the company, which is developing other health technology products not related to the CMS image rule that plans to market.
But the landscape has changed recently. ACR said in a statement by Judy Burleson, Vice President of ACR for quality management programs, which CMS is allowing other suppliers, and that ACR itself is “under discussion with Alara” on the collection and presentation of data. In addition, a company called Medisolol, which works as a medical care, said that at least one client is working with another supplier, Imalogix, in CT dose data.
Several dozen quality organizations and health safety, including some national patient safety leaders, such as the Institute for Health Improvement, have supported CMS efforts.
The concerns about the TC dose are long data. A historical study published in JAMA Internal Medicine in 2009 for a research team that included experts from the National Cancer Institute, the Department of Veterans Affairs and Universities estimated that the computerized tomographs were responsible for 29,000 cases of excess cancer per year in the United States, approximately 2% of all cases diagnosed annually.
But the number of computerized tomographs continued to rise. For 2016, it was estimated at 74 million, 20% more in a decade, although radiologists say that exploration radiation doses have decreased. Some researchers have noticed that US doctors order many more images than doctors in other developed countries, arguing that part of this is wasteful and dangerous.
More recent studies, some who analyze pediatric patients and some that are based on the radiation exposure data of the survivors of atomic bomb attacks against Hiroshima and Nagasaki in Japan, have also identified the risk of computed tomography.
Older people can face greater cancer risks due to the images they had previously in life. And scientists have emphasized the need to be particularly careful with children, who may be more vulnerable to radiation exposure, while they are young and face the consequences of accumulated exposure as they age.
Max Wintermark, Neurroradiologist of the MD Anderson Cancer Center in Houston, who has been involved in the field work on the proper use of the images, said that doctors generally follow dosing protocols for computerized tomography. In addition, technology is improving; He hopes that artificial intelligence will soon help doctors to determine the optimal use and dose of images, delivering “the minimum amount of radiation dose to take us to the diagnosis we are trying to reach.”
But he said he welcomes the new CMS regulations.
“I think the measures will help accelerate the transition to always lower and lower doses,” he said. “They are useful.”
