H.A. Abella

A Centers for Medicare and Medicaid Services proposal meant to streamline billing and other imaging management duties could actually backfire and create administrative havoc, according to radiology administrators.

The decision detailed in CMS's Transmittal 1823, issued Oct. 2, requires physicians and hospital administrators to disclose separately the place and date of service using new codes for the professional and technical components of imaging exams.

Medicare says the codes should reflect the actual place where each service was provided. Hospitals customarily bill based on where the examination occurred, not where the interpretation took place. Because the events usually take place at different locations and times, the new rules will mostly affect providers of imaging services by increasing paperwork and overhead costs, said Michael R. Mabry, executive director of the Radiology Business Management Association.

“It is really hard to figure out what the reimbursement impact would be from these changes,” Mabry said. “But we do know that it is going to change the way we practice and store information.”

Language in the transmittal suggests CMS harbored concerns that many physicians were misusing current place code 11. CMS tried to address this issue, but-largely by accident rather than design-it has issued guidelines that run counter to the way practices currently operate, Mabry said.

“In an attempt to help, CMS has potentially made the situation worse,” he said.

Responding to a request from the RBMA, the American College of Radiology, the Association for Medical Imaging Management, the Healthcare Billing and Management Association, and the Medical Group Management Association to delay implementation, CMS in December rescinded Transmittal 1823, replacing it with Transmittal 1873. The new document enforces the place of service requirement as of Jan. 4, but delays implementation of the date of service requirement until July.

The group had acknowledged the agency's move was well-intentioned, but worried the proposed reporting rules could confuse providers and lead to unforeseen adverse consequences.

“There is major confusion over the place of service transmittal. So far, Medicare administrative contractors are reported anecdotally to be telling radiologists not to change their billing practices,” said Thomas Greeson, a healthcare attorney with the law firm of Reed Smith in Falls Church, VA. “RBMA has crafted a questionnaire to aid business managers seeking guidance from Medicare carriers on how to respond to the transmittal.”

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Guidelines set admins scrambling

A study by U.S. and Egyptian researchers has challenged the conventional wisdom regarding cardiovascular disease. Using CT, the investigators found evidence that, unlike other chronic conditions that plague affluent postindustrial Western societies, atherosclerosis has been around since at least the time of the ancient pharaohs.

“Some of the patients I have mentioned the study to have had a certain sense of relief,” lead investigator Dr. Randall Thompson told 

. “They were blaming themselves for having had a heart attack and were happy to learn that the disease has been around since the time of Moses.”

Thompson and colleagues sought evidence of arterial disease in individuals who lived three millennia or longer ago. They performed whole-body multislice CT scans on 22 mummies preserved in the Egyptian National Museum of Antiquities in Cairo. The investigators found evidence of atherosclerosis of the abdominal or thoracic aorta or peripheral arteries in nine of 16 mummies with visible cardiovascular tissue. This included seven subjects who were 45 or older and two who were younger than 45 when they died. Findings appeared in the Nov. 18 issue of the 

Journal of the American Medical Association.

The study lacks a direct pathological correlation and the power to explain the prevalence or severity of atherosclerosis in the distant past. However, it does provide proof that ancient Egyptians belonging to the upper social strata who were middle-aged or older already faced a genetic and environmental predisposition to develop the condition, said Thompson, a cardiologist at St. Luke's Hospital's Mid America Heart Institute in Kansas City, MO.

“The findings challenge the concept that this is primarily a disease of Western lifestyles,” he said.

A study by U.S. and Egyptian researchers has challenged the conventional wisdom regarding cardiovascular disease.

Atherosclerosis thrived in antiquity, mummy scans show

RSNA president Dr. Gary J. Becker opened with a sports quotation. “Today we are going to learn how to put on our socks and lace our shoes.” With that he exhorted attendees at the opening session to join a drive for quality in radiology that could bolster the specialty in the face of the challenges that are to come.

The phrase, spoken by legendary college basketball coach John Robert Wooden, was a reference to what lies ahead for radiologists, Becker said. Wooden revisited these fundamentals before sending out to the court any of the teams that won him a record 10 National Collegiate Athletic Association titles. Sock wrinkles inside improperly laced shoes could turn to blisters that would keep the young stars from practicing and, ultimately, from shining. Wooden believed such minutiae could affect a team's ability to win and thus required a focus on quality improvement starting from the very first day of practice.

“Today we radiologists find ourselves in a similar situation. One of the most vital priorities for our profession is the adoption of a new focus on quality improvement,” Becker said. “I believe quality and our commitment to it will be a key factor in determining our future.”

Issues such as disregarding quality improvement principles, holding on to preconceived notions and attitudes, and the lack of a culture of improvement could wreak havoc in the field unless radiologists acknowledge and deal with them soon, Becker said. If radiologists choose to ignore them, they do so at their own risk because the demand for individual transparency and accountability from patients, families, and public and private healthcare organizations is only going to grow.

“All this means we are going to need to increase our focus on safety, quality, performance measurement and improvement, and value,” he said.

According to Becker, the most efficient care, and the end to a culture of preventable medical error, waste, and service fragmentation, will depend to a significant degree on the implementation of quantitative imaging and informatics. Big gains in quality improvement can be achieved through the use of computerized radiology order entry and decision support systems and through the use of structured reporting and computer-aided diagnosis.

The quantitative potential of the latest imaging technologies will give radiologists a central role in the new age of personalized, preemptive, predictive, and participatory, or “P-4,” medicine, Becker said. He encouraged attendees to check the meeting program and other resources available through rsna.org for information on quality improvements.

A number of studies have shown that quality can be improved, but complacency can ultimately spoil any gains. Radiologists should strive for ways to effectively measure and maintain quality beyond economics in order to earn the public trust once again, Becker said.

“When price is the differentiator for quality, quality pays the price,” he said.

A scientific paper presented at the RSNA meeting provided an example of one of many quality issues plaguing radiology today. Researchers from Massachusetts General Hos-pital in Boston found the number of unidentified and uncorrected errors in radiology reports of spine MRIs is significantly higher than that of corrected errors.

The investigators reviewed more than two million radiology reports of spine MRIs performed at their institution from January 2006 through December 2007. They found 14 reports with addended errors, or errors identified after the report was signed, and 20 with errors that had never been identified until their review. They also found that, in 2006, it took between five and seven days to correct an error and nearly twice as long the following year. Almost half the errors occurring in all the reports were probably or definitely clinically important.

According to the researchers, radiologists should check for errors and encourage colleagues to correlate the level of radiological lesions with clinical complaints and images. One of the most important implications of the study, they said, is a potential role for software applications like natural language processing to identify errors at the time of dictation or final signoff.

Dr. Steven Swenson, director of qua-lity at the Mayo Clinic in Rochester, MN, and chair of the American College of Radiology's quality metrics committee, made his contribution to the topic with a presentation on patient-centered radiology. Swenson reminded his audience that Hippocrates set the bar high for physicians when he made patient care the centerpiece of the medical profession. But, as Swenson pointed out, the same demand offers radiologists hope.

“If we live that patient-centeredness, the risk of commoditization goes away,” Swenson said.

Swenson also shared the conclusions from a group of 14 academic deans and medical officers he joined in 2008. One of them was that academic medical centers could not be patient-centered because this role conflicted with their academic mission. Even if it did not, the research mission funded by big pharmaceutical and device manufacturing companies would, he said.

Radiology could meet the challenge by granting patients five wishes: the information to make a choice, the right exam, open communication, a fair cost, and a safe exam.

“A key part of improvement is starting with a baseline,” Swenson said. “If you don't know where you're at, you don't have an opportunity to improve.”

RSNA president Dr. Gary J. Becker opened with a sports quotation. “Today we are going to learn how to put on our socks and lace our shoes.”

RSNA chief calls 2009 quality theme future for radiology

Using functional magnetic resonance imaging, researchers in the U.K. have gained a better understanding of what goes on in the minds of patients who have sustained severe neurological damage.

According to investigators, fMRI could yield evidence that patients might be fully aware even when the clinical assessment suggests they are comatose.

Clinicians typically infer whether patients with brain injury are conscious based on their behavior. However, recent studies indicate that 40% of patients who seem behaviorally unresponsive are, in fact, in a minimally conscious state and are erroneously diagnosed as being vegetative.

Such mistakes could have huge medical, ethical, and even legal consequences if they lead to termination of lifesupporting therapies, said principal investigator Martin M. Monti, Ph.D., a research scientist for the U.K. Medical Research Council and Brain Sciences Unit, a University of Cambridge research partner institution.

Monti and colleagues enrolled 20 healthy volunteers and one minimally conscious patient diagnosed with anoxic brain injury in 2007. Subjects underwent imaging while instructed to listen to a sequence of words first and then count the number of times a key word was heard. All showed activation of neural areas governing target detection and working memory while performing the counting task. This suggests that even the minimally conscious patient could retain information over time and act upon it. It also shows that it is possible to tell if a patient is conscious or not, Monti said. The report was released online Oct. 8 in the journal 

“This use of fMRI can help us better diagnose patients and diminish the misdiagnosis rate by allowing us to detect consciousness beyond what is apparent,” Monti told 

Such questions as how to know if patients who suffer severe brain injury are conscious, or how to tell whether they can hear, see, and understand, haunt neuroscientists. If patients can blink an eye in response to a command, physicians know they must be conscious. Trouble begins when perfectly conscious patients cannot move or produce any behavioral sign to convey this fact. The study makes a fundamental contribution in this regard, Monti said.

“The clinical application is immediate: If a patient is aware, but unable to produce a motor sign to communicate her state of awareness, it may be possible to gain this knowledge just by looking at her brain response.”

fMRI indicates cognition in unconscious patients

MRI has been adopted as a definitive measure for fair play by the International Federation of Association Football, the governing body for international soccer competition. FIFA launched a program of random MRI wrist screening to verify the age of players competing in the Under-17 World Cup hosted by Nigeria between Oct. 24 and Nov. 15.

The issue of fielding over-age players has been around for some time. It made headlines again last March at the Confederation of African Football's Under-17 Championship in Algeria when Niger was disqualified for fielding an older player. FIFA announced Aug. 31 that MRI would be used to check the age of players in order to protect the integrity of the World Cup in Nigeria.

“Randomly selected players will be tested in Nigeria under the supervision of FIFA's medical experts,” FIFA wrote in a statement.

The global competition draws talent from many parts of the world where age cannot be clearly determined. With this method, FIFA will guarantee that all players are really biologically under 17, said FIFA's chief medical officer Prof. Jiri Dvorak.

“MRI can determine age below or over 17 with a certainty of 99%,” Dvorak told 

The technique looks at the degree of fusion of the distal radial physis using a grading system that correlates with the player's age. As age increases, so does the fusion grading.

X-rays had been used for this in the past during FIFA-sanctioned competitions. Three countries underwent disciplinary action at the Asian Football Confederation U-16 Championship in Vietnam in 2001 based on x-rays taken during the tournament. However, several member associations raised concerns this time about exposing young athletes to ionizing radiation. This led the organization to look for MRI instead, Dvorak said.

Although the effective dose of the wrist radiographs was low, no radiation is better than even a little in this pediatric population, said Dr. Bruce Forster, a professor of radiology at the University of British Columbia in Vancouver.

“Using MRI instead of radiographs would make good sense, especially for athletes who may not be patients per se,” said Forster, who is also director of imaging for the Vancouver 2010 Winter Olympic Games.

Age-doping is an issue that affects many sports, not only international soccer, Forster said. To protect the athletes and the credibility of such tournaments, an easy, safe, and accurate method of determining bone age is needed. MRI of the wrist fulfills most of these criteria, he said.

Dvorak and colleagues collected data on a large sample of subjects from Africa, Asia, Europe, and South America to demonstrate the reliability of the method. They found a highly significant correlation (p < 0.001) between age and grade of fusion in adolescents between the ages of 14 and 19. The screening scan requires a single T1-weighted sequence on a 1T or 1.5T magnet with a wrist coil and can be performed in less than 15 minutes (Br J Sports Med 2007;41[1]:45-52).

MRI is still relatively difficult to obtain in many countries, including World Cup host Nigeria. Overcoming such fiscal issues to allow all athletes fair access would be a great advance in ensuring that both intentional and unintentional breaching of age restrictions in sport would be recognized, Forster said.

“I am not aware of this method being used in other sports, but its future is bright. I welcome this announcement,” he said.

MRI has been adopted as a definitive measure for fair play by the International Federation of Association Football, the governing body for international soccer competition.

MRI cracks down on 'age doping' in international youth sports

Findings of a study by researchers in Italy suggest C-11 choline PET/CT could diagnose prostate cancer recurrence sooner than transrectal ultrasound, CT, MRI, or bone scintigraphy in patients who have undergone radical prostatectomy.

Up to 30% of patients with prostate cancer who have undergone radical prostatectomy will relapse within 10 years. The statistics are more discouraging for those treated with externalbeam radiotherapy, as more than half will experience some form of recurrence within five years.

Prostate-specific antigen (PSA) levels remain the most reliable way to determine recurrence. Accurate characterization, staging, and localization of disease become the most crucial steps for management when biochemical relapse is confirmed. However, conventional imaging modalities, such as transrectal ultrasound, CT, MRI, and bone scintigraphy, have limited value.

According to a research group from the University of Bologna led by nuclear physician Dr. Paolo Castellucci, PET/ CT with C-11 choline has emerged as a promising alternative.

“In most patients with biochemical relapse after radical prostatectomy, conventional imaging methods often return false-negative results,” Castellucci said. “Our study found that for some patients, PET/CT with choline can improve the detection of cancer soon after PSA levels are measured.”

Castellucci and colleagues retrospectively evaluated 190 patients with biochemical relapse after radical prostatectomy who underwent C-11 choline PET/CT. Researchers classified patients by their PSA levels as well as PSA kinetic factors such as PSA velocity-the rate at which PSA levels change-and PSA doubling time.

The investigators found that detection of cancer recurrence with wholebody choline PET/CT in patients with biochemical relapse after prostatectomy correlates significantly with PSA levels and PSA kinetics. Results validated previous findings that suggest PSA kinetics improve detection, particularly in patients with low PSA levels. Findings appeared in the September issue of the 

According to the U.S. National Cancer Institute, one in six men will be diagnosed with cancer of the prostate during his lifetime. This year alone, nearly 200,000 U.S. men will be diagnosed with the condition and more than 13% of them will die. The numbers are not much better in Europe, where incidence of the condition has recently increased and the mortality rate has reached about 30 patients per 100,000 cases, according to data from the European Society for Medical Oncology.

The analysis of PSA kinetics could improve patient selection for PET/CT scanning, reduce false-negative scans, and increase detection rates. Although further studies are needed to confirm these theories, whole-body C-11 choline PET/CT imaging has the potential to become a one-stop test to identify those patients with early relapse who have the best chances for curative treatment, investigators said.

“This enables physicians to tailor treatment to individual patients in the early stages of recurrence, thus increasing their chances of recovery,” Castellucci said.

C-11 Cho PET/CT helps localize prostate cancer recurrence

Interventional radiologists should refrain from performing either kyphoplasty or vertebroplasty unless the procedure, intended mostly for the management of pain from vertebral compression fractures, is done in the context of clinical trials. 

  Dr. David F. Kallmes, an interventional radiologist at the Mayo Clinic in Rochester, MN, came to this conclusion after analyzing reams of data that nonetheless have been deemed inconclusive. The clinical practice should resume only after results from large, prospective, multicenter trials prove benefits from one or both procedures. 

  Kallmes was the keynote speaker at a musculoskeletal session at the 2009 RSNA meeting. 

  “The one thing we learned that is more important than anything else is that we don’t know what we are doing,” Kallmes said. 

  Recollecting his own experience, Kallmes acknowledged having published several papers on the subject that were “inherently very weak.” Self-criticism aside, he held the whole interventional community accountable for failing to scrutinize research on vertebral stabilization. 

  “I published pretty bad papers, but they were never criticized. The methods were never questioned, and people accepted them as excellent work,” he said. 

  The comments also came in the context of two placebo-controlled studies: one by Kallmes, published in the August issue of the 

 (Investigational Vertebroplasty Efficacy and Safety Trial, INVEST), and the Australian Vertebroplasty trial. Both found vertebroplasty no better than a procedure that simulated vertebroplasty but lacked the bone filler material. 

  According to Kallmes, INVEST researchers were keen on probing vertebroplasty’s outcomes compared with those of the sham procedure, particularly in regards to pain reduction. But they found no statistically significant differences between them. 

  The findings were in stark contrast to previous research, which often tended to overstate the positive effects of kyphoplasty and vertebroplasty procedures. Many new questions have been raised, which strongly suggests that investigators, as well as providers, need to plan the future around more trials, Kallmes said. 

  Members of the audience fervently questioned Kallmes’ data, which came as no surprise. He acknowledged frequent receipt of correspondence from many physicians who have had a hard time accepting and digesting his findings. Most of their accounts, however, reflect only anecdotal experience, he said. 

  “The successful outcomes we have seen outside clinical trials are simply anecdotes. It is not evidence,” he said. 

  Despite the controversy fueled by the INVEST and the Australian trials, which have flaws and limitations of their own, their conclusions should not be dismissed, Kallmes said. Both have shed valuable light on the clinical questions that need answering before the minimally invasive repair of vertebral compression fractures becomes an established practice, Kallmes said. 

  “Practitioners are in an ideal position to advance the field if-and only if-they enroll their patients into clinical trials,” he said.

Interventional radiologists should refrain from performing either kyphoplasty or vertebroplasty unless the procedure, intended mostly for the management of pain from vertebral compression fractures, is done in the context of clinical trials.

IR urges moratorium on vertebral compression fracture interventions

The FDA has issued a new set of preemptive recommendations after identifying at least 50 more stroke patients who were exposed to excessive radiation during CT perfusion of the brain. 

An ongoing investigation has so far turned up 50 new cases of patients exposed to radiation doses nearly eight times higher than the accepted standard involving at least two CT scanner manufacturers and health facilities in several states. Patients connected with theses new cases have reported symptoms compatible with radiation poisoning, including skin burns and hair loss. As an interim measure while the investigation continues, the FDA issued the guidelines Dec. 7 aimed at practitioners and imaging facilities to help them prevent new cases. 

 The FDA issued the original alert Oct. 8 when it revealed that 206 patients who had undergone perfusion CT scans for imaging of stroke at Cedars-Sinai Medical Center in Los Angeles had been exposed to radiation doses of 3 Gy and 4 Gy. That exposure is far above the 0.5 Gy standard. Hospital officials revealed that modifications to the CT perfusion protocol involved in the accidents went undetected for 18 months. 

  The new guidelines apply to all types of CT perfusion imaging, not just the brain, and ask that providers:

Identify patients who may have undergone perfusion CT scans with radiation doses in excess of recommended levels.

Implement quality control procedures to ensure proper scanning doses apply to individual exams every time.

Ensure radiation dose is appropriately adjusted if more than one study is performed on the same patient during the same imaging session.

The FDA has advised manufacturers to review customer training procedures and the information they share with healthcare facilities, as well as come up with new ways to identify these issues in a timely fashion. 

 Facilities should step up efforts to make sure perfusion CT exams are done safely, said Dr. Jeffrey Shuren, acting director of the FDA’s Center for Devices and Radiological Health. 

 “The FDA is making progress in the investigation of this problem,” Shuren said. 

 CT stakeholders, including members of the American College of Radiology and the Medical Imaging and Technology Alliance (MITA), a branch of the National Electrical Manufacturers Association, met with FDA officials Nov. 30 in Chicago during the 2009 RSNA meeting. 

 The FDA shared its recommendations with the group in advance of their release to the public and stressed the need to improve quality assurance in CT procedures to avoid new cases, said MITA’s director of industry programs Stephen Vastagh, who organized the stakeholders’ meeting. 

 “We want to cooperate in the FDA investigation and we want to do whatever we can to make sure that cases of radiation overexposure don’t happen anymore,” said MITA’s managing director Dave Fisher.

The FDA has issued a new set of preemptive recommendations after identifying at least 50 more stroke patients who were exposed to excessive radiation during CT perfusion of the brain.

Radiation poisoning cases lead FDA to issue new CT perfusion imaging guidelines

Using functional MRI, researchers in the U.K. have gained a better understanding of what goes on in the minds of patients who have sustained severe neurological damage.

Such mistakes could have huge medical, ethical, and even legal consequences if they lead to termination of life-supporting therapies, said principal investigator Martin M. Monti, Ph.D., a research scientist for the Medical Research Council and Brain Sciences Unit, a University of Cambridge research partner institution.

fMRI lights up gap between consciousness and cognition

Though generally deemed safe, high-intensity focused-ultrasound ablation of liver and pancreas cancers can lead to delayed complications. According to Korean researchers, practitioners should be aware of-and watch closely for-local and systemic post-HIFU side effects several years down the road. 

  “It is essential to have awareness of the possible, and especially delayed, complications after HIFU and their imaging features for avoiding a more serious situation,” said principal investigator Dr. Seung-Eun Jung, a professor of radiology at the Catholic University of Korea. 

  “If a possible complication develops during HIFU, the procedure must be stopped immediately,” said Jung in an interview with 

.

  Jung and colleagues at the university’s St. Mary’s Hospital in Seoul evaluated local and systemic complications from HIFU in patients with hepatic and pancreatic cancer. One hundred fourteen consecutive patients with hepatocellular carcinoma (n = 57), pancreatic cancer (n = 35), and liver metastases (n = 22) were enrolled from January 2006 through December 2008. Researchers monitored patients’ vital signs, hepatorenal function, skin burns, local reactions, and overall systemic effects before, during, and after HIFU. All patients underwent MR imaging before and two weeks after ablation. Those with delayed complications on follow-up underwent CT and additional MRI scanning.

The investigators found that, though fairly common, a number of HIFU complications may not become apparent until about a month after the procedure while some may take up to three years to show up. Jung released her group’s findings at the 2009 RSNA meeting. 

  All patients had skin redness, edema, and pain in the treatment area while two of them suffered third-degree degree burns. All patients with liver tumors developed rib necrosis at the intersection of the ultrasound beam path; the condition did not require further treatment. One patient had a pneumothorax linked to the artificial pleural effusions done in 53 patients to create a sonographic window for optimal liver mass ablation. Another had a spontaneous periprocedural pleural effusion requiring drainage. Another patient developed a biliary obstruction and died. 

  All pancreatic cancer patients developed vertebral body necrosis due to unwanted deep penetration; 10 of them suffered subcutaneous fat necrosis of the anterior abdominal wall; and two developed fistulas between the tumor and duodenum. 

  Extremely delayed HIFU-related complications appeared only in patients with liver tumors. Investigators caught a fistula between an abscess of the abdominal wall and the ablated tumor in one patient at four-week follow-up. They also found a diaphragmatic rupture in one patient and rib fractures in another at, respectively, 24- and 32-months follow-up. 

  Most operators are careful during HIFU and the immediate complication rate remains low and usually manageable. However, major complications, which had not been reported until now, can be expected two or even three years after the procedure, Jung said. 

  “Most complications are developed mainly around the targeted lesions or along the ultrasound path and are closely associated with ultrasound bioeffects,” she said.

Though generally deemed safe, high-intensity focused-ultrasound ablation of liver and pancreas cancers can lead to delayed complications. According to Korean researchers, practitioners should be aware of-and watch closely for-local and systemic post-HIFU side effects several years down the road.