ACR, Institute of Medicine clash on technologists' role

In September, Diagnostic Imaging documented the mammography access problem. This report examines proposed solutions and the controversies they have generated.

On any given day, 156,000 women in the U.S. undergo screening mammography. The 10-minute radiological exam is considered the most powerful diagnostic weapon available to fight breast cancer, which kills 40,000 women in the U.S. annually.

The public's broad acceptance of mammography has not come easily. The equipment and examination protocols have taken years to perfect, regulate, and validate through the analysis of sometimes contradictory and controversial clinical trials.

Now other challenges have arisen. The key question concerning mammography has shifted from whether the procedure is valid to whether mammography will become unavailable because radiologists are unwilling to interpret the studies.

The Institute of Medicine of the National Academies of Science and the American College of Radiology each announced strategies this year that are designed to protect mammography access. The IOM's views were published in June in a 296-page report, Saving Women's Lives: Strategies for Improving Breast Cancer Detection, which focused on enhancing the quality of mammography. Among numerous recommendations, frequently inspired by European experiences, the IOM proposed training radiologic technologists to perform initial or double readings of screening mammography.

The ACR immediately condemned the proposal, expressing dismay that nonphysicians could be considered qualified to interpret breast imaging. The ACR Leadership Council issued a resolution in May opposing the interpretation of any medical imaging exam by a nonphysician.

"When you talk about the radiology assistant issue, the line is in the sand against interpretation," said Dr. James Borgstede, chair of the ACR board of chancellors.

In response to the IOM report, the ACR reiterated its four-point plan to preserve mammography access, which advocates the following:

- tort reform to reduce the threat of malpractice litigation that discourages radiologists from performing mammography;

- higher reimbursement for mammography to address low payments thought to be associated with a net loss of 699 breast imaging services in the U.S. from April 2001 to March 2001;

- a 300-slot increase in the number of radiology residency positions subsidized by Medicare; and

- new technologies such as digital mammography, MR imaging, teleradiology, and computer-assisted diagnosis to improve the efficacy and accuracy of mammographic interpretations.

Although the IOM report recommends many of the same technological solutions as the ACR objectives, its authors can't see how the ACR will realize its goals. In the report's executive summary, the IOM concludes that legal problems associated with mammographic interpretation are unsolvable. The authors note that their analysis aims at reducing the likelihood of missed diagnosis rather than focusing on strategies designed to protect radiologists from lawsuits.

The problem with seeking higher payments from Medicare, as the ACR advocates, is that it is a zero-sum game, according to an official who helped prepare the IOM report. If mammography rates are raised, other rates must be lowered, she said during an interview.

The same IOM source questioned the logic behind the ACR's support for more residency slots. A 2003 survey by Dr. Lawrence Bassett, breast imaging director at the University of California, Los Angeles, documented widespread disinterest in mammography among radiology residents. As a result, there is little reason to believe that more residents will specialize in mammography just because more students receive radiology training, she said.

Although the ACR and IOM appear to be at loggerheads, evidence can be found to support both sets of proposed solutions. The use of technologists in the U.K. suggests to some radiologists that nonphysicians can assist with screening interpretation under specific circumstances. In the U.S., attaining some of the ACR's goals may not be as formidable as critics claim.

TECHS READ MAMMOGRAPHY

The British National Health Service Trust has endeavored for more than a decade to give radiographers-the university-trained British equivalent of radiologic technologists-more authority to assist radiologists with medical imaging interpretation. The rationale for the trend is a severe radiologist shortage in the U.K., exacerbated by chronic healthcare spending restrictions.

Speaking at the International Congress of Radiology in June, Dr. Richard Price, chair of the School of Paramedic Sciences, Physiotherapy and Radiography at the University of Hertfordshire, noted that radiographers are providing either preliminary or double reading of mammography in 103 of 470 NHS imaging clinics and hospitals.

Previous surveys found that as early as 1995, 70% of British hospitals allowed some radiographers to perform preliminary readings under the terms of "red dot" programs. Radiographers mark suspicious studies from various imaging modalities with adhesive red dots before handing them over to a radiologist for the actual interpretation. This year's NHS survey identified 3336 radiographers at 177 hospitals who are authorized to use the red-dot system, Price said.

Double reading has long been the standard for screening mammography at Royal University Hospital in Orpington and affiliated hospitals in Kent, according to consulting radiologist Dr. Adrian M.K. Thomas. The task is performed by two radiologists reading simultaneously, but at government health facilities elsewhere in the region, the second seat is often occupied by a radiographer.

"The radiologist and the radiographer look at the films together," Thomas said.

Radiographers hoping to qualify for this responsibility complete a week of university-based training before beginning direct mentoring by a local radiologist. The total training period covers a year, with candidates conducting a mandatory 600 supervised exams in the process. They are finally certified after successfully reviewing three sets of "performs," a rigorous series of mammography interpretation tests that all British mammographers must pass annually to continue performing breast imaging.

Although British radiographers can qualify to read mammography, the NHS takes the risk of possible misinterpretation seriously, Thomas said. As in the U.S., missed breast cancer is a leading cause of medical malpractice litigation in the U.K.

"Obviously, you are not going to allow radiographers to report mammograms unless you are very happy about the quality. If radiographers don't perform well on the national audit, they aren't allowed to report," he said.

U.S. radiologists cite numerous reasons why the British approach isn't actually working for the British and cannot easily be exported to the U.S. The quality of film interpretation is higher in the U.S. than in the U.K., according to Dr. D. David Dershaw, president of the Society of Breast Imaging.

"We know this by the size of the cancers being found. We find smaller, earlier tumors," he said.

In any case, the medical liability risks are too high for U.S. mammographers to trust a technologist's interpretation, said Dr. Robert Schmidt, a professor of radiology at the University of Chicago.

"This country is lawsuit-happy. You can't hand off that function without first indemnifying the people performing interpretation," Schmidt said.

Still, the clamor over the IOM's recommendation surprised Dr. Etta Pisano, a radiologist who served on its advisory committee. The idea of technologists performing preliminary readings is analogous to radiology residents reading exams before their instructors sign off on the interpretation, she said.

"They preview images, mark them, and help facilitate the interpretation. Techs can do that right now. There is no reason why a tech can't help facilitate the interpretation," Pisano said.

MEDICAL LIABILITY REFORM

The short-term odds that the IOM recommendation will become reality are no worse than the chances for ACR-supported tort reform. Legislation proposing a $250,000 cap on noneconomic damages for malpractice claims against emergency physicians and ob/gyns failed in the U.S. Senate. President George W. Bush supports a cap, and Sen. John Kerry favors binding arbitration.

More success was found at the state level, where eight states approved tort reforms and five states had rejected proposals as of September, according to the American Medical Association.

Although deteriorating conditions are increasing the likelihood of reform, the situation has yet to achieve the critical mass that will impel Congress to take action, said Dr. Leonard Berlin, chair of radiology at Rush North Shore Medical Center in Chicago.

"Things will have to get worse before they get better. Then we will get some reform," he said.

Radiologists scored victories this year in California and Illinois in disputes over private insurance rates and coverage. At the national level, the ACR failed to persuade Aetna to pay a premium for providing CAD to its 13.4 million beneficiaries. The college also slogged away at correcting errors in the formula used to calculate technical fees for mammography covered by Medicare's resource-based fee schedule.

California Blue Cross announced in September that it would boost the rates its PPOs pay for screening and diagnostic mammography to levels closer to Medicare payment rates. Its action came in response to a complaint from the California Radiological Society executive director Robert J. Achermann. The PPOs pay 77% of the Medicare rate for bilateral mammography interpretation and 60% of the Medicare rate for the professional component of screening mammography. Higher rates will be implemented in February 2005.

Grassroots action by radiologists in Illinois persuaded Blue Cross of Illinois to cover full-field digital mammography. An Illinois Blue Cross technology assessment concluded last year that the medical literature had yet to establish the clinical efficacy of the full-field digital technique. The report led Blue Cross plans in Illinois, Texas, and New Mexico to refuse to pay for digital procedures, according to Dr. Ellen Mendelson, a professor of radiology at Northwestern University.

Radiologists responded with a full-court press to set the insurer straight. Ed Hendrick, Ph.D., a principal investigator in the American College of Radiology Imaging Network digital mammography clinical trial, was joined by Dr. Michael Racenstein, then-president of the Chicago Radiological Society, Dr. Richard Ninser, then-CRS-president-elect, and Robert G. Britain, vice president of medical products at the National Electrical Manufacturers Association, to argue the case in favor of the new technology. The policy was reversed in April. Insurers in the three states now compensate radiologists for full-field digital mammography at the same rate as screen-film mammography, Mendelson said.

Although federal antitrust law limits what the ACR can do about private insurance reimbursement, the college frequently communicates with various committees about Medicare payment rates. It is, for example, negotiating with the AMA/Specialty Society relative value update committee (RUC) on how to address flaws in the relative value scale formula's calculation of technical reimbursement for mammography. The RUC has accepted data from the ACR that may improve the accuracy of Medicare payments (and raise breast imaging payment rates) in 2006, said Pamela Kassing, ACR senior economics director.

TRAIN MORE RADIOLOGISTS

While the ACR remains vigilant about Medicare reimbursement rates, the first opportunity since 1996 to convince Medicare to fund more radiology residency slots may have escaped its attention. That opportunity was defined in Section 422 of the 2003 Medicare Modernization Act, in which Congress, having capped the number of Medicare-funded slots in 1996, instructed the Centers for Medicare and Medicaid Services to redistribute funded but unfilled slots to medical schools willing to use them. Between 2000 and 3000 slots may be redistributed, according to Medicare officials. The deadline for applying to participate in this one-time reallocation plan is December 1.

The potential size of this program surprised Josh Cooper, the ACR's director of congressional relations, when the program was brought to his attention in September. The provision was listed in an ACR summary as a potential benefit of the modernization act, but Cooper was skeptical as to whether so many slots would actually be redistributed.

"But it probably isn't a bad idea to put out something to remind our members of this opportunity," he said in an interview.

Although Section 422 does not focus on any particular medical specialty, it could increase funded slots for radiology, said Dr. Carol M. Rumack, chair of the radiology review committee of the Accreditation Council for Graduate Medical Education. The RRC accredits radiology residency programs.

"This is an important event," Rumack said. "This is the first opportunity since 1996 for radiology residency programs to increase the number of funded slots. Radiology program directors should urge their medical schools to apply."

At the ACR's request, the RRC has raised the number of accredited radiology residency slots by 425 to 4436 since 1999, Rumack said. But students are not recruited for many new slots because of Medicare's funding restrictions.

ADOPT BETTER TECHNOLOGIES

Both the ACR and the IOM support CAD to boost physician performance. Initial studies have shown that CAD can improve the diagnostic acumen of general radiologists close to the level of fellowship-trained mammographers.

According to the ACR's Borgstede, CAD can soften the resistance of radiologists who hesitate to perform mammography without assistance.

"CAD can provide backup, and it's often reimbursable," he said.

Although the IOM report concludes that digital mammography's effect on cancer detection rates and workflow has not been determined, some radiologists, including Borgstede, argue that digital mammography will make a difference.

"Image manipulation helps mammographers become more confident in their interpretation," he said.

MR mammography is generally accepted for screening high-risk women and for evaluating cancer patients before surgery, said Dr. William R. Poller, associate director of breast imaging for the Allegheny Health System in Pittsburgh, PA.

For invasive breast cancer, MR now has a proven role to play after diagnosis and before surgery. It is used for staging and to determine the extent of disease before lumpectomy in the breast with the primary tumor and in the contralateral breast, which may have occult disease, Poller said.

OTHER SOLUTIONS

Also inspired by the British experience, the IOM supports a system of self-evaluation for U.S. mammographers. The report balances the concern that tighter physician scrutiny will encourage more mammographers to leave the field against the opportunity to raise performance standards through self-testing.

It also recommends that reporting accuracy could improve if centralized reading sites were established to boost reading volumes. The authors saw this principle applied to good effect at hub-and-spoke breast imaging networks in Sweden and the Netherlands.

Studies by Craig A. Beam, Ph.D., of the H. Lee Moffitt Cancer Center in Florida found that physicians specializing in mammography who read more than 5000 mammograms annually find up to three times more cancers per 1000 exams than generalists reading lower volumes.

Yet the IOM's recommendation for a greater use of teleradiology to help centralize interpretation was also greeted with skepticism. Schmidt at the University of Chicago doubts if the nation's telecommunications system could inexpensively handle the volume.

"The images are bigger and bigger. GE digital systems produce 9-MB images. Fuji and Fischer produce files up to 36 MB. There is just too much information," he said.

Ultimately, mammography may be an interim step toward better solutions for diagnosing and eradicating breast cancer, according to the IOM report. Its authors look to molecular medicine for ways to identify the risk factors for developing breast cancer and biomarkers that can help diagnose its early development.

It is too soon to tell if help is on the way from this quarter or from other areas of relief included in the ACR's goals and the IOM recommendations. By consensus, screening mammography has been an essential weapon against breast cancer. Access has been threatened in some communities, but the powers that govern radiology and influence public healthcare policy appear to be taking steps to protect it.

Deborah R. Dakins contributed to this article.