ACR Calls for the Preservation of Quality and Safety of Diagnostic Medical Imaging Services
The American College of Radiology took its campaign to rein in unnecessary diagnostic imaging to the biggest stage recently, with an appearance before a congressional subcommittee that raised the national profile of the dangers and costs associated with the relocation of diagnostic medical imaging from hospitals to the offices of physician entrepreneurs.
"We are deeply concerned by the exponential growth in office-based imaging by those who may lack the education, training, equipment, and clinical personnel to safely and effectively use these studies to better their patients' health," James P. Borgstede, MD, chair of the ACR Board of Chancellors, told the House Ways and Means Subcommittee on Health during his March 17 appearance. "The real harm is excessive exams and unnecessary exposure to radiation leading to a missed diagnosis, which can result in additional patient injury or even patient death."
This critical hearing was held to examine the recent recommendations by the Medicare Payment Advisory Commission (MedPAC) on how to better manage the use of imaging services. In its March 1 report, MedPAC officials unanimously agreed to recommend that Congress direct the Secretary of the Department of Health and Human Services to establish standards for providers who bill Medicare for interpreting diagnostic medical imaging studies. Moreover, HHS should also set standards for providers who bill Medicare for performing these studies, the commission urged. These standards would be administered by a private organization, such as the ACR, and would cover critical areas of quality, safety, education, training, and experience.
Physicians who own and operate imaging equipment in their own office not only order the imaging study for their patients, but also perform and interpret it; therefore, the ordering physician may bill Medicare for both the technical and professional components of the exam. This form of self-referral is permissible because it falls under the exception for in-office ancillary services found in the Stark self-referral law. As a result, the ability to control the type and number of services that patients receive has made diagnostic medical imaging equipment an attractive accessory for the offices of many nonradiologists. In fact, when questioned by Rep Pete Stark (D, Calif), David Rollo, MD, chief medical officer for Philips Medical Systems who testified on behalf of the National Electrical Manufacturers Association (NEMA), acknowledged that Philips and other NEMA members would sell their diagnostic imaging equipment to any party, regardless of qualification.
MedPAC focused more of its attention on this issue in 2003 as it recognized the proliferation in the number of high-cost imaging procedures performed each year and the danger they posed to the financial health of the Medicare program. Last fall, the ACR began working closely with MedPAC staff as it examined ways to preserve the solvency of the Medicare program by curbing imaging utilization while at the same time improving quality and safety for Medicare beneficiaries.
In his subcommittee testimony, Borgstede unequivocally stated that the ACR supports many of the MedPAC recommendations and took the opportunity to elaborate on the College's proposed policy. He noted that the ACR prefers a policy where the scope is limited to "computed tomography, magnetic resonance imaging, positron emission tomography, and any 'fusion' technologies that may be developed in the future." He cited Medicare records that demonstrate that imaging performed by nonradiologists skyrocketed between 1998 and 2003. For example, in Alabama and Ohio, in-office imaging among nonradiologists was up more than 3,000%—30 times the national average by all providers during that span. Other states showed similar rates.
"Private insurers who have looked into this issue found a disturbing trend and took steps to clamp down on the practice," Borgstede told the House panel. "A recent Blue Cross Blue Shield study shows nearly a third of imaging performed by nonradiologists to be unnecessary, and another well-regarded study shows that number to be as high as 50%."
View from the Other Side
The ACR's primary opponents on this important issue also appeared before the House subcommittee and denounced the MedPAC report to a potentially favorable panel. Kim Allen Williams, MD, director of nuclear cardiology at the University of Chicago, speaking on behalf of the American College of Cardiology (ACC) and the Coalition for Patient-Centered Imaging (CPCI), disputed the belief that financially motivated self-referral was the primary driver of increased utilization. Williams added that his groups would "vigorously oppose" limiting the exception for in-office ancillary services.
Williams' comments presumably carried considerable weight with some of the panel members, especially Republicans, who side with the ACC and CPCI on the issue of self-referral. Republican lawmakers are traditionally viewed as "pro-business" and view the Stark law as anticompetitive. Consequently, they are unlikely to strengthen the rule.
Despite their opposition to MedPAC's recommendations, the ACC and CPCI seem to believe either Congress will legislate or CMS will act administratively to implement the policy. Williams argued that before Congress directs CMS to establish standards for physicians who interpret clinical images, "credible studies [must] be commissioned that examine the quality of imaging services among all modalities and among all physician disciplines." Many observers believe this request is merely a delaying tactic designed to utilize CMS' current trend of promulgating demonstration programs.
However, ACR officials have identified several other solutions to this political obstacle. One solution is the "pay for performance" paradigm, which links quality and safety to reimbursement, a concept that has generated some interest among members of Congress. After examining the recent implementation of selective privileging programs by private insurers, the ACR determined that linking reimbursement for these services to quality and safety standards could accomplish significant reductions in imaging services provided by nonradiologists, as well as boost the safety and quality of these services for Medicare beneficiaries.
During their testimony, both Borgstede and MedPAC Executive Director Mark Miller, PhD, clearly established MQSA as the legislative precedent for government intervention in providing standards for physicians, ancillary personnel, and imaging equipment. Each cited Government Accountability Office reports from 1995 to 1997 that illustrated how MQSA successfully improved the quality of mammography services without adversely affecting women's access to such services. Borgstede and Miller explained to the panel that because several private payers have employed selective privileging programs, there will not be an unreasonable burden on physicians who want to continue to provide quality diagnostic medical imaging services to Medicare beneficiaries.
Both Borgstede and Miller emphasized that MedPAC's standards were knowledge-based, not specialty-based, to ensure that no qualified physician is excluded. Miller noted several times during his testimony that the standards would differentiate by modality, not by medical specialty. Moreover, he added, such an oversight program would be promulgated by HHS, not by a specific medical specialty.
The change is necessary, Miller maintained, because the shift in site of services from hospitals to physician offices has compromised the quality and safety for patients undergoing diagnostic medical imaging studies. He noted that while hospitals have institutional standards that govern the performance and interpretation of imaging studies, physician offices have far less quality oversight. This lack of standards, he added, may allow old, poorly maintained equipment in these physician-office settings. This problem, when coupled with a physician who may lack appropriate training in imaging, can result in inaccurate studies, misdiagnoses, and inappropriate treatments, such as unnecessary surgical procedures.
Lack of Oversight and Inexperienced Personnel
Both sides presented their views on the quality of nonradiologist physicians' training in diagnostic medical imaging.
"Unaccredited, nonradiologist imaging facilities may use poor, perhaps malfunctioning equipment, and employ poorly trained technologists," Borgstede told the panel. "This raises material radiation safety concerns even though the adverse effects of these quality problems may not show up in the form of increased cancer risk for decades."
Miller told the panel that if a physician lacks appropriate training in imaging the result will be a greater likelihood of inaccurate studies, misdiagnoses, and inappropriate treatment such as an unnecessary surgical procedure, adding additional burdens to the nation's health care system.
Williams, however, countered these arguments, telling the panel that "Specialist physicians are uniquely qualified to provide imaging services specific to their specialty because they are trained in both diagnostic imaging techniques, and in the structure and function of the organs and systems they are imaging."
Williams' response drew a sharp rebuke from Borgstede, who disagreed with the generalization and reiterated that imaging performed by nonradiologists often results in excessive exams. Furthermore, he told the subcommittee, while radiologists receive 4 to 6 years of post-medical school training, other specialties may rely on little more than a weekend workshop to become qualified in imaging for that specialty.
In response to subcommittee members' concerns that an implementation of the MedPAC recommendations for diagnostic imaging would result in a compromising of patient access to quality health care services, Williams cited patient convenience as an important advantage of performing medical imaging services in the physician office setting.
"When I conduct images in my office, I can read them immediately to expedite a diagnosis and begin treatment," he told the panel.
Borgstede was quick to refute Williams' access argument.
"Patient convenience will not go away with the implementation of quality and safety standards and it seems reasonable to point out that convenient access to poor quality or unnecessary services is hardly a patient benefit," Borgstede maintained.
In fact, the ACR urges Congress to preserve patient access to quality imaging care by continuing to permit the interpretation of clinical images via teleradiology, as well as by directing the HHS Secretary to provide alternative standards for rural or medically underserved areas as necessary.
"More Work Remains"
Borgstede summarized his appearance before the House subcommittee in a message to the ACR membership that was posted on the ACR's Web site shortly after the hearing's conclusion.
"I thought the hearing of the subcommittee was a significant success," Borgstede said. "First, we have elevated our concerns about the explosive growth in these services and the rampant growth in self-referral by nonradiologists to such a degree that not only has MedPAC endorsed many of our policy recommendations, but now the major committee in the US House of Representatives has held a hearing to vet the issue and to educate its members on the costs and quality concerns we have raised."
However, Borgstede maintained that despite the ACR's recent success with this issue, it is still faced with a tremendous challenge to see it successfully to the end.
"While I feel there is now a broader understanding by these members of Congress of our concerns, we recognize that more work remains," he noted in his Web message. "This process is just beginning. If Congress decides to garner savings from the Medicare program this year, I feel that linking quality standards to imaging will be a policy that could well be endorsed.
"We will know more in the days and weeks ahead," he continued, "but I am extremely pleased that with all of our work, both staff and leaders alike, we are getting our 'day in court,' and I feel optimistic that we are making significant inroads on a divisive, yet important, issue for us all."
For more information on the hearing before the House Ways and Means Subcommittee on Health or the ACR's legislative efforts, please contact Josh Cooper, ACR senior director for government relations, at joshuac@acr.org, or Jay Greissing, ACR assistant director for congressional relations, at johng@acr.org.
Members of the House Ways and Means Subcommittee on Health Attending the March 17 Hearing
Nancy Johnson (R, Conn), chair
Pete Stark (D, Calif), ranking member
Jim Ramstad (R, Minn)
J. D. Hayworth (R, Ariz)
John Lewis (D, Ga)
Mike Thompson (D, Calif)
Rahm Emanuel (D, Ill)
Witnesses Before the House Ways and Means Subcommittee on Health
James P. Borgstede, MD, chair, ACR Board of Chancellors
Mark Miller, PhD, executive director, MedPAC
Kim Allen Williams, MD, director of nuclear cardiology, University of Chicago
Cherrill Farnsworth, chair, National Coalition for Quality Diagnostic Imaging Services
David Rollo, MD, chief medical officer, Philips Medical Systems