Clinical images courtesy of (clockwise) OrthoView, TeraRecon, Amicas, Amicas, MIMvista

By any measure, 2009 has been a rough year for medical imaging. The U.S. House of Representatives passed legislation that could change Medicare payments for advanced diagnostic imaging procedures, such as MRI, CT, PET and nuclear medicine, through an increase in the equipment utilization rate assumption from 50 percent to 75 percent.

This could lower the technical component payments for these services. The bill also seeks to increase the payment reduction on contiguous body parts from its current 25 percent to 50 percent. Both of these provisions would become effective Jan. 1, 2011.

In November, the U.S. Preventive Services Task Force reversed course from its 2002 recommendations and issued new guidelines against routine screening mammography in women aged 40-49 years. In addition, it suggested that biennial screening mammography was sufficient for women aged 50-74 years. Industry debate continues. (See story, page 16)

However, PET proponents scored major victories when the Centers for Medicare & Medicaid Services (CMS) expanded the exams for which it will reimburse use of the modality. Also, some cardiac PET studies saw an uptick in their reimbursement rate, a bright spot in a year of double-digital cuts to CT and MR payments in 2010.

Health Imaging & IT checked in with leaders from SNM, ACR, RSNA and ARRS and got their reaction to events of the past year and thoughts on what the future may hold for imaging.

Making it molecular
Molecular imaging got some good news earlier this year on the reimbursement front for imaging several new cancer types. And to validate imaging biomarkers for use in streamlining the development and registration of investigational therapeutics, the SNM Clinical Trials Network was introduced.

“There are two reasons we created the network: the first is to support pharmaceutical companies that are using PET imaging in clinical trials and are having trouble with obtaining reliable, quantitative imaging,” says Michael Graham, MD, PhD, SNM president and professor of radiology and director of nuclear medicine at the University of Iowa Carver College of Medicine. “The second is to provide a platform supporting uniform trials for new imaging agents that are in the public domain, such as the fluorothymidine (FLT) marker for DNA synthesis, and fluoromisonidazole (F-MISO) for imaging hypoxic tumor tissue.

“To test new therapies early on, determine whether to go ahead with larger-scale trials, and accumulate data for FDA approval, a large, centralized effort is necessary,” Graham explains. “Because these agents are generic, there is no profit motive for an individual pharmaceutical vendor to do it; it has to be done by an economically disinterested group such as the SNM.”

A growth area for nuclear medicine is the assessment of response to therapy and the development of personalized medicine. “Nuclear medicine physicians are helping to test chemotherapy agent effectiveness and tailor therapy for individual patients after only a few doses. They save money and time by figuring out in the first week or two if the course of therapy is really working,” says Graham. One example of this is customizing the dosage of new agents directed against receptors on tumors, such as Gleevec.

Isotope supply concerns
One great challenge to nuclear medicine over the past couple of years has been the threat to the supply of the oft-used molybdenum-99 (Mo-99)—the parent isotope of technetium-99m (Tc-99m)—the most widely utilized radioisotope in the world for molecular and nuclear diagnostic imaging studies. Approximately 80 percent of worldwide clinical nuclear medicine is dependent on the availability of Mo-99. Currently used reactors are 40 to 50 years old, and are experiencing downtime related to aging, leading to instability in the supply. This is a global issue being addressed locally.

Shortages have resulted from the unexpected and scheduled shutdowns of the largest—albeit aging—producers of Mo-99: the National Reactor Universal (NRU) reactor in Chalk River, Ontario, and the High Flux Reactor (HFR) in Petten, Netherlands.

Together, these reactors produce two-thirds of the world’s Mo-99 supply. In August, the shutdown of NRU was extended into the first quarter of 2010. To date, based on their proximity, the U.S. and Canadian medical communities have been most affected by the current shortage. In fact, about 91 percent of U.S. nuclear medicine physicians suffered shortages during the most recent crisis. Meanwhile, referring physicians are seeking alternative tests.

“There are only a handful of these isotope-producing reactors in the world,” Graham explains. “In the 1990s, the Canadians had started construction of two new reactors that would have ensured the isotope supply for decades; however, a design error was discovered during construction, and they pulled the plug in summer 2008. The good news is that there is solid collaboration internationally among the current operators and distributors, ensuring equitable distribution of the supply. In the short term, the existing Canadian reactor may be back up and running next year, which would help stabilize the supply, especially if the Netherlands reactor goes down for maintenance.

“In the mid-term, the House of Representatives has just passed a medical isotopes bill authorizing $163 million for the development of a new domestic supply; now it will head to the Senate,” he notes. “A new reactor also is planned in the Netherlands, with a newer design. The Missouri reactor will be upgraded, and other new reactors are in discussion. Overall, there seems to be a reasonable likelihood of maintaining a stable supply.”

Hybrid technology and imaging agents
The use of solid-state photodetectors has led to some exciting innovations in functional imaging technology, such as pre-clinical SPECT/MRI and PET/MRI systems. Graham comments, “Solid-state detectors, such as avalanche photodiodes, are evolving that approach the photosensitivity of the current photomultiplier tubes, but are not as sensitive to magnetic fields, so they can be inserted into the MRI and operated simultaneously. This supports the development of more compact gamma cameras and PET scanners, lowers the cost, and offers hybrid imaging with MRI. There is growing enthusiasm for this new combination, but the machines are not yet widely available; currently, they are being used mainly for head imaging.”

PET radiotracers also hold great promise. “The sodium fluoride ion (18F-NaF) is a superb bone imaging agent, offering an alternative to technetium for metastatic bone disease. It has already been approved in Canada,” he says. “In the U.S., it is under consideration by the CMS, and clinical trials are underway. That is the most likely tracer to be approved next, as it also helps to address the supply issue for medical isotopes. Others include FLT, and F-DOPA [an indicator of protein synthesis] for movement disorders and tumors, both within the next few years.”

As for the future role of molecular imaging in the diagnostic continuum, Graham observes, “Nuclear medicine will continue to be used for diagnosing coronary artery disease, and diagnosis and staging of tumors. Radio-labeled therapeutic agents are a little further off, as they are expensive and only for select patient populations. And we will continue to work in collaboration with our radiology colleagues on hybrid solutions; it’s a team effort.”

It’s about the economy
John Patti, MD, is vice chair of the American College of Radiology (ACR) Board of Chancellors, and immediate past chair of the ACR Commission on Economics and ACR Audit Committee, current chair of the ACR Task Force on Value Added, and vice chair of the ACR Commission on Government Relations. A radiologist at Massachusetts General Hospital in Boston, he shares his views on the impact of current healthcare reform initiatives and other legislation on radiology reimbursement.

According to Patti, the most likely impact of healthcare reform will be to decrease payments for the technical component of radiology. “This may force some outpatient imaging centers to close, or to not upgrade equipment as often as they would like. Ultimately, the effects may include limitations on access for patients, longer waits for imaging appointments, and higher volumes at hospital radiology departments,” he says.

Noting that the ACR is working closely with members of the Congressional committees involved in healthcare reform to educate them on the ramifications, he adds, “The Deficit Reduction Act [DRA] of 2005 already severely cut payments, and new entities under the DRA are looking to take more money out of radiology and other medical specialties that use imaging. But we have been able to mitigate some possible effects of the current proposals being considered.”

Fueling utilization and growth
In spite of these challenges, Patti believes the future of radiology to be very bright, especially because the demand for imaging services continues to increase. “The frequency of utilization shows a very positive trend, due to the evolution of the technology and its demonstrated benefits,” he says. “New applications of existing technology, such as CT and MRI, and newer technologies, such as nuclear imaging and biomarkers, are contributing to this trend.”

Echoing Graham, he notes, “Radiology will play a great role in personalized medicine, identifying members of the patient population who are at greatest risk, to support early intervention.”

“The theme of last year’s RSNA Conference was personalized medicine, i.e., how the patient’s genetic and historic health markers should impact the selection of imaging,” notes Robert Quencer, MD, a professor and chairman of the department of radiology of the University of Miami School of Medicine, and chairman of the RSNA Scientific Program Committee. “It follows from this year’s theme of quality in imaging, which includes tracking the outcomes and performance of radiologists and the utilization of the various modalities, and ensuring appropriate matching of the patient’s clinical condition or symptoms to the imaging study that is ordered. While we are seeing increased demand, one of our goals is to reduce the volume of overutilized tests.”

Along with the escalation of utilization, Patti hopes to see a corresponding increase in funding to support the education of more radiology residents. “We also need to work on becoming more efficient,” he observes. “For example, physician extenders [radiology assistants with a bachelor’s or master’s degree] can take on more of the procedural tasks; this is a position advocated by the ACR to allow the radiologists to focus more on interpreting images.”

New tools & technology
John Brink, MD, is a professor and chairman of the department of diagnostic radiology at the Yale University School of Medicine in New Haven, Conn., as well as vice president of the American Roentgen Ray Society (ARRS). He sees the forthcoming investment in health IT mandated by the American Recovery and Reinvestment Act (ARRA) of 2009 as beneficial to radiology.

“Radiology will benefit greatly from a well-positioned EMR,” he says. “Not only will this deliver on the promise of greater clinical information flow to radiology, but patients will benefit from improved communication from radiology to the EMR. It will be a two-way street.”

He adds, “Real improvements are possible when it comes to radiology order entry. We’d like to integrate a decision-support tool as part of the radiology order entry screens in the EMR. This will allow for utilization control and will help with radiation concerns [from duplicate studies] and reduce overall medical waste.”

With new technologies and techniques being delivered into the clinical realm, non-invasive imaging will continue to chart the diagnostic course of medical practice. “Radiologists need to recognize the value-added service they provide, and the integral role they play on the patient care team,” Patti concludes. “We are true consultants, and with increasing specialization, we are well-positioned to become leaders in the clinical community.”