IRs look for silver lining as government pushes quality

Interventional radiologists, like their diagnostic counterparts, remain under pressure as payers ratchet back reimbursements. But they continue to fight on the reimbursement front and see some silver linings in new government programs designed to improve the quality of care.

Interventional radiology practitioners and researchers, as well as IR-related technology developers, could use to their advantage federal plans such as the Physician Quality Reporting and Critical Path initiatives. Such plans may help them to streamline workflow, protect reimbursement, and bring about better drugs and devices more quickly and cheaply, according to members of a panel presentation at the recent Society of Interventional Radiology meeting.

A white paper published in 2003 by the American College of Radiology Task Force on Interventional Radiology noted that the onslaught of competing specialties would push interventional radiology out of business unless it were willing to make the outpatient clinic model its cornerstone. Until then, IRs had been traditionally trained as hospital-based physicians who stayed out of the evaluation and management side of patient care.

The publication of that paper started a revolution. The trend toward clinically oriented care in outpatient clinics operated by IRs became all the rage-until Congress passed the Deficit Reduction Act of 2005, which snowballed into a series of policymaking efforts to contain imaging costs.

The new plans laid out by Congress and the Centers for Medicare and Medicaid Services since 2007 have hit interventional radiology hard. CMS rules for the 2008 Hospital Outpatient Prospective Payment System, published late last year, imposed a bundled approach to reimbursement that mixes technical components of imaging guidance, such as contrast media use, with therapeutic aspects that had traditionally been billed separately.

SIR supports the concept of bundling but questions its implementation. Under the proposed rule, for instance, the CPT code 37210 for uterine artery embolization was assigned the ambulatory payment classification code 0202, with a payment rate of $2720.36, using the bundling approach. SIR complained that this APC code did not make up for UAE's intensive use of device and imaging resources. The society proposed instead APC 0229-used for intravascular cathether and shunt placement-as more appropriate and having a rate ($5639.26) more in line with UAE's actual technical, professional, and resource demands. CMS ultimately adopted SIR's advice regarding UAE. It ignored similar recommendations, however, for a host of other procedures.

Reimbursement bundling may discourage CT or MR guidance in favor of cheaper modalities such as fluoroscopy and ultrasound, according to ACR and SIR officials. It could also affect the availability of vital interventional services such as angioplasty and stenting. The ACR's Economics and Health Policy Department predicted that IRs could face a loss of about a quarter of their revenues through the new HOPPS regulations. To add insult to injury, the National Correct Coding Initiative has turned into another aggressive policymaking tool to rein in reimbursement, SIR officials noted at the annual meeting. CMS had originally started the NCCI in 1996 to hinder improper coding.

Minimally invasive imaging-guided interventional (IGI) therapies, such as tumor ablation or vertebroplasty, are crucial for the health of U.S. residents in particular and the healthcare system in general, said SIR panel moderator Dr. Katharine L. Krol, an interventional radiologist at St. Vincent Hospital in Indianapolis.

IRs share concerns about imaging overutilization. Across-the-board cuts to contain it, however, could only weaken interventional radiology's call to bring about medicine's future, Krol said.

"IGI therapies are much different from diagnostic imaging and should be treated differently as the policy decisions are being made," she said.

DAMAGE CONTROL

Legislation passed in 2006, the Tax Relief and Healthcare Act, included a provision to delay a reduction in the sustainable growth rate formula for physician payment contained in the DRA. Although originally viewed as a remedy worse than the disease-the provision implied that Congress would offset Medicare's budget at the expense of radiologists-it also established the Physician Quality Reporting Initiative.

This voluntary program provided for an incentive payment to physicians who reported quality measures outlined in the PQRI system from July 1 through Dec. 31, 2007. Those who joined pocketed an extra 1.5% on top of all charges covered by the Medicare Physician Fee Schedule during that six-month period. The Medicare, Medicaid, and State Children's Health Insurance Program Extension Act of 2007 has extended the PQRI until the last day of 2008.

The program was not intended for physicians to just jump through a hoop and cash in for reporting some data. It was meant to help improve healthcare quality though coordination among physicians, said panelist Dr. Michael T. Rapp, director of CMS's Quality Measurement and Health Assessment Group.

Under the current system, most physicians try to narrow the scope of their liabilities and thus shy away from responsibility beyond their control. Looking at the big picture, however, this approach is not in the best interest of patients, Rapp said.

"(The PQRI) is a way you could promote broader healthcare quality goals, even though you don't actually do all the procedures yourself," he said.

IRs have seen explosive practice growth in IGI therapy of stroke, spinal fracture, and oncology. The PQRI provides several measures covering these areas as well as other more conventional IR procedures:

• timing, administration, and discontinuation of antibiotics in the perioperative period;
• screening and management of osteoporosis;
• prevention of infections due to central venous catheter insertion; and
• stroke imaging and reporting.

When it comes to cancer care, vascular disease, or spinal fracture, IRs usually work in groups comprising internists, oncologists, surgeons, and other specialists. More often than not, however, patient management follows a silo approach rather than a coordinated multidisciplinary approach. PQRI measures foster collaboration and, most important, coordination among treating physicians, said panelist Dr. Sean M. Tutton, cochair of SIR's economics committee.The measures related to osteoporosis screening and management provide one vivid example of this model, Tutton said. Patients with spinal fractures may see many physicians as they go through the system: emergency room physicians, diagnostic and interventional radiologists, rheumatologists, and surgeons. IRs could use the clinical pathway developed by SIR to report the PQRI measures and help other physicians they work with do the same. This approach translates into reduced hospital stays and fewer complications, improved patient outcomes, and greater money savings, said Tutton, an interventionalist at the Froedtert Memorial Lutheran Hospital in Milwaukee."We need to work with CMS and the SIR leadership to develop those PQRI initiatives that make sense for us," he said.CMS is considering more measures for inclusion in the program, which may be extended until 2009. For details, physicians can visit:

www.cms.hhs.gov/PQRI

.

CRITICAL PATH

Physicians and medical researchers tout personalized medicine as the wave of the future in U.S. healthcare. The new paradigm will rely on prevention, screening, and therapies that target a specific organ or biological process at the molecular level. The goals: provide early diagnosis and treatment, avoid more invasive procedures, and reduce healthcare costs.

About half of all interventional radiologists are or have been involved in R&D of drugs and devices for use in interventional procedures, according to the SIR Foundation. They face the challenge of developing and validating biomarkers for triage, monitoring, and surveillance as well as for image-guided interventions and devices that fit the personalized medicine paradigm, said panelist Dr. Gary S. Dorfman, research vice chair at Weill Medical College of Cornell University in New York City.

Researchers face a paradox, however. An increase in the number of investigational new drugs or devices (INDs) filed with the FDA in recent years has been accompanied by a decrease in the drug and biological label applications during the same period. FDA figures show that of the 646 drugs in clinical trials for cancer in 2006, fewer than 1% were approved, at an overall cost of about $1 billion. The process has become burdensome and expensive for public as well as private investors, Dorfman said.

"INDs fail mostly due to safety or efficacy or problems with industrialization. Or their return on investment is deemed insufficient," he said.

In March 2004, the FDA announced its Critical Path Initiative to streamline the approval process for new drugs, biological products, and medical devices. The plan called for a joint effort among academia, industry, and the FDA to turn ideas into safe and effective treatments faster and more cost-effectively while maintaining scientific rigor. IRs need to engage in this path and stop doing single-center, statistically insignificant studies, Dorfman said.

"Let's design meaningful trials and work on them all together," he said. "Let's subvert our individual desire for stroking our egos and glory to a greater goal of delivering meaningful treatment to our patients."

Critical Path could help researchers and industry speed up the development process of their products, said panelist Ashley B. Boam, acting deputy director for engineering and science review at the FDA Center for Devices and Radiological Health's Office of Device Evaluation.

Image-guided therapies have to undergo a long but not uncertain process before obtaining market approval. Individual investigators, academic institutions, and public and private medical research organizations engaged in the process need to design studies that minimize limitations and boost clinically meaningful results. They are also required to lay out a sound strategy for production, distribution, and accurate labeling of their products.

The FDA encourages not only formal but also informal meetings with manufacturers and investigators to reduce unnecessary time and costs spent on device evaluations, Boam said. These meetings help determine the product development protocols and scientific evidence needed to demonstrate safety and effectiveness of a device before its use on patients in the U.S., be it for marketing or investigational purposes only.

The FDA approves and regulates devices with specific indications for their use. This approach may seem restrictive, but it could be the springboard to some creative maneuvers leading to product approval, Boam said.

Some patients, such as those in small population groups or with multiple comorbidities, are difficult to study. Many therapies in use have never established what the FDA calls "proof of concept," which requires large trials, and some are used together or in series for the treatment of certain conditions. Often, individual investigators or companies try to validate a single device for the treatment of multiple indications.

The use of established databases or registries-a trend that has achieved a certain notoriety of late-can provide control subjects for studies in which randomization is problematic for ethical or practical reasons.

Manufacturers and investigators could work together by pooling their drugs and devices in large trials. That strategy may not only establish the proof of concept but could potentially lead to the approval of individual devices as well, Boam said.

"It's important to look at the big picture. Where there are multiple places that a device could be used, multiple hospital beds for example, we want to take a holistic approach to evaluating a device, thinking about where data on this have already been gathered on one indication that can be leveraged or used to reduce the requirements for additional indications," she said.

Mr. Abella is associate editor of Diagnostic Imaging.