In recent years, the controls of managed care have become looser, with many plans eliminating preauthorization for services, eliminating the need for referrals from primary care physicians, and eliminating use of closed provider panels in their HMOs, while more enrollees have moved to preferred provider organizations (PPOs), which have even fewer restrictions than HMOs. These changes have been accompanied by a steep increase in utilization of health care services, and the perception by health plans of inappropriate overutilization – especially of high-end diagnostic imaging services.

The much-anticipated imaging policy changes comes after Highmark placed a moratorium on all new managed care contracts for high-end imaging providers in January of this year. Citing increasing costs and a rising number of requests for contracts from new imaging centers, the company stopped doing business as usual and embarked on a reprivileging and recredentialing initiative for all of its imaging providers. The initiative was introduced via a letter to about 1,000 current and would-be Highmark providers this past July. The letter says that going forward, Highmark will only contract with, and pay for, imaging services rendered by providers and imaging centers where staff and equipment meet new quality standards outlined in new privileging guidelines. Providers were given 30 days to respond with intent to comply. Highmark has contracted with National Imaging Associates to help with the implementation of the program. Privileging criteria for all imaging modalities are included in the four-page guidelines, but of most significance are the requirements regarding advanced imaging services such as Magnetic Resonance Imaging (MRI), Computed Tomography (CT) and Positron Emission Tomography (PET) scans. Some of those include:

·  Requiring diagnostic imaging services offered for a minimum of 40 hours per week on business days, including one evening per week until 8:00, and at least two Saturdays per month for a minimum of four hours per day.

·  Requiring centers to be staffed on-site by a Highmark-credentialed radiologist with advanced cardiac life support (ACLS) certification.

·  Requiring a minimum of five modalities at each provider location offering CT, MRI and Fluoroscopy.

·  Requiring PET technology to be provided in a hospital setting only.

In addition, providers now must notify Highmark when ordering MRI, CT or PET. The insurer wants to use data gathered through the notification process to identify appropriate and inappropriate utilization trends of these high-end imaging modalities, says Carey Vinson, M.D., Medical Director of Quality Management for Highmark. The notification process will also allow Highmark to educate providers on evidence-based criteria for ordering such imaging, says Vinson. Requiring notification is a precursor to the imaging pre-authorization program (limited to MRI, CT and PET) Highmark plans to implement sometime in 2005.

Highmark put an imaging pre-authorization program in place in 1999, but abandoned it in 2001. Since then, the insurer has experienced a dramatic increase in both its number of imaging facilities and advanced imaging costs – growing 20 percent annually for three consecutive years. In 2003, employer groups paid the price for those increases with a rise in premiums equaling 20 and 30 percent. "We were getting pressure from employer groups about what we were doing to monitor rising imaging costs," Vinson says of one motivator for the program.

There are many stakeholders affected by the Highmark initiative. Highmark contracts with more than 42,000 providers and insures over four million people, or 60 percent of the insured population in western Pa. and 20 percent of central Pa.’s insured. Vinson says it is the insurer’s responsibility to ensure safe and quality services for its membership.

G. Alan Yeasted, M.D., Chairman of the Board, for Allegheny County Medical Society (ACMS), says that, while ACMS supports Highmark’s attempt to ensure that the right patients receive the appropriate radiologic procedures, the Society is concerned that the program will burden primary care physicians with increased paperwork and time delays. "Delays in needed testing are not in the best interest of patients," he says.

Patients and physicians aside, financials signaled policy review at Highmark. In a year where 78 percent of HMOs were profitable, reporting record profits equaling $6.7 billion for the first nine months of 2003, Highmark was struggling. In March of this year, the company reported that its health care business had an operating loss close to $18 million in 2003; the loss was attributed to double-digit claims costs, fueled by higher-cost medical services, including specialty pharmaceuticals and increased use of advanced imaging. A spokesperson for Highmark says that, while the costs for pharmacy are expensive, growth in imaging costs have surpassed them. "Imaging is the best place to concentrate our energies," says Vinson.

Researchers concur, finding that, while pharmaceuticals are a factor driving rising health care costs, utilization of radiology services – especially that of high-end diagnostic imaging – has grown at a particularly rapid rate. In a June 2004 report to Congress by the Medicare Payment Advisory Commission (MedPAC) volume growth per beneficiary for imaging services, including MRI, CT, nuclear medicine, and heart echography, is reported to have increased by 13 to 17 percent between 2001 and 2002. And, while there is undisputed evidence that advances in imaging technology have proven beneficial for things such as early detection of disease using MRI, variation in the utilization of these services has brought into question whether all the growth in volume is appropriate. In testimony before Congress one month prior to the MedPAC report’s release, Glenn M. Hackbarth, J.D., Chairman of MedPAC said that, while growth that produces meaningful gain to patients is desirable growth, variation in volume may be an indication that, "not all growth is good." MedPAC reports there is wide variation in volume of imaging services geographically.

Questions about appropriateness in utilization have private and public insurers alike searching for the perfect prescription for balancing imaging’s cost-benefit ratio. Blue Cross Blue Shield Association (BCBSA) companies across the nation have already implemented imaging policies, and just last month, Blue Cross Blue Shield of Kansas City announced its own intention to institute an imaging program that mirrors Highmark’s. Legislators, too, are considering imaging initiatives for Medicare that are similar to Highmark’s including, enforcing safety standards, limiting the types of providers qualified to deliver a service, and reviewing appropriateness of claims.

Analysts say an effective policy considers not just "the where" imaging dollars are spent, but also "the why." Patient demand for new technology, and physicians practicing defensive medicine are factors considered to be fueling demand. Another factor, self-referral, fuels not only demand, but controversy. Radiology falls outside of Stark laws, so long as the imaging equipment is within the physician’s practice, and many speculate that lack of regulation has physicians turning to imaging to increase revenue.

A BCBSA-commissioned report on imaging released last year suggests that digital imaging is sometimes over-used, and that the increasing number of imaging machines being installed at freestanding facilities and in physician offices may be one reason why. Researchers speculate that increasing volume in imaging services may be a result of providers trying to recover the high fixed-cost associated with owning and installing imaging equipment, and that imaging done may be an attempt to spread those costs over a large number of cases. The study highlights trending in utilization of advanced-imaging equipment as an example of this phenomenon: data provided by the American College of Radiology (ACR) shows that, between 1999 and 2001, the number of MRI scans rose by more than 45 percent, from 9.3 million to 13.5 million. In Pennsylvania, the number of MRI scans grew just under national average. However, the number of MRI scans per 1,000 residents in Pa. at baseline 1999 exceeds the national average by approximately 10 tests per 1,000 residents. Significantly, national data show that in 2001, for Medicare Part B patients, 40 to 54 percent of all MRI scans were performed outside of hospitals – in physicians’ offices or freestanding facilities.

Radiologists have been particularly vocal about self-referral of imaging by non-radiologists. William T. Thorwarth, Jr., M.D., President of the ACR, says that, "the growth rate of imaging costs in the self-referral segment far outpaces the growth of imaging performed on a referral basis by radiologists." Thorwarth asserts that the most effective cost-containment measure for Highmark is to control who is ordering an imaging study by minimizing or limiting self-referrals. A July 6, 2004 New York Times Op-Ed piece by the former chairman of radiology at Thomas Jefferson University Hospital, David C. Levin, M.D. echoes that sentiment. Levin writes of self-referral that, while he sympathizes with his non-radiologist colleagues’ need to increase revenue, imaging costs rise and quality suffers when doctors in other fields try to practice radiology without the benefit of training.

As consumers take a more active role in their health care, physicians are not alone in requesting imaging studies. Doctors are treating the "worried well" says Pamela B. Peele, Ph.D., Associate Professor & Vice Chair Health Policy and Management, Graduate School of Public Health University of Pittsburgh, and with small co-pays and no deductibles they want every test possible. Of the Highmark program, Peele says literature strongly suggests quality of imaging services will improve with the five-modality rule. "It will cause a concentration of services, and high procedure volume equals procedure quality," she says. Whether or not imaging volume will decrease for Highmark is unclear, says Peele. Demand may just shift to surviving centers and emergency departments, and whether inappropriate demand may go unserviced remains to be seen, she says. Patients don’t understand what overutilization is, (which she defines as the use of health care services that have no measurable outcome), says Peele. She notes even the most well-intentioned policies are difficult to enforce at the patient level. They are designed for populations of people, and "when a doctor walks into an examination room, he or she is treating an individual with individual demands," she says. Peele predicts Highmark will realize benefit when surviving imaging centers take on the extra demand. "Highmark gets more with less," she says.

Highmark’s revised policies will benefit some Pa. physicians as well. For Frank Madonna, M.D., a radiologist and president of Lucien Diagnostic Imaging, the Highmark program is just what the doctor ordered. "It insures three things: quality, appropriateness and safety," he says. And for Madonna compliance means business as usual. According to Gary R. Keeling, CPA, MBA, practice administrator for Lucien, all 23 of the practice’s physicians are in compliance with Highmark requirements, and two of the three company imaging centers already meet the five-modality requirement. He says they to plan to invest $600,000 to bring the third center into compliance. Madonna says the stricter policy will drastically reduce the number of imaging centers the insurer contracts with, but he contends that demand for his practice will not be depleted because it is driven primarily by hospital EDs. "Our ERs are booming," he says, "and because of the malpractice crisis imaging is often ordered as a safety measure."

Data confirms Madonna’s assertions. The Centers for Disease Control (CDC) reports that, from 1992 through 2002, the number of ED visits have increased 23 percent, up from 89.8 million to 111.2 million visits annually, and that imaging was provided over 40 percent of the time. Researchers contend some of that imaging is not evidence-based, but rather, imaging ordered by physicians in an attempt to quell the threat of litigation.

Not everyone is happy with the Highmark program. Ajit Shah, M.D., M.B.A., says the plan seems to be about controlling quantity, not quality. Last year, Shah, a radiologist specializing in PET technology, left hospital care after 17 years to open Suburban Imaging Associates in Sewickley. Now, because Highmark is requiring that all PET scans be provided at hospitals, he may have to close his doors. "I won’t be happy, but I may not have a choice," says Shah of his possible return to hospital medicine. He says he could add other modalities, but "PET is what I do." Shah doesn’t understand the hospitals-only rule, arguing that most hospitals administer scans in a mobile van just like at his center.

Highmark considered the quality of care delivered at a hospital when determining the hospital-only rule for PET. According to Vinson, it isn’t about whether a scan is administered in a van; it’s about what is done with the results. To that end, "hospitals are appropriate," he says. Pennsylvania hospitals provide a "global system" of imaging by having all modalities available, says Ian Rawson, Ph.D., president of the Hospital Council of Western Pennsylvania. That takes a huge investment in equipment and personnel. Highmark’s directing of imaging to hospitals shows an appreciation of that investment, Rawson says. American Hospital Association (AHA) data show that in 2001, 80 to 89 percent of Pa. hospitals had CT, and 50 to 59 percent had MRI. While there is no AHA data on availability of PET technology in Pa., nationally, less than 10 percent of hospitals had PET that year. Vinson says the insurer is concerned about patient access and will monitor any signs of restriction.

Physicians say there is yet another potential problem with the Highmark program: radiologists are in short supply. Finding enough radiologists to staff all imaging centers 40 hours a week will be a challenge, says Richard B. Kasdan, M.D., a neurologist and President of Associates in Neurology of Pittsburgh. His five-physician practice has a radiologist on staff, but with three imaging centers to cover, one radiologist is not enough. Kasdan hopes Highmark will ultimately revise the radiologist-onsite requirement, recognizing the expertise a board-certified neurologist provides to neuroimaging.

Clinicians assert that specialists other than radiologists guarantee equal quality; health insurers reference studies showing otherwise. MedPac reports that, when imaging centers are inspected for quality performance, radiologists perform exceptionally well, with a one percent failure rate, while, on average, non-radiologist offices fail 35 percent of the time. Highmark’s new program requires that contracted providers agree to random safety inspections.