The Pa. Dept. of Environmental Protection (DEP) has prohibited walk-in patients, i.e., scans without the physician referral, and the Pa. Dept. of Health has recently issued a warning to consumers about limiting unnecessary exposure to radiation produced by these scans, a position backed up by numerous national medical societies and health organizations.

These developments raise questions and concerns about government’s role in regulating the practice of medicine, potentially stifling medical innovation.

Since the beginning of 2001, a half dozen medical facilities that perform CT screening have opened in the Delaware Valley alone—three in suburban Philadelphia and three in adjacent New Jersey counties. These facilities operate outside of established institutional providers of CT services located in hospitals and medical centers. Unlike the majority of institutional providers, which have built-in physician referral networks and generally use CT procedures to diagnose illness in symptomatic individuals, the free-standing CT facilities in this area have adopted a medical model, common in other states, stressing disease prevention. A salient, and controversial, component of that model concerns the use of CT to screen asymptomatic individuals without a physicianprescription. Screened for are a range of diseases, principally calcium deposits within coronary arteries, an early indicator of heart disease, and pulmonary and gastorenterological disease, particularly lung, liver, and pancreatic cancer. In addition, whole-body CT procedures are available that screen for all of these diseases at once.

The medical model of free-standing CT facilities necessitates marketing strategies that communicate to consumers the importance of taking initiative for acquiring preventative health care. "Put health care back into your own hands" states the print ad of Oracle Preventative Health, located in Plymouth Meeting, Pa. The message in this advertisement is twofold. First, "own hands" means "out of one’s pocket," a reference to the point that potential patients are being encouraged to by-pass the cost controlling constraints of insurance companies, who, for the most part, do not cover services performed at the CT facilities.

In addition, "own hands" alludes to the role of personal initiative. The entrepreneurial model of at least two of CT facilities, Philadelphia LifeScans in Bala Cynwyd and HealthPrint Diagnostic Testing Center in Villanova, was conceived to garner business from those educated and conscientious individuals who wanted CT screening without first getting physician referral. In those cases, medical staff at both facilities still performed a thorough evaluation of the individual’s family and medical history before performing a scan. Rose Covalesky, a licensed Physician Assistant and medical educator at Philadelphia LifeScans, notes that individuals were not scanned simply because they walked in, asked for a procedure, and demonstrated the ability to pay for it. "The practice of medicine and the medical care given to people always superceded the business aspect," she says, "and in cases where an individual’s medical history or risk factors did not warrant screening, the individual was turned down."

Although new to the Philadelphia area, facilities that do CT screening have taken root elsewhere in the United States, notably in California, where the screening business began almost a decade ago. Beverly Hills alone has 11 free-standing screening facilities, notes Philip Seluchins, the Executive Director of Philadelphia LifeScans. But a close relationship exists between the practice of medicine and the regulatory bodies of individual states, and health officials in Pennsylvania were quick to act once the screening facilities opened.

In October 2001, the Pa. Department of Environmental Protection (DEP) ordered the Villanova site of HealthPrint—the company operates another facility in Haddon Heights, NJ—to cease conducting CT screens on individuals who did not have a physician referral. The order, carried out under statutory authority of the DEP, was delivered two months after the facility opened. "As soon as the order came, we complied," says Michael Ryan, M.D., a clinical cardiologist affiliated with the Cardiovascular Associates of Southeastern Pennsylvania and the medical director of HealthPrint’s Villanova facility. "HealthPrint never stopped seeing patients for a single hour," he adds.

Likewise, the DEP ordered Philadelphia LifeScans, which opened in late November 2001, to stop performing procedures on individuals who did not have a physician referral. However, unlike at HealthPrint, this facility faced an interruption of service. "Someone from DEP came in at 4 p.m. on a Friday afternoon in early February," says Howard Kessler, M.D., Chairman of the Department of Radiology at Graduate Hospital and medical director of the Philadelphia LifeScans. "At the same time," adds Kessler, "the order showed up on the DEP website and the story was picked up by the local news media the next day."

"The DEP ruling jeopardized our existence," says Seluchins of Philadelphia LifeScans. "Before the doors were closed, we were just starting to do well—we had eight patients the day they walked in and we were averaging about seven clients a day. To comply with the ruling we had to shut down for three weeks. The situation damaged our business and our credibility."

"It’s been an enormous expense having to deal with the DEP," says Kessler. "We’ve spent over $50,000 in medical expenses and legal fees dealing with them."

The third Pennsylvania-based CT screening facility, Oracle Preventative Health, opened in April 2002, after the DEP’s actions against Philadelphia LifeScans and HealthPrint had occurred. "Before we opened, we had several discussions and conference calls with DEP," says Munir Uwaydah, M.D., a surgeon specializing in diseases of the spine and the president of Oracle. "We explained our model very carefully. They approved it because they agreed that we were not using radiation for screening purposes."

The fledgling CT screening facilities in Pennsylvania operate under a different set of regulations than their counterparts in New Jersey. The HealthPrint facility in Haddon Heights, Able Imaging in Cherry Hill, and Scan for Health in Voorhees are permitted to scan patients who do not have a physician referral, although all of the facilities conduct medical and family histories of prospective patients who are under the age of forty. "Clients under forty are thoroughly evaluated beforehand by a radiologist," says Charlene Sims, director of operations at Able Imaging, adding that individuals who are 18-25 are sometimes rejected because the low likelihood of finding positive results contraindicates the risk of radiation exposure.

The DEP’s intervention at Philadelphia LifeScans and at HealthPrint provides a good case study of the symbiotic relationship between government oversight and medical practice. "No one in the state is pleased when individuals who have invested time and dollars, and are doing something they believe in, are then faced with regulatory issues that don’t seem to allow them to move forward," says Robert Muscalus, D.O., Pa. Physician General, who played an integral role in shaping the state’s regulatory policy since the inception of the CT screening facilities. "But CT scanning without physician referral encompasses safety issues, the practice of medicine issue, the issue of what is accepted medical care."

Basis of Pa. Regulations

In May 2002, the Pa. DEP, in conjunction with the Pennsylvania Department of Health (DOH), issued a public advisory against the practice of self-referral CT screening examinations—after it had already taken action against Philadelphia LifeScans and HealthPrint on this practice. "The two actions target different groups," explains Ronald Ruman, a press officer at the DEP who spoke on behalf of DEP Secretary David Hess. "DEP’s decision to order facilities to cease self-referral CT screening goes directly to groups or individuals operating such facilities. The other notice is meant to alert the public and the press about the medical community’s position on CT screening, about the DEP’s position on it, and to offer both the public and the press more information through our website."

Instrumental in the DEP’s public advisory was a recommendation from a meeting of the 14-member Radiation Protection Advisory Committee (RPAC), which operates within the DEP. RPAC issued its recommendation in March 2002 after having reviewed information from various medical societies, including the American College of Radiology, American College of Cardiology, American Heart Association, and American Lung Association. In addition, RPAC consulted the Food and Drug Administration and Pa. Physician General Muscalus, who had been making inquiries from the State Board of Medicine about the propriety of CT screening for asymptomatic patients since the facilities first appeared.

Although the RPAC recommendation figures heavily in the DEP’s public advisory, the two documents are functionally independent. "While the two certainly go hand in hand," says Ruman, "RPAC could have issued its advisory even if DEP was not handling the problem as it did, and DEP could have taken its position regardless of whether RPAC had recommended a public advisory." Still, RPAC concluded that none of the regulatory and medical organizations it consulted currently support the use of self-referral CT screening for the general public. (The position statements of these organizations can be accessed from the Commonwealth’s website: www.state.pa.us, PA Keyword: "CT Screening").

Couched within the views of the wider medical and regulatory communities, Pa. regulatory policy is a blend of two major concerns, both of which pivot on the DEP’s mandate to protect the safety and health of the public. "The arrival of the screening facilities in the Commonwealth brought to our attention two related issues," Muscalus says. "One was a safety issue about radiation exposure and the qualifications of individuals to perform and read the scans. The second issue dealt with the practice of medicine and the extent to which people can have access to certain services in the absence of a physician’s referral.

"I think that without being oversimplistic, the DEP wanted to make sure the procedure was medically necessary, that it be substantiated based on their medical history and symptoms, that it was going to be performed and interpreted by individuals who were qualified."

Given its role to oversee the use of equipment that emits radiation, the Pa. DEP drew from information provided by the FDA, which has a mandate to oversee the manufacture of radiation-emitting equipment, about the potentially dangerous levels of radiation emitted by CT scanning equipment. Concomitantly, the DEP drew from FDA conclusions about the efficacy and prudence of using CT equipment for purposes of screening asymptomatic individuals.

A report published by the FDA’s Center for Devices and Radiological Health (CDRH) states, "The dose a patient receives during a typical CT procedure is generally much larger than the radiation doses associated with most conventional x-ray imaging procedures," adding that "the particular radiation dose will depend on the size of the body part examined, the type of procedure, and the type of CT equipment and its operation." The report states that the effective dose from a whole-body CT exam "can be several hundred times that of a chest x-ray"—this on top of the fact that "estimates of the effective does from a diagnostic CT procedure can vary by a factor of 10 or more."

Concerns about radiation dosage figure heavily into the FDA’s—and the DEP’s—position about the use of CT for screening asymptomatic individuals. The CDRH report states, "Currently some medical imaging facilities are promoting a new use of computed tomography (CT). This practice, called whole-body CT scanning or whole-body CT screening, is marketed as a preventative or proactive health care measure to healthy individuals who have no symptoms or suspicion of disease. At this time the FDA knows of no data demonstrating that whole-body CT screening is effective in detecting any particular disease early enough for the disease to be managed, treated, or cured and advantageously spare a person at least some of the detriment associated with serious illness or premature death."

The report adds that the FDA has "never approved CT screening for any part of the body, for any specific disease, let alone for screening the whole body when there are no specific symptoms of disease at all."

The FDA contends that there are still not enough medical studies on the long-term efficacy of CT screening. It argues that ongoing clinical studies do not conclusively show that whole-body screening detects diseases early enough to enable efficacious treatment beyond what would occur with the use of CT scans for symptomatic individuals. Regarding CT screening that targets specific areas of the body, the FDA states that ongoing studies focus on high-risk groups for specific diseases (e.g., cigarette smokers for lung cancer). Given these data, the FDA is wary of widespread CT screening, stating that CT procedures still produce too many false positives, which only serves to heighten patient anxiety and necessitate costly and unnecessary follow-up exams.

Corroborating the views of the FDA—at least on the topic of whole-body screening—is the American College of Radiology (ACR). Its Board of Chancellors issued a statement in September 2000 that "the ACR at this time does not believe that there is sufficient scientific evidence to justify recommending total body CT screening for patients with no symptoms or a family history suggesting disease." The statement adds, "The ACR is concerned that this procedure will lead to numerous findings that will not ultimately affect patients’ health, but will result in increased patient anxiety, unnecessary follow-up exams and treatment and wasted expense."

The FDA and the Pa. DEP are aware that there have been striking technological advances in the delivery of CT procedures that may serve to allay medical fears about harmful radiation dosage. Because the essence of CT imaging is to use x-rays to obtain cross-sectional images of the body, these advances have come in the form of increasing the speed at which the CT machine takes images, thereby reducing radiation exposure. Speed has been achieved in two ways. Multislice helical scanners produced by GE, Siemens, Picker, and Toshiba are capable of imaging more than one slice of the anatomy simultaneously. The other development, called Electron Beam Tomography (EBT), uses a scanner manufactured by Imatron, which was purchased by GE in December 2001. EBT imagers use an electron beam as the x-ray source, enabling quicker image acquisition than traditional (i.e., mechanical) helical scanners. In 2001, the FDA approved EBT scanners to measure coronary plaque and accurately image the heart; it has offered no such approval for mechanical scanners. Still, the FDA maintains that no manufacturer has submitted data to support the safety and efficacy of whole-body screening.

The Pa. DEP maintains that it is open to changing its policy on screening asymptomatic individuals. The change will happen, says Muscalus, when primary care physicians and specialists begin to accept that screening for diseases in individuals who do not yet manifest high-risk factors for coronary disease, and for other diseases, becomes accepted medical practice. He notes that mammography for women over 40, which is approved by the FDA and sanctioned by the Pa. DEP, shows how and research and practice in medicine, in conjunction with government oversight, have combined to produce efficacious use of screening.

In the meantime, the DEP feels that in order to protect the public health and safety, CT screening centers will not be allowed to perform procedures on individuals who do not have a physician referral.

"It may very well be that there are certain asymptomatic or low-risk individuals who in fact should have certain screening procedures done—whether they are CT scans of the coronary arteries, total body CT scans, or other types," says Muscalus. "But that decision should be made between that person and their physician, so that the person will have a dialogue with their doctor who can tell them of their options for different kinds of exams."

"I’m not saying that these types of exams should not be done," says Muscalus, "but I’m not sure we are at a point where people can be exposed to procedures when they haven’t had the opportunity to explore other options."

Reaction from Practitioners

Health care professionals from the three Philadelphia-area CT facilities express a range of views about the implications for the delivery of medicine in the Commonwealth’s current hands-on regulatory environment.

"I like the idea of the requiring a prescription," says Ryan, medical director at HealthPrint, whose initial business was calcium scoring of the coronary arteries and which now does CT scans of the chest and total body. "The reason why is that our facility is providing a service and it’s extremely important to us that we work for and with the physicians. We’re very sensitive to point that the physician is in control of the patient’s care."

Pasquale Procacci, M.D., a clinical cardiologist with the Cardiology Consultants of Philadelphia and an investor in Philadelphia LifeScans, expresses a very different view. He says, "The DEP ruling infringes upon the freedom of choice of the citizens of Pennsylvania to avail themselves of an important kind of medical treatment. They are regulating the practice of medicine under the auspices of protecting the public from too much radiation."

Adds Selucins, Executive Director at Philadelphia LifeScans, "The DEP is not denying access [to CT scans], they are controlling the way that access is obtained."

Even practitioners who agree with the DEP ruling about physician referral point out that its regulatory stance has the potential to stifle opinion in the Pennsylvania medical community about the merits of screening. They argue that the Pa. DEP is in effect discouraging physicians from learning more about the role of CT procedures in the context of primary prevention and risk assessment, a problem that, in turn, reduces the likelihood that physicians will recommend CT procedures. In the end, all practitioners—from those who are sympathetic to the DEP to those who are not—believe that current regulatory policy is acting, to one degree or another, to thwart the diffusion of innovative medical techniques.

Uwaydah, president of Oracle Preventative Health, says, "Our facility was approved by the DEP because they agreed that we were not screening. There are some unique regulatory issues in Pennsylvania regarding the use of radiation for screening purposes and I agree that people should seek the advice of their doctors before getting a CT procedure done. But I think that their view of not allowing CT’s for screening is short-sighted because there is a strong medical case and statistics that argue against that position."

The heart of the debate involves the use of CT screening to identify for coronary artery calcification (CAC, or atherosclerosis). The classic symptom for coronary disease, explains Ryan, is chest pain. But to get to that point without having had any treatment, he says, an individual must have ignored—or never been made of—certain precursor risk factors.

Practitioners at the CT facilities say that traditional tests for heart disease, both invasive and non-invasive, miss early signs of cardiac heart disease (CHD), a problem that underscores the need for other diagnostic techniques. "Suppose you are an executive; you get a yearly executive physical and part of that exam is a stress test," says Ryan. "In order for a stress test to be positive, you must have at least one majority coronary artery with a 60 percent narrowing or obstruction. Whether it’s an exercise treadmill stress test, stress echocardiography, or stress nuclear test, that test will be normal unless you have the 60 percent narrowing in at least one artery. About 250,000 people in the U.S. drop dead every year of a heart attack, and the majority of those have narrowing of coronary arteries of less than 60 percent." According to Ryan, for 65 percent of all men and 45 percent of all women who at some time in their life develop heart disease, the first symptom is sudden death or extensive myocardial infarction requiring immediate hospital treatment.

"There are many people who die prematurely of heart attack," says Procacci. "In the past when I saw an asymptomatic patient with certain risk factors like strong family history or increased cholesterol who wanted to know their risk for heart attack, I would order a regular stress test. But a negative stress test can falsely reassure the patient and a positive stress test could force the individual into the invasive and costly types of tests that in all likelihood will not demonstrate significant obstruction of the coronary arteries."

Both Ryan and Procacci advocate the use of CT screening as part of the risk assessment process for CHD. Although both physicians are affiliated with scanning facilities—Ryan is a medical director, not an investor, at one; Procacci is an investor, not an employee, at another—each one emphazies that the medical and regulatory community should have a more accurate picture of the value of CT screening for CHD, above and beyond their interest in the financial health of their respective facilities. Only then, they say, will primary care physicians be encouraged to learn more about CT screening, a necessary condition in altering the regulatory environment toward a more postive view of these procedures.

Advocates of screening for CHD point to medical literature demonstrating that certain applications of CT are effective at complementing existing office-based risk assessment procedures. In a report published in Circulation, a team of reseachers headed by Philip Greenland, M.D., of the Department of Preventative Medicine at Northwestern University Medical School noted that Electron Beam Tomography (EBT) should be used to as follow-up test for CHD in the category intermediate risk patients. This category represents roughly 40% of the adult U.S. population and is composed of individuals who have at least one risk factor outside the positive range (e.g., the Framingham Risk Score) or a positive family history of CHD. Working in the climate of preventative health set up by the American Heart Association (AHA), they encourage the adoption of noninvasive approaches like EBT to improve or refine the risk assessment or risk reduction process.

Matthew Budoff, M.D., a clinical cardiologist at the Harbor-UCLA Medical Research Center, takes an even more proactive approach toward the use of EBT for cardiac calcuim scoring in asymptomatic (i.e., intermediate and low risk) people. In an article published in the Journal of Clinical Outcomes Management, he conducted a meta-analysis of nine studies that followed a total of 6320 persons thousands of patients over period of time averging 3.5 years. After examining studies involving EBT (he could locate no prognostic studies involving multislice helical scanners), he found that the presence of coronary artery calicification (CAC) was the strongest predictor of acute coronary events, and that EBT screening was particularly effective at detecting CAC, more so than office-based tests like the Framingham Risk Score.

"CT screening of the coronary arteries has been shown to be an accurate way to identify people who are at intermediate-to-high risk for having a problem and don’t know it," says Rose Covalesky, medical educator at Philadelphia LifeScans whose subspecialty as a Physician Assistant is in internal medicine and cardiology. (Covalesky notes that she trained with Budoff, who helped set up the EBT facility at Philadelphia LifeScans). "This is very exciting in cardiology; it’s like the world is no longer flat," Covalesky adds.

Advocate/practitioners of CT screening for CAC believe that they have the evidence to counter the prevailing views of the FDA, other medical organizations, and the Pa. DEP. They argue that because CT screening for CAC is accurate and strongly predictive of serious or life-ending cardiological events, the term "screening" should not have negative connotations. Nor, they say, should the practice of screening be discouraged.

However, there are vocal detractors about the efficacy of EBT screening for CAC. In a published statement aimed at health care professionals, the American Heart Association and the American College of Cardiology proclaim, "The majority of members of the writing group would not recommend EBT for diagnosing obstructive coronary heart disease because of its high percentage of false-positive results, which can result in additional expensive and unnecessary testing."

Practitioners at the Pa. facilities that do not use EBT—HealthPrint and Oracle both use helical scanners—cite evidence supporting the view that both types are effective at detecting CAC to the same degree, and that although helical scanners give off more radiation than EBT scanners, total output is not dangerous. "Our scanner gives radiation that is akin to a chest x-ray," states Uwaydah of Oracle, which performs from 35-40 exams a week, including heart scans and virtual colonoscopies. "The radiation output is not alarming by current standards."

Some practitioners at area CT facilities speculate that the DEP’s watchful eye is a combination of medical conservatism and a belief that the business aspect of the facilities has the real potential to trump sound medical practice. But Uwaydah notes that a business aspect permeates medical practice, in most cases under the radar of regulatory practice. Regarding the DEP’s entry into issues concerning the new CT facilities in Pa. he relates this scenario:

"A patient can go to an orthopedic surgeon thinking that they might have a herniated disk. Most orthopedic surgeons would order a set of x-rays. Traditionally, five x-rays are shot of a spine. The probability that something abnormal would show up on x-ray on patient with symptoms of a herniated disk is close to zero. But he shoots five x-rays that he knows will most likely be negative knowing that the person’s insurance will pay for five. There is so much potential abuse in the system. If you want to clean up the system, there is so much to clean up rather than fighting this new technology that has a lot of merit. There is a lot of unnecessary radiation being given to people in situations that are accepted as being completely kosher."

Similarly, Kessler says, "There’s a symbiotic relationship between the business world and the regulatory world and certainly there is need for a regulatory board regarding radiation. We made a conscious effort to get state-of-the-art-technology and we took into consideration the radiation dose that individuals would be exposed to, and the radiation dose has been documented in the medical literature about the low dose of this EBT. We have an executive board and an advisory board. We have a registered radiological technologist, a licensed Physician Assistant...there are no shortcuts here. If the DEP thinks they are acting on behalf of members of the Commonwealth, they are entitled to do that. But they’d be better off looking at the radiation dose people get in an unregulated, unlicensed tanning salon where the dose is known to be significantly higher."

Given the hands-on regulatory policy in Pa., practitioners assert that the financial and medical success of their facilities depends on educating various groups. "We have a designated person that goes to doctors offices and we invite doctors to come and see what we do," says Uwaydah. "The thrust of out marketing effort is to educate the medical community more so than the public. Certainly we also advertise to the public, but we stress advertising to the medical community."