Bottom Line, Culture Clash Impeding Cooperation Of Managed-Care Organizations In Clinical Trials

Managed-Care Organizations In Clinical Trials RAY OF HOPE: Cancer-prevention specialist Jon Kerner says MCOs support Phase III trials in some cases. With the advent of managed-care organizations (MCOs) and their focus on cost competitiveness, academic scientists are concerned that clinical trials will suffer from decreased patient participation. MCOs, they say, have been refusing to pay for ancillary tests and procedures performed in the course of a trial that they would otherwise pay. Researchers, MCOs, and government agencies all believe that their traditional roles in clinical research must change along with the market. Meanwhile, state legislators across the United States are drafting bills that force the issue, with the aim of ensuring that patients have access to trials. MCOs claim that clinical-trial expenses are not part of their responsibility to provide cost-effective care. But some people affiliated with MCOs point out that under the right circumstances, their organizations will participate in clinical research. Many argue that the problem is a cultural conflict between the MCOs, which are looking to provide patient care in an economical and timely manner, and the academicians, who have research as well as treatment objectives. Barbara Edelman Lewis, executive director of consulting and education for Collaborative Clinical Research Inc., suggests that part of the problem in stimulating cooperation between academic medical researchers and MCOs is a lack of communication. "It just really depends on how they [the academic researchers] approach the HMO to do it [participate in a clinical trial]," says Lewis, whose Cleveland-based organization facilitates clinical trials and outcomes research for pharmaceutical companies. Lewis is the former director of research at Fallon Clinic/Community Health Plan, an HMO in Worcester, Mass. "Fallon's feeling about research, and something that has caused some tension between academic centers and Fallon," she notes, can be summed up in a simple question: "Are we a partner in this study or are we only a source of patients?" MCOs, which include health-maintenance organizations (HMOs) and preferred-provider organizations-which are groups of providers that contract to work together as a network-combine organized health-care delivery systems with financial and organizational controls to provide cost-effective health-care benefits, according to Robert Mechanic, a senior manager at Lewin Group, a Fairfax, Va.-based health-care management consulting and research firm. Mechanic coauthored a study contracted by the U.S. Public Health Service to investigate clinical scientists' claims about the increasing difficulty in enrolling patients in clinical research protocols (R. Mechanic et al., The Impact of Managed Care on Clinical Research: A Preliminary Investigation: Final Report, PHS Contract No. 282-92-0041, January 1996). Researchers from academic medical centers in seven metropolitan areas were interviewed along with medical directors at HMOs. MCOs rely on several tools to control costs that will affect clinical research, according to the report. They may deny coverage for experimental treatment, reduce patients' hospital-stay lengths, or provide reduced coverage for diagnostic tests. MCOs may have selective contracts with medical providers and may not allow participation in trials conducted at non-contract sites. They may use primary-care physicians to act as gatekeepers, determining patient referrals. Furthermore, they may create financial pressure on academic medical centers through fee negotiation. CULTURAL DIFFERENCES: HMO consultant Barbara Edelman Lewis says HMOs and academic physicians distrust each other. While most researchers interviewed for the study said that managed care had a limited impact on them, they were concerned that it would affect academic medical centers in the future. "Managed-care organizations are negotiating lower rates in competitive markets," explains Mechanic. Academic centers rely on insurers to support research, but HMOs are not working with these centers because their costs run "25 [percent] to 35 percent higher than community hospitals," he says. That added cost allows academic centers to support their research efforts. Clinical trials for testing the safety and efficacy of drugs, medical devices, or new techniques are required by the U.S. Food and Drug Administration (FDA) for drug and device approval. They are divided into four major phases. Phase I trials determine whether a drug or product is safe in humans. These tests usually enroll fewer than 100 patients. Phase II trials test for efficacy in a slightly larger group of patients. Phase III and Phase IV studies often have multiple sponsors. Phase III trials are big, multicenter, randomized-control studies that recruit thousands of people to test the safety and efficacy of the therapy within the general population. These tests take several years to complete. Phase IV trials-often called outcomes studies-investigate a product once it is on the market and may look at cost-effectiveness and quality of life. The federal government traditionally funds Phase I and Phase II trials, which often are conducted by academic medical centers. The National Institutes of Health spent nearly $1.2 billion funding clinical trials in FY 1995. However, NIH usually does not cover all patient costs, other than for treatment at small, intramural facilities. "The assumption is and the hope is [that the costs] will be borne by the third-party payer [medical insurer]," says Mary McCabe, the special assistant to the director of the National Cancer Institute's (NCI's) Division of Cancer Treatment, Diagnosis, and Centers. Such care may include laboratory tests, X-rays and scans, pharmaceuticals that are not provided free of charge, and basic medical care that is not directly part of the research or would be needed whether or not the patient were enrolled in the trial. McCabe points out that in the past, although health-care insurers may have had clauses in their contracts that excluded payment for "experimental" studies, in fact, the insurers often paid the bills. But, some say, the growth of managed care has changed that. Who is going to pay for clinical research has become, in McCabe's words, "a growing problem." To participate in some clinical trials, patients must undergo tests to ensure that they qualify for inclusion in the study. Usually, the expenses for those tests are billed to the patient's medical insurers. While researchers argue that such procedures would be necessary for any practitioner to make a diagnosis, MCOs counter that these tests are part of trials that are considered experimental and refuse payment. For example, Nunzio Pomara, director of geriatric psychiatry at the Nathan S. Kline Institute for Psychiatric Research in Orangeburg, N.Y., often requests CT scans to determine if a potential clinical-trial subject is eligible for Alzheimer's disease trials. "It's really responsible for a physician to order a CT scan . . . to exclude disorders other than Alzheimer's," he notes. He would request a CT scan to rule out a brain tumor as the cause of a patient's dementia. THERE OUGHTA BE A LAW: Pennsylvania State Sen. Roy Afflerbach has cosponsored legislation to ensure that cancer patients are included in trials. For one of his few patients enrolled in an MCO, he recalls, "a justification was required on approval for a procedure that constitutes part of the current diagnostic investigation workup." The MCO was reluctant to pay because it deemed the CT scan "experimental," although the scan would have been necessary for any other medical treatment. "To [get insurers to] pay, you have to go through a lot of hoops," laments Jones Kumi, director of specialty disease services at Detroit's Mercy Hospital and a participant in the National Institutes of Health-funded Terry Beirn Community Program for Clinical Research on AIDS. "Many managed-care plans are interested in clinical research," says Mechanic's report. But it contends they are more interested in outcomes and effectiveness research-Phase IV-than in the more preliminary research done in Phase I or II trials. "Payers argue that their responsibility to customers includes offering competitive premiums; therefore, they should only pay for proven, cost-effective clinical care," the report says. Phase I, II, and III studies are not considered "proven." Bill McGivney, vice president for clinical and coverage policy at Aetna Health Plans in Middletown, Conn., contends that Phase I and II studies "are the responsibility of the government, or the pharmaceutical or medical device companies." He notes that Aetna is currently in discussions with NCI about covering patients participating in Phase III trials. He adds, "The focus of the managed-care industry is: How can we work with NCI or the NIH to provide support to the important trials?" Jon Kerner, associate director for prevention and control at Georgetown University Medical Center's Lombardi Cancer Center, says that some MCOs have been willing to support Phase III trials, "when they think the technology that's being tested is nearly state-of-the-art." He points out that Kaiser, a conglomerate of 14 HMOs based in California, supports clinical trials in bone-marrow transplantation for breast cancer treatment, although the procedure has not yet been proved more effective than conventional breast-cancer treatment regimens. As MCOs choose which clinical trials to support, recruitment of patients is suffering, researchers report. "This year we've probably had a 20 percent drop in accruals [recruitment of patients into clinical trials] based primarily on HMOs [that refuse to participate in experimental studies]," observes Michael Foster, coordinator of clinical trials at Creighton University Cancer Center in Omaha, Neb. Currently, the Creighton cancer center is running more than 70 clinical protocols. "Randomized studies that have a placebo arm are definitely frowned upon by the HMOs," Foster states. "The HMO organizations will flatly deny any coverage for a patient who goes on a trial that is considered 'investigational.'" While randomized trials are necessary to prove a treatment's efficacy, MCOs like Aetna's still refuse to pay for patient participation. McGivney explains that "randomized, controlled trials are the gold standard" on which Aetna's policies for proven treatment are based. But in most cases, he acknowledges, Aetna will not pay for participation in these trials. "In general, Aetna does not pay for investigational technologies," McGivney states. CALLING ALL PATIENTS: Vermont's Lise MacDonald had to abandon a clinical trial for lack of participants. "Some [HMO administrators] have their ears perked up for the word 'research'" and will deny payment on that basis, maintains Lise MacDonald, clinical research supervisor in the department of orthopedics and rehabilitation at the University of Vermont, Burlington. According to MacDonald, a multicenter, FDA-approved clinical trial of a new design of spinal fixeter (a device that stabilizes unstable spinal fractures), partially supported by Howmedica Inc., an orthopedic-implant company in Rutherford, N.J., was abandoned because only 21 patients in total were enrolled at the 15 medical centers involved, including MacDonald's department at the University of Vermont. "It was projected to have 300 people enrolled," states MacDonald, who blames MCOs for the limited participation. "They won't pay because it's research," she says. "You have someone who has an unstable fracture of the spine that needs to be stabilized. The procedure isn't research." She recalls that 10 years ago, she would call medical-care providers to ask them to send patients for her groups' studies, and the patients would materialize. That no longer occurs, she contends. She rhetorically asks: "How many studies are you going to have [that] enroll 12 people? What's the value of those studies?" CHANGING TIMES: Fox Chase Cancer Center's Robert Young predicts that all Medicaid patients in his area will be enrolled in HMOs by 1998. MCOs' refusal to pay discourages or prevents specific groups or patients from joining clinical trials, scientists assert. Based on research he has done on Medicaid managed-care networks in Southeastern Pennsylvania, Robert Young, president of Fox Chase Cancer Center in Philadelphia, predicts that almost all the Medicaid recipients in that area will be enrolled in HMOs by 1998. He fears that as these networks change their stand on clinical trials, specific segments of the population that Medicaid supports-the elderly and poor-will be excluded from clinical trials. He adds that at Fox Chase, "we treat people and then go after the insurance companies later. But Fox Chase could not do that if 25 percent of its patients were on Medicaid and the Medicaid HMOs excluded coverage," Young states. Lewis explains that MCOs can be divided into three categories: those like Kaiser, which are known for their research; those that do not get involved in research at all; and, increasingly, those like Fallon Clinic/Community Health Plan, which will become involved in clinical research as long as it fits into and does not interfere with their mission of "cost-effective, timely patient care," as Lewis puts it. Lewis, who remains a research consultant to Fallon, says that Fallon's oncology and cardiology departments in particular "are very, very interested in research and are involved in a large number of clinical-trial protocols." However, she points out, the cultural differences often account for misunderstandings. She believes that "friction sometimes comes about" when an academician looks at the numbers of patients enrolled in HMOs and decides he or she wants to enroll those patients "without building a bridge"-a true partnership between the HMO and the academic institution. In an ideal relationship, planning, responsibilities, and funding for the research would be shared among the two institutions, she says. Lewis indicates that there is a degree of distrust between the world of the HMO and the world of the academic physician: "The immediate, gut feeling is that this academic person might be doing [clinical-trial research] so that he or she may have another publication." She believes that the academic must see "the managed-care organization as a potential partner . . . sort of have respect for whom [he or she is] working with." In a recent paper on clinical research and managed care, Cynthia Kirman, manager of the clinical pharmacy program at Selectcare Inc., an MCO in Troy, Mich., claimed that MCOs have their own misconceptions about research. "Decision-makers in MCOs view participation in clinical trials as a potential disruption of the core mission of providing cost-effective health care rather than as an opportunity to obtain important information," she wrote (C. Kirman, Drug Benefit Trends, 8[4]:17, April 1996). Lewis believes that MCOs will increasingly become involved in academic clinical trials. "I think that it's really important that those partnerships be developed, as more and more people get their care from managed care and more and more physicians work for managed care. You really want to study those who represent the average patient," she asserts. Her advice to academic clinical researchers: "If somebody is going to be putting in a grant to the federal government and they want to use managed-care sites, I think they ought to approach the managed-care site at the time that they're putting the proposal together." She points out that Fallon helped design a joint study with a Massachusetts-based researcher who is working with Harvard Medical School, "in such a way so that it would minimize the impact on patient care." She names some accommodations made: "Patients could be seen [for the study] at the time of an existing office visit; the appropriate staff was hired to work with nurses at the station so that the nurses would not be asked to provide any extra scheduling or to describe the study to patients." But more important, Lewis adds, is that "we got the head of physicians and nurses involved in the planning process so there was 'buy-in' into the study. This was something they were involved in and excited about; they had a voice in shaping it." Lewis suggests "learning what the system is in the managed-care organization and adapting, as much as possible, the protocol so there's synergy rather than conflict." DIFFERENT PRIORITIES: Harlem Hospital's Harold Freeman says MCOs will not support research or teaching. Some, however, view Fallon as the exception rather than the rule, although others acknowledge that the system will have to change. "Managed-care companies are driven to pay only for what they define as necessary care," states Harold Freeman, head of surgery at New York City's Harlem Hospital. "Therefore, research certainly is not in the picture of what they want to pay for, and teaching is not in the system, either." MONEYMAKERS Oregon State Sen. Bill Kennemer says MCOs are only "interested in their business." Others posit that the MCOs are in business to make money and not to provide service to society. "These people are not interested in health care. They're interested in their business," declares Oregon Republican State Sen. Bill Kennemer. Kennemer is a sponsor of the state's Patient Protection Act (Senate Bill 979), passed in 1995, which mandates that patients be informed that clinical trials and experimental care are available. "There's certainly a business end to everything that's done," acknowledges Lewis. However, she says about MCOs' interest in health care: "I think that doctors who practice in managed care are like doctors everywhere, and they're interested in the best outcomes for their patients." Some believe that legislation is the only way to ensure access to clinical trials. Pennsylvania now is working on a more encompassing law that will ensure that at least cancer patients in clinical trials will have their costs covered by their medical insurance. A bill touted as the first in the U.S. that will guarantee that insurers pay for cancer patient-care costs within clinical trials that have therapeutic intent is within legislative committee in the Keystone State. Pennsylvania State Senate Bill No. 1334 was cosponsored by Democratic State Senator Roy C. Afflerbach. According to legislative analyst Jodi Ford Firestone, who works with Afflerbach, the bill arose because the University of Pittsburgh Cancer Institute approached the head of the Senate Banking and Insurance Committee 21/2 years ago, asking for help in ensuring participation and getting payments from insurers. The bill reflects, in part, the Alexandria, Va.-based American Society of Clinical Oncology's (ASCO's) long-standing position that "high-quality clinical trials should be covered by third-party payers," says ASCO's manager of public policy, Julie Taylor. Aetna's McGivney says his concern is that such legislation will force insurers to pay for all approved trials, even some "that will draw patients away from NCI-sponsored studies." He adds: "If you're talking about an FDA-approved protocol, I don't think it's the responsibility of the managed-care industry to support the product-development costs of the major pharmaceutical and medical-device companies." Not all states, however, will necessarily jump into legislation. Alfred Goldson, chairman of the radiation oncology department at Howard University Hospital in Washington, D.C., and a member of the National Cancer Advisory Board, proposes a middle-of-the-road approach until a state passes legislation. He points out that managed-care programs already are spending money for biopsies, surgery, and radio- and chemotherapy for cancer patients. "Let's figure out a way to use those same dollars to do something different from what [MCOs] are already doing," Goldson proposes. He sees the MCOs spending their money "haphazardly" for cancer-patient treatment. He suggests that the pool of dollars allocated by MCOs for cancer-patient diagnosis, care, and treatment be used, in part, to support clinical trials in cancer within the MCOs. Aetna's McGivney believes that MCOs and academic medicine will and must cooperate. "There's a natural alliance between the academic medical centers and managed care," he explains, continuing that both groups make decisions "based on clinical scientific data." Lewis is pragmatic. "Yes, there are problems, but there are also ways around each of these problems," she says. "Working with the MCOs is the best way of getting these processes started." "American health care has to change," Goldson firmly states. He sees this as a national issue: "Either we're going to lead or we're going to follow. It's about dollars and facilities." He laments that unless the U.S. takes a stand to make sure that clinical research will continue in the country, "we may lose some of our leadership [in science]." Myrna E. Watanabe is a science writer based in Yonkers, N.Y.

Bottom Line, Culture Clash Impeding Cooperation Of Managed-Care Organizations In Clinical Trials

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