Presidential Panel Faults Managed Care on Clinical Trials

BETHESDA, Md--The President's Cancer Panel, after nearly a year of study,has concluded that managed care overall has adversely affected clinicalcancer research, patient access to clinical trials, and physicians whoparticipate in studies.

"We believe there is a true impact on clinical cancer researchin particular," panel chair Harold P. Freeman, MD, told the NationalCancer Advisory Board.

Dr. Freeman, director of surgery, Harlem Hospital Center, New York,cited testimony from one of the panel's four public hearings on the issue:"The greatest threat to biomedical research is not a particular modeof payment, but the exploding cost of health care itself." In thiscontext, he said, managed care could play a positive role.

However, he added, "managed cost" rather than managed care,dominates the current system. Managed care's message, he said, tends torun something like this: "We will pay for the care we define as care,which might be different from how our physicians define care, and we willnot pay for research or training."

Dr. Freeman said that the presidential panel sought to determine howrecent changes in health care delivery have affected the national cancerprogram and the reduction of cancer burden on the American people. He acknowledgedthat the panel's study did not constitute strict scientific evidence, butadded, "if we wait for scientific proof of what is happening, it maybe rather late."

Findings in Six Areas

Although the panel was still finishing its final report to the WhiteHouse, Dr. Freeman described its basic findings in six areas.

Clinical research: Historical sources of funding for clinicalresearch, including premiums from Medicare, Medicaid, and private insurers,"are shifting, and, at present, there seems to be no replacement,"Dr. Freeman said. Many managed care plans deny reimbursements for servicesprovided on a research protocol.

To compensate for lost dollars, many institutions are increasing thenumber of patients they see and decreasing the amount of time providersspend with patients, Dr. Freeman said. They are also curtailing non-patientassociated costs, including training and education.

Despite decreased patient income, some institutions told the panel thatthey had not reduced their level of clinical cancer research, althoughsome have maintained their efforts by obtaining increased funding frompharmaceutical companies. Dr. Freeman fears that, in time, this trend couldlimit "the investigator-stimulated research that has been the sourceof much advance in science."

He noted that pharmaceutical companies in America "put somethingback into research," while, in general, managed care seems unwillingto help fund research "that will be to the benefit of the people beingserved and, perhaps later, to the company itself." The panel did hearof some plans that support clinical trials, "so what we are sayingis not meant to be taken as universal."

Nonetheless, the panel found virtually unanimous support for policiesthat would require all beneficiaries of clinical cancer research, "notjust managed care, but all others, even the government," he said,to share in paying for research and education costs.

Patient access to clinical trials: The panel heard testimonythat managed care organizations impede access to clinical trials by denyingreimbursement for clinical trial costs, referring patients away from certaininstitutions, requiring more paperwork, and shifting patients to generalistsrather than to oncologists, Dr. Freeman said.

Managed care plans also rarely approve entry into phase I and phaseII studies, testimony indicated, and plans are more likely to refuse patientsentry into phase III trials if the trial requires a second hospitalizationor a distinct standard of care.

"We believe these are significant issues that affect not only whetherpatients are receiving the best and most appropriate cancer care, but alsothe validity of clinical studies outcomes," he said.

Furthermore, concern was expressed to the panel that trials may becomeskewed toward those that are more easily financed, such as shorter outpatienttrials, and that important scientific questions might be disregarded.

Dr. Freeman said that managed care also appears to limit access to pediatricclinical trials, although more than 70% of pediatric cancer patients areenrolled in clinical studies. And concern exists about the access of managedcare patients to supportive cancer services, such as pain relief and hospicecare.

Clinical researchers: Many physicians appear to have less timeto participate in clinical trials because of an increased patient load,Dr. Freeman said. Those who do "must make a decision to either worklonger hours or generate less revenue by seeing fewer patients."

Ethical Challenge

Physicians are also increasingly facing the ethical challenge of maintainingtheir role as patient advocates, while contracting with managed care companiesthat may have requirements that seem to go against what the physician feelsis ethically correct.

Research institutions: Major changes confronting academic medicalcenters include changing infrastructures, in-creases in overhead costs,higher levels of unreimbursed patient care costs, and decreased patientreferrals, Dr. Freeman noted. As a result, centers are instituting newcase management systems, clinical research cost information systems, andintensified clinical trial review processes. "However," he added,"building these core resources is expensive, and with declining revenuefrom patient care, reinvestment in clinical infrastructure may be out ofreach for many centers."

Training and education: The panel heard repeated testimony aboutthe adverse affects of managed care on training and education. Some fearedfewer young investigators would seek research careers. Concerns were heardthat "it is becoming harder, if not impossible, for academic physiciansto excel as clinicians, researchers, and teachers, the so-called triplethreat type of doctor."

If this scenario persists, Dr. Freeman said, "we believe teachingwill suffer because nobody will want to pay for it."

Industry: Testimony also indicated that, under managed care,pharmaceutical and biotechnology companies are assuming a greater rolein financing trials and developing cancer therapeutics.

Although there is nothing inherently wrong with this, Dr. Freeman didnote that "according to its own representatives, industry studiescannot replace academic research, and the overreliance on this resource,we believe, would be unwise." Further reductions in investigator-initiatedresearch "could result in important questions not being asked,"he added.

Dr. Freeman concluded that "access, cost containment, and qualityof care are the competing priorities with which we are currently strugglingto achieve a balance. This balance is essential, because without qualityand successful clinical research, progress in the war against cancer willbe undermined."