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Presidential Panel Faults Managed Care on Clinical Trials

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 clinical cancer research, patient access to clinical trials, and physicians who participate in studies.

"We believe there is a true impact on clinical cancer research in particular," panel chair Harold P. Freeman, MD, told the National Cancer 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 mode of payment, but the exploding cost of health care itself." In this context, 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 to run 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 will not pay for research or training."

Dr. Freeman said that the presidential panel sought to determine how recent changes in health care delivery have affected the national cancer program and the reduction of cancer burden on the American people. He acknowledged that the panel's study did not constitute strict scientific evidence, but added, "if we wait for scientific proof of what is happening, it may be rather late."

Findings in Six Areas

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

Clinical research: Historical sources of funding for clinical research, 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 services provided on a research protocol.

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

Despite decreased patient income, some institutions told the panel that they had not reduced their level of clinical cancer research, although some have maintained their efforts by obtaining increased funding from pharmaceutical companies. Dr. Freeman fears that, in time, this trend could limit "the investigator-stimulated research that has been the source of much advance in science."

He noted that pharmaceutical companies in America "put something back into research," while, in general, managed care seems unwilling to help fund research "that will be to the benefit of the people being served and, perhaps later, to the company itself." The panel did hear of some plans that support clinical trials, "so what we are saying is not meant to be taken as universal."

Nonetheless, the panel found virtually unanimous support for policies that would require all beneficiaries of clinical cancer research, "not just 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 testimony that managed care organizations impede access to clinical trials by denying reimbursement for clinical trial costs, referring patients away from certain institutions, requiring more paperwork, and shifting patients to generalists rather than to oncologists, Dr. Freeman said.

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

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

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

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

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

Ethical Challenge

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

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

Training and education: The panel heard repeated testimony about the adverse affects of managed care on training and education. Some feared fewer young investigators would seek research careers. Concerns were heard that "it is becoming harder, if not impossible, for academic physicians to excel as clinicians, researchers, and teachers, the so-called triple threat type of doctor."

If this scenario persists, Dr. Freeman said, "we believe teaching will 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 role in financing trials and developing cancer therapeutics.

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

Dr. Freeman concluded that "access, cost containment, and quality of care are the competing priorities with which we are currently struggling to achieve a balance. This balance is essential, because without quality and successful clinical research, progress in the war against cancer will be undermined."

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