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
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."
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,"
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