U.S. medical research is the envy of the world. No other nation has produced so many life-saving and life-enhancing technologies in the past three decades.
One reason we have cured many childhood cancers and developed clot-busting heart attack drugs is because the research is well-funded with federal money and support from two important private industries: health insurers and drug companies. Now, health insurers want to take their money off the table.
The health insurance industry, including managed care plans such as health maintenance organizations, no longer wants to pay to have patients treated in medical research called clinical trials.
Clinical trials are studies where new treatments, such as a new drug for cancer that is not yet approved by the Food and Drug Administration, are compared with treatments that are already in use. Clinical trials offer patients the most advanced treatment available. In diseases such as cancer and AIDS, they frequently are a patient's last chance.
The insurance industry's turnabout is a dramatic shift in philosophy because the industry used to pay for clinical trials. But now, cost pressures in competitive managed care markets have led to cost-cutting. If there is less financial support for clinical trials, we will have fewer studies, fewer new treatments and a lot less knowledge about which medical practices are best.
The change in insurers' thinking is purely financial, and it attempts to shift to the federal government and drug companies costs that insurers once covered. Financial support for clinical trials comes in two parts.
First, there are costs to run the study. These include the costs of the drugs being studied, diagnostic tests related specifically to the research and costs related to administering the trial (for example, gathering and analyzing patient data). Government agencies, such as the national Institutes of Health (NIH), or drug companies pay for this. No one is asking insurers to pick up any of these costs.
The second group of costs are routine patient care costs, which include doctor visits, nursing care, hospital stays and laboratory tests. Patients in clinical trials receive these routine medical services regardless of whether they get the new, unapproved drug or the drug already in use.
Also, patients get this routine care if they are not in a clinical trial, in which case the insurer will pay for it without question. Thus, routine patient care costs to insurers are the same whether or not patients are in the clinical trial.
Many insurers now say that if a patient is in a clinical trial, someone other than the insurer should pick up the routine patient costs. This is ironic, given that insurers will pay for equally costly -- and potentially less effective -- care if the patient is not enrolled in a clinical trial.
Insurers have everything to gain by supporting clinical trials.
Clinical trials provide valuable information on new treatments that can save lives or improve quality of life. Clinical trials not only collect and analyze medical data, they also gather information on the costs of alternative treatments. Thus, clinical trials identify therapies that are cost-effective, letting patients -- and their insurers -- get the greatest value for the dollars spent.
For example, clinical trials of the oral drug tamoxifen showed that certain patients with breast cancer do better when this medication is taken for five years after surgery instead of 10 years. Consequently, medication costs for many breast cancer patients will decrease by 50 percent.
Another clinical trial showed that widespread screening for lung cancer, using chest X-rays and sputum analysis, is medically futile and financially wasteful.
There is movement toward a broader recognition of the importance of financial support for patient care costs in clinical trials.
For example, other states are considering legislation similar to that recently proposed in Maryland, and Rhode Island already requires coverage of some clinical trials. Nationally, the Departments of Defense and Veterans Affairs have just concluded agreements with the NIH to give military personnel and veterans access to care in clinical trials.
The Health Care Financing Administration (which runs Medicare and Medicaid), in conjunction with NIH, is sponsoring a clinical trial involving lung-reduction surgery for patients with advanced lung disease.
Finally, two senators plan to introduce a bill in Congress that will require the Medicare program to cover the patient care costs of Medicare recipients for care in clinical trials.
This legislative session, the Maryland General Assembly defeated a House Bill 230, sponsored by Del. Carolyn J. Krysiak, which would have required insurers to pay for routine care provided to patients who are treated in selected clinical trials.
The principles embodied in HB 230 will resurface, however. The Baltimore Democrat and other of the bill's supporters clearly understand what opponents of insurance coverage of clinical trials do not: Insurance coverage for routine patient care costs in high-quality trials guarantees patients access to cutting-edge therapy, advances medical knowledge that enhances care, saves money and does this at no additional cost to health insurers.
Vikram Khanna is a health policy consultant with State Health Policy Solutions, L.L.C. and Henry Silverman, M.D., is a professor of medicine at the University of Maryland.
Pub Date: 4/06/97