When the critics of managed care gather to share horror stories, a standard tale is the breast cancer patient whose health plan refused to pay for a bone marrow transplant that might save her life. It's a heart-wrenching story, one that for the past decade has been heard in courtrooms and statehouses across the country.
Advocates for treatment of breast cancer with high-dose chemotherapy with autologous bone marrow transplantation or peripheral blood stem support (HDC-ABMT) forced many, if not most, health plans to reimburse providers for that expensive and unproven treatment.
Yet last spring, the cause suffered a stunning blow as four prospective, randomized comparisons of the treatment against standardized chemotherapy--including one study begun in 1990--demonstrated that patients treated with HDC-ABMT fared no better than patients treated with standard chemotherapy. Earlier this year, the lone researcher whose controlled study indicated that HDC-ABMT was more effective admitted that he falsified his data. In the weeks after that announcement, at least one major managed-care company said it would no longer cover HDC-ABMT for breast cancer.
The reaction to these startling revelations has been surprisingly subdued. Rather than silently consign this treatment to the Museum of Questionable Medical Devices (yes, there is such a place in Minneapolis), the critics and supporters of managed care should examine what went wrong in the debate over HDC-ABMT for breast cancer. The failure to learn from the mistakes of the past decade will doom medical researchers, managed-care companies and the courts to repeat them as soon as the next "promising" treatment for breast cancer, AIDS or any other politically charged disease comes along.
Hijacking healthcare policy. A movement of dedicated, angry and understandably impatient breast cancer sufferers and their advocates wrested control of the medical debate from the medical experts. By the mid-1980s, researchers had proven that intensifying the doses of chemotherapy prolonged the lives of people suffering from leukemia and lymphoma. Preliminary studies of patients with solid cancers such as breast cancer were encouraging. Rather than allow randomized clinical trials to provide definitive answers about the benefits of the treatment for breast cancer patients, advocates prematurely forced managed-care companies to reimburse for the treatment.
Seemingly every breast cancer sufferer wanted to forge ahead with the highly experimental treatment. Few wanted to volunteer for a clinical trial and risk receiving standard chemotherapy. Yielding to that understandable preference proved self-defeating for the medical research community as necessary clinical trials--which would eventually show the two therapies result in equal rates of survival--were starved for participants and unnecessarily delayed. The huge sums of money spent on treating patients outside of the trials produced useless data, so the consequence of allowing a political movement to dictate healthcare policy was a waste of precious time and money.
The breast cancer movement is, undeniably, political. "Breast cancer activism and politics are joined at the hip," said Geri Barish, executive director of "1 in 9: The Long Island Breast Cancer Action Coalition," after being criticized for making a political attack ad for Texas Gov. George W. Bush's presidential campaign before the New York GOP primary in March. But politicization of the movement isn't only a recent phenomenon. Advocates of HDC-ABMT lobbied hard and effectively on Capitol Hill and in state legislatures throughout the 1990s.
Advocates for the treatment also brought their emotional cause to the courts. No pattern or overarching theme emerged as courts found for and against insurers that denied coverage for the treatment depending on the language of the policies. In the first wave of cases that were decided against insurers, the rulings were based on health plans' failure to sufficiently define the experimental treatment exclusion in the policy or reserve interpretation of that exclusion to the insurance company. After insurers corrected those policy defects, some courts found a way around them. By finding that the insurer's financial interest in denying coverage conflicted with the interests of their insureds, the courts refused to defer to the insurer's interpretation of the policies and were able to pick and choose from conflicting evidence to justify and order reimbursement. Most often that evidence was the testimony of the referring oncologist and the research center physician who agreed to provide the treatment on the condition that the court order the insurer to pay for it.
Once researchers testified that HDC-ABMT was something other than experimental, university research centers lost control over the treatment. Payment for the long stays in intensive care during restoration of the immune system offered a significant revenue stream to hospitals providing the treatment.
Personal-injury lawyers also benefited. In 1993, a California jury awarded $89 million to the family of a breast cancer patient whose insurer denied coverage for HDC-ABMT. Although the case was later settled for less, that huge verdict sent shockwaves through the health insurance industry. The fear of large damage awards and horrible publicity might have influenced the decision of many other insurers to cover the treatment.
The better part of the 1990s was wasted arguing about the effectiveness of one of the most punishing treatments in modern medicine. The major difference between the standard and experimental treatments--other than the price--is the side effects of high-dose chemotherapy. Besides attacking the cancer, the drugs also destroy the patient's bone marrow and, thereby, the body's ability to produce new blood cells needed to maintain its immune system. The theory was that the patient could withstand otherwise lethal chemotherapy so long as her bone marrow was replenished after treatment. In practice, high doses of chemotherapy produce a chemical burn throughout a patient's gastrointestinal tract from mouth to rectum that leaves the patient in agonizing pain. The destruction of the immune system leaves the body susceptible to a myriad of devastating and potentially fatal contagions. In short, the treatment sometimes killed the patient before the cancer did.
A role for managed care. We need to avoid wasting even more precious time and money as we fight breast cancer and other politically charged diseases. Medical research must be allowed to run its course to definitive answers before new punishing or expensive treatments are widely disseminated. Rather than present an obstacle to medical innovation, managed care can be the catalyst for advancement. The proactive measures developed by managed care should be applied to experimental treatments.
Although health plans are entitled to exclude such coverage in the plain language of their policies, the better long-term solution is for managed-care companies to take the lead in research by agreeing to fund randomized clinical trials of experimental treatments; refusing to fund experimental treatments outside those trials; and demanding access to data produced through the trials. Funding experimental treatment will give managed care the opportunity to do what it does best--eliminate inefficient and ineffective treatments by evaluating care rendered by healthcare providers.
In exchange for funding clinical trials, managed-care companies should receive full and immediate access to all data generated. Health plans are as qualified as university professors to perform statistical analysis. Moreover, dissemination of information will increase accountability, productivity and integrity in medical research. The next major clinical trial should not take nine years to report any data. Nor should researchers be able to cover up treatment failures or falsify data.
To ensure that future randomized clinical trials can attract enough participants, health plans should fund experimental treatments only in qualified clinical trials. Referring oncologists shouldn't be able to guarantee that their patients will get the promising treatment under investigation rather than be randomized to the standard treatment arm of a study. However, legislation is needed to make managed-care companies participating in clinical trials immune from liability for refusing to pay for treatment outside of clinical trials. The trend is otherwise. Many of the Patients' Bill of Rights proposals before Congress would gut the existing pre-emption of lawsuits against employer-sponsored plans for damages resulting from denial of coverage.
By leading the charge for a cooperative effort on the funding of experimental treatments, managed care will not only avoid repetition of catastrophes such as HDC-ABMT for breast cancer but also enhance its reputation and eliminate the false perception that managed care is an enemy of the terminally ill. Moreover, it would offer the best odds of finding truly effective treatments as quickly as possible.