When Richard Crusoe was diagnosed with a rare form of soft tissue cancer called liposarcoma, the retired firefighter and his family pinned their hopes of slowing the cancer's aggressive advance on a drug being tested in a clinical trial.
Crusoe, then 57, was approved for the trial, and he and his wife flew from their home in Pembroke Pines, Fla., to the M.D. Anderson Cancer Center in Houston to get the treatment. But the day before he was supposed to begin the trial last September, researchers told the Crusoes that he wouldn't be able to participate after all. The reason: His health plan refused to cover his routine medical care during the trial.
The problem wasn't the costs of the clinical trial itself: The cancer center would pay to administer the drug and analyze the results. But if Crusoe participated, his health plan would stop covering all the other doctor visits, hospital stays, tests and treatment related to his cancer.
The Crusoes were stunned. They appealed to his former employer, the City of Pembroke Pines, which provided his insurance. Like many large employers, the city pays workers' health claims directly rather than buying insurance, even though the employers often use insurance companies to administer the claims and workers may not realize that the money is coming from their employer.
More than a month later, after the family enlisted the Patient Advocate Foundation (http://www.patientadvocate.org) to fight on their behalf, the city relented and granted $250,000 in coverage. But by that time Crusoe had become too weak to participate in the trial. He died a few weeks later.
Crusoe's widow, Debbie, still lives in Pembroke Pines. She says it's hard to pass City Hall every day. The city honored him for his firefighting work, she says, but "when it comes time to save his life, they just blocked it."
Daniel Rotstein, the city's human resources director, declined to comment on the case.
The new healthcare law will prevent such problems, beginning in 2014. The law requires health plans to pay for routine care costs for patients who participate in clinical trials for the prevention, detection and treatment of cancer and other life-threatening diseases and conditions.
Routine patient care refers to the range of medical services people with a particular diagnosis might need. Although regulations will provide greater detail, it includes treatment for side effects and other medical issues that might arise as a result of the trial.
Although Medicare and many private health plans already cover such costs, some health plans decline to do so on the grounds that clinical trials are experimental, experts say. More than half of states, including California and now Florida, require coverage of routine costs in a clinical trial, though state requirements vary. The new health reform law sets a minimum standard.
Employers and insurers who decline to cover routine care in clinical trials are often concerned about their financial exposure. It's a legitimate concern, says Nancy Davenport-Ennis, founder and chief executive of the Patient Advocate Foundation. Patients in clinical trials are likely to have additional blood work, scans and tests, not to mention potentially expensive-to-treat side effects.
But other plans view clinical trials in a different light: "They see it as a way to get better results at a better cost," says Davenport-Ennis.
The new federal law applies to all individual and group health plans, whether self-funded like Pembroke Pines' or fully insured. Plans that were in existence in the spring and have "grandfathered" status under the law are exempt, but policy experts expect many of these plans to lose their special status in time.
Despite what individual plans decide to cover, the insurance industry supports coverage of routine care costs, up to a point. Clinical trials are conducted in phases that are intended to answer different questions about safety, effectiveness, side effects and the like. The new law covers care in all four phases of clinical trials.
The insurance industry supports coverage of routine care costs in the later stages of clinical trials, says Susan Pisano, a spokeswoman for America's Health Insurance Plans, a trade group. However, the industry has concerns about covering costs during a trial's earlier stages, she says, when researchers may be evaluating only whether a drug is safe rather than testing its therapeutic value.
In addition to helping individuals get potentially lifesaving treatment, advocates hope the new law will encourage broader participation in clinical trials, which are essential to developing new drugs and therapies to combat disease. Nearly 20% of cancer patients are eligible for cancer clinical trials, for example, but less than 5% enroll, according to the American Cancer Society's Cancer Action Network.
"Even the perception that costs might not be covered is enough to prevent patients from considering it," says Rebecca Kirch, the network's associate director of policy.
Kaiser Health News is an editorially independent news service and a program of the Kaiser Family Foundation, a nonpartisan healthcare policy research organization. Neither Kaiser Health News nor the foundation is affiliated with Kaiser Permanente.
For other columns in the Insuring Your Health series, see kaiserhealthnews.com.