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updated 8/26/2010 8:39:08 AM ET 2010-08-26T12:39:08

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 that was being tested in a clinical trial.

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Crusoe, then 57, was approved for the trial, and he and his wife flew from their home in Pembroke Pines, Fla., to the MD 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.

Beginning in 2014, the new health law will prevent such obstacles. 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.

The problem for the Crusoes 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 in the trial, his health plan would stop covering all the other doctor visits, hospital stays, tests and treatment related to treating his cancer.

The family was 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 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.

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, say experts. More than half of states require coverage of routine costs in a clinical trial, but state requirements vary. The new health reform law sets a minimum standard.

Employers and insurers who currently 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 CEO 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 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, efficacy, 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 spokesperson 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 only be evaluating whether a drug is safe rather than testing its therapeutic value.

In addition to helping individuals get potentially life-saving 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 percent of cancer patients are eligible for cancer clinical trials, for example, but less than 5 percent 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, associate director of policy at the ACS Cancer Action Network.

© 2012 This information was reprinted with permission from KHN. Kaiser Health News is an editorially independent program of the Henry J. Kaiser Family Foundation, a nonprofit, nonpartisan health policy research and communication organization not affiliated with Kaiser Permanente.

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