E4 Health


INSURING YOUR HEALTH Michelle Andrews


Law gives new rights to patients in clinical trials


W


hen 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 advance on a drug that was 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 MD Anderson Cancer Center in Houston to get the treatment last September. But the day before he was supposed to begin the trial, researchers told the Crusoes that he wouldn’t be able to participate after all. The reason: His health plan was refusing 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 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 Crusoes were stunned.


They appealed to his former employer, the city of Pembroke Pines. Like many large employers, the city pays its workers’ health claims directly rather than buying insurance. (Because such employers often use insurance companies to administer claims, workers may not realize that the payments are coming from their employer.) More than a month later, after the family enlisted the Patient Advocate Foundation to fight on its 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 her husband 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 federal health law


will prevent such disputes, beginning in 2014. The law requires health plans to pay the routine care costs of patients who participate in clinical trials for the prevention, detection and treatment of cancer and other life-threatening conditions. Routine patient care refers


to the range of medical services people with a particular diagnosis might need. 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 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 law sets a minimum standard.


Employers and insurers


that 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 side effects that may be expensive to treat. 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 as at Pembroke Pines or fully insured. Plans that were in existence when the law was signed this spring and have “grandfathered” status under its provisions are exempt, but policy experts expect many of these plans to lose their special status over time. Despite cases like Richard


Crusoe’s, the insurance industry generally supports coverage of routine care costs, up to a point. Clinical trials are conducted in four phases, adding more patients in each round; they are intended to answer different questions about safety, efficacy, side effects and the like. The new law covers care in all phases. The industry supports


coverage of routine care costs in late-phase clinical trials, says Susan Pisano, a spokeswoman for America’s Health Insurance Plans, a trade group. However, it has concerns about covering costs during early-phase trials, she says, when researchers may 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. Nearly 20 percent of cancer patients are eligible for cancer clinical trials, for example, but fewer 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, the network’s associate director of policy.


This column is produced through a collaboration between The Post and Kaiser Health News. KHN, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health-care-policy organization that is not affiliated with Kaiser Permanente.


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times higher than previous esti- mates. Other studies show MRSA rates on the decline, partly be- cause hospitals have worked to reduce them. (A study published this month in the Journal of the American Medical Association showed a 28 percent decrease in all hospital-onset, invasive MRSA infections over the four- year period from 2005 through 2008.) “In many areas, C. diff is the number one hospital-acquired infection,” said Kevin Kavanagh, a Kentucky physician who runs a patient advocacy organization called Health Watch USA. Amajor reason for the surge in cases, doctors said, is the overuse and inappropriate use of antibi- otics; Miller pointed particularly to the prescription of more broad-spectrum antibiotics that work against C. diff, including Ci- pro, for problems such as urinary tract infections that could be treated with drugs designed for a narrower spectrum of bacteria. He said another driver is the in- creased use of alcohol-based hand sanitizers, which don’t kill C. diff spores, instead of soap and water, which does. Hospital offi- cials across the nation say they are working on these issues as they beef up infection control by paying attention to keeping their facilities clean, isolating patients affected by C. diff and ensuring that doctors and nurses wash their hands. But Kavanagh argues that more must be done, and he says public reporting of C. diff rates would speed things along. In the meantime, the problem continues to escalate. Carmody, who used to work for the Office of Naval Intelligence, said he con- tracted C. diff after being treated in a hospital and then a rehab center for a MRSA bladder in- fection; he developed the infec- tion after a catheter to drain his urine was replaced. He surmises that antibiotics used to treat the first infection helped bring on the second because the medica- tion killed off other bacteria in his body but didn’t work against C. diff, allowing it to grow. These days he asks more questions when doctors prescribe antibiot- ics and makes sure health-care workers wash their hands with soap and water before touching him. “You’ve got to be vigilant,” he said.


A growing danger


The C. diff strain was discov- ered in 1935 and first associated with disease in 1978. But it has grown more dangerous in recent years, with the CDC in 2004 re- porting a new, more virulent strain with the ability to produce greater quantities of certain tox- ins. Recent studies have also cit- ed cases in which C. diff bacteria were resistant to Flagyl, a com-


Clostridium difficile, or C.


diff, is a bacteria strain that can cause diarrhea, more-se- rious intestinal conditions such as colitis, and sepsis, or bloodstream infection. In 1 to 2.5 percent of cases, C. diff in- fection is deadly. The typical symptoms of C.


diff disease are watery diar- rhea (at least three bowel movements per day for two or more days), fever, loss of appe- tite, nausea and abdominal pain or tenderness. Signs of more-se- vere cases may in- clude watery diar- rhea 10 to 15 times a day, severe abdominal cramping and pain, blood or pus in the stool, dehydration and weight loss. The ailment is often associ-


ated with hospitalization and antibiotic use; the elderly and people with illnesses or con- ditions requiring prolonged use of antibiotics are at great- er risk. The bacteria are found in the feces, and people can become infected if they touch items or surfaces that are contaminated with feces and then touch their mouth or the inside of their nose. Health-care workers can spread the bacteria to other patients or contaminate sur-


faces through hand contact. C. diff infections are gener- ally treated for 10 days with antibiotics. Although some cases are resistant to treat- ment, generally effective anti- biotics include metronidazole (Flagyl) and vancomycin (Vancocin). Some studies sug- gest that 20 percent of suc- cessfully treated patients can experience a relapse of colitis, but certain probiotics, or “good bacteria,” such as Saccharomyces boulardii, may be helpful against repeat C. diff in-


fections. The best way to


prevent the spread of C.


diff is by washing hands with soap and water, especially af- ter using the restroom and before eating, and by clean- ing surfaces in bathrooms, kitchens and other areas on a regular basis with household detergents and disinfectants. In health-care settings, re- mind doctors and nurses to wash their hands before and after caring for you or a fami- ly member.


— Laura Ungar


SOURCES: Centers for Disease Control and Prevention, MayoClinic.com, American Academy of Family Physicians


KLMNO


TUESDAY, AUGUST 24, 2010


“I hadn’t heard of C. diff. But there it was, eating its way through me.” David Carmody, who developed a serious infection at a rehabilitation center


antibiotics to target particular germs and using a bleach solu- tion to clean in patient rooms and other areas as recommended by federal health officials. Inova has also increased enforcement of standards for hand-washing and the use of gowns by health- care workers; “safety coaches” observe their colleagues and re- mind them of the rules. Still, Morrison said he doesn’t


expect C. diff to disappear any- time soon, given that the popula- tion is aging and the elderly are at high risk for the infection. “A victory could be declared if the rates are stable,” he said. Although some patient-safety groups believe that one of the best tools for reducing infection is to force hospitals to report their infection rates, Morrison opposes the idea. Echoing offi- cials at many hospitals, he said facilities keep C. diff data differ- ently, making comparisons diffi- cult and potentially unfair. But Health Watch’s Kavanagh disagrees. He is one of several safety advocates joining the Con- sumers Union’s Safe Patient Proj- ect in supporting a new federal effort, scheduled to begin in 2012, that will tie hospital Medi- care payments to how well those facilities protect patients from C. diff and other hospital-acquired infections. In June, the organizations sent


mon antibiotic. The C. diff strain normally lives harmlessly in the human di- gestive system but can grow out of control when the body’s deli- cate bacterial balance is disrupt- ed, such as when antibiotics that don’t kill C. diff wipe out its com- petition. Besides sickening the patient, the germ can spread out- side the body through feces and live for a long time on objects and surfaces in hospitals, doctors’ of- fices and nursing homes. According to the American Academy of Family Physicians, the C. diff germ has been cul- tured from bed rails, floors, toi- lets and windowsills, and it can remain in hospital rooms for up to 40 days after infected patients have been discharged. Health- care workers can hasten the spread. One study found C. diff on the hands of almost 60 per- cent of doctors and nurses caring for infected patients — a percent- age experts said could be reduced dramatically if they washed their hands thoroughly with soap and water between patients. Many hospitals have begun to step up efforts to fight C. diff. A poll this year of 1,800 mem-


bers of the Association for Pro- fessionals in Infection Control and Epidemiology showed that 53 percent of respondents had adopted additional measures in the previous 18 months to pre- vent and control C. diff. More than eight in 10 respondents said their hospitals have hand hy- giene programs, including unan- nounced observations. Nearly all said they always isolate C. diff pa- tients and use gowns and gloves while caring for them. And 63 percent said they use both alco- hol sanitizers and soap and water to keep their hands clean. But the poll found room for improvement. While hospital cleaning programs have in- creased, the poll said, monitoring hasn’t kept pace. And patient education lags; only half of re- spondents said they educate pa- tients about C. diff. Allan Morrison, a hospital epi- demiologist for the Inova Health System in Falls Church, said In- ova has attacked the problem on many fronts: by isolating infec- ted patients, not over-prescrib- ing antibiotics for problems that would be appropriately treated in other ways, using the correct


a letter to the Centers for Medi- care and Medicaid Services urg- ing the adoption of proposed reg- ulations that would require all U.S. hospitals to report how many patients develop certain infections during treatment. Those regulations, required un- der the new health-care law, are being developed as part of the Department of Health and Hu- man Services’ five-year plan to reduce hospital infections. Kavanagh said this measure would add an economic incen- tive for hospitals to keep up the fight. From Cameron Flick’s point of


view, anything that makes it harder to get C. diff would be worth it. Flick, 90 and from New Albany, Ind., received a C. diff di- agnosis in March 2009 after be- ing treated at a doctor’s office for pneumonia. His wife, Ruby, said the infection landed him in an emergency room four times. Flick suffered from severe di- arrhea, stomach pain, nausea and fatigue for months, lost 20 pounds and spent most days ly- ing on his recliner. “I felt excruci- ating pain sometimes,” he re- called. “I wasn’t able to do any- thing. The least little thing wore me out.” More than a year later, he said his energy still hasn’t returned. “It just about did me in,” he said. health-science@washpost.com


Ungar is the medical reporter for the Courier-Journal in Louisville and has been a journalist for 20 years.


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