Managed care’s participation in clinical research likely to grow

NEW YORK (Reuters Health) February 20, 2001 – In research centers across the country, a small group of mostly not-for-profit HMOs is doing the kind of work for which managed care rarely gets credit.

The work often involves meticulous studies into clinical interventions that may produce changes in practice guidelines. Other times it involves poring over existing patient data to determine best practices. Some plans are putting new drugs through their paces in hopes of identifying new promising treatments or ruling out ineffective therapies.

Many plans are particular about the kinds of drug studies they will do, avoiding trials of so-called “me-too” drugs, for example, that provide little or no new clinical benefit compared with existing medications.

But managed care’s involvement in clinical research is often overshadowed by the work of large universities and hospitals. “Very few people know, including people that should know,” said Dr. Edward H. Wagner, director of The W. A. Sandy MacColl Institute for Healthcare Innovation at Group Health Cooperative’s Center for Health Studies.

With more clinical care moving into outpatient settings and becoming better able to attract top-flight researchers, health plans are poised to become a stronger magnet for research dollars, experts said.

A number of not-for-profit plans have built fairly visible research programs that are publishing in major peer-reviewed publications, Dr. Wagner said. “In the last 4 to 5 years, it’s kind of taken off.”

Dr. Wagner noted that many health plans are beginning to realize the importance of having competent health research capacity that supports the organization’s health agenda. As an example, he cited a study by Dr. Susan Curry, a Group Health Cooperative investigator, who found that having full insurance coverage for smoking cessation services really does increase the use and effectiveness of those services.

Another example is Kaiser Permanente’s research demonstrating the effectiveness of sigmoidoscopy as a screening approach to prevent colorectal cancer. Kaiser, the nation’s largest not-for-profit managed care organization, runs what it believes to be the largest non-academic research program in the country. The Oakland-based health plan launched its research program decades ago, offering access to clinical trials as early as the 1950s.

Dr. Mary L. Durham directs Kaiser’s Center for Health Research/Northwest and Hawaii, which was begun with the goal of improving care and documenting those practices so they could be exported elsewhere. “It wasn’t to get people to join. It was to be self-critical and to improve the way healthcare was to be delivered,” she said.

“I think today the motivations are a little different,” Durham told Reuters Health.

“Today we have so many opportunities to develop the evidence for evidence-based practice that this is a very compelling reason.” There is a clear return on investment in finding ways to help people stop smoking or to improve breast cancer interventions, she said.

With so many people now receiving care through managed care plans, Durham added, there are new opportunities to deliver those treatments. Take cancer treatment, as an example. Many therapies are experimental and used to be provided primarily in hospital settings, but this is no longer the case.

Recognizing the opportunities that exist, PacifiCare Health Systems Inc., the nation’s largest provider of Medicare managed care plans, recently announced plans to seek participation in cutting-edge research of new drugs and therapies (see Reuters Health report, February 7).

PacifiCare engaged Protocare Inc., a Santa Monica, California-based consulting firm, to create clinical research centers within the managed care organization’s leading medical groups, and to expand the health plan’s ties with drugmakers.

By engaging in the phase II and phase III trials, PacifiCare hopes to gain some insight on the direction that pharmaceutical companies are headed and to give members an opportunity to participate in trials of new and innovative drugs.

“This is truly focused on delivering on our vision, on our mission, if you will, to enhance the health and security of our members,” said Bary G. Bailey, the health plan’s executive vice president and chief strategic officer.

Santa Ana, California-based PacifiCare also believes that setting up such a research infrastructure will help solidify relationships with individual doctors and physician groups that provide care to its members.

Robert E. Patricelli, a long-time managed healthcare executive and entrepreneur, sees PacifiCare’s move to establish clinical research sites as a positive one for the company. “Physicians tend to be a better direct source of recruiting patients than do health plans,” he said.

But launching a research program from scratch is no easy task, experts said. Some observers are, indeed, quite skeptical.

“The whole thing feels to me like a little bit of smokescreen groundcover for a company that has some other issues to deal with,” said one managed care executive, who asked not to be identified. “PacifiCare would have to have some sort of competitive edge to earn a margin.”

PacifiCare’s Bailey defended the company’s strategy, explaining that it chose Protocare because of its experience and expertise. “This gives us an opportunity to leap-frog ahead of others,” he told Reuters Health.

Despite the lure of pharmaceutical industry money, managed care research executives that Reuters Health spoke with say that they remain very selective about the types of trials in which they will participate.

Kaiser’s Portland, Oregon-based Center for Health Research, which also encompasses Hawaii, will receive roughly 6% of its $25 million research budget this year from drug companies, according to Durham.

Most plans still receive the bulk of their research dollars from federal funders, such as the National Institutes of Health and the US Centers for Disease Control and Prevention.

Kaiser also said that it maintains very strict policies to prevent financial conflicts of interest. Spokeswoman Laura Marshall explained that the Kaiser Foundation Research Institute acts as a “buffer zone” between researchers and payments for research. The funding goes to the Institute, not the investigator, she explained.

The kinds of drug studies that seem to appeal to health plans are ones that advance the science of healthcare delivery. Kaiser, for example, is one of the sites for a study of a drug that may actually build bone mass in women at risk of fractures due to osteoporosis.

“There’s lots of good reasons that HMOs should be involved in clinical trials,” offered Group Health Cooperative’s Dr. Wagner. “My own personal opinion is that managed care’s first obligation is to its enrollees, and if a new therapy offers a potentially significant advantage over an existing therapy and it’s a well-designed study, then I think it’s worth considering involvement in that study,” he said.