Clinical Trials Also Benefit Payers
Date: June 7, 2010
Until the country’s health care reform law was passed this spring, there had been no national standard dictating how insurers should cover patients enrolled in clinical trials. The legislation now states that any group health plan has to cover the usual care for enrollees who join clinical trials.
But after years seeing colleagues battle insurers to cover patients’ participation, Daniel Ford, Johns Hopkins Medicine’s vice dean for clinical investigation, says he’d like to see coverage move from paper into practice.
“Typically, when patients come to Hopkins with cancer and we say, ‘We’d like you to join a clinical trial,’ if their health insurer tells them they won’t pay for research, patients think they can’t participate,” Ford says. “As a result, it takes us longer to enroll participants and complete these studies. But if a study isn’t done quickly, it loses its value for everyone, because treatment recommendations change so quickly in medicine.”
Section 10103 of the Healthcare Reform Law states that group health plans or insurance providers offering group or individual health coverage may not deny coverage of certain routine patient costs associated with participation in “approved clinical trials,” defined as those intended for the prevention, detection or treatment of cancer or other life-threatening diseases or conditions.
The law also prohibits health plans from discriminating against individuals for participating in clinical trials. Routine patient costs to be covered under this provision do not include investigational products such as drugs or devices, or services that are either rendered solely in connection with collecting data about the investigational product or are inconsistent with the standard of care for the condition being studied.
Insurance issues in part have led to a trend in clinical research leaving the United States.
Ford says he’s long been frustrated that telephone representatives for private insurers frequently tell patients or principal investigators they have to run clinical trial participation past their medical director first, even though for the vast majority of clinical trials, the insurers will not incur any additional costs. The added step leads to patients and providers deciding it is easier to not enroll in the studies.
By comparison, Ford notes, the Centers for Medicare & Medicaid Services has a pretty comprehensive policy regarding clinical trial coverage.
“If there is a trial considered to have clinical intent, and it has gone through some type of peer review—and they are liberal on what they consider review—they generally will pay for the usual care component of treatment,” he says. “For example, CMS will not pay for the investigational drug, but they will pay for the administration charge. Often, when you ask private insurers, they may not cover any component of the research.”
Insurance issues in part have led to a trend in clinical research leaving the United States, Ford says. In countries with one payer or more lenient rules on clinical trial participation, he says, enrollment rates are much better.
Johns Hopkins Medicine has a total 854 active clinical trials, 405 of which were started in 2009, Ford says. About half are funded commercially. While the number of trials is still increasing, enrollment rates are not necessarily following along.
In fact, almost 20 percent of sites in national clinical trials do not enroll a single person, Ford says, although in some cases the reason can be that the study involves a rare disease, a specific subset within a more common illness, or a drug that’s applicable only to patients meeting certain criteria.
Still, the results of clinical research both to Hopkins and payers are well worth it, Ford says: “We have more evidence and can make better decisions regarding treatment. We need to streamline the approvals process for patients so our clinical research has better value for all.”