Texas Medical Association Testimony: House Bill 390
March 3, 2009
Presented by: Stan Wang, MD, JD, MPH
Texas Medical Association
Good afternoon. My name is Stan Wang, MD, and I am a practicing cardiologist from Austin Heart. On behalf of the Texas Medical Association and its nearly 44,000 members, I want to thank the chair and committee members for the opportunity to testify today.
I am here today to support House Bill 390, which addresses the obligations of insurers to provide basic ongoing care to health plan beneficiaries who have agreed to participate in clinical research studies designed to improve the care of patients who suffer from various conditions.
Clinical research provides extremely valuable benefits to patients who participate in the trials, as well as to those who do not. Patient participants usually reduce their personal costs of care because the sponsors of the research provide the study drug, lab testing, and close clinical follow-up visits for free. More important, the patients gain access to cutting-edge technology that may improve or even save their life.
As a matter of public policy, the objectives of clinical research are highly desirable. The more people participating in clinical research, the faster the clinical trials proceed, and the quicker we can have answers to important medical questions. Whether they support a beneficial treatment or tell us to stop using a potentially harmful or more costly treatment, the important answers that arise from clinical research are critical to the entire patient population. Research benefits the patients, the community, and ultimately, the insurers as well.
For these reasons, I became the primary investigator in research conducted while I was in practice in North Carolina, and still serve as adjunct assistant professor of medicine at UNC School of Medicine. I came back to Texas last summer, and now help recruit patients for clinical trials as a member of Austin Heart, a cardiology practice in Austin that is heavily engaged in clinical research.
Currently, Austin Heart is actively involved in 44 clinical studies. We have 12 full-time research staff, including eight nurses and one physician, at five locations in Central Texas. Having multiple sites has allowed more opportunities for patients, especially those from rural areas of Texas, to participate in research studies.
Advances in our field of research absolutely require human testing in patients with real diseases (not healthy volunteers or animals). These real diseases require ongoing management, regardless of the patients' participation in a study.
For example, one of our studies involves a comparison of two medications that lower cholesterol in patients with heart attacks. Some of these patients leave the hospital with the study drug, along with several other medications for conditions that are newly diagnosed in the course of the patient's care, such as medical treatments for high blood pressure and diabetes. These medications would have been covered by their health plans if the patients were not participating in a clinical trial on a cholesterol drug. Many of these medications are critical to the patients' continued health. It is important that these patients' insurers continue to provide coverage for these medications and the necessary follow-up visits for monitoring these chronic conditions outside the clinical trial.
Basically, this legislation is about making sure that patients have insurance coverage for regular health care expenses that they would have incurred even if they were not involved in research study.
Twenty-five states have passed legislation requiring health plans to pay routine medical care costs for clinical trial participants. In 2000, Medicare also recognized the benefit of ensuring participation in clinical research and provided coverage for routine health care costs to Medicare patients participating in clinical trials. However, Texas does not require insurance companies to cover routine medical care for patients participating in a clinical trial. Instead, these patients may be at risk for out-of-pocket expenses that should be covered by their insurers.
This bill should not be thought of as a "new" mandate. In reality, these are routine costs of care that already are included in the calculation of the premium by the health plans, as part of the enrollees' - my patients' - basic benefits. These dollars should be used to pay for the patients' routine medical costs when they participate in clinic research studies.
In closing, I ask Mr. Chairman and the committee members to support HB 390. The last thing my patients should have to worry about is if their insurance company is going to pay for routine medical care if they participate in a clinical trial - a trial that could save or prolong their life, or the lives of fellow Texans. Again, I want to thank you for this opportunity to speak on behalf of TMA and of the patients of Texas.