Texas Medical Association Testimony: Senate State Affairs Committee
March 2, 2009
Presented by: John R. Holcomb, MD
Texas Medical Association
Good morning. My name is John Holcomb, MD, and I am a practicing pulmonologist from San Antonio. On behalf of the Texas Medical Association with nearly 44,000 physicians and medical student members, I want to thank the chair and committee members for the opportunity to testify today.
I speak to you today on behalf of the Texas Medical Association in support of Senate Bill 39, which addresses the obligations of insurers to provide basic ongoing care of health plan beneficiaries who agree to participate in clinical research studies designed to improve the care of patients who suffer from various conditions.
I have been engaged in research in San Antonio for the past eight years and have participated in more than 100 research projects, a number of which have led to improvements in the care of patients with debilitating and frequently fatal diseases. I am currently participating in about 20 such studies and am the principal investigator in seven of these projects.
We draw study participants from our own patient populations, those of our practicing colleagues, and from the community. Many of our study participants suffer from a variety of chronic conditions, most of which are unrelated to the specific condition under study. For example, in our studies of subjects with asthma and emphysema, more than half of our study subjects also are troubled with other illnesses; notably, heart disease, diabetes, gastrointestinal problems, and peripheral vascular conditions. As one would expect, these conditions require ongoing management, regardless of the subject's participation in a study of an unrelated problem.
It has been our uniform experience that any complication related to and attributable to study participation is, by contract and as part of the informed consent process, the fiscal responsibility of the study sponsor. For any medical condition not related to the study, such routine medical costs are the responsibility of the individual and his or her health insurance carrier.
Routine patient-care costs are the usual costs of medical care, such as physician visits, hospital stays, clinical laboratory tests, and x-rays that one would receive regardless of participation in a clinical trial.
All of my patients - those in clinical trials and those who are not - require routine medical care, such as a basic blood pressure check, an annual cholesterol evaluation, or blood glucose monitoring.
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 and provided coverage for routine health care costs to Medicare patients participating in clinical trials. But, Texas does not require insurance companies to cover routine medical care for patients participating in clinical trials. Instead, these patients may be at risk for unnecessary and unwarranted out-of-pocket expenses.
Employers and employees pay expensive premiums to cover these costs. They should be able to use that benefit, even when participating in a clinical trial.
This should not be couched as a "new" mandate. In reality, these costs are already included in the calculation of the premium payment by the health plans, as part of the enrollees' - my patients' - basic benefits. By refusing to use that portion of the premium dollar already earmarked for these routine services, the health plan does not give the patient the full value of the health coverage purchased.
This statutory change is necessary because of the irresponsibility of a vanishingly small number of insurance carriers that have chosen to disregard their contractual responsibilities and to deny care for unrelated conditions for their beneficiaries who choose to participate in clinical research studies.
In closing, I ask Mr. Chairman and committee members to support SB 39. The last thing my patients should need 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. Again, I want to thank you for this opportunity to testify before you today.