New Texas Law Removes Barrier
to Clinical Trials:
Insurance
Coverage of Routine Health Services Now Required for Covered Patients Enrolled
in Clinical Trials
September 1, 2009 (Austin, TX) Effective September 1,
2009, Texas joins 27 states that require health benefit plans to cover routine
costs for patients enrolled in clinical trials such as those for cancer and
other life threatening diseases. Routine costs are medically necessary health services, such as doctor visits,
hospital stays, tests, and x-rays-- care that patients with health insurance
coverage would receive as a covered benefit even if they were not in a clinical
trial. The 81st Texas Legislature passed Senate Bill 39, and
Governor Perry signed the bill on June 19,
2009.
Clinical trials are an essential element
in the development of new, life saving therapies for patients with cancer and
other life-threatening diseases. The success of clinical trials depends on the
willingness of patients to participate. Prior to the passage of this
legislation, many Texans considering enrollment in a clinical trial may have
chosen not to do so due to concerns about losing insurance coverage.
With the passage of this new law, a
significant barrier to Texans considering clinical trials as a treatment option
is removed. Low participation rates in clinical trials prolong the drug
development process, and can delay public access to potentially effective new
treatments. Low participation rates also make it harder for researchers to
answer important questions about comparing existing treatments with new
treatments. Cancer clinical trials enrollment is generally low overall, only
around three percent of adults participate. Minorities, the elderly and
underserved communities, especially African Americans and Latinos and those
living in rural areas are particularly under-represented in clinical trials.
Armin Weinberg, PhD, Director of The
Chronic Disease Prevention and Control Research Center at Baylor College of
Medicine in Houston and co-founder of Intercultural Cancer Council recently
completed a four-year (2005-2009) research program to address problems and
solutions related to improving participation of minority and underserved
patients in clinical trials. The “Eliminating Disparities in Clinical Trials
(EDICT) Project” demonstrates that increasing awareness of and access to
clinical trials requires a systematic approach. Patients need more and better
communication to understand the risks and the benefits of trials to make
informed decisions about their option to participate. There is no silver bullet
–only by promoting change and addressing barriers at the community,
organizational, local, state and national levels will we see significant
increases in clinical trial enrollment.”
Tom Kowalski, CEO of the Texas Health and
Bioscience Institute (THBI) and President of the Texas Life Science Foundation
(TLSF), described the foundation’s plans to develop a Texas Clinical Trial
Network designed to help patients learn about and enroll into trials. “Insurance
coverage for routine care was a big barrier for many patients considering
trials,” said Kowalski. “Now, we need to continue work in Texas to address other
patient barriers to trial participation like lack of awareness, mistrust of
medical professionals, difficulty navigating the healthcare system, and
geographic access. We are developing the Texas Clinical Trial Network to
provide both technology and clinical trial navigators to help increase access to
and participation in trials, especially among underserved and minority
patients.”
Texas ranks first in
the number of cancer clinical trials in the United States
with 1,468 of 9808 open and accruing trials. Texas follows California
and New York
as the state with the third largest number of clinical trials (2,013 out of
28,472 open trials) including trials for cancer and other diseases. Continued
growth of investments in research in Texas from state, federal and private sector
sources – like those from the Texas Emerging Technology Fund and the Texas
Cancer Prevention and Research Institute – will continue to increase the number
of clinical trials opportunities for Texans.
***
Source:
Deborah Vollmer Dahlke
Project Director, TX Clinical Trial Network
Texas Life Science Foundation
dvd@TLSFoundation.org
512.699.4493
www.TLSFoundation.org
About
TLSF --Texas Life Science Foundation (www.TSFoundation.org) is a 501c (3)
nonprofit foundation focused on promoting greater understanding of Texas’ bioscience
community through the exploration of new approaches to technology and research.
Its programs include the Texas Clinical Trial Network, an innovative approach
designed to expand access, accelerate enrollment and provide education and
increased communication about clinical trials in Texas.