Senators Introduce Bipartisan Amendment to Expand and Protect Access to Clinical Trials

Proposal Would Protect Patients' Health Care Coverage While an Individual is Enrolled in Clinical Trials

WASHINGTON, D.C. – U.S. Sens. Sherrod Brown (D-OH) and Kay Bailey Hutchison (R-TX) announced a bipartisan amendment to the health reform bill which would protect access to clinical trials for patients with life-threatening diseases. The amendment would prohibit insurers from dropping a policyholder’s coverage if the patient chooses to participate in a clinical trial and from denying coverage for routine care that the plan would otherwise provide. The amendment is cosponsored by Sens. Al Franken (D-MN), Sheldon Whitehouse (D-RI), Arlen Specter (D-PA), Benjamin Cardin (D-MD), and Bernie Sanders (I-VT).

 “Americans with life-threatening diseases should be able to spend time fighting their illnesses, rather than battling insurance companies,” Sen. Brown said. “This amendment prevents insurance companies from denying patients’ access to routine medical care just because they are enrolled in a clinical trial. If we’re going to make medical breakthroughs, we need to encourage participation in clinical trials, not put up barriers. Patients with chronic conditions should not have their health coverage jeopardized if they choose to enroll in a potentially life-saving trial.”

Video footage of Brown speaking on the Senate floor in support of the amendment can be found HERE (footage takes a few moments to load).

“Maryland’s facilities, including Johns Hopkins, the University of Maryland, and the National Institutes of Health, are home to the world’s leading medical researchers.  For many patients with serious illnesses, clinical trials are their only hope.  They should not be denied the benefits of cutting-edge therapies and treatments because an insurance company refuses to pay for routine costs, such as laboratory services.” Sen. Cardin said. In 2000, as a member of the House Ways and Means Committee, Cardin led the bipartisan effort to secure Medicare coverage for routine patient costs associated with federally-funded or reviewed trials.  

“I am pleased to join Senator Brown in cosponsoring this amendment,” Sen. Specter said.  “Clinical trials are vital to advancing research on treatments and cures to serious illnesses that affect so many Americans, and patients should be able to access these trials without having their insurance company reduce or limit their coverage.”

Clinical trials often offer cutting-edge therapies that are not available through traditional methods. These experimental treatments save lives and advance research. However, many health insurance policies discourage enrollment in these trials by refusing to cover trial participants’ routine health care, those basic services unrelated to the trial and justly owed to the premium-paying policyholder. According to The Ohio State University’s Comprehensive Cancer Center, an estimated 20 percent of patients who attempt to enroll in clinical trials are denied coverage by their insurance. These patients are often prevented from exploring clinical trial options because they risk losing health care coverage for routine services like X-rays, blood tests, and doctor visits.

Low participation rates in clinical trials undermine research and medical advancements. Only about two percent of Americans participate in clinical trials annually and only six percent of people who suffer from severe, chronic illnesses enroll in trials. These low participation rates make it harder to conduct timely trials. In fact, delays in patient recruitment for clinical trials account for an average of 4.6 months lost per trial. Nearly 80 percent of trials run over schedule by more than a month, and only six percent are completed on time.

Brown and Hutchison’s amendment (#2871) is modeled on existing Medicare policy and on more than 30 state laws and regulations that already guarantee patient access to clinical trials. Amendment 2871 would apply to all insurance products, including those offered in the Federal Employees Health Benefits Program, and to all clinical trials that treat cancer or other life-threatening diseases. Brown introduced similar legislation, the Cancer Clinical Trials Act, in February 2009.

The following states have existing policies which protect patients enrolled in clinical trials.

Illinois – law expired
Michigan – cooperative coverage agreement
New Hampshire
New Jersey – cooperative coverage agreement
New Mexico
New York – expedited appeals process, not a requirement
North Carolina
Rhode Island
Washington, DC
West Virginia

The following organizations have endorsed the amendment:

Alliance for Childhood Cancer
Alzheimer’s Foundation of America
American Academy of Pediatrics
American Association for Cancer Research
American Cancer Society Cancer Action Network
American College of Radiology
American Psychosocial Oncology Society
American Society for Radiation Oncology
American Society of Clinical Oncology
American Society of Hematology
American Society of Pediatric Hematology & Oncology
American Thoracic Society
Association Clinical Research Organizations
Association of American Cancer Institutes
Association of American Medical Colleges
Association of Pediatric Hematology/Oncology Nurses
Association of Pediatric Oncology Social Workers
Bladder Cancer Advocacy Network
Breast Cancer Network of Strength
C3: Colorectal Cancer Coalition
Cancer Care
Cancer Support Community
Candlelighters Childhood Cancer Foundation
Chai Lifeline
Children’s Brain Tumor Foundation
Children’s Oncology Group
City of Hope Comprehensive Cancer Center
Cleveland Clinic
Coalition of Cancer Cooperative Groups
CureSearch Childhood Cancer Foundation/HopeStreet Kids
Dana-Farber/Brigham and Women’s Cancer Center/Massachusetts General Hospital Cancer Center
Duke Comprehensive Cancer Center
Education Network to Advance Cancer Clinical Trials (ENACCT)
Fox Chase Cancer Center
Fred Hutchison Cancer Research Center/Seattle Cancer Care Alliance
Friends of Cancer Research
Gateway for Cancer Research
H. Lee Moffitt Cancer Center & Research Institute
Huntsman Cancer Institute at the University of Utah
International Cancer Advocacy Network
International Myeloma Foundation
Kidney Cancer Association
Lance Armstrong Foundation
Lymphoma Research Foundation
Memorial Sloan-Kettering Cancer Center
Multiple Myeloma Research Foundation
National Association of Social Workers
National Coalition for Cancer Research
National Coalition for Cancer Survivorship
National Comprehensive Cancer Network
National Lung Cancer Partnership
National Marrow Donor Program
National Patient Advocate Foundation
Nevada Cancer Institute
North American Brain Tumor Coalition
Oncology Nursing Society
Ovarian Cancer National Alliance
Pancreatic Cancer Action Network
Pediatric Brain Tumor Foundation
Prevent Cancer Foundation
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Roswell Park Cancer Institute
Sarcoma Foundation of America
Siteman Cancer Center at Barnes-Jewish Hospital and Washing University School of medicine
Society of Gynecologic Oncologists
Society of Nuclear Medicine
St. Jude Children’s Research Hospital/University of Tennessee Cancer Institute
Stanford Comprehensive Cancer Center
Susan G. Komen for the Cure Advocacy Alliance
The Children’s Cause for Cancer Advocacy
The Leukemia & Lymphoma Society
The Lustgarten Foundation
The National Children’s Cancer Society
The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
The United Mitochondrial Disease Foundation
The University of Texas M.D. Anderson Cancer Center
The Wellness Community
UCSF Helen Diller Family Comprehensive Cancer Center
University Hospitals Ireland Cancer Center
University of Alabama at Birmingham Comprehensive Cancer Center
University of Michigan Comprehensive Cancer Center
UNMC Eppley Cancer Center at The Nebraska Medical Center
Us TOO International Prostate Cancer Education and Support Network
V Foundation for Cancer Research
Vanderbilt-Ingram Cancer Center


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