U.S. Senator Richard Shelby (R-Ala.) joined Senators Ron Wyden (D- Ore.) and James Inhofe (R-Okla.) in introducing the Improving Access to Clinical Trials (I-ACT) Act. This bill allows patients with rare diseases to participate in clinical drug studies without losing their eligibility for health benefits.
“Scientists and researchers across our nation continually produce new therapies that have the potential to save the lives of countless Americans who suffer from life-threatening rare illnesses,” said Shelby. “These patients should not be forced to choose between the health benefits they desperately need and the opportunity to participate in a clinical trial that could improve their medical condition. I am confident that this legislation will open a pathway for more patients to receive life-saving treatments.”
Clinical trials generally pay a modest fee to participants for the duration of the study, about $500 on average. Under current law, this modest compensation is counted as income, and typically pushes public assistance beneficiaries’ income above the program eligibility threshold. This financial penalty prevents significant numbers of people with rare diseases from participating in clinical studies. In addition, researchers developing drugs to treat rare diseases struggle to recruit participants for clinical trials because of limited patient populations.
Specifically, the I-ACT will:
• Allow Supplemental Security Income (SSI) and Medicaid beneficiaries with a rare disease to disregard up to $2,000 of compensation received for participation in a clinical trial in their SSI and/or Medicaid income calculations.
• Increase clinical trial participation and help new therapies move quickly from the laboratory into the hands of patients who need them.