Bipartisan Clinical Trials Compensation Bill Heads to Obama for Signature

Late Monday evening, the House of Representatives cleared the final congressional hurdle for a bill that would compensate individuals who participate in clinical trials for rare diseases.

If signed by President Barack Obama, the legislation -- the Ensuring Access to Clinical Trials Act of 2015, which passed the Senate in July -- would enable those with rare diseases to receive compensation of up to $2,000 for participating in clinical trials without having the compensation be counted as income when calculating eligibility for Supplemental Security Income (SSI) and Medicaid.

The short, two-page bill would permanently allow this exclusion by making permanent the Improving Access to Clinical Trials Act of 2009, which is scheduled to expire in October.

If the bill is not signed into law, some people with rare diseases who receive SSI and Medicaid may end up not participating in clinical research because of the fear that the compensation received would make them ineligible to receive government medical benefits.

Support

In a statement, the Cystic Fibrosis Foundation celebrated the House's passage of the bill, saying it will remove barriers for clinical trial participants with rare diseases, including cystic fibrosis.

In addition to the CF Foundation, 75 patient, industry, academic and medical organizations support the Ensuring Access to Clinical Trials Act, including the National Organization for Rare Disorders, the Muscular Dystrophy Association and the industry group Biotechnology Industry Organization.

The bill was introduced by Sens. Ron Wyden (D-OR), Orrin Hatch (R-UT), Sherrod Brown (D-OH) and Edward Markey (D-MA) in the Senate, and by Reps. Lloyd Doggett (D-TX), Tom Marino (R-PA) and James McGovern (D-MA) in the House.

Text of the Bill