Number: 111- 50
Date: September 23, 2010
House Passes S. 1674, the
Improving Access to Clinical Trials Act of 2010”
On September 23, 2010, the House passed, by voice vote, S. 1674, the “Improving Access to Clinical Trials Act of 2010”. On August 5, 2010, the Senate had passed the same bill by unanimous consent. The legislation now awaits the President’s signature to become law.
S. 1674 contains the following provisions of interest to SSA:
Exclusion of Compensation Received for Participation in Clinical Trials for Rare Diseases or Conditions
- Would exclude from income for SSI purposes the first $2,000 in compensation per calendar year provided to an individual (or spouse) who participates in a clinical trial for rare diseases or conditions1 .
- Would require the clinical trial to be reviewed and approved by an institutional review board, and would require the clinical trial to meet Federal regulatory standards for protection of human subjects.
- Would exclude from resources for SSI purposes any amount received as compensation for participation in a clinical trial that is excluded from income.
- Would take effect on the effective date of final regulations issued by SSA, or 180 days after enactment, whichever occurs earlier. The exclusion of clinical trial compensation for SSI purposes would end 5 years after the date of enactment.
Government Accountability Office (GAO) Study
- Would require GAO to conduct a study within 36 months of the enactment date to evaluate the effect of the measure on the enrollment of SSI beneficiaries in clinical trials for rare diseases or conditions. GAO would submit a report to Congress within 12 months of the study’s completion.
- The study would include an analysis of the percentage of enrollees who were SSI beneficiaries during the 3-year period prior to the effective date compared to such percentage during the 3-year period after the effective date.
- The study would also review the range and average amount of compensation provided to SSI beneficiaries and the overall ability of SSI beneficiaries to participate in clinical trials.