About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline
LOG IN
LOG IN

GAO-14-734R 1 (2014-09-09)

handle is hein.gao/gaobaaiga0001 and id is 1 raw text is: G A O U.S. GOVERNMENT ACCOUNTABILITY OFFICE 441 G St. N.W. Washington, DC 20548 September 9, 2014 Congressional Committees Clinical Trials: Little is Known about Participation by Supplemental Security Income Recipients Clinical trials can help to generate the evidence base for decision-making about the use of new treatments or drugs, and can be especially important for patients with serious or life-threatening health conditions who have limited treatment options. However, because trials are dependent upon voluntary participation from individuals who meet trial-specific criteria, successfully conducting a clinical trial can be challenging if there is a small pool of potential participants, such as individuals with rare diseases. Rare diseases generally include those affecting less than 200,000 individuals, though some such as amyotrophic lateral sclerosis (ALS) and cystic fibrosis affect far fewer individuals. As of March 2014, there were over 4,800 rare disease clinical trials in the United States seeking participants from a relatively small pool of individuals who may each choose to participate or not to participate in these trials for a variety of reasons. For example, Supplemental Security Income (SSI) recipients may be discouraged from participating if the clinical trial offers compensation that could affect their SSI eligibility and benefits, as these are, in part, based on an individual's income and available resources.1 Finding that advances in medicine depend on clinical trial research, that researchers may face challenges enrolling participants in rare disease clinical trials, and that offering payment to participants may pose a barrier to enrollment if the payments threaten participants' eligibility for SSI, Congress passed the Improving Access to Clinical Trials Act of 2009 (the act).2 The act required that the Social Security Administration (SSA) exclude up to $2,000 annually in compensation received by individuals who participate in rare disease clinical trials when determining their SSI eligibility and benefits.3 The act also mandated that GAO review the impact of this change on SSI recipients' participation in rare disease clinical trials.4 We assessed: (1) what is known about SSI recipients' participation in clinical trials for rare diseases, 1Since 1974, the SSI program, under Title XVI of the Social Security Act, as amended, has provided benefits to certain low-income aged, blind, and disabled persons-including adults and children-who meet the SSI program's eligibility requirements, including financial eligibility requirements. The SSI program was established by the Social Security Amendments of 1972 and became effective in 1974. Pub. L. No. 92-603, § 301, 86 Stat. 1329, 1465-78 (codified as amended at 42 U.S.C. § 1381-1383D. 2pub. L. No. 111-255, 124 Stat. 2640 (2010). 3SSA modified its Program Operations Manual System, effective April 3, 2011, to describe its policy and procedures for implementing the act. While this report focuses on SSI, the act also created a $2,000 exclusion for rare disease clinical trial compensation when determining an individual's income eligibility for Medicaid. Under a sunset provision in the act, the amendments that established these exclusions will be repealed on October 5, 2015. 4§ 4, 124 Stat. at 2642. GAO-14-734R Clinical Trials Page 1

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Contact us for annual subscription options:

Contact Us

Already a HeinOnline Subscriber?

Log In

profiles profiles most