[Congressional Record Volume 155, Number 130 (Tuesday, September 15, 2009)]
[Senate]
[Pages S9379-S9380]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. WYDEN (for himself, Mr. Dodd, Mr. Shelby, and Mr. Inhofe):
  S. 1674. A bill to provide for an exclusion under the Supplemental 
Security Income program and the Medicaid program for compensation 
provided to individuals who participate in clinical trials for rare 
diseases or conditions; to the Committee on Finance.
  Mr. WYDEN. Mr. President, I come here today to introduce the 
bipartisan Improving Access to Clinical Trials Act. I would like to 
begin by thanking my friend Congressman Edward Markey for introducing 
this legislation in the House. I also want to thank Senator Dodd, 
Senator Shelby and Senator Inhofe for cosponsoring this legislation. I 
would also like to thank the Cystic Fibrosis Foundation for bringing 
this issue to my attention.
  The legislation I am introducing today is important because it would 
give people who are eligible for Social Security Income and Medicaid 
the same access to clinical trials as those who are more financially 
fortunate. Currently, those with rare diseases, such as Cystic Fibrosis 
and Tuberous Sclerosis rely on clinical trials as their only hope. 
Little is known about these diseases and a clinical trial may often be 
the only way individuals can seek treatment for these rare diseases and 
contribute to helping find a cure.
  Currently, SSI and Medicaid eligible individuals who want to 
participate in a clinical trial have to worry about whether or not they 
will see a loss or a reduction in their benefits for their 
participation in a clinical trial if the trial offers any sort of 
research compensation to participants as part of its approved Internal 
Review Board study design. This legislation would make it so benefits 
that these individuals receive from clinical trials are not counted 
against those who are seeking SSI or Medicaid benefits or those who are 
already eligible for these benefits.
  A good example of why this legislation is needed is Sean from 
Maryland. Sean is a Medicaid beneficiary who voluntarily enrolled in a 
clinical trial. He was paid for his participation in the study and 
subsequently lost his health benefits. Shortly after the study he 
contracted pneumonia and was treated for the illness. After 
hospitalization he found out that the money he received would 
disqualify him for Medicaid. Because he lost his health benefits he now 
owes $80,000 for the two weeks of treatment he received for pneumonia.
  While I believe this bill fixes a fundamental problem that has 
precluded hope for too many people who have a rare disease and receive 
SSI or Medicaid, I have heard some legitimate concerns that research 
compensation may create the wrong kind of incentives for low-income 
people. These are important concerns and when it comes to this issue I 
believe there do need to be important safeguards in place. That is why 
this bill includes a GAO study to make sure that the program is working 
and that it is fair to those on SSI and Medicaid who are participating 
in clinical trials for rare diseases. The bill sunsets in 5 years so 
that Congress can reexamine the issue after getting the GAO report on 
the program.
  I urge my colleagues to support this legislation so that adults on 
SSI and Medicaid can have the same access to clinical trials as those 
more financially fortunate. I look forward to working with Chairman 
Baucus and Ranking Member Grassley on passing this bill this year.
  Mr. INHOFE. Mr. President, I am pleased to introduce legislation 
today with my colleague, Senator Ron Wyden, to introduce the Improving 
Access to Clinical Trials Act, I-ACT, a bill to allow patients with 
rare diseases to participate in clinical drug studies without losing 
their eligibility for public assistance like Supplemental Security 
Income, SSI, and Medicaid. This bill provides potentially lifesaving 
treatments through clinical trials for those suffering with rare 
diseases, like cystic fibrosis, CF, a life-threatening genetic disease 
that affects about 30,000 people nationwide. This hits especially close 
to home for me because I have a staff member, Sage Streck, with CF, and 
she has participated in some of these trials that further drug research 
as they seek better treatments for rare diseases. About half of these 
patients are on Medicare or Medicaid and are eligible for SSI benefits.
  Cystic fibrosis used to be primarily a childhood disease because 
people simply didn't live long enough to reach adulthood. But now, 
thanks to the many treatments discovered through clinical trials, the 
average life expectancy is 37 years old. Additionally, these advances 
in science allow CF patients to live more normal lives and not spend 
all their lives in hospitals or

[[Page S9380]]

using respiratory machines. The more CF patients can participate in 
clinical trials, the faster scientists can discover new treatments and 
eventually a cure.
  Sage has personally seen in her lifetime five drugs that started in 
clinical trials and are now available to CF patients. Each medication 
has increased her quality of life and decreased the amount of time she 
has spent in the hospital or on IV antibiotics. There are more than 30 
promising drugs in the research pipeline right now that the CF 
Foundation is calling miracle drugs so it is imperative that patients 
have access to clinical trials so these drugs can get on the market.
  Under current law, the small compensation provided to trial 
participants, which averages around $500, is included as additional 
income that could cause a person to lose their public assistance 
benefits, like Supplemental Security Income, SSI, and Medicaid. These 
benefits are crucial for patients living with rare diseases. For 
instance, nearly 50 percent of the CF population uses SSI or Medicaid. 
As a result, patients choose not to enroll in clinical trials that 
could dramatically improve their lives out of the fear that they may 
lose the benefits on which they rely.
  This bill allows patients with a rare disease to disregard up to 
$2,000 of compensation received for participation in a clinical trial 
in their SSI and Medicaid income calculations. Though it will have a 
negligible impact on the Federal budget, it will make a dramatic 
difference in the lives of those who will gain access to potentially 
life-saving treatments by enrolling in clinical trials as well as all 
those in the future whose lives will be improved by the medical 
advances that arise from this research.
  Please join me in supporting this legislation that will provide 
patients with rare disease access to potentially lifesaving clinical 
trials without losing their public assistance health benefits.

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