Statements On Introduced Bills And Joint Resolutions

Floor Speech

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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.

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