Washington, D.C. – Yesterday, President Obama signed into law the Improving Access to Clinical Trials (I-ACT) Act finally allowing patients with rare diseases to participate in clinical drug studies without fear of losing their eligibility for public assistance such as Supplemental Security Income (SSI) and/or Medicaid. Introduced by U.S. Senators Ron Wyden (D-Ore.) and Jim Inhofe (R-Okla.), the I-ACT ensures the small amount of financial compensation patients receive to participate in clinical trials is not counted as extra income. For some, that extra compensation is enough to cause one to lose the benefits they rely on to cover medical bills.
“Senator Inhofe and I believe that patients with rare diseases shouldn’t be penalized for seeking treatment in a clinical trial,” Wyden said. “To force someone with a rare disease to choose between the treatment that could save their life or Medicaid and SSI is unfair, uncompassionate and thankfully, because of this bipartisan health care legislation, will be a thing of the past.”
“Having a staffer with cystic fibrosis, I am especially grateful to Senator Wyden for his work in making this measure law,” Inhofe said. “Clinical trials for those suffering with rare diseases, provides hope, better understanding of the disease, and possible life-saving treatment for both themselves and others suffering from the same disease. About half of these patients are on Medicare or Medicaid and are eligible for SSI benefits. With this new law, we can make a dramatic difference in the lives of those who will gain access to potentially life-saving treatments by enrolling in clinical trials.”
Under current law, small monetary compensation provided to a patient involved in a clinical trial is counted as income, forcing the patient’s income to push closer to the level at which they are no longer eligible for public assistance, such as SSI and Medicaid. These benefits are necessary for patients living with rare diseases whose medical bills are often extremely high and who rely heavily on Medicaid and/or SSI. As a result, many patients choose to forego the clinical trial that could dramatically improve their lives out of fear of losing those benefits.
The I-ACT protects those patients receiving public medical assistance from having the compensation counted against them but also includes important safeguards. The law includes a Government Accountability Office study to make sure the program is working and remains fair to those with rare diseases and will sunset in five years, giving Congress an opportunity to reexamine the program.