Kelly, Houlahan introduce "Harley Jacobsen Clinical Trial Participant Income Exemption Act"

WASHINGTON, D.C. -- Today, U.S. Reps. Mike Kelly (R-PA) and Chrissy Houlahan (D-PA) introduced the Harley Jacobsen Clinical Trial Participant Income Exemption Act, legislation that aims to exempt all payments received by participants in clinical trials from being counted towards their gross income.

Under current law, payments that are not categorized as reimbursements are considered taxable income. This disparity can create a financial burden for participants, particularly those in lower income brackets.

"By exempting these payments from gross income, we can alleviate this burden and make participation in clinical trials more accessible and accommodating to individuals’ lives," said Rep. Kelly. "This legislation puts the patients first and aims to improve both patient care and patient outcomes."

“Modern medicine has shown us how crucial clinical trials are to cutting-edge research and development," said Rep. Houlahan. "However, clinical trials often take a toll on participants' time and finances, resulting in less economic diversity in these studies and fewer people able to take part in them. I'm proud to introduce the Harley Jacobsen Clinical Trial Participation Act, which will allow payments received by participants in clinical trials to be tax-exempt. This would not only increase access to these trials and diversify those participating but would also allow for better advancements in our medical research as a result of including a more comprehensive patient population."

BACKGROUND

The Harley Jacobsen Clinical Trial Participant Income Exemption Act aims to:

• Increase diversity of the enrolled-patient populations across all trials, aligning with the strategic goals of the NIH and FDA, thereby improving the effectiveness of drug development for the benefit of the general American public.
• Provide greater access to experimental therapies to the least-empowered Americans (those with disabilities, minority populations, chronic physical illness, low-income populations, low-education level, etc.).
• Eliminate the reporting requirements for both the patient/caregiver (the payment recipient) and the 1099 reporting requirement of the payor. This will also protect participants who rely on social welfare programs such as SNAP, WIC, and others from exceeding income requirements.

Clinical trial participants (the payment recipient) are required to report all clinical-trial-payments received in a calendar year as gross income. The sponsor of the clinical trial (the payor) is required to report payments in equal to or in excess of $600 in a calendar year. 

You can read the full bill here.