Expanding Access to Clinical Trials through the CLINICAL TREATMENT Act

October 23, 2020
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Clinical trials are a promising avenue for expanding treatment options and extending survival for people with cancer. However, out-of-pocket costs associated with clinical trial participation and gaps in insurance coverage create barriers for many cancer patients. By removing barriers to trial enrollment, such as coverage of routine care costs, Congress can help guarantee high-quality treatment for these patients and the inclusion of diverse populations in clinical trials.

The CLINICAL TREATMENT Act guarantees coverage of the routine care costs of clinical trial participation for Medicaid enrollees with life-threatening conditions, like cancer.

Background

Senators Richard Burr (R-NC) and Ben Cardin (D-MD) recently introduced the CLINICAL TREATMENT Act (S. 4742) in the U.S. Senate. This follows companion legislation, H.R. 913, that the U.S. House of Representatives had introduced, in 2019. As of October 2020, the House bill has 56 cosponsors, meaning a representative who has added his or her name as a supporter of the bill.

The CLINICAL TREATMENT Act would expand coverage of approved clinical trials to people who are insured through Medicaid, the government health care program that offers insurance to eligible adults with low incomes, children, pregnant women, elderly adults, and people with disabilities. A clinical trial is a research study to determine whether a new approach to cancer prevention or treatment works better than the best-known available treatment (“standard of care”).

Currently, Medicaid is the only major insurance provider that does not cover routine costs associated with participation in clinical trials. This coverage is already assured for Medicare beneficiaries (the government health insurance program for people who are 65 or older and certain younger people with disabilities) and for patients with private health insurance.

Fifteen states and Washington D.C. require Medicaid programs to cover costs that come along with participating in clinical trials yet there are still as many as 41.6 million Americans insured through Medicaid who may not have this crucial coverage that they need. This legislation would guarantee coverage of routine care costs that come along with clinical trial participation for people who are insured through Medicaid no matter what state they live in.

Why are clinical trials important?

Clinical trials are the main way that doctors find better treatments. Clinical trials compare the new drug, treatment, or approach with the existing “standard of care” and help to answer some important questions, including:

  • Does the new approach to cancer prevention or treatment work?

  • Is the new drug safe and effective?

  • Does the new drug or treatment option work better than the existing treatment?

The results of these trials drive and advance clinical research that can contribute to the process of developing new therapies that have the possibilities to save lives. Research and results that comes from clinical trials also sheds light on the side effects that participants experience during the study. This information can be very valuable for medical professionals and patients to decide what the best treatment options are.

Learn more about clinical trials, including how to participate in one, on our website.

What does this mean for people with cancer?

Cancer clinical trials are a promising avenue for expanding treatment options and extending survival for people with cancer. Clinical trials tend to provide patients with the most innovative, and sometimes the only, treatment option for them.

Yet, fewer than 5% of adults with cancer participate in clinical trials. Medicaid insures one-fifth of the US population, nearly 68 million individuals according to Medicaid.gov. If Medicaid recipients have coverage to participate in clinical trials, then the rate of participation in these studies could rise. Having a large amount of participation in clinical trials means that there can be even more improvements in the quality of research. The research from clinical trials directly impacts breakthroughs and advancements in cancer and therefore, cancer patients could access more innovative treatment options.

How does this impact health equity?

The coverage barrier for people insured through Medicaid means that certain demographics like ethnic minorities and women are not being fully represented in current clinical trials, meaning that these populations are not reflected in the outcomes of clinical research which comes from the result of trials. Increased access to clinical trial participation for people insured through Medicaid helps ensure that cancer research results more accurately capture all populations in the U.S., as well as that all cancer patients, regardless of their insurance provider, have access to the life-saving treatments that they need.

The COVID-19 pandemic has further highlighted the disparities in America’s health care system and the importance of diversity within clinical trials to ensuring widespread patient access to high-quality cancer care.

Take Action

Both the House and Senate bills are currently looking for members of Congress to support this important legislation. Please lend your voice to this important issue by writing to your Representative and Senators asking them to cosponsor the CLINICAL TREATMENT Act.

Sign up for our Grassroots Network to receive regular updates about policies that could impact cancer patients and their families, and make your voice heard with decision makers at every level. Stay tuned for more opportunities for action!