Medicaid Coverage of "Routine Costs" for Clinical Trials

According to a 2021 study by the University of Texas MD Anderson Cancer Center, nearly half of all patients enrolled in early-phase clinical trials face monthly out-of-pocket costs of at least $1,000.

As clinical trial professionals, we understand the costs of extended travel, missed work, and out-of-pocket expenses often inhibit trial participation. However, a patient's income level should not determine access to potentially life-saving treatments via clinical trials.

These upfront healthcare-related expenses create a significant barrier to trial participation for low-income populations, further complicating our industry's challenges to adequately fill trials with diverse patient populations. However, recent changes in legislation may offer relief for those in need.

Clinical Treatment Act

In Dec. 2020, Congress passed a $2.3 trillion Omnibus Appropriations and Coronavirus Relief Package. This bill included a compelling directive to create equal and increased access to clinical trials for the more than 76 million Americans enrolled in Medicaid. Medicaid is a healthcare program funded by both the federal government and individual states, and it covers low-income children, pregnant women, elderly adults, and those with disabilities.

On Jan. 1, 2022, coverage of all "routine costs" associated with clinical trial participation became guaranteed for Medicaid beneficiaries through the Clinical Treatment Act.

A watershed moment for equality in United States healthcare, this new law aims to create access to clinical trials for marginalized communities and minority patient populations who have been historically under-represented.

For clinical trial sponsors and clinical research organizations (CROs), improving access for Medicaid participants means new opportunities to study drugs among more diverse patient populations, the potential to bolster trial enrollments, and improved equity in delivering life-saving treatments to patients.

A brief history of clinical trial coverage and us legislation

In 2000, a federal mandate required Medicare to cover routine costs associated with clinical trial participation. Medicare is a federally funded healthcare insurance program covering Americans aged 65 and over, regardless of income. Due to this mandate, participation in clinical trials in patients over 65 increased. Ten years later, the 2010 Affordable Care Act (ACA) required all private insurers and health plans to provide the same coverage for clinical trial participants.

Yet Medicaid, the government assistance program providing health coverage to Americans of all ages, saw no federal mandate. Prior to Jan. 1, 2022, Medicaid did not guarantee coverage of routine costs for beneficiaries participating in clinical trials. Coverage determinations were at the discretion of individual US states, with only 16 states mandating coverage.

Medicaid's decentralized system resulted in years of inconsistencies and limited access to state-of-the-art treatments for millions of low-income and minority Americans.

Approximately 18% of Americans currently utilize Medicaid, with varying participation numbers among states. Sixty-one percent of Medicaid beneficiaries identify as Black, Hispanic, Asian American, or another non-white race or ethnicity.

The Clinical Treatment Act covers routine costs for patient care resulting from participation in qualifying clinical trials. These costs include fees for hospital stays, doctor and lab visits, diagnostic testing, and other medical services routinely covered if the patient was not enrolled in a clinical trial. The act aims to expand diversity in clinical trials and create increased access to life-saving therapies for low-income and minority populations.

Closing the diversity gap within clinical trials

Historically, minority and low-income populations are underrepresented in clinical research. As a result, trials often fail to collect evidence-based data on diverse patient populations that would benefit from new medications.

To date, clinical trial participants are predominantly white men, a demographic which often has a greater ability to take time away from work and family and pay the required out-of-pocket costs for travel to and from trial sites. White patients in the United States typically have the resources, language skills, and capabilities to research relevant clinical trials and often have more support when committing to study participation.

According to the American Society of Clinical Oncology (ASCO),white patients are nearly twice as likely as Black patients and three times as likely as Hispanic patients to enroll in cancer clinical trials. A 14-year study of minorities and women enrolled in oncology trials found:

• 83% of trial participants are non-Hispanic White (percent of US population 60.7%)
• 6% of trial participants are African American/Black (percent of US population 13.4%)
• 2.6% of trial participants are Hispanic or Latino (percent of US population 18.1%)

When compared against US population data, less than half of the African American/Black population and one-sixth of the Hispanic or Latino population are represented in clinical trials. This disparity in participation is not limited to clinical trials within the United States. One study investigating trial data from 29 countries over the past 21 years revealed that 86% of participants were white.

Drug safety and efficacy cannot be equitably studied among disparate demographic groups without diverse enrollment.

Improving clinical trial access for Medicaid participants, 60% of whom are non-White, carries implications beyond equitable access. More diverse trial populations will enhance the data collected by trial sponsors and CROs, improving the accuracy of the research conducted. Therefore, demographically inclusive research can help drug makers address therapeutic disparities before regulatory approval and broader market release.

Disadvantaged populations and the healthcare system

The Clinical Treatment Act seeks to level the playing field by giving low-income Americans the same benefits Medicare participants and privately insured Americans received years ago. The question is, will this be enough to correct the course of care?

Minority patients are less likely to be referred to clinical trials by their doctors and less likely to participate even when made aware of trials. Logistics such as securing childcare and traveling long distances to trial sites are common factors that hinder participation. Even when expenses are reimbursed, the cost of clinical trial participation is often prohibitive. Patients in households making less than $50,000 per year are 27% less likely to participate in a clinical trial.

In addition, minority populations are more likely to have an illness requiring medical attention and are more likely to have multiple medical conditions. Stringent pre-qualification criteria for trial participation often exclude patients with pre-existing secondary conditions. However, the new Medicaid legislation does not cover screening visits for prospective patients, a critical first step towards trial participation.

Overcoming the barriers facing minorities and people of color is a significant challenge. Pharmaceutical companies and CROs shoulder the responsibility to actively recruit and build trust among minority populations. Only when we intentionally address these challenges will clinical trial diversity expand to reach levels that will improve drug safety and efficacy for all demographics.

Strategic site placements should be considered when designing clinical trial protocols to ease the burden of participation. Setting up trial sites within neighborhoods of minority patients and offering weekend and evening hours for trial recruitment events are two simple ways to better accommodate patients of various demographic groups.

Establishing a trusted presence and communicating with underserved patients in their communities is a vital step in generating interest in clinical trials. Pharmaceutical companies should build relationships with community leaders to help educate the community about the availability and importance of clinical trials and explain the financial support available to participants.

Partnering with a patient support services company experienced in working with diverse patient populations can help trial participants overcome barriers throughout the duration of a clinical trial and improve participant retention. Not surprisingly, trial sponsors providing strong patient support build trust with trial participants from beginning to end.

Additional ways to improve clinical trial diversity

Successful outcomes of demographically inclusive trials during COVID-19 have shown that clinical trial diversity can increase. The new Medicaid mandate is another step in the right direction. In addition, several leading pharmaceutical companies have recently implemented global initiatives focused on diversity and inclusion. The pharmaceutical industry continues to make strides to increase clinical trial diversity, yet our work continues.

Statistics show that most clinical trials are not successful; nearly 80% of trials fail to finish on schedule, and 20% are delayed six months or more. The reasons are complex, but chief among them: 85% of clinical trials cannot retain enough patients, with more than two-thirds of trial sites failing to meet targeted patient enrollment. Improving access to life-saving clinical trials is vital from commercial and ethical perspectives.

Addressing the financial challenges facing patients can have the most significant impact in improving trial participation and retention. Supporting underserved populations through assistance with travel stipends, prepaid travel arrangements, and timely reimbursements for expenses can alleviate the pressure patients and their caregivers feel about paying upfront trial costs.

An opportunity to enhance patient equality

The Clinical Treatment Act is a significant step forward to help create increased and equitable access to clinical trials for millions of Americans. It is an opportunity for our industry to deepen trust and engagement with marginalized communities and historically under-represented patient populations. We must continue to educate providers and patients about these new eligibility and reimbursement programs, ensuring equitable access and care to all.

There is no going backward when facing diversity, equity, and social justice issues. Healthcare must learn from its past and enhance clinical trial diversity to reflect the populations we serve.

Scott Gray is the Co-founder and CEO of Clincierge