Medicaid Mandate 2022: Striving for Equitable Access to Clinical Trials

Scott Gray, CEO, Clincierge

On January 1, 2022, the United States enacted landmark legislation supporting our industry’s ability to sponsor more diverse, equitable, and inclusive clinical trials via the Clinical Treatment Act. 

Passed as part of the $2.3 Trillion Omnibus Appropriations and Coronavirus Relief Package, this compelling legislation aims to create equal and increased access to clinical trials for more than 76 million Americans¹ enrolled in Medicaid. The law guarantees coverage of all ‘routine costs’ associated with clinical trial participation, removing a significant barrier that inhibits low-income Americans from participating.  

Clinical trials backed by substantial patient diversity offer benefits not only to pharmaceutical companies and clinical research organizations (CROs) studying a drug, but also to individual trial participants and populations suffering from specific diseases. 

Providing Medicaid participants better access to trials means new opportunities for our industry to study drugs among more diverse patient populations and create increased access to life-saving therapies for low-income and minority populations. 

Understanding the 2022 Medicaid Mandate 

Income should not determine a patient’s ability to access potentially life-saving care through clinical trials. Yet, as healthcare professionals, we know all too well that ‘routine’ costs associated with trial participation are a primary factor that prevents patients from enrolling, especially low-income and historically underrepresented populations.  

Covered under the Clinical Treatment Act are routine patient care costs for participation in qualifying clinical trials. For example, fees for hospital stays, physician visits, lab work, diagnostic tests, and other medical services are routinely covered for Medicaid patients. 

Although there is more work to be done, the Medicaid mandate is a step in the right direction to further improve health outcomes and correct a longstanding inequity within the United States healthcare system. 

Medicaid’s Coverage Inequity 

Medicaid provides healthcare coverage to low-income children, pregnant women, elderly adults, and those with disabilities. It is funded by both the federal government and individual states. 

About 18%³ of Americans are covered under Medicaid, with participation varying among US states. Of Medicaid beneficiaries, 61% identify as Black, Hispanic, Asian American, or another non-white race or ethnicity. 

Prior to 2022, Medicaid participants were not guaranteed coverage of routine costs for participating in clinical trials. Individual states made coverage determinations, and with only 16 states mandating coverage, millions of Americans were excluded. 

In 2000, a federal mandate required coverage of routine clinical trial costs for all Americans participating in Medicare. Ten years later, privately insured Americans received the same benefit through the 2010 Affordable Care Act (ACA), which required all private insurers and health plans to cover clinical trial participation. 

The inequity lies in the fact that most Medicaid participants were not granted the same benefits as other insured Americans until 22 years later. The result, years of inconsistency and limited access to state-of-the-art treatments for millions of low-income and minority Americans, which begs the question – can we make up the lost ground? 

Clinical Trial Demographics in 2020 

Historically, clinical trial participants have predominantly been white males who usually have greater work and family flexibility and the financial security to manage out-of-pocket expenses. In general, white patients in the United States have the resources, language skills, and capabilities to research relevant clinical trials and often have more support when committing to a clinical trial. 

The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) has a transparency initiative that reviews patient diversity data from clinical trials. The agency’s 2020 report Drug Trial Snapshot4 showed 53 drugs were approved in 2020. The clinical trials supporting these approvals enrolled 32,000 patients with the following demographic breakdown:

• 8% Black or African American (US population 12%) 
• 6% Asian (US population 6%) 
• 11% Hispanic (US population 19%) 
• 75% white (US population 62%) 

When compared against US population data,⁵  less than two-thirds of African American/Black and Hispanic populations were represented in these trials. 

This disparity in participation is not limited to clinical trials within the United States. One study⁶ investigating trial data from nearly 150,000 patients in 29 countries over the past 21 years revealed that 86% of trial participants were white. 

Barriers to Trial Participation for Historically Underrepresented Populations 

The Medicaid mandate is creating momentum to further conversations about patient diversity and inclusivity, strengthening our commitment to all patients. 

Recruitment and retention are chief among the challenges facing clinical researchers, with more than half of trials delayed due to low enrollment and dropout rates exceeding 30%. The mandate offers a much-needed expanded patient population from which to recruit patients. 

Drug safety and efficacy cannot be studied equitably among disparate demographic groups without diverse enrollment. As a first step in improving diversity in clinical trials, it is vital to understand the circumstances that led to the under-representation of minority and low-income populations.  

Access 

Minority patients have less access to clinical trials and are less likely⁷ than white patients to be referred to a trial by their physician. Even when minority patients are made aware of studies, they are less likely to participate. 

Minority8 populations are more likely to have an illness requiring medical attention and are more likely to have a secondary⁹ medical condition, both factors that often exclude patients in early pre-qualification screenings.  

One concerning omission of the Medicaid mandate is screening visits for prospective patients are not covered. 

Costs and practical considerations 

Securing childcare and driving long distances to and from regional trial sites are oft-cited barriers to participation. These day-to-day concerns can be emotionally draining and cost-prohibitive even with reimbursement. 

A 2021 study¹⁰ examining the financial burden associated with clinical trial participation found 48% percent of patients enrolled in early-phase clinical trials had monthly out-of-pocket expenses of at least  $1,000, with 64% of patients reporting unanticipated non-medical expenses. In fact, the heaviest financial burden experienced during clinical trials was reported by patients whose household income was below $60,000. 

With most studies lasting several months to a year or more, the financial burden is high for patients, especially low-income patients. 

Lack of trust in the healthcare system 

There is an unfortunate but fundamental mistrust of the healthcare system among minority populations in the United States. The distrust stems from past ethical violations, historical injustices, and general exclusion from past research. Misinformation and community mistrust also factor in. Black patients are less likely than whites to seek healthcare¹¹ when experiencing the same symptoms. 

The Medicaid mandate improves access for minority patients and creates a critical opportunity to rebuild trust.

Overcoming the barriers facing minorities and people of color is a significant challenge. Pharmaceutical companies and clinical research organizations (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. 

Actionable Solutions for Building More Inclusive Trials 

Last summer, I penned an article for Pharmaceutical Outsourcing titled Achieving Clinical Trial Diversity Through Actionable Steps.

It focused on our industry’s responsibility to advocate for greater diversity in clinical trials.  

Some of the actionable steps trial sponsors, CROs, and other healthcare organizations can explore to build equitable access include:  

• Addressing financial challenges of prospective trial participants 
• Designing trials with site locations in minority neighborhoods 
• Purposefully educating and communicating with targeted communities 
• For rare diseases, dedicating personalized support services for patients and caregivers 

Ease the Financial Burden 

Trial participation presents financial, emotional, and logistical burdens for patients and caregivers, furthering recruitment challenges and poor retention rates. Although economic factors impact almost all patients, they are far more detrimental to historically underrepresented populations.

While the average industry dropout rate hovers at 30%, there are ways to bolster trial retention rates. 

Utilizing patient coordinators who are trained to assist trial participants and caregivers through the duration of the trial to help manage finances, travel, and other logistics can alleviate the burden of participation. It also allows trial site coordinators to focus on essential aspects of the trial. 

Design Trials with Patient Access in Mind 

Strategic site placements should be considered when designing trial protocols to ease the burden of participation. Establishing trial sites in neighborhoods where minority patients live and work and providing weekend and evening hours for trial recruitment events are two simple ways to better accommodate patients of various demographic groups. 

The emergence of decentralized clinical trials – trials that do not rely on a specific site location but instead utilize technology to conduct patient care remotely – offers enhanced access to clinical trials. However, consistent and high-quality access to technology and connectivity will be required to be successful. 

Educate the Community and Prioritize Outreach 

By prioritizing education and relationship-building, we can recruit and retain a more diverse population for clinical trials – moving medicine forward in an equitable way.  

Establishing a trusted presence and communicating with under-served patients in their communities is a vital step in generating interest in clinical trials. Building relationships with community leaders who can help educate the community about clinical trials can enhance enrollment.  

Provide Personalized, Compassionate Resources 

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, partnering with a company that focuses on patient support creates a bridge between patients and the clinical trial site, which improves retention rates. 

The new Medicaid legislation is an opportunity to better serve the healthcare needs of marginalized communities and historically under-represented minority patients and move research and medicine forward for all. 

Increasing diversity in clinical trials is a business and ethical obligation and a promise to the patients and caregivers we serve. It is imperative to invest in the tools and resources to improve community outreach and eliminate barriers to participation. 

References

1. June 2021: Medicaid & CHIP Enrollment Data Highlights. Medicaid.gov. Accessed January  14, 2022. www.medicaid.gov/medicaid/program-information/medicaid-and-chip- enrollment-data/report-highlights/index.html  
2. Clinical Treatment Act: MEDICAID ENROLLEES NEED CLINICAL TRIAL ACCESS. American Society of Clinical Oncology. Accessed January 14, 2022. https://www.asco.org/sites/  new-www.asco.org/files/content-files/advocacy-and-policy/documents/2019-clinical- treatment-act-infographic.pdf  
3. KEISLER-STARKEY K, BUNCH L. Health Insurance Coverage in the United States: 2020, Report P60-274. Census.gov. Accessed Jan 14, 2022. https://www.census.gov/library/ publications/2021/demo/p60-274.html 
4. 2020 Drug Trials Snapshots Summary Report. Fda.gov. Accessed January 14, 2022. htps:// www.fda.gov/media/145718/download 
5. Jensen E, Jones N, Rabe M, Pratt B, Medina L, Orozco K, Spell L. The Chance That Two People Chosen at Random Are of Different Race or Ethnicity Groups Has Increased Since 2010. August 12, 2021. Census.gov. Accessed Jan 14, 2022. https://www.census.gov/  library/stories/2021/08/2020-united-states-population-more-racially-ethnically-diverse- than-2010.html  
6. Editors. Clinical Trials Have Far Too Little Racial and Ethnic Diversity. Scientific American. Sept 1, 2018. Accessed January 14, 2022. https://www.scientificamerican.com/article/ clinical-trials-have-far-too-little-racial-and-ethnic-diversity/ 
7. Hamel, Lauren M et al. “Barriers to Clinical Trial Enrollment in Racial and Ethnic Minority Patients with Cancer.” Cancer control: journal of the Moffitt Cancer Center vol. 23,4 (2016): 327-337. doi:10.1177/107327481602300404 
8. Price, James H et al. “Racial/ethnic disparities in chronic diseases of youths and access to health care in the United States.” BioMed research international vol. 2013 (2013): 787616. doi:10.1155/2013/787616 
9. Ralph NL, Mielenz TJ, Parton H, Flatley A, Thorpe LE. Multiple Chronic Conditions and Limitations in Activities of Daily Living in a Community-Based Sample of Older Adults in New York City, 2009. Prev Chronic Dis 2013;10:130159. DOI: http://dx.doi.org/10.5888/ pcd10.130159 
10. Huey, Ryan W et al. “Patient-Reported Out-of-Pocket Costs and Financial Toxicity During Early-Phase Oncology Clinical Trials.” The oncologist vol. 26,7 (2021): 588-596. doi:10.1002/ onco.13767 
11. Bulatao RA, Anderson NB, editors. Understanding Racial and Ethnic Differences in Health in Late Life: A Research Agenda. National Research Council (US) Panel on Race, Ethnicity, and Health in Later Life. Washington: National Academies Press; 2004. Accessed January 14, 2022. https://www.ncbi.nlm.nih.gov/books/NBK24693/  

About the Author

Scott Gray is the co-founder and CEO of Clincierge, the leader in patient support services for clinical trials. Since 2015, Clincierge patient coordinators have managed logistics and reimbursements for more than 300 clinical trials worldwide. For more information, visit clincierge.com

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