Hidden within the $ 2.3 trillion omnibus aid and spending package approved by Congress in December 2020 is a little-known but powerful provision designed to promote equitable access to clinical trials. Beginning in January 2022, coverage for “routine costs” associated with participation in clinical trials will be guaranteed for all Medicaid beneficiaries for the first time in program history. The absence of federal policy in this area has so far in all likelihood suppressed the representation of minority and low-income populations in the clinical research underlying therapeutic advances, thus limiting equitable access to potentially modern therapies and compromising generalization. . of research results.
Adapted with permission from the Clinical Oncology Association.
For years, Medicare and private taxpayers have covered so-called routine costs that accompany participation in clinical trials, such as fees associated with doctor visits, hospital stays, diagnostic tests, and other standard clinical services. which would have been covered in the absence of the patient’s participation in a trial. A national coverage determination in 2000 forced these costs to be covered for Medicare beneficiaries. Later, the Affordable Care Act (ACA) extended this mandate to include commercially insured patients (with the exception of those enrolled in notice plans, who were exempt from the requirement). However, Medicaid beneficiaries were excluded from these federal measures, an omission that left states to legislate their own coverage policies. As a result, state Medicaid programs vary in the degree to which they cover the routine costs associated with participating in trials, with only 15 states requiring coverage (see map).
Meanwhile, participation rates in clinical trials remain low for racial and ethnic minority groups, resulting in study samples that do not accurately reflect populations that could benefit from the products being studied. For example, non-Hispanic white patients are almost twice as likely as black patients and three times as likely as Hispanic patients to enroll in clinical trials on cancer, a gap that has widened over time. 19 pandemic, which has disproportionately affected non-white patients, without its proportional representation in Covid-19 therapy trials.
Several factors at the patient, physician, organizational, and structural level explain these persistent inequities. Low rates of participation in trials among non-white patients have been attributed, in part, to cultural and linguistic barriers, mistrust of the health system stemming from a history of abuse, inequalities in access to health care, implicit biases among clinicians and researchers, limited availability of resources in hospitals that care primarily for non-white patients, and restrictive eligibility criteria for studies that disproportionately exclude patients living in marginalized communities. 3 In addition, minority and racial groups are likely to be particularly affected by financial barriers to study participation, which include the costs associated with more frequent clinic visits, time off work, and expenses related to travel. Financial concerns, including concerns about delays and denials of insurance reimbursement for routine costs related to trials, are often cited as deterrents for enrollment in clinical trials.
Medicaid programs are well positioned to mitigate inequalities in clinical trial enrollment by improving access to care and directly addressing financial barriers to patient-level participation. The ACA expanded Medicaid to millions of Americans who were not previously eligible for the program, which led to dramatic improvements in coverage for low-income people and racial and ethnic minority groups. The expansion of Medicaid has been associated with better access to care, greater financial protection, and better health outcomes. More recent evidence suggests that state Medicaid programs have provided a strong safety net amid the loss of pandemic-related health insurance. The expansion of Medicaid, combined with the new policy of covering costs related to clinical trials, has the potential to increase trial participation rates and reduce enrollment inequalities, both expanding coverage of routine costs. as, more generally, improving access to medical services for people who were not previously insured.
The question now is how to take advantage of the coverage mandate to address ongoing barriers to trial participation and reduce persistent inequalities in trial enrollment. We believe that there are several important steps that state and federal policymakers must take to ensure the success of this provision.
First, states and provider organizations could use the Medicaid non-urgent medical transportation benefit (NEMT) benefit to ensure affordable access to appointments associated with clinical trials. Although the NEMT benefit is most often used to increase access to behavioral and preventive health services and care for chronic conditions, it could play an important role in facilitating participation in trials for to unattended groups who report disproportionately on transportation-related challenges, including low-income seniors. , and racial and ethnic minority populations. Some states, including Indiana and Iowa, have limited NEMT benefit as part of Medicaid expansion demonstration projects; early evidence suggests that these waivers probably had an adverse effect on access to care. In the future, we believe that centers for Medicare and Medicaid services should deny waivers that limit access to NEMT benefit, given the prevalence of transportation-related barriers to care in the Medicaid population. In addition, states could work to raise awareness of this benefit, reduce the administrative burdens of physicians and patients associated with Medicaid-covered NEMT services, and avoid imposing unnecessary restrictions on the use of these services, including restrictions on numbers. of travel, type of route and distance of route.
Second, states could use Medicaid funding to invest in patient navigation programs to help people access clinical trials and negotiate the complex trial participation process. Patient browsers help people meet social and health needs and have been shown to improve patients ’access to care and outcomes for a range of clinical conditions. Navigation programs have the potential to increase and maintain the accumulation of minority patients in clinical trials. 4 Serving as an important bridge between the community and academic medical centers, patient navigators are well positioned not only to improve access to health and the availability of social supports, but also to build trust in health care systems. among marginalized populations, in particular those who have been the object of historical neglect or ill-treatment by suppliers and institutions.
Finally, in addition to calling for standardized reports and greater transparency regarding the participation of marginalized populations in clinical trials, we believe that stronger accountability measures are needed. Although agencies such as the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) have outlined strategies to increase the representation of minority groups in research, these strategies lack significant enforcement measures and do not gain access. equitable in clinical trials. A recent study that examined 230 trials that led to FDA approval of cancer drugs found that only participants ’race data were reported in 63% of trials; in studies that reported data on race and ethnicity, black and Hispanic patients were underrepresented in relation to the distribution of people with cancer in the United States.5 The NIH and the FDA could pilot and evaluate new mechanisms to promote accountability, for example, withholding part of the funding from centers designated by the National Cancer Institute that do not demonstrate equitable access to and participation in clinical trials. If successful, this policy could be generalized to institutional funding for clinical research in other areas of disease. To protect marginalized populations from the potential for coercion or ill-treatment, while improving access to valuable opportunities, data control and security boards should be responsible for assessing equity in recruitment and retention. ‘trials, in addition to ensuring the safety of members of these groups in the trials.
Extending mandatory federal coverage of routine costs related to trials to Medicaid beneficiaries could help improve long-standing barriers that have removed the enrollment of low-income, non-white patients in research in the United States. It is now up to federal and state policymakers, working together with health systems and researchers, to ensure that the new legislation fulfills its full promise of reducing inequalities in participation in clinical trials, inequalities that compromise both the scientific process and access to new therapeutic products. people who could benefit from it.