A Lesson Learned in Patient Centricity

Applied Clinical Trials, Applied Clinical Trials-02-01-2022, Volume 31, Issue 1/2

Looking to US Medicare/Medicaid to increase patient participation.

Many signs point in the right direction for the potential to increase the dismal numbers of patients participating in clinical trials. The lessons regarding remote and hybrid clinical trials during COVID, the increased response to Clinical Research As a Care Option (CRAACO), and a growing number of companies—be they analytics or integrated research organizations—seek to place patients as participants in trials, closer to their physician and diagnosis.

Recent changes, coupled with existing policies, to the largest single payer of healthcare in the United States, The Centers for Medicare and Medicaid Services, could also positively impact the numbers of people participating in clinical trials. First up, learned through this article written by Scott Gray, co-founder and CEO of patient support services provider Clincierge, are legacy Medicare changes.

Medicare, the largest single healthcare payer for Americans aged 65 and over, required routine costs associated with clinical trial participation be covered. This year 2000 mandate led to increased clinical trials participation in patients over 65, from 25% to 38% between 1993 and 2003. Ten years later, the 2010 Affordable Care Act required all private insurers and health plans to provide the same coverage for clinical trial participants. These covered 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.

It was only Jan. 1, 2022, that Medicaid, funded by both the federal and state governments, granted clinical trials coverage to its 76 million American beneficiaries—mostly underrepresented populations. Sixty-one percent of Medicaid beneficiaries identify as Black, Hispanic, Asian American, or another non-white race or ethnicity.

Though this does offer sponsors and CROs new opportunities to diversify and increase patient populations, it is not without its challenges. There remain ever-present obstacles to recruiting patients, as well as retaining them.

One can only assume that Medicaid patients will need navigation help through site assistance to achieve clinical trials coverage. However, a recent experience leaves me slightly pessimistic as to the ability of the healthcare system to help improve clinical trials. If true changes to help patients navigate all healthcare systems, which includes their caregivers, family, and support systems, are to help clinical trials, healthcare needs a lesson in patient centricity learned from clinical trials.

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at lhenderson@mjhlifesciences.com.