3 - Implementing a Policy to Prevent Inequitable Subject Selection Based on Insurance Status

Background:  Corporate-sponsored investigational device exemption (IDE) studies have increasingly required participant insurance coverage to pay for the costs of the investigational device, related clinical procedures, and subject injury. When Centers for Medicare & Medicaid Services (CMS) or commercial insurance does not agree to pay these costs, participants are either excluded or at risk of incurring the bill.

Program

Description:  The requirement for insurance coverage to enroll in a clinical trial does not meet the IRB approval criterion requiring the equitable selection of subjects (45 CFR 46.111(a)(3)). Exclusion based on insurance status skews generalizability, creates barriers to enrollment for underserved populations, and does not fairly distribute the benefits and burdens of research. An IRB, collaborating with a Clinical Trials Office, drafted a policy to require corporate sponsors to pay any non-covered costs for investigational devices, related clinical procedures that are not standard of care, and subject injury for IDE studies, enabling enrollment of any eligible participant regardless of insurance status. Corporate sponsors are required to obtain CMS approval or agree to pay non-covered costs for investigational devices and related clinical procedures that are not standard of care. If a participant’s commercial insurance authorization is denied, the sponsor is required to pay for the costs of the investigational device and related clinical procedures that are not standard of care.

Program

Assessment:  The program consisted of drafting a policy and obtaining multidisciplinary feedback from investigators, institutional officials, and sponsors. Implementation is planned for 2024, pending revisions to the draft policy to address challenges identified during the feedback sessions. Ongoing feedback from the research community will be elicited and incorporated. Discussions to bring together payors, regulators, sponsors, investigators, and HRPPs/IRBs are required.

Limitations: The program focused only on corporate-sponsored IDE trials. Although they occur less frequently, similar concerns of inequity exist for investigational drug studies, e.g., requiring participant insurance to pay for FDA-approved medications seeking a new off-label indication in a clinical trial, though this policy did not address them. Input from IDE clinical trial participants was not elicited prior to policy implementation, which could have been important to support decision-making and track participant experience over time.

Discussion:  Exclusion based on insurance status does not represent equitable subject selection (i.e., does not meet the regulatory criteria for IRB approval of research) and does not fairly distribute the benefits and burdens of clinical research. We drafted a policy to address this problem of inequitable subject selection based on insurance status. Implementation of this policy poses significant challenges to human research protection programs (HRPPs), IRBs, institutions, and investigators, including prolonged clinical trial agreement negotiations requiring extensive staff time, delayed initiation of trials with competitive enrollment, and rejection as a study site by the sponsor. Implementation also poses challenges to clinical trial sponsors, including budget considerations, the challenge of prospectively identifying the anticipated total of non-covered costs, and the complexities of Medicare payor laws. Equitable and fair access to clinical research is a shared responsibility between institutions, HRPPs, IRBs, investigators, sponsors, payors, and regulators and necessitates collaboration between all parties to find new solutions. Most corporate-sponsored IDE clinical trials have multiple study sites. To generate generalizable findings and to ensure study-wide equitable subject selection, it is critical for other institutions to implement similar policies. Other institutions can customize language from this draft policy to be operationalized by their IRB. Single IRB review for FDA-regulated research will facilitate study-wide enforcement of such policies as a requirement for obtaining IRB approval. A collective approach by IRBs and institutions will carry weight with corporate sponsors, payors, and regulators by setting an expectation for what is required to conduct ethical research and will limit shopping for sites with less strict policies.