State Payer Mandates to Cover Care in US Oncology Trials: Do Science and Ethics Matter?

Abstract

ResultsTwenty-six states mandated coverage. Four states (15%) required scientific peer review for all studies. For 20 states (80%), an approved investigational new drug qualified as scientific review. In 10 states (38%), institutional review board (IRB) approval could replace scientific review. Twenty-four states (92%) permitted trials without academic medical connection. All states covered privately insured patients; seven (27%) included government and Medicaid patients. Fourteen states (54%) covered phase I to phase IV trials. Sixteen states (62%) covered treatment trials only; one (4%) covered prevention, detection, treatment, and palliation. Thirteen states (50%) covered research-related injuries. Only seven states (27%) required IRB approval. Three states (12%) required commensurate risks and benefits; 23 (88%) had no standard. Eight states (31%) required clinical equipoise with standard care; eight (31%) had no standard; and remaining states (46%) had unique standards. Two states (8%) addressed publication or registries. ConclusionsMost states did not demand independent scientific review, IRB review, or basic ethical features of high-quality trials; provided partial coverage; omitted prevention, detection, and palliation research; and omitted mandated coverage for research-related injuries. Few required evaluation, independence in publication, or posting trial results. Further research on the impact of diverse state choices would improve policy making.

Effect of state-mandated insurance coverage on accrual to community cancer clinical trials

“…Of the 37 states and territories represented, 14 states implemented a policy during the study period; 23 did not. One state (Illinois) allowed its mandate to expire [24] and CCOPs in two states closed (and thus their states dropped from the dataset), one before its state policy was implemented (see Figure 1). In total, 13 states contributed data both before and after policy implementation.…”

“…Finally, state policies mandating trial coverage vary in scope [24]. All require private insurers to cover trial costs, but some states additionally require certain government sponsored plans to participate [13, 24].…”

“…The study dataset represents the full population of CCOPs and includes CCOP-level characteristics and state-level factors describing the CCOP environment and associated with CCOP performance. Publicly available state policy information was abstracted from the NCI State Cancer Legislative Database, supplemented with details from the American Cancer Society and published research [10, 13, 23-24]. In 2007, new Institute of Medicine cancer clinical trial restructuring recommendations went into effect, limiting the number of trials offered, so data is restricted to the 17 years of data available prior to 2008.…”

“…Thus, a set of dummy variables indicating calendar years is included to capture changes in accrual over time, such as changes in national trial availability and the national Medicare Coverage Determination signed by President Bill Clinton in 2001 and implemented across all states [24], among other global trends.…”

“…The requirements and breadth of policies vary among states [24], thus we also assessed a measure of policy strength by assigning a single score to each state, which assigned one point for each phase of trial covered (I-III) and one point for each payer type required to provide coverage, as these aspects should have most directly affected treatment trial accrual.…”