State laws mandating clinical trial reimbursement
Kansas saw a negligible increase in insurance coverage as a result of the ACA thus lack of insurance coverage is likely to remain a concern for cancer patients.The Patient Protection and Affordable Care Act (ACA) is a law that affects the cost of and access to medical care. Included in this law, are regulations regarding the coverage of clinical trials.ASCO believes that insurance should cover the routine patient costs for people participating in cancer clinical trials.
It requires, for example, coverage of routine care costs for clinical trial participants in self-insured plansthat is, plans typically offered and run by employers who are paying the full cost of providing the benefitsgoverned by the federal ERISA law, Brow said." The standard of care for many cancers often provides limited benefit and significant toxicities.
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To assess the number of Kansas adults aged 19–64, newly covered with health insurance for participation in oncology clinical trials as a result of the ACA, a cross sectional design using extracted data from the 2012 American Community Survey, Public Use Microdata Sample to estimate the number of individuals covered by insurance and data from the 2014 Department of Health and Human Services Health Insurance Marketplace enrollment to estimate those newly enrolled through ACA.
Three main factors limit the effectiveness of the ACA provisions in expanding clinical trial coverage: 1) ‘grandfathered’ self-funded employer plans not subject to state Employee Retirement Income Security Act (ERISA) regulations, 2) Medicaid coverage limits not addressed under the ACA, 3) populations that remain uninsured.