Insurance Approval Rates for Enrollment in Oncology Clinical Trials Increased Under Affordable Care Act

Key Points

  • Approval rates for clinical trial participation increased from about 85% prior to implementation of the Affordable Care Act (ACA) to approximately 95% after the law went into effect.
  • Rates of prolonged time to insurance clearance have decreased under the ACA, although the rates of prolonged clearance trended similarly for both privately insured patients and those insured through Medicare and Medicaid.

The Patient Protection and Affordable Care Act (ACA) of 2010 was the first federal law to mandate that group health insurance plans and state-licensed insurance issuers provide coverage of standard-of-care costs for patients enrolled in approved clinical trials, effective on January 1, 2014. Under the law, “approved” trials included approved or funded studies by the National Cancer Institute, Centers for Disease Control and Prevention, Centers for Medicare & Medicaid Services, Department of Defense/VA, cooperative group or center affiliated with these agencies, or the Department of Energy.

A study by Kehl et al examining the impact that requirement in the ACA had on clinical trial participation has found that approval rates rose from about 85% prior to the ACA mandate to approximately 95% after the mandate. In addition, patients with private insurance experienced fewer delays in being approved for participation in clinical studies. These study findings were published in Clinical Cancer Research.

Study Methodology

The researchers analyzed the database of the Clinical Center for Targeted Therapy at The University of Texas MD Anderson Cancer Center. Among patients referred for sponsored trials, the researchers examined rates of insurance clearance and prolonged time to clearance (at least 14 days) in three different time periods: from July 2012 to June 2013; July 2013 to December 2013; and January 2014 to June 2015. They used multivariable logistic regression models to compare rates across these time periods.

The researchers identified 2,404 referrals for insurance clearance.

Study Results

The researchers found that among privately insured patients, insurance clearance rates were higher for those referred from January 2014 to June 2015 than for those referred from July 2012 to June 2013 (odds ratio [OR] = 4.72; 95% confidence interval [CI] = 2.9–7.51). There was no association between referral period and clearance rates for Medicare/Medicaid patients (P = .25). Referral from January 2014 to June 2015 was associated with lower rates of prolonged clearance among both privately insured (OR = 0.57; 95% CI = 0.38–0.86) and Medicare/Medicaid patients (OR = 0.39; 95% CI = 0.19–0.83).

“Within the large early-phase clinical trials program at our institution, we found that rates of successful insurance clearance for clinical trial enrollment among privately insured patients have increased following implementation of the clinical trials coverage requirement for private plans under the ACA. Rates of prolonged time to insurance clearance have decreased following implementation of the requirement, although this change occurred among both privately insured patients and patients with government insurance,” concluded the study authors.

Improving Access to Clinical Trials

“Clinical trials are crucially important in helping get drugs to the patients [who] need them,” said David S. Hong, MD, Deputy Chair and Associate Professor in the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center and a coauthor of this study, in a statement. “This study is one piece of evidence that the ACA is helping more patients get access to these trials.” 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.