Payers Still Denying Coverage Despite Clinical Trial Mandate

Kelly Johnson @OncKelly
Published: Tuesday, Mar 29, 2016
Blase Polite, MD, MPP

Blase Polite, MD, MPP

A mandate enacted after the 2010 Patient Protection and Affordable Care Act (ACA) was supposed to improve health coverage for patients enrolled in clinical trials. However, nearly 63% of cancer centers and organizations that responded to a recent survey reported insurance denials of routine care costs associated with patient involvement in clinical trials during 2014 (Figure 1).

“Oncologists continue to be very worried about putting people on clinical trials and having the coverage denied,” Blase Polite, MD, MPP, chair of the Government Relations Committee for the American Society of Clinical Oncology (ASCO), said. “When patients ask us if their insurance is going to cover this, I don’t think there’s an oncologist out there who would say, ‘Don’t worry about it. You’re fine because you’re covered by the law.’ We’ve just been burned on that too many times.”

Section 2709 of the Public Health Service Act, enacted January 1, 2014, under the ACA, prevents most commercial insurance companies from denying coverage associated with clinical trials. Healthcare professionals disagree on how much the provision has helped (Figure 2).

Figure 1: Sites Experiencing Clinical Trial Insurance Denials


“Patient coverage during trials has significantly improved since the implementation of the provision,” said Howard Burris, III, MD, chief medical officer and executive director of drug development at the Sarah Cannon Research Institute. Before the advent of the ACA, insurance approvals for clinical trials could be described as “all over the place,” he said. “Since the ACA, it’s just accepted that standard of care will be paid for within the clinical trials and there won’t be so much picking and choosing and asking questions about it. We have not had much in the way of denials.”

Prior to the ACA, 38 states and the District of Columbia had laws or agreements in place requiring insurance companies to cover routine costs for patients participating in clinical trials, including physician and hospital visits, imaging testing, laboratory tests, and approved medications. The clinical trial sponsor covered the costs of the experimental procedures, tests, and therapies specifically related to the research and data collection.

Loosely Written Law Makes Enforcement Difficult

The 2014 mandate broadened the scope of coverage by forcing payers to cover qualified individuals enrolled in approved phase I to IV clinical trials conducted in relation to prevention, detection, or treatment of cancer or other life-threatening diseases or conditions.

Whereas the mandate appears to spread the coverage umbrella over a greater proportion of healthcare expenses, it has been criticized for what some have called ambiguous language and loopholes that enable insurance companies to deny coverage.

In order to analyze disparities in coverage for clinical trials and their impact on trial participation, PhD student Christine Mackay, RN, MSA, CCRP, site development director of the Clinical Trials Office at the University of Kansas Cancer Center, joined fellow researchers in conducting the survey of members of cancer centers and organizations throughout the country. The five question study garnered 252 analyzable responses from individuals associated with organizations doing clinical trials. It was performed in collaboration with the Association of American Cancer Institutes (AACI), the Oncology Nursing Society, and the Midwest Cancer Alliance.

One finding was that policyholders are likely to be turned down for clinical trial coverage by insurance plans that were in existence prior to the signing of the ACA in March 2010 and that are exempt from the clinical trial coverage requirements. In many cases, patients may not be aware that they are insured under one of these plans until they are denied coverage, Mackay said. These plans could account for about 40% of current plans in the United States, according to Mackay.

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