Payers Still Denying Coverage Despite Clinical Trial Mandate


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.

Christine Mackay, RN, MSA, CCRP

Christine Mackay, RN, MSA, CCRP

Christine Mackay, RN, MSA, CCRP

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.

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.

Among their findings is 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 are thus exempt from the clinical trial coverage requirements. Mackay explained that in many cases, patients may not be aware that they are insured by one of these plans, which account for about 40% of current plans in the United States, until they are denied coverage.

“This is a problem for us because we don’t ask insurance companies if patients are covered until after patients have reviewed and gone through the informed-consent process, which means that they’ve already agreed to participate in the trial,” Mackay said. “That’s the process that we follow. It’s similar, but not exactly the same at all institutions.”

The study also found that where prior insurance approval of a procedure, test, or medication is required, patients were three times more likely to experience denials than at sites without precertification requirements.

Of note, sites in those states with existing laws or agreements for coverage had similar rates of insurance denial post ACA as states without prior regulation, indicating the previous laws did not serve their intended purpose. Mackay added that many patients in line for a clinical trial choose a different treatment path because the 10-to-30-day waiting period associated with the precertification process is unacceptable to them.

Sometimes coverage is denied without justification, Mackay added. “Once you push the insurance companies a little bit and ask them how they’re exempt from the federal mandate, we found that some of the initial denials were wrong denials,” she said. “The patients are truly covered, but then it’s really a timing issue. The patient may not want or have that much time to wait to initiate treatment.”

In some cases, the time-consuming hurdle of unjustified denials could be attributable to third-party administrators. With a history of inconsistent state legislation and varying coverage by state, the administrators may be unaware of the federal mandate and are quick to deny clinical trial coverage, Mackay explained.

Mackay attributes the differences in coverage partly to a lack of clarity and enforcement of the mandate, explaining that it’s up to the insurance companies to follow the rules.

“Despite the fact that the advocacy groups requested and even suggested specific guidelines on how to follow this piece of the mandate, those guidelines were not issued,” she said. “I don’t know that insurance companies have taken the time to really understand the pieces of the mandate.”

Since her initial study, Mackay has administered a subsequent, detailed survey to shed light on the extent of coverage denials, as well as highlight the reasons behind unjustified denials. She also aims to identify whether fear of insurance denials affects clinical trial patient enrollment.

Mackay hopes to have results of this study soon. In the meantime, she said, providers need to educate their patients on the importance of participating in trials and encourage them to find out how much their insurance covers.

“Without clinical trials, we’re not able to move the field forward. It’s through the clinical trial process that new treatments become available to the widespread market,” she said. “Lack of adequate enrollment to trials and delays in enrollment limit the generalizability of the results and cause trials to fail to gather enough data. Removing the insurance barrier should help.”

Mackay C, Antonelli K, Bruinooge S, et al. Cancer center and community research program experience with insurance denials for clinical trial participation after ACA mandate. Presented at: 2015 AACI/CRI Meeting; October 25-27, 2015; Washington, DC.

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