Payers Still Denying Coverage Despite Clinical Trial Mandate

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.”

Loosely Written Law Makes Enforcement Difficult

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.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.

Precertifications Help to Avoid Coverage Problems

“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 after the establishment of the ACA as states without prior regulation, indicating the previous laws did not serve the 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.

Figure 2: Reasons Given for Clinical Trial Coverage Denials

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 serviced by the insurance companies for large corporations. 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.

Burris added that the majority of the denials he has encountered at Sarah Cannon Research Institute were refusals by third-party payers. “We have had very few, but when denials come up, it tends to be a self-paid plan where someone works for a major corporation and they’re self-insured and the commercial insurer is the administrator of the plan,” Burris said. “In those scenarios, whenever we have gone forward and made the request back to the payer, the employers always allowed them to be done.”

Recommendations for Improving Patient Access to Coverage

Mackay attributes the differences in coverage partly to a lack of clarity and the failure to enforce 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.”Members of ASCO and dozens of other organizations have recommended ways for the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services to implement the clinical trial mandate. These suggestions include establishing safeguards to prevent delays and administrative barriers that bar access to coverage during a trial. They also recommend that coverage information be clarified for enrollees and that limits be imposed on the distance a cancer patient must travel to receive treatment.

Polite said that he is interested in collecting stories from patients about insurance denials. “CMS at this point is not convinced that it’s a problem. That’s the issue,” he said. “It’s the job of us at ASCO to bring to their attention that you may think that this isn’t a problem. But I can tell you from on the ground: this is what’s going on.”

“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.