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Insurance Coverage for Clinical Trial Participation: Significant Barriers Remain

September 19, 2017

by Lisa Schlager

Patients are denied insurance coverage for participation in clinical trials. It is estimated that less than 5% of adults with cancer enroll in clinical trials. About a fifth of adult cancer clinical trials fail to recruit enough participants to complete the research.[1] These two facts hinder the development of better, safer methods to treat and prevent cancer. To help improve this situation, the Affordable Care Act (ACA) includes a provision requiring most private health insurers to pay for routine patient care provided to participants in clinical trials. This component of the law is important because insurance denial of these costs—and the length of time it takes to receive a response about coverage from the insurer—have been identified as significant barriers to adult cancer clinical trial enrollment.

Before the ACA, insurance coverage for clinical trial participation was inconsistent at best. Federal regulations required trial coverage for Medicare beneficiaries. State laws covered patients under other plans but varied in the types of trials, beneficiaries, and payers affected. Even now, some insurance plans are exempt from the trial coverage mandate.

Researchers examine insurance coverage of clinical trial participation

Research published in the August 1, 2017 issue of Cancer, looked at whether insurance denials persist after the implementation of the ACA clinical trial mandate for cancer patients. Investigators also explored the reasons used to deny coverage and any research-site factors associated with denials.

The researchers deployed a survey to cancer research centers and community-based institutions to gather details on insurance denials of coverage for trial participation. Of the reasons provided to justify coverage denial, the most frequent explanations were:

  1. Insurer claimed that the plan did not cover trial participation
  2. Study site was out of the insurers’ provider network
  3. Plan was grandfathered (i.e. the plan was in place prior to the passage of the ACA and is exempt from many of the consumer protections required under the ACA)
  4. Participation in a Medicare Advantage (MA) plan

Nearly 80% of trial sites reported not receiving a coverage response from the health insurer within 72 hours. Delays in coverage notification may have a significant effect on participation in trials with patients experiencing additional uncertainty, emotional distress, and concerns about disease progression/postponement of treatment.

Complicating matters, there is no publically available list of grandfathered health insurance plans. A 2015 Kaiser Family Foundation survey reported that about a quarter of covered workers were enrolled in grandfathered plans, with the highest percentage (41%) in companies with 25-49 workers.[2] While these plans are expected to lose their grandfathered status over time, a significant part of the population may currently lack trial coverage.

Medicare coverage for participation in clinical trials

Patients who participate in a Medicare Advantage (MA) plan are protected under the clinical trial policy issued in 2000 by the Centers for Medicare & Medicaid Services through traditional Medicare. The MA plan is required to compensate the enrollee only for the difference in out-of-pocket costs between traditional Medicare and their MA plan.[3] As such, MA plans routinely deny coverage because they are not required to cover clinical trials—but they often fail to clarify that the patient still has coverage under traditional Medicare. MA participants may miss trial participation opportunities if they don’t understand that they have coverage via traditional Medicare.

Medicaid coverage for participation in clinical trials

A few study sites reported that potential participants were excluded from trials because of Medicaid denials. Medicaid coverage rules are set by each state so trial coverage (or lack thereof) varies significantly among Medicaid plans. Only a fifth of states have rules that ensure trial coverage for Medicaid beneficiaries; the majority do not clearly require coverage. This is problematic as clinical trial results are often criticized for underrepresentation of certain cancer population subgroups, including racial and ethnic minorities and the elderly.

Lack of insurance coverage, either real or perceived, likely deters cancer patients and their health care providers from considering clinical trials. While insurance coverage is only one component of the enrollment process, guaranteed trial coverage would result in fewer barriers to participation. This study shows that despite the ACA mandate, insurance denials continue to be a significant barrier to trial enrollment. As with other health care barriers, consumer education can help patients know their rights and equip them with tools to appeal health plan denials.

Ultimately, better clinical trial participation helps all segments of society. If we are to realize the promise of accelerated research, more effective therapies and fewer adverse effects, insurers need to step up to the plate and recognize their role in clinical trial enrollment. The approval of better treatments with fewer side effects can ultimately save health insurers money as inferior treatments are replaced with more effective, less toxic options.

References:

[1] Hutch News, “Why 1 in 5 cancer clinical trials fizzle.”

[2] Kaiser Family Foundation. 2015 employer health benefits survey. Section thirteen: grandfathered health plans.

[3] Centers for Medicare & Medicaid Services. Medicare & clinical research studies.

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