Patient participation in clinical research is of vital importance for the development of advancements in medicine and cures to major diseases spanning therapeutic areas from treating cancers to cardiovascular to autoimmune disorder to central nervous system disease.  As is reported in a blog post below it is estimated that less than 5% of adults with cancer enroll in clinical trials.  About 20% of adult cancer clinical trials fail to recruit enough participants to complete the research. https://www.fredhutch.org/en/news/center-news/2015/12/one-in-five-cancer-clinical-trials-fizzle-fred-hutch.html. There are a host of reasons why clinical trials sponsors face ongoing challenges in securing sufficient numbers of participating patients.  TrialSite News will not address a comprehensive analysis of why there is a lack of participation in clinical trials in this entry.  We will focus on the critical need for insurance coverage (commercial and public payer) to ensure that those that may benefit from participating in clinical trials receive payer support for this potentially life-saving activity.  What follows is a brief survey of some literature on the subject.

The ACA included provisions for clinical trial coverage—see http://www.alicaremed.com/news/issuebrief/ammc_trial/The-Impact-of-the-Affordable-Care-Act-on-Clinical-Trials.html

In 2009 A Descriptive Analysis of State Legislation and Policy Addressing Clinical Trials Participation was published by authors Claudia R. Baquet, MD (University of Maryland School of Medicine); Shiraz I Mishra, MD, PhD (Baylor College of Medicine) and Armin D. Weinberg, PhD (Baylor College of Medicine). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3626735/.

The American Society of Clinical Oncology (ASCO) provides an overview of which states provide for insurance coverage of clinical trials.  https://www.asco.org/research-progress/clinical-trials/insurance-coverage-clinical-trials

In 2010 Italian researchers Sabina Gainotti and Carlo Petrini published Insurance Policies for Clinical Trials in the United States and in Some European Countries.   The authors’ comparative analysis highlights the strengths and weaknesses of the analyzed legislations and proposes a model for the insurance and compensation of injured research participants. https://www.omicsonline.org/insurance-policies-for-clinical-trials-in-the-united-states-and-in-some-european-countries-2155-9627.1000101.php?aid=1056

In 2015 and interesting analysis was published titled: Clinical Trial Insurance Coverage for Cancer Patients Under the Affordable Care Act, authored by Christine B. Mackay (University of Kansas Medical Center); Tami Gurley-Calvez (University of Kansas Medical Center); Kristen D Erickson (University of Kansas Cancer Center) and Roy A Jensen (University of Kansas Cancer Center). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5935846/. The authors concluded that there were three main elements limiting the impact of the ACA provisions for expanding clinical trial coverage including

  • ‘Grandfathered self-funded employer plans not subject to state Employee Retirement Income Security ACT (ERISA) regulations
  • Medicaid coverage limits not addressed under ACA
  • Populations that remain uninsured.

The authors reported that there was a nominal increase in insurance coverage based on ACA and therefore lack of insurance coverage was likely to remain a concern for cancer patients.

The ACA required private insurers to pay the standard of care costs for patients participating in approved clinical trials. A study published in Clinical Cancer Research http://clincancerres.aacrjournals.org/content/early/2017/07/13/1078-0432.CCR-16-3027 found that the rate of patients cleared by their insurer to take part in early-phase oncology trials had increased.  The study looked at both rates of insurance clearance and prolonged to clearance at the clinical trial center of MD Anderson Cancer Center in Houston, Texas. The study authors noted that the provision of the ACA had been intended to expand access to clinical trials, but little research had been conducted to analyze the law’s actual impact on cancer trial participation.

Despite ACA era rules supporting coverage of clinical trials, authors published in The Journal of Oncology Practice in Insurance Denial of Coverage for Patients Enrolled in Cancer Clinical Trials is Still a Problem in the Affordable Care Act, http://ascopubs.org/doi/full/10.1200/jop.2015.010454 authored by Nitin Jain, MD, David Steensma, MD, David J. Stewart, MD and Hagop Katarjian, MD.  The authors note “Unfortunately, despite the ACA mandate, we continue to encounter situations in which the insurance companies create barriers to clinical trial enrollment. These barriers include denial of insurance coverage for clinical trials despite the ACA mandate when the patient is enrolled in a “grandfathered plan.” (Grandfathered plans are defined by HealthCare.gov as “health plans that were in existence on March 23, 2010, and haven’t been changed in ways that substantially cut benefits or increase costs for plan holders.” Some ACA provisions still apply to such plans, but others, including the clinical trial coverage requirement, do not.) Other barriers include lengthy approval processes that do not reflect the clinical time-scale of rapidly evolving cancers, such as hematologic malignancies, and unnecessary bureaucratic red tape, such as a requirement for multiple peer reviews. Collectively, these continue to hamper clinical trial participation by patients.”  Read this article for reports of denial of coverage and unacceptable delays.  Kelly Johnson of Onclive reported in 2016 https://www.onclive.com/publications/oncology-business-news/2016/april-2016/payers-still-denying-coverage-despite-clinical-trial-mandate that Payers are Still Denying Coverage despite Clinical Trial Mandate!

Lisa Schlager in the Force Blog publishes in 2017 Insurance Coverage for Clinical Trial Participation: Significant Barriers Remain. http://www.facingourrisk.org/get-involved/HBOC-community/BRCA-HBOC-blogs/FORCE/advocacy/insurance-coverage-clinical-trials/.

TrialSite News will continue to monitor insurance coverage laws and rules as well as denial of coverage and other material issues that impede the progress of clinical research. We invite readers to send us any direct experience you have had with insurance companies and clinical trials.  Editorial Staff.

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