Insurance denials for cancer clinical trial participation after the Affordable Care Act mandate

BACKGROUND The Affordable Care Act (ACA) includes a mandate requiring most private health insurers to cover routine patient care costs for cancer clinical trial participation; however, the impact of this provision on cancer centers’ efforts to accrue patients to clinical trials has not been well des...

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Vydané v:Cancer Ročník 123; číslo 15; s. 2893 - 2900
Hlavní autori: Mackay, Christine B., Antonelli, Kaitlyn R., Bruinooge, Suanna S., Saint Onge, Jarron M., Ellis, Shellie D.
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: United States Wiley Subscription Services, Inc 01.08.2017
Predmet:
Academic Medical Centers
Affordable Care Act
Affordable Care Act–exempt
barrier
Cancer
cancer clinical trial
Clinical trials
Clinical Trials as Topic
Communities
Confidence intervals
Hospitals, Community
Humans
Informed consent
Institutions
Insurance
Insurance coverage
Insurance Coverage - legislation & jurisprudence
insurance denial
Insurance, Health - legislation & jurisprudence
Laws
Medical research
Multivariate Analysis
Neoplasms - therapy
Oncology
Patient Protection & Affordable Care Act 2010-US
Patient Protection and Affordable Care Act
Patient Selection
R&D
Research & development
Research facilities
Surveys and Questionnaires
United States
insurance denial
barrier
cancer clinical trial
Affordable Care Act
Affordable Care Act-exempt
ISSN:0008-543X, 1097-0142, 1097-0142
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Shrnutí:BACKGROUND The Affordable Care Act (ACA) includes a mandate requiring most private health insurers to cover routine patient care costs for cancer clinical trial participation; however, the impact of this provision on cancer centers’ efforts to accrue patients to clinical trials has not been well described. METHODS First, members of cancer research centers and community‐based institutions (n = 252) were surveyed to assess the status of insurance denials, and then, a focused survey (n = 77) collected denial details. Univariate and multivariate analyses were used to examine associations between the receipt of denials and site characteristics. RESULTS Overall, 62.7% of the initial survey respondents reported at least 1 insurance denial during 2014. Sites using a precertification process were 3.04 times more likely to experience denials (95% confidence interval, 1.55‐5.99; P ≤ .001), and similar rates of denials were reported from sites located in states with preexisting clinical trial coverage laws versus states without them (82.3% vs 85.1%; χ = 50.7; P ≤ .001). Among the focused survey sites, academic centers reported denials more often than community sites (71.4% vs 46.4%). The failure of plans to cover trial participation was cited as the most common reason provided for denials (n = 33 [80.5%]), with nearly 80% of sites (n = 61) not receiving a coverage response from the insurer within 72 hours. CONCLUSIONS Despite the ACA's mandate for most insurers to cover routine care costs for cancer clinical trial participation, denials and delays continue. Denials may continue because some insurers remain exempt from the law, or they may signal an implementation failure. Delays in coverage may affect patient participation in trials. Additional efforts to eliminate this barrier will be needed to achieve federal initiatives to double the pace of cancer research over the next 5 years. Future work should assess the law's effectiveness at the patient level to inform these efforts. Cancer 2017;123:2893–900. © 2017 American Cancer Society. Insurance denials for participation in adult cancer clinical trials continue despite the Affordable Care Act's clinical trial policy. Both academic and community research sites have experienced insurance denials and delays as barriers to patient enrollment.
Bibliografia:Initial survey data were presented at the 2015 American Association of Cancer Institutes/Clinical Research Initiative Annual Meeting; July 8‐9, 2015; Chicago, IL. Preliminary data were presented at the 2015 American Association of Cancer Institutes/Cancer Center Administrators Forum Annual Meeting; October 25‐27, 2015; Washington, DC. The data were partially presented at the 2016 Practical Applications of New Agents in Oncology Conference; February 5, 2016; San Antonio, TX. The study was presented as abstract e14047 at the 2016 American Society of Clinical Oncology Annual Meeting; June 3‐7, 2016; Chicago, IL.
We thank the members of the Association of American Cancer Institutes/Clinical Research Initiative, the American Society of Clinical Oncology/Research Community Forum, the Midwest Cancer Alliance, and the Oncology Nursing Society/Clinical Trial Nurses Special Interest Group for participating in this study. We also appreciate the editorial staff of
for their support.
Cancer
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ISSN:0008-543X
1097-0142
1097-0142
DOI:10.1002/cncr.30689