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 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.
Department of Health Policy and Management, University of Kansas Medical Center, Fairway, Kansas.|University of Kansas Cancer Center, Fairway, Kansas.
Christine B
http://orcid.org/0000-0002-1582-346X
CB
Mackay
American Society of Clinical Oncology, Alexandria, Virginia.
Kaitlyn R
KR
Antonelli
American Society of Clinical Oncology, Alexandria, Virginia.
Suanna S
SS
Bruinooge
Department of Health Policy and Management, University of Kansas Medical Center, Fairway, Kansas.
Jarron M
JM
Saint Onge
Department of Health Policy and Management, University of Kansas Medical Center, Fairway, Kansas.|University of Kansas Cancer Center, Fairway, Kansas.
Shellie D
SD
Ellis
D000046:Academic Medical Centers; D002986:Clinical Trials as Topic; D006764:Hospitals, Community; D006801:Humans; D019458:Insurance Coverage / Q000331:legislation & jurisprudence*; D007348:Insurance, Health / Q000331:legislation & jurisprudence*; D015999:Multivariate Analysis; D009369:Neoplasms / Q000628:therapy*; D058991:Patient Protection and Affordable Care Act; D018579:Patient Selection; D011795:Surveys and Questionnaires; D014481:United States
Affordable Care Act; Affordable Care Act-exempt; barrier; cancer clinical trial; insurance denial