More States Mandate Coverage of Clinical Trial Costs, But Does It Make a Difference?

McBride, Gail

doi:10.1093/jnci/95.17.1268

Cited by 9 publications

(10 citation statements)

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“…There have been myriad calls to improve reimbursement for clinical trials and establish federal and state policies to lower barriers to insurance coverage for trial participants. 38,39 While such policies have had mixed evidence of effectiveness, 40,41 “pay-for-performance” and other emerging plans are gaining momentum, with a central premise of reimbursement incentives for higher quality care. 42,43 It may be that a pay-for-performance reimbursement premium for improved quality will underwrite clinical research inefficiencies, and in a circular fashion the concomitant greater quality will help justify that premium.…”

Section: Discussionmentioning

confidence: 99%

Translating Research Into Practice

Carpenter

Meyer

et al. 2012

Medical Care

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Background Provider-based research networks (PBRNs) – collaborative research partnerships between academic centers and community-based practitioners – are a promising model for accelerating the translation of research into practice; however, empirical evidence of accelerated translation is limited. Oxaliplatin in adjuvant combination chemotherapy is an innovation with clinical trial-proven survival benefit compared to prior therapies. The goal of this study is to examine the diffusion of oxaliplatin into community practice, and whether affiliation with the National Cancer Institute’s (NCI’s) Community Clinical Oncology Program (CCOP) – a nationwide cancer-focused PBRN – is associated with accelerated innovation adoption. Design, Setting, and Participants This retrospective observational study used linked SEER-Medicare and NCI-CCOP data to examine Medicare participants with stage III colon cancer initiating treatment in 2003 through 2006, the years surrounding oxaliplatin’s FDA approval. A fixed-effects analysis examined chemotherapy use among patients treated outside academic centers at CCOP-affiliated practices compared to non-CCOP practices. Two-group modeling controlled for multiple levels of clustering, year of chemotherapy initiation, tumor characteristics, patient age, race, comorbidity, Medicaid dual-eligibility status, and education. Results Of 4,055 community patients, 35% received 5-FU, 20% received oxaliplatin, 7% received another chemotherapy, and 38% received no chemotherapy. 25% of CCOP patients received oxaliplatin, compared to 19% of non-CCOP patients. In multivariable analysis, CCOP exposure was associated with higher odds of receiving guideline-concordant treatment in general, and oxaliplatin specifically. Conclusions These findings contribute to a growing set of evidence linking PBRNs with a greater probability of receiving treatment innovations and high quality cancer care, with implications for clinical and research policy.

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Section: Discussionmentioning

confidence: 99%

Translating Research Into Practice

Carpenter

Meyer

et al. 2012

Medical Care

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“…Several factors limited the comprehensive nature of these efforts including inconsistent state legislation and regulations that do not apply to self-insured plans often offered by large employers, and varying Medicaid coverage rules set by each state. Research suggests these laws had varying effects on overall clinical trial accrual rates [9] , [16] , [17] , [18] Nearly one in five individuals aged 19–64 were not covered for trial participation based solely on not having health insurance coverage in 2012 [19] .…”

Section: Pre-aca Attempts To Address Coveragementioning

confidence: 99%

Clinical trial insurance coverage for cancer patients under the Affordable Care Act

Mackay

Gurley-Calvez

Erickson

et al. 2016

Contemporary Clinical Trials Communications

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BackgroundParticipation in cancer clinical trials has been shown to increase overall survival with minimal increase in cost, but enrollment in adult cancer clinical trials remains low. One factor limiting enrollment is lack of insurance coverage, but this barrier should be reduced under the 2010 Patient Protection and Affordable Care Act (ACA), which includes a provision requiring coverage for clinical trial participation as of 2014.MethodsTo assess the number of Kansas adults aged 19–64, newly covered with health insurance for participation in oncology clinical trials as a result of the ACA, a cross sectional design using extracted data from the 2012 American Community Survey, Public Use Microdata Sample to estimate the number of individuals covered by insurance and data from the 2014 Department of Health and Human Services Health Insurance Marketplace enrollment to estimate those newly enrolled through ACA.ResultsIn 2014, there was an estimated increase of 3% (54,397; 95% CI: 44,149–64,244) for a total of 72% (1,171,041) of Kansans aged 19 to 64 with health insurance coverage for clinical trial participation.ConclusionThree main factors limit the effectiveness of the ACA provisions in expanding clinical trial coverage: 1) ‘grandfathered’ self-funded employer plans not subject to state Employee Retirement Income Security Act (ERISA) regulations, 2) Medicaid coverage limits not addressed under the ACA, 3) populations that remain uninsured. Kansas saw a negligible increase in insurance coverage as a result of the ACA thus lack of insurance coverage is likely to remain a concern for cancer patients.

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“…In 2001, Bennett et al (7) found that some states had already been experimenting with mandates that insurers who did business within their borders cover routine care costs in oncology trials. In 2003, McBride (8) reported an increase in state cancer trial coverage mandates. However, their impact, as measured by accrual increases since 2001, appeared to be modest, nonexistent, or unknown (depending on the state), perhaps, guessed some, because few participants were aware of them.…”

Section: From the Editorsmentioning

confidence: 99%

State Payer Mandates to Cover Care in US Oncology Trials: Do Science and Ethics Matter?

Taylor¹

2010

JNCI Journal of the National Cancer Institute

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ResultsTwenty-six states mandated coverage. Four states (15%) required scientific peer review for all studies. For 20 states (80%), an approved investigational new drug qualified as scientific review. In 10 states (38%), institutional review board (IRB) approval could replace scientific review. Twenty-four states (92%) permitted trials without academic medical connection. All states covered privately insured patients; seven (27%) included government and Medicaid patients. Fourteen states (54%) covered phase I to phase IV trials. Sixteen states (62%) covered treatment trials only; one (4%) covered prevention, detection, treatment, and palliation. Thirteen states (50%) covered research-related injuries. Only seven states (27%) required IRB approval. Three states (12%) required commensurate risks and benefits; 23 (88%) had no standard. Eight states (31%) required clinical equipoise with standard care; eight (31%) had no standard; and remaining states (46%) had unique standards. Two states (8%) addressed publication or registries. ConclusionsMost states did not demand independent scientific review, IRB review, or basic ethical features of high-quality trials; provided partial coverage; omitted prevention, detection, and palliation research; and omitted mandated coverage for research-related injuries. Few required evaluation, independence in publication, or posting trial results. Further research on the impact of diverse state choices would improve policy making.

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More States Mandate Coverage of Clinical Trial Costs, But Does It Make a Difference?

Cited by 9 publications

References 0 publications

Translating Research Into Practice

Translating Research Into Practice

Clinical trial insurance coverage for cancer patients under the Affordable Care Act

State Payer Mandates to Cover Care in US Oncology Trials: Do Science and Ethics Matter?

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