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. 2012 May;8(3 Suppl):41s-6s.
doi: 10.1200/JOP.2012.000547.

Payer coverage for patients enrolled onto clinical trials: making the process easy and transparent for everyone

Carol S Palackdharry, David L Evans, Robert S McDonough, Melissa E Clarke, James D Cross, Ira M Klein, Lonny Reisman

Payer coverage for patients enrolled onto clinical trials: making the process easy and transparent for everyone

Carol S Palackdharry et al. J Oncol Pract. 2012 May.
No abstract available

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Figures

Figure 1.
Figure 1.
The Affordable Care Act (ACA) definitions of “routine costs,” “qualified individual,” and “approved clinical trial.” AHRQ, Agency for Healthcare Research and Quality; CDC, Centers for Disease Control and Prevention; CMS, Centers for Medicare and Medicaid Services; DOD, Department of Defense; IND, investigational new drug No.; NIH, National Institute of Health; VA, Veteran's Administration.
Figure 2.
Figure 2.
List of proposed data elements to be provided to payers for patients on clinical trials. The majority of these data elements are trial-specific and could be formulated onto a template. The documentation questions require only a yes or no answer and not transmission of those documents to the payer or plan manager. The inclusion of these details will increase trial transparency for patients and payers. These data would also allow payers to not only provide appropriate support but collect valuable data for comparative effectiveness research and outcomes. DOB, date of birth; ECHO, echocardiogram; ECOG, Eastern Cooperative Oncology Group; ID, identification; IND, investigational new drug No.; IRB, institutional review board; PFT, pulmonary function testing; PS, performance status.
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Comment in

References

    1. Section 2709 of the Patient Protection and Affordable Care Act: Coverage for individuals participating in approved clinical trials. 42 U.S.C. §300gg-8, p 52.
    1. US Department of Health and Human Services. Guidance for industry oversight of clinical investigations: A risk-based approach to monitoring. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati....
    1. Gutmann A, Wagner J, et al. Moral Science: Protecting Participants in Human Subjects Research. Washington, DC: Presidential Commission for the Study of Bioethical Issues; 2011. http://bioethics.gov/cms/node/558.