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APHA Scientific Session and Event Listing

Regina El Arculli, MA¹, Carissa Baker², Kerri M. Lowrey, JD; MPH², and Melissa Schober³. (1) Project Director, State Cancer Legislative Database Program, National Cancer Institute's Office of Policy Analysis and Response, Building 31, Room 10A48, 31 Center Drive, MSC 2580, Bethesda, MD 20892, 301-496-5217, elarculli@nih.gov, (2) The MayaTech Corporation, Center for Health Policy and Legislative Analysis, 1100 Wayne Avenue, Suite 900, Silver Spring, MD 20910, (3) Senior Legislative Analyst, Women’s Policy Inc., 409 12th St, SW, Ste. 310, Washington, DC 20024

A 2005 report by the Agency for Healthcare Research and Quality identified over 100 barriers to accrual to cancer clinical trials by priority populations. Foremost among the reported barriers were underinsurance and a lack of culturally and linguistically competent health professionals. In an attempt to ameliorate barriers faced by these priority populations, patient navigator (PN) programs have been created and some states have mandated health insurance coverage for clinical trials. Mandatory coverage of clinical trials not only encourages accrual but is also consistent with the International Covenant on Economic, Social and Cultural Rights (U.N., 1976) which recognizes the right of individuals to “enjoy the benefits of scientific progress” and “[attain] the highest…standard of physical…health.”

For this presentation, we analyzed state-level legislative data from the National Cancer Institute's State Cancer Legislative Database (SCLD) to show which states mandate insurance cover for cancer clinical trials. In addition, we reviewed the extant literature and additional state-level policies governing PN programs.

Preliminary data from SCLD reveals that, as of December 31, 2005, less than 30 percent of states statutorily mandate some level of insurance coverage for clinical trials, and less than 10 percent require coverage for Phase I clinical trials. While federal legislation has been enacted to fund PN demonstration projects, there is a paucity of state-level policy and legislation. A review of state statutes reveals that few have either codified guidelines published by NIH or the AMA supporting the inclusion of women and minorities in clinical trials or introduced legislation calling for PNs.

Learning Objectives:

• At the conclusion of this presentation, participants will be able to recognize common barriers to accrual to cancer clinical trials and current legislative efforts to ameliorate said barriers. Participants will also be able to describe the extent to which state laws require insurers to provide coverage for cancer clinical trials.

Keywords: Legislative, Clinical Trials

Related Web page: www.scld-nci.net

Presenting author's disclosure statement:

Not Answered