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Whether a third-party carrier will provide reimbursement to patients for clinical trials participation is often uncertain. As a result, the prospect of paying for trial participation out of pocket may prevent patients with cancer from enrolling onto a trial, even though it may provide the best treatment option. Despite the benefits of clinical trials, attempts to federally mandate coverage of clinical trial–related costs have not been successful. Efforts in state legislatures have been more successful with clinical trials legislation. As of November 2006, 20 states have clinical trials coverage laws (Table 1). In addition, insurers in Georgia, Michigan, and New Jersey have signed agreements to voluntarily cover the costs of clinical trials. In Ohio, the primary health plan for state employees has agreed to reimburse covered individuals for participating in a clinical trial.
Medicare began coverage of clinical trials in late 2000, providing reimbursement for all trial items and services, except the following: the investigational item or service itself, items and services provided solely to satisfy data collection and analysis needs, and items and services usually provided free of charge by the trial sponsor. In July 2006, the Centers for Medicaid & Medicare Services (CMS) issued a notice that it is reconsidering this coverage policy. It is unlikely that CMS will rescind coverage, but it does intend to address issues that have arisen with implementation, such as the definitions of routine care and research costs, the registering of clinical trials, removal of the self-certification process, and federal oversight of trials exempt from the Food and Drug Administration investigational new drug review. ASCO submitted comments in response to CMS' July 2006 notice and submitted additional information to a December 2006 Medicare Coverage Advisory Committee meeting. (Both sets of comments are available by contactinggro.ocsa@hcraeserrecnac.) [Editor's note: See the November 2006 issue of the Journal of Oncology Practice for articles on “Navigating the Clinical Trial Billing Maze” on page 280 and “Developing an Effective and Compliant Plan for Billing Clinical Trials” on page 265.]
The state laws differ in the types of trials covered with respect to phase and disease (cancer only or life-threatening diseases), as well as whether the trial addresses prevention, treatment, palliation, or early detection. Specific trial-related costs and other criteria also vary across laws and agreements. Oncologists should check with the relevant laws in their own states to better understand coverage requirements. More detailed information on the state laws can be found online at www.jopasco.org.