In an innovative move to open access for Michigan cancer patients to cancer clinical trials, one MCC member, the Michigan Society of Hematology and Oncology, convened a unique coalition of patient advocate groups, employers, insurance companies, and the representation of health care providers of clinical trials from both the academic and community outpatient setting to address this barrier.
In a precedent-setting agreement, all 25 members of the Michigan Association of Health Plans agreed to work to increase participation in select cancer-related clinical trials by making payment for services within this context predictable. All member health plans stated a willingness to provide coverage for the routine care costs of patient participation in approved clinical trials.
administrative costs are borne by the research cancer center;
expenses specifically generated by the clinical trial are covered by the pharmaceutical company; and
costs associated with routine patient care, delivery of the investigational agent, and treatment of adverse side effects are paid by the health plans.
The consensus document also spells out the protective parameters under which this coverage will occur:
The guidelines are applicable to Phase II and Phase III trials only.
Only studies with potential for therapeutic benefit for patients will be considered for coverage.
The specific trials adhere to procedural and ethical standards pertaining to conflict of interest and protection of human subjects, including peer review and review and approval by an Institutional Review Board (IRB).
Censorship by industry sponsors is prohibited.
The trial is being sponsored or has been approved by one or more of the following agencies: the National Institutes of Health (NIH) and NIH Cooperatives; the National Cancer Institute (NCI); the Department of Defense (DOD); the Food and Drug Administration (FDA); the Department of Veteran’s Affairs (VA); the Centers for Medicaid and Medicare; the Agency for Healthcare Research and Quality (AHRQ); the Centers for Disease Control (CDC); or a non-governmental research entity abiding by NIH guidelines.
Ad hoc investigational treatments not meeting these standards are not covered. Clinical trials related to cancer prevention may be covered outside the scope of this agreement by individual health plans according to their individual policies and procedures.
By clearly delineating the relationship between Michigan’s managed care plans and clinical trials within the state, this innovative document — it is one of only five such documents nationwide — seeks to increase access to clinical trials and thereby improve the quality of care for its members.
This accomplishment was announced during a press conference at the Michigan State Capitol building in February 2002.
MCC Clinical Trials Action Plan presentation highlighting the creation of the Michigan Working Group to Improve Cancer Outcomes (presentated to the MCC Board of Directors, Nov. 15, 2000; available as a Microsoft PowerPoint file)**
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