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09300SB2339sam001 |
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LRB093 17610 WGH 48877 a |
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| exemption under Section 505(l) of the federal Food, Drug, |
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| and Cosmetic Act or an investigational device exemption |
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| under Section 520(g) of that Act), or a qualified |
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| nongovernmental cancer research entity as defined in |
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| guidelines of the National Institutes of Health or a peer |
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| reviewed and approved cancer research program, as defined |
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| by the U.S. Secretary of Health and Human Services, |
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| conducted for the primary purpose of determining whether or |
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| not a cancer treatment is safe or efficacious or has any |
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| other characteristic of a cancer treatment that must be |
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| demonstrated in order for the cancer treatment to be |
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| medically necessary or appropriate; |
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| (4) the trial is being conducted at multiple sites |
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| throughout the State; |
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| (5) the patient's primary care physician, if any, is |
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| involved in the coordination of care; and |
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| (6) the results of the investigational trial will be |
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| submitted for publication in peer-reviewed scientific |
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| studies, research, or literature published in or accepted |
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| for publication by medical journals that meet nationally |
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| recognized requirements for scientific manuscripts and |
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| that submit most of their published articles for review by |
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| experts who are not part of the editorial staff. These |
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| studies may include those conducted by or under the |
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| auspices of the federal government's Agency for Health Care |
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| Policy and Research, National Institutes of Health, |
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| National Cancer Institute, National Academy of Sciences, |
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| Health Care Financing Administration, and any national |
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| board recognized by the National Institutes of Health for |
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| the purpose of evaluating the medical value of health |
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| services.".
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