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3"632.87
(6) (a) 1. Except as provided in subd. 2., in this subsection, "routine
4costs" means all health care services, items, and drugs that are typically provided in
5health care; all health care services, items, and drugs that are required solely for the
6provision of the health care service, item, or drug; the appropriate monitoring of the
7effects of the health care services, items, and drugs; the prevention of complications
8arising from the health care services, items, and drugs; and health care services,
9items, and drugs that are needed for reasonable and necessary care arising from the
10provision of the health care service, item, or drug.
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2. "Routine costs" does not include the health care service, item, or
12investigational drug that is the subject of the trial; any services provided solely to
13satisfy data collection and analysis needs that are not used in the direct clinical
1management of the patient; any services, items, or drugs provided by the trial
2sponsors free of charge for any patient; or any services, items, or drugs that are
3eligible for reimbursement by a person other than the insurer, including the sponsor
4of the trial.
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(b) No policy, plan, or contract may exclude coverage for any routine costs".
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1"3. The clinical trial is not designed exclusively to test toxicity or disease
2pathophysiology but has therapeutic intent.
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4. The clinical trial enrolls individuals with diagnosed disease rather than
4healthy individuals, except that if the clinical trial tests a diagnostic intervention it
5may enroll healthy individuals in order to have a proper control group.".