(c)

1. (1) “Routine patient care costs” means the costs associated with the provision of health care services, including drugs, items, devices, and services that would otherwise be covered by the County Organized Health System if those drugs, items, devices, and services were not provided in connection with an approved clinical trial program, including:

   1. (A) Health care services typically provided absent a clinical trial.
   2. (B) Health care services required solely for the provision of the investigational drug, item, device, or service.
   3. (C) Health care services required for the clinically appropriate monitoring of the investigational item or service.
   4. (D) Health care services provided for the prevention of complications arising from the provision of the investigational drug, item, device, or service.
   5. (E) Health care services needed for the reasonable and necessary care arising from the provision of the investigational drug, item, device, or service, including the diagnosis or treatment of the complications.

2. (2) For purposes of this section, “routine patient care costs” does not include the costs associated with the provision of any of the following:

   1. (A) Drugs or devices that have not been approved by the federal Food and Drug Administration and that are associated with the clinical trial.
   2. (B) Services other than health care services, such as travel, housing, companion expenses, and other nonclinical expenses, that an enrollee may require as a result of the treatment being provided for purposes of the clinical trial.
   3. (C) Any item or service that is provided solely to satisfy data collection and analysis needs and that is not used in the clinical management of the patient.
   4. (D) Health care services that, except for the fact that they are being provided in a clinical trial, are otherwise specifically excluded from coverage under the enrollee’s County Organized Health System.
   5. (E) Health care services customarily provided by the research sponsors free of charge for any enrollee in the trial.

(d) The treatment shall be provided in a clinical trial that either:

1. (1) Involves a drug that is exempt under federal regulations from a new drug application.

2. (2) Is approved by one of the following:

   1. (A) One of the National Institutes of Health.
   2. (B) The federal Food and Drug Administration, in the form of an investigational new drug application.
   3. (C) The United States Department of Defense.
   4. (D) The United States Veterans’ Administration.