(b)

1. (1) In accordance with Section 1396d(gg)(1) of Title 42 of the United States Code, “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 under the Medi-Cal program 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 a beneficiary may require as a result of the treatment being provided for purposes of the clinical trial, except as required under the Medicaid Program (42 U.S.C. Sec. 1396a et seq.).
   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 items or services that, except for the fact that they are being provided in a clinical trial, are not otherwise covered by the Medi-Cal program.
   5. (E) Health care services customarily provided by the research sponsors free of charge for any beneficiary in the trial.