(a) The provisions of this section shall be applicable to any county that seeks to provide or arrange for the provision of health care services provided under Article 2.8 and to Santa Barbara County if it seeks to provide or arrange the provision of health care services pursuant to Section 14499.5.

(b) For an enrollee diagnosed with cancer and accepted into a phase I, phase II, phase III, or phase IV clinical trial for cancer, every County Organized Health System contract that is issued, amended, delivered, or renewed in this state, shall provide coverage for all routine patient care costs related to the clinical trial if the enrollee’s treating physician, who is providing covered health care services to the enrollee under the enrollee’s County Organized Health System contract, recommends participation in the clinical trial after determining that participation in the clinical trial has a meaningful potential to benefit the enrollee. For purposes of this section, physicians that are providing care under a subcontract with an entity under contract with a County Organized Health System shall be considered to be physicians providing covered health care services to the enrollee under the County Organized Health System contract. For purposes of this section, a clinical trial’s endpoints shall not be defined exclusively to test toxicity, but shall have a therapeutic intent.

(c) (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:

(A) Health care services typically provided absent a clinical trial.

(B) Health care services required solely for the provision of the investigational drug, item, device, or service.

(C) Health care services required for the clinically appropriate monitoring of the investigational item or service.

(D) Health care services provided for the prevention of complications arising from the provision of the investigational drug, item, device, or service.

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

(A) Drugs or devices that have not been approved by the federal Food and Drug Administration and that are associated with the clinical trial.

(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.

(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.

(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.

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

(2) Is approved by one of the following:

(A) One of the National Institutes of Health.

(B) The federal Food and Drug Administration, in the form of an investigational new drug application.

(C) The United States Department of Defense.

(D) The United States Veterans’ Administration.

(e) In the case of health care services provided by a participating provider, the payment rate shall be at the agreed-upon rate. In the case of a nonparticipating provider, the payment shall be at the negotiated rate the plan would otherwise pay to a participating provider for the same services, less any applicable copayments and deductibles.

(f) Nothing in this section shall be construed to prohibit a County Organized Health System from restricting coverage for clinical trials to participating hospitals and physicians in California unless the protocol for the clinical trial is not provided for at a California hospital or by a California physician.

(g) The provision of services when required by this section shall not, in itself, give rise to liability on the part of the County Organized Health System.

(h) Nothing in this section shall be construed to otherwise limit or modify any existing requirements under the provisions of this chapter.

(Added by Stats. 2001, Ch. 172, Sec. 3. Effective January 1, 2002.)