CA Ins Code Section 10145.4

(a)

For an insured diagnosed with cancer and accepted into a phase I, phase II, phase III, or phase IV clinical trial for cancer, every policy of disability insurance that provides hospital, medical, or surgical coverage in this state shall provide coverage for all routine patient care costs related to the clinical trial if the insured’s treating physician, who is providing covered health care services to the insured under the insured’s health benefit plan contract, recommends participation in the clinical trial after determining that participation in the clinical trial has a meaningful potential to benefit the insured. For purposes of this section, a clinical trial’s endpoints shall not be defined exclusively to test toxicity, but shall have a therapeutic intent.

(b)

(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 under the plan or contract if those drugs, items, devices, and services were not provided in connection with an approved clinical trial program, including the following:

(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 insured 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 which, except for the fact that they are not being provided in a clinical trial, are otherwise specifically excluded from coverage under the insured’s health plan.

(E)

Health care services customarily provided by the research sponsors free of charge for any enrollee in the trial.

(c)

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 or (2) that 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.

(d)

In the case of health care services provided by a contracting provider, the payment rate shall be at the agreed-upon rate. In the case of a noncontracting provider, the payment shall be at the negotiated rate the insurer would otherwise pay to a contracting provider for the same services, less applicable copayments and deductibles. Nothing in this section shall be construed to prohibit a disability insurer from restricting coverage for clinical trials to 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.

(e)

The provision of services when required by this section shall not, in itself, give rise to liability on the part of the insurer.

(f)

This section shall not apply to vision-only, dental-only, accident-only, specified disease, hospital indemnity, Medicare supplement, CHAMPUS supplement, long-term care, or disability income insurance, except that for specified disease and hospital indemnity insurance, coverage for benefits under this section shall apply, but only to the extent that the benefits are covered under the general terms and conditions that apply to all other benefits under the policy. Nothing in this section shall be construed as imposing a new benefit mandate on specified disease or hospital indemnity insurance.

(g)

Nothing in this section shall be construed to prohibit, limit, or modify an insured’s rights to the independent review process available under Section 10145.3 or to the Independent Medical Review System available under Article 3.5 (commencing with Section 10169).

(h)

Nothing in this section shall be construed to otherwise limit or modify any existing requirements under the provisions of this chapter or to prevent application of deductible or copayment provisions contained in the policy.

(i)

Copayments and deductibles applied to services delivered in a clinical trial shall be the same as those applied to the same services if not delivered in a clinical trial.