1370.6
. (a) For an enrollee diagnosed with cancer and accepted into
a phase I, phase II, phase III, or phase IV clinical trial for
cancer, every health care service plan contract, except a specialized
health care service plan 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 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 enrollee. 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:
(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 health plan.
(E) Health care services customarily provided by the research
sponsors free of charge for any enrollee in the trial.
(3) Nothing in this section shall require a health care service
plan contracting with the State Department of Health Services for the
purpose of providing Medi-Cal benefits to enrolled beneficiaries or
contracting with the Managed Risk Medical Insurance Board for the
purposes of providing benefits under the Healthy Families Program,
the Access for Infants and Mothers Program, or the California Major
Risk Medical Insurance Program, to be responsible for reimbursement
of services excluded from their contract because another entity is
responsible by statute or otherwise for reimbursement of the service
provider.
(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.
(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.
(d) 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.
(e) Nothing in this section shall be construed to prohibit a
health care service plan 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.
(f) The provision of services when required by this section shall
not, in itself, give rise to liability on the part of the health care
service plan.
(g) Nothing in this section shall be construed to limit, prohibit,
or modify an enrollee's rights to the independent review process
available under Section 1370.4 or to the Independent Medical Review
System available under Article 5.55 (commencing with Section
1374.30).
(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 copayment or deductible
provisions in a plan.
(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.