(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.
Source:
Section 1370.6, https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=HSC§ionNum=1370.6..