(a)For a beneficiary diagnosed with cancer and accepted into a phase I, phase II, phase III, or phase IV clinical trial for cancer or for any other qualifying clinical trial, as defined by Section 1396d(gg)(2) of Title 42 of the United States Code, the Medi-Cal program shall provide coverage for all routine patient care costs related to the clinical trial if the beneficiary’s treating physician, who is providing covered health care services to the beneficiary under the Medi-Cal program, recommends participation in the clinical trial after determining that participation in the clinical trial has a meaningful potential to benefit the beneficiary. For purposes of this section, a clinical trial’s endpoints shall not be defined exclusively to test toxicity, but shall have a therapeutic
i
Free access — add to your briefcase to read the full text and ask questions with AI
(a)
For a beneficiary diagnosed with cancer and accepted into a phase I, phase II, phase III, or phase IV clinical trial for cancer or for any other qualifying clinical trial, as defined by Section 1396d(gg)(2) of Title 42 of the United States Code, the Medi-Cal program shall provide coverage for all routine patient care costs related to the clinical trial if the beneficiary’s treating physician, who is providing covered health care services to the beneficiary under the Medi-Cal program, recommends participation in the clinical trial after determining that participation in the clinical trial has a meaningful potential to benefit the beneficiary. 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)
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:
(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 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.).
(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 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.
(E)
Health care services customarily provided by the research sponsors free of charge for any beneficiary in the trial.
(c)
The treatment shall be provided in a qualifying clinical
trial, which means a clinical trial, in any clinical phase of development, that is conducted in relation to the prevention, detection, or treatment of any serious or life-threatening disease or condition and is described in Section 1396d(gg)(2)(A) of Title 42 of the United States Code.
(d)
This section does not prohibit the Medi-Cal program 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.
(e)
The provision of services when required by this section shall not, in itself, give rise to liability on the part of the Medi-Cal program.
(f)
This section shall be implemented only to the extent that any necessary federal approvals are obtained, and federal
financial participation is available and not otherwise jeopardized.
(g)
The amendments made to this section by the act that added this subdivision shall become effective on July 1, 2022.