Cal. Health & Safety Code § 1370.6
Standards
Redline — January 1, 2011 → current.View current text →
Current — January 1, 2019
As of January 1, 2011
(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.
(a) An individual or group health care service plan contract that is issued, amended, or renewed on or after January 1, 2020, shall not:
(1) Deny a qualified enrollee’s participation in an approved clinical trial.
(2) Deny, limit, or impose additional conditions on the coverage of routine patient care costs for items and services furnished in connection with a qualified enrollee’s participation in an approved clinical trial.
(3) Discriminate against an enrollee based on the qualified enrollee’s participation in an approved clinical trial.
(b) (1) Subdivision (a) applies to:
(A) A qualified enrollee participating in an approved clinical trial conducted by a participating provider.
(B) A qualified enrollee participating in an approved clinical trial conducted by a nonparticipating provider, including a nonparticipating provider located outside this state, if the clinical trial is not offered or available through a participating provider.
(2) If one or more participating providers is conducting an approved clinical trial, a health care service plan may require a qualified enrollee to participate in the clinical trial through a participating provider if the participating provider accepts the enrollee as a clinical trial participant.
(3) A health care service plan may restrict coverage to an approved clinical trial in this state, unless the clinical trial is not offered or available through a participating provider in this state.
(c) (1) The payment rate for routine patient care costs provided by a nonparticipating provider under a contract that is issued, amended, or renewed on or after January 1, 2020, shall be the negotiated rate the health care service plan would otherwise pay a participating provider for the same services, less applicable cost sharing.
(2) Cost sharing for routine patient care costs shall be the same as that applied to the same services not delivered in a clinical trial, except that the in-network cost sharing and out-of-pocket maximum shall apply if the clinical trial is not offered or available through a participating provider.
(3) This section does not limit or modify any existing requirements under this chapter or prevent application of cost-sharing provisions in a contract, except as provided in paragraph (2).
(d) For purposes of this section:
(1) “Approved clinical trial” means a phase I, phase II, phase III, or phase IV clinical trial conducted in relation to the prevention, detection, or treatment of cancer or another life-threatening disease or condition that meets at least one of the following:
(A) The study or investigation is approved or funded, which may include funding through in-kind donations, by one or more of the following:
(i) The National Institutes of Health.
(ii) The federal Centers for Disease Control and Prevention.
(iii) The Agency for Healthcare Research and Quality.
(iv) The federal Centers for Medicare and Medicaid Services.
(v) A cooperative group or center of any of the entities described in clauses (i) to (iv), inclusive, the Department of Defense, or the United States Department of Veterans Affairs.
(vi) A qualified nongovernmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants.
(vii) One of the following departments, if the study or investigation has been reviewed and approved through a system of peer review that the Secretary of the United States Department of Health and Human Services determines is comparable to the system of peer review used by the National Institutes of Health and ensures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review:
(I) The United States Department of Veterans Affairs.
(II) The United States Department of Defense.
(III) The United States Department of Energy.
(B) The study or investigation is conducted under an investigational new drug application reviewed by the United States Food and Drug Administration.
(C) The study or investigation is a drug trial that is exempt from an investigational new drug application reviewed by the United States Food and Drug Administration.
(2) “Life-threatening disease or condition” means a disease or condition from which the likelihood of death is probable, unless the course of the disease or condition is interrupted.
(3) “Qualified enrollee” means an enrollee who meets both of the following conditions:
(A) The enrollee is eligible to participate in an approved clinical trial, according to the clinical trial protocol, for the treatment of cancer or another life-threatening disease or condition.
(B) Either of the following applies:
(i) The referring health care professional is a participating provider and has concluded that the enrollee’s participation in the clinical trial would be appropriate because the enrollee meets the conditions of subparagraph (A).
(ii) The enrollee provides medical and scientific information establishing that the enrollee’s participation in the clinical trial would be appropriate because the enrollee meets the conditions of subparagraph (A).
(4) “Routine patient care costs” include drugs, items, devices, and services provided consistent with coverage under the contract for an enrollee who is not enrolled in an approved clinical trial, including the following:
(A) Drugs, items, devices, and services typically covered absent a clinical trial.
(B) Drugs, items, devices, and services required solely for the provision of an investigational drug, item, device, or service.
(C) Drugs, items, devices, and services required for the clinically appropriate monitoring of the investigational drug, item, device, or service.
(D) Drugs, items, devices, and services provided for the prevention of complications arising from the provision of the investigational drug, item, device, or service.
(E) Drugs, items, devices, and services needed for the reasonable and necessary care arising from the provision of the investigational drug, item, device, or service, including diagnosis and treatment of complications.
(5) “Routine patient care costs” does not include the following:
(A) The investigational drug, item, device, or service itself.
(B) Drugs, items, devices, and services provided solely to satisfy data collection and analysis needs that are not used in the direct clinical management of the enrollee.
(C) Drugs, items, devices, and services specifically excluded from coverage in the contract, except for drugs, items, devices, and services required to be covered pursuant to this section or other applicable law.
(D) Drugs, items, devices, and services customarily provided free of charge to a clinical trial participant by the research sponsor.
(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.
(e) This section shall not be construed to limit coverage provided by a health care service plan contract with respect to clinical trials.
(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.
(f) The provision of services required by this section shall not, in itself, give rise to liability on the part of the health care service plan.
(g) This section does not apply to a specialized health care service plan contract.
(h) This section does not 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.
Official source: California Legislative Information. Reproduced from public-domain California statutes; confirm against the official source for the current text. Not legal advice.