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AB-1107 Oncology Clinical Pathway Act of 2017.(2017-2018)

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Date Published: 03/22/2017 04:00 AM
AB1107:v98#DOCUMENT

Amended  IN  Assembly  March 21, 2017

CALIFORNIA LEGISLATURE— 2017–2018 REGULAR SESSION

Assembly Bill No. 1107


Introduced by Assembly Member Nazarian

February 17, 2017


An act to amend Section 1370 of the Health and Safety Code, relating to health care service plans. An act to add Section 1372.5 to the Health and Safety Code, and to add Section 10123.25 to the Insurance Code, relating to health care coverage.


LEGISLATIVE COUNSEL'S DIGEST


AB 1107, as amended, Nazarian. Health care service plans. Oncology Clinical Pathway Act of 2017.
(1) The Knox-Keene Health Care Service Plan Act of 1975, among other things, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care. A willful violation of the act is a crime. Existing law also provides for the regulation of health insurers by the Department of Insurance. Existing law requires health care service plan contracts and health insurance policies to provide coverage for specified benefits.
This bill would enact the Oncology Clinical Pathway Act of 2017, requiring a health care service plan or health insurer that develops and implements a clinical pathway, as defined, to comply with certain requirements for cancer treatment. The bill would prohibit a plan or health insurer from, among other things, developing and implementing a clinical pathway that discourages patient access to clinical trials. Because a willful violation of the act by a health care service plan would be a crime, this bill would impose a state-mandated local program.
(2) The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care and makes a willful violation of the act a crime. Existing law requires every health care service plan to establish procedures in accordance with department regulations for continuously reviewing the quality of care, performance of medical personnel, utilization of services and facilities, and costs.

This bill would make technical, nonsubstantive changes to that provision.

Vote: MAJORITY   Appropriation: NO   Fiscal Committee: NOYES   Local Program: NOYES  

The people of the State of California do enact as follows:


SECTION 1.

 Section 1372.5 is added to the Health and Safety Code, to read:

1372.5.
 (a) This section and Section 10123.25 of the Insurance Code shall be known and may be cited as the Oncology Clinical Pathway Act of 2017.
(b) For purposes of this section, “oncology clinical pathway” shall mean a cancer treatment plan used by a provider to direct patient care for a defined patient or specific patient presentations, such as type or stage of the disease or for patients undergoing a specific procedure, that is used by the provider to make medical treatment decisions for the care of an enrollee or subscriber, in which the different tasks, interventions, or treatment regimens used by the provider are strictly defined and sequenced. The use of an oncology clinical pathway by a provider relates to the practice of medicine and is not a coverage decision, as defined in subdivision (c) of Section 1374.30.
(c) Care provided as a result of an oncology clinical pathway is subject to this chapter, including, but not limited to, the provisions regarding grievances, appeals, or independent medical review (Article 5.55 (commencing with Section 1374.30)), and the external medical review process to examine coverage decisions regarding experimental or investigational therapies pursuant to Section 1370.4.
(d) (1) A health care service plan that develops and implements an oncology clinical pathway shall do all of the following:
(A) Ensure that each oncology clinical pathway is evidence-based, clearly provides the level of scientific evidence supporting the oncology clinical pathway, conforms to recommendations within the National Comprehensive Cancer Network for that disease, and developed by a group of actively practicing physicians with clinical expertise in the therapeutic area or an organization generally recognized within the relevant medical community as a body with clinical expertise in the therapeutic area.
(B) Review and update, as new therapies emerge, but not less than annually, each oncology clinical pathway. A health care service provider shall consider requests from network physicians on initiating a review of an oncology clinical pathway.
(C) Provide to contracting providers, upon request, all of the following:
(i) A copy of the complete oncology clinical pathway.
(ii) The scope of the oncology clinical pathway, including, but not limited to, the therapeutic area covered by the oncology clinical pathway and any limitation on the patient population or treatment setting for which the oncology clinical pathway was designed, or other limitations on the scope of the oncology clinical pathway.
(iii) All scientific data and evidence summaries evaluated in the development of the oncology clinical pathway.
(iv) Key clinical features of the oncology clinical pathway, including, but not limited to, the process and rationales for decisionmaking, including those for quality, toxicity and cost.
(v) The names, qualifications, institutional affiliations, and any conflict of interests of the physicians and other individuals who conducted the research, developed the analysis, and assessed the oncology clinical pathway.
(vi) Information on the process for and timing of the health care service plan’s anticipated review and update of the oncology clinical pathway.
(2) A health care service plan that develops and implements an oncology clinical pathway shall not do any of the following:
(A) Develop and implement an oncology clinical pathway that discourages patient access to clinical trials.
(B) Require any practitioner participation in an oncology clinical pathway protocol or adherence to specific treatments within the oncology clinical pathway.
(C) Develop and implement an oncology clinical pathway for use by providers that interferes with the independent clinical judgment of a provider in the care of a patient.
(e) This section shall not be construed to require a health care service plan contract to cover a benefit not otherwise required by law or not otherwise covered under the plan contract.

SEC. 2.

 Section 10123.25 is added to the Insurance Code, to read:

10123.25.
 (a) This section and Section 1372.5 of the Health and Safety Code shall be known and may be cited as the Oncology Clinical Pathway Act of 2017.
(b) For purposes of this section, “oncology clinical pathway” shall mean a cancer treatment plan used by a health insurer to direct patient care for a defined patient or specific patient presentations, such as type or stage of the disease or for patients undergoing a specific procedure, that is used by the health insurer to make medical treatment decisions for the care of an insured or policyholder, in which the different tasks, interventions, or treatment regimens used by the health insurer are strictly defined and sequenced. The use of an oncology clinical pathway by a health insurer relates to the practice of medicine and is not a coverage decision.
(c) Care provided as a result of an oncology clinical pathway is subject to this chapter, including, but not limited to, the provisions regarding grievances, appeals, or independent medical review (Article 3.5 (commencing with Section 10169)).
(d) (1) A health insurer that develops and implements an oncology clinical pathway shall do all of the following:
(A) Ensure that each oncology clinical pathway is evidence-based, clearly provides the level of scientific evidence supporting the oncology clinical pathway, conforms to recommendations within the National Comprehensive Cancer Network for that disease, and developed by a group of actively practicing physicians with clinical expertise in the therapeutic area or an organization generally recognized within the relevant medical community as a body with clinical expertise in the therapeutic area.
(B) Review and update, as new therapies emerge, but not less than annually, each oncology clinical pathway. A health insurer shall consider requests from network physicians on initiating a review of an oncology clinical pathway.
(C) Provide to prescribing practitioners, upon request, all of the following:
(i) A copy of the complete oncology clinical pathway.
(ii) The scope of the oncology clinical pathway, including, but not limited to, the therapeutic area covered by the oncology clinical pathway and any limitation on the patient population or treatment setting for which the oncology clinical pathway was designed, or other limitations on the scope of the oncology clinical pathway.
(iii) All scientific data and evidence summaries evaluated in the development of the oncology clinical pathway.
(iv) Key clinical features of the oncology clinical pathway, including, but not limited to, the process and rationales for decisionmaking, including those for quality, toxicity and cost.
(v) The names, qualifications, institutional affiliations, and any conflict of interests of the physicians and other individuals who conducted the research, developed the analysis, and assessed the oncology clinical pathway.
(vi) Information on the process for and timing of the health insurer’s anticipated review and update of the oncology clinical pathway.
(2) A health insurer that develops and implements an oncology clinical pathway shall not do any of the following:
(A) Develop and implement an oncology clinical pathway that discourages patient access to clinical trials.
(B) Require any practitioner participation in an oncology clinical pathway protocol or adherence to specific treatments within the oncology clinical pathway.
(C) Develop and implement an oncology clinical pathway for use by providers that interferes with the independent clinical judgment of a provider in the care of a patient.
(e) This section shall not be construed to require a health insurance policy to cover a benefit not otherwise required by law or not otherwise covered under the health insurance policy.

SEC. 3.

 No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.
SECTION 1.Section 1370 of the Health and Safety Code is amended to read:
1370.

(a)Every health care service plan shall establish procedures in accordance with department regulations for continuously reviewing the quality of care, performance of medical personnel, utilization of services and facilities, and costs. Notwithstanding any other law, there shall be no monetary liability on the part of, and no cause of action for damages shall arise against, any person who participates in plan or provider quality of care or utilization reviews by peer review committees which are composed chiefly of physicians and surgeons or dentists, psychologists, or optometrists, or any of the above, for any act performed during the reviews if the person acts without malice, has made a reasonable effort to obtain the facts of the matter, and believes that the action taken is warranted by the facts, and neither the proceedings nor the records of the reviews shall be subject to discovery, nor shall any person in attendance at the reviews be required to testify as to what transpired thereat. Disclosure of the proceedings or records to the governing body of a plan or to any person or entity designated by the plan to review activities of the plan or provider committees shall not alter the status of the records or of the proceedings as privileged communications.

(b)The prohibition under subdivision (a) relating to discovery or testimony shall not apply to the statements made by any person in attendance at a review who is a party to an action or proceeding the subject matter of which was reviewed, or to any person requesting hospital staff privileges, or in any action against an insurance carrier alleging bad faith by the carrier in refusing to accept a settlement offer within the policy limits, or to the director in conducting surveys pursuant to Section 1380.

(c)This section shall not be construed to confer immunity from liability on any health care service plan. In any case in which, but for the enactment of the preceding provisions of this section, a cause of action would arise against a health care service plan, the cause of action shall exist notwithstanding the provisions of this section.