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

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Date Published: 05/02/2017 09:00 PM
AB1107:v97#DOCUMENT

Amended  IN  Assembly  May 02, 2017
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 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. 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. treatment, as specified. Because a willful violation of the act by a health care service plan would be a crime, this the 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.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: YES  

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 physician and surgeon 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 physician and surgeon 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 physician and surgeon are strictly defined and sequenced. The use of an oncology clinical pathway by a provider physician and surgeon 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 section does not affect any other provision of 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 plan shall consider requests from network physicians on initiating a review of an oncology clinical pathway.
(C) Provide to contracting providers, a contracting physician and surgeon, 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 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.

(2) The contracting physician and surgeon is prohibited from releasing any information that is requested pursuant to subparagraph (C) of paragraph (1).
(e) This section shall not be construed to does not 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 physician and surgeon 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 physician and surgeon 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 physician and surgeon are strictly defined and sequenced. The use of an oncology clinical pathway by a health insurer physician and surgeon 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 section does not affect any other provision of 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, a contracting physician and surgeon, 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 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.

(2) The contracting physician and surgeon is prohibited from releasing any information that is requested pursuant to subparagraph (C) of paragraph (1).
(e) This section shall not be construed to does not 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.