BILL NUMBER: AB 2209	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  APRIL 7, 2016

INTRODUCED BY   Assembly Member Bonilla

                        FEBRUARY 18, 2016

   An act to add Section 1372.5 of 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 2209, as amended, Bonilla. Health care coverage: clinical
 care  pathways.
   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. 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 prohibit, on and after January 1, 2017, a health
care service plan or health insurer that provides hospital, medical,
or surgical expenses from implementing clinical care pathways, as
defined, for use by providers in order to manage an enrollee's or
insured's care. Because a willful violation of this prohibition by a
health care service plan would be a crime, this bill would impose a
state-mandated local program.  
   The bill would require a health care service plan or health
insurer that adopts the use of a clinical pathway, as defined, to
comply with certain requirements, including that the plan or health
insurer ensures that each clinical pathway is developed in accordance
with specified procedures. The bill would prohibit a plan or health
insurer from, among other things, adopting a clinical pathway that
hinders education, research, patient screening, or patient access to
clinical trials. The bill would require a plan or health insurer that
adopts the use of a clinical pathway to make publicly available
specified information for each clinical pathway adopted. 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. 
   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.
State-mandated 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 shall be known and may be cited as the
Patient-Centered Clinical Pathway Act of 2016.
   (b) For purposes of this section, the following definitions shall
apply:
   (1) "Clinical pathway" means a multidisciplinary management tool
based on evidence-based practices used by providers involved in
patient care, for a defined patient group with a particular disease
or condition, or undergoing a particular procedure, that is used by
the provider as a tool to make medical treatment decisions to manage
the enrollee's care, in which the different tasks, interventions, or
treatment regimens used by the provider involved in the enrollee's
care are defined, optimized, and sequenced. The use of a clinical
pathway by a provider relates to the practice of medicine and is not
a coverage decision.
   (2) "Coverage decision" shall have the same meaning as set forth
in subdivision (c) of Section 1374.30.
   (c) (1) A health care service plan that adopts the use of a
clinical pathway shall do all of the following:
   (A) Ensure that each clinical pathway is developed in accordance
with the following procedures:
   (i) The clinical pathway is developed by a multidisciplinary 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. A health care service plan may collaborate with
prescribing practitioners to include clinical pathways that are
already established or integrated into the prescribing practitioners'
treatment patterns, provided the clinical pathway is in compliance
with the requirements of this subparagraph.
   (ii) Prior to finalization, the clinical pathway is reviewed and
endorsed by a formal, identified review panel of which all panel
members are actively practicing physicians within their respective
medical specialties, and a majority of panel members are
board-certified physicians in the relevant medical specialty.
   (iii) Prior to finalization, the clinical pathway is subject to an
opportunity for review by stakeholders, including, but not limited
to, prescribing practitioners and their professional societies,
medical institutions or organizations, patients, patient advocacy
groups, pharmaceutical and medical device manufacturers, and public
input that is to be considered in finalizing the clinical pathway.
   (B) Ensure that each clinical pathway specifies that a prescribing
practitioner participating in a clinical pathway should make
recommendations concerning the treatment, management, or prevention
of the relevant disease or condition for a specific patient in
accordance with the prescribing practitioner's clinical judgment and
the individual patient's needs and medical circumstances.
   (C) (i) Review and update, as appropriate, but not less than
annually, each clinical pathway. However, if a clinical pathway's
therapeutic area is subject to rapid changes or a major development
occurs in that therapeutic area, the health care service plan shall
review and update that clinical pathway on a more frequent or regular
basis.
   (ii) Establish and maintain a procedure by which prescribing
practitioners may seek a review or an update of a clinical pathway
when a new treatment option becomes available and disclose those
procedures to prescribing practitioners.
   (D) Provide prescribing practitioners, enrollees or subscribers,
and the public with readily available access to all of the following:

   (i) Each clinical pathway.
   (ii) All scientific data and evidence summaries evaluated in the
development of the pathway.
   (iii) The names of the physicians and other members who conducted
the research, developed the analysis, and assessed the clinical
pathway.
   (2) A health care service plan shall not do either of the
following:
   (A) Adopt a clinical pathway that hinders education, research,
patient screening, or patient access to clinical trials.
   (B) Require any practitioner participation in a pathway protocol
or adherence to specific treatments within the clinical pathway.
   (d) A health care service plan that adopts the use of a clinical
pathway shall make publicly available for each clinical pathway all
of the following information:
   (1) The scope of the clinical pathway, including the therapeutic
area covered by the clinical pathway and any limitations on the
patient population or treatment setting for which the clinical
pathway was designed, or other limitations on the scope of the
clinical pathway.
   (2) The key clinical features of the clinical pathway, including
the decisionmaking steps and key treatment recommendations to be made
at each step.
   (3) The names, qualifications, and any conflicts of interest of
the physicians or organization that developed the clinical pathway.
   (4) A listing of all panel members who participated in the review
of the clinical pathway. The listing shall include the institutional
affiliations, medical specialties, and any conflicts of interest of
the panel members.
   (5) The sources of evidence on which the clinical pathway is
based. If the clinical pathway is based in part on a clinical
practice guideline or similar document with recommendations on
treatment, management, or prevention of a particular disease or
condition, but the clinical pathway uses a more narrow set of items
or services than the underlying clinical practice guideline or
similar document, the individuals or organization that developed the
clinical pathway shall identify the differences between the clinical
pathway and the underlying clinical practice guideline or similar
document, and explain why the clinical pathway excludes particular
items or services.
   (6) A narrative providing a comprehensive summary of the evidence
on which the clinical pathway is based, including important issues
the physicians or organization considered in interpreting the
evidence and developing the clinical pathway.
   (7) Information on the process for, and timing of, the health care
service plan's review and update of clinical pathways, as required
under subparagraph (C) of paragraph (1) of subdivision (c). 
   SEC. 2.    Section 10123.25 is added to the 
 Insurance Code   , to read:  
   10123.25.  (a) This section shall be known and may be cited as the
Patient-Centered Clinical Pathway Act of 2016.
   (b) For purposes of this section, the following definitions shall
apply:
   (1) "Clinical pathway" means a multidisciplinary management tool
based on evidence-based practices used by providers involved in
patient care, for a defined patient group with a particular disease
or condition, or undergoing a particular procedure, that is used by
the provider as a tool to make medical treatment decisions to manage
the insured's care, in which the different tasks, interventions, or
treatment regimens used by the provider involved in the insured's
care are defined, optimized, and sequenced. The use of a clinical
pathway by a provider relates to the practice of medicine and is not
a coverage decision.
   (2) "Coverage decision" shall have the same meaning as set forth
in subdivision (c) of Section 10169.
   (c) (1) A health insurer that adopts the use of a clinical pathway
shall do all of the following:
   (A) Ensure that each clinical pathway is developed in accordance
with the following procedures:
   (i) The clinical pathway is developed by a multidisciplinary 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. A health insurer may collaborate with prescribing
practitioners to include clinical pathways that are already
established or integrated into the prescribing practitioners'
treatment patterns, provided the clinical pathway is in compliance
with the requirements of this subparagraph.
   (ii) Prior to finalization, the clinical pathway is reviewed and
endorsed by a formal, identified review panel of which all panel
members are actively practicing physicians within their respective
medical specialties, and a majority of panel members are
board-certified physicians in the relevant medical specialty.
   (iii) Prior to finalization, the clinical pathway is subject to an
opportunity for review by stakeholders, including, but not limited
to, prescribing practitioners and their professional societies,
medical institutions or organizations, patients, patient advocacy
groups, pharmaceutical and medical device manufacturers, and public
input that is to be considered in finalizing the clinical pathway.
   (B) Ensure that each clinical pathway specifies that a prescribing
practitioner participating in a clinical pathway should make
recommendations concerning the treatment, management, or prevention
of the relevant disease or condition for a specific patient in
accordance with the prescribing practitioner's clinical judgment and
the individual patient's needs and medical circumstances.
   (C) (i) Review and update, as appropriate, but not less than
annually, each clinical pathway. However, if a clinical pathway's
therapeutic area is subject to rapid changes or a major development
occurs in that therapeutic area, the health insurer shall review and
update that clinical pathway on a more frequent or regular basis.
   (ii) Establish and maintain a procedure by which prescribing
practitioners may seek a review or an update of a clinical pathway
when a new treatment option becomes available and disclose those
procedures to prescribing practitioners.
   (D) Provide prescribing practitioners, insureds, and the public
with readily available access to all of the following:
   (i) Each clinical pathway.
   (ii) All scientific data and evidence summaries evaluated in the
development of the pathway.
   (iii) The names of the physicians and other members who conducted
the research, developed the analysis, and assessed the clinical
pathway.
   (2) A health insurer shall not do either of the following:
   (A) Adopt a clinical pathway that hinders education, research,
patient screening, or patient access to clinical trials.
   (B) Require any practitioner participation in a pathway protocol
or adherence to specific treatments within the clinical pathway.
   (d) A health insurer that adopts the use of a clinical pathway
shall make publicly available for each clinical pathway all of the
following information:
   (1) The scope of the clinical pathway, including the therapeutic
area covered by the clinical pathway and any limitations on the
patient population or treatment setting for which the clinical
pathway was designed, or other limitations on the scope of the
clinical pathway.
   (2) The key clinical features of the clinical pathway, including
the decisionmaking steps and key treatment recommendations to be made
at each step.
   (3) The names, qualifications, and any conflicts of interest of
the physicians or organization that developed the clinical pathway.
   (4) A listing of all panel members who participated in the review
of the clinical pathway. The listing shall include the institutional
affiliations, medical specialties, and any conflicts of interest of
the panel members.
   (5) The sources of evidence on which the clinical pathway is
based. If the clinical pathway is based in part on a clinical
practice guideline or similar document with recommendations on
treatment, management, or prevention of a particular disease or
condition, but the clinical pathway uses a more narrow set of items
or services than the underlying clinical practice guideline or
similar document, the individuals or organization that developed the
clinical pathway shall identify the differences between the clinical
pathway and the underlying clinical practice guideline or similar
document, and explain why the clinical pathway excludes particular
items or services.
   (6) A narrative providing a comprehensive summary of the evidence
on which the clinical pathway is based, including important issues
the physicians or organization considered in interpreting the
evidence and developing the clinical pathway.
   (7) Information on the process for, and timing of, the health
insurer's review and update of clinical pathways, as required under
subparagraph (C) of paragraph (1) of subdivision (c). 
   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 1372.5 is added to the
Health and Safety Code, to read:
   1372.5.  (a) On and after January 1, 2017, a health care service
plan that provides coverage for hospital, medical, or surgical
expenses shall not implement clinical care pathways for use by
providers in order to manage an enrollee's care.
   (b) For purposes of this section, "clinical care pathways" means a
multidisciplinary management tool based on evidence-based practices
used by providers involved in patient care to manage the enrollee's
care, in which the different tasks, interventions, or treatment
regimens used by the provider involved in the enrollee's care are
defined, optimized, and sequenced.  
  SEC. 2.    Section 10123.25 is added to the
Insurance Code, to read:
   10123.25.  (a) On and after January 1, 2017, a health insurer that
provides coverage for hospital, medical, or surgical expenses shall
not implement clinical care pathways for use by providers in order to
manage an insured's care.
   (b) For purposes of this section, "clinical care pathways" means a
multidisciplinary management tool based on evidence-based practices
used by providers involved in patient care to manage the insured's
care, in which the different tasks, interventions, or treatment
regimens used by the provider involved in the insured's care are
defined, optimized, and sequenced.  
  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.