Amended in Assembly April 26, 2016

Amended in Assembly April 7, 2016

California Legislature—2015–16 Regular Session

Assembly Bill No. 2209

Introduced by Assembly Member Bonilla

February 18, 2016

An act to add Section 1372.5 begin delete of end delete begin insert to end insert 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 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.

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The

end delete

begin insert This end insert bill would require a health care service plan or health insurer that begin delete adopts the use of end delete begin insert develops and implements end insert 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, begin delete adopting end delete begin insert developing and implementing end insert a clinical pathway that begin delete hinders education, research, patient screening, or end delete begin insert discourages end insert patient access to clinical trials. The bill would require a plan or health insurer that begin delete adopts the use of end delete begin insert develops and implements end insert a clinical pathway to make publicly available specified information for each clinical pathway begin delete adopted. end delete begin insert developed and implemented. end insert 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 begin delete Patient-Centered end delete Clinical Pathway Act of 2016.

(b) For purposes of this section, the following definitions shall
apply:

(1) “Clinical pathway” means a begin delete multidisciplinary management
tool end delete begin insert treatment plan end insert based on evidence-based practices used by
providers begin delete involved in end delete begin insert to direct end insert patient care, for a defined begin insert patient
or end insert patient group with a begin delete particular end delete begin insert specific end insert disease or condition, or
undergoing a begin delete particular end delete begin insert specific end insert procedure, that is used by the
provider begin delete as a tool end delete to make medical treatment decisions begin delete to manage
the end delete begin insert for an end insert enrollee’s begin insert or subscriber’s end insert care, in which the different
tasks, interventions, or treatment regimens used by the provider
involved in the enrollee’s begin insert or subscriber’s end insert care are begin delete defined,
optimized, end delete begin insert strictly defined end insert 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.

begin insert

(3) Care provided as a result of a clinical pathway is subject
to this chapter, including 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.

end insert

(c) (1) A health care service plan that begin delete adopts the use of end delete begin insert develops
and implements end insert 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.

begin delete

(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.

end delete

(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)  begin delete (i) end delete begin delete   end delete Review and update, as appropriate, but not less than
annually, each clinical pathway. begin delete 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. end delete begin insert Health care service providers shall consider requests
from network physicians on initiating a review of clinical pathways. end insert

begin delete

(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.

end delete

(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)  begin delete Adopt end delete begin insert Develop and implement end insert a clinical pathway that
begin delete hinders education, research, patient screening, or end delete begin insert discourages end insert
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 begin delete adopts the use of end delete begin insert develops
and implements end insert 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. begin delete 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. end delete

(6) A narrative providing a begin delete comprehensive end delete summary of the
evidence on which the clinical pathway is begin delete based, including
important issues the physicians or organization considered in
interpreting the evidence and developing the clinical pathway. end delete

begin insert based. end insert

(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).

begin insert

(e) Nothing in this section shall 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.

end insert

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 begin delete Patient-Centered end delete Clinical Pathway Act of 2016.

(b) For purposes of this section, the following definitions shall
apply:

(1) “Clinical pathway” means a begin delete multidisciplinary management
tool end delete begin insert treatment plan end insert based on evidence-based practices used by
providers begin delete involved in end delete begin insert to direct end insert patient care, for a defined begin insert patient
or end insert patient group with a begin delete particular end delete begin insert specific end insert disease or condition, or
undergoing a begin delete particular end delete begin insert specific end insert procedure, that is used by the
provider begin delete as a tool end delete to make medical treatment decisions begin delete to manage
the end delete begin insert for an end insert insured’s begin insert or policyholder’s end insert care, in which the different
tasks, interventions, or treatment regimens used by the provider
involved in the insured’s begin insert or policyholder’s end insert care are begin delete defined,
optimized, end delete begin insert strictly defined end insert 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.

begin insert

(3) Care provided as a result of a clinical pathway is subject
to this chapter, including filing a complaint or appeal and
independent medical review (Article 3.5 (commencing with Section
10169)).

end insert

(c) (1) A health insurer that begin delete adopts the use of end delete begin insert develops and
implements end insert 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.

begin delete

(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.

end delete

(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)  begin delete (i) end delete begin delete   end delete Review and update, as appropriate, but not less than
annually, each clinical pathway. begin delete 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. end delete

begin insert Health care service providers shall consider requests from network
physicians on initiating a review of clinical pathways. end insert

begin delete

(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.

end delete

(D) Provide prescribing practitioners, begin delete insureds, end delete begin insert insureds or
policyholders, end insert 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)  begin delete Adopt end delete begin insert Develop and implement end insert a clinical pathway that
begin delete hinders education, research, patient screening, or end delete begin insert discourages end insert
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 begin delete adopts the use of end delete begin insert develops and
implements end insert 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. begin delete 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. end delete

(6) A narrative providing a begin delete comprehensive end delete summary of the
evidence on which the clinical pathway is begin delete based, including
important issues the physicians or organization considered in
interpreting the evidence and developing the clinical pathway. end delete

begin insert based. end insert

(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).

begin insert

(e) Nothing in this section shall 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.

end insert

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.