Bill Text: CA AB2209 | 2015-2016 | Regular Session | Amended
Bill Title: Health care coverage: clinical pathways.
Sponsorship: Partisan Bill (Democrat 1)
Status: (Failed) 2016-11-30 - From committee without further action. [AB2209 Detail]
Download: California-2015-AB2209-Amended.html
BILL NUMBER: AB 2209 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY APRIL 26, 2016
AMENDED IN ASSEMBLY APRIL 7, 2016
INTRODUCED BY Assembly Member Bonilla
FEBRUARY 18, 2016
An act to add Section 1372.5 of 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 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.
The
This bill would require a health care service plan or
health insurer that adopts the use of
develops and implements 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
developing and implementing a clinical pathway that
hinders education, research, patient screening, or
discourages patient access to clinical trials. The bill would
require a plan or health insurer that adopts the use of
develops and implements a clinical pathway to
make publicly available specified information for each clinical
pathway adopted. developed and implemented.
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 treatment plan based on
evidence-based practices used by providers involved in
to direct patient care, for a defined
patient or patient group with a particular
specific disease or condition, or undergoing a
particular specific procedure, that is used by
the provider as a tool to make medical treatment
decisions to manage the for an enrollee'
s or subscriber's care, in which the different tasks,
interventions, or treatment regimens used by the provider involved in
the enrollee's or subscriber's care are defined,
optimized, strictly defined 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.
(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.
(c) (1) A health care service plan that adopts the use of
develops and implements 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.
Health care service providers shall consider requests from network
physicians on initiating a review of clinical pathways.
(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 Develop and implement a
clinical pathway that hinders education, research, patient
screening, or discourages 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
develops and implements 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. based.
(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).
(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.
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 treatment plan based on
evidence-based practices used by providers involved in
to direct patient care, for a defined
patient or patient group with a particular
specific disease or condition, or undergoing a
particular specific procedure, that is used by
the provider as a tool to make medical treatment
decisions to manage the for an insured'
s or policyholder's care, in which the different tasks,
interventions, or treatment regimens used by the provider involved in
the insured's or policyholder's care are
defined, optimized, strictly defined 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.
(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)).
(c) (1) A health insurer that adopts the use of
develops and implements 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. Health
care service providers shall consider requests from network
physicians on initiating a review of clinical pathways.
(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,
insureds or policyholders, 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 Develop and implement a
clinical pathway that hinders education, research, patient
screening, or discourages 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
develops and implements 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. based.
(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).
(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.
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.
