AB 2209,
as amended, Bonilla. Health care coverage: clinicalbegin delete careend delete 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.
end deleteThe 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.
end insertThe 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:
begin insertSection 1372.5 is added to the end insertbegin insertHealth and Safety
2Codeend insertbegin insert, to read:end insert
(a) This section shall be known and may be cited as
4the Patient-Centered Clinical Pathway Act of 2016.
5
(b) For purposes of this section, the following definitions shall
6apply:
7
(1) “Clinical pathway” means a multidisciplinary management
8tool based on evidence-based practices used by providers involved
9in patient care, for a defined patient group with a particular
10disease or condition, or undergoing a particular procedure, that
11is used by the provider as a tool to make medical treatment
12decisions to manage the enrollee’s care, in which the different
13tasks, interventions, or treatment regimens used by the provider
14involved in the enrollee’s care are defined, optimized, and
15
sequenced. The use of a clinical pathway by a provider relates to
16the practice of medicine and is not a coverage decision.
17
(2) “Coverage decision” shall have the same meaning as set
18forth in subdivision (c) of Section 1374.30.
19
(c) (1) A health care service plan that adopts the use of a
20clinical pathway shall do all of the following:
21
(A) Ensure that each clinical pathway is developed in
22accordance with the following procedures:
P3 1
(i) The clinical pathway is developed by a multidisciplinary
2group of actively practicing physicians with clinical expertise in
3the therapeutic area or an organization generally recognized
4within the relevant medical community as a body with clinical
5expertise in the therapeutic area. A health care service
plan may
6collaborate with prescribing practitioners to include clinical
7pathways that are already established or integrated into the
8prescribing practitioners’ treatment patterns, provided the clinical
9pathway is in compliance with the requirements of this
10subparagraph.
11
(ii) Prior to finalization, the clinical pathway is reviewed and
12endorsed by a formal, identified review panel of which all panel
13members are actively practicing physicians within their respective
14medical specialties, and a majority of panel members are
15board-certified physicians in the relevant medical specialty.
16
(iii) Prior to finalization, the clinical pathway is subject to an
17opportunity for review by stakeholders, including, but not limited
18to, prescribing practitioners and their professional societies,
19medical institutions or organizations, patients, patient advocacy
20groups, pharmaceutical and medical device
manufacturers, and
21public input that is to be considered in finalizing the clinical
22pathway.
23
(B) Ensure that each clinical pathway specifies that a
24prescribing practitioner participating in a clinical pathway should
25make recommendations concerning the treatment, management,
26or prevention of the relevant disease or condition for a specific
27patient in accordance with the prescribing practitioner’s clinical
28judgment and the individual patient’s needs and medical
29circumstances.
30
(C) (i) Review and update, as appropriate, but not less than
31annually, each clinical pathway. However, if a clinical pathway’s
32therapeutic area is subject to rapid changes or a major
33development occurs in that therapeutic area, the health care service
34plan shall review and update that clinical pathway on a more
35frequent or regular basis.
36
(ii) Establish and maintain a procedure by which prescribing
37practitioners may seek a review or an update of a clinical pathway
38when a new treatment option becomes available and disclose those
39procedures to prescribing practitioners.
P4 1
(D) Provide prescribing practitioners, enrollees or subscribers,
2and the public with readily available access to all of the following:
3
(i) Each clinical pathway.
4
(ii) All scientific data and evidence summaries evaluated in the
5development of the pathway.
6
(iii) The names of the physicians and other members who
7conducted the research, developed the analysis, and assessed the
8clinical pathway.
9
(2) A health care service plan shall not do either of the
10
following:
11
(A) Adopt a clinical pathway that hinders education, research,
12patient screening, or patient access to clinical trials.
13
(B) Require any practitioner participation in a pathway protocol
14or adherence to specific treatments within the clinical pathway.
15
(d) A health care service plan that adopts the use of a clinical
16pathway shall make publicly available for each clinical pathway
17all of the following information:
18
(1) The scope of the clinical pathway, including the therapeutic
19area covered by the clinical pathway and any limitations on the
20patient population or treatment setting for which the clinical
21pathway was designed, or other limitations on the scope of the
22clinical pathway.
23
(2) The key clinical features of the clinical pathway, including
24the decisionmaking steps and key treatment recommendations to
25be made at each step.
26
(3) The names, qualifications, and any conflicts of interest of
27the physicians or organization that developed the clinical pathway.
28
(4) A listing of all panel members who participated in the review
29of the clinical pathway. The listing shall include the institutional
30affiliations, medical specialties, and any conflicts of interest of the
31panel members.
32
(5) The sources of evidence on which the clinical pathway is
33based. If the clinical pathway is based in part on a clinical practice
34guideline or similar document with recommendations on treatment,
35management, or prevention of a particular disease or condition,
36but the clinical pathway uses a more narrow set of
items or services
37than the underlying clinical practice guideline or similar document,
38the individuals or organization that developed the clinical pathway
39shall identify the differences between the clinical pathway and the
40underlying clinical practice guideline or similar document, and
P5 1explain why the clinical pathway excludes particular items or
2services.
3
(6) A narrative providing a comprehensive summary of the
4evidence on which the clinical pathway is based, including
5important issues the physicians or organization considered in
6interpreting the evidence and developing the clinical pathway.
7
(7) Information on the process for, and timing of, the health
8care service plan’s review and update of clinical pathways, as
9required under subparagraph (C) of paragraph (1) of subdivision
10(c).
begin insertSection 10123.25 is added to the end insertbegin insertInsurance Codeend insertbegin insert, to
12read:end insert
(a) This section shall be known and may be cited
14as the Patient-Centered Clinical Pathway Act of 2016.
15
(b) For purposes of this section, the following definitions shall
16apply:
17
(1) “Clinical pathway” means a multidisciplinary management
18tool based on evidence-based practices used by providers involved
19in patient care, for a defined patient group with a particular
20disease or condition, or undergoing a particular procedure, that
21is used by the provider as a tool to make medical treatment
22decisions to manage the insured’s care, in which the different
23tasks, interventions, or treatment regimens used by the provider
24involved in the insured’s care are defined, optimized, and
25
sequenced. The use of a clinical pathway by a provider relates to
26the practice of medicine and is not a coverage decision.
27
(2) “Coverage decision” shall have the same meaning as set
28forth in subdivision (c) of Section 10169.
29
(c) (1) A health insurer that adopts the use of a clinical pathway
30shall do all of the following:
31
(A) Ensure that each clinical pathway is developed in
32accordance with the following procedures:
33
(i) The clinical pathway is developed by a multidisciplinary
34group of actively practicing physicians with clinical expertise in
35the therapeutic area or an organization generally recognized
36within the relevant medical community as a body with clinical
37expertise in the therapeutic area. A health insurer may collaborate
38
with prescribing practitioners to include clinical pathways that
39are already established or integrated into the prescribing
P6 1practitioners’ treatment patterns, provided the clinical pathway
2is in compliance with the requirements of this subparagraph.
3
(ii) Prior to finalization, the clinical pathway is reviewed and
4endorsed by a formal, identified review panel of which all panel
5members are actively practicing physicians within their respective
6medical specialties, and a majority of panel members are
7board-certified physicians in the relevant medical specialty.
8
(iii) Prior to finalization, the clinical pathway is subject to an
9opportunity for review by stakeholders, including, but not limited
10to, prescribing practitioners and their professional societies,
11medical institutions or organizations, patients, patient advocacy
12groups, pharmaceutical and medical device manufacturers, and
13
public input that is to be considered in finalizing the clinical
14pathway.
15
(B) Ensure that each clinical pathway specifies that a
16prescribing practitioner participating in a clinical pathway should
17make recommendations concerning the treatment, management,
18or prevention of the relevant disease or condition for a specific
19patient in accordance with the prescribing practitioner’s clinical
20judgment and the individual patient’s needs and medical
21circumstances.
22
(C) (i) Review and update, as appropriate, but not less than
23annually, each clinical pathway. However, if a clinical pathway’s
24therapeutic area is subject to rapid changes or a major
25development occurs in that therapeutic area, the health insurer
26shall review and update that clinical pathway on a more frequent
27or regular basis.
28
(ii) Establish
and maintain a procedure by which prescribing
29practitioners may seek a review or an update of a clinical pathway
30when a new treatment option becomes available and disclose those
31procedures to prescribing practitioners.
32
(D) Provide prescribing practitioners, insureds, and the public
33with readily available access to all of the following:
34
(i) Each clinical pathway.
35
(ii) All scientific data and evidence summaries evaluated in the
36development of the pathway.
37
(iii) The names of the physicians and other members who
38conducted the research, developed the analysis, and assessed the
39clinical pathway.
40
(2) A health insurer shall not do either of the following:
P7 1
(A) Adopt a clinical pathway that hinders education, research,
2patient screening, or patient access to clinical trials.
3
(B) Require any practitioner participation in a pathway protocol
4or adherence to specific treatments within the clinical pathway.
5
(d) A health insurer that adopts the use of a clinical pathway
6shall make publicly available for each clinical pathway all of the
7following information:
8
(1) The scope of the clinical pathway, including the therapeutic
9area covered by the clinical pathway and any limitations on the
10patient population or treatment setting for which the clinical
11pathway was designed, or other limitations on the scope of the
12clinical pathway.
13
(2) The key clinical
features of the clinical pathway, including
14the decisionmaking steps and key treatment recommendations to
15be made at each step.
16
(3) The names, qualifications, and any conflicts of interest of
17the physicians or organization that developed the clinical pathway.
18
(4) A listing of all panel members who participated in the review
19of the clinical pathway. The listing shall include the institutional
20affiliations, medical specialties, and any conflicts of interest of the
21panel members.
22
(5) The sources of evidence on which the clinical pathway is
23based. If the clinical pathway is based in part on a clinical practice
24guideline or similar document with recommendations on treatment,
25management, or prevention of a particular disease or condition,
26but the clinical pathway uses a more narrow set of items or services
27than the
underlying clinical practice guideline or similar document,
28the individuals or organization that developed the clinical pathway
29shall identify the differences between the clinical pathway and the
30underlying clinical practice guideline or similar document, and
31explain why the clinical pathway excludes particular items or
32services.
33
(6) A narrative providing a comprehensive summary of the
34evidence on which the clinical pathway is based, including
35important issues the physicians or organization considered in
36interpreting the evidence and developing the clinical pathway.
37
(7) Information on the process for, and timing of, the health
38insurer’s review and update of clinical pathways, as required
39under subparagraph (C) of paragraph (1) of subdivision (c).
No reimbursement is required by this act pursuant to
2Section 6 of Article XIII B of the California Constitution because
3the only costs that may be incurred by a local agency or school
4district will be incurred because this act creates a new crime or
5infraction, eliminates a crime or infraction, or changes the penalty
6for a crime or infraction, within the meaning of Section 17556 of
7the Government Code, or changes the definition of a crime within
8the meaning of Section 6 of Article XIII B of the California
9Constitution.
Section 1372.5 is added to the Health and Safety
11Code, to read:
(a) On and after January 1, 2017, a health care service
13plan that provides coverage for hospital, medical, or surgical
14expenses shall not implement clinical care pathways for use by
15providers in order to manage an enrollee’s care.
16(b) For purposes of this section, “clinical care pathways” means
17a multidisciplinary management tool based on evidence-based
18practices used by providers involved in patient care to manage the
19enrollee’s care, in which the different tasks, interventions, or
20treatment regimens used by the provider involved in the enrollee’s
21care are defined, optimized, and sequenced.
Section 10123.25 is added to the Insurance Code, to
23read:
(a) On and after January 1, 2017, a health insurer
25that provides coverage for hospital, medical, or surgical expenses
26shall not implement clinical care pathways for use by providers in
27order to manage an insured’s care.
28(b) For purposes of this section, “clinical care pathways” means
29a multidisciplinary management tool based on evidence-based
30practices used by providers involved in patient care to manage the
31insured’s care, in which the different tasks, interventions, or
32treatment regimens used by the provider involved in the insured’s
33care are defined, optimized, and sequenced.
No reimbursement is required by this act pursuant to
35Section 6 of Article XIII B of the California Constitution because
36the only costs that may be incurred by a local agency or school
37district will be incurred because this act creates a new crime or
38infraction, eliminates a crime or infraction, or changes the penalty
39for a crime or infraction, within the meaning of Section 17556 of
40the Government Code, or changes the definition of a crime within
P9 1the meaning of Section 6 of Article XIII B of the California
2Constitution.
O
98