BILL ANALYSIS Ó
AB 2209
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Date of Hearing: April 19, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
AB 2209
(Bonilla) - As Amended April 7, 2016
SUBJECT: Health care coverage: clinical care pathways.
SUMMARY: Establishes the Patient-Centered Clinical Care Pathway
Act of 2016 and sets requirements for health care service plans
(health plan) and health insurers when implementing clinical
care pathways (CCPs). Specifically, this bill:
1)Defines CCP as 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. Specifies that the use of a CCP by a provider
relates to the practice of medicine and is not a coverage
decision.
2)References the definition of coverage decision in existing
law.
3)Requires a health plan or health insurer that adopts a CCP to
do all of the following:
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a) Ensure that each CCP is developed in accordance with the
following procedures:
i) The CCP 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 plan or health insurer may collaborate with
prescribing practitioners to include CCPs that are
already established or integrated into the prescribing
practitioners' treatment patterns, as required; and,
ii) Prior to finalization, the CCP is reviewed and
endorsed by a formal, identified review panel as
specified and is subject to an opportunity for review by
stakeholders, as specified.
b) Ensure that each CCP specifies that a prescribing
practitioner participating in a CCP 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) Review and update, as appropriate, but not less than
annually, each CCP, and establish and maintain a procedure
by which prescribing practitioners may seek a review or an
update of a CCP, as specified; and,
d) Provide prescribing practitioners, enrollees or
subscribers, and the public with readily available access
to all of the following:
i) Each CCP;
ii) All scientific data and evidence summaries evaluated
in the development of the pathway; and,
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iii) The names of the physicians and other members who
conducted the research, developed the analysis, and
assessed the CCP.
4)Prohibits a health plan or health insurer adopting a CCP that
hinders education, research, patient screening, or patient
access to clinical trials or requiring any practitioner
participation in a pathway protocol or adherence to specific
treatments within the CCP.
5)Provides that a health plan that adopts the use of a CCP shall
make publicly available for each CCP all of the following
information:
a) The scope of the CCP, as specified;
b) The key clinical features of the CCP, as specified;
c) The names, qualifications, and any conflicts of interest
of the physicians or organization that developed the CCP;
d) A listing of all panel members who participated in the
review of the CCP, including the institutional
affiliations, medical specialties, and any conflicts of
interest of the panel members;
e) The sources of evidence on which the CCP is based,
including the identification of the differences between the
CCP and the underlying clinical practice guideline or
similar document, if any, and explanation why the CCP
excludes particular items or services;
f) A narrative providing a comprehensive summary of the
evidence on which the CCP is based, including important
issues the physicians or organization considered in
interpreting the evidence and developing the CCP; and,
g) Information on the process for, and timing of, the
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health care service plan's review and update of CCPs, as
required.
EXISTING LAW:
1)Establishes the Department of Managed Health Care (DMHC) to
regulate health plans and the California Department of
Insurance (CDI) to regulate health insurers.
2)Requires health plans to maintain the following:
a) Complete drug formulary or formularies, including a list
of prescription drugs on the formulary of the plan by major
therapeutic category with an indication of whether any
drugs are preferred over other drugs;
b) Records developed by the pharmacy and therapeutic
committee of the health plan that fully describe the
reasoning behind formulary decisions; and,
c) Health plan arrangements with entities that are
associated with activities of the health plan to encourage
formulary compliance or otherwise manage prescription drug
benefits.
3)Requires health plans to disclose or provide for the
disclosure the process the health plan, its contracting
provider groups, or any entity with which the plan contracts
for services that include utilization review or utilization
management functions, uses to authorize, modify, or deny
health care services under the benefits provided by the health
plan, including coverage for sub-acute care, transitional
inpatient care, or care provided in skilled nursing
facilities. Requires health plans to disclose those
processes to enrollees or persons designated by an enrollee,
or to any other person or organization, upon request.
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Provides that the criteria or guidelines used by health plans,
or any entities with which plans contract for services that
include utilization review or utilization management
functions, to determine whether to authorize, modify, or deny
health care services shall:
a) Be developed with involvement from actively practicing
health care providers;
b) Be consistent with sound clinical principles and
processes; and,
c) Be evaluated, and updated if necessary, at least
annually.
4)Requires health plans to demonstrate that medical decisions
are rendered by qualified medical providers, unhindered by
fiscal and administrative management.
5)Establishes the Independent Medical Review (IMR) process as
part of the DMHC or CDI appeal process.
6)Requires health plans or insurers or specialized dental plan
or insurance contracts that issue, sell, renew, or offer
contracts to, no later than September 30, 2015, and each year
thereafter, to file a report, to be known as the Medical Loss
Ratio (MLR) annual report, with the departments that contains
the same information required in the 2013 federal MLR Annual
Reporting Form. Requires the DMHC or the CDI, as applicable
and, if a financial examination is determined to be necessary
to verify the representations in the MLR annual report, to
provide the health plan or health insurer with a notification
before conducting the examination, and would require the
health plan or health insurer to electronically submit to the
appropriate department specified requested records, books, and
papers. Declares the intent of the Legislature that the data
reported pursuant to these provisions be considered by the
Legislature in adopting a MLR standard for health plans and
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specialized health insurance policies that cover dental
services that would take effect no later than January 1, 2018.
Authorizes the DMHC and the CDI, until January 1, 2018, to
issue guidance to health plans and health insurers of
specialized health insurance policies subject to these
provisions regarding compliance with these provisions, as
specified.
FISCAL EFFECT: This bill has not yet been analyzed by a fiscal
committee.
COMMENTS:
1)PURPOSE OF THIS BILL. According to the author, CCPs are
structured care plans used to detail the care of patients for
a specific disease and dictate the exact sequence of
treatments that physicians should follow. Medical groups and
hospitals develop CCPs in a scientific and transparent manner
by publicly convening a committee of subject matter experts
from varying professional backgrounds and recommending best
patient treatment practices. Once developed, the CCP is
continually reviewed and modified to reflect the latest
breakthroughs in research and treatment practices. The author
notes that the method of development, experts consulted, and
reviewed research are all open to scrutiny. Additionally, the
author states that CCPs dictate what cancer drugs will and
will not be used to treat a specific cancer type.
Capitalizing on the ability to influence and limit cancer drug
usage, health plans have begun to develop their own CCPs.
Health plans refuse to fully disclose how they develop
pathways, making it impossible to determine if health plans
prioritize maximum cost savings over quality cancer care.
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The author contends that high quality patient care should
remain the priority when designing treatment plans. When
health plans design their own CCPs, top priorities get shifted
towards cost management. This bill will protect patients by
ensuring that CCPs developed by health plans are based on
cutting edge science and clinical experience and each
patient's specific circumstances where the top priority is to
provide high quality patient care.
According to the sponsors of this bill, Association of
Northern California Oncologists, Medical Oncology Association
of Southern CA, and California Medical Association, in January
2015, the American Society of Clinical Oncology (ASCO)
established the Task Force on Clinical Pathways to review the
current landscape of oncology pathway use and recommended a
set of principles for the development and use of CCPs in
cancer care. The Task Force gathered and reviewed extensive
information regarding the rapidly evolving environment of
oncology pathways in the United States. The deliberations of
the Task Force have been reviewed and were approved by ASCO's
Board of Directors on August 12, 2015, as recommendations by
ASCO for the development and use of CCPs in oncology. As part
of the nine items recommended, ASCO indicated that oncology
pathways should be developed through a process that is
consistent and transparent to all stakeholders. ASCO
concluded that when used appropriately, oncology pathways can
be instrumental in managing value-based payment models being
proposed and used going forward. However, oncology pathways
must be developed and used appropriately and efficiently to
guide care recommendations and coverage policies.
2)BACKGROUND.
a) California Health Benefits Review Program (CHBRP)
analysis. AB 1996 (Thomson), Chapter 795, Statutes of
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2002, requests the University of California to assess
legislation proposing a mandated benefit or service and
prepare a written analysis with relevant data on the
medical, economic, and public health impacts of proposed
health plan and health insurance benefit mandate
legislation. CHBRP was created in response to AB 1996. SB
125 (Ed Hernandez), Chapter 9, Statutes of 2015, added an
impact assessment on essential health benefits, and
legislation that impacts health insurance benefit designs,
cost sharing, premiums, and other health insurance topics.
The Committee requested CHBRP to conduct an analysis of
this bill but states that it is unaware of any standard
clinical or legal definition of CCPs and the definitions
provided in literature vary. Based upon the definition as
introduced in the bill (this bill was subsequently amended
on April 7, 2016), CHBRP noted that it was unable to
identify the extent to which this bill would prohibit
health plans and insurers use of utilization management
techniques so it was unable to provide a traditional
analysis of the potential medical effectiveness, cost, or
utilization impacts of this bill. As such, CHBRP prepared
a brief that provides background and discusses the impact
on health outcomes and health interventions identified in
medical literature and cautions the introduced language
could have much broader impacts.
i) Defining CCPs. CHBRP is unaware of any standard
clinical or legal definition of CCPs, and the definitions
provided in the literature vary greatly. A literature
review by De Bleser et al. (2006) identified 84 different
definitions for CCPs. These definitions included broad
terms such as care pathway, protocol, and guideline. A
team of Cochrane Review authors reviewed the 84
definitions of CCPs and put forth several criteria that
they suggested be used as a basis for development of a
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standardized, internationally accepted definition of
CCPs:
(1) The intervention consists of a structured
multidisciplinary plan of care;
(2) The intervention is used to assist the
translation of guidelines or evidence into practice;
(3) The intervention details a set of necessary or
recommended steps in a course of treatment or care in
a plan, pathway, algorithm, guideline, protocol, or
other "inventory of actions;"
(4) The intervention describes timeframes or
criteria-based progression to proceed through the
steps; and,
(5) The intervention aims to standardize care for
a specific clinical problem, procedure, or episode of
health care in a specific population.
To date, it appears that CCPs are used by payers/insurers
for educational purposes or to offer incentives for
adherence to the pathway; CHBRP found no published
evidence of payers/insurers requiring adherence to CCPs
or reducing payments if providers used treatments not on
the pathway. CHBRP identified multiple issues that
complicate the assessment of the effectiveness of CCPs.
The first issue relates to the portion of a physician's
practice affected by any specific CCP used by a health
plan or health insurer. When providers are paid by
several plans or health insurers that use different CCPs
for a specific condition, the possibility of conflicting
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CCPs could substantially diminish any positive effects.
By contrast, when a CCP for a specific condition is used
by a group of providers, it has the potential to be
consistently implemented for all patients in the practice
or group for whom the CCP is applicable. A second
complicating factor in assessing the effectiveness of
CCPs is that published studies of health plan or insurer
use of CCPs are much more limited and have focused on
oncology in the outpatient setting, where treatment often
spans several months or longer. By contrast, published
studies of provider use of CCPs are more variable in the
diseases and conditions studied and the length of a
treatment episode. CHBRP states that the heterogeneity
of the studies limits the generalizability of the
findings, and the available evidence is insufficient to
conclude that CCPs are more effective when implemented at
the initiation of providers than at the initiation of
plans/insurers.
ii) Impacts on health outcomes, processes of care, and
costs. Additionally, CHBRP states the evidence on the
impacts of CCPs on health outcomes, processes of care,
and costs tends to be condition-specific, so study
results cannot be generalized beyond the
diseases/conditions studied. For health plan or health
insurer use of CCPs, there are very few published
studies, and the evidence is insufficient to assess the
impacts on health outcomes. There is limited evidence
from three studies with weak research designs using data
from two health plans showing reduced oncology costs for
oncology patients, and there is insufficient evidence to
draw conclusions about cost impacts when CCPs are used
for other conditions. For provider use of CCPs, there is
stronger evidence from higher-quality research studies
that their use leads to improved health outcomes and
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improved processes of care. There is also evidence from
studies with moderate to weak research designs that
provider use of CCPs lowers costs. The available
evidence is insufficient to conclude that CCPs are more
effective when implemented by providers than by
plans/insurers.
b) Conflict of Interest. This bill requires the health
plans and health insurers to identify any conflicts of
interest of the physicians or organization that developed
the CCP. The federal Department of Health and Human
Services, Office of Inspector General has expressed concern
regarding the Centers for Medicare & Medicaid Services
(CMS) lack of oversight of Medicare Part D Pharmacy and
Therapeutics (P&T) Committees conflicts of interest. As
the entities responsible for making Medicare Part D
formulary decisions, P&T Committees must ensure that their
decisions are made based on scientific evidence and not
based on the personal financial interests of committee
members. Federal regulations require that Medicare Part D
sponsors follow their P&T Committee's decisions regarding
which drugs to place on formulary. However, sponsors
ultimately can determine the tier placement of such drugs
based on P&T Committee recommendations. With respect to
conflicts of interest, federal laws and regulations
stipulate that at least one physician and at least one
pharmacist on the P&T Committee must be free of conflict
relative to the Part D sponsor, Part D plan, and
pharmaceutical manufacturers.
3)SUPPORT. The California Retired Teachers Association (CalTRA)
states that this bill would ensure that health plans and
insurers cannot implement CCPs that would limit access to
necessary care and insurance payment for that necessary care.
CalTRA believes that medical professionals and patients should
be able to determine the best appropriate care for individuals
based on sound medical practices. California Chronic Care
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Coalition (CCCC) states that pathways are structured care
plans used to detail the care of patients for a specific
disease and dictate the exact sequence of treatments that
physicians should follow. CCCC contends that health plans
have begun to develop their own pathways to capitalize on the
ability to influence and limit cancer drug usage and focus on
cost rather than patient care. CCCC contends that health plans
refuse to say how they develop pathways, making it impossible
to determine if health plans prioritize maximum cost savings
over quality cancer care. Additionally, CCCC states that when
health plans design their own pathways, top priorities get
shifted towards cost management. The CCCC supports this bill
because it will protect patients by ensuring that when a
health plan develops pathways, they are doing so with 100%
transparency and accountability, using cutting edge science
and clinical experience and each patient's specific
circumstances where the top priority is to provide high
quality patient care.
The Association of Northern California Oncologists (ANCO)
state that extensive research from clinical trials and
peer-reviewed publications is used in the development of the
CCP and once developed, it is continually reviewed and
modified to reflect the latest breakthroughs in research and
treatment practices. ANCO further states that the method of
development, experts consulted, and research reviewed are all
open to scrutiny. The Medical Oncology Association of
Southern California (MOASC) also describes the ideal pathway
process and states that pathways can also be a dangerous
slippery slope that allows for insurance plans to dictate
medical treatments and can lead to social injustice where
treatment is determined by the insurance care in your pocket.
MOASC contends that these pathways focus on cost containment,
rather than optimal patient care, which is appropriate for a
for-profit corporation beholden to shareholder interest.
MOASC also states that health plans refuse to say how they
develop pathways, criteria for selecting treatments, the
identities, qualifications, affiliations, or conflicts of who
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develops the pathway, and goals and objections such that it is
impossible to determine if health plans prioritize max cost
savings over quality cancer care.
4)OPPOSITION. The California Association of Health Plans
(CAHP), the Association of California Life and Health
Insurance Companies, and America's Health Insurance Plans
contend that health insurance mandates threaten efforts of all
health care stakeholders to provide consumers with meaningful
health care choices and affordable coverage options. They
state that the Patient Protection and Care Act (ACA) requires
the state to pay for the increased cost associated with the
mandate for those enrollees who purchase health insurance on
the Exchange. They also state that benefit mandates eliminate
the ability of health insurers and HMOs to provide unique
benefit packages aimed at the needs of consumers by requiring
individuals and employers to purchase benefits prescribed by
the Legislature, not driven by consumer choice. Finally, the
opposition note that health benefit mandates stifle the use of
innovative, evidence based medicine.
Blue Shield of California (BSC) states that this bill would
create unnecessary barriers to health plans implementing CCPs,
which are evidence-based practices used by providers to treat
some of the most serious illnesses. BSC contends that the
health plan and its provider partners utilize evidence-based
programs across a range of services, covering everything from
joint replacement to cancer treatment. California Association
of Provider Groups (CAPG) contends that CCPs are hard to
define; are a primary tool to reduce variation in practice
among providers; and, tying CCPs to financial incentives is an
effective way to improve quality of care.
Kaiser Permanente (Kaiser) states that this bill is vague and
broadly written that could enact onerous new reporting
requirements on the use of CCPs. Kaiser states it does not
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require the use of or dictate CCPs, however it contends that
the collaborative nature of its model could be included in
this bill. Kaiser notes that because its medical groups may
develop pathways in collaboration with health personnel
employed by the health plan and Kaiser Foundation Hospital
system, Kaiser's medical group must assume that any of
Kaiser's clinical guidelines, work flows and other practice
pattern could fall under this bill. This includes its KP
HealthConnect, the electronic medical record system, and the
development of pharmaceutical formularies. Finally, Kaiser
raises concerns with respect to the comment and review from
external groups indicating that this unprecedented process can
hinder appropriate changes to Kaiser's medical group's
practices based on new research.
According to Anthem Blue Cross (Anthem), it developed the
Cancer Care Quality Program (Program) to address issues with
respect to medical evidence and best practices; huge cost
variations; and current business models for oncologists.
Anthem states that its Program creates voluntary pathways that
in-network physicians can use to provide patients with
clinically appropriate, quality care with minimal side effects
at the best cost. Anthem contends that this bill elects to
single out health plan pathways with additional oversight
standards. While some of the provisions of this bill are
consistent with Anthem practice, Anthem opposes the
requirement that health plans release the names of third party
panelists and raises concerns that this is an attempt by drug
companies and others to gain access to the names of providers
in an attempt to influence the process. Anthem also raises
concerns with the provision of this bill that hinders
education, research, patient screening or patient access to
clinical trials. Finally, Anthem notes that this bill should
be applied to pathways developed by others, including pathways
and clinical drug trials in which providers are paid by drug
manufacturers for participation.
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5)POLICY COMMENTS. This bill requires health plans to provide
information with respect to the implementation of CCPs as
defined in this bill. However, as the CHBRP background
indicates, there is no standard clinical or legal definition
of CCPs and there is a lack of CCP studies and cost impacts
and the availability of standard elements of a CCP and the
process for development.
a) CCP Study. In an effort to better understand the CCP
process and give the Legislature sufficient information to
determine the appropriate mechanism or standard to use when
regulating CCPs, the Committee recommends that instead of
imposing specific requirements on CCP's, this bill should
instead require health plans beginning January 1, 2018, to
submit to the DMHC their existing procedures and protocols
or processes for establishing or administering CCPs. As
part of this reporting requirement, health plans should
submit specified information on CCPs, including how they
are currently utilized, for what purposes, membership, and
any other information that could be relevant. The DMHC
then reviews these filings and submits a report of its
findings to the Legislature.
b) Definition of CCPs. The Committee may wish to consider
narrowing the definition of CCPs as opponents have raised
concerns that the current definition may include practices
that are not currently identified as CCP, such as drug
formulary determinations and other potential
patient-centered assessment tools utilized by health plans
as part of the pre-authorization process.
c) Other entities. Since CCPs are also developed by other
entities, like providers and medical groups, hospitals, and
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drug manufacturers, the Committee may wish to consider
applying this bill to other entities.
d) IMR. With respect to the coverage decision referenced
in the definition of a CCP, the author may wish to consider
this reference and its impact on the IMR process in that a
particular service within a CCP can potentially be excluded
as not a covered benefit and therefore not subject to the
IMR process.
REGISTERED SUPPORT / OPPOSITION:
Support
Association of Northern California Oncologists
Medical Oncology Association of Southern CA
National Council of Asian Pacific Islander Physicians
California Medical Association
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California Chronic Care Coalition
California Retired Teachers Association
Latinas Contra Cancer
National Council of Asian Pacific Islander Physicians
Ovarian Cancer Coalition of Greater California
Opposition
America's Health Insurance Plans
Anthem Blue Cross
Association of California Life and Health Insurance Companies
Blue Shield of California
California Association of Health Plans
California Association of Provider Groups
Kaiser Permanente
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Analysis Prepared by:Kristene Mapile / HEALTH / (916) 319-2097