BILL ANALYSIS Ó
AB 1977
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Date of Hearing: May 3, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
AB 1977
(Wood) - As Amended April 13, 2016
SUBJECT: Opioid Abuse Task Force.
SUMMARY: Establishes the Opioid Abuse Task Force (Task Force)
to develop recommendations to the Legislature regarding the
abuse and misuse of opioids in California. Specifically, this
bill:
1)Requires health care service plans (health plan) and health
insurer representatives, in collaboration with advocates,
experts, health care professionals, and other entities and
stakeholders that they deem appropriate, to convene a Task
Force, on or before February 1, 2017, that will develop
recommendations regarding the abuse and misuse of opioids, as
specified.
2)Requires the Task Force to address all of the following:
a) Interventions that have been scientifically validated
and have demonstrated clinical efficacy;
b) Interventions that have measurable treatment outcomes;
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c) Collaborative, evidence-based approaches to resolving
opioid abuse and misuse that incorporate both the provider
and the patient into the solution;
d) Education that engages and encourages providers to be
prudent in prescribing opioids and to be proactive in
defining care plans that include a plan to taper and stop
opioid use; and,
e) Review and consider medication coverage policies and
formulary management and development of an
interdisciplinary case management program that addresses
quality, fraud, waste, and abuse.
3)Requires the Task Force to submit a report detailing its
findings and recommendations to the Governor, President pro
Tempore of the Senate, Speaker of the Assembly, and the Senate
and Assembly Committees on Health, on or before December 31,
2017.
4)Terminates the Task Force on June 1, 2018.
5)Repeals the provisions of this bill on January 1, 2019, unless
a later enacted statute deletes or extends that date.
EXISTING LAW:
1)Establishes the Knox-Keene Health Care Service Plan Act of
1975, which provides for the licensure and regulation of
health plans by the Department of Managed Health Care (DMHC),
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and provides for the regulation of health insurers under the
Insurance Code by the California Department of Insurance
(CDI).
2)Mandates 10 federally required essential health benefits
(EHBs) in the individual and small group market and
establishes the Kaiser Small Group health plan as California's
EHB benchmark plan, including prescription drug benefits, as
specified, and incorporates by reference state law and
regulations related to outpatient prescription drug coverage.
3)Classifies controlled substances into five designated
schedules, with the most restrictive limitations generally
placed on controlled substances classified in Schedule I, and
the least restrictive limitations generally placed on
controlled substances classified in Schedule V.
4)Provides for the licensure and regulation of pharmacists by
the California Board of Pharmacy.
5)Prohibits the delivery of Schedule II, III, or IV controlled
substances to a pharmacy unless a receipt for the merchandise
is signed by a pharmacist or authorized receiving personnel.
FISCAL EFFECT: None.
COMMENTS:
1)PURPOSE OF THIS BILL. According to the author, not enough is
being done to curb the growth of opioid abuse, and health care
providers and parents need tools to help guard against the
abuse of opioid medication. The author cites education for
patients on the proper storage and disposal of opioids, as
well as the development and availability of abuse-deterrent
opioids, which are formulated to prevent manipulation of the
drug for the purpose of misuse, as strategies that should be
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encouraged to combat opioid abuse. The Task Force will engage
various stakeholders to discuss such strategies to
specifically address the problems related to the abuse and
misuse of opioids. The Task Force will then submit a report
detailing its findings and recommendations to the Legislature
for consideration of a hopefully more comprehensive approach
to deal with this issue.
2)BACKGROUND.
a) Opioids and opioid abuse. Certain drugs are classified
under the federal Controlled Substances Act of 1970 (CSA)
into one of five schedules. Placement in a given schedule
depends on whether a drug has a currently accepted medical
use, its relative abuse potential, and its likelihood of
causing either addiction or physical dependency when
abused. The Attorney General, acting through the Drug
Enforcement Administration, is responsible for scheduling
controlled substances. Most opioid analgesics are schedule
II drugs, in that they have a recognized medical use, but
also have a high potential for abuse which may lead to
severe psychological dependence or severe physical
dependence. The CSA places a number of restrictions on
prescribers and pharmacies that dispense controlled
substances like opioids. Additionally, refills are not
permitted and a new written prescription must be presented
each time the drug is dispensed.
Opioids are a class of narcotic drugs that include
medications such as hydrocodone, oxycodone, morphine,
codeine, and other related drugs. Taken as prescribed,
opioids can be used to manage pain safely and effectively.
However, opioids may also produce other effects, and
according to the National Institute on Drug Abuse (NIDA),
some individuals experience a euphoric response to opioid
medications since these drugs affect the regions of the
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brain involving reward response.
NIDA states that those who abuse opioids may seek to
intensify their experience by taking the drug in ways other
than those prescribed. For example, OxyContin is an oral
medication used to treat moderate to severe pain through a
slow, steady release of the opioid. However, NIDA states
that people who abuse the drug may crush or dissolve the
drug in order to snort or inject it, thereby increasing
their risk for serious medical complications, including
overdose. NIDA states that when abused, even a single
large dose of opioids can cause severe respiratory
depression and death.
According to the California Department of Public Health
(DPH), in the past, prescription opioids were prescribed
for relieving short-term, acute pain. However, today, they
are increasingly being used for long-term (chronic) pain
management. As a result, sales of opioid pain relievers
quadrupled in the past 10 years. By 2010, enough opioid
pain relievers were sold to medicate every American adult
(about 240 million people) every four hours for an entire
month. DPH states that in California, deaths involving
opioid prescription medications have increased 16.5% since
2006. In 2012, there were more than 1,800 deaths from all
types of opioids - 72% involved prescription opioids.
b) Prescription Opioid Misuse and Overdose Prevention
Workgroup. In response to the national epidemic of
prescription medication misuse and overdose, DPH and its
state partners, including the Board of Pharmacy and the
Medical Board of California, convened a Prescription Opioid
Misuse and Overdose Prevention Workgroup in Spring 2014.
This workgroup is exploring opportunities to improve
collaboration and expand joint efforts among state
departments working to address this epidemic. It has
identified two priorities: expansion and strengthening of
prevention strategies and improvement of monitoring and
surveillance.
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c) Opioid Safety Coalitions Network. The California
HealthCare Foundation (CHCF) is currently providing
technical assistance to 16 Opioid Safety Coalitions in 24
counties across California. Opioid Safety Coalitions
throughout the state bring together a broad group of
stakeholders committed to decreasing opioid overuse and
overdose deaths. CHCF requested that the Opioid Safety
Coalitions identify and implement collective actions to
reduce the opioid overuse epidemic through at least one
intervention in each of the following federal priority
areas: supporting safe prescribing practices; expanding
access to medication-assisted addiction treatment; and,
increasing naloxone access.
d) Federal Responses. Recently, President Obama introduced
a number of policy changes and new grant opportunities to
address the growing opioid abuse epidemic. Among the new
steps announced, the Obama Administration is launching a
new task force on mental health parity aimed at ensuring
that 23 million people in Medicaid receive the same access
to mental health and drug addiction benefits as people with
private health plans. Additionally, President Obama
announced $120 million worth of grants, $94 million of
which had already been promised to community health centers
under the Patient Protection and Affordable Care Act. Most
substantially, President Obama unveiled that the
Administration is aiming to expand access to
medication-assisted treatment by releasing a proposed rule
that changes restrictions on the amount of patients per
practitioner that may be prescribed medications that treat
opioid dependence. Specifically, the proposal would raise
the existing limit of 100 patients per practitioner to 200
patients for a subset of practitioners, provided they
fulfill several additional requirements.
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The House Committee on Oversight and Government Reform
recently convened a hearing to discuss ways to improve the
federal response to the heroin and opioid abuse problem as
the House considers a path forward on bipartisan
legislation. This hearing follows Senate passage of a bill
earlier this year, the Comprehensive Addiction and Recovery
Act (S. 524) (CARA), which would authorize the
Administration to offer grants to states to expand their
treatment offerings and increase access to naloxone, an
overdose prevention drug. CARA would also give the U.S.
Department of Justice additional tools to combat drug
trafficking.
Additionally, the Centers for Disease Control and
Prevention (CDC) issued new prescribing guidelines for
opioids, which may help doctors and patients better
understand the risks associated with prescription
painkiller use. In addition to the CDC guidelines, the
Obama Administration requested more than $1 billion in new
mandatory funding in next year's budget to address opioid
drug abuse. The Food and Drug Administration (FDA)
announced changes to the safety warnings that are required
on the labels of prescription painkillers - the labels must
now include a boxed warning about risks of misuse,
addiction, overdose, and death. FDA also revealed new
steps to scrutinize applications for prescribing opioids.
e) Legislation in other states. According to the National
Conference of State Legislatures, there are approximately
32 bills introduced in 2016 having to do with opioid drug
abuse. In 2015, Tennessee enacted legislation that
requires the commissioner of mental health and substance
abuse services to convene a working group to examine the
problem of opioid abuse in the state and the potential
impact of the use of FDA-approved abuse-deterrent opioids
and the issue of prescription drugs.
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Massachusetts became the first state to establish a
seven-day limit on first-time opioid prescriptions. The
new law, An Act Relative to Substance Use, Treatment,
Education and Prevention, was passed unanimously by the
Massachusetts state legislature, and requires a seven-day
supply limit on initial opioid prescriptions for adults and
all opioid prescriptions for minors.
3)SUPPORT. The County Behavioral Health Directors Association
of California states that this bill is consistent with federal
initiatives, like the Mental Health and Substance Use Disorder
Parity Task Force, and takes an important step toward
addressing opioid abuse by establishing a statewide Task
Force. The County Health Executives Association of California
(CHEAC), the California State Sheriffs' Association (CSSA),
and the California Primary Care Association supported a
previous version of this bill. CHEAC notes that with the
inclusion of abuse-deterrent opioids, physicians in California
would have the option to prescribe drugs that would
effectively manage patient pain while also minimizing the risk
of abuse and diversion. CHEAC also states that local health
departments support efforts to reduce and prevent drug
addiction and related problems. The California State
Sheriffs' Association (CSSA) notes that the abuse of
prescription drugs continue to increase and particularly
alarming is the frequency with which minors use medicine meant
for therapeutic purposes and/or for other persons for
non-medical reasons.
4)NEUTRAL. The America's Health Insurance Plans was previously
opposed to this bill and is now neutral and appreciates the
author's leadership role in addressing the issue of opioid
abuse and looks forward to continuing a constructive dialogue
regarding how best to address this growing epidemic.
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5)OPPOSE UNLESS AMENDED. The California Medical Association
(CMA) opposed a previous version of this bill and states that
effective solutions require a sustained, cooperative effort on
the part of all stakeholders, including physicians, patients,
law enforcement, regulatory agencies, insurers, and the
pharmaceutical industry.
6)OPPOSITION. California Association of Health Plans (CAHP),
the Association of California Life and Health Insurance
Companies, and America's Health Insurance Plans were opposed
to a previous version of this bill and contend that health
insurance mandates threaten the efforts of all health care
stakeholders to provide consumers with meaningful health care
choices and affordable coverage options. CAHP also states
that more work also needs to be done in finding a pathway to
lower-cost options in the opioid market. Kaiser Permanente
(Kaiser) was also opposed to a previous version of this bill
and states that abuse-deterrent drugs are fairly new, quite
costly, and there is insufficient evidence about their
efficacy in deterrence and prevention of abuse. Blue Shield
of California (Blue Shield) was also opposed to a previous
version of this bill and states that coverage of
abuse-deterrent formulations on a health plan's formulary at
the lowest copayment or coinsurance does little to address the
underlying causes of opioid overuse and abuse. It should be
noted that all the provisions that were opposed have been
deleted from this bill.
7)RELATED LEGISLATION. AB 2592 (Cooper) creates within DPH a
pilot program that would award grants to eligible pharmacies
for the purpose of supplying medicine locking closure packages
to patients with prescriptions for opioids. AB 2592 is
currently pending in the Assembly Appropriations Committee.
8)PREVIOUS LEGISLATION.
a) AB 623 (Wood) from 2015 would have prohibited a health
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plan or health insurer from requiring the use of opioid
drug products that have no abuse-deterrent properties in
order to access abuse-deterrent opioid drug products;
required pharmacists to provide a patient receiving an
opioid drug product information about proper storage and
disposal of the drug; and, authorized a provider to
prescribe a less than 30-day supply of opioids analgesic
drugs. AB 623 was held in the Assembly Appropriations
Committee.
b) AB 831 (Bloom) from 2013 would have required, until
January 1, 2016, the California Health and Human Services
Agency (CHHSA) to convene a temporary working group to
develop a state plan to reduce the rate of fatal drug
overdoses and appropriates $500,000 from the General Fund
to CHHSA to provide grants to local agencies to implement
drug overdose prevention and response programs. This bill
was held in the Assembly Appropriations Committee.
c) AB 369 (Huffman) of 2012 would have prohibited health
plans and health insurers that restrict medications for the
treatment of pain from requiring a patient to try and fail
on more than two pain medications before allowing the
patient access to the pain medication, or its generic
equivalent, prescribed by his or her physician. This bill
was vetoed with the Governor's veto message stating that a
doctor's judgment and a health plan's clinical protocols
have a role in ensuring prudent prescribing of pain
medications, and any limitations on the practice of step
therapy should better reflect a health plan or insurer's
legitimate role in determining the allowable steps.
d) AB 1826 (Huffman) of 2010 would have required a health
plan or health insurer that covers prescription drug
benefits to provide coverage for a drug that has been
prescribed for the treatment of pain without first
requiring the enrollee or insured to use an alternative
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drug or product. This bill was held in the Senate
Appropriations Committee.
e) AB 1144 (Price) of 2009 would have required health plans
and health insurers to report to DMHC and CDI specified
information related to chronic pain medication management,
including when the health plan or health insurer requires
an enrollee or insured to use of more than two formulary
alternative medications prior to providing access to a pain
medication prescribed by a provider, or to use pain
medication other than what was prescribed for more than
seven days prior to providing access to the prescribed pain
medication. This bill was held in the Assembly
Appropriations Committee.
REGISTERED SUPPORT / OPPOSITION:
Support
California District Attorneys Association
California Health Executives Association of California (previous
version)
California Narcotic Officers' Association (previous version)
California Primary Care Association (previous version)
California State Sheriffs' Association (previous version)
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County Behavioral Health Directors Association of California
L.A. Care
Pharmaceutical Care Management Association
Public Policy Advocates
Opposition
America's Health Insurance Plans (previous version)
Association of California Life and Health Insurance Companies
(previous version)
Blue Shield of California
California Association of Health Plans (previous version)
California Association of Joint Powers Authorities (previous
version)
California Chamber of Commerce (previous version)
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California Retailers Association (previous version)
California Medical Association (previous version)
CVS Health (previous version)
Express Scripts Holding Company (previous version)
Kaiser Permanente
Pharmaceutical Care Management Association (previous version)
Analysis Prepared by:Kristene Mapile / HEALTH / (916) 319-2097