BILL ANALYSIS Ó
AB 623
Page 1
Date of Hearing: April 28, 2015
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Susan Bonilla, Chair
AB 623
(Wood) - As Amended March 26, 2015
NOTE: This bill is double-referred, having been previously
heard by the Assembly Committee on Health on April 21, 2015 and
approved on a 15-4 vote.
SUBJECT: Abuse-deterrent opioid analgesic drug products.
SUMMARY: Prohibits a health care service plan (plan) or health
insurer (insurer) from requiring the use of opioid drug products
that have no abuse-deterrent properties in order to access
abuse-deterrent opioid drug products; requires pharmacists to
provide a patient receiving an opioid drug product information
about proper storage and disposal of the drug; and, mandates
that a plan and insurer may not prevent a provider from
prescribing a less than 30-day supply of opioids analgesic drugs
and to provide coverage, if otherwise covered, for the less than
30-day prescription.
EXISTING LAW:
1)Establishes the Knox-Keene Health Care Service Plan Act of
1975 (Knox-Keene Act), which provides for the licensure and
regulation of health care service plans by the Department of
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Managed Health Care (DMHC), and provides for the regulation of
health insurers by the California Department of Insurance
(CDI). (Health and Safety Code (HSC) Sections 1340 et seq.)
2)Pursuant to DMHC regulations, states that a plan may require
step therapy and requires a plan to have an expeditious
process in place to authorize exceptions to step therapy when
medically necessary. (California Code of Regulation (CCR)
Title 28 Division 1 Section 1367.24(d)(2))
3)Requires plans and insurers to include information on
cost-sharing tiers and utilization controls, including prior
authorization or step therapy requirements, for each covered
drug. (28 CCR Section 1367.24(d)(2))
4)Allows a plan to limit the amount of the drug dispensed at any
one time to a 30-day supply or, if the treatment is for less
than 30 days, for the medically necessary amount of the drug
and allows for the imposition of a requirement that
maintenance drugs be dispensed in a two months or greater
supply. (28 CCR Section 1367.24(d)(3))
5)Prohibits health plans that cover prescription drugs from
limiting or excluding coverage for a drug on the basis that
the drug is prescribed for use different from that for which
the drug has been approved by the federal Food and Drug
Administration (FDA), provided that specified conditions have
been met, including that the drug is prescribed by a
participating licensed health care professional for the
treatment of a chronic and seriously debilitating condition,
the drug is medically necessary to treat that condition, and
the drug is on the plan formulary. (HSC 1367.21)
6)Prohibits health plans that cover prescription drugs from
limiting or excluding coverage for a drug for an enrollee if
the drug was previously approved for coverage by the plan for
a medical condition of the enrollee and the plan's prescribing
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provider continues to provide the drug for the medical
condition, provided that it is safe and effective for
treatment. (HSC 1367.22)
7)Provides for the licensure and regulation of pharmacists by
the California Board of Pharmacy (BOP). (Business and
Professions Code (BPC) Section 4000 et seq.)
8)Requires, under existing regulations, a pharmacist to provide
oral consultation to a patient in all care settings under the
following circumstances: (16 CCR 1707.2)
a) Upon request by the patient; or,
b) Whenever the pharmacist deems a consultation is
warranted in the exercise of his or her professional
judgment, and,
c) When the prescribed drug has not previously been
dispensed to a patient; or,
d) When the prescription drug is dispensed that has not
been previously dispensed to a patient in the same dosage,
strengths, or with the same directions.
9)Gives the pharmacist the discretionary authority to provide
information during oral consultation relating to any special
directions for use and storage. (16 CCR 1707.2)
10)Allows a patient to waive the oral consultation with a
pharmacist under specified conditions. (16 CCR 1707.2)
THIS BILL:
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1)Requires a pharmacist to inform a patient receiving an opioid
analgesic drug product on proper storage and disposal of the
drug, and authorizes the information to be provided as part of
an oral consultation, as specified.
2)Defines "opioid analgesic drug product" as a drug product in
the opioid analgesic drug class that is prescribed to treat
moderate to severe pain, or other conditions, whether in
immediate release or extended release or long-acting form and
whether or not combined with other drug substances to form a
single drug product or dosage form.
3)Defines "abuse-deterrent opioid analgesic drug product" as a
brand or generic opioid analgesic drug product approved by the
FDA with abuse-deterrent labeling claims that indicate the
drug product is expected to result in a meaningful reduction
in abuse.
4)Prohibits, where an abuse-deterrent opioid analgesic drug
product is available, a plan or insurer from requiring the use
of opioid analgesic drug products without abuse-deterrent
properties first before allowing access to abuse-deterrent
opioid analgesic drug products.
5)Provides that this bill shall not be construed to prevent a
plan or insurer from applying prior authorization requirements
to abuse-deterrent opioid analgesic drug products, provided
that those same requirements are applied to versions of those
opioid analgesic drug products without the abuse-deterrent
properties.
6)Mandates that a plan or insurer may not prevent a health care
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provider from prescribing a less than 30-day supply of an
opioid analgesic drug product and requires the plan or insurer
to cover a less-than 30-day supply if otherwise covered.
7)Makes legislative findings and declarations relating to opioid
analgesic drug abuse.
FISCAL EFFECT: Unknown. This bill is keyed fiscal by the
Legislative Counsel.
COMMENTS:
1)Purpose. This bill is sponsored by the American Chronic Pain
Association , the Power of Pain Foundation , and the United
States Pain Foundation . According to the author, "As a health
care provider focused on the value of prevention, I believe
that not enough is being done to curb the growth of opioid
abuse. Health care providers and parents need tools to help
guard against the abuse of medication by people who are not
necessarily the patient. Curbing abuse will mean fewer
unintentional overdoses. There is nowhere in the state that
is immune to the problem of opioid abuse, particularly among
young people. In Mendocino County, the problem is so acute
that hospital admissions for narcotic overdoses are twice the
state average. . . . Strategies like educating patients on
the proper storage and disposal should help protect
medications from being readily available and accessible for
those wanting to abuse. Additionally, the development and
availability of new drugs, abuse deterrent formula (ADF),
which cannot be manipulated or crushed to intensify a high,
should be encouraged. While it is estimated that these
methods (crushing or dissolving) account for 30% of the abuse,
this form of abuse is what results in the majority of ER
visits, hospitalizations and deaths. . . . The pressures on
cost in our health care system and huge and should not be
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ignored but there are times when it is obvious we either pay
now for something or pay later. We are already paying the
price for abuse. The more widespread ADF's become the more
positive an impact we can have on abuse. The increased
availability and competition will also lead to reduced cost."
2)Background. Opioids are a class of narcotic drugs that
include medications such as hydrocodone (e.g. Vicodin),
oxycodone (e.g., OxyContin, Percocet), morphine (e.g., Kadian,
Avinza) codeine, and other related drugs. Through the
Controlled Substances Act of 1970 (CSA), the Drug Enforcement
Administration (DEA) regulates the manufacture, distribution
and dispensing of controlled substances. The CSA ranks into
five schedules those drugs known to have potential for
physical or psychological harm, based on three considerations:
1) their potential for abuse, 2) their accepted medical use,
and 3) their accepted safety under medical supervision.
Presently, the ADF formulations on the market and pending FDA
approval are Schedule II drugs.
Schedule I controlled substances have a high potential for
abuse and have no generally accepted medical, use such as
heroin, ecstasy, and LSD.
Schedule II controlled substances have a currently accepted
medical use in treatment, or a currently accepted medical use
with severe restrictions, and have a high potential for abuse
and psychological or physical dependence. Schedule II drugs
can be narcotics or non-narcotic. Examples of Schedule II
controlled substances include morphine, methadone, Ritalin,
Demerol, Dilaudid, Percocet, Adderall, and Oxycontin. In
October of 2014, the DEA as a response to the rising
prescription drug abuse epidemic promulgated a rule
rescheduling hydrocodone containing prescriptions (e.g.,
Vicodin) into this more tightly controlled category (21 Code
of Federal Regulations 1308).
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Schedule III and IV controlled substances have a currently
accepted medical use in treatment, less potential for abuse
but are known to be mixed in specific ways to achieve a
narcotic-like end product. Examples include drugs include
Tylenol with Codeine, Ambien, Xanax, and other anti-anxiety
drugs.
Schedule V drugs have a low potential for abuse relative to
substances listed in Schedule IV and consist primarily of
preparations containing limited quantities of certain
narcotics. Examples include Robitussin with Codeine and
Lomotil.
Prescription Drug Abuse. According the Drug Abuse Warning
Network, a division of the Substance Abuse and Mental Health
Agency, prescription drug misuse and abuse is the intentional
or unintentional use of medication without a prescription, in
a way other than prescribed, or for the experience or feeling
it causes. Results from the 2013 National Survey on Drug Use
and Health indicate that about 15.3 million people aged 12 or
older used prescription drugs non-medically in the past year,
and 6.5 million did so in the past month. This issue is a
growing national problem in the United States. Prescription
drugs are abused and misused more often than any other drug,
except marijuana and alcohol. This growth is fueled by
misperceptions about their safety, increasing availability,
and varied motivations for their use from countering anxiety
and helping sleep problems to getting high. A 2011 analysis by
the Centers for Disease Control and Prevention found that
opioid analgesic sales increased nearly four-fold between 1999
and 2010; this was paralleled by an almost four-fold increase
in opioid overdose deaths and substance abuse treatment
admissions almost six times the rate during the same time
period.
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Abuse can stem from the fact that prescription drugs are legal
and potentially more easily accessible, as they can be found
at home in a medicine cabinet. Data shows that individuals
who misuse prescription drugs, particularly teens, believe
these substances are safer than illicit drugs because they are
prescribed by a health care professional and thus are safe to
take under any circumstances. The National Institute on Drug
Abuse (NIDA) data indicates that in actuality, prescription
drugs act directly or indirectly on the same brain systems
affected by illicit drugs, thus, their abuse carries
substantial addiction liability and can lead to a variety of
other adverse health effects.
A 2008 report by the Coalition Against Insurance Fraud
estimates that the abuse of opioid analgesics results in more
than $72 billion in medical costs alone each year. This is
comparable to costs related to other chronic diseases such as
asthma and HIV.
The Senate Committee on Labor held a hearing on March 20th,
2013 entitled Opioids and the Workers Compensation System: A
Discussion on Mitigating Abuse and Ensuring Access during
which the Committee reviewed a series of studies conducted by
the California Workers' Compensation Institute which
highlighted a rise in opioid analgesic prescriptions by
physicians in the state workers' compensation system. The
studies identified trends in widespread, potent use of
Schedule II drugs by patients with low back pain; significant
growth in the prescribing of all Schedule II drugs in the
workers' compensation system; and found that 6.7 percent of
all prescriptions in the system for the first half of 2011
alone were for opioids.
Taken as prescribed, opioids analgesic can be used to manage
pain safely and effectively. However, opioids may also
produce other effects, and according to the NIDA, some
individuals experience a euphoric response to opioid
medications since these drugs affect the regions of the brain
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involving reward response.
The 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, the 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. The
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 (CDPH),
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. The
CDPH states that in California, deaths involving opioid
prescription medications have increased 16.5 percent since
2006. In 2012, there were more than 1,800 deaths from all
types of opioids - 72 percent involved prescription opioids.
Abuse-deterrent opioids. According to the FDA, opioid products
can be abused in a number of ways, including being swallowed
whole; crushed in order to be swallowed, snorted, smoked; and,
dissolved and injected. Opioids formulated with
abuse-deterrent properties are designed to be more difficult
to abuse, while retaining the same clinical effectiveness.
For example, abuse-deterrent opioids may be formulated in ways
that prevent chewing, crushing, grating, or grinding. Others
may be formulated with agents that can make the drug resistant
to dissolving by turning the drug into a gel-like substance
when manipulated. Other formulations can reduce or defeat
euphoria associated with the drug, or result in an unpleasant
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effect if the drug is manipulated.
The FDA released industry guidance on April 1, 2015 regarding
the evaluation and labeling of abuse-deterrent opioids, citing
the development of abuse-deterrent opioids as a potentially
important step toward the goal of creating safer opioid
analgesics, and considers the development of abuse-deterrent
opioids a high public health priority. The FDA also noted
that abuse-deterrent technologies developed to date have not
yet proven successful at deterring the most common form of
abuse - swallowing a number of intact capsules or tables to
achieve a feeling of euphoria. Further, the FDA stated that
the science of abuse deterrence is relatively new, and both
the formulation technologies and the analytical, clinical, and
statistical methods for evaluating the technologies are
rapidly evolving.
Four opioids have been approved for abuse-deterrent labeling
and there are a number of generic and brand opioid products
with different types of abuse-deterrent technologies that seek
labeling. One of the four currently approved is OxyContin,
which, in 2010, was reformulated as an abuse-deterrent opioid.
It was approved for ADF labeling in April 2013, indicating
that the product has physical and chemical properties that are
expected to make abuse via injection difficult and to reduce
abuse via snorting. OxyContin's manufacturer replaced the
original OxyContin formulation in 2010 with its
abuse-deterrent formulation, and upon approval of the labeling
in 2013, the FDA stopped accepting applications for generics
that rely upon the approval of original formulation of
OxyContin.
Potential Public Health Impact. In terms of the public health
impact of abuse-deterrent opioids, the author cites research
published in April 2014 in the Journal of Medical Economics
which estimated that abuse-deterrent formulation of OxyContin
reduced overall health care costs by $430 million annually in
the U.S., with an indirect cost savings of $605 million.
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Using health insurance claims data, government reports and
literature, the study estimated that these savings represented
1.8percent of $58.4 billion in overall societal costs of
prescription opioid abuse.
The author also cites a May 2105 study in Econostats that
compared the financial impact between generic opioids without
abuse-deterrent properties. The article cites, "That the
average cost and most expensive cost for a one-month supply
for patented opioids on the market as of July 2012 was $373
and $692, respectively. The average cost and least expensive
cost for a one-month supply of generic opioids on the market
as of July 2012 was $233 and $48, respectively. The price gap
between the average patented cost and the average generic cost
was $140." When looking at the overall costs of opioid abuse,
"The current evidence shows that abuse-deterrent opioids will
reduce the costs of opioid abuse per opioid patient by $4,568
to $4,645, depending upon the patient's insurance status.
Accounting for the estimated additional cost of
abuse-deterrent opioids (between $612 and $2,811), these
medicines are associated with a net economic benefit between
$1,757 and $4,033."
In a July 2012 article, the New England Journal of Medicine
determined, "Interviews with patients who abused both
formulations of OxyContin indicated a unanimous preference for
the older version. Although 24 percent found a way to defeat
the tamper-resistant properties of the abuse-deterrent
formulation, 66 percent indicated a switch to another opioid,
with "heroin" the most common response. These changes appear
to be causally linked, as typified by one response: 'Most
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people that I know don't use OxyContin to get high anymore.
They have moved on to heroin [because] it is easier to use,
much cheaper, and easily available." It is important to note
that there was no evidence that OxyContin abusers ceased their
drug abuse as a result of the abuse-deterrent formulation.
Rather, it appears that they simply shifted their drug of
choice.'"
Step Therapy. According to the Centers for Medicare and
Medicaid Services (CMS), step therapy is defined as: A health
service plan or insurer may require you to first try one drug
before they will cover another drug for that condition. For
example, if Drug A and Drug B both treat your medical
condition, a plan may require your doctor to prescribe Drug A
first. If Drug A does not work for you, then the plan will
cover Drug B. For example, before your insurance company will
pay for a prescription of Hysingla (a brand name
extended-release ADF formulation of hydrocodone (commonly
known as Vicodin or Norco)), an insurer can currently require
that your have tried regular hydrocodone formulation like
Vicodin or Norco which have none of the ADF properties.
Other States. This year, at least fifteen other bills
relating to abuse-deterrent opioids have been introduced in
other states, including Colorado, Connecticut, Florida,
Kansas, Maryland, Mississippi, Oklahoma, Rhode Island,
Tennessee, Vermont, and Virginia. In 2014, legislation on
this topic was introduced in New Jersey. The requirements of
the bills vary across states, with some bills containing
similar requirements as those proposed in this bill, but
overall, the bills aim to expand coverage and access to
abuse-deterrent opioids. Additionally, there is an abundance
of legislation nationwide relating to various aspects of the
prescription drug abuse epidemic including increasing access
to naloxone (opioid overdose antidote), medication take-back
programs, tighter regulations for identification requirements
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prior to dispensing opioids, and improving prescription
monitoring programs.
Current Related Legislation. ACR 26 (Levine), Chapter 16,
Statutes of 2015, proclaimed the month of March 2015 as
Prescription Drug Abuse Awareness Month and encourages all
citizens to actively participate in prevention programs and
activities, and to safely store and dispose of their
medications on a continual basis.
AB 73 (Waldron) of the current legislative session, provides
that drugs in specified therapeutic drug classes that are
prescribed by a Medi-Cal beneficiary's treating provider are
covered Medi-Cal benefits and requires that a Medi-Cal managed
care plan cover the drug upon demonstration by the provider
that the drug is medically necessary and consistent with
federal rules and regulations for labeling and use. (STATUS:
This bill is pending in the Assembly Health Committee.)
Previous Related Legislation. AB 1535 (Bloom), Chapter 326,
Statutes of 2014, authorizes a pharmacist to furnish naloxone
hydrochloride (opioid overdose antidote) in accordance with
standardized procedures or protocols developed and approved by
both the BOP and the Medical Board of California.
AB 1814 (Waldron) of 2014, would have established that a
prescriber's reasonable professional judgment prevails over
the policies and utilization controls of the Medi-Cal program,
including the utilization controls of a Medi-Cal managed care
plan, in prescribing a pharmaceutical from specified
therapeutic drug classes. (NOTE: This bill was held in the
Assembly Appropriations Committee.)
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AB 831 (Bloom) of 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. (NOTE: This bill was held in the Assembly
Appropriations Committee.)
AB 889 (Frazier) of 2013, would have prohibited a plan and
insurer that provides coverage for medications pursuant to
step therapy or fail first protocol from requiring an enrollee
or insured to try and fail more than two medications before
allowing the enrollee or insured access to the medication
originally prescribed by their provider, and would have
required plans and insurers to have an expeditious process in
place for step therapy exceptions and that the duration of
step therapy be consistent with up-to-date evidence-based
outcomes and current published peer-reviewed medical and
pharmaceutical literature. (NOTE: This bill was held in the
Senate Appropriations Committee.)
AB 369 (Huffman) of 2012, would have prohibited plans and
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. (NOTE: This bill was vetoed by Governor Brown
with a 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.)
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AB 1826 (Huffman) of 2010, would have required a plan or 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 drug or product. (NOTE: This bill was held in the
Senate Appropriations Committee.)
AB 1144 (Price) of 2009, would have required plans and insurers
to report to DMHC and CDI specified information related to
chronic pain medication management, including when the plan or
insurer requires an enroll 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. (NOTE:
This bill was held in the Assembly Appropriations Committee.)
ARGUMENTS IN SUPPORT:
The US Pain Foundation (sponsor) writes a letter in support and
notes, "Both the persistent lack of access to opioids by
patients with legitimate, chronic pain and the rate of
prescription opioid abuse exist side-by-side. Sadly, they also
continue to rise. This is why abuse-deterrent formulations are
needed - to help maintain access while reducing abuse risk."
The Power of Pain (co-sponsor) writes a letter in support and
reports, "Opioids are an important and well-established
component of pain management. However, misuse and abuse of
opioids is a growing public health problem that is driving up
healthcare, criminal justice, and workplace costs. We need to
change our policies to develop a strong, lasting solution to
this health crisis. To help combat the problem, a new approach
has emerged with the development of opioids with technological
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advancements that either prevent physical alterations to the
pills or inhibit the euphoric effects of opioids when abused.
ADF technology represents a significant opportunity to reduce
misuse and abuse of opioids."
The California Healthcare Institute writes a letter in support
and highlights, "The innovative technology of Abuse Deterrent
Formulations (ADFs) medications provide the same pain relief as
conventional opioids but they contain physical or chemical
properties that make crushing, cutting or dissolving for
injection difficult. With these new breakthroughs, the FDA
considers the development of these products a high public health
priority."
Biocom writes a letter in supports and cites, "It is
unconscionable that a plan could make a recovering addict or an
individual at risk of becoming an addict take medication without
the abuse deterrent to save a few dollars."
The Alliance for Patient Access writes a letter in support and
notes, "Insurances policies should acknowledge physicians'
judgment about which formulation a patient needs. Imposing
prior authorization requirements or "fail first" policies to
deter physicians from prescribing abuse-deterrent formulations
does not serve patients' best interests."
The Partnership for Drug-Free Kids writes a letter in support
and cites, "Many have suffered the ultimate tragedy [of misuse
or abuse of prescription drugs], the loss of a daughter or son.
While advancements like abuse deterrent formulations are not the
only solution to solving the nation's prescription drug abuse
problem, it is one common-sense approach to potentially help
another family from losing a child to addiction."
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The California Pharmacists Association writes a letter in
support and notes, "Ensuring the pharmacists inform patients
receiving opioid analgesics of the need to store them away from
children, adolescents, and other at risk for diversion, and
informing patients of the need to properly dispose of controlled
substances, will help reduce the number of diverted drugs."
Healthy African American Families II writes a letter in support
and states, "Having a greater share of the controlled substances
in America's medicine cabinets formulated with abuse deterrent
properties would be an important step forward to curbing
prescription drug abuse while ensuring that these medicines
remain available to those who need them for a legitimate medical
purpose under a physician's care."
The Lupus Foundation of Southern California writes a letter in
support and points out, "While AB 623 will not completely stop
the abuse of prescription drugs, it does contain some important
steps that will reduce it."
The California Hepatitis C Task Force writes a letter in support
and claims, "AB 623 will prevent countless deaths from substance
abuse alone which includes suicides and accidental overdoses but
also consider the secondary impact from communicable, infectious
and chronic diseases."
ARGUMENTS IN OPPOSITION:
California Retailers Association writes a letter in opposition
and caution, "While we support innovations to prevent
prescription drug abuse, we need to be cautious of mandating the
dispensing of these drugs without consideration for efficacy and
cost. Although technological innovations have been developed to
prevent opioid medications such as Oxycontin from being crushed,
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dissolved, chewed, or cut, this does not entirely prevent abuse
and potential overdose because an individual can still ingest
opioids without limitation."
California Chamber of Commerce writes a letter in opposition and
notes, ". . . even though AB 623 allows issuers [sic] to require
pre-authorization and apply for other utilization review
management protocols to opioids generally, this does not
necessarily mean that the measure will not have negative
consequences for purchasers and patients. For example,
physicians may increase the rate at which they prescribe opioids
over other types of pain medications if they know issuers [sic]
are required to cover abuse-deterrent formulations."
California Association of Health Plans writes a letter in
opposition and cites, "The New England Journal of Medicine
concluded in its study of the issue that 'abuse-deterrent
formulations may not be the 'magic bullets' that many had hoped
they would be in solving the growing opioid problem.' As such,
the overall value of abuse-deterrent drugs is still being
evaluated by the FDA."
Pharmaceutical Management Association writes a letter in
opposition and notes, "AB 623 is part of a nationwide effort to
force the use of abuse-deterrent opioid analgesic drug products
by disallowing generic substitution of existing opioid drug with
an available generic. The fact is, Abuse Deterrent Formulations
(ADFs) are not a quick fix for opioid abuse and will raises
costs."
POLICY ISSUES FOR CONSIDERATION:
California Health Benefits Review Program (CHBRP) Review. The
Assembly Health Committee referred this bill to the CHBRP for a
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comprehensive analysis of the overall impact of the bill. The
committee submitted a request to CHBRP, housed within the
University of California, to review this bill and perform an
analysis of the clinical efficacy, cost-effectiveness, and
public health impact of its provisions. CHBRP is established in
state statute to assess legislation that proposes or repeals a
mandated benefit or service for public health, medical and
financial impact. CHBRP's independent analysis will likely
provide valuable information about the potential impact of this
bill and inform the Legislature on key policy questions
regarding the bill. For example, as a part of its role in
determining the cost-effectiveness and public health impacts of
the bill, the CHBRP analysis may estimate the cost implications
of requiring brand name abuse-deterrent opioids over generic
opioids without abuse-deterrent properties. Additionally, the
bill would not require abuse-deterrent drugs to actually
demonstrate reduced abuse in the community before requiring
plans to cover them where available. As such, the CHBRP
analysis may provide insight into the actual or potential public
health impact of abuse-deterrent opioids in the community
through an evaluation of a broader set of available evidence.
Pharmacist Education Provision. This bill would mandate a
pharmacist provide to a patient receiving an opioid analgesic
drug product information regarding proper storage and disposal
of the drug. This provision provides that the pharmacist may
include this information as part of the mandated oral
consultation. However, the current regulations with limited
exceptions allow the patient to waive the oral consultation.
After discussion with the BOP, the language of this provision
may not result in this information being distributed to every
patient being prescribed these medications. For example, since
this provision does not require that the information be placed
in written materials, known as a Fact Sheet, a patient receiving
a prescription for an opioid drug and who waives the oral
consultation might not receive this important information.
Because the BOP recognizes the prescription drug abuse epidemic,
it is considering tightening regulations relating to
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consultation requirements relating to opioids. After
discussions with the author and the sponsors, the committee
recommends and the author agrees to amend this section directing
the BOP to promulgate regulations so that this information is
effectively distributed to targeted patients.
30-day Supply Provision. Currently there is no requirement in
existing law that gives a plan or insurer the authority to
require a health care provider to write for a certain amount of
medication. The health care provider is free to prescribe a
quantity as deemed medically necessary and within the standard
of care. However, the DEA limits Schedule II controlled
substances to less than a 90-day supply and requires a new
prescription for continuation of the medication. Notably, there
is a provision in the insurance regulations that gives a plan or
insurer the authority to require a 60-day or more supply for
maintenance medication. To be clear, this regulation does not
prevent a health care provider from writing a prescription for
any amount as deemed necessary for the condition being treated
but could be grounds for denial of payment for a prescription
for a maintenance opioid that is prescribe for less than sixty
days. The language in the bill suggests that a plan or insurer
has the ability to mandate the prescribing habits of health care
providers. After several discussions with the author, the
sponsors, the Medical Board of California, BOP, and the
California Medical Association, the origin and intent of this
section remains unclear and confusing. At this point, the
author would appreciate more time to investigate the intent of
this section and agrees to clarify the language or delete these
sections as appropriate.
AMENDMENTS:
On page 3, line 15-17 strike out This information may be
included as part of the oral consultation required under Section
1707.2 of Title 17 of the California Code of Regulations. and
AB 623
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following the period after the word "drug" insert: The Board
shall promulgate regulations to implement this section.
REGISTERED SUPPORT:
US Pain Foundation (sponsor)
Power of Pain (co-sponsor)
Biocom
Alliance for Patient Access
California Healthcare Institute
California Hepatitis C Task Force
California Pharmacists Association
California State Sheriffs' Association
Healthy African American Families II
Lupus Foundation of Southern California
Partnership for Drug-Free Kids
AB 623
Page 22
REGISTERED OPPOSITION:
California Retailers Association
California Chamber of Commerce
California Association of Health Plans
Pharmaceutical Management Association
Analysis Prepared by:Vincent Chee / B. & P. / (916) 319-3301,
Christian Jagusch / B. & P. / (916) 319-3301