Bill Text: CA AB623 | 2015-2016 | Regular Session | Amended
Bill Title: Abuse-deterrent opioid analgesic drug products.
Spectrum: Bipartisan Bill
Status: (Failed) 2016-02-01 - From committee: Filed with the Chief Clerk pursuant to Joint Rule 56. [AB623 Detail]
Download: California-2015-AB623-Amended.html
BILL NUMBER: AB 623 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY MAY 4, 2015
AMENDED IN ASSEMBLY MARCH 26, 2015
INTRODUCED BY Assembly Member Wood
( Coauthor: Assembly Member
Waldron )
FEBRUARY 24, 2015
An act to add Section 4069 to the Business and Professions Code,
to add Section 1367.217 to the Health and Safety Code, and to add
Section 10123.203 to the Insurance Code, relating to prescription
drugs.
LEGISLATIVE COUNSEL'S DIGEST
AB 623, as amended, Wood. Abuse-deterrent opioid analgesic drug
products.
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 and makes a
willful violation of that act a crime. Existing law also provides for
the regulation of health insurers by the Department of Insurance.
These provisions require specified services and drugs to be covered
by the various plans.
This bill would, where an abuse-deterrent opioid analgesic drug
product, as defined, is available, prohibit a health care service
plan or insurer from requiring the use of opioid analgesic drug
products without the abuse-deterrent properties in order to access
abuse-deterrent opioid analgesic drug products. The bill would
require a health care service plan or insurer to allow a provider to
prescribe, and if otherwise covered, to provide coverage for, a less
than 30-day supply of an opioid analgesic drug product. Because a
willful violation of these requirements with respect to health care
service plans would be a crime, this bill would impose a
state-mandated local program.
Existing law, the Pharmacy Law, the knowing violation of which is
a crime, provides for the licensing and regulation of pharmacists by
the California State Board of Pharmacy. Existing regulations require
a pharmacist to provide oral consultation to his or her patient or
the patient's agent in all care settings upon request or whenever the
pharmacist deems it warranted.
This bill would require a pharmacist to inform a patient receiving
an opioid analgesic drug product on proper storage and disposal of
the drug, and authorizes this information to be included as
part of the required oral consultation. would require
the board to adopt regulations to implement that provision.
Because a violation of this requirement would be a crime, the bill
would impose a state-mandated local program.
The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. The Legislature finds and declares the following:
(a) Prescription and over-the-counter (OTC) drugs are, after
marijuana and alcohol, the most commonly abused substances by
Americans over 14 years of age.
(b) Over two million people in the United States suffer from
substance use disorders related to prescription opioid pain
relievers.
(c) More people die from overdoses of prescription opioid pain
relievers than from all other drugs combined, including heroin and
cocaine.
(d) Prescription opioid pain relievers can have effects similar to
heroin when taken in doses or in ways other than prescribed, and
research now suggests that abuse of these drugs may lead to heroin
abuse.
(e) Prescription opioid pain relievers can be particularly
dangerous when snorted, injected, or combined with other drugs or
alcohol.
SEC. 2. Section 4069 is added to the Business and Professions
Code, to read:
4069. (a) A pharmacist shall inform a patient receiving an opioid
analgesic drug product on proper storage and disposal of the drug.
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. The board shall adopt
regulations to implement this section.
(b) For purposes of this section, "opioid analgesic drug product"
has the same meaning as defined in Section 1367.217 of the Health and
Safety Code.
SEC. 3. Section 1367.217 is added to the Health and Safety Code,
to read:
1367.217. (a) Where an abuse-deterrent opioid analgesic drug
product is available, a health care service plan shall not require
the use of opioid analgesic drug products without the abuse-deterrent
properties in order to access abuse-deterrent opioid analgesic drug
products.
(b) This section shall not be construed to prevent a health care
service plan 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.
(c) A health care service plan shall allow a provider to
prescribe, and if otherwise covered, shall provide coverage for, a
less than 30-day supply of an opioid analgesic drug product.
(d) For purposes of this section, the following definitions shall
apply:
(1) "Abuse-deterrent opioid analgesic drug product" means a brand
or generic opioid analgesic drug product approved by the federal Food
and Drug Administration with abuse-deterrence labeling claims that
indicate the drug product is expected to result in a meaningful
reduction in abuse.
(2) "Opioid analgesic drug product" means 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.
SEC. 4. Section 10123.203 is added to the Insurance Code, to read:
10123.203. (a) Where an abuse-deterrent opioid analgesic drug
product is available, an insurer shall not require the use of opioid
analgesic drug products without the abuse-deterrent properties in
order to access abuse-deterrent opioid analgesic drug products.
(b) This section shall not be construed to prevent an 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.
(c) An insurer shall allow a provider to prescribe, and if
otherwise covered, shall provide coverage for, a less than 30-day
supply of an opioid analgesic drug product.
(d) For purposes of this section, the following definitions shall
apply:
(1) "Abuse-deterrent opioid analgesic drug product" means a brand
or generic opioid analgesic drug product approved by the federal Food
and Drug Administration with abuse-deterrence labeling claims that
indicate the drug product is expected to result in a meaningful
reduction in abuse.
(2) "Opioid analgesic drug product" means 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.
SEC. 5. No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIII B of the California
Constitution.
