Amended in Assembly May 4, 2015

Amended in Assembly March 26, 2015

California Legislature—2015–16 Regular Session

Assembly Bill No. 623

Introduced by Assembly Member Wood

begin insert

(Coauthor: Assembly Member Waldron)

end insert

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 begin delete authorizes this information to be included as part of the required oral consultation. end delete begin insert would require the board to adopt regulations to implement that provision. end insert 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. begin delete 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. end delete begin insert The board shall adopt regulations
to implement this section. end insert

(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.