BILL NUMBER: AB 1977	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  MARCH 30, 2016

INTRODUCED BY   Assembly Members Wood and Waldron

                        FEBRUARY 16, 2016

   An act to add  Sections 2241.8 and 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  health coverage.   prescription
drugs. 


	LEGISLATIVE COUNSEL'S DIGEST


   AB 1977, as amended, Wood.  Health   Healing
arts: prescriptions: health  coverage: abuse-deterrent opioid
analgesics. 
   (1) Existing law, the Medical Practice Act, provides for the
licensure and regulation of physicians and surgeons by the Medical
Board of California. A violation of specified provisions of the
Medical Practice Act is a crime.  
   This bill would prohibit a physician and surgeon from prescribing
more than a 5-day supply of an opioid analgesic drug product to a
patient the first time that physician and surgeon prescribes a
patient such an opioid for acute pain due to surgery or injury. The
bill would apply that 5-day supply limitation even if the patient has
previously been prescribed such an opioid from a different physician
and surgeon. Because the violation of those limitation requirements
would be a crime under the Medical Practice Act, the bill would
impose a state-mandated local program.  
   (2) Existing law, the Pharmacy Law, provides for the licensure and
regulation of pharmacists by the California State Board of Pharmacy.
 
   This bill would require a pharmacist to inform a patient receiving
for the first time an opioid analgesic drug product on proper
storage and disposal of the drug. The bill would also require the
California State Board of Pharmacy to adopt regulations to implement
that requirement.  
   Because a knowing violation of these provisions would be a crime,
this bill would impose a state-mandated local program. 
    (3)    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 health care service plans and health
insurers.
   This bill would require an individual or group health care service
plan or disability insurance policy issued, amended, or renewed
after January 1, to provide coverage on its formulary, drug list, or
other lists of similar construct for at least one abuse-deterrent
opioid analgesic drug product per opioid analgesic active ingredient.
The bill would require that the total amount of copayments and
coinsurance an enrollee or insured is required to pay for brand name
abuse-deterrent opioid analgesic drug products covered pursuant to
the bill not exceed the lowest cost-sharing level applied to brand
name or generic prescription drugs covered under the applicable
health care service plan or insurer, as specified. The bill would
prohibit a health care service plan or insurer from requiring an
enrollee or an insured to first use a non-abuse-deterrent opioid
analgesic drug product before providing coverage for an
abuse-deterrent opioid analgesic drug product, subject to uniformly
applied utilization review requirements described in the bill.
   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.
    (4)    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 as follows:
   (a) Abuse and misuse of opioids is a serious problem that affects
the health, social, and economic welfare of the state.
   (b) After alcohol, prescription drugs are the most commonly abused
substances by Americans over 12 years of age.
   (c) Almost 2,000,000 people in the United States suffer from
substance use disorders related to prescription opioid pain
relievers.
   (d) Nonmedical use of prescription opioid pain relievers can be
particularly dangerous when the products are manipulated for
snorting, injection, or combination with other drugs.
   (e) Deaths involving prescription opioid pain relievers represent
the largest proportion of drug overdose deaths, greater than the
number of overdose deaths involving heroin or cocaine.
   (f) The number of unintentional overdose deaths involving
prescription opioid pain relievers has more than quadrupled since
1999.
   SEC. 2.    Section 2241.8 is added to the  
Business and Professions Code   , to read:  
   2241.8.  (a) (1) No physician and surgeon shall prescribe more
than a five-day supply of an opioid analgesic drug product to a
patient the first time that physician and surgeon prescribes a
patient such an opioid for acute pain due to surgery or injury.
   (2) The initial prescription in paragraph (1) may be for a
non-abuse-deterrent opioid analgesic drug product and the five-day
supply limitation shall still apply.
   (3) This subdivision does not apply to an opioid prescription for
a patient in chronic pain.
   (b) Subdivision (a) shall apply even if the patient has previously
been prescribed such an opioid from a different physician and
surgeon.
   (c) For the 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 4069 is added to the  
Business and Professions Code   , to read:  
   4069.  (a) A pharmacist shall inform a patient receiving for the
first time an opioid analgesic drug product on proper storage and
disposal of the drug. The board shall adopt regulations to implement
this section.
   (b) For the 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. 2.   SEC.   4.   Section
1367.217 is added to the Health and Safety Code,  immediately
following Section 1367.215,  to read:
   1367.217.  (a) Notwithstanding any other law, an individual or
group health care service plan issued, amended, or renewed on or
after January 1, that provides coverage for an opioid analgesic drug
product shall comply with all of the following:
   (1) The plan shall provide coverage on its formulary, drug list,
or other lists of similar construct for at least one abuse-deterrent
opioid analgesic drug product per opioid analgesic active ingredient.

   (2) Notwithstanding any deductible, the total amount of copayments
and coinsurance an enrollee is required to pay for brand name
abuse-deterrent opioid analgesic drug products covered pursuant to
this section shall not exceed the lowest cost-sharing level applied
to brand name prescription drugs covered under the applicable health
care service plan.
   (3) Notwithstanding any deductible, the total amount of copayments
and coinsurance an enrollee is required to pay for generic
abuse-deterrent opioid analgesic drug products covered pursuant to
this section shall not exceed the lowest cost-sharing level applied
to generic prescription drugs covered under the applicable health
care service plan.
   (4) The plan shall not require an enrollee to first use a
non-abuse-deterrent opioid analgesic drug product before providing
coverage for an abuse-deterrent opioid analgesic drug product. This
paragraph shall not be construed to prevent a health care service
plan from applying utilization review requirements, including prior
authorization, to abuse-deterrent opioid analgesic drug products,
provided that those requirements are applied to all opioid analgesic
drug products with the same type of drug release, immediate or
extended.  This paragraph shall not be construed to preclude the
use of a non-abuse-deterrent opioid for the initial prescription for
a five   -day supply. 
   (b) The following definitions shall apply for purposes of this
section:
   (1) "Abuse-deterrent opioid analgesic drug product" means a brand
or generic opioid analgesic drug product approved by the federal Food
and Drug Administration (FDA) with abuse-deterrence labeling claims
indicating its abuse-deterrent properties are expected to deter or
reduce its abuse.
   (2) "Cost sharing" means any coverage limit, copayment,
coinsurance, deductible, or other out-of-pocket expense requirement.
   (3) "Opioid analgesic drug product" means a drug product that
contains an opioid agonist and that is indicated by the FDA for the
treatment of pain, whether in an immediate release or extended
release formulation and whether or not the drug product contains any
other drug substance.
   SEC. 3.   SEC. 5.   Section 10123.203 is
added to the Insurance Code, to read:
   10123.203.  (a) Notwithstanding any other law, an insurer issuing,
amending, or renewing a policy of individual or group disability
insurance on or after January 1, that provides coverage for an opioid
analgesic drug product shall comply with all of the following:
   (1) The insurer shall provide coverage on its formulary, drug
list, or other lists of similar construct for at least one
abuse-deterrent opioid analgesic drug product per opioid analgesic
active ingredient.
   (2) Notwithstanding any deductible, the total amount of copayments
and coinsurance an insured is required to pay for brand name
abuse-deterrent opioid analgesic drug products covered pursuant to
this section shall not exceed the lowest cost-sharing level applied
to brand name prescription drugs covered under the applicable policy.

   (3) Notwithstanding any deductible, the total amount of copayments
and coinsurance an insured is required to pay for generic
abuse-deterrent opioid analgesic drug products covered pursuant to
this section shall not exceed the lowest cost-sharing level applied
to generic prescription drugs covered under the applicable policy.
   (4) The insurer shall not require an insured to first use a
non-abuse-deterrent opioid analgesic drug product before providing
coverage for an abuse-deterrent opioid analgesic drug product. This
paragraph shall not be construed to prevent an insurer from applying
utilization review requirements, including prior authorization, to
abuse-deterrent opioid analgesic drug products, provided that those
requirements are applied to all opioid analgesic drug products with
the same type of drug release, immediate or extended.  This
paragraph shall not be construed to preclude the use of a non-abuse
deterrent opioid for the initial prescription for a five  
-day supply. 
   (b) The following definitions shall apply for purposes of this
section:
   (1) "Abuse-deterrent opioid analgesic drug product" means a brand
or generic opioid analgesic drug product approved by the federal Food
and Drug Administration (FDA) with abuse-deterrence labeling claims
indicating its abuse-deterrent properties are expected to deter or
reduce its abuse.
   (2) "Cost sharing" means any coverage limit, copayment,
coinsurance, deductible, or other out-of-pocket expense requirement.
   (3) "Opioid analgesic drug product" means a drug product that
contains an opioid agonist and that is indicated by the FDA for the
treatment of pain, whether in an immediate release or extended
release formulation and whether or not the drug product contains any
other drug substance.
   SEC. 4.   SEC. 6.   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.