BILL NUMBER: AB 1977	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  APRIL 13, 2016
	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   add
and repeal Division 10.10 (commencing with Section 11999.30) 
 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 1977, as amended, Wood.  Healing arts: prescriptions:
health coverage: abuse-deterrent opioid analgesics.  
Opioid Abuse Task Force.  
   (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 
    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.   require health care service
plans and health insurers representatives, in collaboration with
certain entities, to convene an Opioid Abuse Task Force on or before
February 1, 2017, for the purpose of developing recommendations
regarding the abuse and misuse of opioids, as specified. The bill
would require the task force to submit a report detailing its
findings and recommendations to specified government entities on or
before December 31, 2017. The bill would require the task force to be
dissolved on June 1, 2018. The bill would provide that a violation
of these provisions by a health care service plan does not constitute
a crime under the Knox-Keene Health   Care Service Plan Act
of 1975. The bill would make related legislative findings and
declarations.  
   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
  no  . State-mandated local program:  yes
  no  .


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. 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. 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. 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. 
   SEC. 2.    Division 10.10 (commencing with Section
11999.30) is added to the   Health and Safety Code 
 , to read:  

      DIVISION 10.10.  Opioid Abuse Task Force


   11999.30.  (a) On or before February 1, 2017, health care service
plans and health insurer representatives, in collaboration with
advocates, experts, health care professionals, and other entities and
stakeholders that they deem appropriate, shall convene an Opioid
Abuse Task Force. The task force shall develop recommendations
regarding the abuse and misuse of opioids as a serious problem that
affects the health, social welfare, and economic welfare of persons
in the state. The task force shall address all of the following:
   (1) Interventions that have been scientifically validated and have
demonstrated clinical efficacy.
   (2) Interventions that have measurable treatment outcomes.
   (3) Collaborative, evidence-based approaches to resolving opioid
abuse and misuse that incorporate both the provider and the patient
into the solution.
   (4) 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.
   (5) Review and consideration of medication coverage policies and
formulary management and development of an interdisciplinary case
management program that addresses quality, fraud, waste, and abuse.
   (b) On or before December 31, 2017, the task force shall submit a
report detailing its findings and recommendations to the Governor,
the President pro Tempore of the Senate, the Speaker of the Assembly,
the Senate Committee on Health, and the Assembly Committee on
Health.
   (c) The task force shall be dissolved and shall cease to exist on
June 1, 2018.
   (d) A violation of this section is not subject to Section 1390.
   11999.31.  This division shall remain in effect only until January
1, 2019, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2019, deletes or extends
that date.