Bill Text: CA SB809 | 2013-2014 | Regular Session | Amended

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Controlled substances: reporting.

Spectrum: Partisan Bill (Democrat 7-0)

Status: (Passed) 2013-09-27 - Chaptered by Secretary of State. Chapter 400, Statutes of 2013. [SB809 Detail]

Download: California-2013-SB809-Amended.html

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BILL NUMBER: SB 809	AMENDED
	BILL TEXT

	AMENDED IN SENATE  MAY 1, 2013

INTRODUCED BY   Senators DeSaulnier and Steinberg
   (Coauthors: Senators Hancock, Lieu, Pavley, and Price)
   (Coauthor: Assembly Member Blumenfield)

                        FEBRUARY 22, 2013

   An act to add Section 805.8 to the Business and Professions Code,
to amend Sections 11165 and 11165.1 of the Health and Safety Code,
and to add Part 21 (commencing with Section 42001) to Division 2 of
the Revenue and Taxation Code, relating to controlled substances, and
declaring the urgency thereof, to take effect immediately.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 809, as amended, DeSaulnier. Controlled substances: reporting.
   (1) Existing law classifies certain controlled substances into
designated schedules. Existing law requires the Department of Justice
to maintain the Controlled Substance Utilization Review and
Evaluation System (CURES) for the electronic monitoring of the
prescribing and dispensing of Schedule II, Schedule III, and Schedule
IV controlled substances by all practitioners authorized to
prescribe or dispense these controlled substances.
   Existing law requires dispensing pharmacies and clinics to report,
on a weekly basis, specified information for each prescription of
Schedule II, Schedule III, or Schedule IV controlled substances, to
the department, as specified.
   This bill would establish the CURES Fund within the State Treasury
to receive funds to be allocated, upon appropriation by the
Legislature, to the Department of Justice for the purposes of funding
CURES, and would make related findings and declarations.
   This bill would require the Medical Board of California, the
Dental Board of California, the California State Board of Pharmacy,
the Veterinary Medical Board, the Board of Registered Nursing, the
Physician Assistant Committee of the Medical Board of California, the
Osteopathic Medical Board of California, the State Board of
Optometry, and the California Board of Podiatric Medicine to increase
the licensure, certification, and renewal fees charged to
practitioners under their supervision who are authorized to prescribe
or dispense controlled substances, by up to 1.16%, the proceeds of
which would be deposited into the CURES Fund for support of CURES, as
specified. This bill would also require the California State Board
of Pharmacy to increase the licensure, certification, and renewal
fees charged to wholesalers, nonresident wholesalers, and veterinary
food-animal drug retailers under their supervision by up to 1.16%,
the proceeds of which would be deposited into the CURES Fund for
support of CURES, as specified.
   (2) Existing law permits a licensed health care practitioner, as
specified, or a pharmacist to apply to the Department of Justice to
obtain approval to access information stored on the Internet
regarding the controlled substance history of a patient under his or
her care. Existing law also authorizes the Department of Justice to
provide the history of controlled substances dispensed to an
individual to licensed health care practitioners, pharmacists, or
both, providing care or services to the individual.
   This bill would require licensed health care practitioners, as
specified, and pharmacists to apply to the Department of Justice to
obtain approval to access information stored on the Internet
regarding the controlled substance history of a patient under his or
her care, and, upon the happening of specified events, to access and
consult that information prior to prescribing or dispensing Schedule
II, Schedule III, or Schedule IV controlled substances.
   (3) Existing law imposes various taxes, including taxes on the
privilege of engaging in certain activities. The Fee Collection
Procedures Law, the violation of which is a crime, provides
procedures for the collection of certain fees and surcharges.
   This bill would impose a tax upon qualified manufacturers, as
defined  , for the privilege of doing business in this state,
as specified. This bill would also impose a tax upon specified
insurers, as defined, for the privilege of doing business in this
state, as specified  . The tax would be 
administered by the State Board of Equalization and would be
 collected  by the State Board of Equalization 
pursuant to the procedures set forth in the Fee Collection Procedures
Law. The bill would require the board to deposit all taxes,
penalties, and interest collected pursuant to these provisions in the
CURES Fund, as provided.  This bill would also allow specified
insurers, as defined, to voluntarily contribute to the CURES Fund, as
described.  Because this bill would expand application of the
Fee Collection Procedures Law, the violation of which is a crime, it
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.
   (5) This bill would declare that it is to take effect immediately
as an urgency statute.
   Vote: 2/3. 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 all of the
following:
   (a) The Controlled Substance Utilization Review and Evaluation
System (CURES) is a valuable investigative, preventive, and
educational tool for law enforcement, regulatory boards, educational
researchers, and the health care community. Recent budget cuts to the
Attorney General's Division of Law Enforcement have resulted in
insufficient funding to support the CURES Prescription Drug
Monitoring Program (PDMP). The PDMP is necessary to ensure health
care professionals have the necessary data to make informed treatment
decisions and to allow law enforcement to investigate diversion of
prescription drugs. Without a dedicated funding source, the CURES
PDMP is not sustainable.
   (b) Each year CURES responds to more than 60,000 requests from
practitioners and pharmacists regarding all of the following:
   (1) Helping identify and deter drug abuse and diversion of
prescription drugs through accurate and rapid tracking of Schedule
II, Schedule III, and Schedule IV controlled substances.
   (2) Helping practitioners make better prescribing decisions.
   (3) Helping reduce misuse, abuse, and trafficking of those drugs.
   (c) Schedule II, Schedule III, and Schedule IV controlled
substances have had deleterious effects on private and public
interests, including the misuse, abuse, and trafficking in dangerous
prescription medications resulting in injury and death. It is the
intent of the Legislature to work with stakeholders to fully fund the
operation of CURES which seeks to mitigate those deleterious
effects, and which has proven to be a cost-effective tool to help
reduce the misuse, abuse, and trafficking of those drugs.
  SEC. 2.  Section 805.8 is added to the Business and Professions
Code, to read:
   805.8.  (a) (1) The Medical Board of California, the Dental Board
of California, the California State Board of Pharmacy, the Veterinary
Medical Board, the Board of Registered Nursing, the Physician
Assistant Committee of the Medical Board of California, the
Osteopathic Medical Board of California, the State Board of
Optometry, and the California Board of Podiatric Medicine shall
increase the licensure, certification, and renewal fees charged to
practitioners under their supervision who are authorized pursuant to
Section 11150 of the Health and Safety Code to prescribe or dispense
Schedule II, Schedule III, or Schedule IV controlled substances by up
to 1.16 percent annually, but in no case shall the fee increase
exceed the reasonable costs associated with maintaining CURES for the
purpose of regulating prescribers and dispensers of controlled
substances licensed or certificated by these boards.
   (2) The California State Board of Pharmacy shall increase the
licensure, certification, and renewal fees charged to wholesalers and
nonresident wholesalers of dangerous drugs, licensed pursuant to
Article 11 (commencing with Section 4160) of Chapter 9, by up to 1.16
percent annually, but in no case shall the fee increase exceed the
reasonable costs associated with maintaining CURES for the purpose of
regulating wholesalers and nonresident wholesalers of dangerous
drugs licensed or certificated by that board.
   (3) The California State Board of Pharmacy shall increase the
licensure, certification, and renewal fees charged to veterinary
food-animal drug retailers, licensed pursuant to Article 15
(commencing with Section 4196) of Chapter 9, by up to 1.16 percent
annually, but in no case shall the fee increase exceed the reasonable
costs associated with maintaining CURES for the purpose of
regulating veterinary food-animal drug retailers licensed or
certificated by that board.
   (b) The funds collected pursuant to subdivision (a) shall be
deposited in the CURES accounts, which are hereby created, within the
Contingent Fund of the Medical Board of California, the State
Dentistry Fund, the Pharmacy Board Contingent Fund, the Veterinary
Medical Board Contingent Fund, the Board of Registered Nursing Fund,
the Osteopathic Medical Board of California Contingent Fund, the
Optometry Fund, and the Board of Podiatric Medicine Fund. Moneys in
the CURES accounts of each of those funds shall, upon appropriation
by the Legislature, be available to the Department of Justice solely
for maintaining CURES for the purposes of regulating prescribers and
dispensers of controlled substances. All moneys received by the
Department of Justice pursuant to this section shall be deposited in
the CURES Fund described in Section 11165 of the Health and Safety
Code.
  SEC. 3.  Section 11165 of the Health and Safety Code is amended to
read:
   11165.  (a) To assist law enforcement and regulatory agencies in
their efforts to control the diversion and resultant abuse of
Schedule II, Schedule III, and Schedule IV controlled substances, and
for statistical analysis, education, and research, the Department of
Justice shall, contingent upon the availability of adequate funds in
the CURES accounts within the Contingent Fund of the Medical Board
of California, the Pharmacy Board Contingent Fund, the State
Dentistry Fund, the Board of Registered Nursing Fund, the Osteopathic
Medical Board of California Contingent Fund, the Veterinary Medical
Board Contingent Fund, the Optometry Fund, the Board of Podiatric
Medicine Fund, and the CURES Fund, maintain the Controlled Substance
Utilization Review and Evaluation System (CURES) for the electronic
monitoring of, and Internet access to information regarding, the
prescribing and dispensing of Schedule II, Schedule III, and Schedule
IV controlled substances by all practitioners authorized to
prescribe or dispense these controlled substances.
   (b) The reporting of Schedule III and Schedule IV controlled
substance prescriptions to CURES shall be contingent upon the
availability of adequate funds for the Department of Justice for the
purpose of finding CURES. The department may seek and use grant funds
to pay the costs incurred from the reporting of controlled substance
prescriptions to CURES. The department shall make information about
the amount and the source of all private grant funds it receives for
support of CURES available to the public. Grant funds shall not be
appropriated from the Contingent Fund of the Medical Board of
California, the Pharmacy Board Contingent Fund, the State Dentistry
Fund, the Board of Registered Nursing Fund, the Naturopathic Doctor's
Fund, or the Osteopathic Medical Board of California Contingent Fund
to pay the costs of reporting Schedule III and Schedule IV
controlled substance prescriptions to CURES.
   (c) CURES shall operate under existing provisions of law to
safeguard the privacy and confidentiality of patients. Data obtained
from CURES shall only be provided to appropriate state, local, and
federal persons or public agencies for disciplinary, civil, or
criminal purposes and to other agencies or entities, as determined by
the Department of Justice, for the purpose of educating
practitioners and others in lieu of disciplinary, civil, or criminal
actions. Data may be provided to public or private entities, as
approved by the Department of Justice, for educational, peer review,
statistical, or research purposes, provided that patient information,
including any information that may identify the patient, is not
compromised. Further, data disclosed to any individual or agency, as
described in this subdivision, shall not be disclosed, sold, or
transferred to any third party.
   (d) For each prescription for a Schedule II, Schedule III, or
Schedule IV controlled substance, as defined in the controlled
substances schedules in federal law and regulations, specifically
Sections 1308.12, 1308.13, and 1308.14, respectively, of Title 21 of
the Code of Federal Regulations, the dispensing pharmacy or clinic
shall provide the following information to the Department of Justice
on a weekly basis and in a format specified by the Department of
Justice:
   (1) Full name, address, and telephone number of the ultimate user
or research subject, or contact information as determined by the
Secretary of the United States Department of Health and Human
Services, and the gender, and date of birth of the ultimate user.
   (2) The prescriber's category of licensure and license number, the
federal controlled substance registration number, and the state
medical license number of any prescriber using the federal controlled
substance registration number of a government-exempt facility.
   (3) Pharmacy prescription number, license number, and federal
controlled substance registration number.
   (4) National Drug Code (NDC) number of the controlled substance
dispensed.
   (5) Quantity of the controlled substance dispensed.
   (6) International Statistical Classification of Diseases, 9th
revision (ICD-9) Code, if available.
   (7) Number of refills ordered.
   (8) Whether the drug was dispensed as a refill of a prescription
or as a first-time request.
   (9) Date of origin of the prescription.
   (10) Date of dispensing of the prescription.
   (e) The CURES Fund is hereby established within the State
Treasury. The CURES Fund shall consist of all funds made available to
the Department of Justice for the purpose of funding CURES. Money in
the CURES Fund shall, upon appropriation by the Legislature, be
available for allocation to the Department of Justice for the purpose
of funding CURES.
  SEC. 4.  Section 11165.1 of the Health and Safety Code is amended
to read:
   11165.1.  (a) (1) A licensed health care practitioner eligible to
prescribe Schedule II, Schedule III, or Schedule IV controlled
substances or a pharmacist shall provide a notarized application
developed by the Department of Justice to obtain approval to access
information stored on the Internet regarding the controlled substance
history of a patient maintained within the Department of Justice,
and, upon approval, the department shall release to that practitioner
or pharmacist, the electronic history of controlled substances
dispensed to an individual under his or her care based on data
contained in the CURES Prescription Drug Monitoring Program (PDMP).
   (A) An application may be denied, or a subscriber may be
suspended, for reasons which include, but are not limited to, the
following:
   (i) Materially falsifying an application for a subscriber.
   (ii) Failure to maintain effective controls for access to the
patient activity report.
   (iii) Suspended or revoked federal Drug Enforcement Administration
(DEA) registration.
   (iv) Any subscriber who is arrested for a violation of law
governing controlled substances or any other law for which the
possession or use of a controlled substance is an element of the
crime.
   (v) Any subscriber accessing information for any other reason than
caring for his or her patients.
   (B) Any authorized subscriber shall notify the Department of
Justice within 10 days of any changes to the subscriber account.
   (2) To allow sufficient time for licensed health care
practitioners eligible to prescribe Schedule II, Schedule III, or
Schedule IV controlled substances and a pharmacist to apply and
receive access to PDMP, a written request may be made, until July 1,
2012, and the Department of Justice may release to that practitioner
or pharmacist the history of controlled substances dispensed to an
individual under his or her care based on data contained in CURES.
   (b) Any request for, or release of, a controlled substance history
pursuant to this section shall be made in accordance with guidelines
developed by the Department of Justice.
   (c) (1) Until the Department of Justice has issued the
notification described in paragraph (3), in order to prevent the
inappropriate, improper, or illegal use of Schedule II, Schedule III,
or Schedule IV controlled substances, the Department of Justice may
initiate the referral of the history of controlled substances
dispensed to an individual based on data contained in CURES to
licensed health care practitioners, pharmacists, or both, providing
care or services to the individual.
   (2) Upon the Department of Justice issuing the notification
described in paragraph (3) and approval of the application required
pursuant to subdivision (a), licensed health care practitioners
eligible to prescribe Schedule II, Schedule III, or Schedule IV
controlled substances and pharmacists shall access and consult the
electronic history of controlled substances dispensed to an
individual under his or her care prior to prescribing or dispensing a
Schedule II, Schedule III, or Schedule IV controlled substance.
   (3) The Department of Justice shall notify licensed health care
practitioners and pharmacists who have submitted the application
required pursuant to subdivision (a) when the department determines
that CURES is capable of accommodating the mandate contained in
paragraph (2). The department shall provide a copy of the
notification to the Secretary of the State, the Secretary of the
Senate, the Chief Clerk of the Assembly, and the Legislative Counsel,
and shall post the notification on the department's Internet Web
site.
   (d) The history of controlled substances dispensed to an
individual based on data contained in CURES that is received by a
practitioner or pharmacist from the Department of Justice pursuant to
this section shall be considered medical information subject to the
provisions of the Confidentiality of Medical Information Act
contained in Part 2.6 (commencing with Section 56) of Division 1 of
the Civil Code.
   (e) Information concerning a patient's controlled substance
history provided to a prescriber or pharmacist pursuant to this
section shall include prescriptions for controlled substances listed
in Sections 1308.12, 1308.13, and 1308.14 of Title 21 of the Code of
Federal Regulations.
  SEC. 5.  Part 21 (commencing with Section 42001) is added to
Division 2 of the Revenue and Taxation Code, to read:

      PART 21.  Controlled Substance Utilization Review and
Evaluation System (CURES) Tax Law


   42001.  For purposes of this part, the following definitions
apply:
   (a) "Controlled substance" means a drug, substance, or immediate
precursor listed in any schedule in Section 11055, 11056, or 11057 of
the Health and Safety Code.
   (b) "Insurer" means  a health insurer licensed pursuant to
Part 2 (commencing with Section 10110) of Division 2 of the
Insurance Code, a health care service plan licensed pursuant to the
Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2
(commencing with Section 1340) of Division 2 of the Health and Safety
Code), and a workers' compensation insurer licensed pursuant to Part
3 (commencing with Section 11550) of Division 2   an
admitted insurer writing health insurance, as defined in Section 106
of the Insurance Code, and an admitted insurer writing workers'
compensation insurance, as defined in Section 109  of the
Insurance Code.
   (c) "Qualified manufacturer" means a manufacturer of a controlled
substance  doing business in this state, as defined in
Section 23101  , but does not mean a wholesaler or
nonresident wholesaler of dangerous drugs, regulated pursuant to
Article 11 (commencing with Section 4160) of Chapter 9 of Division 2
of the Business and Professions Code, a veterinary food-animal drug
retailer, regulated pursuant to Article 15 (commencing with Section
4196) of Chapter 9 of Division 2 of the Business and Professions
Code, or an individual regulated by the Medical Board of California,
the Dental Board of California, the California State Board of
Pharmacy, the Veterinary Medical Board, the Board of Registered
Nursing, the Physician Assistant Committee of the Medical Board of
California, the Osteopathic Medical Board of California, the State
Board of Optometry, or the California Board of Podiatric Medicine.
   42003.  (a) For the privilege of doing business in this state, an
annual tax is hereby imposed on all qualified manufacturers in an
amount  of ____ dollars ($____)   determined
pursuant to Section 42005  , for the purpose of establishing and
maintaining enforcement of the Controlled Substance Utilization
Review and Evaluation System (CURES), established pursuant to Section
11165 of the Health and Safety Code. 
   (b) For the privilege of doing business in this state, a tax is
hereby imposed on a one time basis on all insurers in an amount of
____ dollars ($____), for the purpose of upgrading CURES. 

   (b) The Department of Justice may seek grant moneys from insurers
for the purpose of upgrading and modernizing the CURES. Insurers may
contribute by submitting their payment to the Controller for deposit
into the CURES Fund established pursuant to subdivision (e) of
Section 11165 of the Health and Safety Code. The department shall
make information about the amount and the source of all private grant
funds it receives for support of CURES available to the public.
 
   42005.  Each qualified manufacturer and insurer shall prepare and
file with the board a return, in the form prescribed by the board,
containing information as the board deems necessary or appropriate
for the proper administration of this part. The return shall be filed
on or before the last day of the calendar month following the
calendar quarter to which it relates, together with a remittance
payable to the board for the amount of tax due for that period.
 
   42007.  The board shall administer and collect the tax imposed by
this part pursuant to the Fee Collection Procedures Law (Part 30
(commencing with Section 55001)). For purposes of this part, the
references in the Fee Collection Procedures Law (Part 30 (commencing
with Section 55001)) to "fee" shall include the tax imposed by this
part and references to "feepayer" shall include a person required to
pay the tax imposed by this part.  
   42005.  (a) The board shall collect the annual tax imposed by this
part pursuant to the Fee Collection Procedures Law (Part 30
(commencing with Section 55001)). For purposes of this part, a
reference in the Fee Collection Procedures Law to a "fee" shall
include this tax and a reference to a "feepayer" shall include a
person liable for the payment for the taxes collected pursuant to
that law.
   (b) (1) The board shall not accept or consider a petition for
redetermination that is based on the assertion that a determination
by the Department of Justice incorrectly determined that a qualified
manufacturer is subject to the tax or that a determination by the
Department of Justice improperly or erroneously calculated the amount
of that tax. The board shall forward to the Department of Justice
any appeal of a determination that asserts that a determination by
the Department of Justice incorrectly determined that a qualified
manufacturer is subject to the tax or that a determination by the
Department of Justice improperly or erroneously calculated the amount
of that tax.
   (2) The board shall not accept or consider a claim for refund that
is based on the assertion that a determination by the Department of
Justice improperly or erroneously calculated the amount of a tax, or
incorrectly determined that the qualified manufacturer is subject to
the tax. The board shall forward to the Department of Justice any
claim for refund that asserts that a determination by the Department
of Justice incorrectly determined that a qualified manufacturer is
subject to the tax or that a determination by the Department of
Justice improperly or erroneously calculated the amount of that tax.
 
   42007.  (a) The Department of Justice shall determine the annual
tax by dividing the cost to establish and maintain enforcement of
CURES by the number of qualified manufacturers. For calendar year
2014, the CURES cost shall be four million two hundred thousand
dollars ($4,200,000). Beginning with the 2015 calendar year, and for
each calendar year thereafter, the Department of Justice shall adjust
the rate annually to reflect increases or decreases in the cost of
living during the prior fiscal year, as measured by the California
Consumer Price Index for all items.
   (b) The Department of Justice shall provide to the board the name
and address of each qualified manufacturer that is liable for the
annual tax, the amount of tax, and the due date.
   (c) All annual taxes referred to the board for collection pursuant
to Section 42005 shall be paid to the board. 
   42009.  All taxes, interest, penalties, and other amounts
collected pursuant to this part, less refunds and costs of
administration, shall be deposited into the CURES Fund.
   42011.  The board shall prescribe, adopt, and enforce rules and
regulations relating to the administration and enforcement of this
part.
  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. 7.  This act is an urgency statute necessary for the immediate
preservation of the public peace, health, or safety within the
meaning of Article IV of the Constitution and shall go into immediate
effect. The facts constituting the necessity are:
   In order to protect the public from the continuing threat of
prescription drug abuse at the earliest possible time, it is
necessary this act take effect immediately.