BILL NUMBER: SB 809 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY SEPTEMBER 3, 2013
AMENDED IN ASSEMBLY AUGUST 5, 2013
AMENDED IN ASSEMBLY JUNE 26, 2013
AMENDED IN SENATE MAY 28, 2013
AMENDED IN SENATE MAY 24, 2013
AMENDED IN SENATE MAY 14, 2013
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 Sections 208, 209, and 2196.8 to the Business and
Professions Code, and to amend Sections 11164.1, 11165, and 11165.1
of, and to add Section 11165.4 11165.5
to, the Health and Safety Code, relating to controlled substances.
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 would, beginning April 1,
2014, require an annual fee of $6 to be assessed on specified
licensees, including licensees authorized to prescribe, order,
administer, furnish, or dispense controlled substances, and require
the regulating agency of each of those licensees to bill and collect
that fee at the time of license renewal. The bill would authorize the
Department of Consumer Affairs to reduce, by regulation, that fee to
the reasonable cost of operating and maintaining CURES for the
purpose of regulating those licensees, if the reasonable regulatory
cost is less than $6 per licensee. The bill would require the
proceeds of the fee to be deposited into the CURES Fund for the
support of CURES, as specified. The bill would also permit specified
insurers, health care service plans, qualified manufacturers, and
other donors to voluntarily contribute to the CURES Fund, as
described.
(2) Existing law requires the Medical Board of California to
periodically develop and disseminate information and educational
materials regarding various subjects, including pain management
techniques, to each licensed physician and surgeon and to each
general acute care hospital in California.
This bill would additionally require the board to periodically
develop and disseminate to each licensed physician and surgeon and to
each general acute care hospital in California information and
educational materials relating to the assessment of a patient's risk
of abusing or diverting controlled substances and information
relating to CURES.
(3) 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, by January 1, 2016, or upon receipt of a
federal Drug Enforcement Administration registration, whichever
occurs later, health care practitioners authorized to prescribe,
order, administer, furnish, or dispense controlled substances, 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 their
care. The bill would require the Department of Justice, in
conjunction with the Department of Consumer Affairs and certain
licensing boards, to, among other things, develop a streamlined
application and approval process to provide access to the CURES
database for licensed health care practitioners and pharmacists. The
bill would make other related and conforming changes.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
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 preventive, investigative, and
educational tool for health care providers, regulatory agencies,
educational researchers, and law enforcement. Recent budget cuts to
the Attorney General's Division of Law Enforcement have resulted in
insufficient funding to support CURES and its Prescription Drug
Monitoring Program (PDMP). The CURES 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 800,000 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 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 serve as a tool for ensuring safe patient care, and which has
proven to be a cost-effective tool to help reduce the misuse, abuse,
and trafficking of those drugs.
(d) The following goals are critical to increase the effectiveness
and functionality of CURES:
(1) Upgrading the CURES PDMP so that it is capable of accepting
real-time updates and is accessible in real-time, 24 hours a day,
seven days a week.
(2) Upgrading the CURES PDMP in California so that it is capable
of operating in conjunction with all national prescription drug
monitoring programs.
(3) Providing subscribers to prescription drug monitoring programs
access to information relating to controlled substances dispensed in
California, including those dispensed through the United States
Department of Veterans Affairs, the Indian Health Service, the
Department of Defense, and any other entity with authority to
dispense controlled substances in California.
(4) Upgrading the CURES PDMP so that it is capable of accepting
the reporting of electronic prescription data, thereby enabling more
reliable, complete, and timely prescription monitoring.
SEC. 2. Section 208 is added to the Business and Professions Code,
to read:
208. (a) A Beginning April 1, 2014, a
CURES fee of six dollars ($6) shall be assessed annually on
each of the licensees specified in subdivision (b) to pay the
reasonable costs associated with operating and maintaining CURES for
the purpose of regulating those licensees. The fee assessed pursuant
to this subdivision shall be billed and collected by the regulating
agency of each licensee at the time of the licensee's license
renewal. If the reasonable regulatory cost of operating and
maintaining CURES is less than six dollars ($6) per licensee, the
Department of Consumer Affairs may, by regulation, reduce the fee
established by this section to the reasonable regulatory cost.
(b) (1) Licensees authorized pursuant to Section 11150 of the
Health and Safety Code to prescribe, order, administer, furnish, or
dispense Schedule II, Schedule III, or Schedule IV controlled
substances or pharmacists licensed pursuant to Chapter 9 (commencing
with Section 4000) of Division 2.
(2) Wholesalers and nonresident wholesalers of dangerous drugs
licensed pursuant to Article 11 (commencing with Section 4160) of
Chapter 9 of Division 2.
(3) Nongovernmental clinics licensed pursuant to Article 13
(commencing with Section 4180) and Article 14 (commencing with
Section 4190) of Chapter 9 of Division 2.
(4) Nongovernmental pharmacies licensed pursuant to Article 7
(commencing with Section 4110) of Chapter 9 of Division 2.
(c) The funds collected pursuant to subdivision (a) shall be
deposited in the CURES Fund, which is hereby created within the State
Treasury. Moneys in the CURES Fund shall, upon appropriation by the
Legislature, be available to the Department of Consumer Affairs to
reimburse the Department of Justice for costs to operate and maintain
CURES for the purposes of regulating the licensees specified in
subdivision (b).
(d) The Department of Consumer Affairs shall contract with the
Department of Justice on behalf of 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 Board of the Medical Board of
California, the Osteopathic Medical Board of California, the
Naturopathic Medicine Committee of the Osteopathic Medical Board, the
State Board of Optometry, and the California Board of Podiatric
Medicine to operate and maintain CURES for the purposes of regulating
the licensees specified in subdivision (b).
SEC. 3. Section 209 is added to the Business and Professions Code,
to read:
209. The Department of Justice, in conjunction with the
Department of Consumer Affairs and the boards and committees
identified in subdivision (d) of Section 208, shall do all of the
following:
(a) Identify and implement a streamlined application and approval
process to provide access to the CURES Prescription Drug Monitoring
Program (PDMP) database for licensed health care practitioners
eligible to prescribe prescribe, order,
administer, furnish, or dispense Schedule II, Schedule III, or
Schedule IV controlled substances and for pharmacists. Every
reasonable effort shall be made to implement a streamlined
application and approval process that a licensed health care
practitioner or pharmacist can complete at the time that he or she is
applying for licensure or renewing his or her license.
(b) Identify necessary procedures to enable licensed health care
practitioners and pharmacists with access to the CURES PDMP to
delegate their authority to order reports from the CURES PDMP.
(c) Develop a procedure to enable health care practitioners who do
not have a federal Drug Enforcement Administration (DEA) number to
opt out of applying for access to the CURES PDMP.
SEC. 4. Section 2196.8 is added to the Business and Professions
Code, to read:
2196.8. The board shall periodically develop and disseminate
information and educational material regarding assessing a patient's
risk of abusing or diverting controlled substances and information
relating to the Controlled Substance Utilization Review and
Evaluation System (CURES), described in Section 11165 of the Health
and Safety Code, to each licensed physician and surgeon and to each
general acute care hospital in this state. The board shall consult
with the State Department of Public Health, the boards and committees
specified in subdivision (d) of Section 208, and the Department of
Justice in developing the materials to be distributed pursuant to
this section.
SEC. 5. Section 11164.1 of the Health and Safety Code is amended
to read:
11164.1. (a) (1) Notwithstanding any other
provision of law, a prescription for a controlled substance issued by
a prescriber in another state for delivery to a patient in another
state may be dispensed by a California pharmacy, if the prescription
conforms with the requirements for controlled substance prescriptions
in the state in which the controlled substance was prescribed.
(b)
( 2) All prescriptions for Schedule II,
Schedule III, and Schedule IV controlled substances dispensed
pursuant to this subdivision shall be reported by the dispensing
pharmacy to the Department of Justice in the manner prescribed by
subdivision (d) of Section 11165.
(b) Pharmacies may dispense prescriptions for Schedule III,
Schedule IV, and Schedule V controlled substances from out-of-state
prescribers pursuant to Section 4005 of the Business and Professions
Code and Section 1717 of Title 16 of the California Code of
Regulations.
SEC. 6. Section 11165 of the Health and Safety Code is amended to
read:
11165. (a) To assist health care practitioners in their efforts
to ensure appropriate prescribing, ordering, administering,
furnishing, and dispensing of controlled substances, 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 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, order, administer, furnish, or dispense
these controlled substances.
(b) The Department of Justice may seek and use grant funds to pay
the costs incurred by the operation and maintenance of CURES. The
department shall annually report to the Legislature and make
available to the public the amount and source of funds it receives
for support of CURES.
(c) (1) The operation of CURES shall comply with all applicable
federal and state privacy and security laws and regulations.
(2) 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 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. The Department of Justice shall establish policies,
procedures, and regulations regarding the use, access, evaluation,
management, implementation, operation, storage, disclosure, and
security of the information within CURES, consistent with this
subdivision.
(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, clinic, or
other dispenser shall report the following information to the
Department of Justice as soon as reasonably possible, but not more
than seven days after the date a controlled substance is dispensed,
in a format specified by the Department of Justice:
(1) Full name, address, and and, if
available, 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, license number,
national provider identifier (NPI) number, if applicable,
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, NPI 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) or 10th revision (ICD-10) 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 Department of Justice may invite stakeholders to assist,
advise, and make recommendations on the establishment of rules and
regulations necessary to ensure the proper administration and
enforcement of the CURES database. All prescriber and dispenser
invitees shall be licensed by one of the boards or committees
identified in subdivision (d) of Section 208 of the Business and
Professions Code, in active practice in California, and a regular
user of CURES.
(f) The Department of Justice shall, prior to upgrading CURES,
consult with prescribers licensed by one of the boards or committees
identified in subdivision (d) of Section 208 of the Business and
Professions Code, one or more of the boards or committees identified
in subdivision (d) of Section 208 of the Business and Professions
Code, and any other stakeholder identified by the department, for the
purpose of identifying desirable capabilities and upgrades to the
CURES Prescription Drug Monitoring Program (PDMP).
(g) The Department of Justice may establish a process to educate
authorized subscribers of the CURES PDMP on how to access and use the
CURES PDMP.
SEC. 7. Section 11165.1 of the Health and Safety Code is amended
to read:
11165.1. (a) (1) (A) (i)
A health care practitioner authorized to prescribe, order,
administer, furnish, or dispense Schedule II, Schedule III, or
Schedule IV controlled substances pursuant to Section 11150
or a pharmacist shall, before January 1, 2016, or upon
receipt of a federal Drug Enforcement Administration (DEA)
registration, whichever occurs later, submit an application developed
by the Department of Justice to obtain approval to access
information online regarding the controlled substance history of a
patient that is stored on the Internet and 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).
(ii) A pharmacist shall, before January 1, 2016, or upon
licensure, whichever occurs later, submit an application developed by
the Department of Justice to obtain approval to access information
online regarding the controlled substance history of a patient that
is stored on the Internet and maintained within the Department of
Justice, and, upon approval, the department shall release to that
pharmacist the electronic history of controlled substances dispensed
to an individual under his or her care based on data contained in the
CURES PDMP.
(A)
(B) 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 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)
(C) Any authorized subscriber shall notify the
Department of Justice within 30 days of any changes to the subscriber
account.
(2) A health care practitioner authorized to prescribe
prescribe, order, administer, furnish, or dispense
Schedule II, Schedule III, or Schedule IV controlled substances
pursuant to Section 11150 or a pharmacist shall be deemed to have
complied with paragraph (1) if the licensed health care practitioner
or pharmacist has been approved to access the CURES database through
the process developed pursuant to subdivision (a) of Section 209 of
the Business and Professions Code.
(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) 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.
(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. 8. Section 11165.4 11165.5 is
added to the Health and Safety Code, to read:
11165.4. 11165.5. (a) The
Department of Justice may seek voluntarily contributed private funds
from insurers, health care service plans, qualified manufacturers,
and other donors for the purpose of supporting CURES. Insurers,
health care service plans, qualified manufacturers, and other donors
may contribute by submitting their payment to the Controller for
deposit into the CURES Fund established pursuant to subdivision (c)
of Section 208 of the Business and Professions Code. The department
shall make information about the amount and the source of all private
funds it receives for support of CURES available to the public.
Contributions to the CURES Fund pursuant to this subdivision shall be
nondeductible for state tax purposes.
(b) For purposes of this section, the following definitions apply:
(1) "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.
(2) "Health care service plan" means an entity 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).
(3) "Insurer" means 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.
(4) "Qualified manufacturer" means a manufacturer of a controlled
substance, 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.